[Senate Hearing 110-100]
[From the U.S. Government Publishing Office]
S. Hrg. 110-100
THE NEED FOR FDA REGULATION OF TOBACCO
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
ON
EXAMINING S. 625, TO PROTECT THE PUBLIC HEALTH BY PROVIDING THE FOOD
AND DRUG ADMINISTRATION WITH CERTAIN AUTHORITY TO REGULATE TOBACCO
PRODUCTS
__________
FEBRUARY 27, 2007
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
senate
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut MICHAEL B. ENZI, Wyoming,
TOM HARKIN, Iowa JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico RICHARD BURR, North Carolina
PATTY MURRAY, Washington JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island LISA MURKOWSKI, Alaska
HILLARY RODHAM CLINTON, New York ORRIN G. HATCH, Utah
BARACK OBAMA, Illinois PAT ROBERTS, Kansas
BERNARD SANDERS (I), Vermont WAYNE ALLARD, Colorado
SHERROD BROWN, Ohio TOM COBURN, M.D., Oklahoma
J. Michael Myers, Staff Director and Chief Counsel
Katherine Brunett McGuire, Minority Staff Director
(ii)
C O N T E N T S
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STATEMENTS
TUESDAY, FEBRUARY 27, 2007
Page
Kennedy, Hon. Edward M., Chairman, Committee on Health,
Education, Labor, and Pensions, opening statement.............. 1
Prepared statement........................................... 3
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming,
opening statement.............................................. 6
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio,
opening statement.............................................. 8
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina, opening statement.................................... 9
Myers, Matthew L., President and CEO, Campaign for Tobacco-Free
Kids, Washington, DC........................................... 11
Prepared statement........................................... 13
Huerta, M.D., M.P.H., Elmer, President, American Cancer Society,
Washington, DC................................................. 19
Prepared statement........................................... 21
Land, D.Phil., Richard, President, The Ethics and Religious
Liberty Commission of the Southern Baptist Convention,
Nashville, TN.................................................. 24
Prepared statement........................................... 26
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah,
opening statement.............................................. 31
Henningfield, Ph.D., Jack, Vice President, Research and Health
Policy, Pinney and Associates, Bethesda, MD, and Professor of
Behavioral Biology at Johns Hopkins University School of
Medicine, Baltimore, MD........................................ 33
Prepared statement........................................... 34
Connolly, D.M.D., M.P.H., Gregory, Professor, Harvard School of
Public Health, Former Director of the Massachusetts Department
of Public Health's Tobacco Control Program, Boston, MA......... 41
Prepared statement........................................... 44
Blum, M.D., Alan, Director, University of Alabama Center for the
Study of Tobacco and Society, Tuscaloosa, AL................... 56
Prepared statement........................................... 57
Shames, Lisa, Acting Director, Natural Resources and Environment
Team, Government Accountability Office, Washington, DC......... 61
Prepared statement........................................... 63
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Clinton, Hon. Hillary Rodham, a U.S. Senator from the State
of New York, prepared statement............................ 93
Statements and letters of support:
Matthew L. Myers......................................... 94
John Kirkwood, President and CEO, American Lung
Association, New York, NY.............................. 95
Ron Davis, M.D., President-Elect, American Medical
Association, Washington, DC............................ 95
(iii)
American Medical Association, Washington, DC............. 96
John R. Seffrin, Ph.D., CEO, American Cancer Society
Cancer Action NetworkSM, Washington, DC..... 98
American Dental Association, Chicago, IL................. 100
Partners for Effective Tobacco Policy (PARTNERS),
Washington, DC......................................... 101
Raymond J. Gibbons, M.D., FAHA, President, Andrew B.
Buroker, Esq., Chairman, American Heart Association and
American Stroke Association, Washington, DC............ 102
John A. Strodsnider, D.O., President, American
Osteopathic Association, Washington, DC................ 102
Faith United Against Tobacco, Washington, DC............. 103
Jay E. Berkelhamer, M.D., FAAP, President, American
Academy of Pediatrics, Washington, DC.................. 104
David A. Kessler, M.D., University of California San
Francisco (UCSF), San Francisco, CA.................... 105
Mike Szymanczyk, Chairman and CEO, Philip Morris USA,
Richmond, VA........................................... 105
Statements and letter of opposition:
Henry O. Armour, President and CEO, National Association
of Convenience Stores (NACS), Alexandria, VA........... 110
Laurie Comstock, Private Citizen, Elk Grove, CA.......... 113
K.H. Ginzel, M.D., Professor Emeritus of Pharmacology and
Toxicology, University of Arkansas for Medical
Sciences, Westhampton, MA.............................. 114
Stephen L. Hansen, M.D................................... 126
Michael S. Givel, Ph.D., Professor of Political Science,
University of Oklahoma, Norman, OK..................... 126
William T. Godshall, M.P.H., Executive Director,
Smokefree Pennsylvania, Pittsburgh, PA................. 128
Anne Landman, Tobacco Document Research and Consulting,
Glade Park, CO......................................... 157
John R. Polito, Esq., Editor, WhyQuit, Mount Pleasant, SC 160
Vicki Voldal Rosenau, Barnes County Tobacco-Free Network,
Valley City, ND........................................ 162
Michael Siegel, M.D., M.P.H., Professor, Social and
Behavioral Sciences Department, Boston University
School of Public Health, Boston, MA.................... 162
Elizabeth Whelan, M.P.H., Sc.D., Gilbert L. Ross, M.D.,
and Jeff Stier, Esq., The American Council on Science
and Health (ACSH), New York, NY........................ 174
Joel L. Nitzkin, M.D., M.P.H., DPA, Chairman, American
Association of Public Health Physicians (AAPHP) Tobacco
Control Task Force, Rolling Meadows, IL................ 175
Response by Matthew L. Myers to questions of:
Senator Kennedy.......................................... 177
Senator Enzi............................................. 190
Senator Burr............................................. 192
Senator Hatch............................................ 192
Senator Coburn........................................... 195
Response by Elmer Huerta, M.D., M.P.H. to questions of:
Senator Enzi............................................. 199
Senator Burr............................................. 200
Senator Hatch............................................ 200
Senator Coburn........................................... 201
Response by Richard Land, D.Phil. to questions of:
Senator Enzi............................................. 202
Senator Burr............................................. 204
Senator Hatch............................................ 204
Senator Coburn........................................... 205
Response by Jack Henningfield, Ph.D. to questions of:
Senator Kennedy.......................................... 205
Senator Enzi............................................. 208
Senator Burr............................................. 209
Senator Hatch............................................ 210
Senator Coburn........................................... 212
Response by Gregory Connolly, D.M.D., M.P.H. to questions of:
Senator Kennedy.......................................... 212
Senator Enzi............................................. 213
Senator Burr............................................. 214
Senator Hatch............................................ 214
Senator Coburn........................................... 215
Response by Lisa Shames to questions of:
Senator Enzi............................................. 216
Senator Hatch............................................ 217
Response by Alan Blum, M.D. to questions of:
Senator Enzi............................................. 217
Senator Burr............................................. 223
Senator Hatch............................................ 223
THE NEED FOR FDA REGULATION OF TOBACCO PRODUCTS
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TUESDAY, FEBRUARY 27, 2007
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 9:40 a.m., in
Room SD-430, Dirksen Senate Office Building, Hon. Edward
Kennedy, chairman of the committee, presiding.
Present: Senators Kennedy, Reed, Sanders, Brown, Enzi,
Burr, Isakson, Murkowski, Hatch, Allard, and Coburn.
Opening Statement of Senator Kennedy
The Chairman. Good morning and I apologize to our panelists
and to our members here. We have a ritual here in the Senate
now, which is called the Early Bird Rules. So if you are on
another committee and you have at least a little seniority,
which I'm fortunate to have, you have to go down and check in
at the start of the hearing, to preserve your questioning later
on. All of my colleagues are familiar with it. You find out
some of us come in here out of breath several minutes late at
the opening of these hearings. So we appreciate your
understanding and patience as I hope my colleagues do as well.
I thank all of our witnesses for being here and I'll have
an additional word on that. This hearing focuses on the need
for FDA regulation of tobacco products, the most lethal of all
consumer products. Used as intended by the companies that
manufacture and market them, cigarettes will kill one out of
every three smokers. Yet the Federal agency most responsible
for protecting the public health is currently powerless to deal
with the enormous risks of tobacco use.
Public health experts overwhelmingly believe the passage of
S. 625, bipartisan legislation that will at long last give the
FDA authority to regulate tobacco products, is the most
important action that Congress can take to protect children
from this deadly addiction. If Congress fails to act and
smoking continues at its current rate, more than 6 million of
today's children will ultimately die from tobacco-induced
disease.
Smoking is the No. 1 preventable cause of death in America.
Nationally, cigarettes kill well over 400,000 people each year.
That's more lives lost than from automobile accidents, alcohol
abuse, illegal drugs, AIDs, murders, and suicides combined and
Congress cannot continue to ignore a public health crisis of
this magnitude.
Giving FDA authority over tobacco products will not make
the tragic toll of tobacco use disappear overnight. More than
40 million people are hooked on this highly addictive product
and many of them have been unable to quit, despite repeated
attempts. However, FDA action can play a major role in breaking
the gruesome cycle that seduces millions of teenagers into a
lifetime of addiction and premature death.
What can FDA regulation accomplish? It can reduce youth
smoking by preventing tobacco advertising that targets
children. It can help prevent the sale of tobacco products to
minors. It can stop the tobacco industry from continuing to
mislead the public about the dangers of smoking. It can help
smokers overcome their addiction. It can make tobacco products
less toxic and less addictive for those who continue to use
them. And, it can prohibit unsubstantiated health claims about
supposedly ``reduced risk'' products.
Regulating the conduct of tobacco companies is as necessary
today as it has been in the years past. The facts presented in
the Federal Government's landmark lawsuit against the tobacco
industry conclusively demonstrate that the misconduct is
substantial and ongoing. The decision of the Court states:
``The evidence in this case clearly establishes that
Defendants have not ceased in engaging in unlawful activity. .
. . Defendants continue to engage in conduct that is materially
indistinguishable from their previous actions, activities that
continue to this day.''
Only strong FDA regulation can force the necessary change
in their corporate behavior.
We must deal firmly with tobacco company marketing
practices that target children and mislead the public. The
tobacco industry currently spends over $15 billion each year to
promote its products. Much of that money is spent on ways
designed to tempt children to start smoking before they are
mature enough to appreciate the enormity of the health risk.
The industry knows that nearly 90 percent of smokers begin as
children and are addicted by the time they reach adulthood.
If we are serious about reducing youth smoking, the FDA
must have the power to prevent industry advertising designed to
appeal to children wherever it will be seen by children. This
legislation will give FDA the authority to stop tobacco
advertising that glamorizes smoking to kids. The FDA's
authority must extend to the sale of tobacco products as well
to ensure that children under 18 are not able to buy
cigarettes.
The tobacco industry has a long dishonorable history of
providing misleading information about the health consequences
of smoking. The FDA must have clear and unambiguous authority
to prevent such misrepresentations in the future. The largest
dis-information campaign in the history of the corporate world
must end.
The nicotine in cigarettes is highly addictive. Medical
experts say that it is as addictive as heroin or cocaine. Yet
for decades, while tobacco companies were publicly denying the
addictiveness of their products, they were actually chemically
manipulating the nicotine in them to make it even more
addictive. A newly released analysis by the Harvard School of
Public Health demonstrates that cigarette manufacturers are
still manipulating nicotine levels. Between 1998 and 2005, they
significantly increased the nicotine yield for major brand
cigarettes.
FDA must have the power to take the necessary steps to help
addicted smokers overcome their addiction and to make the
product less toxic for smokers who are unable or unwilling to
stop.
This legislation will require manufacturers to submit
``reduced risk'' products to the FDA for analysis before they
can be marketed. No health-related claims will be permitted
until they have been verified to the FDA's satisfaction. These
safeguards are essential to prevent deceptive industry
marketing campaigns, which could lull the public into a false
sense of health safety.
Enacting this bill this year is the right thing to do for
America's children. They are depending on us. By passing this
legislation, we can help them live longer, healthier lives.
[The prepared statement of Senator Kennedy follows:]
Prepared Statement of Senator Kennedy
This hearing focuses on the need for FDA regulation of
tobacco products, the most lethal of all consumer products.
Used as intended by the companies that manufacture and market
them, cigarettes will kill one out of every three daily
smokers. Yet, the Federal agency most responsible for
protecting the public health is currently powerless to deal
with the enormous risks of tobacco use. Public health experts
overwhelmingly believe the passage of S. 625--bipartisan
legislation that will at long last give the FDA authority to
regulate tobacco products--is the most important action
Congress can take to protect children from this deadly
addiction. If Congress fails to act and smoking continues at
its current rate, more than 6 million of today's children will
ultimately die from tobacco-induced disease.
Smoking is the number one preventable cause of death in
America. Nationally, cigarettes kill well over 400,000 people
each year. They die from cancers, from lung diseases, from
heart diseases and strokes--all caused by smoking. That is more
lives lost than from automobile accidents, alcohol abuse,
illegal drugs, AIDS, murder, and suicide combined. Congress
cannot continue to ignore a public health problem of this
magnitude.
Giving FDA authority over tobacco products will not make
the tragic toll of tobacco use disappear overnight. More than
40 million people are hooked on this highly addictive product
and many of them have been unable to quit despite repeated
attempts. However, FDA action can play a major role in breaking
the gruesome cycle that seduces millions of teenagers into a
lifetime of addiction and premature death.
What can FDA regulation accomplish?
It can reduce youth smoking by preventing tobacco
advertising which targets children.
It can help prevent the sale of tobacco products
to minors.
It can stop the tobacco industry from continuing
to mislead the public about the dangers of smoking.
It can help smokers overcome their addiction.
It can make tobacco products less toxic and less
addictive for those who continue to use them.
And it can prohibit unsubstantiated health claims
about supposedly ``reduced risk'' products.
Regulating the conduct of the tobacco companies is as
necessary today as it has been in years past. The facts
presented in the Federal Government's landmark lawsuit against
the tobacco industry conclusively demonstrate that the
misconduct is substantial and ongoing. The decision of the
Court states:
``The evidence in this case clearly establishes that
Defendants have not ceased engaging in unlawful activity. . . .
Defendants continue to engage in conduct that is materially
indistinguishable from their previous actions, activity that
continues to this day.''
Only strong FDA regulation can force the necessary change
in their corporate behavior.
We must deal firmly with tobacco company marketing
practices that target children and mislead the public. The Food
and Drug Administration needs broad authority to regulate the
sale, distribution, and advertising of cigarettes and smokeless
tobacco.
The tobacco industry currently spends over $15 billion each
year to promote its products. Much of that money is spent in
ways designed to tempt children to start smoking, before they
are mature enough to appreciate the enormity of the health
risk. Four thousand children have their first cigarette every
day, and one thousand of them become daily smokers. The
industry knows that nearly 90 percent of smokers begin as
children and are addicted by the time they reach adulthood.
Documents obtained from tobacco companies prove, in the
companies' own words, the magnitude of the industry's efforts
to trap children into dependency on their deadly product.
Studies by the Institute of Medicine and the Centers for
Disease Control show the substantial role of industry
advertising in decisions by young people to use tobacco
products.
If we are serious about reducing youth smoking, FDA must
have the power to prevent industry advertising designed to
appeal to children wherever it will be seen by children. This
legislation will give FDA the authority to stop tobacco
advertising that glamorizes smoking to kids. It grants FDA full
authority to regulate tobacco advertising ``consistent with and
to the full extent permitted by the first amendment.''
FDA authority must also extend to the sale of tobacco
products. Nearly every State makes it illegal to sell
cigarettes to children under 18, but surveys show that those
laws are rarely enforced and frequently violated. FDA must have
the power to limit the sale of cigarettes to face-to-face
transactions in which the age of the purchaser can be verified
by identification. This means an end to self-service displays
and vending machine sales. There must also be serious
enforcement efforts with real penalties for those caught
selling tobacco products to children. This is the only way to
ensure that children under 18 are not able to buy cigarettes.
The FDA conducted the longest rulemaking proceeding in its
history, studying which regulations would most effectively
reduce the number of children who smoke. Seven hundred thousand
public comments were received in the course of that rulemaking.
At the conclusion of its proceeding, the Agency promulgated
rules on the manner in which cigarettes are advertised and
sold. Due to litigation, most of those regulations were never
implemented. If we are serious about curbing youth smoking as
much as possible, as soon as possible; it makes no sense to
require FDA to reinvent the wheel by conducting a new multi-
year rulemaking process on the same issues. This legislation
will give the youth access and advertising restrictions already
developed by FDA the force of law, as if they had been issued
under the new statute. Once they are in place, FDA will have
the authority to modify these rules as changing circumstances
warrant.
The legislation also provides for stronger warnings on all
cigarette and smokeless tobacco packages, and in all print
advertisements. These warnings will be more explicit in their
description of the medical problems which can result from
tobacco use. The FDA is given the authority to change the text
of these warning labels periodically, to keep their impact
strong.
The nicotine in cigarettes is highly addictive. Medical
experts say that it is as addictive as heroin or cocaine. Yet
for decades, tobacco companies vehemently denied the
addictiveness of their products. No one can forget the parade
of tobacco executives who testified under oath before Congress
that smoking cigarettes is not addictive. Overwhelming evidence
in industry documents obtained through the discovery process
proves that the companies not only knew of this addictiveness
for decades, but actually relied on it as the basis for their
marketing strategy. As we now know, cigarette manufacturers
chemically manipulated the nicotine in their products to make
it even more addictive.
A newly released analysis by the Harvard School of Public
Health demonstrates that cigarette manufacturers are still
manipulating nicotine levels. Between 1998 and 2005, they
significantly increased the nicotine yield from major brand
name cigarettes. The average increase in nicotine yield over
the period was 11 percent.
The tobacco industry has a long, dishonorable history of
providing misleading information about the health consequences
of smoking. These companies have repeatedly sought to
characterize their products as far less hazardous than they
are. They made minor innovations in product design seem far
more significant for the health of the user than they actually
were. It is essential that FDA have clear and unambiguous
authority to prevent such misrepresentations in the future. The
largest disinformation campaign in the history of the corporate
world must end.
Given the addictiveness of tobacco products, it is
essential that the FDA regulate them for the protection of the
public. Over 40 million Americans are currently addicted to
cigarettes. No responsible public health official believes that
cigarettes should be banned. A ban would leave 40 million
people without a way to satisfy their drug dependency. FDA
should be able to take the necessary steps to help addicted
smokers overcome their addiction, and to make the product less
toxic for smokers who are unable or unwilling to stop. To do
so, FDA must have the authority to reduce or remove hazardous
ingredients from cigarettes, to the extent that it becomes
scientifically feasible. The inherent risk in smoking should
not be unnecessarily compounded.
Recent statements by several tobacco companies make clear
that they plan to develop what they characterize as ``reduced
risk'' cigarettes. Some are already on the market making
unsubstantiated claims. This legislation will require
manufacturers to submit such ``reduced risk'' products to the
FDA for analysis before they can be marketed. No health-related
claims will be permitted until they have been verified to the
FDA's satisfaction. These safeguards are essential to prevent
deceptive industry marketing campaigns, which could lull the
public into a false sense of health safety.
This legislation will vest FDA not only with the
responsibility for regulating tobacco products, but with full
authority to do the job effectively. It is long overdue.
Enacting this bill this year is the right thing to do for
America's children. They are depending on us. By passing this
legislation, we can help them live longer, healthier lives.
The Chairman. Senator Enzi.
Opening Statement of Senator Enzi
Senator Enzi. Thank you, Mr. Chairman. Good morning. I'd
like to thank my colleague, Senator Kennedy, for calling this
hearing. I believe it is always a good idea to discuss
controversial issues like this one in order to better educate
ourselves and the American people about the problem and the
possible solutions.
We can all agree on what our common interest is, which is
stopping people of all ages from starting to smoke and
convincing current smokers to quit that deadly habit. While the
tobacco industry may seemingly share our views on teen smoking,
I am one who doubts they have bought into the idea of getting
adult smokers to stop smoking.
The bill that is now before the Senate proves this point.
Today we should ask ourselves, what will it mean to have
cigarette and tobacco products truly regulated by the Food and
Drug Administration? The FDA is the gold standard among public
health regulators the world over. For the past century, the FDA
has protected the public from filthy conditions in meat packing
plants to thalidomide, which caused thousands of birth defects
in Western Europe. The FDA's constant vigilance is not just a
historical artifact. Last week, there was a recall of peanut
butter due to salmonella contamination and baby food that had
been tainted with botulism. This is how we've come to depend on
the FDA every day to protect us and our children from poisons
that could harm or even kill us.
Senator Kennedy and I have worked on FDA issues for the
last 2 years. We held 10 hearings on the FDA during the 109th
Congress. Again and again, we focused on the FDA's role in
protecting and promoting the public health.
In all of our work together, it was evident that the FDA is
overworked and under funded. We as a Nation currently ask the
FDA to be responsible for so many things: ensuring that new
drugs and medical devices are safe and effective, safeguarding
the Nation's food supply, regulating the manufacture and
distribution of food additives and drugs that will be given to
animals and increasingly, the security of our blood supply.
In each of these key activities, the role of the FDA is to
protect our health. In providing that protection, the FDA
examines key scientific facts and ways to balance the benefit
to our society and risks to our health. It baffles me why we
are here today to talk about the FDA doing a risk/benefit
analysis of tobacco and cigarettes. Everyone agrees that
smoking kills. There is no such thing as a safe cigarette. Any
public statement by the FDA under their current authority would
necessitate the finding that there is no benefit to the use of
cigarettes--only harm.
The bill now before Congress would establish the FDA as a
regulator for tobacco products. However, the bill explicitly
states that the FDA will not be permitted to prohibit the sale
of any tobacco product to adults 18 years or older. That's not
true regulation. The bill would gut the authority that Congress
has bestowed and staunchly defended for the FDA--the authority
to remove health threats from the marketplace. Having the FDA
review and approve cigarettes sends mixed and confusing
messages to the public, creating the sense that cigarettes are
safe or made safer. I can see it now. Tobacco companies being
let off the hook in court because they can now say, ``But
judge, our product was reviewed and approved by the FDA.'' The
FDA can not be put in the position of approving a product that
years of science and personal experience for far too many
Americans have shown to be dangerous. Simply put, it kills
people.
So what can we do? I recognize we can't change behavior
overnight but the data on smoking are trending in the right
direction. Fewer people smoke and teenage smoking is down
dramatically. We can always do more with educational outreach
efforts.
Where are the funds going to come from? I recognize that
the money from the Master Settlement Agreement, MSA, with 46
States came with no strings attached. We all know the genesis
of the agreement was States suing for the cost of healthcare
for smokers and former smokers. The spirit of that agreement
was that the funds would be used for healthcare for smokers and
former smokers, however that is not how the money is being
spent. As the GAO will highlight later today, on average,
States are spending less than 5 percent of the MSA funds on
tobacco control and prevention, and the spending on healthcare
items such as SCHIP may not be focused on assisting smokers
with severe health conditions due to their use of cigarettes.
While States are spending their funds on a variety of projects,
they are not spending key funds on the care of smokers and
former smokers or preventing tobacco use in the first place.
In fiscal year 2007, only three States--Maine, Delaware and
Colorado, are meeting the CDC minimum recommendation of 8
percent of spending on tobacco prevention. The combined total
the States are spending on tobacco prevention amounts to just
2.8 percent of the $21.7 billion in tobacco generated revenue
the States will collect this year from the tobacco settlement
and tobacco taxes. I think the States can do better.
The FDA approves cures not poisons. Forcing the FDA to
regulate tobacco but not letting them ban it would undermine
the long history of the agency protecting and promoting the
public health. I ask my colleagues to think hard about what
they are proposing. My record is clear when it comes to
tobacco. I am no friend to big tobacco and I have never taken a
dime of tobacco money. I don't intend to start now. I
absolutely reject the notion that the way to show that you are
for kids and against tobacco is by sending the Nation's
premiere public health watchdog out to fight for safety with
one hand tied behind its back and allowing this premiere agency
to provide its FDA seal of approval on a deadly product that
has no health benefit.
Now, I have a number of statements from outside groups
regarding this legislation. I ask unanimous consent that they
be entered into the hearing record. I would mention that I
think Philip Morris, by mistake, sent me their letter. I would
still ask that it be made a part of the record but I would
suggest that big tobacco figures that if the FDA controls
tobacco, the cigarettes will have to be put behind the counter
where nobody can see other brands, particularly not 18-year-
olds, that will give the established brands a big push.
So I look forward to the testimony today and hope that we
can do better.
[Editor's Note: The materials presented by Senator Enzi may
be found in Additional Materials.]
The Chairman. Well, there you go. I look forward to our
panel, their testimony.
Senator Burr. Mr. Chairman, could I ask consent of the
Chair and of my colleagues to allow me to make an opening
statement?
The Chairman. Sure. I'd like to accommodate you because
this issue obviously has a particular, very special effect on
your State. My colleague, Senator Brown, who is going to
another hearing, wanted to say a brief word, too. We're trying
to accommodate schedules as best we can but still try to keep
this process moving. But I'll be glad to let both of you speak.
Senator Brown.
Opening Statement of Senator Brown
Senator Brown. Thank you, Senator Burr and thank you Mr.
Chairman. Senator Enzi, thank you for recounting the proud
history of the Food and Drug Administration and the terrific
work it has done for decades. I appreciate that. And Senator
Kennedy, thank you for your work on tobacco issues.
Generally, the story of tobacco addiction is all too
familiar for far too many of our young people. In my State of
Ohio, 20 percent or 134,000 it is estimated, high school
students smoke. Over 18,000 kids under the age of 18 become new
daily smokers each year. The CDC estimates that in just this
one State, 293,000 kids under the age of 18 will die
prematurely as a result of smoking. These children are not
aware of these staggering statistics when they tried their
first cigarette but we are aware of these staggering
statistics. That's why it's our responsibility to make sure our
children are safe and don't fall victim to that unhealthy
addiction.
I applaud the Chairman for holding this hearing and
introducing bipartisan legislation that would grant the FDA
authority to regulate tobacco products. Congress has a
responsibility to the Nation to ensure that children are safe
and are not the victims of suggestive marketing by tobacco
companies and has an equal responsibility to ensure that
citizens are protected from dangerous chemicals and are aware
of all their risks associated with smoking. The Chairman's bill
will give the FDA the authority to regulate tobacco as it does
any other drug. I totally support this legislation. I again
thank the Chairman for holding these hearings.
I, for about a decade, was the Ranking Democrat on the
Health Subcommittee in the House and saw so much of this
testimony and heard so much about this issue. It's time finally
that the Senate and the House act. Thank you.
The Chairman. Thank you very much, Senator Brown. I
appreciate your comments and your presence here.
Senator Burr.
Opening Statement of Senator Burr
Senator Burr. Thank you, Mr. Chairman. Mr. Chairman, you
should be applauded for bringing this up and you and I have a
rich history of working on this issue when I was in the House.
We share concerns.
Clearly, coming from North Carolina, I am somewhat
passionate about this issue and as I told Matt Myers, we've
been doing this a long time. The only difference is, we've both
aged.
The approach that we are still taking today is exactly what
we took 13 years ago when we first started this but so much has
changed. The master settlement brought a lot of changes to the
long list of advertising, the target of children, the use of
cartoon characters, the sponsorship of sporting events--places
where kids might be influenced. It's all gone.
But the framework of regulation that we've chosen to do is
still the same thing. It doesn't take into account that. I'm
not here to go through a long laundry list of items that I
might take a different road than maybe what the Chairman would
take.
I would only say this--that some who have read this bill
suggest that it shields the tobacco companies in the future
from liability. Some have read the bill and said, ``This is a
pathway to the elimination of tobacco products.'' And quite
frankly, I'm not sure that any of us know what will happen if
this legislation becomes law.
I think there are some assumptions that we can make that
are fairly accurate and I just want to point everybody toward
the FDA today. The FDA and its jurisdictions--the authority
that the FDA currently has of 25 cents of every dollar of U.S.
economy--this is not just about whether, in fact, the blood is
safe, whether drugs and biologics and medical devices are, in
fact, approved, labeled correctly and monitored for advertising
effectively. It's a question of whether the safety of the
system has been maintained and Sherrod worked with me on FDA
modernization, now 12 years ago. The No. 1 objective was to
make sure that that gold standard was preserved.
But there is so much that is currently in the FDA
jurisdiction and that we count on as Americans. It's not just
about children. This is about every American and a system that
we are reliant on for our health.
The reality is that we all have to ask ourselves, is this
the appropriate place to put all the regulatory responsibility
of the most regulated industry in America? I'm going to ask for
the other chart to go up.
To hear some describe the lack of regulation, the lack of
oversight on this industry ignores the current regulatory
framework that is in this country. Now granted, some of the
Federal agencies have certain tobacco regulations internal to
their areas of the Government. But when you look at the
Department of Agriculture, when you look at the Federal Trade
Commission, when you look at HHS, what you find is, you find
the most regulated industry in America today before we ever
talk about passing a bill.
So, Mr. Chairman, it's only my hope and my pledge to you
and to our panelists, who are passionate and knowledgeable on
many of the issues, that it is my hope that we will throw away
that template that we created 13 years ago, that we will focus
on the areas where I think we need to make progress. I think it
is reasonable to say, what does it take to assure Matt Myers
that children are not the target of advertising, of marketing,
of promotion? But what allows us to continue some degree of
marketing to consenting adults.
I used to be a tobacco smoker. I'm not today. You can quit.
My children never started. They may be an anomaly. I don't
think they are. It is reasonable for us as legislators, to
expect that we can create a framework that provides more
information for adults to make better choices? I think that is
where our responsibility lies. When we can bring to the table
new information, better information about the health
consequences, then adults can choose, in fact, whether they
want to participate in the use of this product.
Mr. Chairman, it is my hope that over the next days, weeks,
months--whatever your timeline is--that we can sit down in an
informal capacity and talk about a different framework, one
hopefully that we would find tremendous agreement on where we
end up, but possibly the flexibility of how we accomplish that
might be left up to something other than the formal hearing
process. I think we can achieve that and I look forward to
working with the Chairman. I thank you.
The Chairman. Well, thank you very much, as always, a very
provocative and well stated view, Senator. I think this has
been helpful in trying to establish a framework. We've got a
very experienced panel that have strong views from their
vantage points. We all hope that they might be able to catch
the spirit of this hearing. We've heard pretty diverse views
about how we ought to approach it and the witnesses will be
able to add to their own comments what they might, in terms of
responding to some of these issues.
We have very distinguished witnesses. Let me introduce
three panelists at a time and then I will introduce the others
after the first group has spoken. I think that is probably the
most effective way to proceed.
So we'll start with Matthew Myers, President and CEO of the
Campaign for Tobacco-Free Kids, a privately funded organization
established to reduce tobacco use and its devastating
consequences in the United States and around the world. For
over 25 years, Mr. Myers has participated in virtually every
major national tobacco-related legislative effort, worked with
State tobacco prevention advocates and officials around the
country. In 1999, Mr. Myers was asked to serve on the first
advisory committee established to advise the Director General
of the World Health Organization on tobacco issues. In October
2004, Harvard School of Public Health bestowed its highest
honor, the prestigious Julie Richmond Award on Mr. Myers for
his work as an advocate in preventing tobacco industry
marketing to children.
Elmer Huerta is the President-Elect of the National Board
of Directors of the American Cancer Society, and a member of
the American Cancer Society Action Network. Dr. Huerta is
currently Director of the Cancer Preventorium at the Washington
Cancer Institute at the Washington Hospital Center in
Washington, DC., founded in 1994. He is President and Founder
of Prevencion, a nonprofit company dedicated to the production
and dissemination of educational materials for the Latino
community. He was a founding member of the Board of Directors
of the American Legacy Foundation. He is a prominent figure on
Spanish language radio and television.
Dr. Richard Land--Princeton and Oxford educated--has served
as President of the Southern Baptist Convention Ethics and
Religious Liberty Commission since 1988. He represented the
Evangelicals before Congress and U.S. Presidents, and is a
three-time commissioner of the U.S. Commission in National
Religious Freedom. In 2005, Time named Dr. Land one of the 25
most influential Evangelicals. A renowned scholar, Dr. Land has
worked as a pastor, a theologian and a public policymaker. He
is a leading member of Faith United Against Tobacco.
I'm very grateful to have these three individuals here
today.
Let's begin with Mr. Myers.
STATEMENT OF MATTHEW L. MYERS, PRESIDENT AND CEO OF THE
CAMPAIGN FOR TOBACCO-FREE KIDS, WASHINGTON, DC
Mr. Myers. Chairman Kennedy, Senator Enzi, Senator Burr and
members of the committee, thank you very much for the
opportunity to testify today.
S. 625, in the view of virtually every major public health
organization, has the potential to save literally hundreds of
thousands if not millions of lives. Rarely is Congress faced
with an opportunity to do exactly that.
Today, tobacco--America's most dangerous consumer product,
despite what Senator Burr said, is also the one consumer
product that no Federal agency oversees for health and safety
purposes, despite its other regulatory framework. This
carefully crafted, thoughtfully balanced legislation would
correct that glaring problem and bring to tobacco the kind of
government oversight that is already provided to other consumer
products.
As you know, S. 625 was only introduced on February 15, but
the need for legislation giving FDA regulatory authority over
tobacco has been debated for years. Indeed, a bill virtually
identical to S. 625 was debated and overwhelming approved by
the full Senate twice in 2004.
S. 625 has been examined by virtually every major public
health organization in this country. It has broad bipartisan
support, including liberals and conservatives and Senators from
every geographic region of the country. It has been endorsed by
every major national public health organization, many
organizations representing healthcare providers as well as
representative of a wide range of faith groups.
As the letter attached to my testimony reflects, support
for this legislation is a virtual Who's Who of this Nation's
health community and includes 48 national organizations. Rarely
do you see this kind of consensus.
The need for FDA regulation is also supported by a wide
range of Americans. We have just conducted a nationwide poll
and found that 69 percent of voters favor FDA regulation of
tobacco products. What is interesting about that poll is, that
number does not vary by geographic region and it is also
extraordinarily strong in the tobacco growing country.
As you said, Senator Kennedy, more than five decades after
the Surgeon General's historic 1964 report, more than 400,000
Americans die prematurely every year from tobacco. That's
roughly 1,200 people every single day. The critical word is
prematurely. While some hope that the Master Settlement
Agreement would end tobacco marketing to kids, as Federal Judge
Gladys Kessler found just last August, the tobacco
manufacturers continue to market in ways that appeal to young
people and continue, to this day, to recruit children as new
tobacco users. While helpful, the MSA addressed less than 20
percent of the marketing and promotional expenditures of the
tobacco company and it did not even completely eliminate those
practices.
Indeed, between 1998 and 2003, the last year for which we
have data, promotional expenditures by cigarette companies rose
from $6.73 billion a year to a staggering $15.15 billion a
year. That means today and every day, the tobacco companies
will spend more than $41 million marketing their products. We
need to do more.
This legislation will provide FDA with the authority it
needs to appropriately oversee the marketing, manufacture and
sale of tobacco products. In a nutshell, this bill ensures that
oversight of tobacco is based on sound science and conducted by
an agency and personnel with scientific expertise and the
ability to make adjustments based on new scientific evidence.
For the reason that FDA has previously been given authority
of other products, the FDA is the only agency that possesses
these qualities. It requires the tobacco industry to make the
type of disclosures to FDA that other manufacturers are already
required to make. It establishes commonsense standards for
product regulations that are practical, achievable and directed
toward protecting the public. It recognizes, as Senator Enzi
did, that how a product is marketed can also have a major
impact on the number of people who needlessly die from tobacco,
both in terms of encouraging use and discouraging quitting.
Last and very importantly, it provides the FDA with the
resources to do the assigned job capably and without detracting
from FDA's other important missions. It should be noted that
this legislation provides an independent source of funds for
FDA to adequately do the job but even that independent source
of funds would amount to no more than about 2\1/2\ cents per
pack.
Let me just highlight one or two things quickly so that I
don't use much time. Marketing--the bill would put in place a
number of specific advertising restrictions that FDA has
previously determined after a 2-year investigation, have the
greatest impact on tobacco use on children, practices that
continue until today.
And most importantly, it would authorize FDA to take
further action as new marketing practices are discovered, to
address those but in ways that are extraordinarily sensitive to
the first amendment.
In terms of the new products and the products today on the
market, today tobacco products contain more than 60 known
cancer-causing substances and the incidence of disease among
smokers, shockingly, has actually increased--not decreased,
over the years. No Federal agency, no State agency currently
has the authority to require tobacco companies to make
technologically feasible changes to tobacco products to reduce
the number and quantity of harmful substances in those
products.
For the first time in history, this bill gives a Federal
agency the authority to require those kinds of changes in both
new and existing products.
Let me address an important issue. This bill does not use
the same standards to evaluate products as is used for drugs.
It recognizes that the standard FDA normally applies to many
products under its jurisdiction, whether the product is safe
and effective, does not make sense for tobacco products. There
are approximately 50 million Americans already using these
highly addictive products and there is no such thing, I think
we can all agree, of a safe cigarette.
The Chairman. I'm going to ask you to begin to wind up,
please.
Mr. Myers. I just have about 1 minute left. Thus, the
standard in this bill--but the fact that the current standard
doesn't apply doesn't mean there isn't anything we can do. The
standard in this bill is one based on what actions are
appropriate to protect the public health, which in this case,
means those actions that will reduce the number of people
likely to die from tobacco. Changes to tobacco products today
can reduce those harms.
Last, critically, this would prevent tobacco companies from
making the kind of unsubstantiated health claims as they have
for light and low-tar tobacco products and for a whole new
generation of products, which have undermined efforts by the
States and others, to encourage people to quit. This bill would
eliminate the terms light and low-tar, producing an immediate
benefit and equally important is it would set meaningful,
reasonable scientific standards that would require a tobacco
company to prove to FDA that any product for which they wanted
to make a claim actually would result in a reduction in risks
to both individual consumers and the population as a whole.
In conclusion, Senator Kennedy and members of the
committee, this bill is a thoughtful, balanced approach to a
problem that has plagued this Nation for over 50 years. It
isn't perfect but it will result in literally hundreds of
thousands of lives being saved.
Thank you.
[The prepared statement of Mr. Myers follows:]
Prepared Statement of Matthew L. Myers
Chairman Kennedy, Senator Enzi, and members of the HELP Committee,
thank you for this opportunity to testify in support of S. 625, a bill
to provide the U.S. Food and Drug Administration (FDA) with the
authority to effectively regulate tobacco products and their marketing
and to reduce the harms associated with tobacco use. My name is Matthew
Myers, and I am President of the Campaign for Tobacco-Free Kids, the
Nation's largest nonprofit, advocacy organization solely devoted to
reducing the harm caused by tobacco use and exposure to secondhand
smoke.
S. 625 has the potential to save many lives. Today, America's most
dangerous consumer product--tobacco--is also the one consumer product
that no Federal agency oversees for health and safety purposes. This
carefully crafted, thoughtfully balanced legislation would correct that
glaring problem and bring the type of government oversight to the
manufacture, marketing and sale of tobacco products that is already
provided to other consumer products.
As you know, S. 625 was introduced on February 15, 2007, but the
need for legislation giving FDA authority over tobacco has been
discussed for years, and legislation similar to S. 625 has been before
the Senate for close to a decade. A bill virtually identical to S. 625
was debated and overwhelmingly approved by the full Senate in 2004.
It is essential for Congress to act if the public is to be
protected. In 1996, after a 2-year investigation, the U.S. Food and
Drug Administration asserted jurisdiction over tobacco under current
law. Then, in March 2000, the U.S. Supreme Court ruled that the FDA did
not have the statutory authority to regulate tobacco products, and that
only Congress could grant FDA this authority. In a highly unusual
commentary, the Court urged Congress to act given the seriousness of
the public health problem.
Thus, it is no surprise that S. 625 has broad bipartisan support
including liberals and conservatives and Senators from every geographic
region of the country. It has been endorsed by every major national
public health organization, many organizations representing health care
providers, and representatives of a wide range of faith groups.
Virtually identical legislation was also previously endorsed by every
major tobacco-farming group.
The Campaign for Tobacco-Free Kids has measured voter support for
FDA regulation of tobacco products and, not surprisingly, it has broad
support across the country, with 69 percent of voters in a national
poll favoring. State surveys from around the country have consistently
found similarly high levels of support, crossing party and ideological
lines. It even has majority support among smokers. Voter support is
particularly strong for the specific provisions of FDA regulation. When
asked if tobacco companies should be required to take measures to make
cigarettes less harmful; if tobacco companies should be prevented from
making claims that some products are less harmful than others unless
FDA determines those claims are true; or if FDA should restrict tobacco
marketing aimed at children, voter support for each of these elements
exceeds 75 percent.
It is truly time for Congress to act.
why this bill is needed
S. 625 is essential for the protection of the public health. More
than five decades after the Surgeon General's historic 1964 report,
more than 400,000 Americans die prematurely every year from tobacco,
roughly 1,200 people every day. The critical word is ``prematurely.''
Fifty percent of the people who die from tobacco die in middle age, and
almost every one of those deaths is a person who started smoking and
became addicted before they were old enough to be sold tobacco products
legally.
Death from tobacco is almost always the last chapter of a book that
begins in childhood. Every day, approximately 4,000 kids will try a
cigarette for the first time. Another 1,000 will become new, regular
daily smokers, and one-third of these kids will eventually die
prematurely as a result.
While some hoped that the 1998 Master Settlement Agreement (MSA)
would end tobacco marketing to children, Federal District Court Judge
Gladys Kessler found last July that the tobacco manufacturers continue
to market in ways that appeal to young people and continue to recruit
children as new tobacco users. The MSA, while helpful, addressed less
than 20 percent of the marketing and promotional expenditures by the
tobacco companies, and it did not completely eliminate even those
practices. The tobacco companies have easily overcome these
restrictions by dramatically increasing marketing expenditures and
constantly finding new and sophisticated ways to market their products,
many of which impact kids. Between 1998, the year of the MSA, and 2003,
the latest year for which data are available, the major cigarette
companies more than doubled their marketing and promotional
expenditures from $6.73 billion to a staggering $15.15 billion--more
than $40 million each and every day--much of it aimed at kids. As Judge
Kessler concluded in her opinion:
``In fact, the overwhelming evidence set forth in this
Section--both Defendants' internal documents, testimony from
extraordinarily qualified and experienced experts called by the
United States, and the many pictorial and demonstrative
exhibits used by the Government--prove that, historically, as
well as currently, Defendants do market to young people,
including those under 21, as well as those under 18.
Defendants' marketing activities are intended to bring new,
young, and hopefully long-lived smokers into the market in
order to replace those who die (largely from tobacco-caused
illnesses) or quit.''
It's no wonder that our surveys continue to show kids are almost
twice as likely as adults to remember tobacco advertising.
Judge Kessler also concluded that tobacco company marketing to kids
is likely to continue in the future:
``Similarly, Defendants continue to engage in many practices
which target youth, and deny that they do so. Despite the
provisions of the MSA, Defendants continue to track youth
behavior and preferences and market to youth using imagery
which appeals to the needs and desires of adolescents.
Defendants are well aware that over 80 percent of adult smokers
began smoking before the age of 18, and therefore know that
securing the youth market is critical to their survival. There
is therefore no reason, especially given their long history of
denial and deceit, to trust their assurances that they will not
continue committing RICO violations denying their marketing to
youth.''
In addition to allowing virtually unfettered promotion of tobacco
products, the absence of any meaningful regulation continues to allow
the tobacco industry to manipulate their products in ways that can make
them more addictive and/or more harmful. The introduction of so-called
reduced risk products, with no oversight, can also deceive consumers
and undermine their efforts to reduce their risk by luring them into
switching to products that they falsely believe are less hazardous
rather than quitting. It can also attract new smokers with the promise
of less harm.
The lesson is clear: more must be done. The status quo is not
working and current efforts are inadequate. The need for FDA oversight
of the tobacco industry is as great today as ever:
The tobacco industry continues deceptive marketing that
undermines prevention efforts and appeals to children.
Tobacco products remain toxic and addictive and tobacco
companies are free to manipulate products to make them more appealing
and addictive.
There continue to be unsubstantiated health claims made
for new and low tar products.
There are still critical gaps in the industry's
acknowledgement of the health effects of their products.
what this bill will do
This legislation will provide the FDA with the authority it needs
to appropriately oversee the marketing, manufacture and sale of tobacco
products. This authority will benefit public health by reducing illegal
sales of tobacco to kids, by limiting marketing that targets kids to
begin smoking and misleads smokers to discourage them from quitting, by
ensuring that new products that purport to reduce harm actually do so,
and by requiring tobacco companies to make changes in the products that
make them less harmful to smokers unable to quit.
Key principles of the legislation include:
Ensures that oversight of tobacco is based on sound
science and conducted by an agency and personnel with scientific
expertise and the ability to make adjustments based on new scientific
evidence;
Requires the tobacco industry to make the type of
disclosures to FDA that other manufacturers are already required to
make and that are essential to enable the agency to make well-informed
decisions and take effective action;
Establishes common-sense standards for product regulation
and agency action that are practical, achievable and directed toward a
single common goal--to protect the public health and reduce the number
of Americans who die prematurely as the result of their use of tobacco
products;
Recognizes that how a product is marketed can also have a
major impact on the number of people who needlessly die from tobacco
use and establishes marketing standards that are both consistent with
the first amendment and the FDA's public health mission; and
Provides the FDA with the resources to do the assigned job
capably and without detracting from FDA's other important missions.
I want to highlight just a few key provisions of the bill and also
address some of the concerns that have been raised about the
legislation.
Marketing.--Since the Master Settlement Agreement, the tobacco
industry has more than doubled its marketing expenditures with
knowledge of the impact of its marketing on children; continued
marketing ``light'' and ``low tar'' cigarettes despite the evidence
that they do not reduce the risk of disease and the public is misled by
how they are labeled and sold; and introduced new tobacco brands backed
by new unsubstantiated and unproven health claims that mislead the
public. It has become even clearer that State lawsuits, prior voluntary
codes, and current laws have not prevented the tobacco industry from
marketing to children or misleading the public.
This bill would put in place a number of specific advertising
restrictions that FDA previously determined, after a 2-year
investigation, impact tobacco use by children; would require the
elimination of the use of the terms ``light,'' ``low tar'' and similar
terms unless the industry could scientifically demonstrate that
products labeled ``light'' and ``low tar'' actually reduce the risk of
disease; and would otherwise prevent the use of other health claims
unless a manufacturer presents scientific evidence to support those
claims. These are not radical concepts. Manufacturers of other products
regulated by FDA are not allowed to make claims without adequate
scientific substantiation because of the adverse impact on the health
of potential consumers. This bill would finally force the tobacco
industry to play by these reasonable rules.
Equally as important, this bill recognizes that the tobacco
industry has often circumvented rules designed to curtail both
marketing to children and misleading of the public and provides FDA the
needed authority to adopt new rules to address new conditions as they
arise.
Any advertising regulations must be consistent with the first
amendment. The bill states that the authority to develop regulations
that impose restrictions on the advertising and promotion of tobacco
products must be consistent with, but can be exercised to the full
extent permitted by, the first amendment. Given the history of the
tobacco industry's aggressive and misleading marketing, strong
authority to restrict marketing is justified.
The kinds of Federal restrictions on tobacco marketing contained in
S. 625 are consistent with the U.S. Supreme Court's analysis in
Lorrilard Tobacco Company v. Reilly. They would survive constitutional
challenge because they are carefully tailored, scientifically proven
measures to protect the recognized legitimate interests of the
government in protecting (1) children from marketing that contributes
to tobacco addiction and (2) adults from misleading marketing that
encourages tobacco use and discourages quitting. Federal action is
clearly needed because over 50 years of voluntary and State
governmental efforts to change the tobacco industry's behavior have not
solved the problem.
Establishing Appropriate Standards for the Content of Tobacco
Products.--Today, tobacco products contain more than 60 known cancer-
causing substances, and the incidence of disease among smokers has
actually increased, not decreased, over the years, according to the
National Cancer Institute.\1\ Even as the tobacco industry touted that
it had reduced tar and nicotine levels in its products, the level of
potent carcinogens, like nitrosamines, increased without any public
agency having any authority to evaluate the impact of that change.
---------------------------------------------------------------------------
\1\ Risks Associated with Smoking Cigarettes with Low Machine-
Measured Yields of Tar and Nicotine. Smoking and Tobacco Control
Monograph No. 13. Bethesda, MD: U.S. Department of Health and Human
Services, National Institutes of Health, National Cancer Institute, NIH
Pub. No. 02-5074, October, 2001. http://cancercontrol.cancer.gov/tcrb/
monographs/13/.
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No Federal agency currently has the authority to require tobacco
companies to disclose, in a meaningful way, what is in each product;
\2\ to require manufacturers to provide evidence of the impact of
product changes; or to require manufacturers to make technologically
feasible changes to products to reduce the number or quantity of
harmful substances in tobacco products and the smoke of tobacco
products. S. 625 would address this gap in a practical and reasonable
way. It recognizes that the standard FDA normally applies to many
products under its jurisdiction--whether the product is ``safe and
effective''--does not make sense for tobacco products because there is
no such thing as a ``safe cigarette.'' A ``safe and effective''
standard would thus dictate a total ban on tobacco products, and with
close to 50 million Americans addicted to tobacco use, virtually all
public health experts recognize this as infeasible and unproductive. S.
625 recognizes that the goal is therefore to reduce the number of
people who needlessly die prematurely from tobacco use. Thus, the
standard in the bill is one based on what actions are ``appropriate to
protect the public health,'' taking into account the impact of any
proposal on the health of the ``population as a whole, including users
and nonusers'' of tobacco products. The bill puts in place measures to
prevent kids from starting to smoke and to ensure that smokers are not
dissuaded from quitting by misleading claims, and it establishes a
process to reduce the harm from tobacco products to those who are
unable to quit.
---------------------------------------------------------------------------
\2\ The ingredient disclosure requirements of the 1984
Comprehensive Smoking Education Act have proven wholly inadequate for
this purpose. They do not provide the government with information to
identify what chemicals and other ingredients are in each brand of
cigarettes, the quantity of the different chemicals, in each cigarette
or the type of information that is needed to understand or evaluate or
warn the public about what is in each brand of cigarette.
---------------------------------------------------------------------------
The standard in S. 625 recognizes the unique issues raised by the
regulation of tobacco products. This standard looks at the overall
impact on the number of people who will die needlessly from tobacco and
allows the FDA to broadly consider all factors that will affect whether
a proposed product change will increase or decrease the death and
disease caused by tobacco. It instructs the FDA to look at how a
mandated product change will impact individual tobacco users but also
look at its impact on the number of tobacco users by examining its
effect on discouraging smokers from quitting or encouraging nonsmokers
to start. The goal is protecting the pubic and saving lives, and the
standard set forth in S. 625 is right on the mark.
Preventing Unsubstantiated Health Claims While Encouraging Real
Scientific Innovation to Reduce the Harm Caused by Tobacco Products.--
For decades, tobacco manufacturers have been marketing ``light'' and
``low tar'' products with claims that these cigarettes are less risky,
leading millions of consumers to switch to these products thinking they
are actually reducing their risk of disease or that they were taking a
first step toward quitting. The National Cancer Institute, the U.S.
Surgeon General and other credible scientific bodies have subsequently
concluded that ``light and ``low tar'' products did not reduce the risk
of disease and did deter millions of smokers from quitting. Subsequent
to the release of the scientific evidence demonstrating that ``light''
and ``low tar'' products have not reduced the risk of disease, tobacco
companies have continued to mislead consumers and have come out with
new products whose advertising includes even more specific claims of
reduced risk.
The absence of any regulatory body to review health claims has led
to a public health tragedy that has thwarted the well-intended personal
efforts of tobacco users who have attempted to reduce their risk of
disease. This bill would address that problem in a manner consistent
with sound scientific standards. It requires FDA to prevent
unsubstantiated and unproven claims, while permitting a manufacturer
who produces a genuinely less hazardous product, and develops sound
scientific evidence of its impact, to responsibly make claims about any
such innovative product.
This provision by itself has the potential to save many lives.
Before a manufacturer can make a health claim for a product, the
legislation simply requires that manufacturer to demonstrate to FDA
that the product significantly reduces the risk of disease when
compared to other tobacco products, and when used in the manner a
consumer will actually use the product. It also requires the
manufacturer to show that any public health benefit for individual
users will not be offset by the harm caused by marketing of the product
resulting in increased tobacco use or decreased cessation.
This section will benefit manufacturers who develop a genuinely
safer product and will adversely impact only those manufacturers who
have been making unproven claims or marketing their products in ways
that encourage nontobacco users to start or discourage potential users
who would otherwise quit.
Concerns of Tobacco Product Retailers.--Convenience store owners
have expressed concerns about provisions in the bill, including those
that require retailers to check the ID of young persons seeking to
purchase tobacco products. The youth access provisions of the original
FDA regulations in place from 1996 to 2000 were effective in reducing
illegal sales to youth. Congress appropriated funding for this program,
and FDA enforced the youth access restrictions, not by employing
Federal agents, but by contracting with State and local officials, such
as health departments and police departments. By 2000, the FDA had
contracts with every State to conduct the compliance checks and had an
extensive outreach program that provided resources and information to
retailers. This was a program that was producing solid results in
reducing illegal youth access to tobacco in a manner sensitive to State
and local interests.
Although this bill does hold store owners responsible for illegal
tobacco sales to children, it establishes detailed procedures to
protect retailers who diligently require young people to show
government-issued IDs, including procedural protections that were not
in place between 1996 and 2000. In addition, no fines are incurred
until repeated violations occur, and retailers are warned after the
first violation that additional compliance checks will be conducted.
The only retailers who will be punished will be those who repeatedly
sell tobacco to kids illegally.
Impact on FDA's Ability to Regulate Food, Drugs, Devices and Other
Products Currently Under Its Jurisdiction.--We recognize that there are
concerns about FDA's resources and whether it is successfully carrying
out its current responsibilities. The expectation is that FDA would
create a new office and hire additional staff to carry out the
activities required by this legislation. The new responsibilities would
be funded through a user fee on the tobacco industry, so it would have
no impact on the funding provided to FDA to carry out its other
important activities. The user fees are allocated among the
manufacturers of tobacco products sold in the United States, based on
the manufacturers' respective shares of the entire U.S.-
tobacco product market. Many of the groups that support this
legislation care deeply about the many important tasks of the FDA
including drug and device approval and the work the agency does to
protect our food supply. But we also believe that a key to improving
the Nation's health is reducing the harm caused by tobacco products.
Impact on Tobacco Companies.--Some tobacco companies have argued
that this bill will give an advantage to one tobacco manufacturer over
others, claiming that certain tobacco companies can more easily comply
with stringent FDA regulations and that industry leaders will benefit
by the bill's restriction of tobacco marketing. Neither argument has
any merit.
When the FDA sets safety standards for foods and drugs, its focus
is on safety and efficacy, not the size of the manufacturer or the
impact on market share. For those other products, the only
manufacturers who are hurt are those who can't meet FDA's public health
standards. This bill does the same for tobacco products and creates a
level playing field for all manufacturers. The bill's marketing
restrictions are also fair and balanced. Today, close to 90 percent of
all new long-term smokers are children. It is a strength of this
legislation, not a weakness, that it provides a comprehensive attempt
to restrict marketing that appeals to children. The tobacco industry
claims its marketing is about brand competition among smokers; the
industry's own documents and Judge Kessler's decision last August
reflects powerful evidence that the industry's advertising is a major
contributor to tobacco use by youth. What is of paramount importance to
public health is the size of the overall market for tobacco products,
NOT the market share of any particular company. We believe that this
legislation will significantly reduce the number of people who use
tobacco and who become sick and die as a result.
State and Local Authority.--The legislation achieves a reasonable
balance between Federal and State or local authority over tobacco. It
allows the States to continue to regulate the sale, distribution, and
possession of tobacco products and would expand State authority to
regulate tobacco product marketing. To ensure consistent product
standards nationally, however, the legislation reserves to the Federal
Government the right to regulate the product itself, which is
consistent with the way the FDA regulates other products under its
jurisdiction.
We believe that States and localities ought to be able to control
the time, place and manner of tobacco advertising in their communities,
and this legislation will allow them to do that for the first time in
almost 40 years. The bill cuts back, but does not fully eliminate, the
exemption for the tobacco industry passed in 1969 as part of the
Federal Cigarette Labeling and Advertising Act. That act prevented the
States from regulating cigarette advertising, even purely local forms
of cigarette advertising. The bill returns to State and local
governments the ability to impose limitations on the time, place and
manner of marketing and advertising practices, but not on the content
of ads. The States already have this authority for smokeless tobacco
products and other products regulated by FDA, and it has not created
problems for the marketplace.
The sponsors of this legislation were careful to specifically make
clear that the legislation does not curtail any of the areas States
have traditionally used to reduce tobacco use. Under the legislation,
State and local governments would continue to be free to adopt measures
regulating exposure to secondhand smoke; restricting youth access to
tobacco products; and enacting fire safety standards for tobacco
products. In short, the bill in no way restricts States from pursuing
policies such as smoke-free laws, tobacco taxes, fire-safe measures,
age requirements, identification checks, retailer licensing and fines,
and other restrictions on the sale and distribution of tobacco products
that have been instrumental in reducing tobacco use. States would also
be able to impose additional reporting requirements on tobacco
manufacturers (as Massachusetts, Texas and Minnesota have done) if
there was any information FDA was not getting or not sharing that a
State thought would be useful.
The bill does give the FDA exclusive authority in such areas as
tobacco product standards, pre-market approval, adulteration,
misbranding, labeling, registration, good manufacturing standards, or
modified risk products. States could not establish requirements in
these areas. This approach is consistent with Federal law regarding FDA
regulation of drugs, devices, and food because it provides for a
consistent national standard.
Permitting Cross Category Comparative Health Claims.--The bill
permits the FDA to authorize tobacco manufacturers of one type of
tobacco product to make health claims comparing the risks of its
tobacco to other forms of tobacco products, but only if the
manufacturer has presented sufficient scientific evidence that the
advertised product is indeed safer and will reduce the user's risk of
disease--in this regard, the bill is explicit. There has been a debate
about whether the use of smokeless tobacco by committed, addicted
smokers who can't or won't quit can be a useful harm reduction
strategy. This bill sets the scientific standard for FDA making such a
determination, but doesn't prejudge the scientific result. If a
smokeless tobacco manufacturer provides the FDA with adequate
scientific evidence that a specific product or group of products is
less hazardous than a cigarette product and will reduce the risk of
disease among certain tobacco users, FDA is authorized to permit the
smokeless manufacturer to make an approved claim. However, in making
such a determination, FDA is required to consider the population-wide
impact of permitting such claims, including the impact of any claims on
the number of smokers who would otherwise quit using tobacco altogether
and the number of people who begin using tobacco products.
Limitations on FDA's Authority Over Tobacco Growers and Leaf
Tobacco.--The bill contains a number of specific prohibitions against
the exercise of FDA authority on tobacco farms. The bill establishes
FDA authority over tobacco manufacturers and their products and
prohibits FDA from regulating leaf tobacco. Even FDA's standard-setting
authority is limited to standards for manufactured tobacco products.
Many tobacco growers believe American producers, much more easily than
their foreign competitors, will be able to swiftly produce the quality
tobacco leaf manufacturers require, and that consequently the
legislation may provide American growers with a comparative advantage
over foreign competition.
conclusion
Mr. Chairman, in summary, the Campaign strongly suports this bill,
and we firmly believe that it will help protect our kids from tobacco
companies and their deadly products and deceptive advertising. It will
help more adult tobacco users to quit, and it will greatly benefit the
public health of the Nation.
The Chairman. Thank you. You're an old friend and I'm
delighted to have you testifying today.
Dr. Huerta.
STATEMENT OF DR. ELMER HUERTA, M.D. M.P.H., PRESIDENT, AMERICAN
CANCER SOCIETY, WASHINGTON, DC
Dr. Huerta. Good morning, Mr. Chairman. Good morning
distinguished members of this committee and thank you very much
for allowing me to testify this morning.
I am Dr. Elmer Huerta. I am the incoming President of the
American Cancer Society and Director of the Cancer Preventorium
at the Washington Hospital Center here in Washington, DC.
As a physician and researcher who specializes in cancer
prevention and the screening among the medically underserved, I
see firsthand the toll tobacco takes on our country and the
benefits of prevention in combating cancer.
On behalf of the more than 28 million volunteers and
supporters of the American Cancer Society and its sister
organization, the American Cancer Society Cancer Action
Network, I thank you, Mr. Chairman, again and your committee
for inviting me this morning.
The need for FDA regulation of tobacco is great and its
benefits are clear. The tobacco industry made voluntary
promises as part of the Master Settlement Agreement that it
would stop marketing to children. Those promises have been
broken. Our children have been left unprotected and the tobacco
industry is taking advantage of that loophole in sinister
fashion.
Indeed, the most popular cigarettes among children are the
most heavily advertised brands--Marlboro, Camel and Newport.
How does it happen? Here are five ways. First, the MSA did
not place any restrictions on advertising in print media such
as magazines. In fact, cigarette advertising in youth-oriented
magazines actually increased in the 2 years after the MSA.
Second, the MSA did not limit or restrict in-store tobacco
advertising, knowing that 75 percent of teens visit a
convenience store at least once a week. The cigarette companies
increased their advertising and promotion in and around these
stores.
Third, while the MSA banned large billboards, it permitted
outdoor signs up to 14 square feet in size, even if it is
placed right next to schools or playgrounds.
Fourth, the MSA lacks a quick and effective mechanism for
identifying violations and compelling industry compliance.
Finally and most importantly, the MSA did not establish an
enforceable system and comprehensive set of rules to restrict
or eliminate all the major tobacco advertising and marketing
tools that have the greatest influence on our children.
Because the tobacco companies remain unregulated and
unchecked, they have circumvented the limited other tightened
restrictions placed on them by the 1998 MSA and continue to
target children.
Two recent examples include Brown and Williamson's Kool
Mixx campaign and RJ Reynolds candy-flavored cigarettes. The
Kool Mixx campaign focused its marketing images around music
and hip-hop, which is particularly appealing to African
American and Latino youth. The campaign included 14 music
concerts, a DJ competition and special themed packs of
cigarettes. In 2004, RJ Reynolds introduced flavored cigarettes
such as Twista Lime and Winter Mochamint, using colorful
graphics and scratch and sniff marketing tactics in both cases.
The State Attorney Generals asserted that tobacco companies
had violated the MSA by targeting youth through their
advertising and promotions.
This legislation introduced by you, Mr. Chairman and
Senator Cornyn, would provide FDA with the authority and
resources to effectively regulate tobacco products. The FDA
would be authorized to restrict tobacco advertising and
promotions, especially those targeted at children as evidenced
in the examples stated previously. In addition, it would
require the tobacco companies to disclose the ingredients of
tobacco products and smoke constituents, prohibit
unsubstantiated health claims about so-called reduced risk
products and require larger and more informative health
warnings on tobacco products, among other measures.
Last year, in a Department of Justice case against the
tobacco companies, U.S. District Court Judge Gladys Kessler
concluded, knowing that advertising and promotion has
stimulated the demand for cigarettes, defendants use their
knowledge of young people gained through tracking youth
behavior and preferences in order to create marketing
campaigns, including advertising, promotion and couponing that
would appeal to youth in order to stimulate youth smoking
initiation and to ensure that young smokers would select their
brands.
Just this year, RJ Reynolds introduced a new version of its
common brand of cigarettes specifically designed to appeal to
women and girls. These new packs are laced in hot pink and
teal. Ads include the slogans such as Light and Luscious.
Shockingly, the industry is targeting women and girls at a time
when lung cancer is the No. 1 killer of women.
Mr. Chairman, we think that these regulations in the bill
introduced today are extremely important for the public health
for the people and I would just say, with all due respect,
Senator Burr, that the status quo only favors the tobacco
industry. Thank you very much.
[The prepared statement of Dr. Huerta follows:]
Prepared Statement of Elmer Huerta, M.D., M.P.H.
I am Dr. Elmer Huerta, incoming President of the American Cancer
Society and Director of the Cancer Preventorium at the Washington
Hospital Center. As a physician and researcher who specializes in
cancer prevention and screening among the medically underserved, I see
firsthand the toll tobacco takes on our country and the benefits of
prevention in combating cancer. On behalf of the more than 28 million
volunteers and supporters of the American Cancer Society and its sister
advocacy organization the American Cancer Society Cancer Action
Network, I thank you, Mr. Chairman, and your committee colleagues for
inviting me to testify today regarding the need for providing the Food
and Drug Administration with meaningful authority over tobacco products
as is found in S. 625 introduced by you, Senator Kennedy, and Senator
John Cornyn.
As you know, the American Cancer Society is the nationwide,
community-based voluntary health organization dedicated to eliminating
cancer as a major health problem by preventing cancer, saving lives and
diminishing suffering from cancer, through research, education,
advocacy and service. In 2001, the Society created its sister
organization, the American Cancer Society Cancer Action Network,
referred to as ACS CAN, to more aggressively fight cancer through
advocacy. Conquering cancer is as much a matter of public policy as
scientific discovery, so building on the more than 90 years of
excellence of the Society, ACS CAN serves as the lobbying arm and force
necessary to push for legislative changes at the local, State and
national levels.
The Society and ACS CAN have established aggressive goals to reduce
cancer incidence and mortality--goals that we are pursuing with the
cooperation and collaboration of the public, private, and nonprofit
sectors. We know from data and scientific evidence that one of the key
steps to achieving an accelerated reduction in cancer incidence and
mortality is tobacco control--especially when it comes to children--
through meaningful regulation of tobacco products and effective
cessation programs that will help those currently addicted to quit.
The need for FDA regulation of tobacco is great. We're talking
about an industry that sells and markets deadly products and does so
without any accountability. In fact, tobacco products are the only
consumable product not regulated by the FDA. This leaves consumers
uninformed about tobacco products' ingredients and health dangers.
The benefits of FDA regulation are clear. FDA regulation will help
us to combat the vicious marketing practices of a deceptive industry
that has preyed upon our children, minorities, and existing smokers who
are desperately trying to kick their habit. FDA regulation will protect
these groups, and in the process it will help reduce what can only be
considered disturbing disparities in cancer rates and death rates.
Stated simply, FDA regulation will save lives.
We are at a huge disadvantage when it comes to combating the
deceptive marketing practices and false health claims made by the
tobacco industry. Mr. Chairman, over the years, the public health
community and the public at large have worked hard at all levels of
society to combat this Nation's deadly addiction. However, our efforts
simply have not been strong enough. Voluntary guideline promises by
industry have not worked and cannot be enforced. We all agree, Federal
regulation of tobacco is absolutely necessary and now is the time for
Congress to act.
Under your leadership, we have come close several times to passing
this crucial piece of legislation. In 1998, we took a small step closer
to regulation of the tobacco companies with the Master Settlement
Agreement. The Agreement set a promise from the tobacco industry to the
States that marketing to children would cease. But it was just a
promise. The restrictions on cigarette marketing to children outlined
in the MSA do not sufficiently restrict the companies' marketing
practices. Instead, the MSA has changed the companies' public relations
strategies so that the deceptive practices aimed at creating a new
generation of smokers continues. In an attempt to burnish their public
image as ``good partners'' seriously working to implement the spirit of
the MSA, they have even initiated ineffective and sometimes harmful
youth anti-tobacco campaigns.
Despite the MSA provision that the tobacco companies cannot ``take
any action, directly or indirectly, to target youth in the advertising,
promotion or marketing of tobacco products,'' tobacco companies'
marketing and promotion continue to have a direct impact on children.
There are five ways in which the MSA is not strong enough. First, the
MSA did not place any restrictions on advertising in print media, such
as magazines. In fact, cigarette advertising in youth-oriented
magazines actually increased in the 2 years after the MSA. It took R.J.
Reynolds to be found guilty of directly marketing to children in 2002
before they decreased their magazine advertising that reached children.
Second, the MSA did not limit or restrict in-store tobacco advertising.
Knowing that 75 percent of teens visit a convenience store at least
once a week, the cigarette companies increased their advertising and
promotions in and around retail stores, such as convenience stores.
Third, while the MSA banned large billboards, it permitted outdoor or
outdoor-facing signs up to 14 square feet on the properties of
businesses that sell tobacco products, even if those properties are
right next to schools or playgrounds. Fourth, the MSA lacks a quick and
effective mechanism for identifying violations and compelling industry
compliance. And finally and most importantly, the MSA did not put into
place an enforceable system and comprehensive set of rules to restrict
or eliminate all the major tobacco advertising and marketing tools that
have the greatest influence on our children.
Because the tobacco companies remain unregulated and unchecked,
they have been able to circumvent the limited advertising restrictions
placed on them by the 1998 Master Settlement Agreement, continuing to
target children and have even increased their marketing expenditures by
125 percent since the MSA. Worse still, the tobacco industry is
spending more than ever before to market its deadly products. In 2003,
the most recent year data are available, the cigarette companies spent
$15.1 billion, or more than $41 million a day, on marketing their
products. Again and again, the tobacco companies have proven to us they
will manipulate the system to encourage the uptake of smoking and keep
current smokers from quitting by introducing new products and using
creative marketing tactics, particularly aimed at children and other
vulnerable populations. FDA regulation of tobacco is vital to control
this rogue industry and to protect our most vulnerable members of
society.
This is an industry that cannot be trusted. Last year, in the
Depart of Justice case against the tobacco companies, U.S. District
Court Judge Gladys Kessler concluded:
``Knowing that advertising and promotion stimulated the
demand for cigarettes, Defendants used their knowledge of young
people, gained through tracking youth behavior and preferences,
in order to create marketing campaigns (including advertising,
promotion, and couponing) that would appeal to youth, in order
to stimulate youth smoking initiation and to ensure that young
smokers would select their brands.''
The tobacco industry has demonstrated time and again that, if left
to its own devices, it will falsely market its deadly products to our
children, portraying this deadly addiction as glamorous and cool. In
its March 2000 ruling, the U.S. Supreme Court found that tobacco use is
``one of the most troubling public health problems facing our Nation.''
The industry continues to lure in new customers through its seductive
advertising campaigns and price discounting, which has been proven to
greatly affect the uptake of smoking by children.
Researchers and the tobacco companies alike know how great a role
marketing plays in children's uptake of tobacco use. Numerous studies
have shown that children are three times more sensitive to tobacco
advertising than adults. The most popular cigarettes among children are
the most heavily advertised brands--Marlboro, Camel and Newport.
Research tells us that children are more likely to be influenced to
smoke by cigarette marketing than by peer pressure and one third of
tobacco use experimentation by children is attributable to tobacco
advertising and promotions. The tobacco companies know this and use
this information to target children.
The most recent effort by the tobacco industry to entice children
into smoking has been the introduction of candy flavored cigarettes
into the market in 2004. R.J. Reynolds introduced flavors such as
Twista Lime and Winter MochaMint, using colorful graphics and ``scratch
and sniff'' marketing tactics. In 2005, the States' Attorneys General
asserted that R.J. Reynolds had violated the 1998 Master Settlement
Agreement by targeting youth through its advertising and promotion of
flavored cigarettes. As stated by Attorney General Eliot Spitzer,
``Selling candy, fruit and sweetened alcohol flavored
cigarettes is downright irresponsible, given the appeal of
these products to youth. This result reflects a recognition
that the Attorneys General, together with the public health
community, will not tolerate Reynolds' shameful ploys to
introduce our children to smoking and to lure them into a
lifetime of addiction to its deadly products.''
This once again reminds us of the deceptive tactics the industry
will continue to make to attract children to smoking and the desperate
need for FDA regulation. It's a shameful reality, but it's just that--
reality.
The industry also specifically targets minority youth. Brown and
Williamson introduced its own version of flavored cigarettes as part of
its Kool Mixx campaign. The Kool Mixx campaign focused its marketing
images around music and hip-hop, which is particularly appealing to
African American and Latino youth. The Kool Mixx campaign included 14
music concerts around the country and a DJ competition, as well as
special-themed packs of cigarettes with cartoons displayed on them. In
addition, Brown and Williamson placed advertisements in publications
popular with Latino youth, including Latina and Cosmoplitan en Espanol.
The slogans used in these ads included ``It's about old world class and
new world style'' and ``It's about pursing your ambitions and staying
connected to your roots,'' aimed at appealing to the aspirations of
ethnic minorities. The States' Attorneys General found the industry in
violation of the 1998 Master Settlement Agreement, by using the Kool
Mixx campaign to target youth, proving once again that the tobacco
industry is incapable of regulating itself.
Brown and Williamson is not alone. Other tobacco companies have
also specifically targeted minority populations. In 1999 and 2000,
Philip Morris started a magazine ad campaign for Virginia Slims using
the slogan ``Find Your Voice.'' The ads targeted women and girls,
featuring Latinos and other ethnic women, suggesting that independence
and allure could be found by smoking. As recent as 2 weeks ago, R.J.
Reynolds introduced a new version of its Camel brand cigarettes,
specifically designed to appeal to women and girls. The pack of
cigarettes is laced in hot pink and teal and the ads include slogans
such as ``light and luscious.'' Amazingly, the industry is increasing
its attractiveness to women and girls at a time when lung cancer is the
No. 1 cancer killer of women.
FDA regulation presents our country with an historic opportunity to
protect all Americans from tobacco addiction, especially our children.
This legislation is a critical step toward reducing health care
disparities, as tobacco-related cancers remain disproportionately high
among lower-income and minority communities. Because these groups have
been repeatedly targeted by the tobacco industry, they unfairly carry a
greater weight of the health and economic burden tobacco has on our
Nation. I know from my experience as a doctor that prevention is
effective at improving the health and well-being of people, but that
minority groups and low-income populations do not have the same access
to health programs, such as cessation services, as others do. This once
again gives the tobacco industry the unfair advantage. Tobacco use is
the most preventable cause of death and disease in this country and
granting the FDA authority over tobacco products is the key prevention
measure that is missing in this Nation in order to reduce tobacco's
deadly toll.
Some minority and ethnic groups and the medically underserved
suffer from a disproportionate burden of cancer and disease. Similarly,
large differences in tobacco use exist in the United States. For
example, currently, smoking prevalence is 37.5 percent among American
Indian/Alaska Native men, 26.7 percent among African-American men, and
24 percent among white men. This leads to marked differences in
tobacco-related cancer deaths among different groups within the
population. This year, it is expected that the rate of lung and
bronchus cancer deaths for white males will be 73.8 per 100,000 while
for African Americans it will be 98.4 per 100,000. Lung cancer death
rates for women have increased by at least 150 percent in the last two
decades alone and have yet to go down.
We have made real progress on the cancer front. For the second
straight year, we have seen a decrease in cancer deaths large enough to
outpace the aging and growth of the U.S. population. These declines can
be attributed in part to smoking cessation and other preventive
efforts, such as earlier and better cancer screenings. Mortality rates
from lung cancer in men decreased by about 1.9 percent per year from
1991 and 2003. We have also seen a decrease in the incidence of lung
cancer in men, from a high of 102 cases per 100,000 in 1984 to 78.5
cases in 2003.
Despite the significant gains we have seen in decreasing overall
cancer incidence and mortality rates, approximately 1.4 million
Americans still will be diagnosed with cancer this year and more than
550,000 will lose their battle with the disease, costing more than $206
billion in direct and indirect health care costs. While we are
encouraged by the overall decreased mortality from cancer, we have to
recognize that death rates from lung cancer in women have not yet
declined.
The health consequences from tobacco go beyond cancer and have an
enormous health and economic impact on our Nation. Tobacco use is
responsible for nearly one in five deaths in the United States--a
needless and tragically preventable loss of more than 400,000 American
lives each year. Tobacco kills more Americans than AIDS, drugs,
alcohol, car accidents, homicides, suicides, and fires combined. More
than 30 percent of all cancer deaths, 80 percent of chronic obstructive
pulmonary disease deaths, 21 percent of coronary heart disease deaths
and 18 percent of stroke deaths are attributable to smoking and tobacco
use. And sadly, we are starting to see the progress we've made in
reducing youth smoking initiation slip away. Overall, tobacco costs our
Nation over $96 billion in direct health care costs annually, and an
additional $97 billion in lost productivity.
While we have made progress on some fronts of the fight against
tobacco addiction, the enormous number of preventable deaths from
tobacco tells us how important FDA regulation of these products is now.
Deaths from tobacco can be prevented if our Nation seriously and
comprehensively addresses tobacco and makes a long-term investment in a
sustained campaign to prevent tobacco-related disease and death, which
includes Federal legislation to regulate an industry that has evaded
regulation for decades.
This legislation introduced by you, Mr. Chairman, and Senator
Cornyn would provide the FDA with the authority and resources to
effectively regulate the manufacturing, marketing, labeling,
distribution and sale of tobacco products. The FDA would then be
authorized to restrict tobacco advertising and promotions, especially
those targeted at children, including banning candy-flavored
cigarettes. It would also require the tobacco companies to disclose the
ingredients of tobacco products and smoke constituents. The FDA would
have the authority to prohibit unsubstantiated health claims about so-
called ``reduced risk'' products, and require larger and more
informative health warnings on tobacco products, among other measures.
The American Cancer Society and ACS CAN hope the introduction of
your and Senator Cornyn's bill will encourage Congress to act now to
grant the FDA authority to stop the tobacco industry's harmful and
deceptive practices, before more children become addicted and more
people die prematurely because of tobacco-caused disease. The Society
and ACS CAN urge policymakers to take action to ensure that disparities
in tobacco use and the associated adverse health outcomes are
addressed. We have prioritized the reduction and elimination of the
unequal burden of cancer as a top nationwide priority. As part of
meeting this challenge, the Society is working at all levels of the
organization to advance policies and programs that work to reduce
health disparities among minority and ethnic populations and the
underserved.
Mr. Chairman, on behalf of the Society and ACS CAN's nationwide
volunteers and staff, again thank you for your ongoing leadership on
tobacco issues and for providing us this opportunity to discuss with
you and your colleagues the importance of Federal regulation of tobacco
products. The need for FDA authority over tobacco products has never
been greater. The Nation's deadliest consumer product must not continue
to be unregulated. Mr. Chairman and members of the committee, we look
forward to working with you and your colleagues to address this issue.
We stand ready to join with you to protect our children from tobacco
use and to help those currently addicted to quit.
The Chairman. Dr. Land, we want to welcome you and thank
you very much for joining with us today and we know you've got
an important message.
STATEMENT OF RICHARD LAND, D.PHIL., PRESIDENT, THE ETHICS AND
RELIGIOUS LIBERTY COMMISSION OF THE SOUTHERN BAPTIST
CONVENTION, NASHVILLE, TN
Mr. Land. Thank you, Senator. Good morning, Mr. Chairman,
Senator Enzi and members of the committee. I'm Richard Land,
President of the Southern Baptist Convention's Ethics and
Religious Liberty Commission. The Southern Baptist Convention
is the Nation's largest Protestant denomination with more than
16 million members worshiping in nearly 44,000 autonomous local
congregations with a physical presence in 99 percent of the
counties of the United States.
The Ethics and Religious Liberty Commission is the official
Southern Baptist entity charged by the Southern Baptist
Convention to speak to our Nation's moral, cultural and
religious liberty issues. I appreciate this opportunity to
testify in favor of S. 625, The Family Smoking Prevention and
Tobacco Control Act, life saving legislation to authorize the
Food and Drug Administration to regulate tobacco products. We
have made the enactment of this tobacco legislation one of our
top legislative priorities for the 110th Congress. This is an
idea whose time has come.
Southern Baptists have strongly opposed the tobacco
industry for a long time. We have a book containing all the
resolutions passed by the Southern Baptist Convention in our
offices in Nashville and Washington. I perused them before this
testimony, Senator, and I found that--and these are just the
resolutions that call for control, regulation, and restriction
on the tobacco industry. There are about a dozen more that call
upon Southern Baptist to refrain from the use of tobacco but
the ones that actually call for action--2005, 1988, 1984, 1973,
1969, 1964--strongly commending the Surgeon General's report,
the first opportunity the Convention had to do so--1937, 1933,
and 1932. Interestingly, the 1984 resolution called upon
Southern Baptists who grew tobacco to switch to another crop if
at all feasible, to minimize the availability of this product.
I'm also here as a representative of a broad-based
coalition of faith leaders known as Faith United Against
Tobacco. Since it was founded in 2002, Faith United Against
Tobacco has grown to include over 20 national faith
denominations and organizations. In addition to the Ethics and
Religious Liberty Commission of the Southern Baptist
Convention, this coalition includes the General Board of Church
and Society of the United Methodist Church, the National
Council of Churches in Christ, the Presbyterian Church USA, the
Commission on Social Action and Reform Judaism, the Seventh Day
Adventists, the American Region of the World Seat Council and
the Islamic Society of North America.
Just yesterday, 24 national faith leaders from our
coalition sent a letter to every member of the U.S. Senate and
House of Representatives, urging support for the FDA
legislation. As you can see, the signers of this letter
represent very diverse groups, including Christian, Jewish,
Muslim and Seek Faith Traditions, whose members include many
tens of millions of Americans from every part of the country.
We all know the terrible statistics about the toll of
tobacco on our families. Over 400,000 Americans die every year
from tobacco caused illnesses. Hundreds of thousands of others
suffer every year from tobacco caused illnesses, such as lung
cancer and heart disease.
I have too many relatives, personally, particularly
paternal uncles who have had their lives tragically shortened
by their addiction to nicotine. Millions of Americans have had
their lives snuffed out before their time, often in their
prime, at the peak of their careers, with a spouse and children
at home, with many other responsibilities and joys before them.
The Southern Baptist Ethics and Religious Liberty
Commission and the other faith groups in the coalition join
America's public health community in viewing FDA regulation of
tobacco as a critically needed tool to reduce tobacco use.
This legislation would allow the FDA to prevent tobacco
companies from adding ever more deadly and addictive
ingredients, require larger and more informative health
warnings, prohibit candy-flavored cigarettes, prevent tobacco
sales to under-aged children and limit advertising and
promotion of tobacco products that lure children into a deadly
habit. Like many of you, we find it incredible that the FDA can
ensure the safety of everyday items like cold medicines,
cookies and even dog food but has no authority over tobacco, a
product that causes more preventable deaths than any other.
Faith leaders are not asking for a ban on tobacco products
or even that they be treated differently than other items. We
are simply asking that tobacco products be subject to the same
commonsense rules that apply to other products. We want to
level the playing field. Why should manufacturers of cessation
products that help people quit smoking be subject to FDA
regulation but not the products that kill over 400,000
Americans every year? No one wants too much government
regulation. What we are asking for is not overly burdensome. It
would simply assure the protection of consumers, particularly
our children. There is a broad consensus in the faith
community, both conservative and liberal, that this product
must be regulated and that is why we support this bill.
We also support it for moral reasons. While each person
bears responsibility whether he or she chooses to engage in
tobacco use, responsibility also falls upon those in authority
who have the power to end tobacco deception and significantly
reduce the illness and the death that it can produce. My faith
tradition teaches me that it is morally wrong to know the good
that should be done and not do it. I also believe it is morally
wrong to leave the most impressionable among us, our children,
unprotected from the tobacco enticements that confront them. So
I believe that those who are called to positions of leadership
and power have a moral imperative to safeguard the men, women
and children of our country from falling into the pitfalls of
tobacco use.
The members of the Faith United Against Tobacco Coalition
believe the U.S. Congress must do a better job of protecting
our children from tobacco addiction and the suffering of
tobacco-caused illness and death. As political leaders, you
have a moral obligation to act, to protect our children and
families. You have the means to curb the cycle of allurement
and addiction of disease and death caused by tobacco. We
believe you owe to the families of America to do so.
So we urge you to act quickly to enact this legislation, to
provide the Food and Drug Administration authority to regulate
tobacco products. I also have the copies of these resolutions
that I'd like to have----
The Chairman. They will be included as part of the record.
Mr. Land. Thank you.
[The prepared statement and resolutions submitted by Mr.
Land follow:]
Prepared Statement of Richard Land, D.Phil.
Good morning, Mr. Chairman, Senator Enzi, and members of the
committee. I am Dr. Richard Land, President of the Southern Baptist
Convention's Ethics & Religious Liberty Commission. As you are aware,
the Southern Baptist Convention is the Nation's largest non-Catholic
denomination, with more than 16 million members worshipping in nearly
44,000 autonomous local congregations, with a presence in 99 percent of
the counties of the United States. The Ethics & Religious Liberty
Commission is the official Southern Baptist entity charged by the
Southern Baptist Convention to speak to our Nation's moral, cultural,
and religious liberty issues.
I appreciate this opportunity to testify in favor of S. 625, the
Family Smoking Prevention and Tobacco Control Act, life-saving
legislation to authorize the Food and Drug Administration (FDA) to
regulate tobacco products. We have made enactment of the tobacco
legislation, introduced by Senators Kennedy and Cornyn and
Representatives Waxman and Davis, one of our top legislative priorities
for the 110th Congress. This is an idea whose time has come, and, on
behalf of most Southern Baptists, I strongly urge you to take action
now and enact this important legislation.
I am also here as a representative of a broad-based coalition of
faith leaders known as Faith United Against Tobacco. Since it was
founded in 2002, Faith United Against Tobacco has grown to include over
20 national faith denominations and organizations. In addition to the
Ethics & Religious Liberty Commission of the Southern Baptist
Convention, this coalition includes the General Board of Church and
Society of the United Methodist Church, the National Council of
Churches in Christ, the Presbyterian Church (USA), the Commission on
Social Action of Reform Judaism, the Seventh-day Adventists, the
American Region of the World Sikh Council, and the Islamic Society of
North America. Other broad-based groups, such as Church Women United
and the Health Ministries Association, which represents thousands of
faith community nurses across the country, have also joined Faith
United Against Tobacco.
In addition to our national effort to convince Congress to enact
the FDA regulation of tobacco legislation now before you, Faith United
Against Tobacco has worked successfully across the country to enact
tobacco control measures such as increased tobacco taxes, full funding
of tobacco prevention programs, and smoke-free workplace legislation.
In Indiana in 2005, for example, there was a very serious effort to
dramatically cut funding for that State's landmark tobacco control
program. A group of faith leaders, led by United Methodists, Southern
Baptists, and faith community nurses, formed the Hoosier Faith and
Health Coalition and took the lead in preventing these cuts from
happening, which has saved many Hoosiers, particularly children, from
tobacco addiction. Similar collaborations exist in other States,
including Alabama, Kentucky, New Jersey, North Carolina, Ohio, and
Texas. You can learn more about the history and accomplishments of
Faith United Against Tobacco at www.faithunitedagainsttobacco.org.
Our focus at the Federal level has always been on enacting
legislation to give the FDA authority over tobacco products. Just
yesterday, 24 national faith leaders from our coalition sent the
attached letter to every Member of the U.S. Senate and House of
Representatives, urging support for the FDA legislation. As you can
see, the signers of this letter represent very diverse groups,
including Christian, Jewish, Muslim, and Sikh faith denominations,
whose members include many tens of millions of Americans from every
part of the country. I think it is also important to note that the 24
leaders who signed this letter are often on opposite sides of other
very important social and political issues. But we are united in our
desire to reduce smoking, especially among children, and in our
commitment to the enactment of legislation authorizing the FDA to
regulate tobacco products.
We all know the terrible statistics about the toll of tobacco on
our families--over 400,000 Americans die every year from tobacco-caused
illnesses; hundreds of thousands of others suffer every year from
tobacco-caused illnesses such as lung cancer and heart disease; and
every day over 1,000 of our children become addicted to this deadly
product. For us in the faith community, these statistics are especially
tragic because every day we must bury mothers, fathers, sisters, and
brothers who die early from preventable deaths caused by tobacco
addiction that, more often than not, began at a young age. We, then,
are left with the task of trying to comfort their grieving survivors. I
speak this morning from personal experience. I have sought not only to
bring comfort to families and individuals, but to find comfort for my
own loss.
I have too many relatives, particularly paternal uncles, who have
had their lives tragically shortened by their addiction to nicotine.
One uncle, who died in his late forties from lung disease, horribly
exacerbated by smoking, still smoked even when reduced to carrying a
portable oxygen supply with him wherever he went in his final months.
He was literally a fire hazard to those around him. I am grateful that
both my father and my mother, once heavy smokers, were able with much
difficulty to break their tobacco habit in their late fifties. And
thus, they are still with us at 84 and 82, respectively. If they had
not quit smoking, they would both be long dead by now, a fact they
readily acknowledge. They would have missed their five grandchildren's
graduation from college, if not high school, and three of their
grandchildren's weddings. Other children have not been as fortunate as
I have been. They lost their parents prematurely to that ferocious
killer, tobacco.
Millions of Americans have had their lives snuffed out before their
time, often in their prime--at the peak of their careers, with a spouse
and children at home, and with many other responsibilities and joys
before them. The families of America must not continue to be lured
toward futures of incomplete chapters. Men and women deserve to know
the toxic chemicals rolled into every cigarette. Young sons and
daughters deserve to enjoy their youth without being confronted with
tobacco marketing tailored to their age.
Like the many Members of Congress from both parties and across the
political spectrum who are cosponsoring this legislation, the Southern
Baptist Ethics & Religious Liberty Commission and the other faith
groups in the coalition join America's public health community in
viewing FDA regulation of tobacco as a critically needed tool to reduce
tobacco use. This legislation would allow the FDA to prevent tobacco
companies from adding even more deadly and addictive ingredients;
require larger and more informative health warnings; prohibit candy-
flavored cigarettes; prevent tobacco sales to underage children; and
limit advertising and promotion of tobacco products that lure children
into a deadly habit. Like many of you, we find it incredible that the
FDA can ensure the safety of everyday items like cold medicines,
cookies, and even dog food, but has no authority over tobacco, a
product that causes more preventable deaths than any other.
Faith leaders are not asking for a ban on tobacco products or even
that they be treated differently than other items. We are simply asking
that tobacco products be subject to the same commonsense rules that
apply to other products. We want to level the playing field. Why should
manufacturers of cessation products that help people quit smoking be
subject to FDA regulation but not the products that kill over 400,000
Americans every year? No one wants too much government regulation. What
we are asking for is not overly burdensome; it would simply assure the
protection of consumers, particularly our children. There is broad
consensus in the faith community, both conservative and liberal, that
this product must be regulated, and that is why we support this bill.
We also support this bill for moral reasons. My faith tradition
informs me that our bodies are gifts from God and, therefore, should be
treasured and treated with dignity. This means we should refrain from
engaging in activities or abusing substances that pose grave threats to
our health. Tobacco is one such substance. While each person bears
responsibility for whether he or she chooses to engage in tobacco use,
responsibility also falls upon those in authority, who have the power
to end tobacco deception and significantly reduce the illness and death
that it can produce. My faith tradition teaches me that it is morally
wrong to know the good that should be done and not do it. I also
believe that it is morally wrong to leave the most impressionable among
us, our children, unprotected from the tobacco enticements that
confront them. And so, I believe that those who are called to positions
of leadership and power have a moral imperative to safeguard the men,
women, and children of our country from falling into the pitfalls of
tobacco abuse.
I find it unconscionable that Congress, knowing the deadly effects
of tobacco use, continues to leave tobacco companies virtually
unchecked, left to use their own discretion to determine what
carcinogenic chemicals to include in their products. I find it
unconscionable that Congress, knowing that the overwhelming majority of
adult smokers began their habit as minors, would do nothing more than
call unfortunate the tobacco companies' marketing targeted at children.
Almost 10 years ago, in 1998, Congress debated comprehensive
tobacco control legislation but failed to enact anything. In 2004, the
Senate overwhelming passed legislation virtually identical to S. 625,
but it was killed in a conference committee. Throughout this time
tobacco companies have continued to spend billions of dollars every
year marketing their deadly products to children and, as a result, far
too many high school students smoke and far too many people will die
prematurely from tobacco-caused diseases.
The Ethics & Religious Liberty Commission of the Southern Baptist
Convention and all other members of Faith United Against Tobacco
believe that the U.S. Congress must do a better job of protecting our
children from tobacco addiction and the suffering of tobacco-caused
illness and death. As political leaders, you have a moral obligation to
act to protect our children and families. You have the means to curb
the cycle of allurement and addiction, of disease and death, caused by
tobacco. You owe it to the families of America to do so. We, therefore,
urge you to act quickly to enact S. 625, bipartisan legislation to
provide the Food and Drug Administration authority to regulate tobacco
products.
Mr. Chairman, Senator Enzi, and other members of the committee, I
thank you for permitting me to testify this morning. I will be happy to
entertain any questions.
Resolution of Reducing Teen Smoking (June 2005)
WHEREAS, Human beings are created in the image of God (Genesis
1:26-27); and
WHEREAS, Being created in the image of God endows humans with great
dignity and inestimable worth; and
WHEREAS, More than four hundred thousand Americans die every year
from tobacco-caused diseases; and
WHEREAS, Every day in our Nation, five thousand children under the
age of eighteen, including adolescents of childbearing age, smoke their
first cigarette; and
WHEREAS, Every day in our Nation, two thousand children become
regular daily smokers, one-third of whom will die prematurely as a
result of tobacco-caused diseases; and
WHEREAS, Approximately one out of five pregnant teenagers passes
the risks of smoking on to her baby directly or through exposure to
secondhand smoke; and
WHEREAS, Preventing and reducing smoking and other tobacco use
among teenagers and other children requires a strong commitment from a
broad, diverse range of organizations and individuals concerned about
our Nation's youth and public health; and
WHEREAS, According to the American Cancer Society and other
national health organizations, one of the most effective ways to reduce
smoking and other tobacco use, particularly among adolescents, is to
raise the price of cigarettes, smokeless tobacco, and other tobacco
products through tax increases; now, therefore, be it
RESOLVED, That the messengers to the Southern Baptist Convention
meeting in Nashville, Tennessee, June 21-22, 2005, commit to add our
efforts to those of such national organizations as the American Cancer
Society, American Heart Association, Campaign for Tobacco-Free Kids,
and the American Lung Association to work to reduce tobacco use,
especially among teens; and be it further
RESOLVED, That we encourage our churches to redouble their efforts
to educate our youth about the dangers of tobacco use; and be it
further
RESOLVED, That we applaud those jurisdictions that have helped
reduce teen smoking with substantial tax increases on tobacco products;
and be it finally
RESOLVED, That we commit ourselves to seek ways, through personal
efforts and coalitions, to become more involved in our communities and
States to prevent and reduce smoking and other tobacco use, especially
among teens.
______
Resolution on Exportation of Alcohol and Tobacco (June 1988)
WHEREAS, The United States Government is actively pursuing export
markets for alcohol and tobacco industries; and
WHEREAS, The alcohol and tobacco industries are making profits at
the expense of the health of those who consume their products; and
WHEREAS, The United States Government is involved in the war
against addictive drugs; and
WHEREAS, Alcohol and tobacco are addictive.
Be it RESOLVED, That we encourage the United States Government to
cease to assist these industries via trade talks; and
Be it finally RESOLVED, That Southern Baptists in their annual
meeting, June 14-16, 1988, in San Antonio, Texas, declare their
opposition to these hypocritical practices by the United States
Government on behalf of the alcohol and tobacco industries.
______
Resolution on Cigarette Smoking (June 1984)
WHEREAS, We as Christians know that our bodies are temples of the
Holy Spirit, and that we should therefore refrain from defiling our
bodies; and
WHEREAS, The United States Government has for many years required
that tobacco companies state in their advertising and on cigarette
packages that smoking is hazardous to health; and
WHEREAS, Cigarette smoking is habit forming and often becomes a
physical addiction comparable to other drug addictions; and
WHEREAS, The Surgeon General of the United States, C. Everett Koop,
M.D., has described cigarette smoking as ``the most important health
risk in the country''; and
WHEREAS, Cigarette smoking is causally related to lung cancer and
coronary heart disease, as well as other diseases, and is the leading
cause of chronic bronchitis and emphysema; and
WHEREAS, The Surgeon General's report blames chronic lung disease
for more limitation of activity than any other type of disease, with
more than 500,000 hospital admissions a year attributed to this
disease; and
WHEREAS, More than 62,000 Americans have died of chronic
obstructive lung disease in 1983 with as many as ninety percent of
these deaths blamed on cigarette smoking, and costs the Nation forty
billion dollars a year in health expense and productivity; and
WHEREAS, The Surgeon General's report stated that children of
smoking parents have a higher prevalence of respiratory symptoms and
more frequent bouts of bronchitis and pneumonia in early life; and
WHEREAS, Mothers who smoke during their pregnancy have a higher
incidence of congenitally deformed and low-birth weight babies.
Therefore, be it RESOLVED, That the messengers of the Southern
Baptist Convention meeting in Kansas City, Missouri, June 12-14, 1984,
encourage churches to give people the facts regarding the physical harm
involved in cigarette smoking, beginning with children of an early age;
and
Be it further RESOLVED, That we encourage schools to make
information regarding the harm of cigarette smoking part of the
curriculum for students of all ages; and
Be it further RESOLVED, That we encourage parents by personal
example to teach abstinence from cigarette smoking; and
Be it further RESOLVED, That our churches, associations, State
conventions, and the Southern Baptist Convention take leadership in
encouraging our people, pastors, and SBC leaders to refrain from using
tobacco in any form, including cigarettes; and
Be it further RESOLVED, That we encourage Southern Baptists
presently engaged in the growing of tobacco, which has no use except
for cigarettes and related products, to cease such agriculture and,
where feasible, to switch to another cash crop in order to make such
products less accessible; and
Be it finally RESOLVED, That we encourage the Congress and Senate
to terminate all agricultural funding and subsidies to those who plant,
grow, or sell any tobacco products.
______
Resolution on Alcohol and Other Drugs (June 1973)
WHEREAS, The drug problem a complex and intricately interrelated
phenomenon in our society, now including a widespread misuse of
valuable prescription products, a broad spectrum of unscientific self-
medication, a deeply implanted custom of cigarette smoking, deeply
entrenched customs of drinking alcohol beverages, and an alarmingly
developing culture involving marijuana and other illegal drugs, and
WHEREAS, This pervasive drug orientation of our culture is
resulting in widespread social disruption and destruction of life by
cancer, emphysema, coronary heart disease, accidents, alcoholism and
other drug addiction, and is a factor in other serious social problems
such as crime, family disruption, industrial waste, and automobile
accidents, and
WHEREAS, Basic factors now recognized as perpetuating the drug
approach to life are commerical promotion of alcohol, tobacco, and
over-the-counter drugs; glamorization of the use of alcohol and
tobacco; social pressures for smoking, drinking, and other drug usage;
and widespread ignorance of accurate information pertinent to personal
usage of these drugs, and
WHEREAS, Contemporary efforts of government, church, civic groups,
and other independent agencies are failing to cope effectively with the
drug orientation of our culture.
Therefore, be it RESOLVED, that we encourage the Congress--also
such agencies as Food and Drug Administration; Department of Health,
Education, and Welfare; Department of Environmental Control; Federal
Communications Commission; Office of Consumer Affairs; Federal Trade
Commission; Office of the Attorney General; and the Office of the
President--to take action to control advertising of alcohol, tobacco,
and other addictive drugs which perpetuate the drug orientation of the
culture, and
Be it further RESOLVED, that we call for the broadcast possible
offensive to be mounted to restrain commercial promotion of all such
products, and
Be it further RESOLVED, that we pledge our cooperation with others
to neutralize social pressures and minimize glamorization of drug
usage, and
Be it further RESOLVED, that preventive education in the homes, the
churches, and the schools be strongly encouraged, and
Be it further RESOLVED, that the Christian Life Commission be
encouraged to work diligently with appropriate agencies of the Southern
Baptist Convention to publicize this position and to encourage
cooperation with others seeking these same objectives.
______
Resolution on Cigarette and Liquor Advertisement (June 1969)
WHEREAS, There is pending legislation in the National Congress
dealing with the regulation and possible deletion of cigarette and
liquor advertisement from the mass media,
Therefore, be it RESOLVED, That we give encouragement and support
to all Congressmen who are backing this legislation.
______
Resolution on a Request of President Lyndon B. Johnson (June 1964)
WHEREAS, The Surgeon General's Committee appointed by President
Kennedy rendered our Nation a much-needed service in pointing out the
hazards of cigarette smoking, which report can have far-reaching
benefits to human health and well-being,
WHEREAS, The serious problem of beverage alcohol also deserves the
same careful medical and scientific investigation,
We go on record as a Convention as requesting President Johnson to
appoint a similar commission to investigate and to make known to our
American people the hazards to personal health and to society presented
by the use of alcohol as a beverage.
______
Amendment to Report by the Social Service Committee (adopted) (May
1937)
``It is the sense of this Convention that the prevalence of smoking
among Christian people, especially among preachers, church leaders and
denominational workers, is not only detrimental to the health of those
who participate, but is hurtful to the cause of Christ in that it
weakens the message and lowers the influence of those who are charged
with the preservation and spread of the Gospel.''
______
Resolution on Tobacco (May 1933)
J. M. Shelburne offered the following amendment and it was adopted:
RESOLVED, That we respectfully suggest to the ministers of our
churches and to the teachers in the schools of our land, and to the
fathers and mothers of our boys and girls, that they consider the
probable ultimate effect of the growing and excessive use of tobacco by
our boys and girls, with a view to arriving at some kind of cooperative
measures by which at least some of our young people may hope to escape
the experience of an habitual slavery to tobacco.
______
Social Service Committee Recommendation Concerning Race Relations
(adopted) (May 1932)
10. That we respectfully suggest to the ministers of our churches
and to the teachers in the schools of our land that they consider the
probable ultimate effect of the growing and excessive use of tobacco by
our boys and girls with a view to arriving at some kind of cooperative
measure by which some of our young people, at least, may hope to escape
the experience of an habitual slavery to tobacco.
The Chairman. Thank you very much.
Senator Hatch. Mr. Chairman, could I just take 1 minute
because I have to----
The Chairman. OK.
Senator Hatch.
Opening Statement of Senator Hatch
Senator Hatch. I'm very interested in what all of you have
to say and I will read all of the record. I'm really
appreciative of the Chairman and what he is trying to do here.
On the other hand, I'm worried sick about burdening FDA
with more responsibilities with maybe not enough finances to
take care of it. So I just want to express my concern because I
have a tremendous interest in everything you're talking about
regarding this matter. I have a tremendous interest in FDA. I'm
just really worried about it and I want to work with other
members of this committee to try and resolve these problems and
get them resolved in a way that is equitable for all but will
help to advance the cause of healthcare in our society. I just
appreciate your letting me say that, Mr. Chairman, because I'm
concerned about it and I appreciate the efforts that all of you
have made and I feel guilty that I have to leave. But I just
wanted to make that as clear as I could under the
circumstances. Thank you, Mr. Chairman.
The Chairman. Senator Hatch has had a long career ensuring
that we're going to have an FDA that is going to meet its
responsibilities in terms of oversight. This has been something
that he has been very much involved in. So we appreciate his
comments and involvement.
I'll introduce now the remainder of the panel. Dr. Jack
Henningfield is Adjunct Professor of Behavioral Biology in the
Department of Psychiatry at the Johns Hopkins University School
of Medicine. He is also Vice President for Research and Health
Policy at Pinney and Associates. He is the former head of the
laboratory of the National Institute of Drug Abuse, where he
evaluated the addictive potential of drugs, including cocaine,
sedatives, nicotine in various forms. He was assigned to be
editor of the 1988 Addiction Report of the Surgeon General,
advised the FDA on its tobacco regulations in the 1990s, and
advised the World Health Organization on issues related to
tobacco control.
Greg Connolly, is an old friend from Massachusetts, now a
Professor at Harvard School of Public Health who teaches and
conducts research in tobacco control policies and projects. He
has published over 70 scientific articles on smoking and health
issues. He is the former Director of the Massachusetts
Department of Public Health's Tobacco Control Program, one of
the largest campaigns to curb tobacco use in the world. Over
the 10 years that he directed the program, cigarette
consumption fell 50 percent in Massachusetts, three times the
national average. That is an impressive record. I don't think
there is a State in the country that used the money from the
Master Tobacco settlement more effectively, during this period
to combat tobacco use, and Gregory Connolly was the head of
that program. Under our recent governors, the money was cut out
for that program, which is very unfortunate.
Dr. Alan Blum is Professor and Endowed Chair in Family
Medicine, University of Alabama. He directed the Center for the
Study of Tobacco and Society. From 1977 to 2002, he led the
Doctor's Ought to Care. He has written over 100 articles on
tobacco problems. In recognition of his efforts to prevent
smoking, Dr. Blum has received the first Surgeon General's
Medallion from Dr. Koop, and the first public health award by
the American Academy of Family Physicians. We very much
appreciate your presence.
And Ms. Lisa Shames is currently GAO Acting Director for
Food and Agricultural Issues. Her portfolio covers issues of
food safety, agro-terrorism, agricultural conservation and farm
program payments.
Let's start with Dr. Henningfield.
STATEMENT OF JACK E. HENNINGFIELD, PH.D., VICE PRESIDENT,
RESEARCH AND HEALTH POLICY, PINNEY AND ASSOCIATES, BETHESDA,
MD, AND PROFESSOR OF BEHAVIORAL BIOLOGY AT JOHNS HOPKINS
UNIVERSITY SCHOOL OF MEDICINE, BALTIMORE, MD
Mr. Henningfield. Mr. Chairman, members of the committee,
thank you for the opportunity to testify and to serve. I have
studied drug addiction and health for three decades at Johns
Hopkins Medical School, the National Institute on Drug Abuse
and through my consulting at Pinney Associates to
GlaxoSmithKline on smoking cessation medications.
Many people think of tobacco products as relatively simple
concoctions of tobacco and flavorings that people smoke for
simply pleasure and with full awareness of the dangers and that
smoking is a completely free choice. Nothing could be further
from the truth.
Tobacco products are sophisticated drug delivery systems.
They are engineered and manufactured to increase addiction risk
and without any meaningful regulatory oversight to draw the
line on practices that unnecessarily increase harmful and
addictive effects.
FDA authority could lead to less addictive and less harmful
products and regulation of marketing could reduce deception.
Existing and future products need to be regulated. Existing
products are used by more than 50 million Americans a year,
killing more than 1,000 every single day. Setting standards for
chemicals that can heighten addictiveness, such as ammonia and
acetaldehyde and flavorings, such as menthol and chocolate
could be steps toward less addictive and less attractive
tobacco products.
Developing performance standards for toxicants such as
pesticide residues, tobacco specific nitrosamines, carbon
monoxide and formaldehyde could reduce toxic exposure in those
who continue to use tobacco. Regulation is needed to prevent
deceptive designs that are killing Americans.
Today, more than two-thirds of cigarette smokers smoke
light cigarettes. My sister was one of them. As she told me,
you can tell Marlboro Reds are worse. They felt stronger and
left my throat raw compared to lights.
Well, let me tell you a few things she didn't know. She
assumed there were government standards for light cigarettes.
She assumed that the FTC test method for tar and nicotine
reflected health effects or at least actual intake, as is the
case for food labeling. She assumed that cooler, smoother smoke
meant it was weaker and less harmful. She couldn't believe the
Government would allow such a scam.
Cigarette ventilation is one deadly scam you can see for
yourself. If you tear the paper from just about any cigarette
filter and especially a light cigarette and if your cameras are
looking for what I'm going to show you, they won't be able to
see them. You have to look close. You tear the paper off, hold
it up to the light, you can see tiny bands of holes. These
holes allow air to come into the smoking machine and fool the
machine into thinking the smoke is much weaker than it is. They
do the same thing for the smoker. What the smoker does is
inhale more deeply and more smoke and more deeply into the
lungs. The holes are right where they can be easily covered by
fingers or lips.
Unbeknownst to most smokers, covering some of the holes can
double or triple the amount of tar and nicotine. I did this
demonstration a few years ago for my son's third grade class.
They reacted with passion and clarity. They said, ``that's
cheating.'' They can't do that. The third graders got it.
Well, Senators, that is cheating and there is a means of
preventing and stopping such deception for food products but
not for tobacco, not until tobacco is regulated by the FDA.
But light cigarettes are just the tip of the iceberg. New
generations of products appear to be following the commercially
effective model of light cigarettes, which is to develop highly
addictive products with designs and marketing efforts that
assuage fears about tobacco so as to hook more people and keep
them using tobacco. These products will need their own
standards. They will need their own standards so that their
potential effects are understood before they are marketed,
before they are allowed on the market and to make sure that
marketing does not inappropriately promote use, including does
not inappropriately use FDA's regulation to promote use.
FDA is the right agency and the only agency with
appropriate experience to develop and enforce product
performance standards. I have heard the entire range of
arguments about why FDA should not be granted regulatory
authority, including that FDA was not designed to evaluate
cigarettes or inherently dangerous products. The fact is, FDA
was designed to assess a few ingredients and toxic exposures
for a broad range of products. Furthermore, tobacco products
are drug delivery systems at heart. Even the tobacco industry
documents admit this. Moreover, tobacco products are designed
and marketed to deceive and heighten addiction risk.
Finally, let me emphasize that FDA's authority will not
make tobacco products safe, will not make them nonaddictive and
should not been seen as a substitute for comprehensive tobacco
control efforts to reduce all forms of tobacco use and disease.
This is not an either/or situation. In fact, FDA regulation
should be viewed as a partner to tobacco control, finally
bringing FDA, the most powerful health regulatory agency in the
world, to the table alongside tobacco control professionals to
position and be positioned to serve these efforts because it
will restrict the ability of the industry to modify products
and use descriptors that undermine prevention and cessation.
I therefore urge expeditious passage and implementation of
the bill. Thank you for the opportunity.
[The prepared statement of Mr. Henningfield follows:]
Prepared Statement of Jack E. Henningfield, Ph.D.
Thank you for the opportunity to testify on S. 625, the Family
Smoking Prevention and Tobacco Control Act, that would provide ``the
Food and Drug Administration with effective authority to regulate
tobacco products.'' FDA regulation is not only the right thing to do,
it is urgent. More than 4 million Americans have died prematurely since
FDA asserted jurisdiction and issued its Final Rule to regulate
cigarettes and smokeless tobacco in 1996. Although we have made modest
progress in reducing tobacco use, I believe FDA regulation would have
made the progress significantly greater. Furthermore, the tobacco
industry is unleashing new products, new claims, and clandestinely
modifying conventional products at a terrifying rate, with no
plausibly-effective regulatory mechanism in sight, except for the
approach embodied in the Senate bill. Even the FTC has thrown in the
towel and apparently given up on its own widely criticized and deeply
flawed method of cigarette testing.
basis for testimony
I am speaking on my own behalf and not as a representative of the
organizations, of which I am a member, consult for, or voluntarily
serve. I am an Adjunct Professor of Behavioral Biology (Adjunct),
Department of Psychiatry, The Johns Hopkins University School of
Medicine; and Vice President for Research and Health Policy, Pinney
Associates. I was trained in behavioral science, pharmacology, and
other disciplines relevant to understanding addictive substances. I
have focused on tobacco-related issues for nearly three decades. From
1980 to 1996, I conducted and led tobacco and other drug research at
the National Institute on Drug Abuse (NIDA). While at NIDA, I was
liaison frequently to the FDA on tobacco products and tobacco addiction
treatment. I contributed to numerous Surgeon General's reports as well
as reports by other agencies. I presently serve on the World Health
Organization (WHO) Tobacco Regulation Study Group (TobReg) which
provides scientific guidance for implementation of several articles of
the international tobacco treaty, the WHO Framework Convention on
Tobacco Control (FCTC); a treaty (signed by not yet ratified by the
United States) which includes many directives in harmony with the
proposed FDA tobacco regulation.
By further way of disclosure and to provide you with some basis for
my perspective, let me tell you that part of my role at Pinney
Associates is to advise companies on how to minimize the risk of abuse,
addiction, misuse and harmful effects of drugs with a known or
suspected potential to cause addiction, including opioid analgesics,
stimulants, sedatives, and many others. In many cases it is not only
the chemical entity itself but the formulation and marketing of the
drug that poses the challenge for risk minimization. This work includes
advising GlaxoSmithKline Consumer Healthcare on its treatments to help
people quit smoking. I also share two patents on a tobacco dependence
treatment product under development which has given me additional
perspectives on FDA regulation. On the tobacco side, I have reviewed
thousands of pages of previously secret document and testified on
behalf of the U.S. Department of Justice (DOJ) and other plaintiffs
against the tobacco industry concerning the many ways by which this
industry has been able to manipulate its products to heighten their
addiction risk under the cover of darkness left by the regulatory
vacuum. I have gained first hand experience in understanding the
challenges and benefits of FDA regulation of the tobacco industry and
its products through these activities.
tobacco products are sophisticated drug delivery systems--engineered
and manufactured to increase their potential to cause and sustain
addiction
Tobacco products are diverse and all are harmful and share the
common feature of being designed to cause and sustain addiction to
nicotine. The World Health Organization said in its 2006 World No
Tobacco Day report, an effort to which I contributed: all tobacco
products are deadly and addictive in any form or disguise. Products
vary widely in their form and degree of sophistication in engineering.
The most elaborately designed and manufactured product, the cigarette,
accounts for the vast majority of the more than 1,000 tobacco-
attributable deaths that occur every day in the United States.
For most consumer products, extensive research and design expertise
by manufacturers is often used to improve safety and reduce risk.
However, this is not true for cigarettes: much of the research and
engineering has been dedicated to increasing their risk of causing and
sustaining addiction and high levels of use. In fact, many features are
intended to make it easier to inhale the deadly poisons deep into the
lungs where the damage is greatest. Why? Because this increases the
addictive impact of nicotine by producing explosively fast absorption
in the massive alveoli bed of the lung. This undoubtedly helps explain
why lung cancer risk increased in the 1980s and 1990s even though
machine measured tar levels declined. It also may help to explain the
increasing proportion of the especially deadly deep airway small cell
adenocarcinomas relative to squaemous cell lung cancer in the recent
decade.
Cigarette design and manufacture is extensively researched and
engineered to control features that contribute to deceiving smokers
into thinking they are getting less harmful exposures, to make it
easier to take up smoking, and to cause and sustain addiction. Much of
this was summarized in the FDA's Final Tobacco Rule (1996) and more
recently in the 1,700-page findings by Judge Kessler in her ruling in
the U.S. Department of Justice litigation against the tobacco industry.
She wrote:
``Every aspect of a cigarette is precisely tailored to ensure
that a cigarette smoker can pick up virtually any cigarette on
the market and obtain an addictive dose of nicotine.''
(Paragraph 1368).
Further, Judge Kessler concluded:
``Defendants have designed their cigarettes to precisely
control nicotine delivery levels and provide doses of nicotine
sufficient to create and sustain addiction.'' (Paragraph 1366).
The remarkable range of features includes control over the
following aspects of cigarette design, delivery, and addictive impact.
Ignition propensity and burn rate are controlled with burn accelerants
and paper porosity to help control nicotine dosing and make cigarettes
convenient to use. Smoke particle size is engineered to facilitate
efficient inhalation of smoke deep into the lung. Smoke temperature and
harshness are controlled to make it easier to take up smoking, to
inhale deeply and provide smoother smoke that fools the smoker into
assuming it's not as harmful. Smoke and ash color are controlled with
chemicals in the tobacco and paper to make the process as neat and
attractive-appearing as possible. Ingredients are further added to
smooth, flavor and make the smoke more attractive to target
populations, even if they yield additional carcinogens to the smoke
(such as burned chocolate does). Still other chemicals are added that
prolong shelf life and control humidity, which, in turn, helps control
nicotine dosing and smoke sensations. The inclusion of some of these
ingredients on FDA's Generally Recognized as Safe (GRAS) list is
virtually meaningless when they are used in cigarettes. These
ingredients have not been tested and approved for use in burned
products. They are ``GRAS'' for use in food, not for inhalation in
combination with burned tobacco material. Certain agricultural
practices, storage, shipping and handling add still other questionably-
safe chemicals, such as herbicides, pesticides, fertilizer residues,
heavy metals, cyanide, arsenic, and insect parts. The fact that many
American tobacco growers maintain high standards does not obviate the
need for regulation of the substances in tobacco plant material,
particularly since so much tobacco is imported.
A number of chemicals used in manufacturing process further alter
the addictiveness of the product through manipulation of the chemical
form of nicotine (e.g., ratio of free-base or unionized nicotine to
ionized nicotine). These compounds increase the amount of free base
nicotine, probably increasing the addictiveness of cigarettes because
free-base nicotine is more readily released from the cigarette and
absorbed in the mouth. For example, ammonia compounds can alter the
free base fraction of the smoke while also making it easier to inhale.
The practice of manipulating the free base fraction of nicotine is not
unique to cigarettes: smokeless tobacco products marketed as
``starter'' products (an industry term) are mildly alkaline to yield a
smaller proportion of free base nicotine than the more alkaline
maintenance products such as Copenhagen. Why? Too much nicotine
delivered too rapidly to the novice user can cause acute nausea and
discourage further use. By contrast, highly tolerant smokeless users
who have ``graduated'' (another industry term) to higher levels of
daily use seek stronger and faster doses to satisfy their addictions.
Cigarette filter technology is also extremely sophisticated and
reduces certain throat burning sensations but not necessarily the
deadliest of the toxicants. Filters can help ensure that nicotine is
readily delivered in a form that can be easily inhaled deep into the
lung where addiction potential is maximized, and lung disease risk is
increased by the inhalation of smoke particles that carry nicotine
molecules into the lung. Filters also commonly include elaborate
ventilation systems (described in greater detail below), which can
increase the free-base fraction of nicotine and enable smokers to
obtain addictive levels of nicotine regardless of its advertised yield.
It is time to rein in the addictiveness and harmfulness of tobacco
products by giving FDA the authority to enact performance standards to
regulate and restrict levels of ingredients (added or residual) that
are toxic, and to reduce the ability of the industry to maximize the
addictive potential of their products.
it is vital to give fda the authority to regulate tobacco products and
develop product performance standards as will be accomplished through
senate bill s. 625
FDA could develop performance standards that, over time, could lead
to less addictive and less harmful products. One key feature of the
legislation is that mere compliance with a performance standard cannot
be used as the basis for product claims. This will help ensure that
communications about the dangers are not weakened. After all, the
products will still remain highly toxic and addictive by any ordinary
standards and communications should not be used to imply anything
contrary to these facts.
Performance standards can and should be developed for all smoke
constituents including those that affect addictiveness and
attractiveness as ammonia compounds, acetaldehyde, menthol, flavorings,
as well as substances emitted in the normal course of use of the
products, such as carbon monoxide gas and carcinogens. In addition,
performance standards could cover substances that may not have been
intended for the final product but are residual from tobacco growing,
storage and processing, such as pesticide and herbicide residues, as
well as contaminants including heavy metal residues, cyanide, insect
parts and other materials. Performance standards can also be developed
for product emissions commonly known as tar but which include deadly
carcinogens such as tobacco specific nitrosamines, and formaldehyde.
Nicotine content and dosing need to be regulated. Nicotine is
regulated in medicines and it must be regulated in tobacco products
where content and delivery are often much higher than is allowable in
medicines. For example a typical ``pinch'' of some of the most popular
snuff products contains 10-20 mg nicotine compared to 4 mg in the
highest dose of nicotine gum or lozenge.
Tobacco delivered nicotine, particularly from cigarettes, is
particularly addictive because of the various ingredients and design
features that function to increase the addictiveness of the products.
For example, the level of free-base nicotine allowed in cigarette smoke
needs to be examined and considered for performance standard
development. Other ingredients that appear to synergistically increase
the addictiveness of the product such as acetaldehyde need to be
examined from this perspective in performance standard development.
Perhaps most controversial is whether performance standards should
be developed with the intent of phasing nicotine out of cigarettes. I
have published papers on the potential benefits (e.g., making tobacco
products less addictive) and obstacles (e.g., precipitating increased
use, mass withdrawal, and inadequate treatment infrastructure for
tobacco dependence) for such an effort. However, I am in agreement with
the World Health Organization, that at present it would be premature to
attempt to drastically alter levels through regulation. The bill will
give FDA the flexibility and authority to develop the additional
science, as necessary, to set performance standards for nicotine
content and delivery.
Regulatory flexibility to address emerging science and evolving
products is part of FDA's strength that will be enabled by the Senate
bill. If we think of tobacco products as analogous to deadly globally
spread viruses, then we must also think of them as constantly evolving,
requiring vigilant oversight and the sort of authority to regulate that
FDA exerts over foods and drugs. This means that performance standard
setting and evaluation will be a continuous process as long as tobacco
products are marketed. This is also important because we need to assume
that in any science-based regulatory process, new science will emerge
that requires an agency like FDA to reconsider and, if needed, modify
previously issued regulations. By contrast, as described below, the
light cigarette fraud emerged and persisted over several decades and
was not even irrefutably unmasked until the 2001 publication of
National Cancer Institute Monograph 13. But yet the fraud continues
unabated in the regulatory vacuum!
product misrepresentation, health and harm reduction related claims
need to be regulated
With the recognition by the Surgeon General in 1964, that cancer
risk was related to overall tobacco exposure, cigarette smokers were
encouraged to quit. Those who did not quit were encouraged to reduce
their exposure. The focus was on ``tar'' because this conglomerate
smoke condensate contained many substances that separately and together
were clearly implicated in cancer and lung disease. This gave birth to
the Federal Trade Commission's method for tar and nicotine assessment
and communications. Nicotine was included in part because of its
presumed role (probably over estimated at the time) in heart disease.
The intentions of the FTC were good but it is not a science and health
agency, and it adopted a method that was well understood and easily
defeated by the tobacco industry. Armed with a flawed method and little
expertise in understanding drug delivery systems, assessing drug
delivery, or monitoring and evaluating health effects, the FTC was no
match for the tobacco industry. The industry co-opted the FTC's ratings
of tar and nicotine as marketing tools to reduce smokers concerns about
smoking. By designing cigarettes that generated lower tar and nicotine
ratings, labeling those below certain levels ``light'' and ``reduced
tar and nicotine'' the industry had a powerful force to prevent or at
least delay life-saving smoking cessation by many people.
After reviewing evidence and listening to various experts, Judge
Kessler, in the Findings from the DOJ trial concluded as follows:
``They [tobacco company defendants] also knew that the [FTC]
Method was totally unreliable for measuring actual nicotine and
tar any real life smoker would absorb'' (Paragraph 2627).
Further,
``By engaging in this deception, Defendants dramatically
increased their sales of low tar/light cigarettes, assuaging
fears of smokers about the health risks of smoking . . . ''
(Paragraph 2629).
the light cigarette fraud continues: regulation is needed to prevent
deceptive designs that are killing americans
Today, more than two thirds of cigarette smokers smoke light
cigarettes. My sister was one of them. As she told me: ``You can tell
Reds (Marlboro Regular Cigarettes) are worse: they felt stronger and
left my throat raw compared to Lights.'' Let me tell you a few things
she didn't know and that angered her when she found out. She assumed
that there were government standards for light cigarettes and that the
FTC testing method intended to measure tar and nicotine yield reflected
health effects or at least actual intake as is the case for food
labeling. She assumed that cooler, smoother smoke meant that it was
weaker and less harmful. She had no idea that a hidden ventilation
system was diluting the poisons for smoking ventilation by allowing
fresh air to be ``inhaled'' by smoking machines, whereas she and other
smokers were probably taking in two to three times as much tar and
nicotine than indicated by the ratings. She couldn't believe ``the
government'' would allow such a scam.
Since the light and low-tar scam began with a vengeance in the late
1960s America has lost tens of millions of its citizens prematurely as
they smoked light cigarettes to their graves, all the time not knowing
that tobacco industry marketing of ``light'' and ``low'' cigarettes was
completely misleading and that these products were not any less harmful
than other cigarettes. In 2001, the National Cancer Institute in
Monograph 13 finally concluded definitively: ``Epidemiological and
other scientific evidence . . . does not indicate a benefit to public
health from changes in cigarette design and manufacturing over the past
50 years.''
how did it happen? what can we learn? looking into lights--through
their holes
Most aspects of cigarette design that contribute to harm and
addiction require sophisticated equipment and procedures to detect,
such as CDC's approach to measuring free-base nicotine. However,
cigarette ventilation is one deadly scam you can see for yourself. If
you tear the filter paper from a cigarette filter and hold it up to the
light, you can see bands of tiny vent holes about \3/8\ to \1/2\ inch
out from the filter end. This is right where they can be easily covered
with lips or fingers. Unbeknownst to most cigarette smokers, blocking
of the holes with lips or fingers can easily double or triple delivered
tar and nicotine. On most cigarettes they are difficult to see because
the designs are intended to hide them. When the cigarettes are smoked
according to the FTC method, the holes leak anywhere from about 20-90
percent air into the testing apparatus, thereby contributing to the
deceptively low advertised rating. I did this demonstration a few years
ago for my son Vincent's third grade class and his classmates reacted
with clarity and passion. Their comments included: ``that's cheating!''
and ``they [the companies] can't do that.''
By analogy, this is like punching holes in a fruit drink container,
allowing some of the beverage to leak out, then testing the residual
beverage for calorie and sugar content and listing those figures on the
box even though consumers may consume several times more sugar than was
listed on the package or in advertisements. That would be cheating, and
there is a means of stopping and preventing it with food products, but
not for tobacco products--not until tobacco is regulated by FDA, which
routinely addresses such issues with food and drug products. In fact,
for any food or beverage in America, including Kraft cheese, Miller
Lite beer, Oreo cookies, and potato chips made by tobacco company
affiliates, such fraudulent misrepresentation of products can result in
the products being pulled from shelves and/or penalties. Manufacturers
can't even claim dog food is low fat if it is not true. Companies that
market addictive drugs for therapeutic use must formulate and market
them to reduce risk of addiction and other adverse side-effects, or the
drugs can be refused approval, pulled from the market, or be subject to
new limitations on marketing, as has happened to several potentially
addictive medications in recent years. Tobacco products are not
therapeutic but many of the same principles apply.
``Light'' and ``low tar'' cigarettes can be considered the first
generation of putative but fraudulent ``harm reduction'' products
designed to address smokers concerns about health but not really to
reduce their health risks. Light cigarettes may just be the tip of the
iceberg though.
New generations of products appear to be following the commercially
effective model of light cigarettes, which is to ensure that new
products are highly addictive to sustain use, with designs and
marketing efforts to assuage fears about tobacco. There is the
theoretical potential to reduce actual toxin exposure and an Institute
of Medicine Report released in 2001 acknowledged this, giving the
potential product category a new name: Potential Reduced Exposure
Products or PREPS. It urged, however, regulation by FDA to provide a
framework for evaluation of the products, determine what communications
would be appropriate, and monitor their use and impact. Absent with
such regulation, products termed PREPS by an unfettered industry could
be the next generation of lights, further undermining prevention and
cessation, and killing many of their users.
Fortunately, we have learned a lot in the past decade that will arm
FDA in its regulation of PREPS, lights, and all other tobacco products.
Much of this information emerged thanks to the 1990s investigation by
FDA as part of its Tobacco Rule development. More information emerged
through litigation against tobacco companies that made public millions
of pages of previously secret internal tobacco industry documents,
giving birth to a new research discipline called ``tobacco document
research,'' which involves increasingly sophisticated analysis to
determine what the industry knew about health effects and addiction
engineering, as well as many of its actual practices. We also have
empirically derived knowledge from NIH and CDC research relevant to
tobacco product design and effects. Perhaps most importantly, we have
learned, through the tobacco industry documents, how much more the
industry knows than it discloses, how much it knows about designs and
ingredients to heighten addiction risk, and how much more we need to
learn if we are to more effectively prevent continued product
manipulation. I believe that an empowered FDA could demand and evaluate
such information, and put it to use to serve public health.
For example, as you have learned, the State of Massachusetts
cigarette testing program shows nicotine levels had gradually increased
in many brands since the late 1990s. There has been considerable debate
as to why this was done. My opinion is that this was done to make it
easier for cigarette smokers to get their daily addictive fix of
nicotine when faced with restrictions on smoking and higher costs that
drive their daily cigarette intake down. To tobacco companies, keeping
their customers addicted and satisfied is better than allowing
cigarette smokers to reach that point that sustaining nicotine is such
a hassle that they are more driven to quit. However, that is my
opinion, and in the absence of regulatory oversight there is no way to
find out the basics: the how, what, why and when. You see, regulation
would give FDA the authority to demand an explanation and even to ban
the manipulation if it deemed that it was contrary to the interests of
public health. FDA could freeze levels; it could even require reduction
of various toxicants and nicotine over time.
Senators, it is time that the American public be truthfully told
what the tobacco industry knows about the ingredients, delivery, and
effects of the products, and that the products they buy and use are
honestly labeled regarding ingredients and maximum possible exposure
levels. We would not tolerate such deception with food manufacturers or
the makers of any other products consumed by Americans. It is time to
stop protecting the tobacco companies and start making them play by the
same rules as the manufacturers of other products consumed by
Americans. The deception continues and is poised to worsen: tobacco
products are mutating undeterred by regulatory oversight. Learning the
truth and developing appropriate communications for consumers for
existing products and the pipeline of new drugs or consumed products,
is central to FDA's mission.
Absent regulation, the deadly deception I have described continues.
Cigarettes and smokeless tobacco products are designed to addict,
designed to go beyond the addiction risk of their relatively crudely
manufactured ancestors. Cigarettes are designed to taste smooth and
garner misleadingly-low tar and nicotine ratings because consumers
react to such information as meaning substantially-less harmful.
Tobacco products are researched, designed, manufactured and marketed to
maximize the likelihood of trial, the graduation from trial to
addiction, and to retain their addicted users despite efforts to quit.
Products are fine tuned to attract various populations, including the
young, with flavors, designs, and dosing characteristics. This is far
beyond simply satisfying existing needs and desires of adults.
And the problem appears to be worsening: More Americans than ever
before are concerned about smoking, and want to quit. But without
regulation these individuals will turn to light cigarettes or new
tobacco products that falsely claim (at least implicitly) to be less
harmful. These products have been shown to reduce the motivation to
quit smoking because of the false reassurance that the smoker is
``doing something'' that represents a healthier step in the right
direction. But delaying tobacco cessation is deadly: disease risk is
more strongly related to years of smoking than to the number of
cigarettes smoked per day.
Worse still, the pipeline of new products and claims is growing.
Some of you may have seen advertisements in widely-circulated magazines
such as Parade, trumpeting cigarettes such as Omni and Eclipse that are
``lower in carcinogens'' and ``may present less risk of cancer, chronic
bronchitis and possibly emphysema.'' Eclipse, delivers very high levels
of the deadly odorless gas carbon monoxide. Marketed versions were also
reported to deliver glass fibers from its aluminum and glass inner
chamber that can penetrate the lung.
Philip Morris is now test marketing what many smokers might be
truly waiting for, a Marlboro with reduced risk claims: Marlboro Ultra
Smooth. Philip Morris has admitted that it is premature to make harm
reduction claims for the product though they tout the product's
potential to reduce exposure to harmful substances. In the void of
regulation, however, Philip Morris is test marketing the product and
creating the illusion of reduced harm through its clever name and
descriptions of the potential of the product to reduce certain
substances. Furthermore, it is using messaging such as ``Filter
Select'' and ``new carbon filter'' which might be reasonably construed
by a consumer to indicate advances in filtration of harmful elements.
One widely-advertised cigarette, Quest from Vector, even claimed to
be ``nicotine-free'' supporting the claim by asserting it met the
``standard'' of Benowitz and Henningfield. Now, without detracting from
my own work with Dr. Benowitz, we are not FDA, and we never intended a
recommendation for reducing the addictiveness of cigarettes to stand in
place of FDA evaluation and regulation. This would be laughable if it
were not deadly and still being perpetuated.
I am not here to testify, that products such as Quest and Marlboro
Ultra Smooth are, in fact, as deadly as conventional products. The
problem is there is no way to know if they are potential steps in the
right direction or as fraudulent and deadly as light cigarettes. And
there will be no way to tell until we have an authorized and empowered
FDA to find out.
There is also an increase in widely advertised smokeless tobacco
products from ``for when you can't smoke,'' implying you don't need to
quit smoking because you can use their products when you can't smoke.
The lure is increased by touting new products and implied benefits. One
product is packaged to resemble a medicinal cessation product with its
label reading ``for when you can't smoke.'' These manufacturers are
using Americans as guinea pigs without informed consent. They are
introducing new products; modifying products with new designs and
ingredients; and making claims, implicit and explicit, without
regulatory oversight from the one agency, FDA, that is charged with the
oversight of consumable products that have health effects, and require
consumer communications that are honest and do not mislead. These
efforts not only are deceptive, they help the industry thwart tobacco
prevention and cessation efforts.
regulation is overdue and urgent
For several decades, the tobacco industry anticipated but fought
FDA regulation, as illustrated by Philip Morris scientist William
Dunn's warning to his superiors in 1969:
``I would be more cautious in using the pharmic-medical
model--do we really want to tout cigarette smoke as a drug? It
is of course, but there are dangerous FDA implications to have
such a conceptualization go beyond these walls.''
Dr. Dunn was right in his apparent assumption that FDA authority
could have reined in many deceptive practices of the tobacco companies.
fda is the right agency and the only agency with appropriate experience
to develop and enforce product performance standards
I have heard the entire range of arguments about why FDA should not
be granted regulatory authority, including that FDA was not designed to
evaluate cigarettes. The fact is that FDA was designed to assess
safety, ingredients, and resultant exposure to a broad range of drugs
and foods. Tobacco products are drug delivery systems at heart. They
are sophisticated and complicated with many ingredients, just as many
drugs are. Even the tobacco industry admits this in their documents.
Moreover, they are designed to deceive, and designed to heighten
addiction risk.
Foods and drugs that are designed and/or marketed to deceive,
whether by intent or not, can be judged as misbranded or recalled, and
lead to various correctional actions ordered. This happens frequently
and routinely many times each year for foods and drugs. FDA has more
experience and sophistication in the regulation of drugs and drug
delivery systems than any agency in the world. This is the same
expertise that needs to be applied to tobacco.
For any product, whether food, drug or dog food, FDA can ask and
must be given answers to the basic questions that many consumers of
those products undoubtedly believe are being addressed for tobacco
products: WHO is the product for? WHAT is in it? WHY is it designed and
manufactured as proposed or done? HOW is it manufactured? WHEN were
changes made? FDA can require surveillance to detect unintended
consequences of products already marketed or proposed for marketing
approval if it has residual concerns.
Finally, what is communicated to consumers about product content
will be vital, so that eventually tobacco products, like other
consumable products, are labeled in meaningful ways that do not confuse
or obscure the truth, do not inappropriately make or imply claims, and
do not unintentionally undermine efforts to prevent tobacco use from
beginning and tobacco users from quitting.
FDA's authority will not make tobacco products safe, and should not
be seen as a substitute for comprehensive tobacco control efforts to
reduce all forms of tobacco use and disease. In fact, FDA regulation
should be viewed as a partner in these efforts and be positioned to
serve these efforts because it will restrict the ability of the
industry to modify products and descriptors to undermine prevention and
cessation. For all of these reasons and more, FDA regulation of all
tobacco products is vital in setting our Nation on a healthier path.
Directing the FDA to develop its regulatory system with urgency,
empowering it to rise to the challenge of tobacco regulation, and
providing it with the support to get the job done can be accomplished
through Senate bill S. 625. I therefore urge its most expeditious
passage and implementation.
Senator Sanders. Mr. Chairman.
The Chairman. Yes?
Senator Sanders. I'm going to apologize. I have to leave as
well. I just wanted to thank all of our guests here today and I
would just say, Mr. Chairman, the idea that we throw drug
pushers and heroin dealers into jail because of what they do to
our kids and the idea that we do not regulate those people who
are pushing cigarettes and addicting kids and killing kids,
cause lung disease and emphysema and everything else, it's
incomprehensible. So thank you very much for holding this
important hearing.
The Chairman. Thank you.
Senator Sanders. I look forward to working with you.
The Chairman. Dr. Connolly.
STATEMENT OF GREGORY N. CONNOLLY, D.M.D., M.P.H., PROFESSOR,
HARVARD SCHOOL OF PUBLIC HEALTH, FORMER DIRECTOR OF THE
MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH'S TOBACCO CONTROL
PROGRAM, BOSTON, MA
Mr. Connolly. I think it's over 20 years of coming before
this committee and it's like watching the Red Sox. We always
hope that next year, next year. Not only being a Red Sox fan,
my son-in-law is from Columbus so we watch the Buckeyes every
year very carefully.
When I was in Massachusetts, we achieved a 50 percent
decline but we still got stuck at 18 percent of our adults. We
still got stuck with youth rates and not enough change. So we
tried to fill the void with the Federal Government. We
regulated advertising on schools and playgrounds. We acquired
ingredients. We have a new testing protocol that the feds don't
apply in Massachusetts but we found we lacked the resources and
we lacked the legal authority to do so.
Clearly we need the Federal Government to step in and fill
this void. If we wanted to put a warning label on Marlboros, as
a State we couldn't do it, the way they do it in Britain, the
way they do it in Brazil, a developing country. We couldn't do
it. So States like Massachusetts, Ohio, Wyoming, North
Carolina--basically that's third-world states with Brazil,
Jordan and others having much more effective warning labels.
We looked at--and I have a slide, could we see it, please?
We looked at nicotine through the Massachusetts testing system
and we found that over the past 8 years, there has been a 11
percent increase of nicotine, both in the smoke and the raw and
you can see here, there is significant increases.
Next slide, please, next chart, please. We looked at
Marlboros in particular and we found that--we took into account
random fluctuation that this was, in fact, a significant
increase. I wish we didn't see this increase. I wish we saw
post the MSA, nicotine levels going down.
Why did this occur? We have no clue as a State. We don't
have the resources. The Harvard School of Public Health doesn't
have the resources. Why did they do it? We don't know. Did this
increase addiction among kids or adults trying to quit? We
don't know. But all of those questions can be answered by the
Food and Drug Administration if this bill is passed.
We just don't know. Is it a real increase? The industry has
challenged us and said, ``no it is a real increase.'' We took
into account through very good statistics, which haven't been
applied by the tobacco industry, we found an increase. Is it
new? It's not new. This has been occurring through decades. The
only new issue here is that this occurred after the MSA.
Also, the train has left the station on reduced risk
products. There are over 38 that have been marketed, mostly
after the MSA with claims that they reduce cancer risk, that
they lower carcinogens.
Next chart, please.
We conducted research among 600 smokers and we asked the
question, do these reduced-risk products lower your risk to
disease versus light cigarettes and versus regular cigarettes.
Even if you are seeing an implied claim, universally the
smokers who looked at the advertisements for these reduced-risk
products--Eclipse, Omni, Advance--perceive the implied claim as
an explicit claim. They perceived it as a way to forestall
quitting. They perceived it as a way to reduce their cancer
risk. So it's a repetition of the failed history of light
cigarettes.
What we found through the Harvard research at the Nurse's
study that light cigarettes only increase the risk of disease
versus others. So we need FDA regulation, not to regulate only
explicit claims but implied claims until we show it is safer.
Are we saying we want to ban Marlboros? I don't think so. I
think it's unrealistic. I think it's unreasonable but we maybe
want to create Marlboros so that they are like lard. They are
legal but we regulate the constituents, we regulate the
toxicity, we regulate whatever--so it sits back on the shelf
and no one uses it.
And FDA tomorrow can give us warning labels or a ban on
lights. They can give us restrictions on ads near schools but
it may take some time to come up with a product where we can
make perhaps a claim that it is safer, but it's worth waiting
for that. It's worth that legislation.
Next chart, please.
Post the MSA, we looked at advertising and we scored youth
ads versus adult ads and we found on this chart here that at
least for two companies, that the exposure to adults and youth
are equivalent. That is a rating of 100--100 exposures and the
same for adults and kids. They haven't changed their marketing
to youth. They've just gotten smarter. This is an ad for the
new custom Kool and I've asked how many people wear running
shoes like this into the committee room today. But this is in
magazines like Rolling Stone, with more youth readership,
enough for the FDA provision.
Next, please.
The Chairman. Could you adjust the chart. The light is
reflecting off of it. I don't understand quite what's going
down and what's going up.
Mr. Connolly. OK, what we did here is we looked at pre- and
post- the MSA and we looked at exposures to advertising among
youth and adults. So before the MSA--1997, 1998, we had about
160 exposures on average to adults and about the same for
youth. That was 12 through 17. MSA came in and we saw a general
reduction in advertising so that was good, primarily driven by
Philip Morris and I'm not thanking them for that because they
could still get rid of their marketing but for RJ Reynolds,
Brown and Williams and RAI, the youth exposure equals the adult
exposure. So there is no change. Kids are still being exposed
to advertising at the same levels that adults are being
exposed.
One of the tragedies is, we went from--in the advertising,
we went from 19 percent of the ads for menthol ads, which are
popular with black kids--we're now at 50 percent. Half of the
advertising is for menthol. Like this. We found the industry is
manipulating the menthol levels, post the MSA, to make those
products more attractive with young African Americans. And what
happened? OK, the youth rights went down with the adolescent
white kids, is old men wear ties. That's great. But for black
African Americans, the young adults, rates had gone up 30
percent from 2002 to 2005, based on the SAMSA research. Yeah,
we've been successful with those guys. But this industry
clearly is going after the high-risk population with
manipulation of menthol, increased marketing and advertising
for menthol and what is the result? It's a negative population
impact.
Next please and I'm going to finish up here. This is the
candy-flavored cigarette. No one knew this was here. RJ
Reynolds had this in the tank prior to the MSA. But after the
MSA, they introduced this new pellet, which impart a candy-like
flavor to the smoke. No one knew it was there, not even
smokers. The only people who knew it was there was Philip
Morris. We went out and we found an internal document, brought
it and--would we allow this to be put in a food product without
telling anyone? We then ran a gas spec and we found foreign
constituents in that pellet and no one had a clue what those
constituents did, either in helping youth to start or its
toxicity and the FDA can do that with this action.
Has the industry changed after the MSA? Yeah, but maybe not
for the better. And I'll end by saying 40 years ago, a Senator
from New York gave the opening address at the First World
Conference on Smoking and Health and he prophetically warned
that 28 million Americans will be killed by smoking unless
urgent action was taken. Fifty million Americans have been
killed since that date, since that Senator made that statement.
He told the attendees at that meeting to be equal to the task,
for the stakes are nothing less than the lives and health of
millions all over the world. I know it is a battle which will
be won. Our battle--that Senator's vision--will be won when
this Congress passes this historic legislation. The States
can't do it alone, Senator. As one who has fought in the
trenches, pushed the envelope of the States, we can't do it
alone. We need your help. Thank you very much.
[The prepared statement of Mr. Connolly follows:]
Prepared Statement of Gregory N. Connolly, D.M.D., M.P.H.
My name is Gregory N. Connolly. I am a professor at the Harvard
School of Public Health (HSPH) and direct the Tobacco Control Research
Program. Prior to coming to Harvard, I served as the director of the
Massachusetts Department of Public Health's Tobacco Control Program and
in that capacity, oversaw one of the largest public health programs to
curb tobacco use in the United States achieving a 50 percent decline in
cigarette consumption from 1993 to 2003. Massachusetts was the first
State to require warning labels on smokeless tobacco, the second for
warnings on cigars and the first to require public disclosure of
tobacco product additives and nicotine yield. Massachusetts has led all
States in attempting to fill the Federal void in regulating tobacco
products and marketing. We clearly found that States lack the resources
and legal authority to effectively do so. FDA regulation is urgently
needed today. My opinion is based on the following:
1. Despite the Tobacco Industry's Admission that Nicotine is
Addictive, Following the MSA Manufacturers Have Increased Nicotine
Content in Cigarettes and Cigarette Smoke.
Our research has found a significant increase in nicotine to
cigarette tobacco and smoke from 1997 to 2005 (12 percent). Industry
manipulation of nicotine is nothing new, what is new is that it is
still occurring post the MSA. A statistically significant trend
confirmed an increase in smoke nicotine yield of 0.019 mg per cigarette
(1.1 percent) per year over the period 1997-2005 for an 11.7 percent
increase. The increasing trend was observed within all major market
categories (mentholated vs. nonmentholated and full flavor vs. light,
medium (mild), or ultralight).
Increasing smoke nicotine yield was associated with increasing
nicotine concentration in the tobacco and number of puffs per
cigarette, and decreasing percent filter ventilation of the cigarette.
Such changes increased the elasticity of the cigarette making it
potentially more addictive.
In her August 2006 decision, Judge Kessler devoted 140 pages to
describing the tobacco industry's long history of nicotine
manipulation. She concluded that tobacco manufacturers:
``. . . have designed their cigarettes to precisely
control nicotine delivery levels and provide doses of nicotine
sufficient to create and sustain addiction.''
``. . . have extensively studied smoking intake and
inhalation, compensation, addiction physiology, smoker psychology, the
pharmacological aspects of nicotine, the effects of nicotine on brain
waves, and related subjects.''
``. . . intentionally developed and marketed cigarettes
which, in actuality, delivered higher levels of nicotine than those
measured by the FTC method.''
These studies consisted not only of consumer smoking panels but
also large-scale human clinical trials, electrophysiological studies of
brain waves, chemical and physical brand analyses, and other
sophisticated techniques. Factors such as use of blends, genetic
modification of tobacco, and in particular, ammonia or other chemical
agents are used to alter the chemical form of nicotine delivered to the
smoker. Detailed evidence shows that manufacturers could and did
manipulate free nicotine delivery through product changes and that even
``small'' increases in free nicotine delivery could significantly
increase their ability to deliver an ``optimum'' dose of nicotine
capable of creating and sustaining addiction in cigarette smokers.
Our research is not new but only shows that this historical pattern
of nicotine manipulation has not changed. We don't know why nicotine
has increased. The tobacco industry regulatory oversight by the FDA is
necessary to evaluate changes in product delivery and their effects on
smoker initiation and use; and possibly to make the product less
addictive.
2. Since the MSA Tobacco Manufacturers Have Greatly Increased the
Marketing of ``Safer'' Cigarettes to Health Conscious Smokers in the
Absence of Independent Scientific Evidence They are Actually ``Safer.''
This Nation has already suffered immensely from the failed history
of light cigarettes when they were presented in the 1970s as a
``safer'' alternative to regular brands. The Harvard School of Public
Health's Nurses Study found that smokes of ``lights'' had the same risk
of cardiovascular diseases as smokers of regular brands. The National
Cancer Institute concluded in 2001 that smoking ``lights'' did not
reduce the risk of lung cancer. In the absence of FDA regulation, the
failed history of ``lights'' will only be repeated with the promotion
of cigarettes today as being safe.
Potentially Reduced (tobacco) Exposure Products (PREPS) are being
marketed with explicit and implicit claims that they reduce health
risks in the absence of scientific evidence to show they actually do.
Over 35 PREPS have been marketed over the past few years (see Appendix
A).
In 1998, RJR claimed that there is ``No Cigarette Like Eclipse''
based on a comparison of its smoke chemistry to a typical ultralight
cigarette (Merit) and also claimed that Eclipse may reduce cancer risk.
We analyzed the smoke chemistry of Eclipse versus two conventional
ultralight cigarettes (NOW and Carlton) and found that Eclipse had up
to five times the levels of cancer causing agents than the existing Now
or Carlton brands. There are ``Cigarettes like Eclipse'' in the
marketplace. A careful review of other research conducted by RJR on
Eclipse found serious problems with the methodology that supported the
lung cancer reduction claim.
When sales for Eclipse faltered in the late 1990s, RJR altered the
filter design by drilling a hole in it but not alerting consumers to
the change. The new design resulted in an increase of 300 percent in
two cancer causing agents called NNN and NNK. Consumers were not
informed of the design change on increase in toxins.
We tested two prototypes of the new carbon filtered PREP, Marlboro
UltraSmooth (MUS), test marketed in the United States beginning in
2005, using both standard (FTC/ISO) and intensive (Health Canada)
machine methods to measure gas/vapor and particulate phase smoke
constituents. When tested under the standard regimen, gas phase
constituents of MUS prototypes were reduced compared with a
conventional low yield cigarette. However, far smaller reductions in
gas phase constituents were observed under the intensive regimen,
suggesting that the carbon technology employed in MUS is less effective
when smoked under more intense conditions. Particulate phase
constituents were not reduced by the carbon filter under either machine
smoking regimen. Studies of human smoking show that MUS is likely to be
smoked intensively, thus negating its potential for toxic constituent
reductions.
PREPS have been marketed include nicotine hand gel, nicotine
chewing gum, modified cigarettes (Omni, Advance and Marlboro
UltraSmooth) and electrically heated nicotine inhalers (Accord) (see
Appendix). All of these products have been sold with implied or
explicit claims of reduced risk without review or approval of
independent scientific agencies such as the FDA.
Other research we conducted showed that consumers perceive implied
claims for reduced levels of toxins in smoke as explicit claims for
reduced health risks when, in fact, there is no science to support the
claims. We studied 600 adult smokers who reviewed advertisement for
regular and PREP cigarettes. Smokers perceived PREP products as having
lower health risks (mean=5.4 on a scale of 1-10) and carcinogens (6.6)
than light cigarettes (5.8 and 6.9, respectively, p < .001), and lights
as having lower health risks and carcinogen levels than regular
cigarettes (8.2 and 8.8, respectively, p < .001). Although no
advertisements explicitly said that the products were healthy or safe,
advertisements for PREP products and light cigarettes were interpreted
as conveying positive messages about health and safety. Most smokers
believed that claims made in cigarette advertisements must be approved
by a government agency. The results indicate that advertisements can
and do leave consumers with perceptions of the health and safety of
tobacco products that are contrary to the scientific evidence. This
supports regulating the promotion, advertising, and labeling of PREP
tobacco products and light cigarettes. Effective FDA regulation should
focus on consumer perceptions resulting from advertisements not just
the explicit content of advertising text. This is needed to prevent a
repeat of the failed history and disease burden by the marketing of
``lights.'' The unintended consequences of PREP marketing by youth
initiation and deterrence of quitting can also be monitored by the FDA.
The bill will give the FDA authority to prevent such
unsubstantiated claims from being made. FDA will require scientific
support and closely examine the real world performance of PREPs such as
Eclipse and MUS. Regulation of PREPS by independent health agencies
such as the Food and Drug Administration is needed to protect the
public health and validate both the industry science and its claims.
3. Advertising After the Master Settlement Agreement has Become
More Targeted to Youth, Minorities and Other High-Risk Groups.
Following the Master Settlement Agreement (MSA), youth and other
high-risk groups, including low-income women and African Americans,
have been targeted with disproportionate levels of magazine advertising
for tobacco products. Our analysis of tobacco magazine advertising post
the MSA found, from 1998-2005 on average, every youth in the United
States was exposed to 559 tobacco ads, every adult female 617
advertisements, every African American adult 892 ads, and every
Hispanic adult 605 ads.
Exposure to a magazine advertisement is measured as the percentage
of a population group that reads the magazines that runs the
advertisement in the studied time period.
Compared to adults, youth had greater exposure to magazine
advertising for cigarettes or major manufacturers including R.J.
Reynolds, Brown & Williamson and Lorillard and were disproportionately
exposed to magazine advertising for brands and varieties preferred more
by youth including Newport and Camel, and mentholated and full flavor
cigarettes. Philip Morris ended magazine advertising in 2003 but the
other companies have more than made up for PM's absence. Despite the
MSA, cigarettes were advertised in magazines with 15 percent or greater
youth readership and in magazines with 2 million or more youth readers
in every year from 1998 to 2005, criteria used in the 1994 FDA rule to
define a youth magazine.
Regulation by the FDA can eliminate cigarette advertising to youth.
Among young, Black smokers, Newport has traditionally been the most
popular menthol brand. Newport has the lowest menthol levels (0.24
percent weight of tobacco filler among King-size, full flavor) compared
to its major competitor (Kool, 0.36 percent). Between 1993 and 2005,
Newport's market share doubled, from 4 percent of market to 8 percent,
while Kool and Salem's share of market has remained relatively steady.
Reynolds American Tobacco aggressively competed against Lorillard
and recently re-designed Kool under the name Kool XL and heavily
advertised it to compete against Newport's dominance among young
Blacks. Kool Smooth Fusions is a candy-flavored menthol brand, promoted
through dance clubs and hip hop music venues beginning in 2004. Philip
Morris has followed Reynolds American promotion of Kool with Marlboro
Smooth, a new menthol product, available in March 2007. Both brands
employed the selling message ``smoother'' a possible connation of a
reduction in menthol levels to target young Black smokers. Expenditures
for magazine advertising of mentholated cigarettes has increased from
13 percent of total ad expenditures in 1998 to 49 percent by 2005.
Among Black young adults (age 18 to 25) menthol smoking rates
increased significantly by 30 percent between 2002 and 2005 from 19.8
percent (95 percent CI: 17.7-21.9 percent) to 25.8 percent (95 percent
CI: 23.5-28.1 percent), but did not increase significantly among same-
aged Whites and Hispanics during that time. Nonmenthol cigarette use
decreased by 39 percent among African-American young adults, although
this change was not significant (from 7.9 percent in 2002 to 4.8
percent in 2005). In 2002, 19.8 percent (95 percent CI: 17.7-21.9
percent) of African Americans age 18-25 smoked menthol cigarettes (an
additional 7.8 percent smoked nonmen-
thols). In 2004, 25.8 percent (95 percent CI: 23.5-28.1 percent) of
African-American young adults smoked menthol (while an additional 4.0
percent smoked nonmenthols). In 2005, this proportion decreased
slightly, but remained above pre-2004 levels.
Menthol Use in Past 30 Days Among Young Adults, by Race, 2002-2005
The rates of menthol smoking among African Americans ages
18-25 years have increased by 10 percent per year since 2002 (OR =
1.10, 95 percent CI = 1.04-1.18).
No statistically significant trends over time since 2002
are seen in the rates of menthol smoking among Whites and Hispanics
ages 18-25 years or among Blacks or Hispanics ages 12-17 years.
The rates of menthol smoking among Whites ages 12-17 years
have decreased since 2002 (OR = 0.95, 95 percent CI = 0.90-0.99).
Following the MSA, R.J. Reynolds acquired the second largest
smokeless company Conwood for $4.8 billion and introduced its own
smokeless brand called Camel Snuss. Philip Morris introduced its new
smokeless tobacco brand in Indianapolis called Taboka and acquired a
Swedish smokeless company the same year. Lorillard has entered into an
agreement with Swedish Match North America to produce its smokeless
brand in 2007. The cigarette companies, rather than offering smokeless
products as an alternative to cigarettes, have only produced and sold
smokeless products as a temporary way to receive nicotine through
smokeless tobacco in places where smoking is banned thus perpetuating
smoking.
FDA regulation is needed to prevent cigarette companies from
marketing smokeless tobacco to perpetuate smoking. FDA authority is
needed to require manufacturers to adopt new technologies to reduce
toxins in all smokeless products not just the ones they make ``safer''
claims for.
In 2002, RJR introduced Camel ``Exotic'' Blends and Brown and
Williamson ``Kool Fusion'' brands all with candy-like flavors in the
product. The Exalt Camel brand used a plastic pellet in the filter to
deliver flavors to smokers. No public health agency knew it was
present, its toxicity or how it contributed to youth initiation. Candy-
like flavorants mask the natural toxicity of smoke and could enhance
initiation and addiction.
Examples of recent candy flavored cigarettes and flavor delivery
systems
The use of flavorants to appeal to young nonsmokers is consistent
with other research on the reformulation of Camel cigarettes in the
1980s, a brand then popular with older men. The newly designed Camel
was targeted to first-time young smokers by using additives that masked
the harshness, making it smoother and easier to inhale. Market share
for Camels rose among adolescent males three-fold post the
reformulation from 3 to 10 percent.
conclusion
Post the MSA manufacturers have become more aggressive in targeting
high risk groups including minorities and youth with aggressive
advertising, re-designed products with more not less nicotine,
introducing candy-like flavored product and aggressively marketing
brands popular with young African Americans.
Forty years ago, a Senator from New York gave the opening address
at the First World Conference on Smoking and Health and prophetically
warned that 28 million Americans would be killed prematurely by smoking
unless urgent action was taken at that time. None was taken. The same
Senator urged the attendees to: ``be equal to the task. For the stakes
are nothing less than the lives and health of millions all over the
world. I know it is a battle which will be won.'' (Robert Kennedy,
First World Conference on Smoking or Health) Our battle will be won and
that vision fulfilled when the Congress passes this historic
legislation.
The Chairman. Thank you.
Dr. Blum.
STATEMENT OF ALAN BLUM, M.D., DIRECTOR, UNIVERSITY
OF ALABAMA CENTER FOR THE STUDY OF TOBACCO AND SOCIETY,
TUSCALOOSA, AL
Dr. Blum. Chairman Kennedy, Senator Enzi and members of the
committee, the public entrusts the Food and Drug Administration
to evaluate the safety and efficacy----
The Chairman. Do you have your button on there? Just bring
your microphone closer, thank you. I think we're going to be
okay.
Dr. Blum. The public entrusts the Food and Drug
Administration to evaluate the safety and efficacy of
medications. Having served on an FDA advisory panel, I have
sympathy for the over-extended staff at this beleaguered
agency. But placing the Nation's most lethal consumer product,
cigarettes, under the control of FDA would be unwise. And
asking a food and drug bureau to promulgate product safety
standards for cigarettes is an oxymoron that will perpetuate
the myth long fostered by the tobacco industry that this
inherently harmful product can be made safer.
The promotion of this bill by Philip Morris USA, maker of
Marlboro and by far the biggest of big tobacco, with 50 percent
of the market, should prompt skepticism about the measure and
its purported public health benefits. Although the bill will
strictly regulate new and potentially less hazardous
noncombustible tobacco products, it would not apply these
standards to the most harmful form of tobacco, namely Marlboro
and other cigarettes, which caused the deaths of nearly half a
million Americans a year and although the bill bans candy
flavorings and no doubt will get rid of the term lights and
will have new, bigger and improved warning labels, it does not
require the FDA to eliminate menthol, the mint-flavored
anesthetic agent added to the brands most heavily targeted to
African American and Latino American consumers.
Nor is there a mandate for the FDA to eliminate toxic
gases, including cyanide or the more than 40 known cancer
causes in cigarette smoke, such as benzene, nitrosamines and
radioactive polonium. The bill will most assuredly cause
confusion about the difference between reduced exposure and
reduced harm. If consumers are told that 1, 2, or even 22
cancer causes in tobacco smoke have been reduced, they are
going to assume that a problem has been taken care of. They are
going to believe that cigarettes are safer and they are going
to continue to smoke.
This is, of course, deja vu all over again. For more than
70 years, every report on the dangers of cigarette smoking was
disputed by the tobacco industry, who claim more research was
needed and who promised to identify and remove any component of
smoke that was found to cause disease. This led to marketing
gimmicks to allay public anxiety about smoking, such as filters
that promised double-barreled health protection and claimed to
be ``just what the doctor ordered'' or in at least one
instance, was made of asbestos.
In spite of the fact that the cigarette filter does not
confer any reduced health risk whatsoever, more than 95 percent
of persons who smoke buy filtered brands in the false belief
that they are safer. Yet this bill will not ban the filter, the
biggest and longest running scam of big tobacco.
Similarly, when the Federal Trade Commission mandated that
tar and nicotine levels be printed on cigarette advertisements,
tobacco companies were only too happy to oblige. Carlton is
lowest. It's official, confirmed by the U.S. Government, now is
lowest. To this day, hardly a day goes by when a patient
doesn't proudly tell me, but doc, I smoke Marlboro Lights
because it's got only one milligram of tar. I try to tell these
young ladies that they are being duped but they don't want to
believe it.
Few consumers have caught on that such numbers mean
nothing. History has shown that the tobacco industry has
circumvented every attempt to impose Federal regulations on
cigarette marketing. The goal of the Cigarette Advertising and
Labeling Act of 1970 was to remove cigarette ads from the
broadcast media but no sooner had the commercials ended than
televised sporting events began, such as Nascar Winston Cup
racing and the Virginia Suns Women's Tennis Circuit, providing
even greater cigarette brand image exposure than ever.
We still see Marlboro logos on TV, auto racing worldwide.
Research has documented that the kinds of marketing
restrictions imposed by this bill are not effective in reducing
youth exposure to cigarette advertising. The proposed FDA bill
will simply change who is committing consumer fraud. Currently,
it is still the tobacco companies marketing reduced tar and
nicotine cigarettes in a way that deceives consumers into
believing that these products are safer. If the FDA bill is
enacted, then the Government will be doing the dirty work for
the tobacco companies. Small wonder why Philip Morris embraces
this bill, which will permit it to tell consumers that it is
complying with strict product safety standards, making
government-approved cigarettes.
In summary, there is no evidence that this bill will save
any lives at all. It goes from A to Z without telling us how B
to Y are going to work. To the contrary, the bill will
perpetuate great harm to its grandfathering of high risk
cigarette products, its hindering of the introduction of
reduced risk, noncombustible tobacco products and its
eliminating litigation for consumer fraud. However well
intended, the bill is misguided. It could well be renamed, the
Marlboro Protection Act. It should carry its own Surgeon
General's warning that this legislation is deceptive and it
will prove devastating to public health.
[The prepared statement of Dr. Blum follows:]
Prepared Statement of Alan Blum, M.D.
Mr. Chairman and members of the committee, the public trusts the
Food and Drug Administration (FDA) to safeguard the medicines and food
products that contribute to good health and well-being. Having served
as a member of an FDA advisory panel, I have great respect for this
agency's work in assuring the safety of medications and medical devices
used in the diagnosis and treatment of disease.
As we have known for decades, cigarettes are the Nation's leading
cause of cancers, heart disease, and emphysema. Placing our most lethal
consumer product under the control of the Food and Drug Administration
makes no sense. Asking this agency to promulgate ``product safety
standards'' for this death-dealing device is an oxymoron and will
perpetuate the myth that cigarettes can be made safer. Safer than what,
one might ask, fresh air?
The championing of this bill by Philip Morris USA, America's top
cigarette manufacturer with 50 percent of the market, should prompt
skepticism about the measure and its alleged public health benefits.
Reading the fine print bears this out. Consider these three points:
First, the bill would stringently regulate new and potentially less
hazardous tobacco products but would not apply these same standards to
the most harmful form of tobacco, namely Marlboro and other existing
cigarettes which cause the deaths of nearly half a million Americans
each year.
Second, although the bill will enable the FDA to prevent the
introduction of new cigarette brands, it seems inappropriate for the
protection of public health that the bill permits Marlboro and the
other most popular existing cigarette brands to remain on the market,
even though they are far and away the leading public health threat.
Third, although the bill specifically bans the use of strawberry,
grape, chocolate, or similar flavoring additives in cigarettes, it does
not require the FDA to eliminate (or even reduce the level of) toxic
gases, including hydrogen cyanide or the more than 40 known cancer-
causers in cigarette smoke such as benzene and radioactive polonium.
The agency would be given the authority to take such action but there
is no mandate to regulate these poisons.
The only sensible and ethical action for a health agency charged
with regulating cigarettes could be to ban them, which is an
unrealistic prohibition.
As Yogi Berra would say, this bill is deja vu all over again. For
more than 70 years, every newly published scientific report on the
countless diseases caused by cigarette smoking was disputed by the
tobacco industry, which claimed more research was needed and which
promised to remove any constituents of smoke that might be found to
cause disease. This led to a proliferation of marketing gimmicks to
allay growing public anxiety about smoking, foremost among them filters
that promised ``Double-barrelled health protection,'' or claimed to be
``Just what the doctor ordered,'' or in at least one instance was made
of asbestos.
In spite of the fact that the cigarette filter does not confer any
reduced health risk whatsoever, more than 95 percent of persons who
smoke buy filtered brands in the false belief that they are safer. The
second most sensible and ethical action for a health agency charged
with regulating cigarettes would be to ban the filter, but this would
hardly pass muster with Philip Morris.
When the Federal Trade Commission mandated that tar and nicotine
levels be printed on cigarette packs and in advertisements, tobacco
companies were only too happy to engage in a ``tar derby.'' ``Carlton
is lowest,'' was a long-running ad campaign. ``It's Official: U.S.
Government proves NOW is lowest,'' was another. Few consumers caught on
that such numbers are meaningless. It's akin to advertising Wonder
Bread as having ``only one ounce of poison in every loaf '' or
Campbell's touting its soups as ``low-arsenic.'' Hardly a week goes by
when a patient doesn't proudly tell me, ``But Doc, I smoke Carlton
'cause it's got only 1 milligram of tar.'' I try to tell these women
they're being duped, but it's very difficult.
History has shown that the tobacco industry has outwitted us at
every attempt to impose Federal regulation on cigarette manufacture and
marketing. The main goal of the Federal Cigarette Advertising and
Labeling Act of 1970 was to remove cigarette ads from the broadcast
media. Yet no sooner had cigarette commercials left the airwaves than
televised sporting events such as NASCAR Winston Cup and The Virginia
Slims Women's Tennis Circuit began airing for hours on end, providing
even greater cigarette brand name exposure than ever before. Today we
still see Marlboro logos on televised auto racing worldwide.
Tobacco companies have also out-maneuvered health advocates who
believed they had found a way to utilize the industry's money to fund
anti-smoking education. The Master Settlement Agreement of 1998 has
resulted in a tiny fraction of settlement funding being directed toward
smoking prevention and cessation programs. Only four States are
currently allocating to tobacco prevention the minimum amount
recommended by the Centers for Disease Control and Prevention; all
told, only 2.6 percent of tobacco revenues are being spent on tobacco
prevention and cessation.
Meanwhile, Philip Morris has not skipped a beat in cultivating
financial relationships with dozens of career centers at universities
across the country in an aggressive attempt to recruit college students
as Marlboro sales interns and Marlboro territory sales managers. Thus
these well-educated individuals who are least likely to smoke are being
hired to promote cigarettes to the least educated and poorest sectors
of our population. Bold ads in college newspapers brag about Philip
Morris' innovative, redefined marketing strategies. When I asked one
student why he was interviewing with Philip Morris, he told me ``It's a
great company. They don't just sell cigarettes. They help prevent
smoking.''
Instead of concentrating on regulation, we should be putting most
of our efforts into reducing demand, especially major multimedia paid
counter-advertising campaigns that young people will see daily and
remember. In other words, we need to fight smoke with fire.
Research has documented that the kinds of marketing restrictions
imposed by this bill are not effective in reducing youth exposure to
cigarette advertising. There are simply too many venues for tobacco
companies to market their products, and anything short of a near-total
ban on advertising and promotion of tobacco products (which could
violate the first amendment) is unlikely to have a substantial effect
on youth smoking.
There is no evidence that the system of product safety standards
set up by the bill would result in a safer product. Essentially, the
bill gives the FDA a mandate which it cannot carry out. The only way to
know whether any reductions in specific constituents of tobacco smoke
would result in a safer product would be to conduct long-term studies,
using smokers as guinea pigs. Perhaps some would view that as
acceptable because the product is dangerous anyway. However, the
problem is that smokers are going to assume that these reduced exposure
products are safer.
There are an estimated 40 compounds in tobacco smoke that cause
cancer. What sense does it make to require the manufacturers to take
out 2 or 3 of them or even 25? What if smokers then believe that this
is a safer product and start smoking more? This approach will kill
people, not save lives.
The bill would make it virtually impossible for modified risk
products to enter the market, while at the same time permitting reduced
exposure products to be falsely marketed as reduced risk products. At
least that's how consumers are going to perceive them. How else would
someone interpret a claim of reduced exposure?
The bill will diminish the public's appreciation of the inherent,
irredeemable harmfulness of cigarettes. By promulgating health
standards, the FDA will be fostering the perception that cigarettes are
now safer to smoke. Few of my patients who still smoke realize that
there are 4,000 poisons and 40 cancer-causers in cigarette smoke. If
they are told that the nitrosamines have been reduced or removed, they
are going to assume that a problem has been taken care of. Since we
know that smoking prevalence is directly proportional to the degree of
perceived harm from smoking, this will lead to an increase in smoking
prevalence, compared to what would have occurred without this bill.
In her opinion, in the Department of Justice lawsuit against the
tobacco companies, Judge Gladys Kessler ruled last year that decade
after decade the defendants had engaged in fraud by marketing
cigarettes that rated lower tar and nicotine yields via machine testing
in a way that misled consumers to believe that these product offered a
health benefit over higher machine-yield products. The basis of her
decision was the body of literature demonstrating that machine-yields
of nicotine and other tobacco smoke constituents have no direct
relationship with actual human exposure, and thus with actual health
risk, either on an individual or a population level.
The bill implies that reductions in nicotine yields would be a good
thing. But the reality is that reduced nicotine yields could be harmful
to public health because they would likely increase cigarette
consumption due to the smoker compensating by inhaling more deeply
leading to increased exposure to poisons (tar and toxic gases) and
resulting in higher rates of lung cancer and emphysema.
The proposed FDA bill will simply change who is committing consumer
fraud. Currently, it's still the cigarette companies, marketing reduced
tar and nicotine cigarettes in a way that deceives consumers into
believing that these products are known to be safer. If the FDA bill is
enacted, then the government will be doing the dirty work. Small wonder
why Philip Morris embraces this legislation. It completely removes the
risk of litigation for fraud, yet allows the tobacco companies to tell
consumers that they are complying with stringent product safety
standards, assuring a safer product produced under the nose of the FDA.
In summary, I regret that there is no evidence to suggest that this
bill will save any lives at all. To the contrary, there is well-
documented evidence to suggest that the legislation will not reduce the
risks of cigarette smoking. The bill is likely to cause harm through
its grandfathering of high-risk products; its hindering of the
introduction of reduced risk products; its eliminating litigation for
fraud; and its inhibiting tougher State and local legislative tobacco
control efforts.
However well-intended, the Family Smoking Prevention and Tobacco
Control Act is misguided. While setting up an impossible standard for
new products, it gives the most harmful (and most consumed) existing
product a free ride. This bill could well become known as the Marlboro
Protection Act. At the very least, it should come with its own Surgeon
General's warning: ``This legislation is harmful to public health.''
This submission is an extension of a commentary in the medical
journal, The Lancet, co-authored with Michael Siegel, M.D., Professor
of Social and Behavioral Sciences, Boston University School of Public
Health. (Siegel M., Blum A. FDA regulation of tobacco: reprieve for the
Marlboro man? Lancet 2006; 368: 266-68.) I also relied on additional
critical analysis of the Family Smoking Prevention and Tobacco Control
Act by Dr. Siegel ([email protected]).
The Chairman. Ms. Shames.
STATEMENT OF LISA SHAMES, ACTING DIRECTOR, NATURAL RESOURCES
AND ENVIRONMENT TEAM, GOVERNMENT
ACCOUNTABILITY OFFICE, WASHINGTON, DC
Ms. Shames. Thank you. Chairman Kennedy, Senator Enzi and
members of the committee, I am pleased to be here today to
present GAO's findings on the State's tobacco settlement
payments under the Master Settlement Agreement.
There have already been a number of references to the MSA.
As you know, in 1998, 46 States signed what is called the
Master Settlement Agreement, with four of the largest tobacco
companies. The States sued these companies to be reimbursed for
healthcare costs caused by the public's use of tobacco.
The settlement was the largest civil settlement in U.S.
history. It committed the tobacco companies to pay what was
then an estimated $200 billion over the first 25 years.
Payments are to continue in perpetuity. Congress required GAO
to report annually on how the 46 States allocated their tobacco
settlement payments.
This morning, I will present our findings from these
reports.
First, we found collectively that States received over $52
billion in tobacco settlement payments over fiscal years 2000-
2005. Of the $52 billion, about $36 billion were payments from
the tobacco companies and about $16 billion were advance
payments that 15 States received by issuing bonds, backed by
their future payments from the tobacco companies. Annually,
total payments ranged from a high of $14.1 billion in 2001 to a
low of $5.8 billion in fiscal year 2005. These total payments
varied because they are adjusted for fluctuations in cigarette
sales, inflation and other variables.
Second, we found that States have allocated their payments
to a wide variety of activities. Let me emphasize that the
Master Settlement Agreement imposed no restrictions on how
States could spend these payments. Some States told us that
they viewed the tobacco settlement payments as an opportunity
to fund those needs that they were not able to fund in the
past, because of the high cost of healthcare.
Many States deliberated, such as through special
commissions, on how to allocate their payments. This chart to
my left shows how the States allocated their payments, from
fiscal years 2000-2005. The purple slice shows States allocated
the largest portion of their total payments, 30 percent or
$16.8 billion, toward healthcare activities, such as Medicaid,
health insurance, hospitals, medical technology and research.
The white slice shows a closely related category, tobacco
control. States allocate about $1.9 billion or 3.5 percent of
their total payments. Tobacco control addresses prevention,
education enforcement and cessation activities. The red slice
shows States allocated the second largest portion of their
payments, about 23 percent or $12.8 billion, to help balance
their budgets or reduce their deficits.
In descending order, States used their tobacco settlement
payments on general purposes and for structure projects,
education and debt service on secure-type funds. The other tan
slice category includes economic development for tobacco
regions, social services reserve funds, tax reductions and
payments to tobacco growers.
In summary, tobacco settlement payments have varied from
State to State and from year to year. The Master Settlement
Agreement imposed no restrictions on how States could spend
these settlement payments. As such, the States have allocated
their payments to a wide variety of activities. States
allocated the largest portion of their payments toward
healthcare and the second largest to budget shortfalls.
Mr. Chairman, this concludes my statement. I'd be pleased
to respond to any questions that you or other members of the
committee may have.
[The prepared statement of Ms. Shames follows:]
Prepared Statement of Lisa Shames
Tobacco Settlement--States' Allocations of Payments from Tobacco
Companies for Fiscal Years 2000 through 2005
why gao did this study
In the 1990s, States sued major tobacco companies to obtain
reimbursement for health impairments caused by the public's use of
tobacco. In 1998, four of the Nation's largest tobacco companies signed
a Master Settlement Agreement, agreeing to make annual payments to 46
States in perpetuity as reimbursement for past tobacco-related health
care costs. Some States have arranged to receive advance proceeds based
on the amounts that tobacco companies owe by issuing bonds backed by
future payments.
This testimony discusses (1) the amounts of tobacco settlement
payments that the States received from fiscal years 2000 through 2005,
the most recent year for which GAO has actual data, and (2) the States'
allocations of these payments. We also include States' projected fiscal
year 2006 allocations.
The Farm Security and Rural Investment Act of 2002 required GAO to
report annually, through fiscal year 2006, on how States used the
payments made by tobacco companies. GAO based this testimony on five
annual surveys of these 46 States' Master Settlement Agreement payments
and how they allocated these payments.
what gao found
From fiscal year 2000 through 2005, the 46 States party to the
Master Settlement Agreement received $52.6 billion in tobacco
settlement payments. Of the $52.6 billion total, about $36.5 billion
were payments from the tobacco companies and about $16 billion were
advance payments which several States had arranged to receive by
issuing bonds backed by their future payments from the tobacco
companies.
The Master Settlement Agreement imposed no restrictions on how
States could spend their payments, and as such, the States have chosen
to allocate them to a wide variety of activities. Some States told us
that they viewed the settlement payments as an opportunity to fund
needs that they were not able to fund previously due to the high costs
of health care. States allocated the largest portion of their payments
to health care--$16.8 billion or 30 percent--which includes Medicaid,
health insurance, hospitals, medical technology, and research. States
allocated the second largest portion to cover budget shortfalls--about
$12.8 billion or about 22.9 percent. This category includes allocations
to balance State budgets or reduce deficits that resulted from lower
than anticipated revenues, increased mandatory spending, or essential
expenditures. Included among the next largest categories are
allocations for infrastructure projects, education, debt service on
securitized proceeds, and tobacco control.
Mr. Chairman and members of the committee, I am pleased to be here
today to contribute to your deliberation on the need for the Food and
Drug Administration to regulate tobacco products. Tobacco use is the
leading cause of preventable death in the United States. Most adults
who use tobacco started using it between the ages of 10 and 18. A
Surgeon General's report to the Congress concluded that preventing
youth from starting to use tobacco is key to reducing tobacco-related
deaths and disease. The Centers for Disease Control and Prevention
reported a few years ago that, on average, more than 440,000 deaths and
$76 billion in medical expenditures are attributable to cigarette
smoking annually. Reducing tobacco-related deaths and the incidence of
disease, along with their associated costs, is a significant public
health challenge.
Beginning in the mid-1990s, States sued the major tobacco companies
for reimbursement of the cost of health impairments caused by the
public's use of tobacco. The States alleged that the industry had
violated antitrust and consumer protection laws, withheld information
about the adverse health effects of tobacco, manipulated nicotine
levels to keep smokers addicted, and conspired to keep less risky and
less addictive tobacco products out of the market. Forty six States,\1\
along with the District of Columbia and the five U.S. territories,
negotiated and signed a settlement agreement, called the Master
Settlement Agreement, with four of the largest tobacco companies--
Philip Morris, USA; R.J. Reynolds Tobacco Company; Brown & Williamson
Tobacco Corporation; and Lorillard Tobacco company. The settlement was
the largest civil settlement in U.S. history. It committed the tobacco
companies to pay the 46 States an estimated $200 billion \2\ over the
first 25 years of the agreement, with payments to continue in
perpetuity. In addition, it restricted the tobacco companies' marketing
and advertising practices, among other things.
---------------------------------------------------------------------------
\1\ The four States that are not party to the Master Settlement
Agreement--Florida, Minnesota, Mississippi, and Texas--reached earlier,
individual settlements with the tobacco companies.
\2\ This original estimate does not take into account adjustments
in tobacco companies' payments that have and will occur.
---------------------------------------------------------------------------
Today, I will focus on how the 46 States party to the Master
Settlement Agreement have allocated their settlement payments.
Specifically, I will discuss (1) the amounts of Master Settlement
Agreement payments that the States received from fiscal years 2000
through 2005, the most recent year for which we have actual data, and
(2) the States' allocations of these payments. The Farm Security and
Rural Investment Act of 2002 (the 2002 Farm bill) required GAO to
report annually, from fiscal years 2002 through 2006, on how these 46
States used their Master Settlement Agreement payments.\3\ My testimony
is based primarily on these annual reports.
---------------------------------------------------------------------------
\3\ GAO, Tobacco Settlement: States' Allocations of Phase II Funds,
GAO-03-262R (Washington, DC.: Dec. 3, 2002); GAO, Tobacco Settlement:
States' Allocations of Fiscal Years 2002 and 2003 Master Settlement
Agreement Payments, GAO-03-407 (Washington, DC.: Feb. 28, 2003); GAO,
Tobacco Settlement: States' Allocations of Fiscal Year 2003 and
Expected Fiscal Year 2004 Payments, GAO-04-518 (Washington, DC.: Mar.
19, 2004); GAO, Tobacco Settlement: States' Allocations of Fiscal Year
2004 and Expected Fiscal Year 2005 Payments, GAO-05-312 (Washington,
DC.: Mar. 21, 2005); and GAO, Tobacco Settlement: States' Allocations
of Fiscal Year 2005 and Expected Fiscal Year 2006 Payments, GAO-06-502
(Washington, DC.: April 11, 2006).
---------------------------------------------------------------------------
Our reports were based on our yearly surveys of the 46 States. Each
year we asked the States to report (1) the amount of payments they
received for the current State fiscal year, (2) the amount of payments
they expected to receive for the next State fiscal year, and (3) their
allocations of these payments among 13 spending categories. We
independently corroborated the States' data to the extent possible by
analyzing budget-related and legislative documents, and interviewing
State budget officials, staff from State attorneys generals' offices
and governors' offices and others as needed to clarify information. We
performed our work in accordance with generally accepted government
auditing standards.
In summary, from fiscal year 2000 through fiscal year 2005, the
States received $52.6 billion in Master Settlement Agreement payments
from the tobacco companies in amounts that varied from state-to-state
and from year to year. Of the $52.6 billion, about $36.5 billion were
payments from the tobacco companies and about $16 billion were advance
payments (securitized proceeds) that 15 States arranged to receive by
issuing bonds backed by their future payments from the tobacco
companies. The annual payments from the tobacco companies' are adjusted
based on several factors that include fluctuations in the volume of
cigarette sales, inflation, and other variables, such as the
participating companies' shares of the tobacco market. Also, each
State's share of the tobacco companies' annual payments is a fixed
percentage based on smoking-related health care costs, which reflect
population and smoking prevalence.
The Master Settlement Agreement imposed no restrictions on how
States could spend these settlement payments and, as such, the States
have allocated their payments to a wide variety of activities. Some
States told us that they viewed the settlement payments as an
opportunity to fund needs that they were not able to fund previously
due to the high costs of health care. States allocated the largest
portion of their payments--30 percent or $16.8 billion--toward health
care activities such as Medicaid, health insurance, hospitals, medical
technology, and research. States allocated the second largest portion
of their payments--about 23 percent or $12.8 billion--to help balance
State budgets or reduce deficits that resulted from lower than
anticipated revenues, increased mandatory spending, or essential
expenditures.
In descending order, the next largest categories where States used
their tobacco settlement payments were general purposes, infrastructure
projects, education, debt service on securitized funds, and tobacco
control.
States' Annual Tobacco Settlement Payments Have Varied
The 46 States reported receiving a total of nearly $52.6 billion in
payments in varying annual amounts from fiscal year 2000 through fiscal
year 2005. Of the nearly $52.6 billion, about $36.5 billion were
payments from the tobacco companies and about $16 billion were
securitized proceeds that 15 States arranged to receive, as shown in
table 1.
Table 1.--Master Settlement Agreement Payments and Securitized Proceeds Received by the 46 States (Fiscal Years
2000-2005)
----------------------------------------------------------------------------------------------------------------
Securitized
Fiscal year Payments proceeds Total
----------------------------------------------------------------------------------------------------------------
2000-2001.............................................. $13,200,000,000 $928,900,000 $14,128,900,000
2002................................................... 6,238,393,496 3,838,376,465 10,076,769,961
2003................................................... 6,306,329,459 6,482,764,469 12,789,093,928
2004................................................... 5,340,128,223 4,374,698,723 9,714,826,946
2005................................................... 5,453,132,303 389,977,667 5,843,109,970
--------------------------------------------------------
Total................................................ $36,537,983,481 $16,014,717,324 $52,552,700,805
----------------------------------------------------------------------------------------------------------------
Sources: GAO-01-851, GAO-03-407, GAO-04-518, GAO-05-312, GAO-06-502, State budget offices or their designees,
and GAO analysis.
Note: This table does not include payments to cities and counties in California and New York.
The tobacco companies' annual payments are adjusted based on
several factors contained in the Master Settlement Agreement that
include fluctuations in the volume of cigarette sales, inflation, and
other variables, such as the participating companies' share of the
tobacco market. Declining tobacco consumption alone would result in
lower Master Settlement Agreement payments than originally expected.
Tobacco consumption has declined since the Master Settlement Agreement
was signed in 1998--by about 6.5 percent in 1999 alone--mostly due to
one-time increases in cigarette prices by the tobacco companies after
the agreement took effect. Analysts project that, in the future,
tobacco consumption will decline by an average of nearly 2 percent per
year.\4\ As a result, tobacco consumption is estimated to decline by 33
percent between 1999 and 2020.
---------------------------------------------------------------------------
\4\ Cigarette consumption peaked in 1981 and has been declining
since.
---------------------------------------------------------------------------
However, the Master Settlement Agreement also includes an inflation
adjustment factor that some analysts have estimated increases payments
more than any decreases caused by reduced consumption. The inflation
adjustment equals the actual percentage increase in the Consumer Price
Index for the preceding year or 3 percent, whichever is greater. The
effect of these compounding increases is potentially significant,
especially given that the payments are made in perpetuity. Assuming a
3-percent inflation adjustment and no decline in base payments,
settlement amounts received by States would double every 24 years.
Also, several tobacco companies' interpretation of the provision
that addresses participants' market share led them to lower their
payments in 2006. Under this provision, an independent auditor
determined that participating tobacco companies lost a portion of their
market share to nonparticipating companies. An economic research firm
determined that the Master Settlement Agreement was a significant
factor in these market share losses. Based on these findings, several
participating companies reduced their fiscal year 2006 payments by a
total of about $800 million. Many States have filed suit to recover
these funds.
Each State's share of the tobacco companies' total annual payments
is a fixed percentage that was negotiated during the settlement. These
percentages are based on two variables related to each State's smoking-
related health care costs, which reflect each State's population and
smoking prevalence. In general, the most populous States receive a
larger share of the tobacco companies' total annual payments than the
less populous States. For example, California and New York each receive
about 13 percent, while Alaska and Wyoming each receive less than 1
percent. However, these percentages are not strictly proportional to
population.
In addition to the annual payments States receive, the Master
Settlement Agreement requires that a Strategic Contribution Fund
payment begin in 2008 and continue through 2017. The base amount of
each year's Strategic Contribution Fund payment is $861 million, which
will be adjusted for volume and inflation and shared among the States.
Strategic Contribution Fund payments are intended to reflect the level
of the contribution each State made toward final resolution of their
lawsuit against the tobacco companies. They will be allocated to the
States based on a separate formula developed by a panel of former State
attorneys general.
states are exercising their flexibility to use tobacco settlement
payments for a wide variety of activities
The Master Settlement Agreement imposed no restrictions on how
States could spend their settlement payments and, as such, the States
have allocated their payments \5\ to a wide variety of activities, with
health-related activities the largest among them. As part of their
decisionmaking on how to spend their payments, some States established
planning commissions and working groups to develop recommendations and
strategic plans for allocating their States' payments. In six States,
voter-approved initiatives restricted use of the funds and, in 30
States, the legislatures enacted laws restricting their use.
---------------------------------------------------------------------------
\5\ When States allocate payments, they may include carry-over
funds from prior years and interest earned; therefore, in any 1 year,
States' payments and securitized proceeds may not equal payments
allocated for spending.
---------------------------------------------------------------------------
Overall, we identified 13 general categories to which States have
allocated their Master Settlement Agreement payments, as shown in table
2. Appendix I provides more details on the categories to which States
allocated their payments.
Table 2.--Amount and Percentage of States' Allocations of Master
Settlement Agreement Payments and Securitized Proceeds by Category,
Fiscal Years 2000-2005
[Dollars in millions and percent]
------------------------------------------------------------------------
Category Dollars Percent
------------------------------------------------------------------------
Health.............................................. $16,807 30.0
Budget shortfalls................................... 12,806 22.9
Unallocated......................................... 6,639 11.9
General purposes.................................... 3,955 7.1
Infrastructure...................................... 3,350 6.0
Education........................................... 3,078 5.5
Debt service on securitized funds................... 3,005 5.4
Tobacco control..................................... 1,943 3.5
Economic development for tobacco regions............ 1,490 2.7
Social services..................................... 961 1.7
Reserves/rainy day funds............................ 810 1.4
Tax reductions...................................... 616 1.1
Payments to tobacco growers......................... 521 0.9
-------------------
Total............................................. $55,981 100.1
------------------------------------------------------------------------
Source: GAO analysis of data from State budget offices and their
designees.
Note: Percentages do not total to 100 due to rounding. Also, States'
allocations do not match the payment amounts on an annual basis
because States have carried over funds from 1 year to the next and
earned interest on their payments.
States allocated the largest portion of their payments--about $16.8
billion, or 30 percent of the total payments--to health-related
activities. To a closely related category--tobacco control--States
allocated $1.9 billion, or 3.5 percent of their total payments. States
allocated the second largest portion of their payments--about $12.8
billion or 22.9 percent--to cover budget shortfalls. Some States told
us that they viewed the settlement payments as an opportunity to fund
needs that they were not able to fund previously due to the high cost
of health care. Figure 1 illustrates the relative magnitude of the
categories receiving allocations.
The seven largest categories of allocations, in descending order,
are health, budget shortfalls, general purposes, infrastructure,
education, debt service on securitized funds, and tobacco control.
States' allocations to these categories have varied considerably from
year to year--with some categories showing wide fluctuations. For
example, for budget shortfalls, the States allocated from 2 to 44
percent of the total payments. On the other hand, for health care, the
States allocated from 20 to 38 percent of the total payments. Figure 2
shows these annual changes for these seven categories.
Information about how States have allocated their Master Settlement
Agreement payments follows.
Health.--From fiscal years 2000 through 2005, States allocated
about $16.8 billion of their Master Settlement Agreement payments to a
variety of health care programs, including Medicaid; health insurance;
cancer prevention, screening, and treatment; heart and lung disease;
and drug addiction. Over this period, the amounts States allocated to
health care ranged from about $1.9 billion in fiscal year 2005 to
nearly $4.8 billion in fiscal years 2000-2001 combined.
In fiscal year 2005, the most recent year for which we collected
actual data, 36 of the 46 States allocated some of their Master
Settlement Agreement payments to health care. Of the 36 States, 5
States allocated two-thirds or more of their payments to health care;
19 States allocated one-third to two-thirds; and 12 States allocated
less than one-third. Ten States did not allocate any of their payments
to health care activities. In fiscal year 2005, Pennsylvania, Illinois,
Michigan, and Maryland allocated larger amounts to health care than the
other States. Pennsylvania allocated over $326 million of its payments
to health care programs for adult health insurance, uncompensated care,
medical assistance for workers with disabilities, and community medical
assistance. Illinois allocated nearly $204 million of its payments to
health care, citing Medicaid drugs as a key program that would receive
funds. Michigan allocated over $185 million of its payments to areas
such as elder pharmaceutical assistance and Medicaid support programs.
Maryland allocated nearly $100 million of its payments to areas such as
Medicaid; cancer prevention, screening, and treatment; heart and lung
disease; and drug addiction.
Budget Shortfalls.--From fiscal years 2000 through 2005, States
allocated about $12.8 billion of their Master Settlement Agreement
payments to budget shortfalls. Over this period, the amounts the States
allocated to budget shortfalls ranged from a high of about $5.1
billion, or 44 percent of the total payments in fiscal year 2004, to
$261 million, or 4 percent in fiscal year 2005. In fiscal year 2005,
only 4 of the 46 States allocated some of their Master Settlement
Agreement payments to budget shortfalls. Of these States, only Missouri
allocated more than one-third of its total payments--about $72
million--to budget shortfalls.
General Purposes.--From fiscal years 2000 through 2005, States
allocated about $4 billion of their Master Settlement Agreement
payments to general purposes, including law enforcement, community
development activities, technology development, emergency reserve
funds, and legal expenses for enforcement of the Master Settlement
Agreement. Over this period, the amounts States allocated to general
purposes ranged from $623 million, or about 5 percent of the total
payments they allocated in fiscal years 2000-2001 combined, to about
$1.1 billion, or 8 percent in fiscal year 2003.
In fiscal year 2005, 27 of the 46 States allocated some of their
Master Settlement Agreement payments to general purposes. Of these 27
States, 4 States allocated two-thirds or more of their total payments
to general purposes; 2 States allocated one-third to two-thirds; and 21
States allocated less than one-third. Nineteen States did not allocate
any of their payments to general purposes. Massachusetts, Tennessee,
Connecticut, and Colorado allocated the largest amounts to general
purposes in fiscal year 2005. Massachusetts allocated nearly $255
million of its payments to general purposes for its General Fund,
Tennessee allocated nearly $157 million of its payments to its General
Fund, and Connecticut allocated about $113 million of its payments to
its General Fund. Colorado allocated about $64.5 million of its
payments to general purposes, but did not specify which programs would
receive funds.
Infrastructure.--From fiscal years 2000 through 2005, States
allocated about $3.4 billion of their Master Settlement Agreement
payments to infrastructure-related activities, including capital
maintenance on State-owned facilities, regional facility construction,
and water projects. Over this period, the amounts States allocated to
infrastructure have ranged from $31 million, or about 1 percent of the
total payments in fiscal year 2005, to about $1.2 billion, or 10
percent in fiscal year 2002.
In fiscal year 2005, 5 of the 46 States allocated some of their
Master Settlement Agreement payments to infrastructure. Of these 5
States, North Dakota was the only State that allocated more than one-
third of its total payments to infrastructure. North Dakota, Hawaii,
and Kentucky allocated the largest amounts to infrastructure in fiscal
year 2005. North Dakota allocated about $10.5 million of its payments
to infrastructure for work on water projects. Hawaii allocated
approximately $10 million of its payments to infrastructure, citing
debt service on University of Hawaii revenue bonds issued for the new
Health and Wellness Center as a primary program that would receive
funds. Kentucky allocated $6.1 million of its payments to service debt
on such things as water resource development and a Rural Development
Bond Fund.
Education.--From fiscal years 2000 through 2005, States allocated
about $3 billion of their Master Settlement Agreement payments to
education programs, including early childhood development; special
education; scholarships; after-school services; and reading programs.
Over this period, the amounts States allocated to education ranged from
between $280 million or 2 percent of the total payments in fiscal year
2004, to over $1.1 billion, or 9 percent, in fiscal year 2002.
In fiscal year 2005, 16 of the 46 States allocated some of the
Master Settlement Agreement payments to education. Of the 16 States,
only New Hampshire allocated more than two-thirds of its total payments
to education; 4 States allocated between one-third and two-thirds to
education; and 11 States allocated less than one-third. Thirty States
did not allocate any of their payments to education-related activities.
Michigan, New Hampshire, Nevada, and Colorado allocated the largest
amounts to education in fiscal year 2005. Michigan allocated over $99
million of its payments to education for Merit Award scholarships and
tuition incentive grants for higher education students; the Michigan
Educational Assessment Program testing for K-12 students, nursing
scholarships, the Michigan Education Savings Plan, and general higher
education support. New Hampshire allocated $40 million of its payments
to areas such as an Education Trust Fund, which distributes grants to
school districts in the State. Nevada allocated about $33 million of
its payments to education programs, citing a scholarship program for
Nevada students attending Nevada's higher education institutions as a
key recipient. Colorado allocated over $16 million of its payments to
education, including its Read to Achieve program.
Debt Service on Securitized Funds.--From fiscal years 2000 through
2005, States allocated about $3 billion of their Master Settlement
Agreement payments to servicing debt on securitized funds. This
category consists of amounts allocated to servicing the debt issued
when a State securitizes all or a portion of its Master Settlement
Agreement payments. Over this period, the amounts States allocated for
this purpose have ranged from $271 million, or about 2 percent of the
total payments in fiscal year 2002, to about $1.4 billion, or about 24
percent, in fiscal year 2005. In fiscal year 2005, four States--
California, Rhode Island, South Carolina, and Wisconsin--allocated 100
percent of their Master Settlement Agreement payments to servicing debt
on securitized funds, while New Jersey allocated just under 100
percent. In addition, Alaska, Louisiana, and South Dakota, allocated
more than half of their payments for this purpose. In fiscal year 2005,
California and New York allocated the largest amounts to servicing debt
on securitized funds.
Tobacco Control.--From fiscal years 2000 through 2005, States
allocated about $1.9 billion of their Master Settlement Agreement
payments to tobacco control programs, including prevention, cessation,
and counter marketing. Over this period, the amounts States allocated
to tobacco control ranged from $790 million, or about 6 percent of the
total payments in fiscal years 2000-2001 combined, to $223 million, or
about 2 percent, in fiscal year 2004.
In fiscal year 2005, 34 of the 46 States allocated some of their
Master Settlement Agreement payments to tobacco control programs. Of
the 34 States, Wyoming allocated more than one-third of its payments to
tobacco control, while 33 States allocated less than one-third. Twelve
States did not allocate any of their payments to tobacco control-
related programs.
Pennsylvania and Ohio allocated more than the other States to
tobacco control--about $44 million and $37 million, respectively--in
fiscal year 2005.
Mr. Chairman, this concludes my prepared statement. I would be
pleased to respond to any questions that you or other members of the
committee may have.
______
Appendix I: Categories of States' Allocations
To standardize the information reported by the 46 States, we
developed the following categories and definitions for the program
areas to which States allocated their payments.
Budget Shortfalls.--This category is comprised of amounts allocated
to balance State budgets and close gaps or reduce deficits resulting
from lower than anticipated revenues or increased mandatory or
essential expenditures.
Debt Service on Securitized Funds.--This category consists of
amounts allocated to service the debt on bonds issued when the State
securitized all or a portion of its Master Settlement Agreement
payments.
Economic Development for Tobacco Regions.--This category is
comprised of amounts allocated for economic development projects in
tobacco States such as infrastructure projects, education and job
training programs, and research on alternative uses of tobacco and
alternative crops. This category includes projects specifically
designed to benefit tobacco growers as well as economic development
that may serve a larger population within a tobacco State.
Education.--This category is comprised of amounts allocated for
education programs such as day care, preschool, Head Start, early
childhood education, elementary and secondary education, after-school
programs, and higher education. This category does not include money
for capital projects such as construction of school buildings.
General Purposes.--This category is comprised of amounts allocated
for attorneys' fees and other items, such as law enforcement or
community development, which could not be placed into a more precise
category. This category also includes amounts allocated to a State's
general fund that were not earmarked for any particular purpose.
Amounts used to balance State budgets and close gaps or reduce deficits
should be categorized as budget shortfalls rather than general
purposes.
Health.--This category is comprised of amounts allocated for direct
health care services; health insurance, including Medicaid and the
State Children's Health Insurance Program (SCHIP); hospitals; medical
technology; public health services; and health research. This category
does not include money for capital projects such as construction of
health facilities.
Infrastructure.--This category is comprised of amounts allocated
for capital projects such as construction and renovation of health
care, education, and social services facilities; water and
transportation projects; and municipal and State government buildings.
This category includes retirement of debt owed on capital projects.
Payments to Tobacco Growers.--This category is comprised of amounts
allocated for direct payments to tobacco growers, including subsidies
and crop conversion programs.
Reserves/Rainy Day Funds.--This category is comprised of amounts
allocated to State budget reserves such as rainy day and budget
stabilization funds not earmarked for specific programs. Amounts
allocated to reserves that are earmarked for specific areas are
categorized under those areas--e.g., reserve amounts earmarked for
economic development purposes should be categorized in the economic
development category.
Social Services.--This category is comprised of amounts allocated
for social services such as programs for the aging, assisted living,
Meals on Wheels, drug courts, child welfare, and foster care. This
category also includes amounts allocated to special funds established
for children's programs.
Tax Reductions.--This category is comprised of amounts allocated
for tax reductions such as property tax rebates and earned income tax
credits.
Tobacco Control.--This category is comprised of amounts allocated
for tobacco control programs such as prevention, including youth
education, enforcement, and cessation services.
Unallocated.--This category is comprised of amounts not allocated
for any specific purpose, such as amounts allocated to dedicated funds
that have no specified purpose; amounts States chose not to allocate in
the year Master Settlement Agreement payments were received that will
be available for allocation in a subsequent fiscal year; interest
earned from dedicated funds not yet allocated; and amounts that have
not been allocated because the State had not made a decision on the use
of the Master Settlement Agreement payments.
The Chairman. Thank you very much. We'll have a 5-minute
time limit on questioning. Dr. Land, let me ask you this--you
must represent a part of the country where smoking is widely
used, or perhaps used more frequently than in other parts of
the country. What do your parishioners say about your
involvement on this issue, when they've got a range of
different kinds of moral issues that they're concerned about.
Do they say, why are you interested in this smoking issue when
there are many other negative activities that are going on in
their communities or in the country or the world?
Mr. Land. No, sir. They expect us to be able to walk and
chew gum at the same time. They think our attention span is up
to the task. As I pointed out at the beginning of my testimony,
Southern Baptists have long had concern about tobacco use and
indeed, we do have a lot of constituents in parts of the
country where tobacco has been an important product but those
resolutions are passed by majority vote of the constituents who
elect their representatives. The Southern Baptist Convention,
when it meets every June and passes these resolutions, is the
largest deliberative parliamentary body in the world. Those
44,000 autonomous churches elect messengers who go to the
convention and conduct business and they vote on these issues.
They also voted to elect the trustees that elected me. I serve
at the pleasure of the Southern Baptist Convention. There is
somewhat of a generation gap. People older than myself tend to
have somewhat different views toward tobacco than people
younger than myself and since I'm now 60, a lot of the people
who would be more ambivalent about this are older or have--you
know, tobacco smokers tend to be a declining constituency
because they die. When I first came to the Commission in 1988,
we have several Sundays on the Denominations Calendar where we
are charged to produce materials to help them observe these
Sundays and one of those Sundays is Alcohol and Drug Abuse
Sunday. The first one that I had the opportunity to choose the
issue we were going to deal with, I chose nicotine for 1990 and
this raised some eyebrows in 1988. They said, ``Wow, you're
going to take on tobacco?'' And I said, ``We absolutely are.''
We were braced for a large response, negative and we got very,
very little. I would remind you that in 1984, the Southern
Baptist Convention, in session, passed a resolution,
overwhelmingly, that called for government to end subsidies to
tobacco growth and to encourage individual Southern Baptists
who were tobacco farmers, to find alternative means and
alternative crops and to no longer grow tobacco. That was in
1984 and it was passed by the elected messenger to the
Convention overwhelmingly.
The Chairman. OK. This is primarily because of the dangers
to children. Am I right?
Mr. Land. Well, we are particularly concerned about these
deceptive advertising messages to children who do not have the
maturity and the responsibility to make these decisions but
it's also because it has obviously seeped into the conscious of
people in the faith community as it has other people in this
society, that this is a very dangerous product and I don't
think there is any American who has reached maturity, who
doesn't know people personally who have died from the use of
this product. It really has seeped into the conscious. I smiled
when I heard the reference to lard. I mean, it really is--
people do understand that this is really a destructive product.
The Chairman. Thank you. Mr. Myers, let me come back to you
for a quick response to Dr. Blum, who says there is no evidence
that this bill will save lives. He says, it's deceptive, it's
harmful to the public health, it's a Marlboro Protection Act.
It should carry its own warning label. Pretty strong indictment
of the legislation. Your response?
Mr. Myers. I have great respect for Dr. Blum but I think it
is not an accurate factual representation of what is in the
bill. He said that the bill would strictly regulate new
products but not apply the same standards to existing products.
That's just wrong. Section 907 gives the FDA broad authority to
regulate existing products as well as new products; in fact,
it's the strongest regulatory standard ever proposed for any
regulatory agency whatsoever.
He said it will inhibit the introduction of new products.
That too, is wrong. What it will do is inhibit manufacturers
from making health claims for new products before they have the
scientific evidence from doing so. As we know, our experience
shows that if you allow tobacco companies to make claims for
products, not only will they mislead the public but they won't
have any incentive to make actually less hazardous products. If
anything, this bill will, for the first time, give tobacco
companies and others, the incentives to make serious changes to
those products.
He said it has no mandates to eliminate toxic gases. That's
wrong. It provides the FDA with full authority to require
changes in toxic materials, including gases, in them. We have
to understand what the status quo is. The status quo is nobody
has any authority to require any tobacco company to make any
change in its product and as a result of that, the status quo
is that the changes the tobacco companies make are more
accurately what Dr. Henningfield described--those that make the
product more addictive, more attractive without regard to its
health hazards. He spoke about the past failed efforts. The
problem is, we have relied on voluntary action in the past. So
when he talks about advertisements about Carlton is the lowest,
he ignores the fact that this bill would allow the FDA--a
matter of fact, it would mandate that the FDA prevent exactly
those kinds of claims, absent scientific evidence. Not only
that the claim is truthful but that the claim is being made in
such a way so that it won't discourage millions of people from
smoking. He claims that it doesn't mandate the elimination of
menthol. Well, that's one of those half-truth statements that
is very important. It gives FDA authority to regulate menthol
but to do it in a way based on sound science as opposed to
making a political decision without knowing what the impact
would be automatically today of eliminating it.
Dr. Blum's experience in this field is unparalleled in
terms of its length. But when you look at the terms of this
legislation, it presents a very different picture when you look
at its details than what was presented as the underpinning of
his testimony.
The Chairman. Dr. Blum, my time is up, but I will give you
an opportunity to respond if you don't get that opportunity
with other questioners.
Senator Enzi.
Senator Enzi. Mr. Chairman, I won't be able to pass up the
opportunity on that but I've got to tell you, I've got hundreds
of questions--no, I started with hundreds of questions. Now
I've got a lot more and I do appreciate that all of you
volunteered to testify. I hope you also volunteered to answer
questions that we won't have time to put in, in just 5 minutes.
Mr. Myers, to follow up just a little bit on what you said,
before I give Mr. Blum a chance to unload----
[Laughter.]
Even if it is a new product and the FDA says that it's okay
to sell it, isn't that putting an FDA stamp of approval on a
product that is going to kill them? Or is it going to be made
safe enough that it won't?
Mr. Myers. You raise a very thoughtful and important
question. The bill was carefully crafted; in fact, there are at
least five different sections of the legislation that would
authorize FDA to prohibit a manufacturer from saying that a
product is FDA approved. If FDA found that that was necessary
to protect the public health because the drafters of this
legislation were concerned about the same issue. In fact, FDA
doesn't approve most products. What FDA does is approve--well,
whether or not there is adequate scientific evidence to make a
claim so that will prevent the tobacco companies from
misleading the public the way they currently do. And the only
time the FDA actually gets in the process of approving whether
a new product comes on the market, is when it is not
substantially equivalent. So the issue you raise is a very
important one. This legislation has tried in a very thoughtful
way----
Senator Enzi. My time is pretty limited. I think you've
made your point.
Mr. Myers. To prevent the tobacco companies from doing
exactly what you're----
Senator Enzi. Actually, from the FDA hearings that we've
had, they can't control labeling, they can't control
advertising. They can suggest.
Mr. Myers. But this is----
Senator Enzi. Now, on a reform bill that we have, there
would be some additional criteria on that, but any way you look
at it, they'll be able to say, the constituents were approved
or looked at. I wish I had time to ask Mr. Henningfield some
more questions about some things like that. Another thing that
will come into it, is who is going to pay the fees on this?
We're looking at the medical device and drug user fee programs
and trying to figure out how to get all of the pay for that
sort of thing. Can we get the companies to pay for all of the
testing? And I do suggest that we would have to back up to the
very beginning on the testing and test every single ingredient
every time there is a change. Mr. Blum, you looked like you had
a few comments you wanted to make on those, too.
Dr. Blum. Part of the unloading process here, thank you,
Senator Enzi. I think this bill creates a bridge on the River
Kwai for the tobacco industry. It's what they want, at least
Philip Morris does, because it will have government sanctioned
cigarettes. We already know what Marlboro does. Marlboro kills.
Whatever the market share is, it's 40 percent of the market--
Marlboro is taking the lives of 40 percent of those 400,000
that die from tobacco smoke every year. What more is there to
know? The definition of--research that we need to know more on
is the definition of infinity. There are always going to be
curious questions. But we already know what cigarettes do to
you. All the other tobacco products put together do not cause
the harm that cigarettes do and this regulation largely
grandfathers in Marlboro. Sure, as Matt Myers said, it does
grant the authority of the FDA to do certain things, to maybe
consider these things and modify the product but it doesn't
mandate. The only thing the bill mandates is candy flavorings,
bigger warning labels or new and improved warning labels so if
the deaf person can't hear you, you've got to yell louder. And
it has more of the kinds of reliance on machine measurements,
which Dr. Connolly, in his recent article in Tobacco Control,
has said is bogus. So the science that the FDA is going be
relying on is by those who study what kinds of statistics we're
relying on anyway, through machine measurements of tar and
nicotine are already unreliable. Where is the science standard
going to come from? I don't think anybody knows that.
There is also the matter of ethics. If you were to conduct
research to show whether or not a product is going to cause
reduced harm, I don't know of any institutional review board at
any university that would approve those subjects to take
Cigarette A or Cigarette B or tobacco product A and tobacco
product B and study those over the 20 and 30 years that it will
take to see whether one product reduces harm over another.
This cigarette bill will not affect the sale of cigarettes
in pharmacies. We're the only country in the world where
cigarettes are sold alongside medications. As Paul Harvey said,
``America is the only place where the sick people have to walk
all the way in the back to get their medicines and healthy
people get their cigarettes right up front.''
Senator Enzi. I thank you and as I mentioned, I've got
questions for everybody. I have particularly some numbered
questions as the only accountant, I'm always fascinated by the
numbers, so I apologize for not having an opportunity to ask
them right now but I will put those in writing and would
suggest that maybe the Federal Trade Commission ought to be
involved in this, maybe as opposed to the FDA. They are the
ones that really control false advertising or I hope control
false advertising. And that's what we're talking about here,
besides the need to do more testing and have more disclosure.
But I just worry a lot about this FDA seal of approval, whether
implied or actual, that's going to come about through this
process. We've got to find some way. The oncologist that worked
with my wife had the hospital attorney visit him because he
said that he wasn't going to treat people that smoked anymore
for cancer because they were working against themselves and
there's a little bit of a brouhaha going on over that. But we
know that cigarettes kill. Now we've got to figure out how we
can keep it from killing as many people.
The Chairman. Senator Brown.
Senator Brown. Thank you, Mr. Chairman. As we know, smoking
kills some 400,000-plus Americans a year and we also know the
tobacco companies know they have to replace those customers
with young smokers and that's sort of been the thrust, it seems
in all of this. We've sat through hearings for years, many of
us and seen the sort of growing sophistication of the tobacco
industry. It used to be Joe Camel. It used to be billboards
near schoolyards, clever mailings, free samples, all the things
they do. Dr. Huerta mentioned Camel No. 9 and I have a mailing
here that this is--those of you that buy perfume can see that
this looks a lot like it could be a perfume package, Camel No.
9. And you open this up, Camel No. 9 introducing our smoothest
smoke sensation. Light and luscious. Are you ready to flaunt
it? No. 9, take your No. 9 experience to the next level. This
stylish, sexy cigarette case. If you look in really small
print--and because I'm way older than the people they are
appealing to, I have to use these cheap $6 glasses--an offer is
on a Web site restricted to legal and tobacco consumers. But it
says, just your smokes to the nines with a complimentary
cigarette case. Take a pack at Camelsmokes.com and you'll be
smoking in style in no time. Then again, light and luscious.
You pull this out. I believe they can't actually send you a
pack of cigarettes. That's the DMSA, I believe, but you open
this up and it looks a lot like it. Then you strike gold with
four coupons, $2 off, $2 off. Buy one pack, get one free, buy
one pack, get one free. This is the kind of--and it's strains
the imagination to think that this campaign is aimed at anybody
other than 15, 16, 17-year-old girls, something that is a
violation of the MSA, to be sure but maybe more importantly,
pretty morally repugnant and a violation of what I think Dr.
Land with his values and what all the public health people, all
of whom find this pretty repugnant. Dr. Huerta, my question for
you is about price. As you know, the 10 percent is pretty
elastic--elastic economics, if you will, to the pricing of
cigarettes. Ten percent increase in price generally brings a 7
percent decline in youth consumption. They are still finding
ways, obviously, to make tobacco, the introduction of smoking
to young people, they're finding a way to make it less and less
expensive and more and more appealing until they're addicted
and they may go beyond that.
The tobacco industry, I understand, spends about $10
billion on promotion, price promotion, obviously much of it to
children, to recruit new people as the 400,000 people a year
die. How should FDA, if this bill passes, how should FDA
address things like this? How should FDA especially, more
pointedly, address the whole issue of price and the kinds of
price deals that the tobacco industry offers?
Dr. Huerta. Thank you for the question. What the FDA, in my
opinion, should do is base all their opinions on signs. And if
the signs say that the tobacco companies are not allowed to
make any claim, then FDA should not allow the companies to make
that particular claim regarding marketing. Marketing--it's a
whole chapter in the FDA regulation now, even we see that every
day with the pharmaceutical companies that are doing this
direct to consumer marketing practices on television and we are
seeing that FDA is now taking a very active approach to these
marketing techniques. So I would say that's a chapter that
needs to be discussed among the experts of marketing but my
feeling is that if the claim that the tobacco companies want to
do is not based on science, they shouldn't be allowed to do it.
The Chairman. Thank you very much.
Senator Burr.
Senator Burr. Thank you, Mr. Chairman. I have listened
intently to everybody's testimony and I want to applaud you for
bringing a lot to the table. There is only one major difference
I have, it is that I am not yet convinced that all the things
that you pointed out have to happen at the FDA. I have very few
disagreements with some of the items that were highlighted by
each of you and I'll try to go through some of those but let me
ask first, just so I know.
If given the authority, would you outlaw tobacco today?
Just a quick yes or no.
Matt.
Mr. Myers. No, sir.
Senator Burr. Dr. Huerta.
Dr. Huerta. No.
Senator Burr. Dr. Land.
Mr. Land. No, sir.
Senator Burr. Right down the line.
Mr. Henningfield. No.
Mr. Connolly. No.
Dr. Blum. No. I'm not in favor of prohibition.
Senator Burr. I'm not going to ask you.
Ms. Shames. I can't----
Senator Burr. Dr. Huerta, you mentioned five things and I
only got four of them but I think the four really do encompass
what your message was. Magazine advertising--still going on,
still affects children. In-store advertising--it certainly goes
on, affects children. Outdoor signage, billboards gone but
outdoor signage based upon the agreement in the MSA still
exists, could influence children's decisions. Let me just
simply ask you--and you mentioned no compliance. If we could
address that in a way that you and I and Matt Myers and others
said, you know, we have eliminated the ability to advertise to
children. Can you live with that authority, staying at the
Federal Trade Commission and the Department of Justice?
Dr. Huerta. It seems to me that--of course, I'm a profound
respectful person of the first amendment but there are limits
for what you can--the way you can promote your products.
Senator Burr. Clearly to accomplish this without a
constitutional challenge would require an agreement by the
industry as well, to ban certain things. If we could accomplish
that, are you comfortable that the Federal Trade Commission and
the Department of Justice can, in fact, bring that degree of
compliance and assurance to you and to me and to everybody
else?
Dr. Huerta. It's going to be difficult and would probably
require a lot of discussion.
Senator Burr. Difficult to believe that they could bring
that level of regulation? To enforce it?
Dr. Huerta. Well, they are different forces playing here. I
mean, the tobacco industry, obviously they want to sell their
products and we want to protect the public so we meet you----
Senator Burr. Dr. Huerta, let me stop you. I'm talking
about a direct, specific ban. Are you comfortable with a direct
specific ban being administered by the Federal Trade Commission
and the Department of Justice?
Dr. Huerta. No. Bans are not good for society. That's what
I can tell you.
Senator Burr. OK. Matt, are Phase 4 clinical trials
important at the FDA for the safety and efficacy of drugs?
Mr. Myers. For drugs?
Senator Burr. Yes, sir.
Mr. Myers. We're not talking about--and I apologize to you.
I'm not an expert on drug clinical trials so I need to be
careful with regard to those issues.
Senator Burr. Sure.
Mr. Myers. And that's not what we're talking about with
regard to this legislation.
Senator Burr. Well, I appreciate you acknowledging that,
but that's exactly my point--there are some that are very
engaged in this but have absolutely no idea what the FDA is
faced with, day in and day out. And Phase 4 clinical trials
determine dosage. The safety and efficacy is already determined
long before then but yes, Phase 4 trials are extremely
important to the outcome for a patient.
Dr. Connolly, you went--put your props back up there, would
you? I mean, I appreciate the fact that you brought something
that visualizes the challenge. And the challenge is that we're
way behind the curve from the standpoint of the degree that we
make adults aware of the risk. Now, let's assume for a second
that whether it was the half a pack size warning or whether it
was the full back of the pack size warning, which I think is
Brazil. If we codified that into law, would you feel
comfortable if, in fact, the enforcement for that was part of
the FTC and the Department of Justice versus the FDA?
Mr. Connolly. No. I think the thing that you're forgetting
is the product is linked with the marketing. Now, let me just--
let me finish my point--you asked a question, sir. When you saw
that blue pellet up there in Camel--that blue pellet is in the
product. It's unregulated by FTC but that blue pellet, in part,
is a very specific flavor that is tied to a Web site that is
tied to a marketing claim that is tied to----
Senator Burr. Dr. Connolly, I appreciate your point but I'm
asking specifically about the warning label. I don't disagree
with you. I don't disagree.
Mr. Connolly. We don't know. We're testing these--we're
testing warning labels among children in Crete to determine if
this is better than this and we think among the children, this
is better. I wish we could test it----
Senator Burr. Dr. Connolly, my colleagues----
Mr. Connolly. Back to the FDA with data and then let them
make a reasoned choice on what works best--pictorials versus
verbals. My impression would be, the FDA could make that
decision, not the FTC. The FTC's most recent smokers report--
the most recent one is 2001.
Senator Burr. Dr. Connolly, I know where we are today.
Mr. Connolly. Right.
Senator Burr. Legally. I'm talking about if we codify in
law, exactly what it has to say, are you comfortable with the
FTC and the Department of Justice, in fact, enforcing it
because I've got problems--Senator Kennedy has a bill right now
that's addressing drug safety and labeling deficiencies at the
FDA.
Mr. Connolly. I'm very uncomfortable. You need joint
regulation between FDA to regulate the product and regulate the
marketing. Right now, we've got one arm tied behind our back.
We're leaving the attorney generals to deal with consumer
protection issues and the FTC but we're not dealing with public
health issues in the product. What they're adding to the
product can make this the most popular product with kids. We
need combined regulation with both the FDA and with the
consumer protection actions by the FTC and by attorney generals
to address the issue of smoking among youth. If we let the blue
pellets sit in the product, if we let them manipulate menthol
levels, all the work and effort we do to restrain the claims,
the marketing are for naught.
Senator Burr. Dr. Connolly----
Mr. Connolly. We have to have a comprehensive approach in
this Nation. It's about time we had a comprehensive approach,
worried about our children and not about the economic interest
of this industry.
Senator Burr. Dr. Connolly, I appreciate your passion on
this.
Mr. Connolly. Thank you very much, sir.
Senator Burr. And I'm not proposing or suggesting that
there not be a comprehensive approach to this. You, as others,
seem to connect all the pieces and they only end up at one
place. I'm trying to determine whether, in fact, there are
other places where those pieces can be done. In no way am I
trying to diminish the scope of what we could sit at a table
and talk about. I've got to tell you, though. It disturbs me--
concerns me--as to what type of rational conversation we might
be able to have if we got down to talk about where is the best
fit. If, in fact, just the warning label has to be tied to
everything else that you can't comprehend the--the warning
label could be enforced at the Federal Trade Commission or the
Department of Justice, yet you could have an agreement that the
FDA looks at the toxicity of a product and that we've got an
agreement that says, here's the epidemiology study that we're
going to look at to determine whether something is reduced
risk. I think there are agreements we can come to on that but I
think there are also areas that you have highlighted, Dr.
Huerta has highlighted that really don't fit in the FDA.
I thank the Chairman who has been very kind and I
appreciate it.
The Chairman. OK.
Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman. Thank you and
good morning to all of you. I appreciate the testimony. I'm
sorry that I wasn't present for all of it but I have read the
testimony that has been provided.
My interest in this issue is really coming from the
perspective of our kids. As much as I worry about the adults
that make decisions, those are adults that are making decisions
but I worry about the fact that every day, we've got some 4,000
American kids that are trying cigarettes for the first time and
of those 4,000, how many of them go on to become the customers
that we deal with later on in life. So I want to speak
specifically to the issue of the children and why, after all
that has been worked out through the MSA agreements, all that
we have been trying to do in terms of education and getting
into the classrooms, tell me--this is directed to you, Mr.
Myers and Dr. Huerta--what else do we need to do? This
legislation you obviously support. What else can we be doing to
make sure that we're not growing new numbers of tobacco smokers
through our children? Is there more that needs to be done,
either within this legislation or elsewhere, to make a
difference?
Mr. Myers. Thank you and thank you for your longtime
commitment to this issue, Senator Murkowski. One needs a
comprehensive approach to this problem if we're going to really
dramatically reduce tobacco use among our children. This bill
provides key tools for that comprehensive approach but no one
should kid themselves. It's not the panacea by itself. By
eliminating the forms of marketing that have been identified as
having a great impact on children, even after the Master
Settlement Agreement, that allows a mother and father to sit
down across the table with them and talk about tobacco with a
much more even playing field. That's a critically important
step.
By preventing the tobacco industry from implying that
certain products are safer and therefore may be safer to start
smoking--you can delude yourself as a young person into
thinking that there is a safe way to start smoking. It gives us
another tool to prevent the tobacco industry from luring our
children. By doing this, Dr. Henningfield suggested looking at
what the tobacco industry does with regard to nicotine and the
impact of nicotine. We take into account the fact that most
kids--literally 90 percent of all smokers--become long-term
smokers before they're old enough to purchase the product
legally. Many of them are addicted to the product and
therefore, having a hard time to quit. We have not known how
the tobacco industry has altered or controlled nicotine's
impact. This bill would give us that tool at the same time to
do so, which is vitally important as we move forward.
Ease of smoking is another area that Dr. Henningfield has
talked about in his testimony that impacts how quickly kids
start because if it's not to brusque, if it's not too hard when
you start, when your lungs are still pure, what we have
discovered is that more kids will move from that quick,
experimental stage to becoming regular smokers. This bill would
give FDA the authority to look at that issue and address that
issue as well. So this bill has a number of key link tools that
only by bringing those things together can you have a
meaningful approach to kids.
And most importantly, it also, for the first time, gives a
Federal agency the authority to look at what the tobacco
industry is doing with its marketing and if they introduce new
things that are not specifically covered, it gives us an
administrative framework for addressing those issues up to the
limit of the first amendment. It's as far as we can go in our
Nation.
Senator Murkowski. Let me ask you, Dr. Blum, you do not
support this legislation but I understand that you are equally
passionate about making sure that our kids are not the next
customers. How do we address the kids? If this isn't the
answer, what is the answer from the children's perspective?
Dr. Blum. Thank you, Senator. I think that the Master
Settlement Agreement had a hope as Ms. Shames alluded to that
we would have had the resources to provide major multimedia
counter advertising campaigns, such as Senator Kennedy proposed
years ago and I justified before this committee. It's a shame
that that money has been squandered and misused. So I also
would see the possibility of perhaps a separate agency. But the
reason why I oppose this bill is that literally from day one,
if this bill is enacted, you would have the product that kills
more people than all other drugs, food, medications--whatever
else there is that the FDA regulates combined--and that product
would be dithered with and torqued with and regulated when the
elephant in the room would be Marlboro, would be sitting there,
doing its damage every day. I think that it makes no sense
whatsoever. It's good to talk about children but I think that
it's the definition of infinity if we're going to try to
regulate every single brand that comes out. They're going to
come up with everything in the world to keep us on our toes, to
constantly keep regulating. I think that the reason that we
need to be here is to consider how do we reduce demand for this
product, not how we regulate the product.
Senator Murkowski. Thank you.
Mr. Connolly. If I could add, Senator, we could research
about 10 years ago, looking at the internal documents on a
reformulation of Camel. At the time, Camel was smoked by old
men. RJ Reynolds intentionally affected the nicotine level.
They added more flavorings to make it more sugar-like and also
affected the smoothness and they did rankings against Marlboro
cigarettes. This was among 18-year-olds but in fact, it's what
they did. They affected the smoothness of the product, they
affected the nicotine yield, they added sugars so it would make
it easier for a youngster to inhale. Now, the whole public
health community is worrying about cartoon advertising when
they were worrying about the product. I think if you want to
address kids' use, we have to say, if you're going to
reformulate and change the product, then tell us what you're
doing with it. Why are you adding these sugars? Why are you
affecting nicotine yield? And just to sit back and say, go
ahead and have our children, with your product, and ban
advertising. It's just a flawed public health strategy.
The Chairman. Senator Coburn.
Senator Coburn. Thank you, Mr. Chairman. Dr. Land, I
remember as a young boy hearing an Evangelist by the name of
Angel Martinez and his famous statement was, ``as a believer,
you wouldn't go to hell for smoking. You'd just get to heaven
sooner and smell like you'd been there.''
[Laughter.]
And that has stuck with me through a number of years. I'm
somewhat perplexed at where we find ourselves. I'm a big
believer in prevention. As a matter of fact, I'm getting
ready--March 15, to introduce a large prevention bill in this
country. We spend almost $7 billion a year on prevention
through 21 different agencies. We don't get much for it because
it's not been focused properly, and I'm highly disturbed that
less than $1.5 billion out of $50 billion has gone to fund
prevention. The question I have for you is, why not pass a bill
(rather than the FDA and all this other stuff) that says you'll
get all the carcinogens out of your product by 9 years from
now. You will be decreasing the nicotine level by ``X'' percent
every year for the next 10 years. Why not go after it? We can't
ban advertising without consent, based on the first amendment,
but we certainly can say what you can and can't produce when it
is such a great health hazard. So my question is--I know where
Senator Kennedy wants to eventually go with this and I'm not
necessarily opposed to getting rid of the addictive potential
of cigarettes--but why not do it directly? Why don't we set it
up? We know what to do. We know how to do it. Why are we not
doing that? Why are we going through this? You know, the No. 1
reason for the Food and Cosmetic Act was for determining safety
and efficacy. There is no safety in tobacco products of any
type and the only thing they are efficacious at is addiction.
And we're going to put that through an agency? Why not go for
the gold. Why don't we go for the meat? Why don't we say,
you've got this many years to get all 60 carcinogens out and
you've got this many years by which you'll reduce the
percentage and in the meantime, let's do some Federal
tinkering, in terms of mandates, through incentives to States.
If you don't spend some of your tobacco money, a larger
percentage, on prevention and anti-smoking campaigns, then this
will cost you this. And why don't we spend some of the $7
billion a year that we're now spending on prevention, to
directly go after this? We can win this fight. Answer those
questions for me. I don't care who answers them.
Mr. Connolly. I think what you're doing is applying a
scientific agency to make those very decisions. There is no
reason why, under this legislation, that the FDA couldn't ramp
the levels of nicotine down in 30 years to the levels in
tomatoes.
Senator Coburn. We don't need FDA to do that. We can do it
right here.
Mr. Connolly. Well, I would argue that you've got a complex
issue that takes time to weigh. Do you take the toxins out, the
nicotine out, you take both and you give them----
Senator Coburn. You set up a separate commission. You say,
here's your charge. Here's the 10-year goal. Go do it. We're
going to compliment----
Mr. Connolly. I think the bill adequately does that,
Senator.
Dr. Blum. Senator, I'd like to answer. One specific comment
you made that might be in error and that relates to this bill,
which talks about nicotine. We all know that's the addictive
component--of nicotine but this bill only mandates that
nicotine be adjusted in one level and that is downward, yet the
experience of the individuals who smoke is to compensate by
inhaling more deeply and thus, we could regulate nicotine all
we want but the fact is, not even to acknowledge that what
science has found is that people who smoke are inhaling more
deeply, putting themselves at far greater risk for emphysema,
heart disease and lung cancer by smoking the low nicotine
cigarettes is mind-boggling to me.
Senator Coburn. Well----
Mr. Myers. Senator, could I just----
Senator Coburn. Let me make one point. There is wonderful
new research about drugs that are coming out that hinder the
addictive components of nicotine in the brain. So, the new
treatments that are on the market for addiction, in combination
with lowered carcinogens, this can help solve this problem.
Matt.
Mr. Myers. Just quickly, Senator. Several years ago, we
actually proposed that States be given incentives to spend more
money on tobacco prevention. We don't see that it is an either/
or. We think it is vitally important that we do everything we
can to encourage States to do so. So if that's something you
would like to work on, we would be delighted to work on it with
you because we do think that more should be done to encourage
States to do so.
And your notion is an intriguing notion about setting a 10-
year goal for doing these sorts of things and a number of
people have talked about that very idea in the past. The more
experts you talk to who really look at this product, the more
they tell you, just as Dr. Blum just did, is there are things
that we don't know the answer to, which is one of the reasons
for trying to give this to an agency with real scientific
expertise, hold their feet to the fire, for them to come up
with the kind of rigorous standards that can make a difference
and I don't think anybody here today can tell you what they
are. But in the past, when legislative bodies--not just in the
United States but elsewhere, have thought they understood the
issue without knowing all the detailed science and you know it
better than most do, what we have found is that all it does is
lead the tobacco industry into a pathway around it. So it is
the reason that many of us have come to the conclusion that the
best thing we can do is give it to an agency, give them a
mandate, watch over them to make sure they do it and they do it
in a way that, in the end, has the kind of public health,
scrutinize them in the way you're talking about doing over the
long-term.
Senator Coburn. The only problem with that theory is the
Bureaucrats' Law of Washington--never do what is right when you
can do what is safe. And that will mess up all your plans, I
promise you, as I've seen many great plans messed up at the
FDA. So that's a nice utopian goal but I'm here to tell you,
that ain't going to work. The FDA is like a balloon. You push
in one place, it goes out somewhere else. They are smart enough
to get around anything--and they'll move around that, too. So
the goal has to be everybody recognizing what the problem is.
There's no question. We need to work on that end in terms of
supply but the No. 1 thing is prevention. Prevention is the No.
1 thing and how do we counter what Senator Burr was talking
about? If you could get an agreement where the first amendment
rights were limited by agreement and then we poured the money
into prevention, we could make a big impact in this country, a
big impact. We're not going to make any kind of impact with
this for 5, 10, or 15 years. We could do that tomorrow. We
could start saving 40,000 lives a year tomorrow if we would go
with prevention and some type of agreement where we limited
first amendment rights in terms of tobacco products.
Mr. Chairman, thank you. I've gone over my time.
The Chairman. Could I just ask Dr. Henningfield, who is an
expert on this whole issue of addiction. Maybe you could make a
comment?
Mr. Henningfield. I'd appreciate it. Being from Minnesota,
I tend to wait and then you don't get in line.
The Chairman. You don't get any time, any floor time.
Mr. Henningfield. Prevention is vital. Prevention won't pay
off in terms of death reduction for 20 to 30 years in a big
way. We've got 50 million-plus tobacco users that we need to
help earlier. The idea is intriguing of setting a standard and
say 10 years or 9 years, to take all the carcinogens out. That
sounds like a 10-year clock to prohibition. It's a legitimate
thing to discuss. That really is a political/social discussion.
But FDA does not design foods, drugs. Congress doesn't design
foods, drugs. I work with WHO--they don't design foods, drugs.
They say, these are the standards that you must achieve in
light of today's science. As the science evolves, as the
products evolve, you evolve the standards and hopefully,
tighten up the standards. That, I think, is the regulatory
approach to----
Senator Coburn. Let me respond to that, if I might. So
we're going to tighten up the standards. There is no difference
in that and in going to abolition. You're going to trust an
agency to do what we don't have the courage to do as a
Congress. That's what you're really saying to me. We don't have
the guts to stand up and say, here's where we need to go. We
can create a small commission and we can fund it and we can
figure out a way to do that. We don't have the courage to do
what is really necessary--take a combination of our ideas for
an agreement on both advertising and warnings, and really
invest in prevention. We don't have the courage to do that.
We're going to shuffle this over and in 10 years, we're going
to be back here talking about the same thing, because Marlboro
will be Marlboro tomorrow.
Mr. Henningfield. Senator, I hope you will have the courage
to stand up and argue for much more funding for prevention. I
think it is atrocious that States haven't spent more money on
prevention. I think we all agree with that. But you can give us
the work in prevention too, an asset, so companies can't come
out with Camel No. 9 or if they try to, we can say, what, when,
how, why.
Senator Coburn. That's what Senator Burr is offering you.
Mr. Henningfield. The FTC is clueless. It can't----
Senator Coburn. But they are now. What makes you think the
FDA is any better?
Mr. Henningfield. The FDA is----
Senator Coburn. On these same issues?
Mr. Henningfield. Well, the FDA's entire authority and
history is health regulation, toxic regulation.
Senator Coburn. No, it's safety and efficacy. There is
nothing safe and there is nothing efficacious about tobacco
products and we're going to ask an agency whose whole goal is
safety and efficacy to approve our grandfather, what is
obviously not safe and not efficacious.
Mr. Henningfield. Neither FTC nor DOJ nor anyone else
discovered that light cigarettes were a sham. NCI, NIH, CDC and
FDA discovered that. These are health organizations. The FTC is
not a health organization. It doesn't have the culture, the
experience to assess ingredients----
Senator Coburn. I want you to think bigger. I'm talking
about doing the whole thing. I'm not talking about a little
piece here and there. I'm talking about thinking outside of the
box. Let's go after it. Let's create true prevention. Let's--
sorry, Mr. Chairman.
The Chairman. Senator Reed.
Senator Reed. Thank you, Mr. Chairman. Thank you for your
testimony. One of the presumptions of an effective market is
perfect information by buyers and sellers. So Dr. Henningfield,
do you think buyers of cigarettes have perfect information
about what's in the cigarette?
Mr. Henningfield. Not even close. I don't think they
understand the vent holes. I don't think probably anyone here
understands that the vent holes do something else. They
increase the free-base nicotine fraction. CDC discovered that.
It took CDC to jump in and say they not only are a sham but
they increase free-base nicotine. So in order, if this is a
product in the marketplace, in order to make it--the market--
better, consumers need more information, like what's inside the
cigarette, how is it designed to produce nicotine in higher
effects? Wouldn't that sort of be a principle of an effective
market? At least they know what they're getting into when they
start smoking?
Senator Reed. I think it is core and it's what we rely on
the Food and Drug Administration to do, whether it's dog food,
potato chips or anything else, to ask what, when, how, why--
what are the effects?
Mr. Henningfield. Except for cigarettes.
Senator Reed. Except for cigarettes. So the FDA--these
arguments about they don't have the capacity and they can't be
effective in terms of dog food seems to be disputed by--they
actually do things like that. Is that true?
Mr. Henningfield. This is what they do on a routine, daily
basis. One of the sad things about the data that Dr. Connolly
showed about trends in nicotine is, all of us that are expert
in this area are not sure why it's being done, how it's being
done, what the effect is. FDA could do all of that. They could
say why, what, when, how.
Dr. Blum. Senator, could I add something? I'm Dr. Alan
Blum.
Senator Reed. Please, doctor.
Dr. Blum. I served on an FDA advisory committee and again,
I have great respect for the staff and it breaks my heart and I
wasn't prepared to do this, to catalogue the list of abject
failures of the FDA over the last 10 years. We all know about
them, from antibiotics in animal feed that have resulted in
resistance and contamination to women's hormones to
antidepressants in children, cash donations to doctors from
drug companies--it's all been botched and this is an agency
that is now going to take over a product that has no redeemable
health value. It strikes me as an exercise in absurdity for
this agency to be the one that the proponents of this bill want
to entrust with the most irredeemably harmful consumer product
in our society. I would love to see a separate agency or a
separate Congress as Senator Coburn said, with the courage to
tackle the elephant in the room, which is Marlboro. That's
what's killing people. It's not little Camel No. 9's or
whatever new little product come on the market that will be the
definition of infinity.
Mr. Connolly. Senator, let me----
Senator Reed. Dr. Connolly, go ahead, please.
Mr. Connolly. I disagree totally with what he said. I mean,
if you read the history of the FDA, it's probably one of the
most--greatest public health institutions known to our country.
It prevented the adulteration of meat by throwing sugar in it.
It stepped in and it stopped that in the early part of the last
century. RJ Reynolds throwing sugar into tobacco products, to
me is no different. It's adulteration of a very harmful product
to make it even more attractive to kids. FDA dealt with HIV,
fast tracking the research, did a wonderful job. FDA has done
food labeling so our Nation's consumers are much, much more
knowledgeable about foods. When Massachusetts--post the MSA,
tried to get the ingredients in cigarettes, we were sued by a
big tobacco--by six companies, by 4 p.m. and spent 6 years in
Federal court, $20 million of their litigation, just trying
tell adult consumers what's in their products so they could
make a choice between one that could be more addictive and less
addictive. If this industry has changed, they wouldn't be suing
us to give adult consumers information about quitting. FDA has
got a wonderful history and I can recommend some very excellent
books to my close friend, Alan, to read about the history of
FDA and I think this agency can do a miraculous job on an issue
that this Congress, this Nation, has failed to address.
Senator Reed. Dr. Henningfield.
Mr. Henningfield. Just to add to that, what FDA does is
find the balance, it tries to find the balance. People,
including Dr. Blum, have criticized the bill that will be too
restrictive on new products, not restrictive enough--well,
that's FDA's job to find the balance and it will make mistakes
at times, as it has made in the past. Then it has mechanisms to
be flexible and corrective. If you just say, Congress orders--
this is the new label. This is the way it should be, that will
be wrong in a while and you won't have a flexible way to
address it. That's what FDA does every day.
Senator Reed. Well, my presumption is that it is a process
involving several institutions. No. 1, Congress lays out
guidelines and an agency like FDA, when it comes to
advertising, perhaps FTC, will implement those, subject to our
approval, appeal, criticism, and changes. What I sense is that
finding fault with the FDA is a way of stopping any type of
progress with respect to regulating what is in cigarettes, the
information consumers might have because I think, again, it's
the classic situation of the perfect becomes the enemy of at
least the barely adequate. And around here, barely adequate
might mean progress. Mr. Myers, do you have any comments?
Mr. Myers. Let me echo what Dr. Henningfield said. There is
no simple solution, as much as we'd all like a simple solution.
This bill gives the FDA the authority to deal with Marlboro as
well as with Camel 9. We're all going to have be vigilant to be
sure that FDA does its job to protect the public to the extent
possible but there simply hasn't been a more thoughtful,
balanced approach presented to Congress to address this problem
in the past. Otherwise, we have the status quo where it's
Philip Morris who controls what goes in Marlboro. It's Philip
Morris who controls what goes in the advertising to young
people today. We need a Federal agency with a mandate to do it
day in and day out and then all of us need to remain vigilant
to make sure they do their job.
Senator Reed. Thank you. Thank you, Mr. Chairman.
The Chairman. This has been enormously interesting and
worthwhile discussion. Now let me ask the panel, what we have
basically underlined in the legislation--we know that it is the
tar and the chemicals that kill. But we know it's the nicotine
that's addictive. So we know that people smoke and they get the
nicotine because that is what is the addictive substance. We've
given the FDA the authority to bring that nicotine level down.
Some will say, ``Well, by bringing it down, smokers are going
to smoke a lot more and they're going to inhale a lot more tar
and chemicals. Therefore, it's going to be just as dangerous
for them.'' Are we saying that medically we don't know whether
you can get nicotine down so low where, from a medical point of
view, it is nonaddictive. These are all scientific questions.
But aren't we all trying to get to the point where we're
reducing the tar and the chemicals, which are the most
dangerous and where we get the nicotine, which is the addictive
substance. In this general kind of discussion, are we getting
mixed up between these different subject matters in terms of
what the legislation is attempting to do?
Mr. Myers. I think you said it very well. The goal is to
reduce the toxic substances with a real goal of reducing the
number of people who die. That's the end measurement in this.
The bill doesn't make a judgment about whether it's good or bad
to raise or lower nicotine levels. What it does is say to the
FDA, you need to take a look at the best available science and
what its impact will be, with the ultimate goal of taking steps
that will reduce the number of people who will die. It doesn't
pre-judge whether that number goes up or goes down or what that
number does and it defers to Congress to make that final
decision in that respect. But the key here is it gives the
agency the authority to take the steps to reduce the things
that are killing people today.
The Chairman. What is the answer to the question that
Senator Enzi mentioned, that the FDA regulation could give the
appearance of an FDA seal of approval on the cigarettes that
they allow to be sold?
Mr. Myers. There are at least five provisions in this bill
that give FDA the authority to prevent a tobacco company from
explicitly or implicitly doing that. If that needs to be made
clear, then we should make that clearer in that respect, I
think everybody agrees. Equally important, there is a standard
in the bill that addresses that issue and that is that FDA must
look at the impact of any action, not just based on an
individual smoker but on the population as a whole so that if
an action has the impact, either by tobacco companies finding a
way to give the impression that it's FDA approved or some other
mechanism, to actually increase tobacco use by encouraging
starters, discouraging quitters, then FDA has the power to step
in to prevent that. It's broadly based on the notion that the
agency should have broad-based flexibility. Dr. Henningfield
may want to add to that.
The Chairman. Please address that, and then address the
point that, since the advertising budgets of the companies are
virtually unlimited, no matter what the FDA has actually done,
the companies' ads will distort it.
Mr. Henningfield. Well, the first thing is, what FDA is
already good at, for better and for worse, is sitting back and
letting the companies spend the money and say, ``Prove it.''
And with this, Camel No. 9, it says it's new. FDA could sit
back and say, ``Is it new? Does that mean we need prior
approval?'' They can get into issues like that. They can look
at--they can ask the company to do focus group testing on the
intent of the marketing and the effect of the marketing and sit
back and say, ``We're not happy. Go do more.'' So the FDA has a
lot of tools at its disposal that are embodied within the
regulation. If I can just touch nicotine?
The Chairman. Go ahead.
Mr. Henningfield. Nicotine, like cocaine, like sedatives,
like stimulants, it's not just the drug. It's how it's
delivered. The National Institute on Drug Abuse that I used to
be a part of made enormous progress. You look at the nicotine
patch. It's minimally addictive. Same chemical. What Marlboro
does is increase the free-base fraction, have other chemicals
along with nicotine. They did research that showed that
acetaldehyde worked synergistically with nicotine. So can we
make a cigarette nonaddictive? Probably not, as long as there
is nicotine. Can we make it less readily addicting? I believe
we can.
Dr. Blum. Senator, it took 10 years to get rid of Joe
Camel. Everyone was jumping around with their necks cut off
about the cartoon character and cigarettes. That did not even
end as a regulatory measure. It was voluntarily withdrawn by RJ
Reynolds. Meanwhile, Marlboro sales soared. You're all upset
about Camel No. 9 but how many days, months, weeks or years
will it take for more regulators to engage our taxpayer money
in looking at each variation of a brand name that comes along?
The most dynamic, creative expert marketing force in this
country is Philip Morris. They have done wonders with any
regulation. They have outwitted us. You know, three quick
examples. This ad ran in the University of Alabama student
newspaper last week. They know all about--the public knows all
about what has been happening about smoking but that doesn't
seem to block Philip Morris from coming into universities--over
35 universities and talking about how they have redefined not
just cigarette marketing but marketing in general, to a one-on-
one experience. And the job interviews are being held all this
week. They are mailing to physicians. That's right--the Philip
Morris Tobacco Company is mailing its Quit Assist booklet to
physicians and asking them if they want more copies for their
waiting room. They are promoting a youth anti-smoking--I call
it anti-youth smoking program and we don't really--we say this
is nonsense and of course, it is but this bill will not prevent
this company from being as dynamic and creative as ever. I
asked a college student, why would you want to work for Philip
Morris? He was interviewing for it and he said, ``Oh, they
don't just sell cigarettes. They help prevent smoking.''
Mr. Connolly. Senator, I would say that--two points. We
don't know the answer. Is it toxicity or nicotine--which to
take out. And I think the FDA is empowered to look at both
issues. Tomatoes have .3 milligrams per gram of nicotine in
them but no one is outside the building today eating bags of
tomatoes. And maybe we want to go down that route but we have
to look at it very, very carefully. If we go down that route,
maybe bring in close products that reduce harm to replace the
nicotine in Marlboros and turn Marlboros into lard. I think
that's conceivable.
I brought some research we did on the safest cigarettes. We
also asked consumers about the advertising claims. Do you think
these claims are approved by government? Eighty percent of our
respondents said, ``Yeah, the Government has approved those
claims.'' So the train has already left the station here. The
Government--I mean the consumers think the Government is
approving those claims so why not put them into--to look at
those claims and regulate claims? I don't think this is going
to impact whatsoever on the litigation front. If the industry
continues to behave the way they have behaved, it will be
continued action within the courts and FDA regulations are not
going to impact on that.
Senator Coburn. Just one short answer. What would be wrong
with the Federal Government having an advertising program
saying that they didn't approve those claims? And that there is
no government endorsement of the product? There is none. So
we've not done that. So we've allowed that kind of response
because we've failed to do what we should be doing.
Mr. Connolly. If you pass this bill, Senator, you will ban
those claims that are being made today for those 38 safer
products. Their claims are being made today. We need this bill
out there today to ban those unfounded, unsubstantiated claims.
And then, based on science, if they do come up with a product
that actually does reduce harm to the consumer, then the
Federal Government should allow those claims. They shouldn't
deny the consumer that information.
Senator Burr. Mr. Chairman, I have found this discussion to
be fascinating and the reality is, the way the bill is written,
there can't be higher nicotine because it bans it. As a matter
of fact, it sets the ceiling at the current product and no
product more harmful, which is the way it should be. More
harmful should be considered, much less approved and yes, there
is an FDA approval but somehow we suggest nobody in America
will realize that when that new product comes out that suggests
less harm, that they will consider that it has the stamp of
approval from the U.S. Government because they are much smarter
than we are, let me assure you. As a matter of fact, in 1938,
when the FDA was created, there were drugs on the market then.
Do you realize all of those drugs that were on the market then
were never required to go through FDA approval? They are
marketed today. They are not FDA approved. But to use your
analogy, we would have to go out as a Federal Government and
force those manufacturers of those compounds to now advertise
that they're not FDA approved. Well, we know, what in fact,
that would do to a compound that might be very useful to a lot
of people, that passed safety and efficacy a long time ago but
when you put, ``it has not been approved,'' boy, you kill the
market for it. So part of the challenge that I've got is that I
have to pick, choose from everything you're trying to do to
figure out--just like the tobacco industry, which ones are they
structuring so they can do this? Which ones are you structuring
so that the outcome is predetermined? Because I think we have
the--we're the only ones that have the challenge of balance,
Dr. Henningfield.
Hold on. I mean, you guys have gotten a lot more time than
I have and I'll ask a few questions. You said that the FDA's
role is fair and balanced. It is not the FDA's role. The FDA's
role is to make sure that the hurdle is never lowered and that
the threshold for safety and efficacy is, in fact, something
that every product that comes through has to meet. So I'm not
sure where, in fact, there is balance on the part of the FDA.
As a matter of fact, Dr. Coburn and I have worked for 13 years,
as has Senator Kennedy and we've seen kids that came in--many
of them cancer victims, patients. And you know what? Picking up
the phone and trying to get the FDA to fast track something 10
years ago was unheard of, even if that was the only choice--the
only option for that child to have a hope of overcoming cancer
and the FDA said, ``No, we don't do that. We have a threshold--
a drug, a biologic, a device must meet that threshold and if it
doesn't, it doesn't go through here. We don't approve it.'' And
you know what? That's the standard that should be maintained.
Now, let me say this. Can you create a new area of FDA that has
limited responsibilities, authority, very well prescribed as to
what it is we want them to look at, what it is that we want
them to regulate? Sure, we can do that. We're the Congress of
the United States. That may be what we need to do. But we've
tried to go through a process today to determine, is this the
most appropriate agency for everything that we're trying to do?
And I would challenge you that it's not. That there are areas
that can do it more effectively, with greater assurance that
it's being done and there may be some things that at the end of
the day, we need to sit down and say, maybe this is something
only the FDA can do. But you know, even for some of the
toxicology studies--I'd challenge you that probably CDC is a
more appropriate place to do that. They do it every day. They
respond in a different fashion. It doesn't encompass everything
in one agency, which is what many want to do in this. But it
can be just as effective.
Now, Dr. Henningfield, I've got to ask two real quick
questions. Do you support granting sovereign control of the
tobacco industry to an international organization and
relinquish American control of the product?
Mr. Henningfield. No.
Senator Burr. Do you support sending taxpayer dollars to
developing countries in order to subsidize their tobacco
production?
Mr. Henningfield. Their tobacco production?
Senator Burr. Production, yes sir.
Mr. Henningfield. I think that's a question with complexity
beyond my ability.
Senator Burr. Well, I've read the World Health Organization
bill that you signed and I think it does exactly those two
things. So I would ask you to go back and look at that. And Dr.
Connolly again, I want to--I really want to comment on your
passion. There is no substitute for that and I appreciate it.
Mr. Connolly. Senator, could I just respond?
Senator Burr. Yes.
Mr. Connolly. By saying, I'd like to----
Senator Burr. But let me make my last point first and then
I'll let you talk all you want to.
Mr. Connolly. No, I don't want to--I just want to just
correct the record, that's all, Senator.
Senator Burr. You know, I expected when I pulled the
numbers up, that I'd find Massachusetts having used all their
tobacco money for health and education. In fact, I found
Massachusetts ranked No. 31. They used 23.4 percent for tobacco
and education. North Carolina is the tobacco State. Our
livelihood is in it--manufacturing, growth. We used 40.2
percent of the MSA money for education and for healthcare. We
were No. 21. There were 20 States that did better than we did.
You know, in large part, I hope you--and I'm sure you
have--displayed some of that passion back in Massachusetts as I
will in North Carolina, to see if we can't use money that was
targeted for this specific thing and to get it out of budget
deficits and transportation dollars and everything else States
love to spend it on.
Mr. Connolly. Well, I didn't have the action but our
Governor Romny, who wasn't a Democratic by the way, cut the
budget. He maintained that--Governor DeVaugn--Patrick has
increased the budget by $18 million 2 days--actually Wednesday,
today, in his budget. So we will be ahead of North Carolina. We
should be much higher. Just as acting as a Senate historian,
the FDA bill was passed in 1906. What the FDA bill is
grandfathered in from the homeopathic pharmacopoeia--all those
substances that were either approved or not approved--nicotine
was one of those substances. Purportedly for passage of the
bill by the Senate in 1906, nicotine was withdrawn from the
homeopathic pharmacopoeia so basically, unregulated by FDA.
Cocaine was in the original 1906 FDA bill. It was in Coca-Cola.
And what happened is FDA then took it out of Coca-Cola, put it
into a schedule so a physician could still prescribe cocaine
and then finally prohibited it. So I think it's a wonderful
Senate--of this chamber and I think when one only has to go
back to 1906 and empower the FDA to do what they've done for
cocaine, to do for tobacco products and this Nation will be
healthier for it. Thank you, Senator.
The Chairman. OK, well.
[Laughter.]
Dr. Land, did you have any final comments?
Mr. Land. Well, I must confess, I experienced some
frustration with the latter part of this process. It seems to
me that we're trying to make the perfect enemy of the good
here. The FDA, like all Federal agencies, like all man-made
creations, has flaws but it has done an enormous amount to
protect the American people over the years and I don't think--I
would not want to be charged with the argument of trying to
make the argument that this bill will not retard the ability of
the tobacco companies to run their scam on the American people.
Are there other things that can be done? Of course. And all of
them together--the end product, the sum--the end product will
be more than the sum of the parts but this bill, we believe,
will help protect the American people and will help to regulate
what is too unregulated an industry. I will go back to what I
said in my testimony--it just seems to me to be irrational that
the FDA controls--has control over products that help people
quit smoking but has no control over the product that they are
trying to quit.
The Chairman. OK. We're running out of time here but I'll
just give 30 seconds to anybody that wants a final comment.
Dr. Huerta. Thank you, Mr. Chairman. When I do my radio
talk shows on a daily basis, we talk about tobacco. Some
listeners, they say, ``Why don't you ban tobacco being so
bad?'' Well, nobody is in agreement with that in this room. So
I see this bill as a positive way to change the environment and
when you change the environment in a Nation, that is the first
step for change for good. Remember our long fight against this
industry. We fought this in the fifties and the sixties and the
seventies, eighties and nineties--well, 2007 now and this will
do the right thing to change the environment.
The Chairman. Thank you.
Dr. Blum.
Dr. Blum. Thank you again, Mr. Chairman, for this hearing.
I have to really claim to be the longest running person in this
field in this room and I believe, unfortunately, that the bill
is the wrong policy for the wrong agency at the wrong time.
Tinkering with a product, with ingredients is the most resource
and labor-intensive and the least effective, least proven,
least relevant and biggest waste of time, money, attention and
focus we can do.
The Chairman. You can see that we don't hear just one side
at these hearings.
[Laughter.]
Senator Coburn. While we're at it, I'd just throw out one
other drug that we ought to consider for FDA control. The FDA
doesn't control alcohol but they control all the drug
treatments for alcohol withdrawal and treatment. This
rationalization--I'm not against the purposes that everybody in
this room is trying to go for. But let's apply the same
standard everywhere. You all have a lot more faith in the FDA
than I have in the FDA and I have a law since January 2000,
signed by Bill Clinton, that said the FDA will label condoms as
to their efficacy. The science is proven on that. But, for the
political correctness, the FDA has kept the information for
that to themselves. So we consequently have no law and we have
no label on condoms that are 80 percent ineffective--and this
can cause cancer in women. Eighty percent ineffective. But yet
we don't have it. So this is the same FDA that you are
entrusting to do everything that you hope to do, but they don't
control alcohol sales. They don't control advertising for
alcohol and I would put forward to you, alcohol consumption in
this country might be a larger problem, or equal, in terms of
the illness and associated morbidities that Americans
experience. Thank you, Mr. Chairman.
The Chairman. We're winding up but I really have to add my
commendation of the Food and Drug Administration. I've been on
this committee for a number of years, 45 years on it, and
I've--particularly Senator Hatch and I--have spent a lot of
time dealing with the FDA. We've been very much involved in the
re-authorization. There are a lot of challenges that are out
there but we are the gold standard in the world, in terms of
the Food and Drug Administration. Just while we're meeting
here, the Chinese are in the process of adapting a Food and
Drug Administration virtually identical to what we have here.
It's been modeled in terms of the countries in Western Europe.
We haven't always had the right answers, but we are in the life
science century and the changes that have been brought on in
terms of products that have made a difference in the lives,
particularly of our senior citizens, have been close to
miraculous. So I can also give my observations about some of
the shortcomings of FDA and we're going to try and address some
of those in the Enzi/Kennedy legislation; but we need to keep
those shortcomings in perspective.
I want to thank all of our panel. We're going to keep the
record open and we're going to keep you all busy with written
questions. There will be more questions, but this has been
very, very helpful to our committee. We're enormously grateful
to all of you and we will stand in recess. Thank you.
[Additional material follows:]
ADDITIONAL MATERIAL
Prepared Statement of Senator Clinton
I would like to thank Chairman Kennedy and Ranking Member
Enzi for convening today's hearing on the importance of
providing the FDA with the authority to regulate tobacco.
We have a duty to safeguard our Nation's health and fight
efforts to target tobacco products to women and children. I am
proud to be an original cosponsor of The Family Smoking
Prevention and Tobacco Control Act, and I am delighted that
this bill has garnered such strong bipartisan support.
I'm also pleased to announce that today, Senator Hagel and
I are reintroducing our lung cancer resolution, which seeks to
draw attention to this terrible, smoking-related disease. This
resolution passed the Senate last year, and I'm hopeful that
the Senate will take quick action again.
It's hard to believe that it's been 7 years since the
Supreme Court ruled that the FDA does not have authority over
tobacco products.
I am fortunate to represent a State where tobacco control
laws are amongst the best in the Nation. This past January, the
American Lung Association ranked New York as the second highest
in the Nation for its efforts. New York particularly received
praise for its exceptional smoking prevention and cessation
programs.
But, despite these laudable efforts, there has been a
troubling increase in smoking-related diseases among women in
New York in the last 30 years. Female smokers are 13-times more
likely to develop lung cancer than women who don't smoke. And
between 1983 and 2003, the annual number of cases of lung
cancer and bronchus among women nearly doubled, increasing from
3,852 to over 6,000 in New York State in that 20-year period.
In fact, lung cancer is the leading cause of cancer deaths
in our Nation, causing more deaths than breast cancer, prostate
cancer, and colon cancer combined.
Each year, 178,000 women die annually from smoking-related
diseases in this country, and over 35 million Americans--male
and female--suffer from chronic lung diseases such as asthma,
emphysema and chronic bronchitis.
Risk of infertility is greater among female smokers
compared to nonsmokers, and there is a higher risk of pregnancy
complications, premature birth, low-birth-weight infants,
stillbirth, and infant death if a woman smokes during
pregnancy.
There is strong evidence that tobacco advertisements
cynically target advertising to adult and adolescent women.
According to an analysis published by the Journal of the
American Medical Association in 1994 and a 2001 report by the
Surgeon General, the tobacco industry has targeted women with
some form of this dangerous promotional strategy for almost a
century, beginning in the 1920s. The latest example of this is
chronicled in a recent New York Times editorial, entitled
``Don't Fall for Hot Pink Camels,'' which discusses R.J.
Reynolds's $25 million to $50 million investment in an
advertising campaign behind the new female-friendly Camel No.
9.
In addition to targeting women, tobacco advertisements are
also designed to appeal to our youth. This is unconscionable.
According to the 2004 Surgeon General's report on the
Health Consequences of Smoking, there is a higher incidence of
respiratory illness in children and adolescents who smoke
compared to their nonsmoking peers. This report also concluded
that the overall health of kids who smoke is worse than their
nonsmoking peers.
I believe that tobacco use constitutes one of the largest
threats to public health, a conclusion that is also expressed
in the 2000 Supreme Court ruling.
In States such as New York, we've seen evidence that
tobacco control efforts can help lower rates of smoking and
tobacco use among kids. Between 2000 and 2004 in New York
State, there was a widespread reduction in use of cigarettes
and other tobacco products by students in both middle and high
school. Frequent use of cigarettes among middle school students
dropped by 55 percent, while high school students' frequent use
decreased by 36 percent.
However, given the damaging effects of tobacco products on
kids, I am still concerned that over 20 percent of high school
students in my State smoke. And that nationally, 25 percent of
children smoke by the time they finish high school.
The United States spends more on health care than any other
industrialized nation and yet we struggle to provide adequate
health care for all our citizens. We literally cannot afford
the myriad of health problems that we know result from tobacco
use: bladder, esophageal, laryngeal, lung, oral, and throat
cancers, chronic lung diseases, coronary heart and
cardiovascular diseases, as well as reproductive effects and
sudden infant death syndrome.
That's why I support S. 625. This important legislation
gives FDA the legal authority necessary to accomplish a
collection of crucial tasks: preventing tobacco advertising
aimed at children--preventing tobacco product sales to minors--
and making tobacco products less toxic. These efforts are
critical in improving our Nation's health and reducing the
burden of health care costs.
I look forward to hearing the expert opinions from our
panelists today, and I hope that with their input, we will
remove any doubts that passing this legislation is critical to
our Nation's health.
Again, I would like to thank both Chairman Kennedy and
Ranking Member Enzi for holding this hearing and I look forward
to working with my colleagues on the committee to ensure
passage of this bill. Thank you.
STATEMENTS AND LETTERS OF SUPPORT
Statement of Matthew L. Myers, President, Campaign for Tobacco-Free
Kids
Washington, DC. (February 15, 2007)--The bipartisan legislation
introduced today to grant the U.S. Food and Drug Administration (FDA)
authority over tobacco products presents the new Congress with a truly
historic opportunity to protect our children, improve the Nation's
health and save countless lives. There are few steps Congress can take
that would make a bigger difference for our Nation's health. It is
truly inexcusable that the most deadly product sold in America today is
one of the least regulated products sold in America. By passing this
legislation this year, the new Congress can end the special protection
the tobacco industry has enjoyed for far too long and at such terrible
cost in health, lives and money.
Along with our many public health, faith and other partners that
have endorsed this legislation, the Campaign for Tobacco-Free Kids
applauds U.S. Senators Edward Kennedy and John Cornyn and U.S.
Representatives Henry Waxman and Tom Davis for their leadership in
introducing this bipartisan legislation. The large number of original
cosponsors in both houses of Congress and from both parties underscores
the strong, bipartisan support for this legislation.
Throughout the coming debate, we should never forget what this
legislation is all about: Reducing tobacco's devastating toll on our
families. Tobacco use is the leading preventable cause of death in the
United States. It kills more than 400,000 Americans and costs the
Nation more than $96 billion in health care bills every year. Tobacco
use kills more of our citizens annually than AIDS, alcohol, car
accidents, murders, suicides and fires combined. Every day, another
1,200 Americans die from tobacco use and more than 1,000 kids become
regular smokers. This deadly toll will continue to mount so long as the
tobacco industry remains unregulated and free to engage in marketing
that appeals to children, to deceive consumers and to resist even the
most minimal steps to make their products less harmful.
Congress has debated the issue of FDA authority over tobacco for
nearly a decade. It is time to finish the debate and take action to
protect children and save lives.
Statement of John Kirkwood, President and CEO, American Lung
Association, New York, NY
Washington, DC. (February 15, 2007)--The American Lung Association
commends Senator Ted Kennedy (D-MA), Senator John Cornyn (R-TX),
Representative Henry Waxman (D-CA) and Representative Tom Davis (R-VA)
for the introduction of the Family Smoking Prevention and Tobacco
Control Act, strong, bipartisan legislation that would give the U.S.
Food and Drug Administration authority over tobacco products. Once
enacted into law, this measure will end the special protection enjoyed
by the tobacco companies for decades and seriously reduce the
devastating impact of tobacco use in the United States.
Tobacco-related diseases are the leading preventable cause of death
in the United States, causing more than 438,000 deaths each year. Each
day, more than 1,140 kids become regular smokers--and one-third of them
will ultimately die from their habit. The tobacco companies spend more
than $15.15 billion a year marketing their deadly products--preying on
our children, who make up the ``replacement generation'' of smokers.
In August 2006, U.S. District Court Judge Gladys Kessler correctly
concluded that tobacco companies have engaged in a long-term,
fraudulent scheme to mislead the American people about the health risks
of smoking, the addictiveness of their products, and their tactics for
marketing their products to children. In her decision, Judge Kessler
wrote that the tobacco companies have ``marketed and sold their lethal
products with zeal, with deception, with a single-minded focus on their
financial success, and without regard for the human tragedy or social
costs that success exacted.'' Unless this important legislation becomes
law, the tobacco companies will continue to aggressively market their
products to children and lie about the health consequences of smoking.
The American Lung Association is committed to working with Congress
to ensure that the legislation becomes law in 2007.
about the american lung association
Beginning our second century, the American Lung Association is the
leading organization working to prevent lung disease and promote lung
health. Lung disease death rates continue to increase while other
leading causes of death have declined. The American Lung Association
funds vital research on the causes of and treatments for lung disease.
With the generous support of the public, the American Lung Association
is ``Improving life, one breath at a time.'' For more information about
the American Lung Association or to support the work it does, call 1-
800-LUNG-USA (1-800-586-4872) or log on to www.lungusa.org.
______
American Medical Association,
February, 15, 2007.
ama applauds legislation to give fda authority over tobacco products
The American Medical Association strongly supports the regulation
of tobacco products by the Food and Drug Administration (FDA). We
applaud Representatives Henry Waxman (D-CA) and Tom Davis (R-VA) and
Senators Ted Kennedy (D-MA) and John Cornyn (R-TX) for their bipartisan
leadership in introducing the ``Family Smoking Prevention and Tobacco
Control Act'' to give the FDA authority to regulate the manufacture,
sale, distribution, and marketing of tobacco products. Passage of this
legislation will end the cruel irony that cigarettes are the most
important preventable cause of death and disease in the United States
and one of the least regulated products in our society.
Every year, 440,000 Americans die from diseases caused by tobacco
use, which kills more Americans than heroin, PCP, cocaine, alcohol and
every other drug combined. Tobacco is responsible for more than $75
billion in health care costs and $92 billion in productivity losses
each year.
Tobacco addiction usually begins in childhood or adolescence. Each
day, 2,000 kids become addicted smokers and one-third will die
prematurely as a result. Some of the provisions in this legislation
would stop illegal sales of tobacco products to children; restrict
tobacco marketing, especially to children; ban fruit and candy
flavorings in cigarettes; and require more informative health warnings.
The AMA urges Congress to protect the public health of Americans by
passing legislation to authorize effective FDA regulation of tobacco
products.
Ron Davis, M.D.,
AMA President-Elect.
______
Statement of the American Medical Association
The American Medical Association (AMA) is pleased to submit this
statement for the record of the Senate Committee on Health, Education,
Labor, and Pensions (HELP) hearing on ``The Need for FDA [Food and Drug
Administration] Regulation of Tobacco Products.'' On behalf of our
physician and medical student members, we applaud Senators Ted Kennedy
(D-MA) and John Cornyn (R-TX) for their bipartisan leadership in
introducing S. 625, the ``Family Smoking Prevention and Tobacco Control
Act,'' to give the FDA authority to regulate the manufacture, sale,
distribution, and marketing of tobacco products. The AMA has a long
history of supporting strong and effective FDA regulation of tobacco
products. We firmly believe that Congress should act this year to
protect the public's health by passing S. 625 and its House companion
bill, H.R. 1108, introduced by Representatives Henry Waxman (D-CA) and
Tom Davis (R-VA).
Cigarettes are one of the least regulated products in our society
but cigarette smoking remains the leading preventable cause of death
and disease in the United States. Passage of this legislation would
address the lack of regulation of this product. We expect the FDA to
carefully monitor and regulate thousands of products that we consume on
a daily basis. There are recent examples of such oversight with peanut
butter, spinach, eye drops and similar products. Our government should
apply the same diligence to the monitoring of tobacco products that it
currently dedicates to ensuring the safety of the food and drug supply.
It is unconscionable that cigarettes remain virtually unregulated with
their ingredients undisclosed a full 43 years after the first Surgeon
General's report on smoking and health.
As physicians, we see daily the devastating consequences of tobacco
use on our patients' health. Patients suffer from preventable diseases
including cancer, heart disease, and emphysema that develop as a result
of a single product--tobacco. The evidence is overwhelming concerning
the health risks of using tobacco products, particularly when used over
decades. Each year, 440,000 Americans die from diseases caused by
tobacco use, including at least 38,000 who die from secondhand smoke.
Smoking kills more people than alcohol, AIDS, car accidents, illegal
drugs, murders, and suicides combined, with thousands more dying from
chewing tobacco use. Millions more suffer from illnesses caused by
smoking. In fact, former Surgeon General Richard Carmona, in releasing
his office's 2004 report on ``The Health Consequences of Smoking,''
stated that ``smoking causes disease in nearly every organ in the body,
at every stage of life.''
In addition to the human toll, the financial consequences of
tobacco use are enormous. The Centers for Disease Control and
Prevention estimates that tobacco use causes over $96 billion in annual
health care expenditures. This includes over $30 billion in total
annual Medicaid costs (Federal and State), or 14 percent of all
Medicaid costs.
Tobacco addiction usually begins in adolescence. Each day,
approximately 4,000 kids will try a cigarette for the first time, and
another 1,000 will become new, regular, daily smokers. As a result,
one-third of these kids will die prematurely. Despite their assertions
to the contrary, the tobacco companies continue to market their
products aggressively and effectively to reach kids. Cigarette
marketing and promotional expenditures have increased dramatically
since the 1998 State tobacco settlement, reaching over $15 billion per
year. Much of this increase was particularly focused on kid-friendly
venues, such as convenience stores where kids hang out and from
magazines that they read. Such marketing has also included fruit and
candy flavorings in cigarettes. Research has shown that kids are three
times more sensitive to tobacco advertising than adults and are more
likely to be influenced by cigarette marketing than by peer pressure.
Although there has been progress in recent years to treat tobacco-
related diseases and encourage all smokers to quit, more needs to be
done to preserve and protect the health of Americans. Congressional
action to grant FDA authority to regulate tobacco products is long
overdue. The AMA strongly supports S. 625/H.R. 1108, which we believe
would finally end special protection for the tobacco industry and
protect our children and the Nation's health instead. In particular, we
believe the following provisions in the legislation are essential to
ensure the effectiveness of the FDA in reducing the number of
individuals who begin using tobacco.
Youth Access and Marketing. The bill would require the FDA, within
1 month after enactment, to republish the 1996 Rule, which was struck
down by the U.S. Supreme Court in 2000. This rule would significantly
restrict access to tobacco products by targeting marketing to children.
The legislation would:
ban all outdoor tobacco advertising within 1,000 feet of
schools and playgrounds;
ban all remaining tobacco brand sponsorships of sports and
entertainment events;
ban free giveaways of any nontobacco items with the
purchase of a tobacco product or in exchange for coupons or proof of
purchase;
ban free samples and the sale of cigarettes in packages
that contain fewer than 20 cigarettes;
require retailers to verify age for all over the counter
sales and provide for Federal enforcement and penalties against
retailers who sell to minors;
restrict vending machines and self-service displays to
adult-only facilities;
limit advertising in publications with significant teen
readership to black and white text only; and
limit any outdoor and all point-of-sale tobacco
advertising to black and white text only.
The FDA would have authority to take additional regulatory steps to
restrict tobacco marketing and to prevent tobacco sales to children
under the age of 18.
Health Information Disclosure. The bill would require detailed
disclosure of ingredients and harmful smoke constituents by tobacco
companies. It would also require that all documents relating to health,
toxicological behavioral or physiological effects of current or future
tobacco products be listed. FDA would have to publish a brand-specific
list of harmful and potentially harmful constituents. These disclosure
requirements would give the FDA the information it needs to require
changes to tobacco products to reduce the harm they cause and to better
educate the public about the dangerous chemicals in tobacco products
and the health effects of tobacco use. It would also provide the public
with much needed information in order to fully understand the toxic
nature of the product. With tobacco companies offering their own
version of smoking cessation programs, the public is misled about the
inherent harm in this product which if used as intended causes
disabling diseases and death.
Authority to Order Removal of Hazardous Ingredients. The FDA would
have the power to establish performance standards, including reduction
or elimination of ingredients, additives, constituents, including smoke
constituents, or reduction in nicotine yields to any level other than
zero. Thus, FDA could reduce nicotine to minimal levels, including
nonaddictive levels, to protect the public health. This is especially
important in light of a recent study conducted by the Harvard School of
Public Health showing that tobacco manufacturers have intensified the
concentration of nicotine in their tobacco and modified cigarette
designs to increase the number of puffs per cigarette. As a result, the
amount of nicotine that smokers typically inhale per cigarette rose by
11 percent from 1998 to 2005, making it much harder for smokers to
quit.
This regulatory authority is also critical in protecting nonsmokers
from secondhand smoke. The scientific evidence on the health risks
associated with exposure to secondhand smoke is overwhelming.
Secondhand smoke is a known cause of lung cancer, heart disease,
chronic lung diseases such as bronchitis and asthma, and results in
thousands of deaths annually in the United States. Sadly, secondhand
smoke also contributes to over 1 million illnesses in children per
year. As the Surgeon General concluded in his recent 2006 report, ``The
Health Consequences of Involuntary Exposure to Tobacco Smoke,'' ``The
scientific evidence indicates that there is no risk-free level of
exposure to secondhand smoke.''
Health Warnings. The FDA would be granted the authority to revise
the health warnings on both cigarettes and smokeless tobacco products,
and in print advertisements, to make them more prominent and explicit.
The warning labels on cigarette packages could be increased from 30
percent up to 50 percent of the front and rear panels.
Standards for Reduced Risk Products. Any so-called ``reduced risk''
products could not be sold or distributed without prior FDA approval.
In order to receive FDA approval manufacturers would be required to
submit data and a sample product to the FDA. They would also have to
demonstrate that the scientific evidence is adequate to conclude that
the product, as actually used by consumers, will significantly reduce
the risk of tobacco-related disease to individuals and that the product
as marketed will benefit the health of the population as a whole. In
addition, tobacco companies would be required to conduct and report to
the FDA postmarket surveillance of approved products' actual usage.
Providing the FDA with review and approval authority of ``reduced-
risk'' claims is a critical safeguard in preventing deceptive industry
marketing campaigns. It is ironic that on the same day that S. 625 was
introduced, the New York Times reported on a new marketing campaign
announced by a major tobacco manufacturer targeting women. The
advertisements describe the product as ``light and luscious,'' and show
flowers surrounding packs of cigarettes, which are in hot pink fuchsia
and minty green teal colors. This legislation would prevent such claims
and advertisements without prior FDA approval, thereby protecting the
health of our Nation's women.
In conclusion, congressional action to provide FDA with strong and
effective regulatory authority over tobacco products is long overdue.
Congress should act now to protect the public's health and save
millions of lives by passing S. 625/H.R. 1108 this year. The AMA is
committed to working with Congress to accomplish this goal.
Statement of John R. Seffrin, Ph.D., CEO, American Cancer Society
Cancer Action Network, Washington, DC
The American Cancer Society Cancer Action NetworkSM (ACS
CAN) applauds the introduction today of ``The Family Smoking Prevention
Tobacco Control Act'', bipartisan legislation in the House and Senate
that would grant the U.S. Food and Drug Administration (FDA) the
authority to regulate the sale, distribution and advertising of tobacco
products. Tobacco, which kills more than 400,000 Americans each year
and remains the leading cause of preventable death in the country, is
the only consumable product the FDA does not regulate.
``Congress has the opportunity to take a monumental step and grant
the Food and Drug Administration the meaningful and long-overdue
authority to regulate tobacco, which kills 440,000 people and costs our
Nation $96.7 billion in health care bills every year,'' said John R.
Seffrin, Ph.D. chief executive officer of the American Cancer Society
and ACS CAN.
``The tobacco industry has demonstrated time and again that, if
left to its own devices, it will falsely market its deadly products to
our children, portraying this deadly addiction as glamorous and cool
and luring 4,000 kids to try their first cigarette every day.
``The FDA has the scientific expertise necessary to effectively
regulate tobacco products and the health-related claims made by the
tobacco companies. As a science-based organization committed to
decreasing the toll tobacco takes on our country, ACS CAN will continue
to fight for American's right to know the contents of a product that
when taken as directed, kills.''
A joint statement from ACS CAN and its public health partners, the
American Heart Association, American Lung Association and Campaign for
Tobacco-Free Kids is also being released today.
Statement of American Cancer Society Cancer Action
NetworkSM, American Heart Association, Campaign for Tobacco-
Free Kids, and the American Lung Association
Washington, DC. (February 15, 2007)--Our public health
organizations strongly support the bipartisan legislation introduced
today in Congress to provide the U.S. Food and Drug Administration
(FDA) with effective authority to regulate tobacco products. This
legislation presents Congress with a truly historic opportunity to
protect our children from tobacco addiction and save lives by
addressing the Nation's No. 1 preventable cause of death. We applaud
U.S. Senators Edward Kennedy (D-MA) and John Cornyn (R-TX) and U.S.
Representatives Henry Waxman (D-CA) and Tom Davis (R-VA) for their
leadership in producing strong bills that would end special protection
for the tobacco industry and protect our children and the Nation's
health instead.
We urge both the Senate and the House to quickly enact this long-
overdue legislation into law and to reject all efforts to weaken it.
Every day Congress fails to act, another 1,200 Americans die from
tobacco use and more than 1,000 children become new regular smokers.
Each year in the United States, tobacco use kills more than 400,000
people and costs the Nation more than $96 billion in health care bills.
The legislation introduced today would save countless lives and improve
health for generations to come by reducing tobacco use and its
devastating consequences, which include cancer, heart disease, chronic
obstructive pulmonary disease (COPD) and diseases that affect virtually
every organ in the human body.
Unbelievably, despite all the harm they cause, tobacco products are
exempt from basic health and safety regulations that apply to other
products, such as food, drugs, cosmetics and even dog food. The tobacco
companies continue to take advantage of this lack of regulation to
market their deadly and addictive products to our children, deceive
consumers about the harm their products cause, make changes to their
products without disclosing them (such as secretly increasing nicotine
levels in cigarette smoke, as recent studies have shown), and resist
any meaningful change to make their products less harmful. Until
Congress grants the FDA authority over tobacco products, the tobacco
companies will continue to get away with their harmful practices that
addict children and make it difficult for smokers to quit.
The proposed legislation would grant the FDA the authority and
resources to effectively regulate the manufacturing, marketing,
labeling, distribution and sale of tobacco products. The FDA would have
authority to:
Restrict tobacco advertising and promotions, especially to
children.
Stop illegal sales of tobacco products to children.
Ban candy-flavored cigarettes, which clearly are starter
products for young new smokers.
Require changes in tobacco products, such as the removal
of harmful ingredients or the reduction of nicotine levels.
Prohibit health claims about so-called ``reduced risk''
products that are not scientifically proven or that would discourage
current tobacco users from quitting or encourage new users to start.
Require tobacco companies to disclose the contents of
tobacco products, changes to their products and research about the
health effects of their products.
Require larger and more informative health warnings on
tobacco products.
Prohibit terms such as ``light,'' ``mild'' and ``low-tar''
that have mislead consumers into believing that certain cigarettes are
safer than others.
These are common-sense measures that should have been enacted into
law long ago. In 2004, the U.S. Senate voted 78-15 to pass FDA tobacco
legislation as an amendment to a corporate tax bill, but it was killed
in the conference committee.
Despite the tobacco companies' claims of reform, recent events
underscore that their harmful practices continue today and show why the
FDA tobacco legislation is so critical:
On August 17, 2006, U.S. District Judge Gladys Kessler
issued a final opinion in the U.S. Government's landmark tobacco
lawsuit that found the major tobacco companies have violated civil
racketeering laws and defrauded the American people by lying for
decades about the health risks of smoking and their marketing to
children. Judge Kessler also found that the tobacco companies'
wrongdoing, including their marketing to children, continues today:
``The evidence in this case clearly establishes that Defendants have
not ceased engaging in unlawful activity.'' However, Judge Kessler felt
constrained by law in the remedies she could order and put the
responsibility on Congress to take additional action: ``In a democracy,
it is the body elected by the people, namely Congress, that should step
up to the plate and address national issues with such enormous
economic, public health, commercial and social ramifications.''
Since Judge Kessler's ruling, two studies--one by the
Massachusetts Department of Health and the other by the Harvard School
of Public Health--have found that the tobacco companies have secretly
and significantly increased the levels of nicotine in cigarette smoke
since 1998. These findings indicate that as smoking rates decline, and
more smokers try to quit, tobacco companies have sought to maintain
addiction among smokers and to addict a new generation of replacement
smokers. The tobacco companies can secretly increase nicotine levels
because no Federal agency has regulatory authority over what they put
in cigarettes.
The tobacco companies have taken advantage of their
unregulated status to introduce so-called ``reduced risk'' cigarettes
with claims like ``all of the taste . . . less of the toxins'' and
``reduced carcinogens, premium taste.'' However, no government agency
currently has the authority to make sure these claims are
scientifically proven and the products are marketed responsibly. These
new products risk a repeat of the public health disaster caused by the
marketing of ``light'' and ``low-tar'' cigarettes. Millions of smokers
switched to these brands thinking they were safer or would help them
quit only to find out decades later that neither is true and the
tobacco companies knew this all along (as the National Cancer Institute
concluded in a November 2001 report).
The major cigarette companies have easily circumvented the
minimal restrictions placed on their marketing by the 1998 State
tobacco settlement and have since more than doubled their marketing to
at least $15.1 billion a year--more than $41 billion every day,
according to the Federal Trade Commission. Much of this marketing
continues to appeal to children. A study published in the December 2006
issue of the peer-reviewed journal Archives of Pediatrics and
Adolescent Medicine found that exposure to tobacco marketing and pro-
tobacco depictions in movies, television and videos more than doubles
the odds that children under 18 will become tobacco users.
______
American Dental Association,
January 29, 2007.
Hon. Ted Kennedy,
Chairman,
Health, Education, Labor, and Pensions Committee,
SD-428 Dirksen Office Building,
Washington, DC. 20510.
Dear Mr. Chairman: We are writing to support your efforts to
introduce and pass legislation to make Federal regulation of tobacco
products an urgent priority for the first session of the 110th
Congress. As associations and organizations involved in improving the
Nation's oral health, we are committed to reducing and preventing oral
cancer and other diseases that are related to tobacco use, especially
spit tobacco. Approximately 30,000 new cases of oral cancer are
diagnosed each year in the United States. According to the American
Cancer Society, oral cancer occurs almost as frequently as leukemia and
claims almost as many lives as melanoma cancer. When detected late, the
overall 5-year survival rate is 50 percent.
Legislation providing the Food and Drug Administration (FDA) with
the authority to regulate the manufacture, distribution, and sale of
tobacco products is critically needed to protect the public health. FDA
oversight is especially required to crack down on illegal sales of
tobacco products to children and to restrict advertising and marketing
that appeal to children. The tobacco industry is aggressively marketing
as well a new generation of products with unproven claims that they are
less harmful. This continued deception of consumers makes ever more
urgent the need for FDA restrictions on advertising and marketing,
especially to children.
Our organizations are especially supportive of legislative efforts
to amend current law to strengthen and highlight spit tobacco warning
labels. We were pleased to see that in previous legislation sponsored
by you, you added a requirement for a new warning label to read,
``Warning: This product is not a safe alternative to cigarettes.'' Our
organizations are opposed to the use of smokeless tobacco as an
alternative to cigarettes or as a smoking cessation technique. We
encourage you to include this provision in your new legislation.
While virtually every other consumer product is regulated, tobacco
products continue to be exempt from the most basic oversight. Tobacco
companies are not required to test additives for safety, prevent
misleading or inaccurate health claims, inform consumers what is in
their products, or take any other action to make their products less
harmful or addictive. In fact, besides containing 28 carcinogens, the
level of addictive nicotine available in smokeless tobacco products is
manipulated to increase the user's dependence on such products.
Congress affords no other industry this degree of special protection,
costing taxpayers billions of dollars each year to treat tobacco-caused
disease through federally funded health programs including Medicare and
Medicaid.
We applaud your efforts to address this situation legislatively and
will work with you for its enactment.
Sincerely,
Academy of General Dentistry; Alabama Dental Association; Alliance
of the American Dental Association; American Academy of Pediatric
Dentistry; American Academy of Periodontology; American Association of
Dental Editors; American Association of Dental Examiners; American
Association for Dental Research; American Association of Oral and
Maxillofacial Surgeons; American Association of Orthodontists; American
Association of Public Health Dentistry; American College of Dentists;
American College of Prosthodontists; American Dental Association;
American Dental Education Association; American Student Dental
Association; Arizona Dental Association; Arkansas State Dental
Association; Association of State and Territorial Dental Directors;
California Dental Association; Colorado Dental Association; Connecticut
State Dental Association; District of Columbia Dental Society; Florida
Dental Association; Georgia Dental Association; Hawaii Dental
Association; Hispanic Dental Association; Illinois State Dental
Society; Indiana Dental Association; International College of Dentists,
USA Section; Iowa Dental Association; Kansas Dental Association;
Kentucky Dental Association; Loma Linda University School of Dentistry;
Loma Linda University School of Public Health; Louisiana Dental
Association; Maine Dental Association; Massachusetts Dental Society;
Michigan Dental Association; Minnesota Dental Association; Mississippi
Dental Association; Missouri Dental Association; Montana Dental
Association; National Dental Association; Nevada Dental Association;
New Hampshire Dental Society; New Jersey Dental Association; New Mexico
Dental Association; North Carolina Dental Society; Ohio Dental
Association; Oklahoma Dental Association; Oregon Dental Association;
Pennsylvania Dental Association; Pierre Fauchard Academy; Rhode Island
Dental Association; School of Nursing at Loma Linda University; South
Dakota Dental Association; Tennessee Dental Association; Texas Dental
Association; Utah Dental Association; Virginia Dental Association;
Washington State Dental Association; West Virginia Dental Association;
Wisconsin Dental Association; Wyoming Dental Association.
______
Partners for Effective Tobacco Policy,
February 15, 2007.
Dear Senator/Representative: As members of Partners for Effective
Tobacco Policy (PARTNERS), we are writing to strongly urge you to
support the Kennedy-Cornyn and Waxman-Davis bills that would regulate
tobacco products. PARTNERS is a coalition of more than 60 national
organizations committed to reducing and preventing the staggering death
and disease caused by tobacco use. Tobacco use kills more than 400,000
Americans annually and is the leading cause of preventable death in the
United States.
Congress has failed to complete action on the strong legislation to
address this epidemic that has been introduced in the last two
Congresses. Moreover, there is overwhelming support of Americans for
regulation of tobacco products by the Federal Food and Drug
Administration (FDA). This support crosses all party, ideological,
regional, State, income and educational lines--even a majority of
smokers support FDA regulation of tobacco products.
Reflecting that support, FDA legislation in the last Congress
enjoyed a broad, bipartisan group of 122 cosponsors in the House of
Representatives and 28 in the Senate. It has the robust support of
every major national health organization and of a broad cross-section
of American faith leaders and organizations. In 2004, this legislation
passed the Senate twice--once overwhelmingly; the second time by
unanimous consent--but year, after year, it has languished in the House
of Representatives.
Legislation providing FDA the authority to regulate the
manufacture, distribution, and sale of tobacco products is critically
needed to protect the public health. FDA oversight is especially
required to crack down on illegal sales of tobacco products to children
and to restrict advertising and marketing that appeal to children. The
tobacco industry is aggressively marketing as well a new generation of
products with unproven claims that they are less harmful. This
continued deception of consumers makes ever more urgent the need for
FDA restrictions on advertising and marketing, especially to children.
While virtually every other consumer product is regulated, tobacco
products continue to be exempt from the most basic oversight. Tobacco
companies are not required to test additives for safety, prevent
misleading or inaccurate health claims, inform consumers what is in
their products, or take any other action to make their products less
harmful or addictive. Congress affords no other industry this degree of
special protection, costing taxpayers billions of dollars each year to
treat tobacco-caused disease through federally funded health programs
including Medicare and Medicaid.
Now that strong, effective FDA legislation supported by the public
health community has been reintroduced, we ask that you cosponsor it
and work for its speedy enactment into law during the first session of
the new Congress.
Sincerely,
American Cancer Society; American Heart Association; American Lung
Association; Campaign for Tobacco-Free Kids; AARP; Alliance of the
American Dental Association; American Academy of Child and Adolescent
Psychiatry; American Academy of Family Physicians; American Academy of
Nurse Practitioners; American Academy of Pediatrics; American
Association for Respiratory Care; American College of Cardiology;
American College of Chest Physicians; American College of Clinical
Oncology; American College of Obstetricians and Gynecologists; American
College of Occupational and Environmental Medicine; American College of
Physicians; American College of Preventative Medicine; American Dental
Association; American Dental Hygienists' Association; American Medical
Association; American Psychological Association; American Public Health
Association; American Society of Addiction Medicine; American Society
of Clinical Oncology; American Thoracic Society; Association of
Maternal and Child Health Programs; Children's Defense Fund; Community
Anti-Drug Coalitions of America; General Board of Church & Society of
the United Methodist Church; Hadassah--the Women's Zionist Organization
of America; Interreligious Coalition on Smoking or Health; March of
Dimes; National African American Tobacco Prevention Network; National
Association of County & City Health Officials; National Association of
Local Boards of Health; National Education Association; National
Hispanic Medical Association; National Latino Council on Alcohol and
Tobacco Prevention; National Partnership for Women & Families; National
Women's Law Center; Oncology Nursing Society; Oral Health America;
Partnership for Prevention; Seventh-day Adventist Church; Society for
Public Health Education; Trust for America's Health; United Church of
Christ.
______
American Heart Association and
American Stroke Association,
February 26, 2007.
Dear Senator Kennedy: The American Heart Association, on behalf of
its more than 22 million volunteers and supporters, is pleased to
endorse the provisions of the Family Smoking Prevention and Tobacco
Control Act of 2007. If enacted into law, this legislation will finally
ensure that the tobacco industry is properly regulated, that Americans
are better informed about the dangers of smoking, and that our children
are appropriately protected from this vigorously marketed product.
Smoking is a major cause of cardiovascular disease and stroke--the
Nation's No. 1 and No. 3 killers. An estimated 180,000 Americans die
each year from cardiovascular diseases caused by smoking. And it's not
just smokers who are at risk: an estimated 35,000 people die from
coronary heart disease every year caused by breathing secondhand smoke.
When the chemical cocktail created from smoking tobacco or
breathing secondhand smoke hits the bloodstream, it can damage arteries
throughout the body: the heart, brain, and other major blood vessels
such as in the legs. Clots in arteries are more likely to form as a
result, causing heart attack or stroke, and the capacity for routine
physical activities markedly declines. Smoking also lowers the level of
HDL or ``good'' cholesterol, raises heart rate and blood pressure, and
replaces oxygen in the blood with carbon monoxide. In short, smoking
wreaks havoc on the cardiovascular system, causing preventable
disability and death for many Americans.
The health risks associated with smoking tobacco are undisputed. It
is therefore alarming that tobacco products remain totally unregulated
in America today. It is vital that Congress pass this legislation of
the tobacco industry and its deadly products. We thank you for your
leadership on this important health issue and look forward to working
with you to advance this important legislation.
Very truly yours,
Raymond J. Gibbons, M.D., FAHA,
President.
Andrew B. Buroker, Esq.,
Chairman.
______
American Osteopathic Association,
February 16, 2007.
Hon. Edward Kennedy,
U.S. Senate,
317 Russell Senate Office Building,
Washington, DC. 20510.
Hon. John Cornyn,
U.S. Senate,
517 Hart Senate Office Building,
Washington, DC. 20510.
Dear Senators Kennedy and Cornyn: As President of the American
Osteopathic Association (AOA), I write to express our strong support
for the ``Family Smoking Prevention and Tobacco Control Act'' (S. 625).
The AOA, which represents the Nation's 59,000 osteopathic physicians,
applauds your efforts to improve the health and wellness of your fellow
citizens, especially children, by reducing their exposure to the
dangers of tobacco products. The AOA advocates greater oversight of the
tobacco industry and a more focused effort on preventing children from
starting smoking in their formative years.
In 1990, the AOA House of Delegates adopted a policy that states,
``The AOA strongly recommends that all Federal and State
health agencies continue to take positive action to discourage
the American public from using cigarettes and other tobacco
products.''
This policy was revised and reaffirmed in 2002. Additionally, the
AOA has adopted and ratified policies that ``endorse a ban on all
advertising of tobacco.''
By granting oversight authority of tobacco to the Food and Drug
Administration (FDA), your legislation proposes important steps towards
reducing the number of people who smoke or use other tobacco products.
Additionally, if enacted, your legislation will contribute to a
reduction in the number of children and teenagers who smoke by limiting
their access and exposure to tobacco products. Ultimately, this will
lead to a healthier population, a decrease in smoking related illnesses
and diseases, and lower health care costs.
This important legislation has fallen short in previous Congresses.
We are hopeful that it will receive a fair evaluation and once again be
approved by the Senate during the 110th Congress. We look forward to
seeing it enacted into law. Please do not hesitate to call upon the AOA
or our members for assistance with this important issue. We stand ready
to help. For additional information, please contact the AOA's
Department of Government Relations at (202) 414-0140.
Sincerely,
John A. Strosnider, D.O.,
President.
______
Faith United Against Tobacco,
February 26, 2007.
Dear Senator/Representative: We are writing to you as leaders of
Faith United Against Tobacco, a faith coalition comprised of clergy and
lay members throughout the country, to strongly urge you to support S.
625 and H.R. 1108, the Kennedy-Cornyn and Waxman-Davis bills that would
authorize the U.S. Food and Drug Administration (FDA) to regulate
tobacco. We in the faith community believe that our Nation's leaders,
and particularly our Members of Congress, have a moral obligation to do
all they can to protect Americans, particularly children, from tobacco
addiction and disease. We are united on this issue.
Granting FDA authority to regulate tobacco products would prevent
tobacco companies from adding even more deadly and addictive
ingredients, prohibit candy-
flavored cigarettes, prevent tobacco sales to underage children and
limit advertising and promotion of tobacco products that lure children
into a deadly habit. We find it incredible that the FDA can ensure the
safety of everyday items like macaroni and cheese, but has no authority
over tobacco, a product that kills over 400,000 Americans every year.
No one wants too much government regulation, but FDA authority to
regulate tobacco products will simply treat tobacco manufacturers like
the manufacturers of other products--it will level the playing field
and assure the protection of consumers and our children.
Over the last few years, Faith United Against Tobacco has been
working with the public health community to draw attention to the need
for FDA oversight of tobacco products. We have spoken out on this issue
because we have spent too much time burying mothers, fathers, sisters
and brothers who die because they became addicted to tobacco products
when they were young. We know that the tobacco companies continue to
spend billions of dollars marketing their deadly products to children
and far too many high school students smoke.
Moreover, the evidence about tobacco industry's misdeeds and the
harm caused by this unregulated product keeps mounting. On August 17,
2006, Federal Judge Gladys Kessler found the major tobacco companies to
be racketeers who have lied--and continue to lie--to the American
people about the health risks of their products and their marketing to
children. Then, on the heels of this court decision, a report by the
Massachusetts Department of Public Health found that tobacco companies
have secretly and significantly increased the levels of nicotine in
cigarette smoke between 1998 and 2004.
Now that strong, effective FDA legislation, S. 625 and H.R. 1108,
has been reintroduced, we ask that you cosponsor it and work for its
speedy enactment into law during the first session of the new Congress
It is time to protect our children and families.
If you have any questions or would like to reply to this request,
please contact Vincent DeMarco, Coordinator for Faith United Against
Tobacco at 410-591-9162 or [email protected].
James Winkler, General Secretary, General Board of Church and
Society, United Methodist Church; Bishop Henry Williamson, Christian
Methodist Episcopal Church; Dr. DeWitt Williams, Director, Health
Ministries, North American Division, Seventh-day Adventists; Julie
Taylor, Executive Secretary for Children, Youth and Family Advocacy,
Women's Division, GBGM, United Methodist Church; Dr. Sayyid M. Syeed,
National Director, Islamic Society of North America; Reverend William
G. Sinkford, President, Unitarian Universalist Association of
Congregations; Manmohan Singh, General Secretary, World Sikh Council--
America Region; Rabbi David Saperstein, Director and Counsel Religious
Action Center of Reform Judaism; Reverend Deborah L. Patterson,
Executive Director, International Parish Nurse Resource Center; Dr.
Walter L. Parrish, II, Executive Minister, American Baptist Churches of
the South; Rev. Dr. A Roy Medley, General Secretary, American Baptist
Churches USA; Peggy Matteson, President, Health Ministries Association;
Dr. Richard D. Land, President, Ethics & Religious Liberty Commission,
Southern Baptist Convention; Phil Jones, Director, Brethren Witness/
Washington Office; Rev. Elenora Giddings Ivory, Director, Washington
Office, Presbyterian Church (USA); Andrew Genszler, Director for
Domestic Policy, Evangelical Lutheran Church in America; Matthew Ellis,
Executive Director, National Episcopal Health Ministries; Reverend Bob
Edgar, General Secretary, National Council of Churches of Christ in the
USA; Reverend Ruben Cruz, Church Finance Council, Christian Church
(Disciples of Christ) Reverend Michael H. Crosby, OFMCap., Coordinator
Tobacco Program, Interfaith Center on Corporate Responsibility;
Patricia G. Burkhardt, Legislative Officer, Church Women United;
Barbara Baylor, M.P.H., Minister for Health and Wellness, United Church
of Christ; Rev. David Adams, General Secretary, General Commission on
United Methodist Men.
______
American Academy of Pediatrics,
March 6, 2007.
Hon. Ted Kennedy,
317 Russell Office Building,
Washington, DC. 20510.
Hon. John Cornyn,
517 Hart Office Building,
Washington, DC. 20510.
Dear Senators Kennedy and Cornyn: On behalf of the 60,000
pediatricians, pediatric medical subspecialists and pediatric surgical
specialists of the American Academy of Pediatrics, I would like to
express our support for H.R. 1108, legislation to protect the public
health by providing the Food and Drug Administration (FDA) with certain
authority to regulate tobacco products. This legislation is a good
first step at curbing the devastating effects tobacco has on
adolescents and young adults.
It is estimated that more than 3 million U.S. adolescents are
cigarette smokers and more than 2,000 children under the age of 18
start smoking each day. If current tobacco use patterns persist, an
estimated 6.4 million children will die prematurely from a smoking-
related disease. Smoking and exposure to secondhand smoke among
pregnant women cause low-birth weight babies, pre-term delivery,
perinatal deaths and sudden infant death syndrome. Other effects may
include childhood cancer, childhood leukemia, childhood lymphomas and
childhood brain tumors. Well over 30,000 births per year in the United
States are affected by one or more of these problems.
H.R. 1108 will lower tobacco use by restricting sales of tobacco
products to children, regulating tobacco marketing, prohibiting
unsubstantiated health claims about tobacco products, requiring
disclosure of harmful ingredients in tobacco products, and mandating
larger and more informative health warnings. By giving FDA this new
authority to regulate tobacco products, we can lower tobacco use by our
adolescents and young adults and reduce the life-threatening risks
tobacco poses to our Nation's youth.
We look forward to working with you to move this legislation
through Congress.
Sincerely,
Jay E. Berkelhamer, M.D., FAAP,
President.
______
University of California San Francisco (UCSF),
March 12, 2007.
Hon. Edward M. Kennedy,
Chairman,
Committee on Health, Education, Labor, and Pensions,
317 Russell Senate Building,
Washington, DC. 20510.
Dear Senator Kennedy: I am writing to compliment you on the
introduction of S. 625, the ``Family Smoking Prevention and Tobacco
Control Act.'' This legislation marks a critical point in our Nation's
long effort to reduce the damage caused by tobacco and to protect our
children and public health.
It has been 13 years since the Food and Drug Administration (FDA)
announced its investigation into whether the evidences warranted FDA's
assertion of jurisdiction over tobacco. That investigation was followed
by regulations that would have addressed the serious problem of youth
tobacco use. Unfortunately, those regulations never went into effect.
During the past 13 years, more than 5.2 million Americans have died
from tobacco-related diseases and over 5 million kids became regular,
daily smokers. The need for FDA jurisdiction over tobacco has never
been stronger. This legislation as introduced would address the goals
that the Food and Drug Administration sought to achieve during the time
I was Commissioner, including reinstating the 1996 FDA rule, and would
make a major contribution to the effort to reduce the number of people
who die from using tobacco.
This is a strong bill and would significantly advance the public
health.
Sincerely yours,
David A. Kessler, M.D.
______
Philip Morris USA,
February 26, 2007.
Hon. Edward M. Kennedy,
U.S. Senate,
Washington, DC. 20510.
Hon. Michael B. Enzi,
U.S. Senate,
Washington, DC. 20510.
Dear Chairman Kennedy and Senator Enzi: Attached hereto is written
testimony that I respectfully request be made part of the record of the
hearing entitled ``The Need for FDA Regulation of Tobacco Products''
scheduled for February 27, 2007 before the Senate Committee on Health,
Education, Labor, and Pensions.
As you know, Philip Morris USA strongly supports enactment of S.
625, The Family Smoking Prevention and Tobacco Control Act. Thank you
for your consideration of these views.
cc. Senator Christopher Dodd, Senator Tom Harkin, Senator Barbara
A. Mikulski, Senator Jeff Bingaman, Senator Patty Murray, Senator Jack
Reed, Senator Hillary Rodham Clinton, Senator Barack Obama, Senator
Bernard Sanders, Senator Sherrod Brown, Senator Judd Gregg, Senator
Lamar Alexander, Senator Richard Burr, Senator Johnny Isakson, Senator
Lisa Murkowski, Senator Orrin Hatch, Senator Pat Roberts, Senator Wayne
Allard, and Senator Tom Coburn.
Prepared Statement of Mike Szymanczyk, Chairman and CEO, Philip Morris
USA, Richmond, VA
introduction
On behalf of the nearly 12,000 employees of PM USA I am very
pleased to submit these remarks, and to express our strong support for
S. 625, legislation that would give the Food and Drug Administration
(FDA) authority to regulate tobacco products. More than 4 years after
we announced our full support for FDA regulation, Philip Morris USA
remains committed to passage of comprehensive regulation of tobacco
products. S. 625 can serve to create a uniform set of Federal standards
for the manufacture and marketing of tobacco products. In addition,
regulations promulgated pursuant to this legislation should provide
clear guidelines and oversight of products that could potentially
reduce the harm caused by tobacco use.
The Family Smoking Prevention and Tobacco Control Act is the result
of many difficult choices and compromises by all those who have been
involved in this process over the last several years. Nevertheless, the
bill clearly provides the framework for comprehensive FDA regulatory
authority over tobacco products. We commend you for moving forward with
this bipartisan legislation that provides important policy solutions to
many of the complex issues involving tobacco products.
We applaud Chairman Kennedy and Senator Cornyn for the leadership
they have shown on this issue. Likewise, we appreciate the leadership
shown by Congressman Waxman and Congressman Davis in introducing
identical legislation in the House of Representatives. We look forward
to working with you and your colleagues in the House to enact this
legislation that is intended to benefit adult consumers by reducing the
harm caused by tobacco consumption, and to establish clear rules that
will be applied to, and hopefully enforced uniformly, throughout the
tobacco industry. Uniform enforcement of such rules by the FDA will be
critical to reducing the harm for adult tobacco product consumers.
harm reduction--first and foremost
We believe that adult consumers should be and will be a primary
beneficiary of FDA regulation. S. 625 will serve to accomplish this
goal by providing a new framework within which manufacturers can re-
focus their efforts in reducing the harm of their products. As in many
other industries, the companies that do the best job of exceeding their
consumers' expectations, while meeting regulatory standards, will both
benefit their consumers and achieve the best business results.
In spite of the controversy that continues to surround our industry
and our company, we at Philip Morris USA spend most of our time running
our factories, working with our suppliers, making our payroll and
paying our taxes and continuing to look for ways to reduce the harm
caused by smoking. We believe that comprehensive regulation of the
tobacco industry makes sense for a number of reasons.
One of our highest priorities at PM USA is the development of
cigarettes and other products that have the potential to reduce the
harm caused by smoking. Of the thousands of compounds present in
tobacco smoke, the public health community has identified a number of
them that are harmful or potentially harmful to smokers. Accordingly,
our basic strategy is to reduce smokers' exposure to as many of these
compounds as we can by developing products that will also provide
continued enjoyment to our adult consumers. It will take some time, but
if we are successful in finding ways of both reducing potentially
harmful compounds and reducing smokers' actual exposure to them under
real-world conditions, we believe that the FDA under this legislation
will be in a position to evaluate whether our product development
efforts are actually reducing the risk of tobacco-related diseases
among current smokers. Our goal, which we believe would ultimately
provide both societal and shareholder value, is to design the best
products we can, and then, ideally under the full regulatory oversight
of the FDA, make them available to adult smokers who do not quit. It
seems clear to us that we will not be able to make progress in this
area unless two critical conditions are met: first, that manufacturers
such as ourselves develop successfully and make available products that
reduce smokers' exposure to harmful compounds compared to conventional
cigarettes, and second, that current smokers are given a reason--
through communication of truthful, nonmisleading information that
avoids unintended consequences--to switch to these products. For people
who continue to smoke, we believe that this is the best way to
meaningfully reduce the overall harm caused by smoking.
We have extensive external and internal research programs that are
focused on advancing our knowledge about tobacco smoke to support our
efforts to develop new product designs. This includes work involving
the compounds of smoke and smokers' actual exposure to them. We are
continuing to devote substantial research and development efforts to
develop and launch products that significantly reduce smokers' exposure
to compounds that have been identified by public health authorities as
harmful or potentially harmful.
We believe these product technologies show promise for the future,
and that the FDA should be empowered as quickly as possible by
enactment of this legislation to evaluate products and their potential
for reducing the risk of contracting smoking-related diseases.
We respectfully urge our future regulators at the FDA to keep in
mind that innovation in developing new products is crucial to the
ultimate success of this legislation. In order to have any real impact,
reduced exposure products must be acceptable to adult smokers. We see
little benefit to consumers or society if harm reduction is not pursued
in the context of cigarettes that adult consumers will enjoy smoking.
As the 1998 Canadian Experts' Committee on this subject concluded,
``[i]f smokers would not buy these products, product modification
initiatives would fail.''
Importantly, once the FDA concludes as a matter of science that a
new product has the potential to offer reduced exposure or reduced
risk, S. 625 grants the agency an essential role in approving and
overseeing any claims, explicit or implied, made about the product by
the manufacturer regarding exposure or risk-reduction. Crafting
appropriate claims regarding these products requires great care and
attention. We are mindful of the critical need for manufacturers to
work closely with the FDA on consumer messages.
Once again, as with determinations regarding the scientific issues
of potential exposure and risk reduction, we believe S. 625 correctly
charges FDA with deciding what communications to consumers are
appropriate on this subject. On the one hand, in terms of public
health, future FDA regulations should ensure that consumers are not
mistakenly led to believe that a particular tobacco product may be an
acceptable alternative to quitting. On the other hand, we do not
believe future regulations should be utilized as a tool to suppress
legitimate, accurate and objective information about product
developments that individuals may find beneficial or important. The key
here is for all FDA-approved communications to consumers to be truthful
and not misleading, all within the context that there is no safe
cigarette.
We are keenly aware that some members of the public health
community are opposed to the very concept of developing and offering
``reduced exposure'' or ``reduced risk'' tobacco products. They are
concerned that the availability of such products might discourage
smokers from quitting or encourage people to start smoking. These
advocates appear to believe that the only acceptable message for the
government to communicate, irrespective of potential alternatives, is a
directive not to consume tobacco products at all. Philip Morris USA
strongly believes if products that could ultimately reduce the harm
caused by smoking are developed, it would be wrong to deny adult
smokers access to information about the potential benefits of such
products. The ``modified risk tobacco products'' section of S. 625 sets
out rigorous requirements that must be met before manufacturers could
communicate about these types of products. We agree fully with the need
for such rigorous requirements while urging future FDA regulators to
take note of the Institute of Medicine admonition that ``[the]
regulatory process should not discourage or impede scientifically
grounded claims of reduced exposure, so long as steps are taken to
ensure that consumers are not misled. . . .''
reducing youth smoking--a critical priority
In 1998 PM USA created a Youth Smoking Prevention department with
the objective of helping to prevent kids from smoking cigarettes. We
are committed to this effort because we firmly believe that kids should
not smoke.
S. 625 aims to help reduce youth smoking. Among other things, it
would prohibit self-service transactions (except in adult-only
facilities), establish a national minimum age of 18, require age
verification for anyone younger than 27 years of age, and prohibit the
sale of unpackaged cigarettes (so-called ``loosies''). We commend the
cosponsors of this legislation for taking these steps. We believe that
by working together, we can all contribute to continuing the reduction
in youth smoking rates that has occurred over the past decade.
A number of other provisions in the legislation deserve further
discussion and comment.
sec. 901--fda authority over tobacco products
S. 625 creates a new chapter within the Food, Drug, and Cosmetic
Act to regulate tobacco products. Importantly, tobacco products will
not be regulated as a drug or device. Moreover, the bill explicitly
states that one of ``the purposes of this Act'' will be ``to continue
to permit the sale of tobacco products to adults in conjunction with
measures to ensure that they are not sold or accessible to underage
purchasers.'' The bill limits the scope of FDA's authority to
manufacturers of tobacco products, making clear that FDA does not have
the authority to regulate tobacco growers. FDA will not be on the farm.
sec. 903--misbranded tobacco products
Pursuant to the legislation, tobacco products will be deemed
misbranded if their label is false or misleading or they are not
correctly labeled. Of real significance to America's tobacco growers
and their families and communities, a tobacco product will be
misbranded if the label does not contain an accurate statement of the
percentage of the tobacco used in the product that is domestically
grown and the percentage that is foreign grown.
sec. 904--submission of health information
The bill requires, within 6 months of passage, submission to the
Secretary of documents any information concerning ingredients,
compounds, paper, filter and other components of tobacco products as
well as content, delivery and form of nicotine. Philip Morris USA fully
supports this requirement with appropriate safeguards to protect our
trade secrets, which this bill provides. We think the FDA should be
able to give smokers confidence that the ingredients added to
cigarettes do not increase the inherent health risks of smoking,
including increasing the addictiveness. Further, we have no objection
to disclosing the results of our own ingredients testing to the FDA so
it can assess every ingredient we use. The same is true for other
information that may be requested by the Secretary under this section
including information related to research activities and findings,
scientific information on reduced risk products and technology and
marketing research.
sec. 905--annual registration
S. 625 requires the registration of every entity that owns or
operates any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of tobacco products. While
these same requirements extend to foreign manufacturers of tobacco
products, it will be critical for FDA to ensure the even-handed
application of the legislation to these foreign manufacturers,
including through appropriate inspections.
sec. 906--general provisions respecting control of tobacco products
The section allows for regulations requiring good manufacturing
practices (GMPs) with input from the public and interested parties and
provides for a 3-year delay for compliance to ensure that manufacturers
have ample opportunity to comply.
sec. 907--product standards
S. 625 grants the Secretary the authority to adopt performance
standards for tobacco products if ``appropriate for the protection of
the public health.'' Although broad, the delegation of authority to the
FDA to issue product standards is fully supported by PM USA. It will
allow FDA to reduce harm by imposing mandatory design changes on
tobacco products. These standards could include provisions to regulate
nicotine yields and other constituents and components of cigarettes. It
also will ban the sale of candy or fruit-flavored cigarettes.
We believe future FDA regulators should be very cautious and avoid
doing what no one should want: to impose changes that are so radical
that tobacco products are effectively banned, or consumers are driven
away from the legitimate market toward illicit, completely unregulated
products. In fact, the legislation explicitly directs FDA to consider
whether a standard would create a significant new demand for
contraband, including counterfeit, products, in determining what would,
and would not, be ``appropriate to protect public health.'' We urge
future FDA regulators to fully consider the warning voiced by the FDA
in the 1996 tobacco rule regarding this subject:
Black market and smuggling would develop to supply smokers
with these products . . . [which] would be even more dangerous
than those currently marketed, in that they could contain even
higher levels of tar, nicotine, and toxic additives.
In addition, a product standard may not have the effect of
``banning all cigarettes'' or reducing nicotine yields ``to zero'';
this power is explicitly reserved to Congress.
A word about nicotine is appropriate at this point. A recent
Harvard University report asserts that Philip Morris USA and other
tobacco companies have deliberately increased the amount of nicotine
that smokers get from cigarettes over the past 7 years. The conclusion
from the report, that there was a trend of more and more nicotine in
cigarettes between 1997 and 2005, and that the cigarettes were designed
to yield greater amounts year after year, is not true for Philip Morris
USA. We have not changed the design of our cigarettes with the
intention to increase nicotine yields in order to make the product more
addictive. The data we submitted to Massachusetts shows that nicotine
yields in Marlboro cigarettes were the same in 1997 as in 2006.
While current skepticism may stand in the way of arriving at a
consensus on these data, we believe that enacting S. 625 will create a
framework to address any public concerns.
sec. 911--modified risk tobacco products
Much of my earlier testimony is focused on the importance of harm
reduction. These provisions are essential to that goal and must be
implemented by FDA in a careful, thoughtful manner in order to be
successful in achieving everyone's goal of reducing the harm caused by
tobacco products. In its report, the IOM committee made two important,
fundamental recommendations: (i) determinations about what is, and what
is not, a reduced-risk or reduced-exposure product should be made by
the government on a purely scientific basis and (ii) any claims made
about such products should be strictly regulated to ensure that
consumers are not misled. We believe S. 625 gives FDA the necessary
level of authority and discretion to achieve both.
Significantly, the bill creates a special rule for certain products
where the label, labeling or advertising contains an explicit or
implied statement that the product contains a reduced level of a
substance, or presents a reduced exposure to a substance if the
Secretary makes such a finding based on a number of criteria. We
believe the bill appropriately and reasonably empowers FDA to approve
applications for products that make exposure-reduction claims for 5-
year periods, utilizing criteria that appear to have been substantially
derived from the Institute of Medicine Report.
sec. 920--user fees
S. 625 requires the Secretary to require tobacco product
manufacturers and importers to pay for providing, equipping and
maintaining adequate service for regulating tobacco products. Philip
Morris USA believes the collection of such user fees is reasonable, but
again strict enforcement by the agency will be essential.
sec. 102--repromulgation of fda's 1996 final rule
Within 30 days of enactment of S. 625 the Secretary is required to
publish a final rule on the advertising of, and access to, tobacco
products, which shall become effective no later than 1 year after the
date of enactment. The rule will be identical in its provisions to the
advertising and access regulations promulgated by the FDA in 1996.
Prior to making any amendments to the rule, the Secretary would be
required to publish a proposed rule.
In addition, under section 906(d) of the legislation, FDA would
have authority to impose additional restrictions on the sale,
distribution, advertising and promotion of tobacco products if the
Secretary determines that the regulation would protect the public
health. The bill specifies that marketing and advertising restrictions
must be consistent with the first amendment.
The bill explicitly provides that FDA will not be permitted to
prohibit the sale of any tobacco product to adults age 18 and over.
Further, it does not permit the Secretary to require that tobacco
products be available only by prescription.
The timing of these requirements raises a broader point. At the
same time that we will be making the transition into the new regulatory
environment, we understand that FDA will also be transitioning into its
new role, including putting the necessary regulatory structures and
resources into place.
As such, it will be critically important for FDA and the industry
to work closely together in order to provide for a smooth transitional
period, such as was accomplished with the State Attorneys General with
respect to the transition into the MSA and with other government
agencies that have been granted new or additional authority over
tobacco products. For example, it will be important to work out
reasonable timelines for the substantial new requirements that are
contemplated by the legislation.
sec. 201--cigarette label and advertising warnings
This section of S. 625 specifies nine new warning labels required
to appear on cigarette packages and advertisements. The warnings must
comprise at least the top 30-percent of the front and rear panels of
the package, and at least 20-percent of the related advertisements. It
will be unlawful for a manufacturer, importer, distributor or retailer
to advertise any cigarette unless its advertising bears one of the
required warning labels. Philip Morris USA fully supports these
provisions.
conclusion
I will conclude by reiterating a point made earlier: a
comprehensive national tobacco policy should bring more, not less,
beneficial competition to the U.S. tobacco industry. Viewed another
way, none of the measures that would be advanced by enactment of S. 625
would give any one tobacco company a commercial advantage,
notwithstanding the assertions of some manufacturers. Tobacco companies
know very well that the first amendment of the Constitution guarantees
that the FDA could not impose a total ban on tobacco product
advertising, which effectively ensures the continuation of vigorous
competition in the market place.
The most significant restrictions placed on the tobacco industry in
recent history were those contained in the Master Settlement Agreement
(``MSA''). Those changes, which restrict billboard and transit
advertising among other things, did not lock in any single company's
market share. In fact, since the adoption of the MSA, there are
examples of both new brands and pre-existing ones that have increased
their market share.
History and the facts simply do not support the contention that the
additional access, advertising or marketing restrictions contained in
S. 625 will lessen competition, create a monopoly or lock in market
share. Indeed, we believe that, with clear guidelines and oversight,
there should be an opportunity for increased competition as both new
and existing manufacturers work to develop and commercialize products
that could potentially reduce the harm caused by tobacco use.
Thank you for allowing us to submit these views to the committee.
Thank you for your leadership and commitment to this issue. Please know
that we will work tirelessly to secure enactment of S. 625, which
represents a truly historic opportunity to establish a comprehensive
and coherent national tobacco policy.
STATEMENTS AND LETTER OF OPPOSITION
Prepared Statement of Henry O. Armour, President and CEO, National
Association of Convenience Stores (NACS), Alexandria, VA
Good morning, Mr. Chairman and members of the committee. My name is
Hank Armour and I am President and CEO of the National Association of
Convenience Stores (NACS). NACS is an international trade association
representing the convenience store industry. The industry as a whole
includes about 140,000 stores in the United States, sold 143.5 billion
gallons of motor fuel in 2005, and employs about 1.5 million workers
across the Nation. It is truly an industry of small businesses; 60
percent of convenience stores are owned by one-store operators.
I know the industry not only from my time running the trade
association, but prior to my tenure at NACS I owned a convenience store
chain that operated primarily in the State of Washington. This topic is
of great interest to our industry because more than one-third of in-
store sales at convenience stores are tobacco products. Customers who
come into our stores to buy tobacco also purchase other items that
often have higher profit margins. Given that the annual per store
profits in the industry average less than $40,000.00, it is not an
exaggeration to say that if convenience stores are put at a competitive
disadvantage in the sale of tobacco, it would threaten many of these
businesses.
Before I relay the concerns we have with the way that the current
legislation grants the Food and Drug Administration (FDA) the authority
to regulate tobacco, I want to make our interest in this issue clear.
NACS is not taking a position regarding whether or how the
manufacturing of tobacco should be regulated. Our industry sells legal
products and goes to great lengths to sell them responsibly. We spend
millions of dollars each year in our industry on training and
compliance programs, including efforts like the We Card program,
internal stings to gauge our compliance, and the like. Selling tobacco
products to minors is both against the law and bad for business. We are
members of the communities where we have stores. We care about these
communities and we make a large financial investment in trying to make
sure we sell tobacco products responsibly.
Our concerns are limited to the parts of the legislation before the
committee that directly impact the retail sale of tobacco products. It
is, in fact, our view that these portions of the bill can be made more
equitable and more effective. With that in mind, we have three main
concerns about this legislation. First, the legislation does not create
incentives for the behavior it is trying to promote or put
responsibilities on the individuals who are best able to affect these
behaviors--all of this undermines the effectiveness of the proposal.
Second, the legislation federalizes an area of regulation where the
States have already demonstrated effectiveness and is already guided by
Federal performance standards. We believe this regime will be less
effective than the current system. Third, the legislation treats
different types of retailers inequitably, which will both create
competitive imbalances and allow for loopholes that undermine the
purposes of the bill. I will address each of these issues in turn.
legislation should place incentives and responsibilities in the right
places
It is a fundamental, equitable precept that an entity should be
held accountable for behavior and acts which it can control and should
not be penalized for actions over which it cannot exert effective
control. NACS believes that everyone involved in the distribution of
tobacco should do everything that can be reasonably expected of them to
avoid the unlawful transfer of these products to minors. However, it is
irrational and counterproductive to penalize any entity for things it
cannot control.
The current legislation makes retailers responsible for things they
cannot control. Socially responsible retailers can train employees
regarding the laws prohibiting sales to minors, have a policy in place
requiring compliance with the law, and take action if an employee does
not follow the policy. Legislation ought to recognize these limits on
the ability of retailers to prevent violations and ought to have
incentives for retailers to take these steps and use best compliance
practices. The current legislation does not do that. Instead, it makes
retailers liable for every violation no matter how extensive the
efforts they take to prevent violations. Legislation ought to provide
socially responsible retailers with a ``safe harbor'' so that a
violation would not cause a retailer to lose its right to sell tobacco
if it has taken the steps it can to prevent a violation. The defense in
the current legislation is inadequate because it is limited to
situations in which the clerk relies upon a fake identification card
and does not cover other errors made by the clerk (intentional or not),
nor does it apply to situations when a minor uses a valid
identification that belongs to someone else. The language in the
legislation also requires the retailer to prove good faith on the part
of the clerk, which introduces a complex and difficult-to-prove legal
standard (particularly in light of the adjudication process).
The legislation also falls short by not having potential penalties
for all of the individuals involved in an illegal transaction. A clerk
who has been trained, for example, should face a penalty if he or she
makes an illegal sale. The only defense for a clerk who has been
trained should be that the clerk relied upon an identification which
appeared to be valid.
Any legislation should also address the minor who makes an illegal
purchase or illegally possesses tobacco products. Minors need to face a
potential penalty for inducing an illegal transaction or they will have
no incentive to stop them from trying to buy tobacco at every retailer
who carries it--until they are successful. Some States have passed
penalties for minors making illegal purchases and these laws have been
quite successful. We do this for alcohol and other products. It makes
no sense to allow teenagers to try to induce violations of law with
impunity and face no countervailing incentive.
Without such a sanction this legislation will not be as effective
in meeting its stated goals as it should be. Some socially responsible
retailers may literally lose their businesses even if they have made
substantial efforts to comply with the law--while teenagers will be
able to smoke in public and attempt to buy cigarettes in the presence
of FDA officials without any fear of sanction.
Similarly, the bill's provisions relating to labeling and
advertising violate the principle of holding people accountable for
only those things over which they can effectively exert control.
Specifically, these provisions would hold retailers strictly liable for
labeling violations, even if the retailer had nothing to do with the
label.
In sum, the current system of retailer regulation in the
legislation looks more closely calculated to move gradually and
surreptitiously toward a system of prohibition of the product than to
reducing consumption of tobacco products by minors.
state regulation makes sense and will be more effective
States have traditionally regulated the sale of tobacco products to
make sure those products are not sold to people under the legal age.
The same is true for alcoholic beverages and other products that are
intended only for adults. In 1992, with the passage of the Synar
Amendment, the Congress set performance standards to ensure that every
State was effectively regulating retail tobacco sales. If States do not
meet Federal performance measures, they can lose the funding they
receive from the Substance Abuse and Mental Health Services
Administration (SAMHSA).
Since passage of the Synar Amendment, youth smoking by high school
students has declined from 31.9 percent to 23 percent among boys and
from 29.8 to 22.9 percent among girls. This basic model is the right
one to follow. There is room for the Congress to set standards for
States to meet in their regulation of tobacco sales. But duplicating
the extensive system of State regulation that already exists--and has
shown results--does not make sense.
There are 300,000 retailers of tobacco products in the United
States. The Food and Drug Administration does not have the resources to
regulate these retailers in an even-handed manner. They may be able to
contract with States to enforce the law--though if that is the answer
it is very difficult to understand why such a system would be
preferable to setting standards for States--but it also ignores that
much of the cost of regulating lies not in enforcement but in
adjudication. Any system of regulation and enforcement needs to meet
basic standards for due process. States already do this with respect to
tobacco retailers and have an extensive infrastructure in place to try
to ensure fairness. It would be exceedingly difficult for the FDA to
provide due process for tobacco retailers. The financial burdens of
hiring and deploying the necessary administrative law judges alone
would be staggering.
Another due process problem with FDA regulation is geography. When
FDA implemented a similar system in the 1990s, before it was struck
down by the U.S. Supreme Court, retailers that wanted to challenge a
violation had the choice of traveling to FDA's headquarters in
Rockville, Maryland, for the hearing or participating by phone.
Obviously, it is far more effective to appear in person than to
participate by phone--we recognize this in the operation of our courts
just as Congress does in the conduct of hearings like this one. But for
many retailers around the country traveling to Rockville not only would
mean a large expense, but it would be significant time away from
running the business. For the 60 percent of the industry who are one-
store operators, this is particularly burdensome.
There is also a long list of logistical issues with which the FDA
would need to grapple in order to duplicate the State system of
regulating retailers. The States have years of experience working with
retailers and have a sense of who buys the products, who owns what
outlet, where notices of violation should be provided, and the like.
The FDA would have to recreate all of this information under the
current legislation. Doing that would be costly and unnecessary.
legislation should treat retailers equitably
The legislation, as currently drafted, would have adverse effects
and loopholes that may not be readily apparent. With respect to
prohibitions on sales to minors, for example, mail order and Internet
sales are exempted. While such sales were a relatively small part of
the market in the mid-1990s, when the FDA drafted its regulations on
this topic, that is not true now. Internet sales of cigarettes, in
particular, have exploded in the last decade. These sales constituted
14 percent of the market in 2005. A brief exploration of some of the
more than 500 Web sites that sell cigarettes demonstrates that
exempting these sales from age verification requirements would be a
problem. Typically, these sites do nothing more than ask a customer
whether he or she is 18 years of age and relies entirely on that
representation to establish the customer's age. In fact, many sites
give only one box to click in response to the question of whether the
customer is 18--and that box says ``yes.'' Even if a customer answers
no, however, many sites still allow that individual to continue to
purchase cigarettes.
Multiple delivery services offer their customers the option of
having the delivery person check and verify identification upon
delivery. There is no reason or justification, then, for treating
Internet and mail order sellers any differently than other tobacco
retailers with respect to age verification.
Native American tribes and reservation retailers also sell a large
volume of tobacco products. We have been concerned about these sales
for many years because the sales are often made without applying the
legally required State taxes. The U.S. Supreme Court has weighed in on
this issue many times and confirmed that States can impose taxes on
reservation sales to everyone other than an enrolled member of the
tribe. Yet many tribes across the Nation continue to illegally evade
these taxes. This is also an age verification loophole. States are
hindered in their efforts to enforce their laws against reservation
retailers because of the tribes' assertion of sovereign immunity--
notwithstanding the fact that the Congress through the Foreign
Sovereign Immunities Act did away with immunity for every other
sovereign in the world when it acts in a commercial, rather than
governmental, capacity. If the Congress is going to pass legislation
regulating the sale of tobacco, it cannot leave this gaping loophole in
the law. It must make clear that Native American tribes and retailers
are fully covered by the law and include a way for the law to be
enforced against those retailers. Any other outcome leaves a gaping
loophole in the law. There is nothing inherently safer about a
cigarette sold by a Native American retailer than one sold at the local
convenience store.
The signage and marketing restrictions in the legislation are also
inequitable. The legislation would not allow for any signage, including
simple displays of brands, if it could be viewed from outside the
store. That restriction will disproportionately impact convenience
stores. NACS has performed extensive studies of store security and
published guidelines for its members recommending that convenience
stores keep the entire store visible from outside. That visibility is
the best deterrent to crime. The result, however, is that while
competitors such as grocery stores and drug stores may be able to place
signage and other advertising inside their stores to let customers know
they carry tobacco products, convenience stores will not. That creates
a competitive imbalance in the marketplace and does not make sense in
light of the stated goals of the legislation. These rules should be
modified to cover all establishments in the same way.
Adult stores (other than tobacco shops), including bars and
restaurants are also advantaged by this legislation. These businesses
would be able to use color advertising in their stores while others
would not have that opportunity. The assumption underlying this
differential treatment--that minors do not enter these adult
establishments--is factually wrong. Minors do enter these
establishments and, if this legislation passes, more businesses will
become ``adult only'' in name though not necessarily in practice.
Again, this inequity should be remedied.
* * *
There are many other details in this legislation (and missing from
it) that are of concern to NACS. If the FDA is going to regulate
retailing of tobacco products and do it the right way, issues as
diverse as where to send notices and how burdensome the recordkeeping
requirements will be must be addressed. But the three principles I have
laid out in this testimony are the primary problems we see and should
be dealt with for this legislation to be fair and effective. We look
forward to working with the members of this committee to address these
issues.
Prepared Statement of Laurie Comstock, Elk Grove, CA
I am opposing the above S. 625--FDA Regulation of Tobacco Products.
I would like to tell you a little about my family's experience with
tobacco products.
I am forwarding you a photo of my beautiful younger sister, Lois.
She started smoking at the age of 13 (in 1968), and died on Oct. 16,
1999 at age 44 from lung cancer. She was my best friend. I miss her
with all my heart and so does my entire family. She leaves behind her
husband and two sons, who were 14 and 17 when she died. She suffered
from lung cancer for 3 long years. She went through several surgeries,
chemotherapy and radiation. In the end her cancer spread throughout her
whole body and she was in excruciating pain. I was with her the last
few weeks of her life. I promised her I would do everything I could to
keep kids from starting to use tobacco and that I would spread the word
about the dangers of tobacco and smoking. This bill is not the answer
to keeping kids safe and would not help people to quit smoking.
We also lost our father to a tobacco-related disease when he was
39. I was 13 when he died, my two brothers were 9 and 11 and my sister
was only 8. He died on Nov. 6, 1963, approximately 2 weeks before
President John Kennedy was assassinated. In those days the public did
not know as much about the dangers of tobacco and smoking cigarettes
and cigars as we do now. Of course the tobacco industry knew even in
those days how deadly their products were as is reflected in the
Legacy.library.ucsf.edu tobacco documents that are online. Our dad
started smoking in his teens.
We have lost many other family members, related both by blood as
well as by marriage, to tobacco-related diseases. My mother is
currently suffering from emphysema and my stepdad has heart problems,
both because of their smoking.
In July 2001, I lost my favorite aunt to lung cancer, caused by
smoking. I was staying at her house, taking care of her property and
taking care of her dogs. I was sitting at her table and reading her San
Diego Union Tribune Newspaper on July 18, 2001. The article I read, I
could not believe. The title of the article was ``Smoking Deaths an
Economic Boon, Philip Morris study says.'' It goes on to say, ``Sick
smokers may burden a country's healthcare system, but dead smokers save
governments money.'' That's the conclusion of a study on the financial
cost of smoking that was commissioned by tobacco giant Philip Morris.''
Even though this study was about the Czech Republic, this just is
unacceptable and unbelievable. Every country and every family deserves
to be protected from this despicable company and the tobacco industry.
Yes, Philip Morris apologized, but I do not accept their apology. I
have lost far too many loved ones because of the tobacco industry's
deadly products. My family has been devastated and so have thousands of
other families, thanks to the tobacco industry.
Philip Morris is the very company that is pushing for FDA
Regulation. Philip Morris may have changed their name to Altria, but
they certainly have not changed their ways. They claim that they don't
want kids to start smoking, that it's an ``Adult Decision'' but that
just causes kids to want to be adults and smoke even more. They think
by smoking that they will be more mature and look more adult. Don't
believe the tobacco industry when they say they don't want kids to
smoke. That is their future. The present smokers will either quit or
die and without kids or young adults taking up smoking, this industry
would no longer exist.
I used to be naive enough to believe that FDA Regulation was the
most important thing. I now realize just how wrong I was. By having
weak FDA regulations, it gives the appearance that the Government is
endorsing smoking by ``regulating it.'' The tobacco industry will be
able to say that cigarettes and tobacco smoking is now regulated by the
Government, implying that smoking is somehow safer or the Government
wouldn't be allowing it. They would also be able to use this as
protection from punitive damages in lawsuits if they were allowed to
bring FDA regulation to the jury's attention.
The Government should not be protecting the tobacco industry and
their rights but should be protecting families from the devastation
that this industry and their addictive and deadly products cause.
I ask this committee to really look long and hard at this bill and
see why Philip Morris, a tobacco company, is pushing for this bill.
There should be many red flags and it should be viewed with strong
suspicion.
I ask this committee to look at the findings and orders of U.S.
District Judge Kessler, after her finding the tobacco industry had
violated the Federal Racketeering laws after the lengthy trial last
year. Her orders really make sense. She found this industry had lied
and deceived the public for over 50 years.
I ask you to disregard anything that Philip Morris (Altria) says or
at least look at it with serious skepticism.
I believe that the big health agencies, American Cancer Society,
American Lung Association and American Heart Association feel that even
a weak bill is better than no bill at all. I strongly disagree with
them.
We should not be negotiating with the tobacco industry on a bill to
regulate them. That's like allowing the fox to guard the henhouse. The
only thing that Philip Morris wants is the ability to continue to sell
their addictive and deadly products. They definitely don't care about
public health or they would get out of the tobacco business.
I ask this committee to look deep into your hearts and souls and do
what's best for the public. Look at my sister's photo and think what if
that were my child or grandchild or wife or mother. Please do not let
my sister or father or the other smokers die in vain. Think of your own
families.
Thank you for your time.
Smoking out Big Tobacco
laurie comstock
Re: ``Camel No. 9 smells of killer marketing,'' commentary, Feb.
21: No matter how much you dress it up, flavor it, decorate the
packages with pink, fuchsia and teal flowers and designs, the truth is
smoking all cigarettes, and using other tobacco products, addicts and
kills people.
The words ``light and luscious'' should be ``black and deadly''
when used in advertising tobacco.
My younger sister started smoking when she was 13. She died from
lung cancer at age 44. I miss her with all my heart and so does my
entire family. She leaves behind her husband and two sons who were 14
and 17 when she died.
I have lost many other family members, related both by blood as
well as marriage, to tobacco-related diseases. All of them started
smoking as teens.
How many other people will die and how many more families will be
devastated before this despicable industry is stopped?
The answer is not weak FDA regulation that Philip Morris (now part
of Altria Inc.) approves of, but implementation of U.S. District Judge
Gladys Kessler's orders when she found the tobacco industry had
violated Federal racketeering laws after a lengthy trial last year.
The tobacco racketeers need to be held accountable for their
crimes. Too bad prison is not an option.
Prepared Statement of K.H. Ginzel, M.D., Professor Emeritus of
Pharmacology and Toxicology, University of Arkansas for Medical
Sciences, Westhampton, MA
I am opposed to any Federal regulatory action that implies formal
approval and indefinite continuation of the commercial trade of tobacco
products (see Attachment 1 and 2). The mission of the FDA is to
oversee, among others, drugs used for the treatment of diseases and to
make sure they are effective and safe.
The inclusion of tobacco products by whatever classification would
pervert this fundamental role of the FDA, especially as nicotine is
increasingly recognized as an extremely harmful substance in addition
to its addictiveness (see Attachment 3).
Age 18 as the age for the legal purchase of tobacco is unacceptable
for the following reasons:
(1) The proposed regulation specifically prohibits the FDA from
raising the legal minimum sale age for tobacco beyond age 18, as
obviously demanded by Altria/PM to retain access to high school
seniors, many of whom are over 18 and would therefore be able to
legally buy tobacco products and pass them on to peers under 18.
(2) Although the majority of adult smokers started smoking under
18, 15 percent to 20 percent may start between 18 and 21. Hence,
smoking would still be perpetuated at a significant level.
(3) Tobacco use, smoked or chewed, imposes a carcinogenic burden
that is more dangerous for the growing organism than for the adult.
Physical growth does not stop at 18 but continues at least until 21.
(4) The age at which the psychological maturity is attained for
making an informed decision about using legal drugs with a high
potential for addiction is at least 21, the age adopted for legal
purchase of alcoholic beverages.
I am attaching the following documents:
(1) My position on tobacco as expressed in a letter to then-
President Clinton and a Memo to the Presidential Task Force on National
Tobacco Policy.
(2) BMJ posting on ``The Future of Tobacco.''
(3) Critical Review on Nicotine, just appeared as electronic
version (publication in print early March).
______
The following two documents express my judgment as to how, in a
civilized society, the true reality of the tobacco issue ought to be
confronted and resolved.
Although they were created in 1997, they are as timely today as
they were then.
______
September 8, 1997.
Hon. William Jefferson Clinton,
President of the United States,
The White House, 1600 Pennsylvania Ave. NW.,
Washington, DC 20500.
Dear Mr. President: It is puzzling beyond comprehension that not a
single argument among those raised in recent weeks against the
``tobacco settlement'' or in favor of alternative solutions to the
leading preventable public health scourge of our time, has truly
confronted reality and proposed the obvious, the obvious being the
phasing out of commercial production and sale of tobacco products.
Tobacco farmers should be assisted in harvesting tobacco for the
commercialization of a high-quality protein that could feed a protein-
starved third world. Smokers who want to quit should be given help,
while those who don't should be allowed to grow their own tobacco
plants strictly for personal use. This is NOT PROHIBITION.
Are we so totally mired in the morass of ideological and political
absurdities that we have lost the ability to think straight and act
responsibly? For more than four decades American scientists have been
at the forefront of accumulating incontrovertible evidence for the
immense harm smoking inflicts on smokers as well as nonsmokers. At the
same time U.S.-based tobacco corporations have occupied the field,
deceived the public, and unashamedly pushed their deadly merchandise in
the domestic and foreign marketplace. And essentially all we are
laboring and fussing about now is how we can let them continue selling
death with impunity, albeit in diminishing numbers. If this type of
mindset had prevailed at the end of the second World War, we would
probably have stopped our advance on the beachhead at Normandy, made
peace with Hitler, and argued about the least offensive way to keep the
concentration camps operating.
Mr. President, circumstances have now granted us one of those rare
opportunities when politics must end and moral courage command our
actions. If you can seize this unique moment, cut through all the sham
to the bedrock of truth, and start the world on the path of liberation
from the lethal addiction to tobacco and to the profits garnered from
the suffering of its victims, you will have a place in history among
the greatest benefactors of humankind.
Respectfully yours,
K.H. Ginzel, M.D.,
Professor of Pharmacology and Toxicology Emeritus,
University of Arkansas for Medical Sciences.
______
August 27, 1997.
MEMO
To: Presidential Task Force on National Tobacco Policy
From: K. H. Ginzel, M.D.
(The tobacco industry is an economic tyrannosaurus rex: enormous,
ferocious, and destined for extinction. The world, and its economies,
will survive the industry's gradual demise quite handsomely.--Kenneth
Warner, The Global War, Seventh World Conference on Tobacco & Health,
Australia, 1990.)
Ever since the first Surgeon General's Report on Smoking and Health
appeared in 1964, the Federal Government has taken a duplicitous stance
vis-a-vis tobacco use and its disastrous consequences for public
health. Up till now one could euphemistically argue that the Government
simply ``condoned'' the death of millions of Americans who succumbed to
tobacco-related diseases during the past 33 years.
However, by adopting the proposed tobacco ``settlement,'' the
Government would formally endorse the continued sacrifice of old and
new lives to the ravages of nicotine addiction. A case in point is the
fact that a negotiated compromise intended to cut teens' smoking in
half in a given number of years inescapably condemns the other half to
the risk of disease and premature death. Hence, if there ever was
pretense of innocence, from that moment on innocence would
irretrievably be lost and liability for inflicted injury would no
longer be limited to industry alone.
Thanks to many years of untiring tobacco control advocacy,
activism, and litigation, we have finally arrived at a juncture of
profound significance and unparalleled opportunity. Numerous compelling
reasons converge to mandate that the Federal Government, empowered by
the Commerce Clause of Article 1, Section 8 of the Constitution, act
responsibly and ban the commercial manufacture and worldwide marketing
of tobacco products by U.S.-based corporations. Sales would have to be
phased out over a specified period of time, during which current
consumers can either seek help for quitting tobacco use or be permitted
to start growing their own tobacco plants for strictly personal use
(This would NOT be PROHIBITION. Tobacco farmers should be assisted in
changing to alternative crops or in harvesting tobacco for the
extraction and commercialization of a high-quality protein that is only
found in tobacco plants. Tobacco giants, which are already highly
diversified, will be able to switch to non-tobacco commodities without
undue hardship. According to Kenneth Warner, the total economic impact
of changing to a non-smoking society would be negligible, if not
beneficial.
If this prescription sounds too Utopian, a reality check may be in
order.
Let everyone try to invoke cogent and logically impeccable
arguments as to why the industrial manufacture and global marketing of
tobacco products by U.S. corporations must continue.
(1) Is it to continue because 50 million Americans still smoke and
need to be provided with cigarettes? (After all nicotine replacement
medication can be purchased over the counter and smokers could still
grow their own tobacco).
(2) Is it because smokers' alleged freedom of choice to continue
smoking--they surely did not exercise choice when they started smoking
as teens--deserves greater protection than their health, as well as the
health of those involuntarily exposed to their smoke?
(3) Or is it because tobacco sales at home and abroad not only
yield huge profits for the tobacco industry and substantial tax
revenues for governments, but also make possible generous corporate
donations to influential Members of Congress?
(4) Or, finally, is it because the premature death of smokers could
help reduce payments from pension funds, and Social Security and
Medicare expenditures?
The issue of a black market for cigarettes, now faced especially by
countries like Canada with high taxes on cigarettes, would largely
disappear once U.S. production has ceased. Europe is now looking at
America's evolving tobacco policy and is likely to follow its example.
If any of the reasons considered above are deemed sufficient to
justify the continued marketing of such a deadly product, this would
suggest that our society places a higher priority on corporate profit
than on the health and happiness of people. If, however, the converse
is true and no valid arguments can be found in support of the status
quo, the time for action has clearly arrived. This is a propitious
moment in history that, if not seized upon now, will probably not
return until tobacco has claimed many more millions of victims.
______
The Future of Tobacco
In addressing ``The Future of Tobacco,'' Nigel Gray suggests two
alternative approaches. One is the prohibition of tobacco, the other
concentrates on finding other nicotine delivery systems to compete with
tobacco. He dismisses the first option because of the notorious failure
of the alcohol prohibition in the United States in the 1920s. Indeed, a
``Prohibition'' patterned after the former would not be a practicable
solution.
However, a fundamentally different kind of ``prohibition'' not only
deserves serious consideration but also follows compellingly from the
extraordinary new stance Philip Morris, the most successful U.S.-based
multinational cigarette maker, has recently adopted. After more than
half a century of blatant denial, PM is suddenly fully embracing the
death and destruction its products inflict (philipmorris.com Web site).
Yet, despite PM's agreement with ``the overwhelming medical and
scientific consensus that cigarette smoking causes lung cancer, heart
disease, emphysema and other serious diseases in smokers,'' it still
conducts ``business as usual,'' continues to advertise and sell its
cigarettes at home and abroad. * The
perfunctory warning labels about the risks of smoking can in no way
compete with the massive pictorial impact of insidious advertising
imagery that uniquely affects the young mind. I am not aware of any product other than cigarettes that,
after being found defective and endangering life, was not withdrawn
from the market, either voluntarily by the manufacturer or by
regulatory or legal fiat of government.
---------------------------------------------------------------------------
* (Note: The two statements added here between < and > in the above
paragraph had been eliminated by the BMJ Editor from the published
version of my RESPONSE).
---------------------------------------------------------------------------
The stage appears to be set to examine if the sale of a product
that kills half of its long-term users and whose manufacturer now
unreservedly endorses its multiple risks and dangers can any longer be
tolerated by society. As one ponders the realities of the free
enterprise system, one is inevitably led to appreciate the role that
Government must play on behalf of its people. In their wisdom, the
Framers of the Constitution granted Congress the right to regulate
commerce, empowering the U.S. Government in the ``Commerce Clause'' of
Article 1, Section 8, of the Constitution to stop the interstate trade
of dangerous merchandise, an authority that could conceivably be
exercised in the case of tobacco. Such action must be clearly
distinguished from prohibition, since individuals would still be able
to grow tobacco strictly for personal use.
The second alternative considered by Nigel Gray aims at a nicotine
delivery device not based on tobacco. Although this would greatly
reduce the burden of toxic and carcinogenic exposure of the user, the
fact that nicotine itself is a tumor promoter and can be converted in
the body to the tobacco-specific nitrosamine, NNK, one of the most
potent lung carcinogens known, would argue against its extended use as
a substitute for tobacco. However, sebacylcholine, an agent that is
chemically different from nicotine but duplicates certain effects of
nicotine, should be tested as a potential substitute (K.H. Ginzel, A
hypothesis on the peripheral origin of smoking satisfaction and its
implication for nicotine replacement. Proc. 7th World Conference on
Tobacco and Health, Perth, Western Australia, 1990, pp. 426-427).
______
Journal of Health Psychology
Critical Review: Nicotine for the Fetus, the Infant and the Adolescent?
k.h. ginzel, gert s. maritz, david f. marks, manfred neuberger, jim. r.
pauly, john r. polito, rolf schulte-hermann and theodore a. slotkin)
abstract
The recent expansion of Nicotine Replacement Therapy to pregnant
women and children ignores the fact that nicotine impairs, disrupts,
duplicates and/or interacts with essential physiological functions and
is involved in tobacco-related carcinogenesis. The main concerns in the
present context are its fetotoxicity and neuroteratogenicity that can
cause cognitive, affective and behavioral disorders in children born to
mothers exposed to nicotine during pregnancy, and the detrimental
effects of nicotine on the growing organism. Hence, the use of
nicotine, whose efficacy in treating nicotine addiction is
controversial even in adults, must be strictly avoided in pregnancy,
breastfeeding, childhood and adolescence.
Keywords: adolescence; carcinogenesis; fetotoxicity; Nicotine
Replacement Therapy; pregnancy; teratogenicity
introduction
With the prospect of causing one billion deaths in the 21st
century, cigarette smoking has entrapped the planet in a pandemic of
tobacco-related morbidity and mortality of unprecedented proportion
(Ginzel, 2001). Since addiction to nicotine is at its core, one should
expect that efforts be focused on helping smokers to overcome their
addiction to nicotine. Instead, nicotine, as in ``Nicotine Replacement
Therapy'' (NRT), is becoming a more and more heavily promoted tool for
smoking cessation.
In support of NRT, it is claimed that the main cause of the health
damage inflicted by smoking is the cigarette smoke with its contingent
of over 4,000 substances, many of which are toxic or carcinogenic, but
not the nicotine to which the smoker is addicted. Therefore, it is
argued, if the addiction to cigarette smoking is too powerful to
respond to treatment, providing nicotine via NRT or even smokeless
tobacco in place of cigarettes is the correct course of action. This
argument is then further strengthened by portraying nicotine as largely
innocent, on par with caffeine, thereby ignoring the abundant evidence
that nicotine itself can imperil health due to a host of adverse
effects independent of its addictiveness.
But even if the toxicity of nicotine were accepted as a given,
would medicinal nicotine from NRT not be preferable to nicotine
contaminated with the bulk of poisons in cigarette smoke? Although this
question may suggest an affirmative answer, it actually hides the need
for uncompromised quitting as the only truly lasting solution. There
are at least two points to consider. For one, the satisfying experience
of a deep inhalation of cigarette smoke correlates with a sudden, steep
spike of the blood nicotine level. The generally much gentler and more
protracted rise following ingestion of NRT or smokeless tobacco can
neutralize the unpleasantness of withdrawal symptoms during quitting
attempts but it fails to eliminate the urge to smoke, prompting a
relapse to smoking. The unsuccessful quitter then smokes either in
alternation or even concurrently with NRT. Despite the inevitable
increase in nicotine exposure that this practice entails, it was
officially endorsed by the ``the new rules'' (see later). Second, for
both the addict and the counselor, the true labor of quitting is
comfortably postponed or suspended by resorting to a simple pill or
patch. By making ``quitting'' look so effortless, the health concerns
and attitudes toward smoking will have lost their urgency.
When the concept of treating nicotine addiction with nicotine first
emerged in the early 1980s, pharmaceutical companies seized upon the
opportunity to develop and market several nicotine preparations for
this purpose. Available today are nicotine chewing gum, transdermal
patch, lozenges, nasal spray and inhaler, which enjoy increasing
popularity among cessation specialists and smokers who are trying to
quit. However, a critical commentary questions the overall utility and
success rate of NRT as an aid to smoking cessation (Polito, 2006).
Also, according to a new meta-analysis, the long-term benefit of NRT is
modest, while existing treatment guidelines, based on only 6-12 months
of followup, overestimate the lifetime benefit and cost-efficacy of NRT
(Etter & Stapleton, 2006).
Despite the lack of evidence for long-term effectiveness, NRT use
continues to grow. In the United Kingdom the Committee on Safety of
Medicines (CSM) and the Medicines and Healthcare Regulatory Authority
(MHRA) have issued new rules, extending the use of nicotine in smoking
cessation to the most vulnerable recipients, the unborn child, the
neonate and children as young as 12 (Action on Smoking and Health,
2005). Yet, in the only two trials conducted in pregnancy, NRT patches
had no greater effect on smoking cessation than placebo (Coleman et
al., 2004). Neither did NRT prove effective in a study of 120
adolescent smokers (Moolchan et al., 2005).
Whether or not successful in achieving quitting, the recommendation
to use NRT in pregnancy and childhood raises the most serious concerns
because of potential long-term consequences of nicotine action for this
target group. In addressing these concerns, we first review the current
state of the science on nicotine's pharmacological profile with its
diverse impact on body functions, in particular its implication in
carcinogenesis, and then zero in on those effects of nicotine that
specifically impinge upon the developing and growing organism, the
primary objective of this article.
a brief synopsis of nicotine action
More than 100 years ago nicotine was first used as a tool in
physiological research. When nicotine was found to duplicate several
effects of acetylcholine (ACh), one of the principal neurotransmitters
in the central and peripheral nervous systems, this type of
``cholinergic'' transmission was designated ``nicotinic.''
The transmission occurs across a synapse between a presynaptic
nerve ending from which ACh is released and the adjacent postsynaptic
neuronal cell body or effector cell that carries specialized receptors
normally stimulated by ACh but also responsive to nicotine. Nicotinic
cholinergic transmission via nicotinic cholinergic receptors (nAChRs)
is a vital process indispensable for the normal functioning of the
living organism but vulnerable to impairment by nicotine. This is one
target for nicotine in the mature nervous system. Yet in the developing
nervous system, very early in gestation, nAChRs are expressed prior to
the formation of the neurons, which later establish synaptic contact
with the nAChRs. By modifying the function of these receptors, nicotine
can interfere with the normal developmental role of ACh (Falk,
Nordberg, Seiger, Kjaeldgaard, & Hellstrom-Lindahl, 2005). These
effects occur in the range of amounts of nicotine derived from smoking
or equivalent sources.
Nicotine also exerts multiple effects on the afferent portion of
the nervous system. In lowest effective doses it stimulates vagal
sensory nerve endings in the lungs, producing reflexly a generalized
relaxation of the skeletal musculature and an activation of the
electroencephalogram (EEG) correlated with mental alertness. This
intriguing combination, experienced and valued by the smoker, is likely
to contribute to nicotine's addictive property (Ginzel, 1987).
Recently an entirely new dimension was added to the wide spectrum
of nicotine action. Neuronal nicotinic acetylcholine receptors, nAChRs,
expressed on many different nonneuronal cell types throughout the body,
including lymphocytes, macrophages, dendritic cells, adipocytes,
keratinocytes, endothelial cells and epithelial cells of the intestine
and lung, appear to be implicated in inflammatory conditions and
diseases as diverse as ulcerative colitis, chronic pulmonary
obstructive disease, Parkinson's and Alzheimer's disease (Gahring &
Rogers, 2006).
Among the classical effects of nicotine are those on heart and
blood vessels mediated via nAChRs in the peripheral autonomic nervous
system. Nicotine affects adult heart rate and rhythm and accelerates
fetal heart rate. More recently, a key role of the inner lining of
blood vessels, the endothelium, in maintaining adequate blood flow to
organs was discovered. In the human brachial artery, the endothelium-
dependent dilatation was found to be impaired by nicotine from
cigarette smoke as well as from NRT nasal spray (Neunteufl et al.,
2002). After a mere 30-minute exposure to environmental tobacco smoke
(ETS), a substantial reduction in the coronary flow velocity reserve,
indistinguishable from that seen in habitual smokers, was observed in
healthy young nonsmokers (Otsuka et al., 2001). The underlying
mechanism was found to be the inhibition by nicotine of the self-
regulatory coronary vasodilatation in response to nitric oxide released
by endothelial cells. Since this effect of nicotine reaches its maximum
already in the small amounts present in ETS, the difference between
passive and active smoking as to their effects on blood vessels is
greatly narrowed. Heart disease from smoking only one to four
cigarettes per day is probably due to this mechanism (Bjartveit &
Tverdal, 2005). By increasing platelet aggregation and low density
cholesterol (LDL) while lowering high density cholesterol (HDL),
nicotine favors clot formation that may lead to heart attacks and
strokes. Nicotine, especially in the presence of a high cholesterol
diet, stimulates the growth of vascular smooth muscle cells and
promotes plaque formation and atherosclerosis (Jeremy, Mikhailidis, &
Pittilo, 1995). The American Heart Association (2006) has questioned
the suitability of NRT for patients with heart disease and for pregnant
smokers.
Nicotine has a whole spectrum of other effects at different stages
of fetal and adult development, which should not be ignored by those
administering or receiving NRT. Some of these are: an increase in
airway resistance; a decrease in fetal respiratory movements; a
decrease in alphal-antitrypsin associated with an increase in elastase
favoring the development of emphysema; gastrointestinal
vasoconstriction combined with a reduction in prostacyclin leading to
stomach ulcers; a depression of the immune response; and multiple
effects on hormones, especially a lowering of estrogen due to an
increase in its metabolism leading to an earlier onset of menopause,
osteoporosis and cardiac problems (U.S. Department of Health and Human
Services, 1988).
nicotine and carcinogenesis
One of the reasons for protecting the developing and growing
organism from exposure to nicotine is the prominent role nicotine plays
in both ``initiation'' and ``promotion,'' the two cardinal stages in
carcinogenesis. Nicotine can be transformed to one of the most potent
lung carcinogens, the tobacco-specific nitrosamine, NNK. As an
initiator, NNK is a prime candidate among the many carcinogens in
cigarette smoke responsible for starting the process toward cancer in
active and passive smokers (Hecht, 2004; Hecht, Hochalter, Villalta, &
Murphy, 2000). NNK and its metabolites are found in the first urine of
infants born to smoking mothers, supporting the hypothesis that in
utero exposure to tobacco carcinogens could be carcinogenic later in
life (Lackmann et al., 1999). Transplacental carcinogenesis associated
with smoking during pregnancy may involve, in addition to nicotine and
NNK, other carcinogens from cigarette smoke. Reduced detoxification
capabilities and increased susceptibility to DNA damage render the
fetus especially vulnerable to carcinogenic risk (Whyatt et al., 2001).
NNK and metabolites have also been recovered from elementary school
children and adults exposed to ETS (Hecht et al., 2001), attesting to
the fact that even the relatively small amounts of nicotine in ETS can
be transformed to NNK in the recipient. Added to this are the minute
concentrations of NNK in ETS that had been formed earlier in stored and
burning tobacco. Nicotine ingested from NRT can also undergo
transformation to NNK (Hatsukami et al., 2004). Fetal pulmonary
neuroendocrine cells as well as lung cancer cells express nAChRs that
bind NNK and nicotine which, in turn, stimulate the growth of these
cells (Minna, 2003). The fact that human lung cancer cells of all
histological types carry nAChRs suggests that nicotine itself may also
play a direct role in the pathogenesis of lung cancer (Minna, 1993).
Tumor growth occurs when the critical balance between cell
proliferation and programmed cell death (apoptosis) in normal healthy
tissues is disturbed. At blood concentrations achieved by smoking, ETS
exposure, or NRT, nicotine activates via nAChRs the cellular signalling
pathway Akt, a protein kinase, which stimulates cell proliferation and
inhibits apoptosis (Tsurutami et al., 2005). Activated Akt has been
identified in all lung cancer samples taken from smokers. By this
mechanism nicotine promotes unregulated growth and tumor formation, an
effect that is not limited to the lungs but can also occur in cancers
of other organs. Nicotine in NRT can be expected to act in a similar
way (Heusch & Maneckjee, 1998).
Nicotine from cigarettes or NRT might also confer a proliferative
advantage to already existing tumors. At concentrations even lower than
those in smokers' blood, nicotine stimulates proliferation of
endothelial cells and the formation of new blood vessels
(angiogenesis), a basic requirement for tumor growth and metastasis
(Villablanca, 1998). Furthermore, through activation of protein kinase
C, nicotine accelerates migration and invasion of human lung cancer
cells (Xu & Deng, 2006). All these actions define nicotine as an
effective tumor promoter. As smoking-related promotion is now being
recognized as the primary etiologic mechanism in carcinogenesis
dominating over smoking-related initiation (Hazelton, Clements, &
Moolgavkar, 2005), nicotine, implicated in both processes, ought to be
a major aim for intervention instead of a tool advocated for use in
smoking cessation.
New research using human tissues raised the question whether
nicotine is ``potentially a multifunctional carcinogen'' (Campain,
2004), since it produces concomitant genotoxic and antiapoptotic
effects, first steps in the neoplastic process. In human gingival
fibroblasts nicotine induced rapid DNA damage at in vitro
concentrations equivalent to those found to occur in the plasma of
tobacco users (Argentin & Cicchetti, 2004). Genotoxicity observed in
human tonsillar tissue and lymphocytes as well as in upper
aerodigestive tract epithelia also suggests a direct tumor-initiating
effect of nicotine (Kleinsasser et al., 2005; Sassen et al., 2005).
Smoking is now recognized as the second most significant cause of
cervical cancer after human papilloma virus (International Agency for
Research on Cancer, 2003). Nicotine which accumulates in cervical mucus
after active and passive smoking and smokeless tobacco use (McCann et
al., 1992), and which is also highly concentrated in the cervical mucus
of women who use nicotine patches (Cancer Weekly, 1995), was found not
only to promote rapid tumor growth and its lympho-angiogenic spread but
also to inhibit an anti-proliferative factor (Lane, Gray, Mathur, &
Mathur, 2005).
Although the preceding experimental data focus largely on adult
cancer incidence implicating nicotine as a causative factor, similar
scenarios can be expected to play out over time following fetal or
childhood exposure to nicotine. Transplacental carcinogenesis
associated with smoking during pregnancy may also involve, in addition
to nicotine, other carcinogens found in cigarette smoke.
nicotine in pregnancy and childhood
Nicotine also acts as a neuroteratogen. There is now abundant
evidence that normal fetal development can be disrupted more
specifically by nicotine than by any other component of cigarette
smoke. Nicotine, which impacts the brain during critical stages of its
intrauterine development in experimental animals, is in the offspring
of smoking mothers also the most likely cause of the deficits in
learning and memory, and the emotional and behavioral problems seen in
childhood and later in life (Levin & Slotkin, 1998; Slikker, Xu, Levin,
& Slotkin, 2005; Slotkin, 1998). In this context, a higher incidence of
attention deficit hyperactivity disorder (ADHD), lower adult
intelligence and mental retardation have been reported (Drews, Murphy,
Yeargin-Allsopp, & Decoufle, 1996). Higher order sensory function
depends in part on the activation of nAChRs in the sensory cortex by
its natural transmitter acetylcholine. When nicotine, even if only
transiently, usurps these receptors in the developing sensory cortex
during a critical period, it can permanently alter sensory-cognitive
function (Metherate, 2004). Just published new findings provide
experimental evidence that nicotine exposure in pregnancy is
responsible for auditory-
cognitive deficits in the offspring. Children with cognitive hearing
deficits have difficulty in understanding speech and verbally presented
information in noisy settings, and may be unable to tell the difference
between similar sounds (Liang et al., 2006). Prenatal nicotine also
primes the adolescent brain for depression (Law et al., 2003), and for
nicotine addiction in future years (Abreu-Villaa, Seidler, Tate,
Cousins, & Slotkin, 2004; Kandel & Davies, 1994; O'Callaghan et al.,
2006).
Significantly lowered levels of catecholamines found in umbilical
cord blood in response to hypoxemia during parturition may explain the
increased perinatal morbidity and mortality associated with smoking
during pregnancy (Oncken et al., 2002). A blunted catecholamine
response to hypoxic stress with a greater risk of death to offspring
was also observed in rats receiving nicotine throughout gestation.
Prenatal nicotine exposure can also have a permanent impact on lung
development and function with potential long-term health consequences
(Fauroux, 2003). Nicotine crosses the placenta and activates nicotinic
receptors located at a wide range of lung cells. In rat experiments, in
doses equivalent to those ingested by smoking mothers, nicotine causes
what appears to be a faster aging of the lungs in the offspring,
characterized by enlarged alveoli, fewer alveoli, a smaller surface
area for gas exchange and microscopic emphysema (Maritz & Windvogel,
2003). NRT use during pregnancy and breast-feeding when the neonate
lungs are still developing should be avoided (Alm, Lagercrantz, &
Wennergren, 2006). Prenatal nicotine exposure can permanently alter
lung development and airway function (Sandberg, Poole, Hamdan,
Arbogast, & Sundell, 2004). Prenatal and postnatal nicotine exposure
have been causally implicated in Sudden Infant Death Syndrome (SIDS)
(Cohen et al., 2002; Huang, Wang, Dergacheva, & Mendelowitz, 2005;
McMartin et al., 2002; Milerad, Vege, Opdal, & Rognum, 1998; U.S.
Department of Health and Human Services, 2006). NRT use during the
first 12 weeks of pregnancy increased the risk of congenital
malformations (Morales-Surez-Varela, Bille, Christensen, & Olsen,
2006).
A well-known consequence of smoking during pregnancy is the
incidence of low birth weight (LBW) babies, but even in the absence of
LBW, nicotine that reaches some 15 percent higher levels on the fetal
side of the placenta than on the maternal side, affects fetal brain
development and newborn neurobehavior (Lambers & Clark, 1996). Nicotine
concentrates in fetal blood, amniotic fluid and breastmilk. Breast-
feeding by smoking or ETS exposed mothers continues the delivery of
nicotine to the baby (Dahlstrom, Ebersjo, & Lundell, 2004). Postnatal
exposure to cigarette smoke also appears to act through nicotine: in a
study of 4,399 children aged 6 to 17 years, even the lowest exposure,
as monitored by the levels of cotinine, the main metabolite of
nicotine, in blood, urine, saliva and hair, was found to significantly
impair, in a dose-related manner, the children's reading, math and
reasoning scores (Yolton, Dietrich, Auinger, Lanphear, & Hornung,
2005).
nicotine in adolescence
According to recent human and animal research, adolescents are more
susceptible to developing nicotine dependence than adults, because a
single drug exposure can lead to lasting neuronal changes associated
with learning and memory (Fagen, Mansfelder, Keath, & McGehee, 2003).
The earlier the exposure to nicotine, the greater is the impact on the
neuronal circuitry of the still developing brain causing irreversible
effects on hippocampal structure, function, learning and memory
(Slotkin, 2002). This experimental finding was borne out of a study of
5,863 students, where a single experience with cigarettes reported at
age 11 was found to significantly increase the risk of becoming a
smoker as an adolescent even after 3 intervening years of nonsmoking.
This dormant vulnerability, termed ``sleeper effect'' (Fidler, Wardle,
Brodersen, Jarvis, & West, 2006), must be made widely known to help
prevent preteens from early experimentation with cigarettes or other
tobacco products. Early exposure to nicotine can also make children
more vulnerable later to stress or depression, prompting them to try
some form of nicotine again.
Adolescent smokers have only recently started to receive NRT. Some
of them reported simultaneous use of NRT and cigarettes. Nonsmoking
teens have also tried NRT and some have even indulged in regular use
(Klesges, Johnson, Somes, Zbikowski, & Robinson, 2003). The easy
availability of NRT poses a special risk for the curious and
adventurous young. Like smoking, NRT has the potential of priming the
brain for nicotine addiction and leading to illegal drug use.
A review of teen smoking cessation approaches reveals their
complexity and the lack of an effective solution (Mermelstein, 2003).
What appears to be missing from the majority of interactions with young
people is a totally honest confrontation and a truthful dissection of
the tobacco problem in its entirety (Ginzel, 2002).
the new rules
Against this background, it is with much concern that we confront
the recently proposed rules issued by the Committee on Safety of
Medicines (CSM) and by the Medicines and Healthcare Regulatory
Authority (MHRA) for the use of NRT in the UK (Action on Smoking and
Health, 2005), likely to set a precedent for other countries to follow.
According to these new rules, all forms of NRT can be used by pregnant
smokers; different forms of NRT can be used alternatively or
concurrently; NRT can be used while still smoking (!) and can be
prescribed for up to 9 months if needed; and all forms of NRT can be
used by young smokers aged 12 to 17 years as well as by patients with
cardiovascular disease if so advised.
These new rules differ fundamentally from past recommendations.
Molyneux (2004) states that the effectiveness of NRT in adolescents and
children who smoke has not been established, and he also urges smokers
not to smoke while using NRT. NRT, especially by transdermal patch,
delivers more nicotine to the fetus than smoking does. Nicotine
concentrations in fetal rat brain are 2.5 times higher than the
mother's blood nicotine level when on continuous nicotine feed; a
similar ratio can be expected in pregnant women using the patch
(Sarasin et al., 2003). Smokers who use NRT may have nicotine
concentrations up to three times higher than the approved dose (Chan,
Jeremy, Stansby, & Shukla, 2004). The U.S. Surgeon General's Report of
2001 on Women and Smoking states: Because of uncertainties over the
safety of nicotine replacement during pregnancy, FDA has assigned a
Pregnancy Category C warning to nicotine gum (``Risk cannot be ruled
out'') and a Pregnancy D warning to transdermal nicotine (``Positive
evidence of risk'') (U.S. Department of Health and Human Services,
2001, p. 557). Since many of tobacco smoke's harmful effects on the
unborn baby can be attributed to nicotine, NRT or smokeless tobacco
products are not a safe alternative to smoking during pregnancy (Cohen
et al., 2005). No data are available on long-term effects of NRT use on
fetal outcomes (Oncken, Bert, Ockene, Zapka, & Stoddard, 2000). The
uncertainty of benefit and the risk of NRT use in pregnancy and by
teens are echoed throughout the literature dealing with this topic. The
risk of oral NRT use also received new emphasis by the recent finding
that nicotine causes concomitant genotoxic and antiapoptotic effects in
human gingival fibroblasts, potentially the first step in the
neoplastic process (Argentin & Cicchetti, 2004).
It is obvious that the smoker whose body is busy dealing with the
nicotine contingent in inhaled smoke ought not to be burdened with
additional amounts of nicotine delivered from NRT but should be
resolutely supported to overcome the addiction to nicotine altogether.
This cannot be achieved by recommending or prescribing nicotine through
NRT. The ultimate goal must be total cessation of smoking and nicotine
intake in any form. NRT simply substitutes one form of nicotine for
another but is neither safe nor as effective as other cessation aids
(Hutter, Moshammer, & Neuberger, 2006; Marks, 2005, 2006; Moshammer &
Neuberger, 2006). Originally, the tobacco industry opposed the makers
of NRT, but now both industrial enterprises seem to be finding common
ground as tobacco and NRT have begun reinforcing each other and keeping
the addiction to nicotine alive.
concluding comments
Prescribing or simply recommending an over-the-counter purchase of
one form or another of NRT is unquestionably quicker and less engaging
for the health professional than any in depth one-to-one counsel that
tries to inspire mind and heart of the mother-to-be so as to make her
cherish and protect the new life she has been entrusted with; it is
also easier than a straight talk with a teen or preteen about a future
eclipsed by addiction, disease and premature death, exploring the real
reasons that made them light up in the first place (Ginzel, 2002). It
is easy not only for the counselors to prescribe NRT, it is also easy
for the clients to receive it: they may conveniently assume that this
is all that needs to be done, and the urge to smoke may go away in due
course. While there is compelling experimental and clinical evidence
that nicotine harms the developing fetus in several ways, evidence is
lacking that NRT aids smoking cessation in pregnancy. There are
pregnant women today who would have quit but are wearing nicotine
patches, persuaded by the safety assurances about NRT use. Moreover,
new evidence reveals that offering a remedy for a risky behavior
inadvertently promotes it by suggesting that the risk is manageable
(Bolton, Cohen, & Bloom, 2006).
If the new UK rules, which extend and multiply a regimen ill-
conceived from the start were followed and also adopted by other
countries, they would perpetuate nicotine addiction rather than
diminish it. And so would a recently proposed policy of extended, or
even indefinitely continuing (!), use of the so-called ``clean
nicotine'' of NRT (Gray et al., 2005). This could actually set us on a
path eventually leading to the end of tobacco control as we know it.
Tobacco control must be nicotine control. Without nicotine control,
nicotine addiction and nicotine's multifarious and insidious impact on
the user would persist and spread at the peril of the unborn, the next
generation and public health in general.
Some 4,000 years ago the code of Hammurabi decreed the penalty of
death for anyone who would harm a child. In an editorial in the New
York Times in March 1985, William G. Cahan of the Memorial Sloan
Kettering Cancer Center identified smoking as the most prevalent form
of child abuse. Will nicotine now join this deplorable distinction?
abbreviations
ACh, acetylcholine; ADHD, attention deficit hyper activity
disorder; CSM, Committee on Safety of Medicines; ETS, environmental
tobacco smoke; FDA, Food and Drug Administration; MHRA, Medicines and
Healthcare Regulatory Authority; nAChRs, nicotinic cholinergic
receptors; NNK, tobacco specific lung carcinogen 4-(methylnitrosamino)-
1-(3-pyridyl)-1-butanone; NRT, nicotine replacement therapy; SIDS,
sudden infant death syndrome.
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Comment of Stephen L. Hansen, M.D.
Prof. Ginzel has it just right. This is a politically achievable
goal of tremendous public health import. Polls support de-legalization
of the sort envisioned here. Let's unify around this approach for the
long run--people are ready for tobacco to go.
Prepared Statement of Michael S. Givel, Ph.D., Professor of Political
Science, University of Oklahoma, Norman, OK
fda legislation requires significant changes to curb cigarette use
Mr. Chairman and distinguished members of the committee, thank you
for the opportunity to allow me to submit this written testimony with
respect to proposed Food and Drug Administration legislation and
regulation of tobacco. I respectfully request that my written statement
be included as part of the committee's official record.
My name is Michael Steven Givel and I am an associate professor of
political science at the University of Oklahoma. My area of research
expertise includes public policy, health policy and tobacco policy. I
have been involved in tobacco policy research for about 10 years and
prior to that was involved for 2 years with Synar youth enforcement
program administration in the State of Missouri. I have published
extensively in scientific peer-reviewed journals with respect to the
issue of Federal tobacco policymaking, including two recent scientific
articles on the Global Settlement and past attempts by the U.S. Food
and Drug Administration (FDA) to regulate tobacco products. I will
preface my written testimony today with comments regarding the adequacy
of the proposed FDA legislation to actually reverse the use of the
Nation's consumption of tobacco products.
The very long title I of this bill with the various requirements
for cigarette product performance, labeling, and monitoring standards
represents a long-term goal by some for an alleged ``safer'' cigarette.
Unfortunately, there is no wide scientific consensus or proof that has
definitively and conclusively shown that a reduction of some
ingredients or product modifications will make a lit cigarette safer.
In fact current scientific evidence and research has provided little
conclusive evidence as to what tobacco ingredients and in what
combination and in what levels is specifically linked to particular
morbidities and mortalities.
For example, even if the FDA were to lower nicotine levels as is
proposed for title I of this bill, this will not make cigarettes, as
some claim, non-addictive or ``safer.'' In fact, lowering of nicotine
levels will lead smokers to compensate to maintain their current level
of nicotine consumption. This will result in these smokers consuming
higher levels of harmful ingredients including tar leading to
continuing high levels of disease and death.
Supposedly safer cigarettes coming on to the market with FDA
approval will also maintain the current market brands of cigarettes
that cause significant disease and death. Given that there is no
scientific evidence conclusively linking varying amounts of ingredients
with specific morbidities and mortalities, testing of the new brands,
which would be very long-term lasting numerous years would be highly
problematic and questionable. In the meantime, the current market would
be maintained.
Another glaring example of the problem with this idea of supposedly
safer cigarettes in title I is the provision to ban all additives
except menthol. Why is there this significant disparity in standards in
banning additives that are all known to unduly entice smokers to smoke
particular brands? This is illustrative of how uncertain actual
agreement is on what constitutes a supposedly safer cigarette.
In fact, if there were such a thing as a safer cigarette, the
shorter title II of this proposed bill requiring stronger warning
labels would not be necessary. Either a cigarette is safer or there is
no need for larger warning labels, but not both. While much of title I
can not currently be justified, at a minimum, in order to mitigate one
very severe problem with title I, I would recommend that this committee
remove by amendment the provision that allows the use of menthol as an
additive.
This legislation also provides a significant litigation shield
(along with provisions of title II, discussed below) that can be
presented to future juries that there are now supposedly stricter
product standards (along with larger and clearer warning labels). With
this litigation shield consumers would have lesser basis to obtain
monetary damages, particularly punitive damages. Thus this bill, which
is based on a far from settled notion that cigarettes can supposedly be
made safer stymies the lawful right of plaintiffs to obtain full
justice in lawsuits. I recommend that this committee ensure that clear
language in this law require that this legislation can not be used to
justify undue lesser legal damages, particularly punitive damages, in
product liability and tort lawsuits.
Title II of this bill does approximate current scientific public
health recommendations for warning labels, except the strongest
labeling requirements also require graphic color pictures depicting
four major diseases due to smoking. These diseases include: heart
disease, stroke, lung cancer in smokers, and lung cancer in non-
smokers. The current legislation makes this a discretionary
requirement. This is an important public health consideration as recent
research indicates that the strongest approach to cause smoker
cessation or smoker consideration of cessation occurs when all diseases
are graphically shown on large warning labels. I recommend that this
committee make color graphics tied to the four major diseases related
to smoking a mandatory and not discretionary requirement.
The legislation also substantially preempts State and local control
in the following areas: tobacco product standards, pre-market approval,
adulteration, misbranding, labeling, registration, good manufacturing
standards, and modified risk tobacco products. In addition, section 906
(3) (ii), of this bill preempts State authority to restrict the minimum
age of sale of tobacco products to no one older than 18. This is an
unprecedented advance of Federal power at the expense of State and
local governments. Several States, which have enacted innovative
regulatory requirements in such areas as adulteration of cigarette
products would have their legislative autonomy and authority
significantly superceded by this legislation. I recommend to this
committee that the clause preempting State and local rights be removed.
Title III addresses another important issue with respect to
smuggling calling for stronger labeling and tracking of tobacco
products. However, this can be easily circumvented with counterfeit
labels and packaging as has been done in the past so this is a very
weak provision. This provision needs to be reconsidered with respect to
more aggressive anti-smuggling policies such as stepped up border
enforcement efforts and equivalence in tobacco tax policies and rates
that do not encourage smuggling from the United States to bordering
countries like Canada or visa versa.
Finally, due to the glaring deficiencies in various key premises of
this legislation, unfortunately this proposed law will not
significantly reduce tobacco use in the United States. Instead, it will
ironically create a stable and thriving adult tobacco market through
the FDA regulatory framework into the far future that unduly sanctions
tobacco products as ``safe'' while removing greater legal liability and
State and local authority to pass more stringent legislation. There is
no conclusive evidence that this legislation will significantly save
lives or reduce disease. What this legislation will do is convince
current and new smokers into believing that cigarettes are supposedly
safer with a likelihood of even stabilizing or increasing consumption
to the detriment of the public health.
I strongly urge this committee to either defeat this bill or in the
alternative significantly amend and correct this bill so that true
progress can be made in reducing tobacco consumption.
Thank you for this opportunity to allow me to present my written
testimony to this committee.
Prepared Statement of William T. Godshall, M.P.H., Executive Director,
Smokefree Pennsylvania, Pittsburgh, PA
Smokefree Pennsylvania is a nonprofit organization founded in 1990
whose goals include protecting people from the involuntary exposure to
tobacco smoke pollution, reducing tobacco marketing to youth,
increasing cigarette prices, preserving civil justice remedies for
injured tobacco victims, and increasing tobacco prevention and
cessation services.
Smokefree Pennsylvania strongly opposes the introduced version of
S. 625, the ``Family Smoking Prevention and Tobacco Control Act'' that
would authorize the U.S. Food and Drug Administration (FDA) limited
regulatory jurisdiction over tobacco products.
In sum, Smokefree Pennsylvania opposes the current text of S. 625
because it would:
mislead the public into believing FDA regulation reduces
tobacco products risks,
protect cigarettes from market competition by less harmful
smokeless tobacco products,
increase Philip Morris' 51 percent cigarette market share,
as well as Marlboro's market share,
increase inaccurate public beliefs that smokeless products
are as hazardous as cigarettes,
encourage FDA to set cigarette emission standards based
upon inaccurate machine tests,
increase inaccurate public beliefs that certain cigarettes
are less hazardous than others,
mandate counterproductive and/or ineffective warning
labels on tobacco products,
fail to adequately inform consumers of comparable risks of
different tobacco products,
prohibit harm reduction marketing of lower risk smokeless
products to smokers,
do very little, if anything, to reduce cigarette-caused
disease, disability and death,
allow tobacco manufacturers and others to promote
cigarettes as FDA approved,
severely limit the FDA's authority to issue effective
tobacco product regulations, and
reduce cigarette manufacturer liability by misleading
potential jury pools.
reducing health risks of future tobacco products
Effective regulations gradually phase out the most hazardous
products, and encourage the development of and transition to lower risk
products. Effective product regulations also adequately inform
consumers of relative and comparable product risks. In sharp contrast,
S. 625 protects the most hazardous tobacco product (cigarettes), the
largest cigarette company (Philip Morris) and the largest cigarette
brand (Marlboro) from market competition from far less hazardous
noncombustible tobacco products by misleading consumers to incorrectly
believe that smokeless tobacco products are just as hazardous as
cigarettes, and by prohibiting truthful harm reduction marketing claims
by smokeless tobacco products that are directed towards already
addicted cigarette smokers.
Cigarettes kill 50 percent of addicted smokers, and up to 63,000
American nonsmokers annually (from secondhand smoke and fires). In
contrast, smokeless tobacco kills about 1 percent of addicted users,
and ZERO nonusers. Swedish smokeless (snus) and other new low
nitrosamine noncombustible tobacco products pose even fewer risks.
Smokers who switch to smokeless products can sharply reduce their
disease and death risks.
But S. 625 perpetuates the myth/fraud that noncombustible tobacco
products are just as hazardous as cigarettes by requiring larger labels
on smokeless packs and advertisements that state: ``This product is not
a safe alternative to cigarettes,'' and by failing to inform smokers
(e.g., via labels on cigarette packs and advertisements) that smokeless
tobacco products pose fewer morbidity and mortality risks than
cigarettes. If U.S. Congress is sincere about truthfully informing
consumers about the health risks of different tobacco products, this
misleading warning MUST be removed from smokeless tobacco products.
S. 625 also could be improved if FDA was encouraged to approve
clean nicotine products (e.g., skin patches, gum, lozenges, inhalers)
for nicotine maintenance instead of just for temporary use as a smoking
cessation aid. Shiffman et al. found that 36.6 percent of nicotine gum
users consumed the product for longer than 6 months, despite the
product warning urging discontinued use after 12 weeks. Clean nicotine
products are far less hazardous than relapsing to cigarettes, and
should be approved for nicotine maintenance.
Although Section 911 of S. 625 includes provisions for FDA to
approve the marketing of ``modified risk tobacco products,'' it is
highly unlikely that any product would be approved since any
manufacturer applying for FDA approval for a modified risk product
would need to demonstrate that the product wouldn't discourage smokers
from quitting tobacco use and wouldn't result in use by nontobacco
users. Besides, the Campaign for Tobacco Free Kids, American Cancer
Society and other proponents of S. 625 have repeatedly alleged that the
marketing of smokeless tobacco products for harm reduction discourages
smokers from quitting and encourages youth to begin using those
products.
In contrast, Section 911(g)(2) of S. 625 would allow a cigarette
manufacturer to apply for and receive FDA approval for ``an explicit or
implicit representation that such tobacco product or its smoke contains
or is free of a substance or contains a reduced level of a substance,
or presents a reduced exposure to a substance in tobacco smoke.'' This
clause could very likely result in the FDA approving the marketing of a
``reduced exposure'' cigarette even if the cigarette is as hazardous as
other cigarettes. Even worse, the marketing of an FDA approved
``reduced exposure'' cigarette is likely to confuse smokers into
believing that the product is less hazardous than other cigarettes.
cigarette machine testing methods are inaccurate, and only serve
to misinform
Effective product regulations also protect consumers from health
frauds. Although S. 625 eliminates cigarette brand descriptors
``Light,'' ``Low-Tar'' and ``Mild,'' (which arguably is the deadliest
consumer fraud of the 20th century), consumers of these products would
barely notice this change because these brands would remain on the
market in their easily recognized package designs and colors (minus one
word). Marlboro Lights, which has the largest market share of any
cigarette, would simply become known as Marlboro Gold, while Marlboro
Ultralights would simply become known as Marlboro Ultras or Marlboro
Silver. Meanwhile, S. 625 does nothing to warn smokers that the brands
previously named ``Lights'' and ``Ultralights'' are just as hazardous
as other cigarettes.
But far more troublesome, S. 625 authorizes the FDA to establish
cigarette emission standards for various smoke constituents based upon
inaccurate smoking machine testing methods similar to the notorious FTC
smoking machine tests that were partly responsible for creating the 35-
year-old consumer fraud that duped smokers into believing that Low-Tar,
Light and Ultralight cigarette brands were less hazardous than other
cigarettes.
Although a recent study by the Harvard School of Public Health
concluded that cigarette companies have increased the nicotine yields
of cigarettes by about 10 percent during the past decade leading some
news reports to claim that cigarettes are now more addictive, that same
study also concluded that (during the past decade) nicotine yields of
Light brands were about 25 percent less than those of Full Flavor
brands, and that nicotine yields of Ultralight brands were about 30
percent less than those of Light brands. But in fact, all cigarettes
are similarly and quite adequately addictive. The fundamental problem
with the Harvard study is that it relied upon another inaccurate
smoking machine testing method somewhat similar to the defective FTC
testing method.
Hammond et al. recently evaluated the accuracy of the International
and Canadian cigarette machine testing methods, and concluded that
neither of those machine testing methods are accurate, and that NO
machine testing method should be relied upon for establishing
government regulatory standards for cigarette smoke emissions.
Besides, cigarette smoke contains more than 50 carcinogens and
3,000 other constituents. So even if an accurate FDA machine testing
method is devised (which doesn't appear viable), an FDA product
standard that reduces or removes one, two or a few chemicals or
carcinogens from cigarette smoke would not reduce the overall health
risks of cigarettes.
Any FDA product standard for cigarettes almost certainly would be
perceived by smokers and the public as making cigarettes less
hazardous, which could discourage smokers from quitting and could
encourage youth and ex-smokers to begin smoking.
S. 625 also authorizes the FDA to reduce nicotine levels in
cigarettes, and some supporters of S. 625 have advocated mandatory
nicotine levels reductions in cigarettes. Yet, there is broad
scientific consensus that smokers of cigarettes with purportedly lower
nicotine yields simply puff more intensely, take more puffs and/or
smoke more cigarettes in order to obtain a similar level of nicotine
that they are accustomed to receiving, which is known as ``nicotine
compensation.'' As such, smokers of purportedly lower nicotine yield
cigarettes inhale greater quantities of smoke, which increases their
disease risks.
Thus, it would be counterproductive for public health if the FDA
mandated reductions in nicotine, because doing so could make cigarettes
even more hazardous. If the FDA were to require any changes in nicotine
content (assuming that an accurate machine testing method could be
developed), it would be better for public health to require higher
levels of nicotine in cigarettes, because smokers would inhale less
cigarette smoke.
constitutional concerns about s. 625
Another concern with S. 625 is that some of its tobacco advertising
restrictions are virtually certain to be struck down by the Supreme
Court for violating a manufacturer's first amendment right to advertise
to its adult customers. That is precisely why in 2001 the Supreme Court
(in Lorillard Tobacco Co. v. Reilly) struck down a Massachusetts
regulation that prohibited outdoor tobacco advertisements within 1,000
feet of a school or playground. And yet, a similar 1,000 foot outdoor
advertising restriction is contained in S. 625.
denying fda authority to effectively regulate tobacco products
Effective product regulations also allow regulatory agencies
unfettered authority to issue regulations that reduce use of and access
to the most hazardous products. But S. 625 prohibits the FDA from
issuing many of the most effective regulations that could reduce
cigarette usage, especially among youth, including prohibiting the FDA
from:
increasing the minimum age to purchase cigarettes beyond
18 years;
eliminating cigarette sales from any type of retail
outlet;
requiring prescriptions to buy cigarettes (as FDA requires
for other hazardous drugs);
removing nicotine from cigarettes; and
eventually removing cigarettes from the market.
While these restrictions limiting the FDA's authority to regulate
tobacco in S. 625 are not necessarily opposed by Smokefree
Pennsylvania, our organization is nevertheless concerned that their
inclusion in S. 625, along with the many truly counterproductive
provisions that were previously cited, have severely compromised this
legislation.
The following report compares the health risks of different tobacco
products and recommends the only viable tobacco product and policy harm
reduction strategy for smokers who are not ready or willing to quit
tobacco use; providing truthful comparable product risk information,
and encouraging switching to a smokeless tobacco product. http://
www.harmreductionjournal.com/content/3/1/37.
Tobacco Harm Reduction: An Alternative Cessation Strategy for
Inveterate Smokers
brad rodu \1\ and william t. godshall \2\
(harm reduction journal 2006)
abstract
According to the Centers for Disease Control and Prevention, about
45 million Americans continue to smoke, even after one of the most
intense public health campaigns in history, now over 40 years old. Each
year some 438,000 smokers die from smoking-related diseases, including
lung and other cancers, cardiovascular disorders and pulmonary
diseases.
---------------------------------------------------------------------------
\1\ Professor of Medicine and Endowed Chair, Tobacco Harm Reduction
Research, School of Medicine, University of Louisville, KY, USA.
\2\ Founder and Executive Director, Smokefree Pennsylvania,
Pittsburgh, PA, USA.
---------------------------------------------------------------------------
Many smokers are unable--or at least unwilling--to achieve
cessation through complete nicotine and tobacco abstinence; they
continue smoking despite the very real and obvious adverse health
consequences. Conventional smoking cessation policies and programs
generally present smokers with two unpleasant alternatives: quit, or
die.
A third approach to smoking cessation, tobacco-harm reduction,
involves the use of alternative sources of nicotine, including modern
smokeless tobacco products. A substantial body of research, much of it
produced over the past decade, establishes the scientific and medical
foundation for tobacco-harm reduction using smokeless tobacco products.
This report provides a description of traditional and modern
smokeless tobacco products, and of the prevalence of their use in the
United States and Sweden. It reviews the epidemiologic evidence for low
health risks associated with smokeless use, both in absolute terms and
in comparison to the much higher risks of smoking. The report also
describes evidence that smokeless tobacco has served as an effective
substitute for cigarettes among Swedish men, who consequently have
among the lowest smoking-related mortality rates in the developed
world. The report documents the fact that extensive misinformation
about ST products is widely available from ostensibly reputable
sources, including governmental health agencies and major health
organizations.
The American Council on Science and Health believes that strong
support of tobacco-harm reduction is fully consistent with its mission
to promote sound science in regulation and in public policy, and to
assist consumers in distinguishing real health threats from spurious
health claims. As this report documents, there is a strong scientific
and medical foundation for tobacco-harm reduction, and it shows great
potential as a public health strategy to help millions of smokers.
i. background
According to the Centers for Disease Control and Prevention (CDC),
about 45 million Americans continue to smoke [1], even after one of the
most intense public health campaigns in history, now over 40 years old.
Some 438,000 smokers die from smoking-related diseases each year,
including lung and other cancers, cardiovascular disorders and
pulmonary diseases [2].
There is clear evidence that smokers of any age can reap
substantial health benefits by quitting. In fact, no other single
public health effort is likely to achieve a benefit comparable to
large-scale smoking cessation. Surveys document that most smokers would
like to quit, and many have made repeated efforts to do so. However,
conventional smoking cessation approaches require nicotine-addicted
smokers to abstain from tobacco and nicotine entirely (as discussed
later, use of nicotine replacement medications is limited to 10-12
weeks, per labels required by Federal regulations). Many smokers are
unable--or at least unwilling--to achieve this goal, and so they
continue smoking in the face of impending adverse health consequences.
In effect, the status quo in smoking cessation presents smokers with
just two unpleasant alternatives: quit or die.
There is a third choice for smokers: tobacco-harm reduction. It
involves the use of alternative sources of nicotine, including modern
smokeless tobacco (ST) products, by those smokers who are unable or
unwilling to quit tobacco and nicotine entirely. The history of
tobacco-harm reduction may be traced back to 1974, with the publication
of a special article in the Lancet by British tobacco addiction
research expert Michael A.H. Russell [3]. Citing the ``high dependence-
producing potency and the universal appeal of the effects of nicotine''
on smokers, Russell likened ``harsher restrictive measures'' and
``intensification'' of anti-smoking efforts to ``flogging a dead horse
harder.'' Russell believed that ``the goal of abstinence and the
abolition of all smoking is unrealistic and doomed to fail.''
Six years later Russell's research group compared nicotine
absorption rates from various tobacco products, which led them to
suggest that nasal snuff use could serve as an effective substitute for
cigarette smoking [4]. This article was cited shortly thereafter by a
short letter in a leading American medical journal [5]. Russell et al.,
published followup studies on nasal snuff in 1981 [6] and on an oral ST
product in 1985 [7]. Lynn Kozlowski, a prominent American smoking and
nicotine addiction expert at Penn State University, noted in 1984 and
1989 that ST products conferred fewer risks to users and therefore
might serve as effective substitutes for cigarettes [8, 9]. In 1994
oral pathologist Brad Rodu and epidemiologist Philip Cole from the
University of Alabama at Birmingham made quantitative comparisons of
the risks from oral ST use and smoking in a series of studies [10-13].
Some of that work was summarized in a 1995 ACSH publication [14].
A substantial body of research over the past decade has been
transformed into the scientific and medical foundation for tobacco-harm
reduction, the substitution of safer sources of nicotine, including
tobacco products, by those smokers who are unable or unwilling to
achieve nicotine and tobacco abstinence. In 2001 the Institute of
Medicine, a subsidiary of the National Academy of Sciences, provided a
now widely accepted definition of a harm reduction product as ``harm
reducing if it lowers total tobacco-related mortality and morbidity
even though use of that product may involve continued exposure to
tobacco-related toxicants'' [15]. The purpose of this report is to
review the evidence for tobacco-harm reduction.
ii. the status quo: cigarette smoking
A. Prevalence
At first glance, the United States (U.S.) appears to be the
quintessential example of the slow but substantial decline of cigarette
smoking in the developed world. Smoking prevalence in the United States
has decreased since at least the mid-1960s, following landmark reports
from the Royal College of Physicians of London in 1962 and the U.S.
Surgeon General in 1964. Smoking among men was 52 percent in 1965 [16],
dropping to 23 percent by 2004 [1]. Prevalence among women declined
from 34 percent in 1965 to 19 percent in 2004. In 1965, only 44 percent
of American adults had never smoked and 14 percent were former smokers;
by 2004, those percentages had increased to 58 percent and 21 percent
respectively.
But declining prevalence overshadows the fact that, with population
growth, the absolute number of smokers in the United States remained
relatively constant at 45 to 50 million over the entire period.
Heavily-addicted, or inveterate, smokers are resistant to conventional
cessation strategies emphasizing tobacco and nicotine abstinence.
Today's smoking population has a higher proportion of heavy smokers
than in the past, and the National Cancer Institute (NCI)-funded
Community Intervention Trial for Smoking Cessation underscores the
challenges facing them [17]. Perhaps the most intensive cessation trial
ever conducted, this 4-year effort had no effect on cessation among
heavy smokers. The published report called the intervention
``disappointing but consistent with the findings of most other
community studies . . .'', and it described heavy smokers as ``more
resistant to change. Reaching these smokers may require new clinical
programs and public policy changes.''
B. Health effects
Cigarette smoking remains the single most important avoidable cause
of death in the developed world. The CDC reports that smoking is
responsible for 438,000 deaths in the United States annually [2], a
figure which has changed little over the last 15 years.
Cigarette smoking was responsible for a large proportion of the
increase in cancer mortality in the second half of the 20th Century, a
trend with important social consequences, including the widespread
misperception that the United States was being consumed by a ``cancer
epidemic'' caused by environmental pollution and industrial chemicals.
In fact, the ``epidemic'' consisted almost exclusively of one disease,
lung cancer, and was due to one lifestyle factor, cigarette smoking. A
retrospective analysis of mortality statistics revealed that, if lung
cancer is excluded, the mortality rate from all other forms of cancer
combined has declined continuously since 1950 [18].
The first reports linking lung cancer to cigarette smoking were
published over 50 years ago [19, 20]. In 2006 there will be 175,000 new
cases of lung cancer in the United States, with a 5-year survival rate
of just 15 percent [21]. The CDC estimates that smoking causes 142,000
deaths per year from lung cancer [2]. Smoking is a risk factor for
other malignancies, including cancers of the oral cavity and pharynx,
larynx, esophagus, stomach, bladder, kidney, pancreas, uterine cervix
and leukemia [2].
According to the CDC, smoking causes 132,000 deaths per year from
cardiovascular diseases, including heart attacks, strokes,
atherosclerosis and aortic aneurysms [2]. Smoking also causes 103,000
deaths per year from pulmonary diseases such as pneumonia, influenza,
bronchitis and chronic airway obstruction [2].
While many Americans are aware that cigarette smoking causes
cancer, cardiovascular and respiratory diseases, most are not aware
that it also increases risks for neurological disorders, reproductive
complications, cataracts and other eye diseases, premature aging of the
skin, osteoporosis and other orthopedic and rheumatologic problems,
psychiatric disorders and surgical complications [22]. Recent studies
have also linked smoking to the development of type 2 diabetes [23-25].
C. Stagnation
As Russell noted 30 years ago, ``There is little doubt that if it
were not for the nicotine . . . people would be little more inclined to
smoke than they are to blow bubbles or light sparklers'' [3]. Nicotine
fulfills all the criteria of an addictive agent, including psychoactive
effects, drug-reinforced behavior, compulsive use, relapse after
abstinence, physical dependence, and tolerance. Nicotine stimulates
specialized receptors in the brain which produce both euphoric and
sedative effects. It has been known for many years that nicotine shares
many features of drug dependence with opioids, alcohol and cocaine.
This includes similar disappointing patterns of relapse [26].
It is for this reason that most attempts at smoking cessation are
not successful, despite the fact that the majority of smokers are aware
that smoking is harmful to their health, and so would like to quit. It
is clear that most smokers would rather quit on their own, and 90
percent of successful quitters use self-help methods because of limited
access to and cost of formal cessation programs [27].
Formal cessation programs have existed for decades and have grown
more complex and sophisticated, but relapse rates remain very high.
According to a 2006 National Institutes of Health (NIH) Consensus
Conference on Tobacco Use, ``70 percent [of smokers] want to quit and
40 percent make a serious quit attempt each year, but fewer than 5
percent succeed in any given year'' [28]. The conference press release
went on to make an astounding admission, ``Effective tobacco cessation
interventions are available and could double or triple quit rates . .
.'' This means that fewer than 15 percent of existing smokers, no more
than 7 million, would be successful with maximum application of
existing cessation strategies. The consensus statement failed to answer
a vital question: What can be done for the remaining 40 million adult
smokers? The rest of this report will review the scientific rationale
and evidence for tobacco-harm reduction as an alternative for these
smokers.
iii. smokeless tobacco use
A. Introduction
The tobacco plant is native to the Western hemisphere, and the use
of tobacco in smokeless forms (placed in the mouth or inhaled as a
powder through the nose) predates the arrival and exploration of the
West by Europeans. According to the historian Jan Rogozinski, the most
common manufactured tobacco product in Europe until the early 1800s was
a compressed plug or cake [29]. This product was relatively simple to
produce and was amenable to transport and storage. The plug could be
cut into large pieces for chewing, grated into smaller pieces for
smoking, or ground into a fine powder for nasal inhalation. Smokeless
forms were the favored method of use because a day's supply could be
carried and conveniently used in industrial and agricultural work
settings.
ST was the dominant form of tobacco used in the United States until
early in the 20th century [29]. Developments in tobacco cultivation,
curing and manufacturing, along with the invention of the safety match,
resulted in the increased popularity of cigarettes. In addition, at the
beginning of the 20th century tobacco spit inaccurately was believed to
transmit tuberculosis, so bans on public spitting and spittoons
resulted in a decline in ST use. The transmission of tuberculosis now
has been understood for decades, and it does not include expectoration
[30].
Use of all types of ST traditionally has been most prevalent in
Southern States and in rural areas throughout the United States.
B. Types of ST
As described below, ST is currently used by only a small proportion
of American tobacco users. This is one reason that most Americans,
including smokers, know almost nothing about ST products, or--even
worse--are completely misinformed about even basic product
characteristics. Thus, it is important to understand what these
products are and how they are used.
ST products are not burned but instead are placed in the cheek or
between the lip and gum. ST is used in many countries around the world,
including those in the Middle East and on the Indian subcontinent.
However, ST products in those regions are considerably different from
those used in the West. For example, in India ST products are made by
individual farmers and small companies with little control over
fermentation and curing, which affects the production of potential
carcinogens called tobacco-specific nitrosamines (TSNAs) [31]. In India
ST is often combined with betel leaf (Piper betle), sliced areca nut
(Areca catechu) and/or powdered agricultural lime [32], additives that
enhance the toxicity as well as the psychotropic effect of tobacco [33,
34]. In addition, Indian ST users often smoke concurrently, which
complicates efforts to assess the health effects of ST use [35, 36].
This report will focus on ST products used in Western societies,
mainly the United States and Sweden. But ST is not a homogeneous
category, even in these countries. Three traditional types of ST are
used in the United States: powdered dry snuff, loose leaf chewing
tobacco and moist snuff, and it is important to understand the
differences among them with respect to their manufacturing and
characteristics, the populations that consume them, and the
consequential health risks, especially mouth cancer.
Powdered Dry Snuff
Dry snuff is made from fermented, fire-cured tobacco that is
pulverized into powder. Nasal inhalation of dry snuff was widely
practiced in Europe in the 17th and 18th centuries but declined
thereafter [37]. Manufacturers in Germany and the United Kingdom still
provide an array of flavored dry snuff products for a small number of
contemporary users in those countries. In the United States powdered
dry snuff, also called dental or Scotch snuff, is sold in small
canisters. Since the early 1800s it has been used primarily by women in
Southern States [29,38], who place the powder on the gum or between the
gum and cheek. However, use of dry snuff is declining, and sales have
fallen 67 percent in the past 15 years [39].
Loose Leaf Chewing Tobacco
Loose-leaf chewing tobacco consists of air-cured leaf tobacco from
Pennsylvania and Wisconsin that is shredded, coated with sweet
flavoring solutions and packaged in foil-lined pouches. It is consumed
primarily by men in the United States, commonly in conjunction with
outdoor activities. Chewing tobacco is typically used in large volumes,
resulting in the archetypical golf ball-sized bulge in the user's cheek
and large quantities of saliva that users usually expectorate.
Consequently, the popularity of this product has waned, with
consumption declining gradually over the past century, dropping by
about 44 percent in just the last 15 years [39].
Moist Snuff
Moist snuff consists of fire- and air-cured dark tobaccos that are
finely cut or ground. It is packaged in round containers, and the user
compresses a ``pinch'' between the thumb and forefinger and places it
inside the lip. Much less bulky than loose leaf chewing tobacco, moist
snuff produces less saliva, but expectoration is still common. It is
now the most popular form of ST in the United States; sales of this
product increased by 66 percent over the past 15 years [39].
In addition to the United States, there is a long tradition of
moist snuff use in Scandinavia, especially in Sweden, where ``snus''
(the generic term for moist snuff in Swedish, pronounced ``snoose'') is
essentially the only type of ST product in use [40]. There are
differences in how American and Swedish moist snuff products are
manufactured. Traditional American products undergo fermentation, which
imparts characteristic flavors but in the past resulted in higher
concentrations of unwanted bacterially mediated by-products, especially
TSNAs and nitrite. In Sweden, moist snuff is subjected during
manufacturing to a heat treatment akin to pasteurization, yielding
virtually sterile products containing very low levels of TSNAs.
However, manufacturing refinements over the past 25 years have resulted
in lower TSNAs in both Swedish and American products. A 1997 report by
the Swedish National Board of Health and Welfare reported that TSNA
concentrations in both Swedish and American ST brands had declined
substantially [41]. The report concluded:
``Recent data suggest that the differences [in TSNA levels
reported in American and Swedish ST] have grown smaller, and
that it is now questionable to make a sharp distinction between
use of American and Swedish moist snuff when assessing risks--
at least where TSNA content is concerned.''
A separate section of this report will discuss how the high
prevalence of snus use in Sweden has played an important role in the
low prevalence of smoking, especially among men.
Modern ST Products
Over the past few years several ST products have emerged that are
not easily classified into one of the previous groups. In fact, one
reason for the popularity of moist snuff is that manufacturers have
gradually refined the products in this category to be more user-
friendly. The traditional pinch of moist snuff is difficult to keep in
place, and the resultant migration is esthetically displeasing. Modern
moist snuff products are sold in pre-portioned pouches similar to
teabags, but much smaller. Because these products remain stationary in
the mouth and generate very little juice, they can be used discreetly
with no expectoration. There is a recent trend among manufacturers to
offer even smaller pouches that are dry, with a wide range of non-
tobacco flavors. Other products in this category consist of small
pieces of leaf tobacco and pellets of compressed tobacco that dissolve
completely. These products all share one important characteristic: they
are of sufficiently small size that can be used invisibly, and without
expectoration.
c. prevalence
The prevalence of ST use has not received nearly as much attention
as that of smoking, but adult prevalence has been documented by the
National Health Interview Survey (NHIS). For adults, NHIS defines
current ST users as those individuals who have used ST at least 20
times in their lives and are using ST every day or some days. In 1991
the prevalence of current ST use among adult men in the United States
was about 5.6 percent (4.8 million), which declined to 4.4 percent (4.4
million) in 2000. In 1991 about 0.6 percent (533,000) of adult women in
the United States were current users, and prevalence declined to 0.3
percent (324,000) by 2000 [42, 43].
In 2000 the prevalence of ST use was higher among men age 18-44
years (6 percent) than among those age 45+ years (3 percent). Men in
the Southern United States had the highest prevalence (7 percent) and
those in the Northeast had the lowest (2 percent). As with smoking,
prevalence of ST use was higher among men with a high school education
or less. Finally, higher male prevalence was seen in rural areas (9
percent), compared with urban areas (3 percent) [43].
In the United States the number of male smokers is tenfold higher
than the number of ST users, so it follows that concurrent use of both
products is common among ST users, but rare among smokers. About 25
percent of men who use ST report concurrent smoking, whereas concurrent
use occurs in fewer than 5 percent of men who smoke [44]. Cigarette
consumption is considerably lower in combined users compared with
exclusive smokers [45-47].
d. health effects
1. Oral leukoplakia
Oral leukoplakia is an ominous sounding term used frequently in
discussions about ST use. The term literally means ``white plaque,''
and it is used to describe areas of the mouth lining that become
thickened by ST use or smoking. The World Health Organization has
determined that leukoplakias resulting from ST use are considerably
different from those resulting from smoking. The distinctions are based
on the frequency of occurrence, the location in the mouth, and how
often these leukoplakias result in mouth cancer [48, 49].
The condition is rare, occurring in less than 1 percent of the
general population, primarily in long-time smokers 40 to 60 years old
[50, 51]. Smoking-related leukoplakias most commonly involve the
undersurface of the tongue and throat area, locations that account for
75 percent of oral cancer in the United States [51, 52].
Oral leukoplakias occur in up to 60 percent of ST users [53, 54],
within 6 months to 3 years of starting ST use [55, 56]. They primarily
occur at the site of ST use and are largely a result of local
irritation [55, 57]. The frequency of appearance depends on the type of
ST that is used. Moist snuff, which is more alkaline than chewing
tobacco, more often leads to leukoplakia [56]. However, moist snuff in
pre-portioned pouches causes fewer cases of leukoplakia than does the
loose form [58].
There are distinct differences in how often ST and smoking
leukoplakias show pre-cancerous changes called dysplasia. Dysplasia is
seen infrequently in ST leukoplakias (less than 3 percent) [49, 59-61].
Furthermore, even when dysplasia is present in ST leukoplakia, it
usually is found in earlier stages than in leukoplakias due to smoking
[62, 63] where it is seen in about 20 percent of cases [64].
ST leukoplakias only rarely progress to cancer. For example, one
prospective study found no case of cancer in 1,550 ST users with
leukoplakia who were followed for 10 years [65], and a second study
reported no case of oral cancer among 500 regular ST users followed for
6 years [66]. A retrospective study of 200,000 male snuff users in
Sweden found only one case of oral cancer per year, an extremely low
frequency [67]. In comparison, a followup study reported that 17
percent of smoking leukoplakias transformed into cancer within 7 years
[68].
In conclusion, oral leukoplakia occurs commonly in ST users, but it
primarily represents irritation and only very rarely progresses to oral
cancer.
2. Oral cancer
ST use has been associated with oral cancer for many decades. It is
widely perceived--both by laypersons and medical professionals--that
the association is strong and applies to all ST products. However,
epidemiologic studies dating back to the 1950s provide convincing
evidence that most ST products increase oral cancer risks only
minimally.
Rodu and Cole reviewed 21 epidemiologic studies published from 1957
to 1998 [69]. Unlike previous reviewers, these authors derived relative
risk (RR) estimates for cancers of the mouth and associated upper
respiratory sites related to use of chewing tobacco, moist snuff, dry
snuff and a fourth category in which the type of ST was unclear or
undetermined (ST unspecified). This study found that use of chewing
tobacco and moist snuff were associated with only minimally elevated
risks, while use of dry snuff conferred somewhat higher risks.
Chewing tobacco has been studied at least once in each of four
decades from the 1960s to the 1990s. The data clearly show that chewing
tobacco use is associated with only slightly elevated cancer risks; RRs
for all anatomic sites are under 2 with confidence intervals including
1 (i.e. the risk elevation was not statistically significant) (Table
1). The first study evaluating the risk of chewing tobacco appeared in
1962 [70]. There were two studies in 1977 [71, 72], two in 1988 [73,
74], and four studies from 1993 to 1998 [75-78].
Table 1.--Chewing Tobacco and Cancer of the Mouth and Upper Respiratory Sites
----------------------------------------------------------------------------------------------------------------
RR (95 percent
Anatomic Site CI) Studies Cases/Controls
----------------------------------------------------------------------------------------------------------------
Oral cavity....................................................... 0.6 (0.3-1.3) 2 283/296
Pharynx...........................................................
Oral cavity + pharynx............................................. 1.1 (0.8-1.6) 4 2113/4454
Larynx............................................................ 1.3 (0.9-1.8) 1 387/2560
Oral + pharynx + larynx........................................... 1.7 (1.2-2.4) 2 362/457
All sites......................................................... 1.2 (1.0-1.4) 8 3145/5245
----------------------------------------------------------------------------------------------------------------
As with chewing tobacco, summary RRs are only slightly elevated for
moist snuff, with three RRs at or below 1 and the highest RR at 1.2
(Table 2). RRs for moist snuff were reported first in 1977 [71].
Another study appeared in 1988 [74], and five additional studies were
published from 1993 to 1998, as this ST type came under intense
scrutiny [75-79].
Table 2.--Moist Snuff and Cancer of the Mouth and Upper Respiratory Sites
----------------------------------------------------------------------------------------------------------------
RR (95 percent
Anatomic Site CI) Studies Cases/Controls
----------------------------------------------------------------------------------------------------------------
Oral cavity....................................................... 1.1 (0.8-1.6) 2 482/995
Pharynx........................................................... 0.7 (0.4-1.4) 1 138/641
Oral cavity + pharynx............................................. 0.7 (0.4-1.2) 3 1682/3931
Larynx............................................................ 1.2 (0.9-1.7) 2 544/3201
Oral + pharynx + larynx...........................................
All sites......................................................... 1.0 (0.8-1.2) 5 2846/4926
----------------------------------------------------------------------------------------------------------------
Two of the seven studies on moist snuff were Swedish, both
appearing in 1998 [78, 79]. These studies have received considerable
attention among tobacco researchers, particularly in Europe, because
they are viewed as showing no oral cancer risk for Swedish products.
They formed the basis for the Swedish government's decision in 1999 to
recommend that the European Union (EU) oral cancer warning labels be
removed from ST products. An EU directive in 2001 accomplished that
objective and specified a new warning, ``This tobacco product can
damage your health and is addictive'' [80]. Notably, the other five
studies contributing to the summary RRs for moist snuff were American,
and they reported RRs very similar to those of the Swedish studies.
Summary RRs for dry snuff use are higher, ranging from 4 to 13,
although the confidence intervals for these estimates are wide (Table
3). The first study appeared in 1962 [70], followed by studies in 1981
[81], 1988 [73], and 1994 [76], spanning a period of 32 years.
Table 3.--Dry Snuff and Cancer of the Mouth and Upper Respiratory Sites
----------------------------------------------------------------------------------------------------------------
RR (95 percent
Anatomic Site CI) Studies Cases/Controls
----------------------------------------------------------------------------------------------------------------
Oral cavity.......................................................
Pharynx...........................................................
Oral cavity + pharynx............................................. 4.0 (2.7-5.9) 3 298/947
Larynx............................................................
Oral + pharynx +larynx 13 (8.0-20) 1 93/393
All sites......................................................... 5.9 (1.7-20) 4 391/1340
----------------------------------------------------------------------------------------------------------------
RRs for ST-unspecified range from 1.5 to 2.8, and most are
statistically significant. For all sites the summary RR is 1.9 (CI =
1.5-2.3), which is intermediate between the low risks reported for
chewing tobacco (1.2, 1.0-1.4) or moist snuff (1.0, 0.8-1.2) and the
higher risk for dry snuff (5.9, 1.7-20) (Table 4). The intermediate
risks for this ST category probably reflect the use of either the
lower- or higher-risk products among different groups within the
studies. Eight studies provided RRs for ST-unspecified, five of which
appeared between 1957 and 1969 [82-86]. Additional studies appeared in
1992 [87], 1993 [75] and 1998 [88].
Table 4.--ST-Unspecified and Cancer of the Mouth and Upper Respiratory Sites
----------------------------------------------------------------------------------------------------------------
RR (95 percent
Anatomic Site CI) Studies Cases/Controls
----------------------------------------------------------------------------------------------------------------
Oral cavity....................................................... 2.8 (1.9-4.1) 4 581/798
Pharynx........................................................... 2.3 (1.2-4.4) 3 169/472
Oral cavity + pharynx............................................. 1.5 (1.1-2.0) 3 655/2718
Larynx............................................................ 1.8 (0.3-9.3 1 23/100
Oral + pharynx +larynx
All sites......................................................... 1.9 (1.5-2.3) 7 1428/3681
----------------------------------------------------------------------------------------------------------------
Tables 1 to 4 are adapted from [69].
Prior to the 2002 analysis by Rodu and Cole, the distinctive risk
profiles of moist snuff and chewing tobacco on one hand, and dry snuff
on the other, had gone unnoticed. In fact, the low oral cancer risk
associated with chewing tobacco had been discussed briefly in only one
article [89]. No distinction in risks had been made previously between
dry snuff and moist snuff, even though these products are considerably
different with regard to tobacco content and processing, as noted
earlier.
The majority of epidemiologic studies regarding ST and oral cancer
have limitations, many of which are typical for case-control studies,
and some important for understanding unique oral cancer risks. Most of
them did not control for confounding by two strong determinants of oral
cancer, cigarette smoking and alcohol use. Positive confounding by
smoking would occur if ST users smoke more than do nonusers of ST. This
would result in artificially high-risk estimates for oral cancer among
ST users. On the other hand, negative confounding is plausible and
would occur if smoking rates are lower among ST users than among
nonusers of ST. This would result in artificially low risks for oral
cancer among ST users.
Only three studies [78, 79, 81] controlled for alcohol use, where
only positive confounding is likely. Thus, control for alcohol
consumption in all studies probably would have reduced, somewhat, many
of the estimates of mouth cancer risk associated with ST use.
However, even with these limitations, the results of these studies
are reasonably consistent with regard to mouth cancer risks from long-
term use of moist snuff and chewing tobacco. In their review Rodu and
Cole concluded that ``the abundance of data now available indicates
that commonly used ST products increase the risk of oral and upper
respiratory tract cancers only minimally.''
Since the 2002 review four epidemiologic studies, one from Sweden
and three from the United States, have been published [90-93]. In all
of these studies ST use was not associated with a significant increase
in mouth cancer risk. In 2004 a group of epidemiologists concluded that
the evidence linking ST use and oral cancer was ``not decisive'' [94].
These investigators commented that many claims in the media
``overemphasize the risk of oral cavity cancer [from ST use], reaching
beyond the scientific data.''
In 2005 the American Cancer Society (ACS) reported that ST users
did not have significantly increased risks for oral and pharyngeal
cancer in either the first or the second Cancer Prevention Study [92].
Despite this finding, the ACS Web site continues to focus on ST as a
cause of mouth cancer, erroneously stating that ``risk of cancer of the
cheek and gums may increase nearly 50-fold among long-term snuff
users'' [95]. A later section of this report will discuss this type of
misinformation.
3. Other cancers
As noted above, cigarette smoking is associated with increased risk
for several cancers in locations not in contact with cigarette smoke.
In comparison, numerous epidemiologic studies have not demonstrated
that ST use is associated with risk of cancer at any site outside the
mouth. In 2004 Waterbor et al. assessed the epidemiologic research
literature and summarized the evidence regarding ST use and cancers in
various locations [94]. Table 5 shows the conclusions of Waterbor et
al. with respect to cancer risks associated with ST use, compared with
the established risks for smoking.
Table 5.--Risk of Cancer in Various Sites Associated with ST Use and
Smoking
------------------------------------------------------------------------
Risks from
Cancer Site Risks from ST Use* Smoking**
------------------------------------------------------------------------
Pharynx......................... No relationship... RR = 5-11
Larynx.......................... No relationship... 13-15
Lung............................ Inadequate........ 13-23
Stomach......................... Not persuasive.... 1.4-2.0
Kidney.......................... No association.... 1.3-3.7
Esophagus....................... Not persuasive.... 7-8
Pancreatic cancer............... Inconclusive...... 2.3
Bladder cancer.................. None.............. 2.2-3.3
------------------------------------------------------------------------
* From [94].
** Among current smokers (men and women), used by the CDC for national
estimates of smoking-attributable mortality [96].
4. Cardiovascular diseases
Over the past 15 years, eight epidemiologic studies have examined
the risk of cardiovascular diseases among ST users. Six of the studies
found that ST users had no increased risk for heart attacks or strokes
[47, 90, 97-100]. The other two reported modestly positive
associations, with ST users having RRs of 1.2 and 1.4 [92, 101], which
are lower than those of smokers. In 2003, Asplund completed a
comprehensive review of the cardiovascular effects of ST use [102]. He
concluded that, in distinct contrast to smokers, ST users do not
exhibit any significant differences from nonusers of tobacco with
regard to the following measures of cardiovascular health: heart rate,
blood pressure, cardiac output and maximal working capacity, levels of
hemoglobin and hematocrit, leukocytes, antioxidant vitamins,
fibrinogen, components of the fibrinolytic system, C-reactive protein
and thromboxane A2 production. In addition, ST users did not show
important smoking-associated vascular changes, including increased
thickness of blood vessels and atherosclerotic plaque development. In
summary, most of the medical and epidemiologic evidence documents that
ST users do not have elevated risks for cardiovascular diseases.
Two studies based in Sweden have examined the impact of ST use as a
risk factor for adult-onset diabetes. One of these studies found that
current ST users had a slightly elevated risk (Odds ratio = 1.5, CI =
0.8-30) [103], while the other reported that the risk of diabetes in ST
users was not significantly increased [104].
iv. scientific rationale for harm reduction with st
A. Nicotine maintenance
1. Nicotine background
Nicotine has been characterized as powerfully addictive. But
nicotine itself poses little or no health hazard. For example, it does
not cause emphysema or cancer [105, 106], and there is no evidence that
it plays a direct role in the development of cardiovascular diseases
[106, 107]. A report from a meeting at the United Nations Focal Point
on Tobacco or Health concluded that ``long-term nicotine use is not of
demonstrated harm, with the possible exception of use during
pregnancy'' [108].
The U.S. Food and Drug Administration (FDA) has acknowledged the
safety of nicotine replacement therapy (NRT) by allowing its sale
without prescription. Long-term use of NRT has not been associated with
any medical risks and is considered far less hazardous than relapsing
to smoking cigarettes [109, 110], prompting authorities in the United
Kingdom (U.K.) to liberalize NRT regulations there recently. The new
guidelines allow NRT use by patients with cardiovascular disease, by
confirmed smokers ages 12 to 17, by pregnant smokers, and concurrently
by those who continue to smoke [111].
Nicotine gum was introduced in the United States in 1984 as a
prescription product to assist in smoking cessation. The gum is
considered to pose no consequential health hazard, and it was granted
over-the-counter status by the FDA in 1996. The gum gives the user only
a limited degree of control over the amount of nicotine absorbed
because its nicotine content is low and only slowly released [112].
Depending on State and local excise taxes and cigarette consumption,
the gum may be competitive on a per-unit basis for the smoker. However,
it is available only in large quantities, making the purchase price far
more expensive than that for cigarettes, a major economic disincentive.
In fact, cost is the reason most frequently cited by smokers for never
using NRT [113].
The nicotine patch was introduced in the United States in 1992 and
was available without prescription by 1996. It continuously delivers
nicotine through the skin for up to 24 hours. Although the patch is
intended to preclude smoking, the rate of nicotine delivery is so low
that smoking while wearing the patch is not uncommon. The patch's major
limitation is its inadequate nicotine delivery, but it is not a
technical problem. A high-dose nicotine patch has been evaluated and
may provide complete nicotine replacement even for heavy smokers [114].
Many smokers overestimate the health risks of NRT products. A 2001
survey of 1,046 adult smokers found that 53 percent incorrectly
believed nicotine causes cancer and 14 percent didn't know [115], and a
2002 survey found that half of all smokers are concerned about negative
side effects of using NRT [116]. A similar problem exists in the United
Kingdom, where recent research found that 69 percent of smokers believe
NRT is as harmful as cigarettes.
Misconceptions are not limited to persons without medical training.
Twenty-two percent of general medical practitioners in the United
Kingdom are concerned that NRT is just as harmful as cigarettes, 40
percent believe that nicotine may cause cardiovascular disease and
stroke, and one-quarter believe it may cause lung cancer [117].
In summary, poor nicotine delivery, high cost and misconceptions
about health risks are the principal reasons that the long-term quit
rate among users of non-
prescription nicotine medications is only 7 percent, according to a
recent meta-
analysis [118].
2. Long-term use of nicotine medications
The FDA specifies that nicotine medications should not be used for
more than 10 to 12 weeks. This restriction is based not on health
considerations, but on a concern about prolonging nicotine addiction.
Considering the limitations of nicotine medications, it is remarkable
that some smokers continue to use the products beyond the 3-month
period specified by the FDA. About 20 percent of those who quit smoking
with nicotine gum used it for more than 1 year when it was available
only by prescription [112]. A cessation study that provided free gum
but encouraged weaning after 2 months use reported that 37 percent of
smoke-free subjects at 1 year were still using nicotine gum [119].
Using a liberal definition of continuous use, a recent study found that
as many as one-third of current nicotine gum users have used the
product for longer than 6 months [120]. That study also reported that,
among persons who start to use nicotine gum, 7 percent will use it for
longer than 6 months and 1 percent will continue use for over 2 years.
The equivalent figures for nicotine patch were 1.7 percent and 0.05
percent respectively.
3. Nicotine concentration and availability from ST products
ST products contain nicotine at far higher concentrations than
nicotine medications, and at levels that are generally acknowledged to
be addictive [121, 122]. Bioavailability of nicotine from ST products
is dependent on the pH of the product, since unprotonated nicotine (in
more alkaline products) is absorbed more efficiently and more rapidly
across the mucous membranes of the mouth than protonated forms of the
drug from more acidic products. The pH-dependent absorption kinetics of
nicotine is a very important reason why ST is not consumed like foods.
The pH of stomach contents is very acidic, which strongly inhibits the
absorption of nicotine [122]
The nicotine absorption profiles of ST products, which have been
known for many years [105, 123], show both advantages and disadvantages
when compared with those from smoking. Nicotine absorption from ST is
somewhat slower than that from cigarettes, although the peak nicotine
levels obtained in venous blood are similar [105]. In addition,
elevated serum nicotine from ST use persists for much longer than that
from smoking [105]. This may explain the observation that unit
consumption of ST products among former smokers was much lower than
prior unit consumption of cigarettes [124, 125]. In the end, ST users
and smokers consume similar quantities of nicotine daily [126].
B. Comparison of risks from ST use and smoking
The established health risks associated with ST use are vastly
lower than those of smoking. In the past 25 years, almost 80 peer-
reviewed scientific and medical publications have acknowledged the
differential risks between the two tobacco products (see Additional
File 1).
In 1980 Michael A.H. Russell and co-workers proposed that powdered
nasal snuff might serve as an effective substitute for cigarettes
because it delivers nicotine effectively without the risks of tobacco
combustion [4]. This article was cited shortly thereafter in a brief
letter in the New England Journal of Medicine [5]. Russell et al.
published followup studies on nasal snuff in 1981 [6] and on an oral ST
product in 1985 [7]. Lynn Kozlowski, a prominent American smoking and
nicotine addiction expert at Penn State University, noted in 1984 and
1989 that smokeless forms of tobacco conferred fewer risks to users and
therefore might serve as effective substitutes for cigarettes [8, 9,
127]. Starting in 1994, University of Alabama at Birmingham researchers
Brad Rodu and Philip Cole provided a quantitative assessment of the
difference in risks for the two products. Using established risk
estimates from accepted sources, Rodu and Cole documented that ST use
confers only about 2 percent of the health risks of smoking [10-12]. In
addition, they established that the average reduction in life
expectancy from long-term ST use was about 15 days, compared with a
reduction of about 8 years from smoking [11].
In 1994 Rodu noted that ST use posed a lower risk for mouth cancer
than smoking [10]. In 2001 this was confirmed by a comprehensive report
on tobacco-harm reduction by the Institute of Medicine, which stated
that ``the overall [oral cancer] risk [for ST use] is lower than for
cigarette smoking, and some products such as Swedish snus may have no
increased risk'' [15].
By the late 1990s some influential organizations acknowledged the
differential risks of ST use and smoking. For example, in 1997 experts
meeting at the United Nations Focal Point on Tobacco or Health
concluded that ``it is now evident that the risk of death and disease
is related to not only the amount but also the nature of tobacco
exposure; for example, daily cigarette smoking is far more dangerous
than occasional use of Swedish snuff'' [108]. That same year a
scientific panel convened by the Swedish National Board of Health and
Welfare concluded that ``the health risks related to smokeless tobacco
are with great probability lower than those related to smoking'' [41].
In 2002 the Royal College of Physicians of London, one of the
oldest and most prestigious medical societies in the world, issued a
report called ``Protecting Smokers, Saving Lives,'' which stated,
``As a way of using nicotine, the consumption of non-
combustible [smokeless] tobacco is on the order of 10-1,000
times less hazardous than smoking, depending on the product.''
The report continued with an even bolder statement, acknowledging
that some smokeless tobacco manufacturers may want to market their
products ``as a `harm reduction' option for nicotine users, and they
may find support for that in the public health community'' [128].
In 2004 a study funded by the NCI assembled an international panel
of experts (including epidemiologists from the NIH and the ACS) to
compare the risks of ST use with those of smoking. The study authors
reported that, ``In comparison with smoking, experts perceive at least
a 90 percent reduction in the relative risk of low-nitrosamine
smokeless tobacco use.'' The authors concluded that ``This finding
raises ethical questions concerning whether it is inappropriate and
misleading for government officials or public health experts to
characterize smokeless tobacco products as comparably dangerous with
cigarette smoking'' [129].
Phillips et al. have provided perhaps the most detailed and direct
comparison of risks from use of Swedish or American ST products and
from smoking, using a spectrum of risk estimates for ST use ranging
from well-substantiated and plausible to highly speculative and
implausible [130]. They estimated that, compared with smoking, ST risks
``in the range of 1 percent or 2 percent, and possibly less, are most
consistent with the epidemiologic evidence. Perhaps most important, our
calculation shows that comparative risk estimates as high as 5 percent,
let alone 10 percent or more, cannot be justified based on the
evidence.''
C. Evidence that ST is an effective substitute for cigarettes
1. Survey data
There is limited evidence from governmental and other surveys that
some smokers have quit by substituting ST products for cigarettes, and
most of the published information on this subject is dated. The 1991
NHIS survey revealed that 33.3 percent (about 1.8 million) of adult
current ST users were former cigarette smokers [42].
The 1986 national Adult Use of Tobacco Survey, conducted by the CDC
Office on Smoking and Health, found that 7 percent (1.7 million) of
male ex-smokers had used ST to help them quit smoking cigarettes. That
same survey found that only 1.7 percent of male ex-smokers (404,600)
had used organized programs to help them quit smoking [131].
The 1998 NHIS survey revealed that 5.8 percent of daily snuff users
reported quitting smoking cigarettes within the past year, that daily
snuff users were three times more likely to report being former
cigarette smokers than never snuff users, and that daily snuff users
were four times more likely to have quit smoking in the past year than
never snuff users [132].
According to the 1987 NHIS survey, 23- to 34-year-old U.S. men who
had smoked cigarettes and subsequently used snuff were twice as likely
to have quit smoking (95 percent CI 1.2-3.5) than were cigarette-only
users [133].
Cohen-Smith and Severson surveyed 51 female and 59 male ST users in
the Northwestern United States, 98 percent and 90 percent of whom
respectively were either current or former cigarette smokers. They
found that 52 percent of women and 59 percent of men used ST in place
of cigarettes while quitting smoking [134].
2. Clinical trial data
One clinical trial, an open-label, nonrandomized pilot study, has
been conducted assessing the efficacy of an ST product in helping
cigarette smokers become smoke-free. The investigators used a low-
intensity approach, consisting of a 20-minute lecture about the health
effects of all forms of tobacco use, followed by information about and
samples of pre-portioned single-dose tobacco packets available
throughout the United States. The investigators used exhaled carbon
monoxide levels to validate participant self-reports regarding smoke-
free status at the conclusion of the original study after 1 year [125]
and after 7 years of followup [135].
Of 63 subjects starting the study, 16 had successfully quit smoking
by switching to ST after 1 year, and 12 were still smoke-free after 7
years. At enrollment, the average cigarette consumption of the
successful participants had been 1.5 packs per day. One year later
average consumption of ST was 2.3 packages per week among the 13
successful quitters using ST (3 were tobacco-free). Four additional
participants had used ST to reduce their cigarette consumption by at
least 50 percent.
3. The Swedish tobacco experience
For the past 100 years, cigarette smoking has been the dominant
form of tobacco consumption in almost all developed countries. One
notable exception is Sweden, where smoking rates, especially among men,
have been considerably lower than those of comparable countries for
decades. (An ACSH article provides historical background on Swedish
snus [136]). Over the past 50 years Swedish men have had the lowest
rates of smoking-related cancers of the lung, larynx, mouth and bladder
in Europe [137], and the lowest percentage of male deaths related to
smoking of all developed countries [138, 139].
A 2004 study revealed that if men in the (15-country) EU had the
smoking prevalence of Sweden, almost 200,000 deaths attributable to
smoking would be avoided each year [140]. In contrast, women in Sweden
smoke at rates much more similar to women in other European countries,
and this is reflected in similar rates of smoking-related illnesses.
The 2004 study found that only 1,100 deaths would be avoided in the EU
at Swedish women's smoking rates.
As Fagerstrom pointed out in a recent study, per capita consumption
of nicotine from tobacco in Sweden is quite high and on par with other
countries such as Denmark, the United States and Austria [141]. The
difference between Sweden and the other countries is how nicotine is
consumed. In Denmark, the United States and Austria, almost all
nicotine consumption is derived from tobacco combustion. In contrast,
ST use, in the form of snus, accounts for almost 50 percent of all
contemporary nicotine consumption in Sweden. Snus use in Sweden is much
more common among men than among women; over 60 percent of nicotine
consumption among Swedish men is from snus. This is not a new
phenomenon; for over a century, Swedish men have had among the world's
highest per capita consumption of ST [142].
Beginning in 2002, an American-Swedish research group used a World
Health Organization database to describe in detail the impact of snus
use on smoking among the population in northern Sweden during the
period 1986-2004 [46, 143, 144].
Among men, the prevalence of all tobacco use was stable during the
study period, at about 40 percent. However, there were striking, and
opposite, changes in prevalence of smoking and snus use. Smoking
prevalence was 19 percent in 1986, and it was lower in all subsequent
surveys, reaching 9 percent in 2004. The prevalence of exclusive snus
use increased from 18 percent in 1986 to 27 percent by 2004. Snus use
was the dominant factor in the higher prevalence of ex-smoking among
men compared to women (prevalence ratio 6.18, 95 percent CI 4.96-7.70).
Among women, the prevalence of all tobacco use also was steady at
27 to 28 percent, and women smoked at higher rates than men in all
surveys. But these studies showed that snus use was associated with
lower smoking rates among women in 1999 and 2004. Smoking prevalence
was about 25 to 27 percent in 1986, 1990 and 1994, but declined to 21
percent in 1999, and 16 percent in 2004. The prevalence of snus use was
0.5 percent in 1986 and increased to 1.9 percent in 1990, 2.0 percent
in 1994, 5.1 percent in 1999 and 8.9 percent in 2004.
In these reports snus use was not associated with smoking
initiation, as the prevalence of smoking among former snus users was
low in all survey years (3-4 percent). The evidence showed that among
adult men in northern Sweden the dominant transition is from smoking to
snus, not vice versa.
In 2003 Foulds et al. reviewed the evidence relating to the effects
of snus use on smoking and concluded, ``Snus availability in Sweden
appears to have contributed to the unusually low rates of smoking among
Swedish men by helping them transfer to a notably less harmful form of
nicotine dependence.'' The investigators noted that ``in Sweden we have
a concrete example in which availability of a less harmful tobacco
product has probably worked to produce a net improvement in health in
that country'' [145].
In 2005 Furberg, et al. examined tobacco use data from the Swedish
Twin Registry, finding that regular snus use was associated with
smoking cessation, not initiation, among almost 15,000 male
participants. Both regular and occasional snus use were protective
against having ever smoked [146].
In 2006 Ramstrom and Foulds examined data from a 2001-02 nationally
representative Swedish social survey. They found that snus use among
men was significantly protective against smoking initiation (OR = 0.3,
CI 0.2-0.4). They also found that snus was the most commonly used
cessation aid among men (used by 24 percent of men on their most recent
quit attempt). Men who used snus as a quit-smoking aid were more likely
to quit successfully than those using nicotine gum (OR = 2.2, CI = 1.3-
3.7) or the patch (OR = 4.2, CI = 2.1-8.6), which was also true for
women [147].
v. policy issues
A. ST use: gateway to smoking cessation, not smoking initiation
Data from research studies in Sweden and the United States do not
support the allegation that widespread use of ST serves as a gateway to
smoking, especially among youth. A 2003 policy statement published in
Tobacco Control, coauthored by Clive Bates, former director of Action
on Smoking and Health (U.K.) and five other eminent tobacco research
and policy experts, dismissed the notion that ST use led to smoking in
Sweden: ``To the extent there is a `gateway' it appears not to lead to
smoking, but away from it and is an important reason why Sweden has the
lowest rates of tobacco-related disease in Europe'' [148]. Foulds
reached a similar conclusion: ``This review suggests . . . that in
Sweden snus has served as a pathway from smoking, rather than a gateway
to smoking among Swedish men'' [145].
A 2005 study examined tobacco use among 15- to 16-year-old
schoolchildren over a 15-year period, from 1989 to 2003 [149]. The
investigators found that the prevalence of regular snus use among
Swedish boys increased from about 10 percent to 13 percent from 1989 to
2003, but the prevalence of regular smoking was very low and declined,
from about 10 percent to under 4 percent. The prevalence of snus use
among girls was very low, and the prevalence of smoking was about
double that of boys over the entire period. The authors concluded that
snus use did not appear to be a gateway to smoking among Swedish youth
but instead was associated with low-smoking prevalence among boys.
In the United States investigators have not found credible evidence
that ST use is a gateway to smoking among American youth. In 2003
Kozlowski et al. analyzed data from the 1987 INHIS survey and concluded
that there was little evidence that ST use was a gateway to smoking,
because the majority of ST users had never smoked or had smoked
cigarettes prior to using ST [133]. The investigators noted that their
results coincided with earlier work from Sweden and with a tobacco
industry-sponsored survey from 1984 [150].
In 2003 O'Connor et al. examined data from the 2000 National
Household Survey on Drug Abuse [151]. They described the impact of ST
use on subsequent cigarette smoking initiation as ``minimal at best.''
O'Connor et al. also examined data from the CDC's Teenage Attitudes and
Practices Survey for evidence that ST use served as a gateway to
smoking among youth [152]. They concluded that ST use was not
associated with smoking initiation after appropriate control for
confounding by well-recognized psychosocial predictors of smoking. This
is in contrast to an earlier report that did not control for
confounding and found a positive association [153].
Claims of a gateway effect persist, even with lack of credible
evidence, prompting O'Connor et al. to note in 2005, ``Continued
evasion of the [harm reduction] issue based on claims that ST can cause
smoking seems, to us, to be an unethical violation of the human right
to honest, health-relevant information'' [154]. That quote introduces
the next topic, information and misinformation about ST and tobacco-
harm reduction.
B. Information and misinformation about ST and tobacco-harm reduction
Kozlowski et al. have argued persuasively that smokers have a
fundamental right to accurate information about safer forms of tobacco
use [155-157]. The research group established the underlying rationale
for the provision of this information, citing principles of the
Universal Declaration of Human Rights, the doctrine of informed
consent, and business ethics contract theory, under which companies
have a moral obligation to inform customers about important information
regarding their products.
In 2001 the U.S. Supreme Court may have provided a legal basis for
holding tobacco manufacturers responsible for providing truthful
information about the differential risks of ST use and smoking. Writing
the majority opinion in Lorillard v. Reilly, in which a 5-4 majority of
the Court ruled that broad advertising restrictions by the Commonwealth
of Massachusetts violated the commercial free-speech rights of tobacco
manufacturers, Justice Sandra Day O'Connor wrote that,
``The State's interest in preventing underage tobacco use is
substantial, and even compelling, but it is no less true that
the sale and use of tobacco products by adults is a legal
activity. We must consider that tobacco retailers and
manufacturers have an interest in conveying truthful
information about their products to adults, and adults have a
corresponding interest in receiving truthful information about
tobacco products'' [158].
1. Fundamental right to information
Over the past 20 years, many public health and tobacco policy
experts have argued that smokers have a fundamental right to accurate
information about less hazardous products so that they can make
informed choices if they are unable or unwilling to quit tobacco
altogether. In 1984 Kozlowski commented on both the challenges and the
potential of tobacco-harm reduction, writing that ``the use of less-
hazardous tobacco, if prohibitionist impulses can be put aside, may
have an important role in the treatment of the smoking and health
problem . . .'' [9].
In 1994 Rodu proposed that a ``public health policy that recognizes
ST as an alternative to smoking would benefit individuals confronted
with the unsatisfactory options of abstinence or continuing to smoke''
[10]. In a 1995 book, Rodu told smokers that ``ST products allow you,
the hard-core and long-term smoker, to take back a measure of control
over your health by indulging in a far safer form of tobacco use''
[13].
One concern about tobacco-harm reduction is that dissemination of
information about less hazardous tobacco products might adversely
affect public health if it creates new users. However, the risk/use
equilibrium addresses this issue [159]. If ST use is 50 to 100 times
less hazardous than smoking, it would require 50 to 100 more ST users
to reach the level of public harm produced by smoking. In other words,
it would take 2.3 to 4.5 billion ST users to have the same death toll
as 45 million American smokers do today, an impossible scenario in the
U.S. population of 290 million people.
Kozlowski's message in 2002 was clear:
``Cigarettes kill about half of those who smoke them . . . It
is urgent to inform smokers about options they have to reduce
risk . . . public health policy in this instance lacks
compelling justification to override the human rights of the
individual. Individuals have the right to such relevant
information [on tobacco risks]'' [155].
That same year, the prestigious Royal College of Physicians of
London made its hopeful statement that ``some manufacturers may want to
market ST as a `harm reduction' option for nicotine users, and they may
find support for that in the public health community'' [128].
Since then a growing number of experts have weighed in on the case
for providing smokers relevant risk information and safer tobacco
options. In 2002 Cummings argued for a market approach involving risk
information:
``Until smokers are given enough information to allow them to
choose products because of lower health risks, then the status
quo will remain. Capitalism, and not government regulation, has
the greatest potential to alter the world-wide epidemic of
tobacco-related disease'' [160].
In 2003 Kozlowski et al. expanded on the rationale that smokers are
entitled to information about safer products, addressing concerns that
provision of risk information might adversely affect public health:
``Public health concerns should trump individual rights only when there
is clear and convincing evidence of harm to society. Lacking that
evidence, individual rights should prevail'' [161].
2. Misinformation from governmental and other organizations
Americans are badly misinformed about the risks of ST use,
especially in comparison with smoking. In 2005 a survey of 2,028 adult
U.S. smokers found that only 10.7 percent correctly believed that ST
products are less hazardous than cigarettes [154]. In another survey,
82 percent of U.S. smokers incorrectly believed that chewing tobacco is
just as likely to cause cancer as smoking cigarettes [162].
A 1999-2000 survey of 36,012 young adults entering the U.S. Air
Force found that 75 percent of males and 81 percent of females
incorrectly believed that switching from cigarettes to ST would not
result in any risk reduction, while another 16 percent of males and 13
percent of females incorrectly believed that only a small risk
reduction would occur. Only 2 percent of males and 1 percent of females
correctly understood that a large risk reduction would occur by
switching from cigarettes to ST [163]. That survey also found that the
overwhelming majority of subjects believed that switching from regular
to low-tar cigarettes conferred greater reduction in risks than
switching from cigarettes to ST.
It is not clear how Americans have become so confused about tobacco
risks. But it is clear that misinformation about ST products is
available in copious quantities from ostensibly reputable sources,
including governmental health agencies and health-oriented
organizations. Phillips et al. have made some of the most pointed
comments about this phenomenon:
``Certain health advocates believe it is acceptable to
mislead people into making choices they would not otherwise
make . . . Through the use of various tactics, advocates who
oppose the use of ST as a harm reduction tool have managed to
convince most people that the health risk from ST is several
orders of magnitude greater than it really is. The primary
tactic they use is making false or misleading scientific claims
that suggest that all tobacco use is the same. . . . Apparently
motivated by their hatred of all things tobacco, they are
trying to convince people to not switch from an extremely
unhealthy behavior to an alternative behavior that eliminates
almost all of their risk'' [164].
The tactic has worked in the United States, as Americans, almost
without exception and regardless of general and health education
levels, believe that the risks from ST are similar to those from
smoking. In particular, Americans incorrectly believe that switching
from smoking to ST use will create a large increased risk for oral
cancer. Phillips has characterized this popular misinformation as the
``you might as well smoke'' message, since it tells people that if they
are using ST, they could switch to smoking with no increase in risk,
while smokers considering switching to ST should not bother [165].
Phillips et al. systematically reviewed content about ST use on the
Web in 2003 and found that the risks of ST use are almost always
conflated with those of smoking [165]. Roughly one-third of the time,
there are explicit claims that ST is as bad as or worse than smoking.
Most of the rest of the time the information is arranged to imply
similar risks, though there is no such explicit statement. There are
also a variety of specific claims that are not supported by the
literature.
Government agencies, other organizations and members of the public
health community have a moral obligation not to misinform smokers about
products that have fewer risks than cigarettes. Nevertheless,
researchers have exposed numerous cases of misinformation from
governmental sources. For example, in 2003 Kozlowski and O'Connor
criticized Web sites of the CDC and the Substance Abuse and Mental
Health Services Administration for erroneously reporting that ST
products were not safer than cigarettes, pointing out that ``the
misleading health information on ST fails to meet the government
criteria against deception in research'' [156].
At a 2003 U.S. House subcommittee hearing, U.S. Surgeon General
Richard Carmona testified:
``I cannot conclude that the use of any tobacco product is a
safer alternative to smoking . . . There is no significant
evidence that suggests ST is a safer alternative to
cigarettes'' [166]. Scott Leischow, Chief of the Tobacco
Control Research Branch at the NCI, presented similar testimony
at a concurrent hearing [167]. Carmona's statement prompted
Rodu, who also presented testimony at that hearing [168], to
comment that the Surgeon General was ``sadly ill-informed about
the Nation's No. 1 health problem, cigarette smoking.'' Rodu
strongly criticized Carmona, writing that he should be
compelled to ``tell American smokers the truth about all
available options for quitting. After all, the 10 million
smokers who will die over the next two decades are, in a very
tangible way, his responsibility and his legacy'' [169].
In March 2004, Ken Boehm of the National Legal & Policy Center
(NLPC), a non-profit organization committed to promoting open,
accountable and ethical practices in government, filed a request under
the Data Quality Act (DQA) for correction of a document from the
National Institute of Aging (NIA) that contained misinformation
regarding the relative risks of ST versus cigarettes. (The other DQA
requests on ST can be seen at the U.S. Department of Health and Human
Services Web site [170]) The request resulted in a change of wording
from the original text: ``Some people think ST (chewing tobacco and
snuff), pipes, and cigars are safer than cigarettes. They are not.''
The revised wording from NIA was: ``Some people think ST (chewing
tobacco and snuff), pipes, and cigars are safe. They are not.''
The claim that ST products are not ``safe'' is a tactic that can be
traced back to the 1986 Comprehensive Smokeless Tobacco Education Act,
which required as one of three warnings on all ST products: ``This
product is not a safe alternative to cigarettes.''
In 1995 Rodu criticized this warning as ludicrous and suggested
that other consumer products like automobiles, lawnmowers, aspirin and
red meat don't meet absolute criteria for safety [13]. A decade later,
Kozlowski and Edwards criticized this type of uninformative warning in
a study entitled, `` `Not safe' is not enough: smokers have a right to
know more than there is no safe tobacco product'' [157]. These authors
believe that smokers deserve more information:
``The `not safe' or `not harmless' messages don't address the
reality that some tobacco products are substantially safer than
others . . . Saying tobacco `isn't safe' isn't incorrect, but
it isn't saying enough. Going beyond the no safe tobacco
message to provide better information on the nature of risks
from tobacco products and nicotine delivery systems is
necessary to respect individual rights to health relevant
information.''
Ken Boehm from NLPC summarized the arguments against
misinformation:
``This is the kind of evidence Americans should be able to
review and make their own decisions. Despite the best efforts
of the largest government bureaucracy in the history of the
Republic, Americans still prefer to do their own thinking. And
as we do our own thinking on the merits of reduced-risk
products such as ST, none of us needs misinformation supplied
by our own government'' [171].
With regard to a policy as ``credible, logical and eminently do-
able'' as tobacco-harm reduction [172], it is unfortunate that
arguments against deception are actually necessary.
vi. conclusion and recommendations
The past 40 years have brought ever more assertive public health
campaigns against cigarette smoking. A coalition of well-funded public
and private agencies has as its goal a reduction in the prevalence of
cigarette smoking. The coalition's influence has resulted in pervasive
health warnings, ever more intensive quit-smoking programs, and
recently the social ostracism of smokers and the industry that supplies
them. Yet 45 million Americans continue to smoke, and far too many die
from smoking-related diseases.
The American Council on Science and Health has been part of this
anti-smoking coalition for several decades. Throughout its history ACSH
has published many articles about the health risks of smoking. And it
has held the tobacco industry accountable for its part of the
devastating toll from tobacco. ACSH founder Elizabeth Whelan published
a landmark anti-smoking book, A Smoking Gun?: How the Tobacco Industry
Gets Away with Murder [173].
ACSH was founded in 1978 by a group of scientists who had become
concerned that many important public policies related to health and the
environment did not have a sound scientific basis. These scientists
created the organization to add reason and balance to debates about
public health issues and bring commonsense views to the public.
The mission of the ACSH is to promote sound science in regulation,
in public policy, and in the courtroom and to assist consumers, via the
media, in distinguishing real health threats from purely hypothetical
ones. ACSH believes that strong support of tobacco-harm reduction is
fully consistent with this mission; as this report documents, there is
a strong scientific and medical foundation for tobacco-harm reduction,
and it shows great potential as a public health strategy to help
millions of smokers.
Tobacco-harm reduction empowers smokers to gain control over the
consequences of their nicotine addiction. At its simplest it is
nonintrusive and solely educational, and therefore has a strong moral
rationale. The strategy is cost-effective and accessible today to
almost all smokers. But its implementation will require rethinking of
conventional tobacco control policies and their premises.
The ACSH believes that the following actions will benefit smokers:
1. Agencies of the Federal Government (most notably the Office of
the Surgeon General) and health promotion organizations (such as the
American Cancer Society and the Mayo Clinic) should discontinue the
campaign of misinformation that irresponsibly misrepresents the
scientific information about and use of ST products. They endanger
their reputations as sources of trusted health information by providing
messages about ST products that are neither accurate nor credible. The
campaign of misinformation should be replaced with an educational
program that emphasizes the differential risks of all forms of tobacco
use.
2. Regulatory restrictions on the manufacture and sale of nicotine
replacement medications should be revised. Nicotine is addictive, but
it plays little or no role in the development of most smoking-related
diseases. Manufacturers of nicotine replacement medications should be
permitted to sell higher doses of the drug within flavor/delivery
systems that are satisfying and enjoyable for smokers at costs that are
competitive with cigarettes. In addition, smokers should be informed
that permanent use of NRT is vastly safer than continuing to smoke.
This could be accomplished by new labels on NRT packaging and
additional labels on cigarette packs: ``Notice: Nicotine does not cause
cancer, heart diseases or emphysema.''
3. Manufacturers of tobacco products should follow the lead of
British American Tobacco (BAT) and acknowledge that ST use is vastly
safer than smoking. BAT has openly admitted that oral ST products are
safer than cigarettes, and this company is actively engaged in test-
marketing Swedish snus in Sweden, Norway and South Africa [174]. At the
press date of this report, cigarette manufacturers in the United States
have introduced ST products in limited test markets, but they have made
no statements regarding differential health risks. This is
unacceptable, given the state of the science documented in this report.
4. Any Federal legislation that addresses the regulation of tobacco
should include provisions that adequately reflect the differences in
risks between combustible tobacco products and ST products or NRT. This
includes careful review of current proposals before Congress to ensure
that the legislation is written to regulate the labeling and marketing
of products based on their risks. The goal should be to give users of
tobacco the necessary information they need to understand the
differences between various tobacco and nicotine products so they can
make the appropriate health choices and decisions.
5. Pending enactment of more comprehensive regulation, the U.S.
Congress should repeal the federally-mandated warning that now appears
on ST products: ``This product is not a safe alternative to
cigarettes.'' This warning not only misleads smokers; it may send a
message to ST users that they might as well smoke. The warning should
be replaced with the following, which would appear as an onsert with
cigarette packages--``Warning: Smokeless tobacco use has risks, but
cigarette smoking is far more dangerous. Quitting tobacco entirely is
ideal, but switching from cigarettes to ST can reduce greatly the
health risks to smokers and those around them.'' Placement of this
warning with cigarettes ensures that it reaches the target audience,
continuing smokers.
6. State legislatures should follow the lead of Kentucky and
establish rational risk-based tax policies for tobacco products. In
2005 the Commonwealth of Kentucky enacted an excise tax structure for
cigarettes and ST products that was based on differential risks. The
final bill stated:
``The General Assembly recognizes that increasing taxes on
tobacco products should reduce consumption, and therefore
result in healthier lifestyles for Kentuckians. The relative
taxes on tobacco products proposed in this section reflect the
growing data from scientific studies suggesting that although
smokeless tobacco poses some risks, those health risks are
significantly less than the risks posed by other forms of
tobacco products. Moreover, the General Assembly acknowledges
that some in the public health community recognize that
tobacco-harm reduction should be a complementary public health
strategy regarding tobacco products. Taxing tobacco products
according to relative risk is a rational tax policy and may
well serve the public health goal of reducing smoking-related
mortality and morbidity and lowering healthcare costs
associated with tobacco-related disease.''
Abbreviations: ACS--American Cancer Society; ACSH--American Council
on Science and Health; BAT--British American Tobacco; CDC--Centers for
Disease Control and Prevention; DQA--Data Quality Act; EU--European
Union; FDA--Food and Drug Administration NCI--National Cancer
Institute; NHIS--National Health Interview Survey NIA--National
Institute on Aging NIH--National Institutes of Health NLPC--National
Legal Policy Center NRT--Nicotine replacement therapy RR--Relative
risk; ST--Smokeless tobacco; TSNA--Tobacco specific nitrosamine U.K.--
United Kingdom; U.S.--United States.
Competing interests
Dr. Rodu is supported by unrestricted grants from the US Smokeless
Tobacco Company and Swedish Match AB to the University of Louisville.
The sponsors are unaware of this work, and thus had no scientific input
or other influence with respect to its design, analysis, interpretation
or preparation of the manuscript. Dr. Rodu has no other financial or
other personal conflict of interest with respect to tobacco use or
cessation.
Mr. Godshall declares that he has no competing interests.
Authors' contributions
Both authors participated in the literature review and drafting of
the manuscript.
Acknowledgements
This manuscript is a position statement of the American Council on
Science and Health. The authors gratefully acknowledge the assistance
of the following ACSH staff who provided critical reviews of content
and perspective, especially with regard to the policy sections of the
report.
Elizabeth M. Whelan, ScD, MPH President and Founder; Gilbert Ross,
MD, Medical/Executive Director.
The authors gratefully acknowledge the following individuals, who
provided peer reviews, critical analysis, commentary and suggestions
during the development of this review, and whose names have been listed
with their permission:
Scott D. Bailin, JD, Tobacco and Health Policy Consultant
Washington DC; Clive Bates, Former Director (1997-2003), Action on
Smoking and Health, UK London, United Kingdom; Ronald W. Brecher,
Ph.D., DABT, C Chem, Principal, Globaltox: Toxicology Focused Solutions
Guelph, ON, Canada; Emil William Chynn, MD, FACS, MBA Medical Director,
IWANT2020.com, Inc. New York, NY; Michael Dubick, Ph.D., Senior
Research Pharmacologist, U.S. Army Institute of Surgical Research San
Antonio, TX; Dwight B. Heath, Ph.D., Department of Anthropology Brown
University, Providence, RI; Rudolph J. Jaeger, Ph.D., DABT, REA
(California) Consulting Toxicologist, Environmental Medicine Inc.,
Westwood, NJ; Michael Kunze, Dr Med, Professor, Institute of Social
Medicine, Center for Public Health, Medical University of Vienna,
Vienna,, Austria; Carl V. Phillips, Ph.D., Associate Professor,
University of Alberta School of Public Health, Director, Alberta
Smokeless Tobacco Education and Research Group Edmonton, AB, Canada;
Lars M. Ramstrom, Ph.D., Director, Institute for Tobacco Studies
Stockholm, Sweden; William O. Robertson, MD, Medical Director,
Washington Poison Center, Emeritus Professor of Pediatrics, University
of Washington School of Medicine Seattle, WA; David Schottenfeld, MD,
John G. Searle Professor Emeritus of Epidemiology, Professor Emeritus
of Internal Medicine, School of Public Health, University of Michigan,
Ann Arbor, MI; Peter G. Shields, MD, Professor of Medicine and
Oncology, Director, Cancer Genetics and Epidemiology, Lombardi
Comprehensive Cancer Center, Georgetown University Medical Center
Washington, DC; Robert B. Sklaroff, MD, Elkins Park, PA; Jacob Sullum,
Senior Editor, Reason, Dallas, TX; David T. Sweanor, BA (Hon), LLB,
Adjunct Professor of Law and Medicine, University of Ottawa, Ottawa,
ON, Canada; John W. Waterbor, MD, DrPH, Associate Professor of
Epidemiology, School of Public Health, University of Alabama at
Birmingham, Birmingham, AL.
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Release. June 28, 2006.
Prepared Statement of Anne Landman, Tobacco Document Research and
Consulting, Glade Park, CO
I have been a tobacco document researcher since 1998. After almost
a decade of reading tobacco industry documents, I have become acutely
aware of the industry's strategies and tactics for undermining public
health. Documents show that Philip Morris is at least 10 years ahead of
the rest of society in anticipating future scenarios to regulate
cigarettes, advertising, etc. For example, they had the basic tenets of
the 1998 Master Settlement Agreement (MSA) drawn up in 1991, in
anticipation that Congress would try to pass a total ban on cigarette
advertising.
It is my belief that legislation to regulate tobacco products
should be thoroughly vetted by highly experienced tobacco control
advocates and public health-sided tobacco industry strategists and that
all loopholes in the existing proposed legislation bill be completely
eliminated. Regulation of tobacco products, should, in fact ideally be
drafted with, or by, experienced public health authorities with the
sole purpose of protecting public health. Tobacco companies should be
permitted input, but they should not be permitted to be the driving
force behind such legislation. Documents show that Philip Morris has
maintained an internal program since 1999 specifically to drive the
enactment of FDA regulations in its favor. Reading the existing
legislation, and knowing of PM's internally devised 5 core principles
(the company's requirements of what it requires in FDA regulations) I
fear Philip Morris has had a hand in drafting, and is currently
driving, the passage of the existing proposed measure.
Realizing that the eventual regulation of cigarettes was
inevitable, in 1999 PM started an internal project to enact Food and
Drug Administration (FDA) regulations on its own terms. The plan was
called the Regulatory Strategy Project. The goal was to enact FDA
regulations according to 5 core principles that would assure the
company retained a measure of control over advertising and marketing,
and assure a future market for cigarettes. The core principles, if
achieved, would have the effect of safeguarding the company's ability
to market cigarettes with a minimum of restrictions, transfer
responsibility for fully informing the public about the dangers of
tobacco use onto the FDA and take it off the manufacturers, and
transfer legal liability for the safety of tobacco products onto the
FDA, while allowing cigarette companies the ability to continue to
design and market cigarettes as they see fit.
A 2001 PM strategy memo shows that pursuit of FDA regulations would
help complicate tobacco issues for the public. This constitutes a
positive for PM, since it would blur the ``black and white'' divisions
between public health and tobacco companies). Pursuit of FDA
regulations would provide a positive public relations benefit for PM.
The memo states,
``Unfortunately for the industry, the tobacco debate in
recent years suffered from oversimplification, perpetuated by
media coverage that depicts tobacco-
related issues as `black and white,' with tobacco companies
playing the predictable role as evil corporate giant . . .''
It continues,
``The debate over FDA reform has the potential to complicate
this portrayal in a manner that will specifically benefit
Philip Morris. The simple fact that other tobacco companies
will likely come out on the opposite side of the issue--against
FDA regulation--provides Philip Morris a chance to distinguish
itself from its competitors as a good corporate citizen.
Positioned appropriately, the campaign can actually serve two
purposes: achieving Philip Morris's goal of instituting
regulation of the tobacco industry while also realizing
significant public affairs benefits.''
(Campaign to Achieve FDA Regulation of Tobacco, Philip Morris memo from
22 March 2001, Bates No. 2085235845/5847.)
specific comments on the proposed legislation
The proposed legislation spends more time listing what FDA cannot
do to regulate tobacco than what it can do. It effectively ties FDA's
hands in responding to current research, science and health threats
posed by tobacco. For example, section 906 of the current legislation
``cements'' the age of sale of tobacco at 18 years. This is despite the
understanding that raising the age of purchase of tobacco products to
19 would make significant inroads in getting cigarettes out of high
schools. However, under the current bill, such a change would be
prohibited nationwide. A measure like this, that limits peoples'
ability to enact stricter legislation, is called Preemption. Philip
Morris has long had an internal program (called its ``Accomodation/
Preemption Program'') to pass preemptive laws benefiting the company in
all 50 States. PM's preemptive programs in my opinion have set back the
progress of public health smoking laws by at least a decade. Preemption
of local ordinances by state-level legislation has long been considered
a ``deal breaker'' by health advocates when clean indoor air
legislation have been introduced. To explicitly avoid preemption,
Congress should pass a bill that sets minimum standards for the FDA,
but that does not preempt the FDA's ability to do more.
The proposed legislation also takes a strong product/ingredient-
focused approach to regulating tobacco. In fact, the tobacco control
community has moved beyond this approach. The tobacco companies
themselves have spent 40-50 years on research and development of their
products without releasing information about their research or
activities for public scrutiny. Current tobacco control theory focuses
less on the product and much more on eliminating the harm done to
nonsmokers from secondhand smoke and denormalizing use of the product.
This approach is not mentioned anywhere in the bill, and should be a
central focus of any FDA effort to regulate tobacco.
The proposed legislation also fails to address or preclude the
likely occurrence that tobacco companies will start including language
on their labels and in advertisements to the effect of ``This product
manufactured in accordance with FDA standards.'' Such messages would
have the effect of seriously misleading the public into believing that
cigarettes have been somehow made safer or less harmful, or that the
Government sanctions their use.
Since the beginning of its existence, the FDA has been charged with
assuring that products under its scrutiny are safe. This bill would
represent the first time the agency would be charged with managing a
product that is inherently unsafe. The appropriateness of this should
be seriously questioned, to the extent that Congress should consider
whether some different and separate agency should be established to
manage the Government's efforts to regulate cigarettes. FDA's
management of a deadly product could seriously erode and undermine the
public's remaining confidence in the agency.
I am also concerned that the current bill will have the effect of
transferring liability for the manufacture of a deadly product onto the
Government, and take liability off the tobacco companies. There is no
provision in the bill that specifically protects the Government from
charges of complicity in the manufacture and distribution of a known
harmful product.
The proposed legislation in many places conflates the pursuit of
public health with avoiding disruption of the tobacco trade, as in an
excerpt from p. 60 that says,
``Such date . . . [of establishing a tobacco product
standard] shall be established so as to minimize, consistent
with the public health, economic loss to, and disruption or
dislocation of, domestic and international trade.''
You simply cannot have it both ways. The fact is that a healthy
tobacco trade is antithetical to public health, within and outside the
United States. This clause is another indication that the bill was
drafted with the tobacco industry's needs in mind, rather than the
public's best interests.
The bill assumes that tobacco use is primarily a problem of youth,
and thus relies heavily on a youth-focused approach to advancing the
public health. The youth-focused view has largely lost favor with
serious tobacco control advocates, since tobacco document research
revealed that a youth-focused approach to tobacco control plays
directly into the hands of tobacco companies. The companies have used
the over-emphasis on youth smoking to deflect the attention of
legislators and rulemakers away from the fact that smoking is a
society-wide problem, not simply a youth problem. Congress should not
lose focus on the fact that the issue is not one simply of youth
smoking (the preferred focus of the tobacco industry); it is the
ongoing promotion and sale of a deadly product.
Congress need also be aware of some very problematic loopholes in
the bill as it is written. In one clause from sec. 908, the bill
states:
(c) Recall Authority.--(1) In General.--If the Secretary
finds that there is a reasonable probability that a tobacco
product contains a manufacturing or other defect not ordinarily
contained in tobacco products on the market that would cause
serious, adverse health consequences or death, the Secretary
shall issue an order requiring the appropriate person
(including the manufacturers, importers, distributors, or
retailers of the tobacco product) to immediately cease
distribution of such tobacco product.
My interpretation is that this clause has the effect of sanctioning
the already-
existing defects in tobacco products that cause illness and death. If a
tobacco product is determined to have a WORSE manufacturing defect that
makes it even MORE deadly, THEN the onus would be on FDA to issue a
cease and desist order for sales of the product. But if the product is
just at its normally deadly level, FDA's hands are tied--no cease and
desist order, no recalls. This simply is bad policy.
There are no provisions in the current bill that address ongoing
problems of contamination that are inherent in the manufacture of
cigarettes, specifically the contamination of cigarettes with bugs and
bug larvae, bits of rubber and lubricating oils from conveyor belts in
manufacturing facilities, pieces of foam from tobacco drying barns,
blood, bits of metal, and other contaminants like ink from printing on
cigarette paper and the off-gassing of plastics used in packaging that
are revealed as ongoing problems in tobacco industry quality control
documents.
FDA should be given full and unfettered authority to act on any and
all current science and research regarding tobacco, and to take
whatever actions are necessary to reduce the problem of society
smoking. FDA should have complete authority to regulate all areas of
nicotine administration, as well as other constituents and ingredients,
and that authority should be made completely explicit.
Taken as a whole, Philip Morris internal documents indicate that
PM's goals in pushing for FDA regulation are:
(1) To assure a future market for cigarettes,
(2) To preserve the company's ability to make cigarettes that
appeal to their market,
(3) To safeguard the company's ability to market cigarettes without
restrictions,
(4) To prevent FDA from obtaining any real authority to restrict
the marketing and promotion of cigarettes,
(5) To give FDA the responsibility of fully informing the public
about the dangers of tobacco use, and take this responsibility off of
the manufacturers,
(6) To transfer legal liability for the safety of tobacco products
onto the FDA, while allowing cigarette companies to continue to design
and market cigarettes as they see fit.
It seems to me that the current bill allows the tobacco industry to
achieve all this.
I urge Congress to carefully go through the bill and re-craft so
that it allows public health authorities to make real progress against
tobacco use in this country. Do not lose this chance to do what is best
for society for a change, instead of what is best for Philip Morris.
Prepared Statement of John R. Polito, Esq., Editor, WhyQuit, Mount
Pleasant, SC
Dear Chairman Kennedy, WhyQuit is the Internet's oldest and largest
quit smoking forum devoted exclusively to abrupt nicotine cessation,
the quitting method employed by 80 percent to 90 percent of all long-
term successful ex-smokers. As an all volunteer forum we dream of the
day when the need for our free education, counseling and support
services is at end and the team can turn their energies and passions to
new causes. But, sadly, the bill before you would better be titled
``The Nicotine Addiction Industry Protection Act.''
It seeks to grant the Food and Drug Administration (FDA) limited
authority to regulate cigarettes and tobacco. At first blush the idea
sounds great. In fact, an initial reading of the full bill will likely
reinforce that opinion. But don't we want America's 9,000 FDA food and
medicine watchdogs ringing alarms when any product is found responsible
for even a single death? How can we not pollute their mission and minds
by commanding them to accept regulatory oversight and thus some degree
of responsibility for hundreds of thousands of smoking-related deaths
annually?
The FDA's full mission statement reads as follows:
``The FDA is responsible for protecting the public health by
assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our
Nation's food supply, cosmetics, and products that emit
radiation. The FDA is also responsible for advancing the public
health by helping to speed innovations that make medicines and
foods more effective, safer, and more affordable; and helping
the public get the accurate, science-based information they
need to use medicines and foods to improve their health.''
Key Congressional ``findings'' from the bill assert that ``tobacco
products are inherently dangerous and cause cancer, heart disease, and
other serious adverse health effects,'' ``nicotine is an addictive
drug,'' ``virtually all new users of tobacco products are under the
minimum legal age to purchase such products,'' and ``tobacco use is the
foremost preventable cause of premature death in America. It causes
over 400,000 deaths in the United States each year and approximately
8,600,000 Americans have chronic illnesses related to smoking.''
Clearly, America's leading cause of preventable death isn't a
medicine or food but by the bill's own findings an inherently dangerous
and highly addictive killer. Isn't it obvious that the Federal Trade
Commission (FTC), pursuant to the Federal Cigarette Labeling and
Advertising Act of 1966 (15 U.S.C. Sec. Sec. 1331-1340, as amended) is
the proper Federal agency for addressing what are primarily tobacco
advertising, marketing and sales oversight responsibilities.
But instead, the bills language, which clearly had strong input
from Philip Morris USA, is loaded with provisions that tie the FDA's
hands. It prohibits the FDA from removing all nicotine from cigarettes,
from banning their sale, from requiring that tobacco be removed from
neighborhood convenience stores (what to youth is the neighborhood
candy, chip, ice cream and soda store), and from raising the age of
purchase above age 18.
Philip Morris USA's Web site notes the February 15, 2007
introduction of the bill and states, ``PM USA strongly supports this
bipartisan legislation and urges Congress to take quick action'' on the
bills. Philip Morris asserts that the bill will bring
``predictability'' to the tobacco industry in the United States.
Predictability?
This bill is a tobacco industry dream come true--an official
government birth certificate that guarantees the right to sell a
chemical that the Surgeon General claims is at least as addictive as
heroin to 18-year-old high school students across the Nation, 18-year-
olds who want to be liked. Try to find any convenience store without a
buy 1 get 1 free or buy 1 get 2 free deal. They make captivating gifts
that all but guarantee that underage recipients will become new friends
who'll soon return begging for more.
Although the bill is well intended, it plays smack dab into the
tobacco industry's hand. The industry always seems two moves ahead of
health policymakers but considering that its economic survival is at
stake it must stay ahead. When the 1998 Master Settlement Agreement
with the States ended tobacco product advertising in high youth
readership magazines they simply shifted those dollars into
neighborhood convenience stores--into what is now ``nicotine addiction
central.''
We beg committee members to think like a tobacco company. Imagine
watching horror as smoke-free workplace laws sweep the Nation and
nearly all States raise cigarette taxes in an attempt to price nicotine
products beyond the disposable income of most youth. But what's now
just starting to sweep the tobacco control community is a realization
that cigarettes, by far the dirtiest drug delivery device ever devised,
are no longer needed.
In November 2003 GlaxoSmithKline consultants reported that nearly
37 percent of all nicotine gum users were engaged in chronic long-term
use of at least 6 months. We have no reason to believe that nicotine
lozenges, releasing 25 percent more nicotine than gum, won't be just as
high. Although nicotine replacement therapy products have shown 1.5- to
2-fold efficacy over placebo in randomized clinical trials, once
outside the door and going head-to-head against cold turkey they fall
flat on their face. But replacement nicotine's true value to society
isn't in cessation but as an ongoing daily dependency alternative to
cigarettes.
Which city in America would have been the first to ban the sale of
all cigarettes and have a city-wide transfer campaign to help smokers
adapt to cleaner forms of nicotine delivery? What would have happened
to youth and adult smoking rates in that community? Like smoke-free
workplace air, could such a movement quickly sweep the entire Nation?
Under this bill we'll never know.
Section 907(b)(3) of the bill, entitled ``POWER RESERVED TO
CONGRESS,'' ``expressly reserves'' to Congress the power to ban all
cigarettes. If we were thinking ahead, instead of another aspect of
Federal preemption why couldn't this reservation have expressly shared
such power with the States or their political subdivisions?
As for tasking the FDA with determining which of 4,000 cigarette
smoke constituents are the most deadly and then battling the industry
to have one or more removed, picture for a moment the marketing
representations that would be made in association with selling this
reduced risk product that's still extremely deadly. In fact, as soon as
this bill is passed all cigarette advertisements will instantly be able
to honestly proclaim that they are in full accord with all Food and
Drug Administration safety requirements. Imagine how that message will
play inside a 15-year-old's mind.
We encourage the committee to amend the bill to task all sales,
marketing and advertising provisions to the FTC while including a
strong preemption disclaimer that makes it clear that the States are
free to regulate all aspects of advertising, marketing and sales,
including the power to ban any or all forms of nicotine delivery, with
the exception of altering required tobacco product health warnings if
tobacco products are sold.
If the committee insists on going forward with this ill-advised
bill it should be amended to:
Make it clear that, as with alcohol, the States and their
political subdivisions have full authority to ban the sale of any or
all classes of nicotine delivery devices, including all forms of
nicotine replacement therapy.
Authorize the FDA to raise the smoking age to 21.
Authorize the FDA authority to limit the sale of any class
of nicotine delivery device to stores to which those who are underage
are denied access. Responsible stores need to make a choice. They
either want to market and sell what many consider earth's most
captivating chemical or cater to children but they cannot do both.
Authorize the FDA to both remove all nicotine from tobacco
products and ban the sale of any class of nicotine delivery device.
Include an express provision that any reference to FDA
regulation of tobacco during any products liability jury trial will
result in a mistrial and a statutory penalty of $100,000.
Amend the warnings to require that alternating nicotine
addiction warnings appear on one side of each cigarette pack sold, with
a health warning appearing on the other side. For example, Canada's
addiction warning reads, ``Warning Cigarettes are Highly Addictive--
Studies have shown that tobacco can be harder to quit than heroin or
cocaine.'' Canadian youth smoking rates have fallen dramatically since
the warning first appeared in 2000. Relative risk information is
critical if youth are to make informed decisions. Youth also need to
know how quickly dependency can occur, the warning signs, and the truth
about how ineffective over-the-counter quitting aids such as the
nicotine patch and gum actually are with a 93 percent 6-month smoking
relapse rate as determined by GlaxoSmithKline consultants. Otherwise we
provide them a false belief that quitting is easy when in fact 50
percent of adult U.S. smokers are losing 13 to 14 years of life. As for
giving dependency warnings equal weight with health warning, it is
nearly impossible to experience most health risks unless the user first
becomes dependent, the greatest risk of all.
Provide clearer language that the Secretary is not only free to
amend existing warnings but to create new warnings.
If this were any other consumer product the FDA would instantly
battle to have it removed from the market. The bill attempts to pound a
square peg into roundness. It cannot be done. Although all sponsoring
this bill are well intended they should put themselves in the shoes of
the average FDA employee and reflect upon how this bill will
fundamentally alter their mission and thinking in regard to product
risk analysis. Is that really what's best for America? We're making
great strides. Give the States full authority to regulate sales and
then, like smoke-free workplace laws, watch the magic unfold.
Prepared Statement of Vicki Voldal Rosenau, Barnes County Tobacco-Free
Network, Valley City, ND
For many years, I have been reading and re-reading expert analyses
and conclusions (both pro and con) regarding the provisions that are
now included in this year's version of so-called ``FDA Regulation of
Tobacco'': the Kennedy-Cornyn bill.
I've probably studied this issue more thoroughly than any other
person in the state of North Dakota. This careful consideration has
brought me to the inescapable conclusion that, if enacted, this
legislation would do significant, serious harm to the public's health.
Because the 155 pages are so fraught with pitfalls and loopholes and
blatant sellouts, it is not feasible to ``amend'' it to a state of
wholesomeness. Therefore, the bill should be abandoned.
As if the compelling negative evidence that has been piling up for
years were not enough, the recent arrival-on-scene of R.J. Reynolds'
cunning ``Camel No. 9'' promotion offers just one final ounce of proof
that the Kennedy-Cornyn bill is a sham. Why? Because, even though this
brand-new, slick, hot-pink fuchsia campaign makes a blatant appeal to
young girls, the proposed ``FDA bill'' would do absolutely nothing to
prohibit this powerful exploitation of youthful vulnerability.
Prepared Statement of Michael Siegel, M.D., M.P.H., Professor, Social
and Behavioral Sciences Department, Boston University School of Public
Health, Boston, MA
I am a Professor in the Social and Behavioral Sciences Department
at the Boston University School of Public Health and as a physician
trained in preventive medicine and public health, I have been a tobacco
control researcher, practitioner, and teacher for the past 21 years. I
spent 2 years at the Office on Smoking and Health at the Centers for
Disease Control and Prevention (CDC), and I am quite familiar with the
issues involved in Federal tobacco control regulation and policy. I was
at CDC during Dr. David Kessler's original investigation into the
possibility of FDA claiming jurisdiction over tobacco products, and
helped advise FDA at that time. I have published more than 60 peer-
reviewed articles in the medical and public health literature, most
concerning tobacco policy. I have testified as a witness for the
plaintiffs in seven tobacco-related lawsuits, including the Engle case
which resulted in an unprecedented $145 billion verdict in favor of the
plaintiffs. I have testified in more than 50 local and State hearings
in support of smoke-free bar and restaurant laws. In summary, I am
about as anti-smoking as one can be.
Proponents of the proposed FDA tobacco legislation have argued that
this bill would end special protections for the tobacco industry,
protect the public's health, reduce tobacco use, make cigarettes safer,
and save lives. However, a detailed analysis of the actual provisions
of the legislation makes it clear that quite the opposite is true. The
bill would provide unprecedented special protections for Big Tobacco--
protections not enjoyed by any other industry whose products are
regulated by the FDA. The bill would harm the public's health at the
expense of protecting the financial interests of the largest tobacco
companies. The bill would likely increase tobacco use, create a false
impression that cigarettes are safer, end the prospects for a truly
safer cigarette, and in the long run, result in an increased number of
deaths from tobacco use. Supporters of the bill are full of rhetoric,
but when you take the time to actually examine the bill and the
regulatory framework it establishes, you see that this legislation is
in the best interests of the Nation's leading tobacco company--Philip
Morris; it is not in the best interests of protecting the public's
health.
1. the regulatory scheme established by the legislation is pure lunacy
The Bill Would Create the Illusion of Safer Cigarettes Without Any
Evidence That the Product Is, or Can be Made Safer
The system of tobacco product safety standards set up by the bill
is pure lunacy. Although the rhetoric by groups like the Campaign for
Tobacco-Free Kids sounds great, the truth is that there is no evidence
that these standards would actually result in a safer product.
The problem is that we simply do not know which of the constituents
in tobacco smoke, and at what quantities, are responsible for what
diseases. So the Campaign for Tobacco-Free Kids can talk all they want
about how FDA will be able to reduce levels of certain toxins and
produce a safer cigarette, but that's a pipe dream. It would be
difficult to conduct, long-term epidemiologic studies, where you'd have
to follow smokers of conventional vs. new products for 10-20 years,
before you could have an answer to this question. But in the mean time,
we wouldn't know what the risks are--or even if the risk could be
decreased.
Essentially, the bill gives the FDA a mandate which it cannot carry
out. The only way to know whether any particular reductions in specific
smoke constituents would result in a safer product would be to carry
out long-term epidemiologic studies, using smokers as guinea pigs.
Perhaps some would view that as acceptable because the product is
dangerous anyway. However, the problem is that smokers are going to
naturally assume that these products are safer--and we won't know that
is true. This legislation would greatly deceive smokers into thinking
that the product is safer, when it may well not be any safer at all,
and could potentially be more hazardous.
Unfortunately, we simply do not have any idea whether it is even
possible to reduce the toxicity of cigarettes by reducing the levels of
specified components.
The entire approach is flawed, because if you want safer
cigarettes, you need to use the free-market approach to set up
competition between the companies for a safer product. This legislation
does the opposite. It takes away the free market completely and puts
all decisions into the hands of FDA. But it gives the FDA a mandate
which sets up impossible standards that could never be met for new
products. What it really does is ensure that existing products will be
institutionalized and protected from competition. This, indeed, is the
reason why Philip Morris supports the bill, and all the smaller
companies oppose the bill. What the smaller companies despise is the
removal of any serious chance to compete in the market--and largely,
the market we are talking about is potentially safer products.
Philip Morris wants to freeze the market as is, so that Marlboro--
one of the highest risk products imaginable--will be able to dominate
the market, without any serious competition from potentially safer
products which could advertise themselves as being safer than Marlboro
and thus gain market share among the ``health-conscious'' segment of
smokers who are looking to reduce their risks while still satisfying
their demand for cigarettes.
If you really think about it, you'll see that the approach of
trying to reduce the levels of specific smoke constituents is complete
lunacy. When you have no idea which constituents, in what combination,
and at what concentrations, cause which diseases that are associated
with smoking, then it is impossible to produce a cigarette that you
know will be safer simply by mandating a reduction in the levels of
various smoke constituents.
The one thing you will never hear the supporters of this
legislation do is estimate the number of lives they think this
legislation will save. All they can do is talk about ``countless''
lives being saved. And they are quite correct. The lives are countless.
You cannot count them because they do not exist.
It is estimated, for example, that there are over 60 compounds in
tobacco smoke which cause cancer. So what sense does it make to require
the companies to take out two or three of them? What if they take out
the wrong ones? What if the actual compound which causes most of the
cancer is not one of those chosen to be removed? What if smokers
believe that this is a safer product and start smoking more? This
approach could actually kill people, rather than save lives.
And it could also kill people by reducing youths' perceptions of
the hazards of cigarette smoking. If youths are led to believe--
correctly--that the FDA now regulates every ingredient of the cigarette
and that--incorrectly--because of this, countless lives will be saved,
does it not make sense for these kids to infer that cigarettes are not
as bad as they used to be? We know for a fact that any decline in the
perceived harm of cigarettes results in an increase in youth smoking.
So the proposed FDA legislation could well kill more people than it
saves.
The bottom line is that there is no point in giving the FDA
regulatory authority over cigarettes unless there is evidence that
there is something that the FDA could do to regulate cigarettes to
unequivocally make the products safer. To start the FDA on a crapshoot
where they would choose random smoke constituents to reduce or
eliminate in cigarettes makes no public health sense. It will give an
FDA stamp of approval to tobacco products, but without actually making
them any safer.
2. the legislation would be a death knell for the development of truly
safer tobacco products
The Bill Would Make it Impossible for Tobacco Companies to Market Truly
Reduced Risk Cigarettes and Would Eliminate Any Incentive to
Develop Such Products
The bill puts a death knell to harm reduction as a strategy. It
prohibits the marketing of any newer, safer cigarette, unless it meets
FDA approval. But here's the catch--in order to meet FDA approval, you
would have to prove that the product improves health, both on an
individual and a population level. To do that, you'd have to conduct
epidemiologic studies in which smokers were followed for 10-20 years.
And you'd have to hope that they stuck with their products
(conventional vs. new), without switching, for the entire period. In
short, this is impossible. Thus, this legislation would make it
impossible to produce and market safer cigarettes. It essentially takes
all the incentive away. No cigarette company is going to want to spend
millions of dollars on testing and producing a safer cigarette when
they know it is going to be virtually impossible for them to ever
market it.
And this is precisely why Philip Morris favors this legislation.
Philip Morris realizes that the bill sets up an impossible standard for
new products. Thus, it ensures that the existing market is basically
frozen--obviously, this is a dream come true for the company with the
largest current market share, because it stifles competition.
The only way to get safer cigarettes would be to allow the free
market to produce them--not by creating this elaborate regulatory
scheme.
In fact, if you actually read the legislation [see section
901(g)(1)], you'll see that it is not just virtually impossible to meet
the standards required to market a reduced risk product, it is actually
impossible. In order to prove that a product reduces health risks as it
is actually used, both on an individual and population basis, you'd
have to demonstrate the results of a study in which the product is
marketed the way it would be marketed in real life--that is, as a
reduced risk product. But you can't market it as a reduced risk product
until you've proven that it reduced risks.
This is truly a catch-22. You cannot market a product as reduced
risk until you've proven it reduces risk, but you cannot possibly prove
that it reduces risk until you've marketed it as such.
Thus, the proposed legislation not only represents a de facto end
to the prospect of truly safer products--it represents an actual death
knell for any meaningful harm reduction strategy.
The critical flaw in the proposed legislation is section 911(g)(1).
This is the Modified Risk Product section of the bill.
The Modified Risk Product section of the proposed FDA legislation
would make it virtually impossible for modified risk products to enter
the market, while at the same time, allowing reduced exposure products
to essentially be falsely marketed as reduced risk products (thus
institutionalizing the very problem that the health organizations have
expressed so much concern about).
Here are the specific problems:
1. The legislation lists several criteria for achieving approval of
a modified risk product. The most important are the following: ``the
Secretary shall approve an application for a modified risk tobacco
product filed under this section only if the Secretary determines that
the applicant has demonstrated that such product, as it is actually
used by consumers, will: (A) significantly reduce harm and the risk of
tobacco-related disease to individual tobacco users; and (B) benefit
the health of the population as a whole taking into account both users
of tobacco products and persons who do not currently use tobacco
products.
Section 911(g)(1)(A), the (A) clause above places an insurmountable
obstacle in the path of approval of modified risk products. In order to
demonstrate that the product, as actually used by consumers, will
significantly reduce the risk of tobacco-related disease to individual
users, large-scale, long-term epidemiologic studies are necessary. Even
ignoring the requirement under 911(g)(1)(B), the (B) clause above
(which itself appears to introduce an insurmountable obstacle), the
bill as currently written precludes any harm reduction approach to
tobacco control both by making it impossible for such products to meet
the conditions for approval and by eliminating any incentive
(especially economic) to develop such products. Thus, the bill may have
the exact opposite effect that many believe it should have. It protects
the existing high-risk products on the market.
It is critical for the public and policymakers to understand the
ramifications of section 911(g)(1). In order to market a reduced risk
product, a cigarette company would have to demonstrate that the
product, as actually used by smokers, would substantially reduce the
actual risk of disease among individual tobacco users.
There is only one way to do this. And that is to conduct a long-
term epidemiologic study in which one compares the disease risk of the
modified product with that of a comparison product over a long time
period and among a large population of smokers.
There are all kinds of complications with conducting such a study.
First, it would be tremendously expensive. Second, it would take, at a
minimum, 10-20 years to follow the smokers long enough to monitor
changes in disease. For cancer risks in particular, you would have to
follow smokers for about 20 years before you would be able to draw
definitive conclusions regarding any reductions in risk.
Third, there are all kinds of research complications that would
make it difficult to draw accurate conclusions. The only way to
credibly demonstrate a reduction in risk would be to conduct a
randomized clinical trial, where smokers were randomized to either
smoke conventional cigarettes or the putative reduced risk cigarettes.
But conducting a randomized trial of smoking would be unethical; such a
study is impossible.
The best that could be hoped for is a natural experiment type of
study in which a product is ``test-marketed'' and that population of
smokers (i.e., guinea pigs) are monitored for 10-20 years. But this is
a catch-22. How can you test-market the product if you need to obtain
FDA approval before you can test-market it? The only way you could do
this would be to market the product as a conventional cigarette (not
let anyone know that it is a potentially reduced risk product). But to
do that, you would destroy the study, because it is your obligation to
demonstrate that as actually used by consumers, the product would
reduce risk. Smokers might use the product very differently if they
believe it is a reduced risk product than if they don't.
In other words, the legislation does not merely make it difficult
to market a reduced risk product. It makes it literally impossible.
2. The bill contains a special rule that would allow FDA to approve
certain modified risk products that cannot meet the criteria listed
under (A) and (B) above. Such products must only claim to be reducing
exposure to, or reducing levels of, or being free of a particular
constituent. Specifically, such products can be approved if
``scientific evidence is not available and, using the best available
scientific methods, cannot be made available without conducting long-
term epidemiological studies for an application to meet the standards
set forth in paragraph (1).'' In such cases, the major criterion that
must be met is as follows: ``the scientific evidence that is available
without conducting long-term epidemiological studies demonstrates that
a measurable and substantial reduction in morbidity or mortality among
individual tobacco users is anticipated in subsequent studies.''
Thus, section 901(g)(2)(A) essentially allows products that do not
claim to reduce risk but merely claim to reduce exposure to or levels
of a particular constituent to be approved by simply showing that a
reduction in risk is anticipated in subsequent studies. This is a very
weak standard. As long as there is any promising preliminary evidence,
one could argue that reduced risk is expected if it were to be studied
(this is a far cry from demonstrating reduced risk, especially given
the many uncertainties including the actual use of the product by
consumers and unintended side effects or consequences).
The effect of 901(g)(2)(A), then, is essentially to allow the
approval of reduced exposure products and to allow these products to be
marketed as such, even though there is shoddy scientific evidence of
any health benefit. This institutionalizes the very problem
(unsubstantiated health claims) that health groups supporting this
legislation have expressed so much concern about. The fact that the
bill does not allow these products to represent themselves as reducing
health risk is largely irrelevant, because consumers are going to
perceive them as reducing risk. How else would someone interpret a
claim of reduced exposure?
Of note, the bill does require that there be testing of consumer
perception which shows that as the product is proposed to be labeled
and advertised, it will not mislead consumers into thinking that the
product reduces health risk. However, there are no restrictions on who
must do the consumer testing and what the conditions or protocols must
be. It would be relatively easy for a company to do consumer testing in
such a way that they obtain the result they want to show. Anyone
familiar with survey research, focus group studies, or other types of
formative research knows that the way questions are asked and the
specific protocols used can shape consumer responses substantially.
Similarly, post-market surveillance protocols are left to the
companies.
The proposed FDA legislation is thus the worst of both worlds. On
the one hand, it allows companies to gain a government sanction to
market products under the guise of reduced risk by merely calling their
product reduced exposure. On the other hand, it prevents companies from
marketing products that may truly be reduced risk products by putting
an impossible regulatory burden in the path of such products.
Despite all the rhetoric, the proposed FDA legislation would do
nothing to save lives, but would instead ensure that the highest risk
products remain firmly entrenched in the marketplace, without any
competition from what could be life-saving alternatives. Of course,
this lack of effective competition is why Philip Morris adores this
legislation.
What it comes down to is protecting the profits of the Nation's
largest tobacco company at the expense of the public's health. That
Philip Morris is lobbying for this legislation makes perfect sense, and
it is the company's fiduciary responsibility to do nothing less. That
the Campaign for Tobacco-Free Kids and other major anti-smoking groups
are joining alongside Philip Morris in promoting this legislation is
nothing less than a travesty.
3. the legislation makes a public health blunder--asking the fda to
prevent the addiction of kids by lowering nicotine levels, but
preventing the agency from eliminating the nicotine
Due to a Mechanism Known as Compensation, Reducing Nicotine Levels
Would be a Public Health Disaster; Smokers Would Smoke More,
Increasing Tar Delivery and Deaths from Cancer and Chronic Lung
Disease
According to a recent report released by the Harvard School of
Public Health,\1\ cigarette companies steadily increased the nicotine
yield of their cigarettes during the period 1997-2005. The report
describes the increase as being a total of 11 percent over the 7-year
period 1998-2005, or an average increase of 1.6 percent each year
during that period.
Major anti-smoking groups also hailed the study and told the public
that it shows the need for FDA regulation of tobacco products. The
Campaign for Tobacco-Free Kids used the study results to call for
passage of legislation that would grant the Food and Drug
Administration (FDA) authority to regulate tobacco products \2\:
``A new study released today by the Harvard School of Public
Health shows the critical need for Congress to enact
legislation granting the U.S. Food and Drug Administration
(FDA) authority over tobacco products. The Harvard study
expands on and confirms an August 2006 study released by the
Massachusetts Department of Public Health that found that
tobacco companies have deliberately increased the levels of
nicotine in cigarette smoke since 1998. The FDA legislation
would require tobacco companies to disclose to the FDA changes
in their products and provide FDA the authority to require them
to reduce levels of constituents, like nicotine that make them
more harmful or more addictive. . . . The fact that the tobacco
companies have been able to secretly increase nicotine levels
in tobacco smoke occurred only because no Federal or State
agency currently has regulatory authority over cigarettes or
what tobacco companies put in cigarettes. . . . The proposed
legislation would grant the FDA the authority and resources to
stop harmful tobacco company practices that continue to addict
children . . . .''
The steady and significant increase in nicotine yields cigarettes
over the past 8 years or so sounds like a concerning finding. It sounds
like cigarette companies are increasing the addictive potential of
their cigarettes and harming the public's health in a way that demands
passage of the proposed FDA tobacco legislation. At least this is what
the major anti-smoking groups want the public to think.
There are, however, two major problems with this.
First, an increase in nicotine yields does not necessarily mean
that the public's health has been harmed. It is well documented that
smokers compensate in response to changes in nicotine yields to
maintain exposure to a relatively constant nicotine dose. This is why
``light'' cigarettes are not safer products. While the nicotine levels
are lower, smokers compensate by simply smoking more; this negates the
potential benefits of reduced nicotine and tar levels.
In a similar way, smokers might be expected to compensate by
smoking slightly less if nicotine yields increase. This could actually
have a marginally positive health benefit if it reduces overall
cigarette consumption.
In fact, the report \1\ acknowledges this important point:
``The increase in smoke nicotine yield does not necessarily
signify any change in exposure within the population of
smokers, particularly as human smoking behavior is compensatory
and will adjust for differences in smoke yield.''
If anything, the proposed legislation would actually harm efforts
to protect the public's health. By focusing on increases in nicotine
yields as if they are necessarily harmful to public health, the
legislation implies that decreases in nicotine yields would be a good
thing. But the truth is that reduced nicotine yields could be harmful
to public health because they would likely increase cigarette
consumption (due to compensation), leading to increased tar delivery
and higher rates of lung and other cancers as well as chronic lung
disease.
If lawmakers are disturbed by the addictiveness of cigarettes, then
there's only one thing that can be done--and that's to require the
elimination of the nicotine. Short of that, there's nothing that can be
done. At least not anything beneficial. Requiring reductions in
nicotine levels would be the worst thing we could do, because cigarette
consumption would rise due to compensation, causing increased tar
delivery and increased disease and death.
Regulating the levels of nicotine to make sure that they don't
increase would be absolutely useless. Forcing the levels to come down
would be absolutely disastrous for the public's health. There is no
point in using the addictiveness of cigarettes to argue for the need
for FDA regulation unless what you are calling for is granting the FDA
the power to eventually eliminate the nicotine from cigarettes.
If the Campaign for Tobacco-Free Kids and other anti-smoking and
public health groups were truly sincere in their public statements that
we need to do something to protect kids from cigarette company attempts
to addict them through the manipulation of nicotine in cigarettes, then
the only viable option is to remove the nicotine. Nothing else would
work--and in fact, merely lowering the levels of nicotine would
actually harm the public's health.
Let's face it. This legislation represents a purely political
compromise to protect the financial interests of the tobacco companies.
Maybe that is the right thing to do, but let's cut out the rhetoric and
simply admit that this is all about politics and not about protecting
our children from the addictive nicotine in cigarettes.
On January 17, Senator Edward Kennedy released a statement \3\ in
response to the Harvard University School of Public Health report which
concluded that nicotine yields of cigarettes have increased steadily
over the past 8 years. In the statement, Senator Kennedy condemned Big
Tobacco for addicting millions of young smokers due to these rising
nicotine levels and called it a travesty for Congress to be an
accomplice to this addiction by failing to enact legislation that would
allow the Food and Drug Administration (FDA) to prevent this from
happening.
Senator Kennedy said \3\:
``This study is an extraordinary public service by Harvard's
School of Public Health. It's dramatic new proof that Big
Tobacco is addicted to addicting millions of young smokers into
lifetimes of illness and early death. Congress has been an
accomplice in the travesty because of the success of the
tobacco lobby in blocking real reform. Hopefully, the study
will be a wake-up call to persuade Republicans and Democrats
alike to enact long overdue legislation allowing the FDA to
regulate cigarettes and deal with their enormous risks.''
Unfortunately, Senator Kennedy's statement deceives the American
public into believing that the legislation which Senator Kennedy has
introduced would actually do something to protect our Nation's youths
from the addictive nature of nicotine in cigarettes.
It turns out that the legislation that is proposed would not do
anything to address the problem of the nicotine addiction of our
Nation's children.
In contrast, the proposed legislation would actually
institutionalize the addiction of our Nation's children into law,
ensuring that the Food and Drug Administration could never address the
problem of nicotine addiction of our children by requiring the
elimination of nicotine from cigarettes. The legislation would ensure
that cigarettes always contain nicotine, and thus always maintain the
potential to addict our children, regardless of whether we ever reach a
point where social norms change in a way that would otherwise make
feasible the FDA's gradual phasing out of nicotine from cigarettes.
Ironically, if you want to give the FDA the power to possibly
reduce the harms of cigarettes, the one thing that might actually work
would be to mandate very high levels of nicotine in cigarettes.
This would have two beneficial effects: first, it would
substantially reduce the intensity of smoking and levels of
consumption, reducing tar delivery and lowering cancer and chronic lung
disease risks.
Second, it would make cigarettes all but ``unpalatable'' for kids,
ensuring that fewer young people would take up the habit and have it
turn into an addiction. But established smokers would still be able to
obtain their nicotine.
This proposed legislation would not allow the FDA to mandate
increases in nicotine levels in cigarettes. According to section
907(a)(4)(a)(i) of the legislation, the FDA could only require
reductions of certain constituents in cigarettes.
4. the legislation would preclude the single most effective regulatory
action to protect health that is politically and technologically
feasible
By Precluding the FDA from Requiring an Increase in the Nicotine Yields
of Cigarettes, the Bill Eliminates a Regulatory Option
Recommended by the Institute of Medicine that Could Produce a
Safer Cigarette
It honestly seems disingenuous to me to condemn the cigarette
companies for addicting our Nation's youths with the nicotine in their
cigarettes and then to support legislation that would institutionalize
the addiction of our Nation's youths by precluding the FDA from
removing the nicotine. It seems disingenuous to me to suggest to the
public that we need FDA legislation to address the problem of the
nicotine in cigarettes, but then support legislation that precludes FDA
from doing anything other than reducing the nicotine levels.
The reason? Reducing nicotine levels will not make cigarettes non-
addictive. Reducing nicotine levels will not stop kids from smoking.
Reducing nicotine levels will not end the problem of the addiction of
our Nation's youths.
What will reducing nicotine levels do? It will create a public
health disaster by deceiving the public into thinking cigarettes are
safer. It will lead to compensation by smokers, who will smoke more to
maintain their dosage of nicotine. These smokers will therefore be
exposed to higher levels of tar, which will lead to more cancer and
emphysema. In short, reducing nicotine levels, without eliminating the
nicotine, will kill people.
I think it is most reasonable to argue that removing the nicotine
from cigarettes is not a feasible solution to the problem of addiction.
I would never criticize someone for suggesting that the FDA should not
be given the authority to require the elimination of nicotine from
cigarettes. However, I find it inappropriate to mislead people by
suggesting that the increased nicotine yields in cigarettes demands
enactment of the FDA legislation that has been introduced in Congress.
If the fact that cigarette companies are using nicotine to addict
youths is a travesty and it needs to be stopped, then the only way to
do that is to get rid of the nicotine. You can't bemoan the presence of
nicotine in cigarettes, suggest that we need legislation to take care
of the problem, and then deceive the American people by supporting
legislation whose fine print actually precludes the FDA from taking
care of the problem.
I can't over-emphasize this fact: reducing the nicotine yields of
cigarettes will not take care of the problem.
What is so disturbing about this story is that we, as tobacco
control advocates, have condemned the tobacco industry for doing
precisely this: reducing the nicotine yields of their cigarettes.
In fact, we have taken the tobacco companies to court and helped to
convict them of racketeering and fraud by virtue of the fact that they
chose to decrease the nicotine yields of their cigarettes and market
the cigarettes as having lower nicotine yields and therefore being
``lighter.'' We have argued, apparently successfully, that marketing
low-nicotine-yield cigarettes is fraudulent, because it deceives the
American people into thinking that the product is somehow safer when
the truth is that it is not any safer.
So why in the world would we propose a regulatory scheme in which
we will do to the public exactly what the tobacco companies have done
and been convicted of a crime for doing?
Tobacco control groups and advocates who are supporting this FDA
legislation are essentially calling on the Government to do exactly
what the tobacco companies tried to do, but for which they were accused
and convicted of racketeering and fraud: to reduce nicotine yields of
cigarettes.
Such an action by the FDA would certainly mislead smokers into
thinking that the product is safer. The truth, however, is that the
product would not be any safer. And it might actually be more
dangerous.
The truth is that, short of removing the nicotine, the only
effective regulatory action that could actually protect the public's
health would be to require increases in the nicotine yields of
cigarettes. Greatly increasing the nicotine/tar ratio of cigarettes
would allow smokers to obtain the same amount of nicotine dosage while
inhaling substantially lower amounts of tar. This could potentially
reduce cancer and chronic lung disease rates.
However, the proposed legislation precludes the FDA not only from
eliminating the nicotine, but also from requiring such increases in
nicotine.
According to section 907(a)(4)(A)(i) of the proposed legislation:
``A tobacco product standard established under this section for a
tobacco product--(A) shall include provisions that are appropriate for
the protection of the public health, including provisions, where
appropriate--(i) for the reduction of nicotine yields of the product.''
So the FDA cannot do the one thing that might actually produce some
health benefits from regulation of the nicotine content of cigarettes.
5. the legislation would essentially transfer the misrepresentation of
the safety of cigarettes from the tobacco companies to the government
By Establishing Product Safety Standards for Which There is Not
Adequate Evidence of a Health Benefit, the Government Would Be
Making Precisely the Same Type of Fraudulent Health Claims for
Which Judge Kessler Found the Tobacco Companies Guilty
In her final opinion in the Department of Justice tobacco lawsuit
against the tobacco companies, Judge Gladys Kessler ruled that the
defendants had engaged in fraud by marketing cigarettes that rated
lower yields via machine testing in a way that falsely led consumers to
believe that these products offered a health benefit over higher
machine-yield products.
A major part of the basis for this decision was a body of
literature demonstrating that machine-yields of nicotine and other
tobacco constituents have no direct relationship with actual human
exposure, and thus with actual health risk, either on an individual or
a population level. Machine yields, for example, do not adequately
account for changes in human smoking behavior (e.g., compensation)
which accompany any change in the yields of cigarettes.
A report published recently in the journal Tobacco Control and
written by a group of tobacco control experts confirmed not only that
machine-measured toxin yield information is virtually meaningless, but
that newer advances in the way in which these yields are measured--
which attempt to more closely simulate actual smoking behavior--are
inadequate, and even these new methods do not yield information that is
of any consumer value.\4\
``Although each of the testing regimes will help to
``characterise'' how a product performs under a given set of
smoking conditions, none of the smoking regimes ``represent''
human behaviour in terms of compensatory smoking and none is
likely to produce emissions that will be markedly associated
with human exposure or risk, either for individual smokers or
for population-level differences between brands.'' . . .
``After nearly 40 years--and after great cost to public
health--the public health community is now coming around to the
realisation that lower ISO emission cigarettes are not lower-
risk products. Unfortunately, many regulators fail to
understand the distinction between ``product characterisation''
and predicting human exposure. At the same time as they insist
that cigarette emissions are not measures of risk, various
regulators continue to use cigarette emissions in ways that
assume a link between the machine emissions and human exposure.
Many jurisdictions continue to require that quantitative levels
of tar, nicotine and carbon monoxide appear on packages. These
numbers continue to be misunderstood and misused by smokers,
including smokers in the most affluent and highly educated
countries in the world. To date, there is no evidence that
quantitative emissions constitute effective consumer
information, and several scientific bodies have rightly called
for the removal of these emissions from packages. . . . the
tobacco industry should be prohibited from using machine
emissions in any of its labelling, advertising or marketing
directed at consumers, even if accompanied by ``warnings'' or
disclaimers, such as those that currently appear in the United
States and Europe.'' . . .
``Patterns of use must be examined to understand the
interaction between product design and smoking behaviour in
humans, and to identify systematic differences across products.
Products that deliver fewer toxins for a fixed volume of smoke
and also promote greater smoke intake when used by consumers
are not lower-risk products. Likewise, products that deliver
higher amounts of toxins, but discourage repeated use might
potentially be seen as harm reducing compared with conventional
cigarettes.''
This is the flawed logic that underlies the proposed FDA
legislation: We know that measurements of the amounts of various
constituents in cigarettes have no demonstrable relationship with
actual human exposure or with actual human health risk, so we propose a
system to regulate the safety of cigarettes that relies upon reducing
the measured levels of various smoke constituents. What an absurd idea.
We attack the tobacco companies for relying upon cigarette
constituent measurements in making implied health claims, take them to
court, get them convicted for fraud, and then proceed to go ahead and
propose to set our own cigarette constituent level regulations, thereby
making our own unsubstantiated implied health claims.
Unfortunately, the idea isn't just absurd. It's also damaging. The
reason? Because like the machine-measured nicotine yields that we
blasted the tobacco companies for relying upon in their communications,
these FDA-sanctioned tobacco constituent levels will have no
demonstrable relationship to the public's health, yet they will most
certainly be interpreted by consumers as conveying an improved degree
of safety.
There is no question that by virtue of cigarettes being placed
under the regulatory jurisdiction of the FDA and by virtue of FDA
promulgating ``product safety standards,'' the public is going to
assume that cigarettes have been made to be a safer product. However,
those product safety standards are none other than specified reductions
in a number of specifically chosen tobacco constituents, whose levels
have not been shown to correlate directly with human health risk.
Essentially, what the proposed FDA legislation would do is simply
change who is committing the fraud. Right now, it's the cigarette
companies doing the dirty work, marketing reduced tar and reduced
nicotine cigarettes in a way that deceives consumers into believing
that these products are known to be safer. If the FDA legislation is
enacted, then it will be the Government who is doing the dirty work,
implying to the public that reduced X and Y cigarettes are known to be
safer, when there is absolutely no evidence that such a product would,
in fact, be safer.
No wonder why Philip Morris loves this legislation so much. It
completely takes away the risk of litigation for fraud, yet allows the
tobacco companies to tell consumers that they are complying with
stringent product safety standards, assuring a safer product that is
produced under the strict scrutiny of the Food and Drug Administration.
This whole thing has the potential to institutionalize the fraud
that the tobacco companies have committed, but to put it into the hands
of our own Government.
The Tobacco Control review article \4\ points out many reasons why
regulation of tobacco smoke constituent levels would not necessarily
produce a safer product:
``Not all constituents change to the same extent or even in
the same direction under different testing regimes--for
example, the NNK and benzo[a]pyrene:
nicotine ratios decrease under more intense puffing conditions,
whereas the nicotine ratio for carbon monoxide increases, as
does the overall tar:nicotine ratio. It is unclear to what
extent certain emissions can be reduced independently of
others. Manufacturers have also shown their skill in
substantially reducing machine emission levels through subtle
design changes. Recent evidence from the United Kingdom
suggests that tobacco manufacturers have adhered to the `10-1-
10' limits on ISO emissions simply by increasing the level of
filter ventilation so that brands provide deceptively low
readings under machine conditions. Filter ventilation is the
most prominent, but by no means the only design change
available to manipulate yields. . . . Emission limits will
require considerable resources to implement and monitor,
resources that may exceed the current capacity of regulators.
There are also concerns that emission limits would exempt
tobacco manufacturers from liability. Most important, it is
uncertain how consumers will respond to emission regulation.
Despite clear scientific statements to the contrary, consumers
may interpret emission limits as an indication that cigarettes
are less harmful--much in the same way that they have
interpreted emission reductions in the past. In fact, future
emission limits may be even more likely to undermine
perceptions of risk than in the past: ``new'' emission
reductions would be based on a ``superior'' machine method,
would be more comprehensive in scope, and may have the formal
endorsement of the [FDA]. . . . one can also envision how
manufacturers might shape consumer response through packaging
and marketing. Overall, regulations that achieve modest
reductions in smoke toxicity but result in fewer quitters or
more initiators are not effective policy measures.''
But the most important reason why the product safety standard
approach taken in the proposed FDA legislation is a potential disaster
is that there is simply no evidence that cigarettes can be made to be a
safer product, in actual human practice, simply by mandating a
reduction in levels of specified smoke constituents.
We simply do not know which constituents, at what levels, and in
what combination, result in what degree of risk of what diseases that
are caused by smoking.
Anyone who promises you that they are going to ``save countless
lives'' via these product safety standards (precisely what the Campaign
for Tobacco-Free Kids is telling its constituents) would probably also
be effective in selling you a bridge in Brooklyn.
In one respect, the Campaign for Tobacco-Free Kids is precisely
correct in stating that this legislation is going to save countless
lives. It is so unclear that product safety standards will do anything
to reduce overall health risks and that it is impossible to count any
lives that will be saved. Perhaps that's why the Campaign is having
trouble counting them.
Ultimately, there's only one way that I think even has the
potential to be successful in developing safer cigarettes or other
tobacco products. And that's to allow the free-market system to work.
Free-market competition could, possibly, result in a race to see which
company could come up with safer products. The proposed FDA
legislation, however, destroys the possibility of this free-market
competition by making it impossible for any tobacco company to market a
truly reduced risk product.
What the bill does, on the other hand, is set up a competition to
see who can market a reduced exposure product, which, just like
reduced-nicotine or reduced-tar cigarettes, is likely to be just as
effective in killing people, but which would most certainly be
interpreted by the public as implying a reduced health risk.
Essentially, what the proposed legislation does is set up a system
of government-administered public fraud in order to benefit the tobacco
companies.
6. rather than set up a meaningful scheme for regulation of tobacco
products, the legislation merely provides window dressing
The legislation that some health groups have been claiming creates
an effective public health policy that actually does the following:
It bans the presence of strawberry, grape, orange, clove,
cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate,
cherry, or coffee in cigarettes, but does not inherently disallow the
presence of hydrogen cyanide, carbon monoxide, N-nitrosodimethylamine,
benzene, radioactive polonium 210, or nitrogen dioxide.
It requires FDA to ban any tobacco product that contains a
severely harmful chemical defect, but explicitly prevents FDA from
doing the same with tobacco products that contain thousands of severely
harmful chemicals, so long as those chemicals are ordinarily contained
in tobacco products.
It provides for stringent regulation to prevent
adulterated or misbranded products, but leaves the ``pure'' and
``properly branded'' deadly products largely unregulated.
It requires that manufacturers report any adverse health
effects of its products that are unexpected, but the expected 450,000
or so deaths per year due to these products require no special
attention.
It expresses grave concern for the tremendous harm to the
public health caused by tobacco products that falsely purport to reduce
disease risk, but does not seem to find the harm caused by the high-
dose products to be of much alarm.
It strictly regulates new tobacco products introduced to
the market for safety and health, but allows existing products to
continue killing hundreds of thousands of Americans each year.
It expresses grave concern over youth access to tobacco
products and calls for comprehensive restrictions on the sale of
tobacco products to minors, but it explicitly prevents FDA from
regulating the sale of cigarettes in any specific retail establishments
(including malls, grocery stores, restaurants, gas stations,
convenience stores, bowling alleys, and even pharmacies).
It provides for extremely rigorous and comprehensive (and
probably impossible) tobacco company reporting of brand-specific levels
of tobacco smoke constituents, but does not require any particular
action concerning the more than 4,000 constituents that are already
known to be harmful.
It requires the FDA to establish a series of health
standards regarding the nicotine and harmful constituents of tobacco
smoke (and no health standard other than finding the cigarette itself
to be inherently and unacceptably toxic is rational or defensible), but
then prevents FDA from requiring even the gradual elimination of
nicotine from cigarettes, or from requiring the gradual shift to a
system of prescription-only cigarette access, or from ever requiring
even a gradual elimination of cigarette products from the market.
It requires the FDA to prescribe labeling requirements for
the proper use of the tobacco product. How does one properly inhale
thousands of dangerous chemicals and scores of deadly carcinogens?
It requires FDA to consider periodically new medical data
on cigarette risks, but the existing evidence on the established risks
of cigarettes can be largely ignored.
It requires notification to all tobacco product users of
the substantial health risks of any new tobacco products, but no
special notification procedures for the existing deadly products.
It requires FDA to recall and ban any tobacco product that
contains a manufacturing defect that is not ordinarily present in
tobacco products, but a serious defect--such as producing death in one
out of every two long-term users--is fine, so long as the deaths are
caused by an ordinary constituent of the product rather than a new
manufacturing defect.
It allows the FDA to prescribe strict regulations to
protect the public's health from sub-standard packing and storage, but
the fact that what is being packed and stored is inherently dangerous
is of little concern. The FDA may prescribe stringent regulations to
eliminate any pesticide residues on the tobacco, but the rest of the
toxins inside the tobacco are not necessarily regulated.
The fatal flaw of the legislation is the unacceptable degree of
restriction of FDA's potential actions which makes it impossible for
FDA to act appropriately within the legislative mandate it is given.
Although this legislation eliminates the chocolate in cigarettes
and prevents cigarette companies from misrepresenting their new
products as being safe, the latter has been happening for more than
half a decade, and the dangers of existing ``normal risk'' products are
far more important than anything else. We should be focusing our
efforts on addressing the Nation's current tobacco-use epidemic, which
is killing more than 400,000 Americans each year.
7. the proposed legislation will be detrimental to the public's health
By Giving Tobacco Products an FDA Stamp of Approval, the Legislation
Will Undermine the Public's Appreciation of the Dangers of
Cigarettes, but Without Actually Ensuring that These Products
are Significantly Safer
This legislation is severely detrimental to the best interests of
the public's health. While the health groups supporting the bill are
arguing that although it's not perfect, it's better than the status
quo, a careful analysis reveals that it is not better than the status
quo, but instead, would represent a substantial loss for public health.
The three major reasons why this is the case are:
(1) The overall regulatory framework of the bill is counter-
intuitive to basic public health principles. The bill would protect
existing cigarette products by making it nearly impossible for
potentially reduced risk products to enter the market. At the same
time, it would allow tobacco companies to market products as having
reduced levels of certain toxins without having to provide any
substantial evidence of a health benefit. Thus, the basic regulatory
framework established by the bill as relates to reduced risk products
would do two disastrous things. First, it would make it virtually
impossible for reduced risk products to enter the market. It would take
away any economic incentive for companies to do meaningful research and
development of potentially significantly safer products. Second, it
would actually institutionalize the problem of misleading health claims
regarding reduced exposure products--the very problem that the health
organizations keep emphasizing is so unacceptable. But the bill itself
creates a regulatory framework by which companies can market their
products as being reduced exposure products without any solid
scientific substantiation of a health benefit. The public does not
consist of scientists. The public is going to interpret a reduced
exposure claim as being a reduced risk claim. Thus, the problem of
unsubstantiated (implied) health claims about tobacco products will not
only remain, it will now be sanctioned and operated through FDA.
(2) The bill would essentially put an end to the prospect of any
meaningful punishment of the industry, receipt of punitive damages for
victims of classes of victims of tobacco-caused death, disease, and
personal suffering, or achievement of real industry changes through
litigation. In previous litigation, the tobacco companies have
successfully used the argument that they are already regulated so there
is no need for further steps to deter future bad behavior. They gained
tremendous mileage from the tobacco settlement in this regard. But they
would gain even greater mileage from FDA regulation. They would then be
able to claim that the Federal Government has assumed jurisdiction over
all aspects of tobacco operations, including manufacture, new product
introductions, health claims, health standards, ingredients, additives,
and smoke constituents, nicotine, advertising, access, and marketing
(which would be true), and that there is therefore no need for any
further injunctive relief or punitive damages to deter future bad
activity--it is all under FDA's control now. And from a public
perception standpoint they would be right.
It is important to understand that the important point is not
whether the legislation actually gives the companies any immunity or
protection from litigation. The important point is simply whether or
not the companies can use the fact of being regulated by FDA to achieve
de facto immunity by taking advantage of the public perception that the
problem is basically taken care of.
(3) This legislation is likely to result in increased, not
decreased deaths from tobacco products, for the following reasons:
(a) It will make it virtually impossible to research, develop,
introduce, and market new potentially less hazardous tobacco products.
It essentially freezes the market as it is and entrenches existing
high-risk products into the market. It puts an end to any meaningful
possibility of harm reduction as a tobacco control approach.
(b) It will undermine current and future litigation: the companies
will be able to successfully use the argument that they are already
regulated to stave off injunctive relief and substantial punitive
damages in litigation by appealing to jurors' perceptions that the
problem is ``taken care of.'' The highly exaggerated claims of the
positive public health impacts of this legislation that the health
organizations are making are only contributing to this perception.
(c) It will reduce the public's perception of the inherent harms of
cigarettes. By promulgating health standards, FDA will be giving the
public the perception that cigarettes are now safer to smoke. The
public is not necessarily aware of the 4,000 toxins and 50+ carcinogens
in the smoke, nor are they epidemiologists--if they are told that the
nitrosamines have been removed, they are naturally going to perceive
that the problem is being taken care of, or at least largely taken care
of. Since we know that smoking prevalence is directly proportional to
the degree of perceived harm from smoking, this will lead to an
increase in smoking prevalence (at least compared to what would have
occurred in the absence of the legislation).
(d) Most importantly, there are no documented mechanisms by which
the legislation will save lives. Health groups supporting this
legislation have not produced a single solid, evidence-based argument
of how this bill will save lives.
There are really only three ways in which this could occur:
First, the bill could save lives if the performance standards
reduced the relative risk of smoking-related diseases. There is
absolutely no evidence that this is the case--we simply do not know the
specific constituents that are responsible for the diseases as well as
the relative contribution of each, alone and in combination, nor do we
have any evidence for there being a decreased relative risk associated
with product changes that eliminate or reduce a single or a few
components.
Second, the bill could save lives if it encouraged the research,
development and marketing of actual reduced risk products. But in fact,
the bill does the opposite. It puts an almost impossible barrier in
front of the development and marketing of these potential products. It
also puts a virtually insurmountable barrier over other potential harm
reduction efforts--such as promoting the use of snus or other less
hazardous nicotine-delivery devices.
Third, the bill could save lives if it reduced youth smoking. It
has been well documented that youth access restrictions, implemented in
actual widespread practice, do nothing to reduce youth smoking. So the
access regulations are essentially meaningless. And the three access
restrictions that could potentially reduce youth smoking have been
precluded (raising the legal age of purchase, restricting the types of
establishments that sell tobacco, and phasing in some sort of
prescription-access system).
Research has also documented that the kinds of marketing
restrictions imposed by the bill are not effective in reducing youth
smoking, or even in reducing youth exposure to cigarette advertising.
There are simply too many avenues for the tobacco companies to market
their products, and anything short of a near total ban on advertising
and promotion of tobacco products (which clearly would violate the
First Amendment based on the Supreme Court's interpretation) is
unlikely to have a substantial effect on youth smoking. A number of
articles document that even major changes in policy, such as removing
ads completely from youth-oriented publications, does not reduce youth
exposure to this advertising to any meaningful (from a public health
perspective) degree.
In fact, Central Hudson provides a perhaps insurmountable obstacle
to the advertising restriction approach to tobacco control, because of
two basically conflicting prongs. First, the restrictions would need to
be comprehensive enough so that they have a substantial impact on
smoking behavior. Second, the restrictions would have to be crafted as
narrowly as is possible to address the relevant government interest. It
remains to be seen whether this can be done and if it can result in
regulations that have a substantial public health effect. We simply
don't have evidence yet that it can be done, and there is no
justification for highly touting this bill as being the ultimate answer
to curtailing cigarette advertising.
Finally, the bill could save lives if it reduced adult smoking (or
youth smoking) by reducing cigarette demand. It won't do that by
increasing the competition in the marketplace and it won't do that by
increasing the public's perceptions of the inherent risks of smoking.
In summary, there simply is no documented evidence to suggest that
(or how) the proposed legislation will save lives. In contrast, there
is well-documented evidence (including substantial literature in the
fields of tobacco product chemistry, tobacco epidemiology, psychology
and public opinion research, framing theory, and mass communications
[including marketing and advertising] research) to suggest that the
legislation is unlikely to provide any public health benefits in terms
of reducing the relative risk of smoking or increasing the use of
lower-risk tobacco products, but that it is likely to produce public
health harm through its institutionalization of high-risk products, its
barriers to the introduction of reduced risk products, its probable
effects on litigation, its probable effects on public opinion and
attitudes towards tobacco products and towards the tobacco industry,
and its probable effects on slowing down the pace of other tobacco
control legislative efforts (including what will be a chilling effect
on State and local tobacco control legislation).
References
1. Connolly GN, Alpert HR, Wayne GF, Koh H. Trends in Smoke
Nicotine Yield and Relationship to Design Characteristics Among Popular
U.S. Cigarette Brands. Boston, MA: Tobacco Research Program, Division
of Public Health Practice, Harvard School of Public Health, January,
2007. (http://www.hsph.harvard.edu/nicotine/trends.pdf).
2. Campaign for Tobacco-Free Kids. Harvard Study Confirms Tobacco
Companies Increased Nicotine Levels In Cigarettes, Highlights Need For
FDA Regulation of Tobacco. Statement of Matthew L. Myers, President,
Campaign for Tobacco-Free Kids (press release). Washington, DC.:
January 18, 2007. (http://tobaccofreekids.org/Script/
DisplayPressRelease.php3?Display=962).
3. Office of Senator Edward M. Kennedy. Statement By Senator Edward
M. Kennedy On Harvard Study Revealing Big Tobacco Efforts To Keep
Smokers Hooked (press release). Washington, DC.: Office of Senator
Edward M. Kennedy, January 17, 2007. (http://kennedy.senate.gov/
newsroom/press_release.cfm?id=0d0ec94c-312c-40d3-9761-0822f6864ef2).
4. Hammond D, Wiebel F, Kozlowski LT, Borland R, Cummings KM,
O'Connor RJ, McNeill A, Connolly GN, Arnott D, Fong GT. Revising the
machine smoking regime for cigarette emissions: implications for
tobacco control policy. Tobacco Control 2007; 16:8-14.
Prepared Statement of Elizabeth Whelan, M.P.H., Sc.D., Gilbert L. Ross,
M.D., and Jeff Stier, Esq., The American Council on Science Health
(ACSH), New York, NY
Mr. Chairman, the mission of the American Council on Science and
Health (ACSH) is to promote sound science and to inform policy debates
about public health, providing independent scientific evidence and
analysis to clarify the scientific record in order to educate the
public and assist policymaking. As such, we are writing on behalf of
ACSH to lend our voice to others who have criticized S. 625, a bill
recently introduced in the Senate and referred to your committee. We
believe, as experts in the field of tobacco-related health effects and
public health policy, that this bill would unnecessarily disregard a
large and growing body of scientific evidence pertaining to the
relative dangers posed by smoking and smokeless tobacco.
As you know, there has been a 50-year public health campaign
against smoking cigarettes in the United States. Evidence has mounted,
and indeed continues to mount, about the health risks associated with
smoking cigarettes. And yet, despite widespread awareness of the
general risks, cigarette smoking remains by far the greatest
preventable cause of death in the United States, claiming more than
400,000 lives every year. While we can hardly say the public health
campaign has failed--indeed, the ubiquitous acknowledgement of
smoking's risks can be considered a major accomplishment of public
health consumer education--the campaign has long offered what should
now be considered a false dichotomy to smokers: quit or die, instead of
fostering awareness of harm-reducing alternatives to cigarettes for
those who cannot quit nicotine altogether.
Indeed, after all these years, there is no reason to doubt that
smokers know that cigarettes are unhealthful, yet they continue to
smoke, in large part because of the difficulty of quitting.
Unfortunately, quit rates with traditional methods are abysmal. This is
where research published by ACSH might prove useful in this particular
debate, and in the crafting of an improved, more beneficial version of
S. 625.
The conventional wisdom, perpetuated not only by cigarette
companies but by otherwise reliable sources, including the U.S. Surgeon
General, includes the fallacy that all tobacco products are equally
harmful to public health. That is, smokeless tobacco, cigars,
cigarettes, and pipe tobacco are, from a public health perspective, the
same thing. Scientific studies have proven that they are not, and a
rapidly-
growing body of evidence confirms that they are not. Any effort to
regulate tobacco products must explicitly acknowledge the differences
in health risks between types of tobacco.
The fact is that modern smokeless tobacco products are considerably
less harmful than cigarettes. No one should start using any form of
tobacco if they can avoid it, of course, but for those who are already
inveterate smokers and unable to quit nicotine altogether, smokeless
tobacco at least provides a far, far safer (albeit not completely risk-
free) way of receiving nicotine. Public policies that ignore this fact
undermine public health, especially the health of those specifically
designated to be in the protected, vulnerable group. Unfounded,
unscientific pronouncements that lump all tobacco products and their
risks together ultimately undermine the basic purpose of tobacco-
regulatory policies. S. 625 does not distinguish between harmful smoked
tobacco and the demonstrably less harmful smokeless tobacco, to the
detriment of millions of nicotine addicts. ACSH supports the announced
goals of S. 625--the reduction of smoking and smoking-related
illnesses, clearer and streamlined regulation of tobacco, and the
protection of children--but we strongly disagree with the bill's
failure to appreciate the opportunity presented by the scientific
evidence distinguishing smoking and smokeless tobacco.
Consider a limited but informative case in Sweden. ACSH recently
reported on a study to gauge the efficacy of a program that encourages
smokers to switch to smokeless tobacco products as an alternative both
to smoking (which they know is harmful to them) and complete tobacco
abstinence (which they have found extremely difficult). The results of
the study are extremely positive. The program works. It works so well,
in fact, that Sweden now has the lowest smoking-related mortality rates
in the world. A similar program in the United States, where smoking is
a bona fide public health disaster, could save thousands of lives and
vast amounts of health-related expenditures. Harm reduction programs
using smokeless tobacco as an option, even small programs, would seem
to be a welcome opportunity to build on the successes and learn from
the failures of our decades-old public health campaign against smoking.
Smokeless tobacco is demonstrably less harmful than cigarettes, while
making it much easier for some smokers to quit cigarettes. A transition
from smoking to smokeless tobacco--and for many, from smokeless to
abstinence--could produce great benefits for public health. It seems
clear that it ought to at least be allowed a chance to work.
With even the U.S. Surgeon General failing in some public
statements to rank the profoundly different health risks from different
forms of tobacco--differences that, if known to the general public,
might save lives by means of harm reduction--we must take care not to
perpetuate the myth of smoking and smokeless tobacco equality. Part of
what S. 625 ought to do is to correct the public record regarding that
myth, and until it does so, ACSH urges that the bill be modified or
amended to allow lower-exposure products, such as smokeless tobacco,
easy or at least equal access to the tobacco marketplace.
______
American Association of Public
Health Physicians (AAPHP),
Rolling Meadows, IL 60008-1842,
February 26, 2007.
Memorandum
To: Senator Mike Enzi, c/o Amy Muhlberg
From: Joel L. Nitzkin, M.D., M.P.H., DPA, Chairman, AAPHP Tobacco
Control Task Force
Subject: Statement for the Record re. S. 625--FDA Regulation of
Tobacco Products; ref 2/27/07 Committee Hearing
Hon. Senator Enzi: I am writing this note in my capacity as a
public health physician with over 30 years of experience dealing with
tobacco-related legislation, and on behalf of the American Association
of Public Health Physicians (AAPHP), as Chair of the AAPHP Tobacco-
Control Task Force.
On behalf of AAPHP, I am urging that the ``fast track'' for this
legislation be temporarily derailed to allow in-depth consideration of
the full text of S. 625/H.R. 1180 by Senators, Representatives, and
national organizations who have endorsed this legislation on the basis
of one or more widely circulated summary descriptions of this bill.
AAPHP endorses FDA regulation of tobacco products in accordance
with Koop-Kessler guidelines (the Report of the Koop-Kessler Advisory
Committee on Tobacco Policy and Public Health (December 18, 2003)
http://repositories.cdlib.org/tc/reports/koop). Unfortunately, this
bill, with its current text, has the potential to do significant harm
in terms of increasing illness, death and other costs to society from
tobacco products. Our reading of this bill, in its current form, leads
us to believe that it offers no possibility of any public health or
other community benefit.
This bill has the enthusiastic endorsement of many prominent
health-related national organizations, apparently on the basis of a
brief description of its contents developed and distributed by the
Center for Tobacco Free Kids (CTFK). Their summary hypes this bill as
enabling FDA to eliminate advertising of tobacco products to children,
disclose the ingredients of their products and require them to remove
or reduce harmful ingredients.
The bill has wording which, if taken out of context, leads to these
impressions. Unfortunately, in the opinion of AAPHP, other wording
included within this 155 page bill totally eliminates any possibility
of public health benefit--and reasonably assures the opposite result.
The text begins with an accurate description of the illness, death
and cost-related burdens now imposed on our society by tobacco
products. It then proceeds to enshrine in law the concept that this
burden is fully acceptable to Congress and the FDA--with the major
purpose of the FDA regulation to prevent misbranding and adulteration
of tobacco products that might threaten even higher risk of illness and
death.
Our huge toll of illness and death from current tobacco products is
not due to adulteration and misbranding. It is due to the inherent
toxicity of the tobacco itself. Framing the problem in terms of
misbranding and adulteration will invite current tobacco manufacturers
to advertise and prominently label their products as ``FDA Approved.''
If this bill, in its current form, is passed into law.
The provisions in the bill to allow FDA to reduce harmful
components of tobacco smoke are more than totally neutralized by a
series of provisions that require FDA to carry a technically impossible
burden of proof (that reduction of that single component will reduce
the health impact), by provisions that give the politically appointed
secretary of the agency veto power over any proposed regulation, by
requiring (rather than passively allowing) congressional action before
any regulation is implemented, and by requiring FDA to ``consider''
whether any proposed regulation would increase the demand for
contraband tobacco products. This last provision stands as an open
invitation to tobacco companies to assert in court that any proposed
change in the composition of its tobacco products that change the
taste, reduce the attraction to nicotine addicts or significantly
increase the cost of manufacture could increase the demand for
contraband.
In addition, the bill prohibits FDA action to ban any tobacco
products, to require reduction of nicotine levels to zero or to raise
the allowable age to purchase tobacco products above 18.
The bill does prohibit marketing directly to children. It does
nothing, however, to inhibit advertising ``directed'' at young adults
to suggest initiation of tobacco use as a rite of passage to adulthood.
The provision of the bill, referencing the tobacco industry's ``first
amendment rights'' imposes on FDA the burden to demonstrate that such
advertising, is, in fact, intended for underage potential smokers.
Both Altria and the public health community have written guidelines
defining what each would consider appropriate FDA regulatory authority.
The tobacco industry guidelines specify the ability to manufacture and
market its products to adults without governmental interference. S. 625
fully meets all of the tobacco industry specifications. The public
health specifications, known as the ``Koop/Kessler Guidelines'' were
originally developed in the mid-1990's, then republished in 2003. They
specify authority by FDA to take whatever action is needed relative to
manufacture, advertising and distribution of tobacco products to
protect the health of the public. S. 625 violates Koop-Kessler
guidelines by virtue of major limitations imposed on FDA authority.
The current regulatory and reporting requirements strongly favor
the current market leader and impose substantial costs and time delays
relative to the introduction of new tobacco products into the
marketplace, while allowing ``minor'' alterations of currently marketed
products with little FDA interference. They specify studies and reports
easily provided by Altria, but prohibitively costly to smaller firms--
thus the strong endorsement by Altria, but opposition from other
tobacco companies.
AAPHP is recommending that S. 625 be temporarily derailed from it's
current fast-track to allow due consideration of the issues noted
above, based on a careful reading of the entire bill rather than brief
and possibly biased summary descriptions.
For easy reference--the full bill, our analysis with page and line-
number specifications of key provisions, and the Koop-Kessler
guidelines have been posted on www.aaphp.org.
Response to Questions of Senator Kennedy, Senator Enzi, Senator Burr,
Senator Hatch, and Senator Coburn by Matthew L. Myers
questions of senator kennedy
Question 1. Does the Federal Trade Commission have the expertise to
effectively regulate tobacco industry marketing? How does the expertise
of the FDA to regulate tobacco industry marketing, as well as tobacco
products, compare with that of the FTC?
Answer 1. The Federal Trade Commission (FTC) does not have the
requisite expertise to effectively regulate tobacco industry marketing
or tobacco products upon which marketing and claims are based. The FTC,
by its own admission, is ``an agency of lawyers and economists'' and is
not a science-based agency and does not have the necessary scientific,
medical and public health expertise to evaluate scientific claims and
data regarding tobacco products.\1\ The FDA is the only science-based,
public health agency with the expertise required to evaluate cigarette
design and content and scientific claims of reduced harm that will
ultimately protect consumers.
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\1\ Testimony by Timothy Muris, FTC Chairman, June 3, 2003, before
the Committee on Energy and Commerce Subcommittee on Commerce, Trade,
and Consumer Protection, U.S. House of Representatives.
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Furthermore, the FTC is a law enforcement agency whose primary task
is to enforce the law--such as the Federal Trade Commission Act's
Section 5 prohibition against false and deceptive advertising--not
protect the public's health. In most instances, the FTC acts
retrospectively against one bad actor once a violation has occurred. In
contrast, FDA is charged with protecting the public's health and as a
public health agency routinely acts prospectively to address problems.
Through the rulemaking process, FDA sets regulation standards for an
entire industry and addresses problems comprehensively. The FTC's
rulemaking authority is extremely limited and rarely used. (maybe
elaborate)
The FTC's track record provides ample evidence of its inability to
carry out the functions that are assigned to FDA in this legislation.
The type of ``light'' and ``low tar'' marketing that has resulted in
millions of Americans switching to these products falsely thinking they
are safer has been allowed to continue by the FTC for decades without
challenge.\2\ The only time the FTC has gone after a manufacturer in
the last 20 years with regard to ``light'' and ``low tar'' marketing
are in the few cases where there is evidence that a company's reports
do not even accurately report tar and nicotine levels according to the
FTC testing system.
---------------------------------------------------------------------------
\2\ National Cancer Institute. Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
Chapter One: Public Health Implications of Changes in Cigarette Design
and Marketing Smoking and Tobacco Control Monograph No. 13. Bethesda,
MD: U.S. Department of Health and Human Services, National Institutes
of Health, National Cancer Institute, NIH Pub. No. 02-5074, October
2001; Tobacco Control Legal Consortium, The Verdict Is In: Findings
from United States v. Philip Morris, Light Cigarettes (2006).
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Furthermore, the only case the FTC has brought with regard to
tobacco marketing is a case challenging the use of a cartoon character
to sell Camels and the FTC did not act for more than 4 years after the
Camel cartoon character was introduced. Despite the overwhelming
evidence linking tobacco marketing to youth tobacco use, a virtual
flood of ads that others have identified as impacting youth tobacco
use, findings by the National Academy of Sciences in 1994,\3\ the
exhaustive findings by the FDA as part of the documentation issued in
support of its Proposed Rule \4\ and other studies linking tobacco
marketing to youth tobacco use, the FTC has taken no action to curtail
or stop any of these campaigns.
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\3\ Institute of Medicine, National Academy of Sciences, Growing Up
Tobacco Free (1994).
\4\ August 1995.
---------------------------------------------------------------------------
The capability of talented and skilled scientists and researchers
currently employed by FDA, who are able to conduct sophisticated
analyses and evaluate complex scientific data, including an analysis of
the impact of different products on the human body, is the best example
of why FDA is the right agency to regulate tobacco products. The FDA's
scientists regularly evaluate the impact of foods, drugs, cosmetics and
medical devices, the same expertise and skills that are needed to carry
out the functions given to the FDA in the pending legislation. For
example, analysis of toxicity data for tobacco products and/or various
constituents (including smoke constituents) could be conducted by the
FDA's National Center for Toxicological Research, whose mission
``involves fundamental and applied research specifically designed to
define biological mechanisms of action underlying the toxicity of
products regulated by the FDA.'' \5\
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\5\ National Center for Toxicological Research, http://www.fda.gov/
oc/oms/ofm/accounting/cfo/2002/NCTR.htm (Web site accessed March 15,
2007).
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FDA's various centers that oversee foods, drugs, medical devices,
and biologics are home to career chemists, toxicologists,
statisticians, epidemiologists, and surveillance and consumer marketing
experts with the relevant skills needed to assume regulatory oversight
of tobacco products. These are the types of functions and skills that
will be critical to building an effective, science-based regulatory
regime for tobacco products. In addition to evaluating complex
scientific data, the FDA applies this knowledge toward the marketing
and advertising associated with any approved product to ensure that it
is consistent with the evidence for that product and delivered to
consumers in an understandable and truthful manner that does not
exaggerate the benefits or misrepresent the risks associated with the
use of that product--key skills and expertise that will be critical in
FDA's oversight of tobacco product marketing and claims.
Question 2. Concern was expressed at the hearing that FDA
regulation of tobacco products would create the public perception that
cigarettes had the FDA ``seal of approval,'' misleading consumers into
believing that the products were less harmful. What provisions are
contained in S. 625 to make clear to the public that the FDA has not
approved the use of cigarettes or other tobacco products? Are there
additional safeguards that could be included in the legislation to make
this even more clear?
Answer 2. The real problem is that today consumers mistakenly
believe that tobacco products are regulated by the Government for
health and safety purposes, not that consumers will be misled about the
relative safety of tobacco products and the Government's role if this
legislation is enacted. This legislation will ensure that consumers are
not misled by the tobacco industry about the relative safety of their
products, and it provides FDA the authority to make sure the tobacco
industry does not misuse the legislation to give the public the false
impression that FDA has concluded that tobacco products are safe.
Many consumers already believe that cigarettes and other tobacco
products--and the claims being made in their advertising--are already
regulated and approved by the Federal Government.\6\ When consumer
misperceptions about government approval are combined with the current
marketing practices of the tobacco companies which are not regulated in
terms of their scientific accuracy, merit, or truthfulness, we have a
recipe for a public health disaster--a disaster we have already seen
take place in the form of light and low tar cigarettes--and a disaster
that this legislation will prevent in the future.
---------------------------------------------------------------------------
\6\ ``Smokers' responses to advertisements for regular and light
cigarettes and potential reduced-exposure tobacco products,'' Nicotine
& Tobacco Research, Volume 6, Supplement 3 (December 2004) S353-S362.
---------------------------------------------------------------------------
The history of light and low tar is a poignant and tragic example
that it is the status quo that is misleading consumers about the
relative safety of tobacco products. In its historic report on light
and low tar cigarettes, the National Cancer Institute \7\ concluded
that:
---------------------------------------------------------------------------
\7\ National Cancer Institute. Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
Department of Health and Human Services, National Institutes of Health,
National Cancer Institute, NIH Pub. No. 02-5074, October 2001, http://
cancercontrol.cancer.gov/tcrb/monographs/13/.
1. Many consumers use the terms ``Light'' and ``Ultra-Light'' as a
guide to the riskiness of particular brands of cigarettes.
2. Many smokers choose Light and Ultra-Light brands because they
believe that such cigarettes are less likely to cause health problems.
3. Individuals who are most concerned about smoking risks and most
interested in quitting adopt low-yield brands.
These types of misleading actions would be corrected by the current
legislation. In addition to consumer misperceptions about light and low
tar, the NCI found, regarding the marketing of these products by the
tobacco companies, that:
1. Advertisements of filtered and low-tar cigarettes were intended
to reassure smokers (who were worried about the health risks of
smoking) and were meant to prevent smokers from quitting based on those
same concerns.
2. Advertising and promotional efforts were successful in getting
smokers to use filtered and low-yield cigarette brands.
3. Internal tobacco company documents demonstrate that the
cigarette manufacturers recognized the inherent deception of
advertising that offered cigarettes as ``Light'' or ``Ultra-Light,'' or
as having the lowest tar and nicotine yields.
Furthermore, as found by Judge Kessler in her August 2006 ruling
against the tobacco company defendants in the Department of Justice
tobacco lawsuit (for more details on Judge Kessler's findings for the
entire case, see Tobacco Control Legal Consortium, The Verdict Is In:
Findings From United States v. Philip Morris (2006), http://
www.tobaccolawcenter.org/dojlitigation.html),
``Contrary to their internal documents, Defendants also
continue to deny that low tar cigarettes are just as hazardous
to smokers as full-flavor cigarettes, in part because of smoker
compensation. In 1998, Philip Morris, RJR, B&W, and Lorillard
jointly stated to the FTC that compensation was so ``weakly
documented'' that the FTC should not require disclosure
warnings to alert consumers, and that they were ``unaware of
evidence,'' other than that presented in Monograph 7,
520842199-2295 at 2243, 2289 (US 88618), that consumers viewed
low-tar cigarettes as safer. Defendants are well aware from
their own research that a majority of smokers believe that low-
tar cigarettes are healthier, are willing to buy them for
precisely that reason, and are willing to sacrifice taste for
what they believe to be less harmful cigarettes. Nonetheless,
to this day, Defendants still deny that, as Monograph 13 found,
low-tar cigarettes are just as dangerous as full-flavor
cigarettes. These RICO violations are likely to continue.''
[Judge Kessler's Final Opinion, page 1609].
Several sections in this legislation give the FDA authority to
prohibit a tobacco company from advertising or asserting that its
product has received ``FDA Approval'' or from making some other similar
affirmative statement in its labeling or advertising from being made.
Sections 903, 906(d), 907 and 910 give FDA specific authority over the
content of labels, labeling and advertising. These sections provide FDA
clear authority to prohibit these types of claims on the basis that
they will mislead consumers about the harmfulness of tobacco products.
Specifically, if the FDA determines that such a statement would result
in increased individual risk and/or population level harm, the
authority FDA is granted over the labeling of the product is sufficient
to allow FDA to prevent such ``seal of approval'' statements from ever
taking place.
Question 3. S. 625 creates an entirely new section of FDA law for
the regulation of tobacco products, with standards that were
specifically designed to deal with the unique issues raised by the use
of tobacco. Contrary to what some have claimed, under the legislation
the FDA would not be regulating tobacco products the same way it
regulates drugs and medical devices. Would you explain the key
differences in the tobacco regulatory process?
Answer 3. S. 625 recognizes that tobacco products are uniquely
lethal \8\ and cannot be ``safe and effective,'' the standard that FDA
applies to many products under its jurisdiction and, therefore, the
bill adopts a different standard that is appropriate for tobacco
products and consistent with the agency's overall mission of protecting
the health of the American public. Instead of maintaining the status
quo under which we do nothing to reduce the harm of tobacco products,
the standard in the bill is based on what actions are ``appropriate to
protect the public health,'' taking into account the impact of any
proposal on the health of the ``population as a whole, including users
and non-users'' of tobacco products. Thus, the bill gives the FDA the
authority to take actions it believes will reduce the number of people
who die from tobacco.
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\8\ U.S. Department of Health and Human Services. The Health
Consequences of Smoking: A Report of the Surgeon General. Executive
Summary. U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, National Center for Chronic Disease
Prevention and Health Promotion, Office on Smoking and Health, 2004.
---------------------------------------------------------------------------
It gives the FDA the authority to use its skills and expertise to
evaluate the health impact of different products on consumers to
reduce, to the extent possible, the harm caused by tobacco products,
using a standard that recognizes that tobacco products are currently
used by approximately 50 million consumers, are not safe and are
addictive. It recognizes that a different standard is needed in this
situation and includes a standard that will allow FDA to save lives.
The bill puts in place measures to prevent kids from starting to
smoke and to ensure that smokers are not dissuaded from quitting by
misleading claims, and it establishes a process to reduce the harm from
tobacco products to those who are unable to quit. The goal of this
legislation is to reduce the number of people who needlessly die
prematurely from tobacco use.
Although the legislation uses a different standard for the
regulation of tobacco products, the agency will apply the same basic
set of skills that it has used for decades. The core competencies of
the FDA can and should be applied to the regulation of tobacco
products. FDA's various centers that oversee foods, drugs, medical
devices, and biologics are home to career chemists, toxicologists,
statisticians, epidemiologists, and surveillance and consumer marketing
experts with the skills required to assume regulatory oversight of
tobacco products. In fact, FDA is the only agency with the scientific
and health expertise, as well as regulatory experience required, to
adequately evaluate tobacco products.
Question 4. Under S. 625, the entire cost of FDA regulating tobacco
products would be paid for by a user fee imposed on the tobacco
companies based on their market share. Therefore, there would be no
impact on the existing resources that FDA receives to discharge its
current regulatory responsibilities. Would you describe how this
funding for tobacco regulation would work?
Answer 4. This legislation creates a new, separate funding
mechanism for FDA's new tobacco product-related responsibilities. The
legislation allows FDA to determine the best way to structure its staff
to carry out the functions assigned to FDA, but funds are provided to
allow FDA to hire the additional staff it will need to carry out the
activities required by this legislation. The new responsibilities would
be funded through a user fee on the tobacco industry, so it would have
no impact on the funding provided to FDA to carry out its other
important activities. The user fees are allocated among the
manufacturers of tobacco products sold in the United States, based on
the manufacturers' respective shares of the entire U.S. tobacco product
market. It should be noted that many of the groups that support this
legislation care deeply about the many current important tasks
conducted by the FDA.
Furthermore, the estimated funding levels provided for in the
legislation, which ramp up to $300 million annually in year three, are
based on FDA's prior experience regulating tobacco from 1996-2000,
along with previous budget estimates provided by FDA to Members of
Congress drafting legislation to provide the agency with authority over
tobacco products.
Question 5. What impact would the user fee paid to the FDA by the
tobacco companies have on the price of a pack of cigarettes?
Answer 5. The user fee would have minimal impact on the price of a
pack of cigarettes. In 2006, 18.1 billion packs of cigarettes were
sold.\9\ If pack sales continue to decline by about 1.5 percent per
year, 17.56 billion packs of cigarettes would be sold in 2008. In 2008,
the cost of the program is estimated to be $85 million. Therefore, it
would take less than half a cent per pack to raise this amount. In
2009, pack sales would be about 17.29 billion and the cost of the
program is estimated to be $175 million. It would take about 1 cent per
pack to raise this amount. When the program is fully funded at $300
million a year, the cost would still be less than 2 cents per pack.
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\9\ Orzechowski & Walker, Tax Burden on Tobacco, 2006.
Question 6. Some have claimed that FDA regulation of tobacco
products would provide a liability shield for tobacco companies. Does
FDA regulation as set forth in S. 625 provide any liability protection
for tobacco companies that are sued by the victims of tobacco-induced
disease?
Answer 6. The bill will not change the rules applicable to product
liability litigation brought by citizens against the tobacco industry.
The bill states explicitly that it does not provide any liability
protection for tobacco companies. There are two specific provisions of
the legislation that address this issue:
Sec. 4(a) of the legislation (p. 15 of S. 625) states,
``Nothing in this Act (or an amendment made by this Act)
should be construed to . . . affect any action pending in
Federal, State or Tribal court, or any agreement, consent
decree, or contract of any kind.''
Sec. 917(b) of the legislation (p. 109 of S. 625) states,
``No provision of this chapter relating to a tobacco product
should be construed to modify or otherwise affect any action or
the liability of any person under the product liability law of
any State.''
In addition to these provisions, it is important to note that just
because an industry is regulated does not mean it is shielded from
legal action for violating State tort laws.
Question 7. In his testimony, Dr. Blum claims that the bill will
``inhibit tougher State and local tobacco control efforts.'' This is
inaccurate. In fact, S. 625 removes certain existing preemptions so
that States and localities will have much greater authority to
regulate, particularly in the area of tobacco advertising and
marketing, than they do under current law. Would you explain what
authority States and local governments will have under this bill to
regulate tobacco products?
Answer 7. The bill allows the States to continue to do all that
they are currently doing or have done to prevent tobacco use, limit
youth access to tobacco, assist and encourage tobacco users to quit and
to protect individuals from secondhand smoke. The legislation also
expands State authority to regulate tobacco product marketing. Under
the legislation, State and local governments would continue to be free
to adopt measures regulating the sale, distribution, and possession of
tobacco products (regardless of age); to limit exposure to secondhand
smoke; to restrict youth access to tobacco products; and to enact fire
safety standards for tobacco products. In short, the bill does not
restrict States from pursuing policies such as smoke-free workplace
laws, tobacco taxes, fire-safety standards, age requirements,
identification checks, retailer licensing and fines, and other
restrictions on the sale and distribution of tobacco products that have
been instrumental in reducing tobacco use. States would also be able to
impose additional reporting requirements on tobacco manufacturers (as
Massachusetts, Texas and Minnesota have done) if there was any
meaningful information FDA was not getting or not sharing that a State
thought would be useful.
Today, States have no authority to regulate cigarette marketing.
The legislation alters the existing preemption of State authority over
cigarette marketing in the Federal Cigarette Labeling and Advertising
Act (FCLAA), so that States will for the first time since 1969 have the
ability to regulate cigarette marketing. As a result, States and
localities could impose bans or restrictions on the time, place and
manner, but not content, of the advertising or promotion of cigarettes,
to the full extent permitted under the first amendment. (States already
have this authority for smokeless tobacco products.) For example, if
permitted under the first amendment, a State could ban or restrict in-
store advertising or limit in-store advertising to locations away from
the checkout counter or near products kids buy or limit the number of
in-store ads.
FDA would have exclusive authority in such areas as tobacco product
standards, pre-market approval, adulteration, misbranding, labeling,
registration, good manufacturing standards, and modified risk products.
This is consistent with the way the FDA regulates other products under
its jurisdiction. This is an area of regulation that the States have
not undertaken in the past and one that would require significant
resources and technical/scientific capability given the complexity of
the issues to be addressed. The FDA is unique in possessing the
combination of scientific expertise and regulatory experience that is
necessary.
In addition to preserving and in some ways expanding State and
local authority, this legislation will also significantly enhance the
impact of State tobacco prevention and cessation initiatives by
curtailing tobacco marketing that encourages children to start using
tobacco and discourages current tobacco users from quitting. The more
than $15 billion a year the tobacco companies spend on marketing \10\
dwarfs the $597.5 million a year the States currently spend on
prevention and cessation.\11\ The bill will enhance State prevention
efforts by giving the FDA authority to restrict marketing that appeals
to children.\12\ It will enhance cessation efforts by banning deceptive
terms like ``light'' and ``low-tar'' and giving the FDA authority to
strictly regulate reduced risk claims that are intended to encourage
smokers to switch rather than quit.\13\ In addition, there is
considerable evidence that the stronger health warnings mandated by the
bill will enhance prevention and cessation campaigns.\14\
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\10\ U.S. Federal Trade Commission (FTC), Cigarette Report for 2003
(2005), data for top six manufacturers only.
\11\ Campaign for Tobacco Free Kids, ``A Broken Promise to Our
Children: The 1998 State Tobacco Settlement Eight Years Later,'' http:/
/www.tobaccofreekids.org/reports/settlements/2007/execsum.pdf.
\12\ National Cancer Institute. Changing Adolescent Smoking
Prevalence `` Where it is and Why. Smoking and Tobacco Control
Monograph No. 14. Chapter 13 ``The Role of Tobacco Advertising and
Promotion in Smoking Initiation''; Tobacco Control Legal Consortium,
The Verdict Is In: Findings From United States v. Philip Morris,
Marketing to Youth (2006); Giovino, G. et al. ``Use of Flavored
Cigarettes Among Older Adolescent and Adult Smokers: United States
2004.'' PowerPoint Presentation; Carpenter, C., et al. ``New Cigarette
Brands with Flavors That Appeal to Youth: Tobacco Marketing Strategies;
Health Affairs, November/December 2005, Volume 24, number 6.
\13\ U.S. Department of Health and Human Services. Reducing Tobacco
Use: A Report of the Surgeon General--Chapter 5: Regulatory Efforts.
Atlanta, Georgia: U.S. Department of Health and Human Services, Centers
for Disease Control and Prevention, National Center for Chronic Disease
Prevention and Health Promotion, Office on Smoking and Health, 2000.
\14\ Campaign For Tobacco-Free Kids Factsheet, ``U.S. Cigarette
Warning Labels Don't Work Well--FDA Legislation Would Fix That.''
Question 8. In his testimony, Dr. Blum claims the legislation is
``grandfathering in high risk products.'' That is inaccurate. Under S.
625, FDA will have the authority to set standards for existing
products, ordering the removal or reduction of toxins and ingredients
that make cigarettes more addictive. Would you explain the process by
which FDA could require changes to be made in the composition of
cigarettes that are already on the market?
Answer 8. The bill gives the FDA broad authority to regulate the
manufacturing, marketing and sale of both existing and new tobacco
products.
More specifically, under section 907 of the legislation, cigarettes
(new or existing products) may not have candy or fruit flavorings--such
as vanilla, chocolate, strawberry, cinnamon, or many other flavors--as
a characterizing flavor.\15\ Section 907 also empowers FDA to require
changes in new and existing products. Section 907 for the first time
gives the FDA the authority to require tobacco companies to make
changes to existing products such as Marlboro, Camel and Newport, the
brands most popular with young people. S. 625 provides FDA the
authority to require changes to tobacco products to protect the public
health through the issuance of product standards. Such changes could
include the reduction or elimination of ingredients, additives,
constituents, including smoke constituents, or reduction in nicotine
yields, or changes to the construction and components of products.\16\
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\15\ Giovino, G. et al., ``Use of Flavored Cigarettes Among Older
Adolescent and Adult Smokers: United States 2004.'' PowerPoint
Presentation; Carpenter, C., et al., ``New Cigarette Brands with
Flavors That Appeal to Youth: Tobacco Marketing Strategies; Health
Affairs,'' November/December 2005, Volume 24, number 6.
\16\ Ashley D. et al., ``Tobacco-specific nitrosamines in tobacco
from U.S. brand and non-U.S. brand cigarettes,'' Nicotine & Tobacco
Research, (2003) 5, 323-331; U.S. Department of Health and Human
Services. Reducing Tobacco Use: A Report of the Surgeon General--
Chapter 5: Regulatory Efforts. Atlanta, Georgia: U.S. Department of
Health and Human Services, Centers for Disease Control and Prevention,
National Center for Chronic Disease Prevention and Health Promotion,
Office on Smoking and Health, 2000; National Toxicology Program, Public
Health Service, U.S. Department of Health and Human Services (HHS),
Report on Carcinogens, Eleventh Edition, January 2005 http://
ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s176toba.pdf.
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In addition, under section 904 of the bill, each tobacco
manufacturer is required to submit to the Secretary a listing of all
ingredients in each tobacco product; a description of the content,
delivery, and form of nicotine in each tobacco product; a listing of
all constituents, including smoke constituents, in each tobacco
product; and all documents that relate to the health effects of their
products, their constituents (including smoke constituents),
ingredients, components, and additives. Further, if at any time a
tobacco product manufacturer changes its products--by adding a new
tobacco additive, increasing the quantity of an existing tobacco
additive, eliminating or decreasing an existing additive, or adding or
increasing an additive--it must notify the HHS Secretary of the
changes. The Secretary will publish a list of the harmful and
potentially harmful constituents by brand and quantity annually.
Question 9. S. 625 authorizes the FDA to ``impose restrictions on
the advertising and promotion of a tobacco product consistent with and
to the full extent permitted by the first amendment to the
Constitution.'' The legislation does not set particular restrictions,
but authorizes the FDA to determine the most effective restrictions by
regulation. This will allow the FDA to respond by regulation to changes
in the marketplace so that the restrictions remain effective over time
in deterring youth smoking and in preventing misleading advertising.
The bill procedurally reinstates the regulation that the FDA adopted in
1996 after an exhaustive fact finding process. However, FDA retains
full authority to modify those regulations going forward. Would you
comment on how this process is structured in the legislation and how it
will operate?
Answer 9. This legislation both adopts specific marketing
restrictions that FDA has found have a significant impact on young
people and gives FDA the authority to restrict tobacco marketing
further ``to protect the public health'' to the extent permitted by the
first amendment. The legislation is carefully crafted to comply with
the requirements of the first amendment.
The bill requires the FDA to reinstate the specific marketing
restrictions previously adopted by the FDA. This allows the FDA to
adjust those regulations without further congressional action if the
situation warrants.
If ever there is a justification for restricting commercial speech,
this is such a case. Tobacco is this Nation's No. 1 preventable cause
of death and disease.\17\ It is illegal to sell tobacco products to
minors, and it has been the legitimate goal of the Government to do
what it can to curtail marketing that encourages young people to start
using tobacco, that misleads adults about the hazards of tobacco and
different tobacco products, and to reduce the number of people who die
from tobacco use.
---------------------------------------------------------------------------
\17\ U.S. Department of Health and Human Services. The Health
Consequences of Smoking: A Report of the Surgeon General. Executive
Summary. U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, National Center for Chronic Disease
Prevention and Health Promotion, Office on Smoking and Health, 2004.
---------------------------------------------------------------------------
Time and time again the evidence has shown that tobacco marketing
plays a role in contributing to youth tobacco use, that tobacco
marketing has mislead millions of consumers, that the marketing of
light and low tar products has misled consumers to switch to these
products rather than quit smoking, and that the marketing of these
products has undermined efforts to educate the public effectively about
the heath hazards of these products.\18\
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\18\ Hamilton, W.L., Norton, G. Ouellette, K., Rhodes, W.M., Kling,
R., Connolly, G.N., Smokers' responses to advertisements for regular
and light cigarettes and potential reduced-exposure tobacco products.
Nicotine & Tobacco Research 2004; 6: (Suppl 3) S353-362; Slade, J.,
Connolly G. and Lymperis, D. Eclipse: does it live up to its health
claims? Tobacco Control 2002; 11 (64-70); Harvard School of Public
Health, Tobacco Research Program, Division of Public Health Practice,
Trends in Smoke Nicotine Yield and Relationship to Design
Characteristics Among Popular U.S. Cigarette Brands 1997-2005, December
2006.
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For over 40 years, attempts have been made to address these
problems through restrictions--both mandatory and voluntary--that are
less restrictive than those imposed by this legislation, but none of
these prior efforts have been successful because of the tobacco
industry's behavior. In the 1960s Congress added a small health warning
to tobacco products and banned cigarette advertising on TV and radio
and the tobacco industry dissuaded Congress from going further by
promising not to market to young people and not to mislead the public
through its own so-called Voluntary Advertising Code. These actions
were not enough to stop the tobacco companies from continuing the same
behavior.
After Congress enacted the TV ad ban, the tobacco companies
promised not to undermine its effectiveness by sponsoring sporting
events on TV, a promise they almost immediately violated by sponsoring
the Virginia Slims tennis tour and later violated again and again by
their sponsorship of motor racing (e.g., NASCAR's Winston Cup). After
the staff of the FTC found in 1981 that tobacco industry marketing
continued to focus on themes that appealed to children and undermined
the existing health warnings, the tobacco industry once again went
before Congress to argue that further regulation was not needed because
they were serious about enforcing their own advertising code. Thus,
while Congress imposed new health warnings on tobacco products, it did
not adopt further marketing regulations.
But in the 1990s, investigations of tobacco marketing revealed once
again that tobacco marketing continued to appeal to and impact
children, deceive adults and minimize the health effects of tobacco
products. In the mid-1990s the FDA conducted an exhaustive study of
tobacco industry marketing, as did the Institute of Medicine of the
National Academy of Sciences and the Surgeon General.\19\ All reached
the same conclusions.
---------------------------------------------------------------------------
\19\ National Academy of Sciences, Institute of Medicine, ``Taking
Action to Reduce Tobacco Use'' (1998), http://books.nap.edu/
catalog.php?record_id=6060#toc; National Academy of Sciences, Institute
of Medicine, ``Growing Up Tobacco Free: Preventing Nicotine Addiction
in Children and Youths, (1994), http://books.nap.edu/
catalog.php?record_id=4757/; 1994 Report of the Surgeon General:
Preventing Tobacco Use Among Young People, http://www.cdc.gov/tobacco/
data_statistics/sgr/sgr_1994/index.htm; 2000 Report of the Surgeon
General: Reducing Tobacco Use, http://www.cdc.gov/tobacco/
data_statistics/sgr/sgr_2000/index.htm; Federal Register: August 28,
1996 (Volume 61, Number 168)], Page 44395-44618, Department of Health
and Human Services, Food and Drug Administration, Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and Adolescents; Final Rule August 11, 1995
FDA Proposed Rule.
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In 1998 the State Attorneys General attempted to curtail deceptive
tobacco industry marketing and tobacco industry marketing that impacted
children. Yet, Judge Gladys Kessler of the U.S. District Court for the
District of Columbia found last August, despite all of these prior
efforts, the tobacco industry continues to engage in marketing
practices that put our children at risk, that mislead consumers and
that wrongfully minimize the health effects of tobacco and tobacco use.
Last August's (2006) ruling by Judge Kessler in the Department of
Justice tobacco lawsuit (USA v. Philip Morris, USA), represents the
most comprehensive and detailed accounting of the tobacco industries
historical and ongoing predatory marketing practices and gives
additional, compelling and strong evidence in support of the rules set
forth in the legislation. Amongst her many findings against the tobacco
company defendants, Judge Kessler found that:
``There is a reasonable likelihood that Defendants' RICO
violations will continue in most of the areas in which they have
committed violations in the past. Defendants' practices have not
materially changed in most of the Enterprise's activities, including:
denial that ETS causes disease, denial that Defendants market to youth,
denial of the addictiveness of nicotine, denial of manipulation of the
design and content of cigarettes, suppression of information and
research, and claims that light and low tar cigarettes are less
hazardous than full-flavor cigarettes.'' [Judge Kessler's Final
Opinion, pages 1606-1607]
``Defendants continue to engage in many practices which
target youth, and deny that they do so. Despite the provisions of the
MSA, Defendants continue to track youth behavior and preferences and
market to youth using imagery which appeals to the needs and desires of
adolescents. Defendants are well aware that over 80 percent of adult
smokers began smoking before the age of 18, and therefore know that
securing the youth market is critical to their survival. There is
therefore no reason, especially given their long history of denial and
deceit, to trust their assurances that they will not continue
committing RICO violations denying their marketing to youth.'' [Judge
Kessler's Final Opinion, pages 1607-1608]
``Although Defendants recently began to finally admit that
smoking is addictive, no Defendant publicly informs consumers that
nicotine is addictive, much less that smoking is a nicotine-driven
addiction. See Findings of Fact Section V(B)(4). Defendants minimize
the issue as a ``quibble over the precise wording of the addictiveness
of smoking.'' JD Br. at 39. To the contrary, the issue is Defendants'
refusal to admit publicly that nicotine is physiologically addictive,
that smoking is a nicotine-driven addiction, and that, therefore,
quitting is not a simple act of willpower. At trial, the General
Counsel for Philip Morris, Denise Keane, admitted that the ``Smoking is
Addictive'' statement that Philip Morris removed from cigarette packs
after buying three Liggett cigarette brands in 1999 was both correct
and material. She also agreed that it is material for people to know
that Philip Morris agrees that the nicotine delivered in cigarette
smoking is addictive, but it does not say so publicly. Keane TT, 1/18/
05, 10458:6-17. The deliberate mission of admittedly material
information about nicotine addiction is not a mere ``quibble.'' It is
fraudulent, with consequences for those who smoke and those, especially
young people, who are considering whether to start smoking. Defendants
have thus made clear that, despite their internal research to the
contrary, they remain unwilling to admit publicly that nicotine is
addictive and that smoking is an addiction driven by nicotine. Such
RICO violations are reasonably likely to continue.'' [Judge Kessler's
Final Opinion, page 1608]
The FDA Rule and the marketing restrictions in this legislation on
tobacco advertising and marketing were carefully tailored to reduce
underage exposure only to the types of tobacco marketing that has the
greatest impact on children, while still leaving numerous ways for
tobacco advertising to reach adult customers. Judge Kessler's decision
demonstrates that there remains a strong factual basis for these
restrictions today even though FDA's investigation was conducted 10
years ago. For example, the FDA Rule's restrictions on outdoor and
point-of-sale tobacco-product advertising to black print on white
background do not restrict what can be said about tobacco products or
otherwise block the communication of truthful information about tobacco
products to adult consumers but only make the ads less attractive or
alluring to kids (and these restrictions do not even apply to tobacco
ads in adult-only locations). In fact, the advertising of financial
investments has long been limited to black and white text-only ads
without any constitutional objections.
After 40 years of attempting to address the Government's legitimate
interests with all of these less restrictive efforts, the specific
marketing restrictions in the pending legislation are amply justified
as a reasonable next step.
Prior to Judge Kessler's ruling in the DOJ trial, there was already
strong and ample legal precedent to support the advertising
restrictions proposed in the legislation. These restrictions are
consistent with the standards set forth by the Supreme Court in
Lorillard Tobacco Co. v. Reilly. The bill's restrictions address a
legitimate government interest; there is significant evidence that they
will advance these interests; and given the prior history and current
tobacco industry marketing practices, there is overwhelming evidence
that these restrictions are necessary to protect the Government's
legitimate interests.
The Court has firmly established that reducing underage use of
tobacco products is a substantial and legitimate government interest
that can justify time, place and manner restrictions on commercial
speech, and that restrictions on tobacco-product advertising practices
that have been documented to impact youth, mislead adults and
wrongfully distort the health effects of tobacco properly advance those
interests.
Question 10. Some have claimed that it will be difficult for
convenience stores and other retailers to comply with the
responsibilities that the legislation places on them to prevent the
sale of tobacco products to minors. Would you explain what the
responsibilities of retail sellers of tobacco products will be, and
what safeguards have been included in the bill to protect retailers who
are attempting to comply in good faith with the regulations?
Answer 10. S. 625 addresses the problem of illegal sales of tobacco
products to children in the manner that has been proven most effective.
When FDA implemented the youth-access provisions of the FDA Tobacco
Rule \20\ between 1996 and 2000, there were no significant problems
with its administration or with retailer compliance, and that should
hold true when the pending legislation passes and the Rule's youth
access provisions are re-implemented. Put simply, the FDA Rule youth-
access provisions require retailers to check the ID of any young person
seeking to purchase tobacco products to prevent and reduce illegal
sales to children. When in place previously, FDA enforced these youth
access restrictions, not by employing Federal agents, but by
contracting with State and local officials, such as health departments
and police departments. By 2000 FDA had contracts with every State to
conduct compliance checks and had an extensive outreach program that
provided resources and information to retailers. FDA tried to ensure
that retailers fully understood their responsibilities under the youth-
access provisions, as well as the penalties associated with
noncompliance. In addition, FDA provided retailers with a mediation
procedure to resolve complaints and avoid litigation.
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\20\ Federal Register: August 28, 1996 (Volume 61, Number 168)],
Page 44395-44618, Department of Health and Human Services, Food and
Drug Administration, Regulations Restricting the Sale and Distribution
of Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents; Final Rule August 11, 1995 FDA Proposed Rule.
---------------------------------------------------------------------------
The National Association of Convenience Stores (NACS) has been the
most active entity complaining about the re-implementation of the FDA
Rule regarding youth access to tobacco products. It should be noted,
however, that NACS did not oppose similar legislation introduced by
Senator John McCain in 1998. The 1998 McCain legislation fully adopted
the 1996 FDA rule that applied to retailers, but did not contain the
provisions that have been added to the pending legislation to address
concerns that have subsequently been raised by NACS.
The current legislation directly addresses previously voiced
retailer concerns.
The pending FDA legislation says that retailers shall not
be held liable for an employee making a sale to a minor who presents a
false government issued ID if the retailer has adopted and enforced a
written policy against sales to youth, and informed its employees of
applicable laws. [Sec. 103(l)(1)(F)].
Section 103(e) provides that ``to the extent feasible, the
Secretary shall contract with the States . . . to carry out inspections
of retailers within that State in connection with the enforcement of
this Act.'' At the same time, it is clear that Federal involvement is
necessary. The so-called ``Synar Amendment,'' currently requires States
to enact and enforce youth tobacco access laws but studies by the State
attorneys general, FDA and others have found that Synar has failed to
curtail illegal tobacco sales to kids effectively. Similarly, a 2001
GAO study found that ``State implementation of Synar and [HHS]
oversight raise concern about the quality of State estimates of the
percentage of retailers that sell tobacco products to minors.'' \21\
The data is clear: current law helps, but has not solved, the youth
sales problem. On the other hand, the implementation of the FDA Tobacco
Rule's youth access provisions from 1996 to 2000 dramatically improved
the situation, and can do so again.
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\21\ U.S. General Accounting Office, Report to the Ranking Minority
Member, Committee on Government Reform, House of Representatives,
``Synar Amendment Implementation: Quality of State Data on Reducing
Youth Access to Tobacco Could Be Improved'' (November 2001).
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The FDA legislation actually states that no retailer shall
be required ``to maintain records relating to individual purchasers of
tobacco products for personal consumption.'' [Title III, Sec.
921(b)(5)]
Some complained that between 1996 and 2000 FDA played ``a
`gotcha' game'' with retailers collecting violations against a retailer
and then dumping them on a retailer all at once, without prior notice,
to get massive fines. According to FDA, that did not happen. In any
case, additional protections to address these complaints have already
been added to the FDA legislation, requiring ``timely and effective
notice to the retailer of each alleged violation at a particular retail
outlet,'' ``an expedited procedure for the administrative appeal of an
alleged violation,'' and numerous other specified procedural rights and
protections for retailers. [Title I. Sec. 103(l)(1)] The bill also
requires clear guidance from FDA as to what constitutes a ``repeated
violation'' and how long a period free of violations would produce a
clean slate. [Sec.103(l)(1)(A&E)]
A provision has been added to the legislation ``providing
for an expedited procedure for the administration of alleged
violations.'' [Section 103(l)(1)(C).]
The FDA legislation has a graduated series of penalties
and does not subject any retailer to higher-level fines or forbid their
sale of tobacco products unless the retailer has repeatedly sold
tobacco products to kids at a specific outlet, repeatedly been caught,
and repeatedly failed to remedy the situation. [Title I. Sec. 103(f)]
The legislation also specifically provides that violators that do not
engage in a new violation for a period of time after their initial
violation get a clean record and cannot be subjected to the penalties
that apply to repeat violators. [Title I. Sec. 103(l)(1)(E)].
The FDA legislation appropriately focuses on the retailers
because they not only directly profit from illegal sales to kids but
also have the most power to stop such illegal sales from occurring.
Moreover, FDA's authority extends to manufacturers, importers,
distributors, and retailers, but not to clerks and end users. The
States already have the authority to pass the kinds of laws NACS
proposes and the FDA legislation does nothing to preempt or weaken any
such State laws. In fact, the vast majority of the States already have
laws on the books that penalize youth who try to purchase tobacco
products.
State attorneys general and other experts have recommended that any
effort to reduce youth access to tobacco products include an agency
designated with clear responsibility for enforcement, frequent and
realistic compliance checks, and meaningful penalties including
graduated fines and ultimately, prohibiting sales of tobacco products
to minors. The provisions of this legislation are based on these solid
research findings and are designed to curtail illegal tobacco sales to
minors.
Other issues that have been raised by retailers that either are
addressed or were corrected previously:
1. The FDA legislation does not establish Federal licensing of all
tobacco product retailers. There is no language in the FDA legislation
or the FDA Tobacco Rule implemented by the legislation that establishes
Federal retailer licensing.
2. This legislation is still needed despite the declines in youth
tobacco use. In fact, recent declines in youth smoking rates have
stagnated and youth smoking remains at unacceptably high levels. Close
to one out of every four high school youth is a current smoker. While
progress has been made, every single day 4,000 additional new kids try
their first cigarette, and another additional 1,000 kids become new
daily smokers.
3. The legislation goes out of its way to treat all retailers
fairly. Many of the restrictions on retailers in the FDA Tobacco Rule
apply to ``any person, who sells cigarettes or smokeless tobacco to
individuals for personal consumption,'' which includes Internet and
other mail-order sellers. [Rule Sec. 897.3(h); 897.14]. Internet and
other mail-order sellers of tobacco products are also specifically
prohibited from redeeming coupons or sending free samples through the
mail. [Rule Sec. 897.16(c)(2)(i)]. Also, FDA has full authority to
establish additional rules that would also apply specifically to
Internet sellers, such as onsite age and identity verification and the
like, as needed. [See, e.g., Title I, Sec. 906(d)(1)] NACS also fails
to acknowledge that separate Federal legislation to place requirements
on Internet and other mail-order tobacco product sellers has been
introduced in a past session of Congress and will be introduced again
soon. In addition, the State attorneys general have already taken steps
toward reducing the Internet tobacco product sales problem.
4. The bill does not give tobacco product retailers in adult-only
facilities an unfair advantage. The vast majority of the provisions
relating to retailers in the FDA legislation and the FDA Rule apply to
all retailers. While certain ad restrictions in the Rule do not
currently apply to some ads in adult-only facilities, Sec. 913 of the
FDA bill orders FDA to apply all advertising restrictions that apply to
retailers in youth-accessible facilities to retailers primarily engaged
in tobacco product sales that are located in adult-only facilities, as
well.
5. Nothing in the FDA tobacco legislation restricts the sales of
such cessation products in convenience stores.
6. Some oppose the FDA bill's provision prohibiting any outdoor
advertising within 1,000 feet of a school or playground because they
say it will prohibit convenience stores located within any such 1,000
feet perimeter from having any indoor tobacco product advertising, In
fact, the provision that establishes the 1,000 feet restriction
specifically prohibits only ``outdoor advertising'' described as
``including billboards, posters, or placards,'' and does not make any
mention of either retail outlets or ads located inside retail outlets.
[Rule Sec. 897.30(b)].
7. The requirement holding retailers liable for selling tobacco
products that do not have the warning labels on them is meant to
curtail the sale of counterfeit tobacco products, parallels provisions
currently in Federal and State law that hold retailers liable for
selling cigarettes without required tax stamps on them (and retailers
could check for proper warning labels at the same time that they are
checking for valid tax stamps). The only tobacco products that would
not have the required labeling (or tax stamps) would be contraband and
counterfeit tobacco products, and retailers should not be allowed to
sell such illegal products. At the same time, to reduce the label-
checking requirements on retailers, the FDA legislation was already
revised to clarify that retailers are not responsible for checking to
see whether warning labels comply with the requirements governing when
warnings need to be rotated.
Question 11. Have there been significant differences in enforcement
of youth sales restrictions under the FDA rule between 1996 and 2000
and under subsequent State efforts pursuant to the Synar Amendment?
Which system has been more effective?
Answer 11. In 1992, Congress passed the Synar Amendment, which
requires States and territories to enact laws prohibiting the sale of
tobacco to minors and to enforce these laws effectively. Study after
study has found that the Synar requirements alone are inadequate and
that it has failed to curtail illegal sales of tobacco to kids. The
State Attorneys General produced such a study in the 1990s,\22\ as did
the FDA in 1995. A 2001 GAO study found weaknesses in State
implementation of Synar provisions and the U.S. Department of Health
and Human Services (or SAMHSA, the agency responsible for overseeing
Synar implementation) oversight of State activity.\23\ Specifically,
GAO found that some States used inaccurate and incomplete lists of
tobacco retailers from which to select samples for inspection. Second,
States did not use a standardized protocol to conduct inspections; as a
result, most States used minors younger than 16 to conduct inspections
and told minors not to carry identification on inspections. Research
suggests that these protocols artificially lower violation rates.
Third, HHS approved some States' reported violation rates even though
the rates were calculated incorrectly. Finally, HHS relied on States to
verify their own inspection results and did little to verify the
accuracy of the State data. This is a particular problem since a
State's substance abuse block grant could be reduced for failing to
meet annual violation rate goals, giving States an incentive to report
artificially low violation rates. Also, there was great variability in
how States enforced the law. Some States did an excellent job enforcing
the law, while many were non-compliant.\24\ More recent data that
suggest that over time, more States have begun to effectively enforce
the Synar requirements, don't take into account the fact that States
measure enforcement differently and the impact of FDA's enforcement
program.
---------------------------------------------------------------------------
\22\ No Sale: Youth, Tobacco and Responsible Retailing. Findings
and Recommendations of a Working Group of State Attorneys General.
December 1994.
\23\ U.S. General Accounting Office, Report to the Ranking Minority
Member, Committee on Government Reform, House of Representatives,
``Synar Amendment Implementation: Quality of State Data on Reducing
Youth Access to Tobacco Could Be Improved'' (November 2001).
\24\ DiFranza JR. ``Are the Federal and State Governments complying
with the Synar Amendment?'' Archives of Pediatric and Adolescent
Medicine 153(10): 1089-97, October 1999.
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Another weakness of the Synar Amendment is that it does not require
States to use penalties to enforce the law; States are only required to
report evidence of actions taken to enforce State laws. Research shows
that enforcing existing laws against cigarette sales to kids through
regular retailer compliance checks and issuing civil penalties to
retailers can significantly reduce youth smoking.\25\ The data are
clear: the Synar Amendment helps but does not solve the problem.
---------------------------------------------------------------------------
\25\ DiFranza JR and Dussalt GF. ``The Federal Initiative to Halt
the Sale of Tobacco to Children--the Synar Amendment, 1992-2000:
Lessons Learned.'' Tobacco Control 14:93-98, 2005.
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In contrast, as a regulatory agency, FDA took a different approach
to limit youth access to tobacco products. FDA's program focused on
enforcement and assessed penalties against retailers who repeatedly
sold tobacco products to youth. The youth access provisions of the
original FDA regulations in place from 1996 to 2000 were effective in
reducing illegal sales to youth. Congress appropriated funding for this
program, and FDA enforced the youth access restrictions, not by
employing Federal agents, but by contracting with State and local
officials, such as health departments and police departments. By 2000,
the FDA had contracts with every State to conduct the compliance checks
and had an extensive outreach program that provided resources and
information to retailers.
Question 12. Several witnesses alluded to the inadequacy of the
Master Settlement Agreement between the States and the tobacco
companies as a means of regulating industry advertising and marketing
practices. Please describe the types of advertising and marketing that
are not covered by the MSA, and explain the limitations on enforcement
of the restrictions that are contained in the Agreement when a company
violates them.
Answer 12. Although a constructive step in the right direction, the
multistate settlement agreement with the cigarette companies (MSA) does
not adequately address the problem of tobacco use in the United States.
According to the cigarette companies, the MSA dramatically changed the
way they market their cigarettes. The cigarette companies also say that
they are no longer trying to increase the number of smokers and no
longer market their deadly products to kids. In fact, studies show that
tobacco-industry marketing has reached record levels since the
settlement, with much of the increase in strategies that reach and
influence kids. From 1998 to 2003, cigarette company marketing
increased by 125 percent nationwide, with cigarette company marketing
in 2003 totaling at least $15.1 billion (or more than $40 million per
day), a record high.\26\ These tobacco industry marketing increases
have overwhelmed any public health benefits from the marketing
restrictions that were put into place in late 1998 by the Master
Settlement Agreement (MSA) between the States and the tobacco
companies. Other examples of cigarette company marketing after the
settlement include:
---------------------------------------------------------------------------
\26\ U.S. Federal Trade Commission (FTC), Cigarette Report for
2003, 2005 [data for top six manufacturers only].
This month, R.J. Reynolds launched Camel No. 9, a
cigarette clearly aimed at girls and young women. Camel No. 9 has sleek
packaging, flowery ads and the slogan ``light and luscious.'' News
reports have estimated that RJR is spending between $25 and $50 million
to launch its new product. Full-page ads are running in women's
magazines that have high youth readership such as Glamour,
Cosmopolitan, Marie Claire, InStyle and Vogue. Point-of-sale marketing
is expected to be heavy and is already saturating stores and bodegas in
New York City.
In 2005, R.J. Reynolds launched a music-themed Kool
marketing campaign, aimed at both African-American and Latino youth.
This Kool Be True advertising campaign featured young, hip, multi-
ethnic models, often with musical instruments, and appeared in
magazines popular with young African-Americans and Latinos, including
Jet, Essence, Latina and Cosmopolitan En Espanol.
In 2004, R.J. Reynolds introduced a pineapple and coconut-
flavored cigarette called ``Kauai Kolada'' and a citrus-flavored
cigarette called ``Twista Lime.'' RJR also introduced Camel ``Winter
Blends'' with flavors including ``Warm Winter Toffee'' and ``Winter
MochaMint.'' Ads for these cigarettes appeared in magazines with
significant youth readership such as Rolling Stone, Glamour,
Cosmopolitan and Elle. The U.S. Smokeless Tobacco Company is marketing
spit tobacco with flavors including berry blend, mint, wintergreen,
apple blend, vanilla and cherry. The marketing of candy-flavored
cigarettes has been condemned by public health experts as being aimed
at trying to get kids to experiment with smoking. A study by the
Roswell Park Cancer Institute found that 17-year-old smokers (23
percent) were more than twice as likely to use flavored cigarettes as
24-26-year-old smokers (9 percent).\27\
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\27\ Giovino, G. et al., ``Use of Flavored Cigarettes Among Older
Adolescent and Adult Smokers: United States 2004.'' PowerPoint
Presentation.
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Also in 2004, Brown & Williamson implemented the Kool Mixx
cigarette marketing campaign clearly aimed at youth, and African-
American youth, in particular. The Kool Mixx campaign featured images
of young rappers, disc jockeys and dancers on cigarette packs and in
advertising. The campaign also included radio giveaways with cigarette
purchases and a Hip-Hop disc jockey competition in major cities around
the country.
In 1999, the first year after the multistate settlement
agreement (MSA), the cigarette companies spent a record $8.2 billion on
advertising and promotions, an increase of $1.5 billion, or 22.3
percent--and the largest 1-year increase since the U.S. Federal Trade
Commission (FTC) began tracking tobacco-industry marketing expenditures
in 1970.\28\
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\28\ U.S. Federal Trade Commission (FTC), Cigarette Report for
2003, 2005 [data for top six manufacturers only].
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A July 2000 study found that after a settlement-mandated
ban on tobacco billboard advertising went into effect, tobacco-company
advertising and promotions increased significantly at retail outlets--
and 75 percent of teens visit a convenience store at least once a
week.\29\
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\29\ Wakefield, M, et al., ``Changes at the point of purchase for
tobacco following the 1999 tobacco billboard advertising ban.''
University of Illinois at Chicago. Research Paper Series, No. 4, July
2000.
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In May 2000, The Wall Street Journal and a new study by
the Massachusetts Department of Public Health separately reported that
cigarette company advertising in magazines with large youth readerships
had increased by 33 percent since the MSA was signed.\30\
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\30\ Turner-Barker, D. & W. Hamilton, Cigarette Advertising
Expenditures Before and After Master Settlement Agreement: Preliminary
Findings, Massachusetts Department of Public Health (May 15, 2000),
http://www.state.ma.us/dph/mtcp/report/mag.htm; Fairclough, G., ``Are
Cigarette Ads in Magazines Angling for Teens?,'' The Wall Street
Journal (May 15, 2000).
It is critical that we address tobacco product marketing because
there is compelling evidence that much of this advertising and
promotion is directed at kids and successfully recruits new tobacco
users. A 2002 monograph by the National Cancer Institute, which
reviewed the research on tobacco advertising and promotion and its
impact on youth smoking, found that tobacco advertising and promotional
activities are important catalysts in the smoking initiation process.
The NCI report also found, based on a review of the extant research,
that ``the conclusion that there is a causal relationship between
tobacco marketing and smoking initiation seems unassailable.'' \31\ The
MSA's restrictions on cigarette marketing do not meaningfully restrict
cigarette company marketing practices, including many that reach and
influence kids.
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\31\ National Cancer Institute, Changing Adolescent Smoking
Prevalence, Smoking and Tobacco Control Monograph No. 14, NH Pub. No.
02-5086, November 2001.
The MSA Allows the Following Cigarette Company Marketing Practices
---------------------------------------------------------------------------
to Continue:
Permits outdoor advertising for cigarettes and other
tobacco products with signs of 14 square feet or smaller on the
buildings or property of any business where tobacco products are sold
(including at stores next to schools and playgrounds) and at any events
sponsored by the tobacco industry.
Places no limits or restrictions on any cigarette or
tobacco product advertising inside the more than half a million
businesses where tobacco products are sold.
Places no limits or restrictions on cigarette or other
tobacco advertisements in newspapers and magazines, even if they have
large numbers of underage readers.
Places no limits or restrictions on advertising or selling
cigarettes or other tobacco products on the Internet. See specific
provisions of FDA Rule.
Places no limits or restrictions on direct-mail
advertising of tobacco products;
Permits each tobacco company to continue a single tobacco-
product brand-name sponsorship of an event not specifically prohibited
(see above), such as auto racing or rodeo events, with the limit of a
``single'' sponsorship defined to allow the companies to sponsor an
entire single series of auto races, rodeos, or other events (such as
all NASCAR races);
Places no restrictions on the televising of tobacco brand-
name sponsored events.
S. 625 addresses each of these areas. It also recognizes that the
tobacco industry has often circumvented rules designed to curtail both
marketing to children and misleading of the public and provides FDA the
needed authority to adopt new rules to address new conditions as they
arise.
The need for this legislation, despite the Master Settlement
Agreement, is further demonstrated by the findings of Judge Kessler
last August. Judge Kessler's Opinion included 238 pages that recite
both the tobacco industry's long time marketing to children and
continued marketing that reaches and impacts young people. It is a
devastating indictment of both the efforts and the ability of the
tobacco companies to continue to use marketing to reach and appeal to
our youth despite the MSA and all prior efforts to retrain their
behavior. As Judge Kessler concluded,
``. . . Defendants continue to engage in many practices which
target youth, and deny that they do so. Despite the provisions
of the MSA, Defendants continue to track youth behavior and
preferences and market to youth using imagery which appeals to
the needs and desires of adolescents. Defendants are well aware
that over 80 percent of adult smokers began smoking before the
age of 18, and therefore know that securing the youth market is
critical to their survival. There is therefore no reason,
especially given their long history of denial and deceit, to
trust their assurances that they will not continue committing
RICO violations denying their marketing to youth.'' [Judge
Kessler's Final Opinion, pgs. 1607-1608]
S. 625 is much needed legislation that would grant FDA the
authority necessary to crack down on marketing and sales to children.
questions of senator enzi
Question 1. The real question here is not whether the Federal
Government should regulate tobacco--it should, and it does already.
Given that numerous Federal and State agencies, including the Federal
Trade Commission, the Federal Communications Commission, the Department
of Justice and many others, already regulate tobacco, why do you
believe involving FDA will have a greater impact?
Answer 1. Despite the fact that there are several Federal agencies
with extremely limited authority over very narrow aspects of the
tobacco issue, tobacco and tobacco marketing remain unregulated for
health purposes. There is no agency with a mandate to regulate tobacco
for the purpose of protecting the public health and/or reducing the
number of people who die from tobacco use. There is no agency with any
regulatory authority that also possesses essential scientific expertise
to protect public health. Overall, there exists a gaping hole in the
Federal safety net as it relates to tobacco.
The FCC's role is limited to monitoring compliance with the decades
old ban on television and radio prohibitions on tobacco advertising.
The DOJ's role is limited to enforcing potential violations of the
congressionally mandated labeling requirements on cigarettes. The FTC's
role is equally limited. It enforces the specific congressionally
mandated labeling requirements for smokeless tobacco products, is
supposed to collect data on total tobacco industry marketing
expenditures and issue a report containing that information. In
addition, section 5 of the FTCA gives the FTC the law enforcement
responsibility over false and deceptive marketing, as that term has
been traditionally defined that includes but is not limited to tobacco.
As the former Chairman and the former Director of the FTC's advertising
division have testified before Congress, the FTC lacks the scientific
expertise and public health mandate to carry out these tasks, even the
tasks related to marketing, that are assigned to the FDA in this
legislation. By its own admission the FTC is ``an agency of lawyers and
economists'' and is not a science-based agency and does not have the
necessary scientific, medical and public health expertise to evaluate
scientific claims and data regarding tobacco products.\32\ Furthermore,
FTC is a law enforcement agency whose primary task is to enforce the
law against false and deceptive advertisements without regard for
whether technically accurate statements have a major adverse impact on
public health and result in consumers making health decisions based on
incomplete information. The FTC's ability to craft industrywide
solutions is extremely narrow. As a result, in almost every instance
the FTC acts retrospectively against one bad actor once a violation has
occurred.
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\32\ Testimony by Timothy Muris, FTC Chairman, June 3, 2003, before
the Committee on Energy and Commerce Subcommittee on Commerce, Trade,
and Consumer Protection, U.S. House of Representatives.
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In contrast, FDA is charged with protecting the public's health and
as a public health agency acts prospectively to address problems. The
FDA possesses talented and skilled scientists and researchers who are
able to conduct sophisticated analyses and evaluate complex scientific
data of the impact of different products on the health of consumers.
For example, the FDA's National Center for Toxicological Research
mission ``involves fundamental and applied research specifically
designed to define biological mechanisms of action underlying the
toxicity of products regulated by the FDA.'' FDA's various centers that
oversee foods, drugs, medical devices, and biologics are home to career
chemists, toxicologists, statisticians, epidemiologists, and
surveillance and consumer marketing experts with very relevant skills
to begin the process of assuming regulatory oversight of tobacco
products. These are the types of functions and skills that will be
critical to building an effective, science-based regulatory regime for
tobacco products. These are the skills we need to employ in the pursuit
of ensuring that all scientific avenues are explored to lower the
toxicity and reduce the morbidity and mortality associated with tobacco
products and their marketing and claims.
FDA is unique in that it is the one agency that combines scientific
expertise with experience in exercising regulatory authority.
Question 2. Dr. Blum included a number of old cigarette ads with
his testimony. In ad after ad, the tobacco companies have co-opted
existing science and regulation as an advantage to their products over
others. For example, in the Carlton ad, it says ``U.S. Government
testing confirms--Carlton is lowest!'' Is there anything in this bill
that precludes a tobacco company from including on its cigarette
package label or in its advertisements a statement that says ``This
product was made in accordance with FDA standards?''
Answer 2. Every ad that Dr. Blum showed would be prohibited by the
current legislation. Dr. Blum correctly used these ads to show how the
tobacco industry has deceived millions of consumers. What he did not
note was that the current bill prohibits these tactics by eliminating
the terms ``light,'' ``low tar'' and claims like ``Carlton is lowest''
because the public incorrectly perceives these types of claims as
indicating that Carlton exposes consumers to lower levels of toxic
substances.
It is also important to note that while Dr. Blum correctly cited a
number of ads as being deceptive and harmful to public health, these
ads were permitted to continue by the Federal Trade Commission. It is a
good example of the limitations of the FTC. FTC does not have the
expertise or the authority to protect the public against this type of
advertising. Dr. Blum's testimony illustrates that currently, no
Federal agency has the authority to review health claims or stop
tobacco companies from misrepresenting the facts and misleading
consumers. The legislation would address this problem in a manner
consistent with sound scientific standards.
In addition, S. 625 gives FDA the authority to preclude a tobacco
company from including on its cigarette package or in its
advertisements a statement that says this product is ``FDA Approved''
or is ``made in accordance with FDA standards.'' Five separate sections
of the bill give the FDA full authority to control what a manufacturer
says in its label, labeling and advertising, authority sufficient to
permit the FDA to ban the kind of statements that are the subject of
this question.
In addition, the bill explicitly prohibits any person from
labeling, advertising or taking any other action directed to consumers
that states or implies that the product is less hazardous than other
tobacco products or reduces exposure to substances in tobacco products
without first having sought and obtained FDA approval according to the
standards set forth in the legislation.
Finally, if the committee believes that the legislation should
contain an express prohibition of the type of statements that are the
subject of this question, the public health supporters of this
legislation would not object.
Question 3. The drug industry user fees pay for more than half of
the FDA drug review program. This has caused a lot of consternation
among some patient and consumer groups who are concerned about
potential industry influence on the agency. Do you have concerns about
the tobacco industry paying for 100 percent of the tobacco review
program?
Answer 3. We would be concerned if this legislation or the fee
structure gave the tobacco industry influence over how the FDA would
implement this legislation. It does not. Under this legislation, the
tobacco industry does not have any authority over how the money is
spent, how FDA sets its priorities, or how much FDA receives. The user
fee system in this bill provides FDA with adequate resources to
effectively regulate tobacco products. Another strength of the user fee
system is that, unlike the MSA, funding for FDA is not dependent upon
the amount of tobacco used, but rather on manufacturers' share of the
entire U.S. market.
Question 4. The bill says a tobacco product cannot be labeled with
the term ``light'' or ``low tar'' unless it has been shown to actually
reduce the risk of harm or disease. However, the legislation does not
demand that existing light or low tar products be removed from the
market or even modified, unless a complicated and lengthy process for
determining a product standard is set. Just the labeling has to be
changed. If we already know that these products are not in fact better
for consumers, why wouldn't we directly try and get them off the
market?
Answer 4. This provision will have an immediate and substantial
benefit to the public health. It is the marketing of these products in
ways that have misled consumers into believing that they are less
hazardous that has caused millions of smokers to switch rather than
quit. Preventing the tobacco companies from continuing to mislead the
American public about the relative harm of these products will
represent a major step forward. However, unless this legislation is
enacted, consumers will continue to be misled by the tobacco industry
on the issue of light and low tar cigarettes--a point highlighted by
Judge Kessler in her August 2006 ruling against the tobacco company
defendants in the Department of Justice tobacco lawsuit,
``Contrary to their internal documents, Defendants also
continue to deny that low tar cigarettes are just as hazardous
to smokers as full-flavor cigarettes, in part because of smoker
compensation. In 1998, Philip Morris, RJR, B&W, and Lorillard
jointly stated to the FTC that compensation was so ``weakly
documented'' that the FTC should not require disclosure
warnings to alert consumers, and that they were ``unaware of
evidence,'' other than that presented in Monograph 7,
520842199-2295 at 2243, 2289 (US 88618), that consumers viewed
low-tar cigarettes as safer. Defendants are well aware from
their own research that a majority of smokers believe that low-
tar cigarettes are healthier, are willing to buy them for
precisely that reason, and are willing to sacrifice taste for
what they believe to be less harmful cigarettes. Nonetheless,
to this day, Defendants still deny that, as Monograph 13 found,
low-tar cigarettes are just as dangerous as full-flavor
cigarettes. These RICO violations are likely to continue.''
[Judge Kessler's Final Opinion, page 1609]
Today, in the absence of this legislation, we are left with a
situation described by the National Cancer Institute \33\ in which:
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\33\ National Cancer Institute. Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
Department of Health and Human Services, National Institutes of Health,
National Cancer Institute, NIH Pub. No. 02-5074, October 2001, http://
cancercontrol.cancer.gov/tcrb/monographs/13/.
1. Many consumers use the terms ``Light'' and ``Ultra-Light'' as a
guide to the riskiness of particular brands of cigarettes.
2. Many smokers choose Light and Ultra-Light brands because they
believe that such cigarettes are less likely to cause health problems.
3. Individuals who are most concerned about smoking risks and most
interested in quitting adopt low-yield brands.
Once enacted this legislation will give the FDA the authority--for
the first time--to also look at whether the establishment of product
standards related to these products can further add to the public
health benefit, but that decision is properly left to the FDA and is to
be based on the best available science. Decisions about the content of
tobacco products and what changes should be ordered in the content of
tobacco products should be made by scientists based on an evaluation of
what changes will best protect the public health and this bill gives
precisely that authority to the FDA.
question of senator burr
Question. How is keeping tobacco products on the market in the best
interest of the public's health? Please provide a direct answer to this
question.
Answer. Without this legislation tobacco products not only remain
on the market, they continue to be unregulated for health purposes. The
status quo is a situation in which no Federal agency has the authority
to require the tobacco companies to disclose what they know about their
product or to require any tobacco company to make any change in any
tobacco product to make it less harmful or less addictive.
Under this legislation, for the first time ever, a science-based
agency will be able to evaluate tobacco products, review health claims,
and assess the risks associated with these products, and require
changes in tobacco products in order to reduce the number of toxins in
them and/or to require changes in nicotine levels based on a scientific
assessment of what will best protect the public health and reduce the
number of people who die from tobacco use. It is long past due that
tobacco products be placed under the jurisdiction of an experienced,
credible, science-based public health agency with the skills and
expertise necessary to evaluate tobacco products and require changes to
protect the public health.
The important issue is whether the legislation provides the most
effective tools to protect the public health and reduce the number of
people who die prematurely from tobacco use. We believe it does. Using
sound scientific techniques, FDA can work to lower the harms associated
with the use of tobacco products and can do so in the most responsible
and effective way possible.
This legislation recognizes that there are approximately 50 million
Americans addicted to tobacco today. Given this situation, the soundest
public policy is one that seeks to reduce the number of those people
who die from tobacco use, positively impacts the efforts of those who
want to quit and prevents the tobacco companies from addicting another
generation of our children. This bill does precisely that.
questions of senator hatch
Question 1. In your testimony, you talk about the surveys that your
organization conducted on tobacco advertising. One of the findings
found that children are almost twice as likely as adults to remember
tobacco advertising. Did your survey go into how many of these children
actually take up smoking? Hasn't the youth smoking trend started to
decline?
Answer 1. There is compelling evidence that much of tobacco
industry advertising and promotion impacts kids and contributes to the
number of children who become tobacco users. A 2002 monograph by the
National Cancer Institute, which reviewed the research on tobacco
advertising and promotion and its impact on youth smoking, found that
tobacco advertising and promotional activities are important catalysts
in the smoking initiation process and concluded ``. . . that there is a
causal relationship between tobacco marketing and smoking initiation
seems unassailable.'' \34\ A study published in the December 2006 issue
of the peer-reviewed journal Archives of Pediatrics and Adolescent
Medicine found that exposure to tobacco marketing, which includes
advertising, promotions and cigarette samples, and to pro-tobacco
depictions in films, television, and videos more than doubles the odds
that children under 18 will become tobacco users. The researchers also
found that pro-tobacco marketing and media depictions lead children who
already smoke to smoke more heavily, increasing the odds of progression
to heavier use by 42 percent.\35\ These data are disturbing because
kids continue to be exposed to tobacco advertising at high rates.
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\34\ National Cancer Institute, Changing Adolescent Smoking
Prevalence, Smoking and Tobacco Control Monograph No. 14, NH Pub. No.
02-5086, November 2001.
\35\ Wellman RJ, et al., ``The extent to Which Tobacco Marketing
and Tobacco Use in Films Contribute to Children's Use of Tobacco: A
Meta-Analysis.'' Archives of Pediatrics and Adolescent Medicine 2006
Dec;160(12):1285-96.
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Tobacco use among young people did decline between 1998 and 2003.
The best available science indicates that these reductions were
prompted by a number of actions, including increases in cigarette
excise taxes, enactment of comprehensive smoke-free workplace laws, and
State tobacco prevention and cessation programs. The national truth
sm campaign, conducted by the American Legacy Foundation,
which is targeted at youth and includes television and radio
advertising, grassroots efforts, and an interactive Web site, has also
contributed to declines in smoking prevalence among high school
students.\36\ While we have made much progress, results from recent
national surveys indicate that the Nation's progress in reducing youth
smoking has stalled or slowed to a crawl.
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\36\ American Legacy Foundation. ``Getting to the Truth: Assessing
Youths' Reactions to the Truth sm and `Think. Don't Smoke'
Tobacco Countermarketing Campaigns,'' First Look report 9, June 2002.
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What is also important to note is that since the Master Settlement
Agreement was adopted in 1998 there has been a dramatic increase in
tobacco industry marketing, including in areas that have been proven to
impact children. Thus, it is no surprise that not a single published
study has attributed any of the decline in youth tobacco use to any
change in the tobacco industry's marketing. In fact, the CDC has
concluded that one possible reason for the fact that the decline in
youth tobacco use has stalled is the dramatic increase in tobacco
marketing. Data from the most recent FTC report show that tobacco
industry spending on marketing and promotion increased by 125 percent
from 1998 to 2005. It also shows that major tobacco companies have
sharply increased their marketing expenditures in categories known to
lead to increased use among youth.\37\
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\37\ U.S. Federal Trade Commission (FTC), Cigarette Report for
2003, 2005 [data for top six manufacturers only].
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It is a fair question to ask: Where would tobacco use rates be, had
the tobacco industry not doubled its marketing efforts and spent its
marketing expenditures in ways known to reach youth? There is consensus
in the public health community that rates would have been lower, and
ultimately fewer youth would die prematurely from smoking-caused
disease. The marketing restrictions in this legislation are based on
the best available science that documents the impact of current tobacco
marketing practices and takes into consideration the evidence of the
tobacco industry's continued marketing practices.
Question 2. I also noted in your testimony that while you
understand why there are concerns about the FDA's resources, you
believe that a new user fee imposed on the tobacco industry will take
care of the resource issue. Mr. Myers, how do you know that the user
fee imposed on the tobacco companies is the appropriate amount of
money? What if it is too little? I would be interested in your thoughts
on this issue.
Answer 2. The goal of this legislation is to insure that FDA is
given adequate resources to do its job well and without taking any
resources from other FDA activities. Thus, this legislation provides
for a new and independent funding mechanism for FDA's new tobacco
product-related responsibilities. The new responsibilities would be
funded through a user fee on the tobacco industry, so it would have no
impact on the funding provided to FDA to carry out its other important
activities. The user fees are allocated among the manufacturers of
tobacco products sold in the United States, based on the manufacturers'
respective shares of the entire U.S. tobacco-product market. The groups
that support this legislation care deeply about the many important
tasks of the FDA including drug and device approval and the work the
agency does to protect our food supply.
The estimated funding levels provided for in the legislation, which
ramp up to $300 million annually in year three, are based on FDA's
prior experience regulating tobacco from 1996-2000 along with budget
documents and estimates provided by FDA during previous congressional
debates on legislation to provide FDA with authority over tobacco
products.
Question 3. There has been a growing tendency both at the Federal
and at the State level to use monies generated from tobacco taxes for a
variety of legislative purposes that are not directly connected to
anti-smoking campaigns, some of which are very legitimate initiatives.
Let's assume two scenarios. First, Congress bans cigarettes tomorrow
and the ban works. We are no longer able to rely upon any revenues,
either at the Federal or the State level, from the sale of tobacco. If
such a ban took place, what would be the budgetary shortfall that we
would have to make up? Second, let's assume the legislation before the
committee is enacted, which is intended, among other things, to result
in a reduction of the sale of cigarettes. What is the budgetary
shortfall we can expect if the current bill is enacted at both the
Federal and State level?
Answer 3. First, nothing in this legislation will lead to a ban on
cigarettes tomorrow and no one who supports this legislation supports
such an action.
Second, the concerns expressed by these questions don't take into
account the fact that tobacco does not just generate revenue for
government, it imposes enormous costs on society and government.
Studies demonstrate that tobacco use is a significant net drain on
State governments, the American government and the economy. In monetary
terms alone, tobacco costs the American economy nearly $97 billion
every year in excess health care expenditures and nearly $98 billion
every year in additional productivity losses.\38\ In human terms,
tobacco results in the annual, preventable deaths of more than 400,000
Americans and more than 8 times that figure in people living with a
tobacco-caused illness or disease.\39\ Clearly, a decline in tobacco
use and a decline in tobacco-related disease will have a positive
impact on the American economy, Federal budget, State budgets and, most
importantly, on American families. If this legislation results in fewer
children smoking and fewer people dying from tobacco, then any modest
impact on tax receipts will be more than offset by gains in
productivity and lower health care costs.
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\38\ Toll of Tobacco in the United States of America, Campaign for
Tobacco Free Kids, http://www.tobaccofreekids.org/research/factsheets/
pdf/0072.pdf (Web site accessed March 9, 2007).
\39\ Toll of Tobacco in the United States of America, Campaign for
Tobacco Free Kids, http://www.tobaccofreekids.org/research/factsheets/
pdf/0072.pdf (Web site accessed March 9, 2007).
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If this bill is enacted and rigorously implemented, it will produce
a benefit for the Government and the public--both in economic terms and
in the health of American families.
Question 4. Unfortunately, one of the consequences of the increased
regulation of cigarettes, as well as an increase in the cost, has been
a burgeoning black market in cigarettes. Again, the legislation is
intended, among other things, to discourage smoking, as well as the
smoking of cigarettes at current levels of nicotine. What provisions
are included in the bill that will enable the FDA to combat not only
the illegal sale of cigarettes in general but the possibility of a rise
in the illegal shipment of cigarettes into this country?
Answer 4. The FDA legislation has a specific section relating to
contraband tobacco products, Title III--Prevention of Illicit Trade in
Tobacco Products. That section requires all packaging of tobacco
products meant for sale in the United States to be labeled with the
statement ``Sale Only Allowed in the United States,'' which will make
illegal diversions of such products more difficult. [Sec. 921(a)] In
addition, that section requires the Secretary, within 9 months of the
enactment of the legislation, to issue regulations regarding the
establishment and maintenance of records by any person who
manufactures, distributes, exports or imports tobacco products in order
to make it easier for the Secretary to track and trace the paths taken
by tobacco products through legal distribution channels and block their
diversion into contraband trafficking. To enhance the Secretary's
abilities in this regard, this section also provides the Secretary with
authority to inspect records and to establish special codes, labels,
and designs on the labels of tobacco products that facilitate tracking
and tracing. [Sec. 921(b)]
Title III also requires manufacturers, importers, and distributors
of tobacco products to report to the Attorney General whenever they
have knowledge indicating that any tobacco product they have
manufactured, imported, or distributed has been diverted from legal
channels and become contraband. [Sec. 921(d)] Pursuant to title III,
the Comptroller General must also conduct a study of cross-border trade
in tobacco products, including illicit trade and trade of counterfeit
products, and issue a related report to Congress no later than 18
months after the enactment of the legislation. [Sec. 302].
Each of these provisions in title III should help to strengthen
existing efforts to prevent and reduce contraband trafficking in
tobacco products both within the United States and across its borders.
At the same time, the FDA legislation does not allow FDA to ban any
class of tobacco products or eliminate nicotine in any tobacco
products, which could prompt contraband trafficking and black market
sales of the prohibited tobacco products or of nicotine-full versions
of the tobacco products with no nicotine. [Sec. 907(b)(3)] In addition,
FDA is directed to take into consideration the possible impact on
contraband trafficking when requiring any changes to existing products
or issuing any new product standards. [Sec. 907(b)(1)(E)].
It is also worth noting that the FDA legislation will not
significantly increase tobacco product prices in the United States; so
it should not promote any price-based increase in contraband
trafficking. On the other hand, to the extent that the FDA legislation
changes the appearance of tobacco product packaging and labeling and
requires new anti-trafficking product codes or markings it will make
tobacco products that are legally made in the United States even more
distinguishable to enforcement officials and even harder to
counterfeit.
questions of senator coburn
Question 1. What constituents would you recommend that the FDA
require to be eliminated or reduced in cigarettes, and by how much
would that reduction or elimination reduce the relative risk of
tobacco-related diseases?
Answer 1. One of the strengths of the pending legislation is that
it properly recognizes that the answer to a question like this should
ultimately be made by individuals with complete information based upon
the best available science with the authority to monitor the impact of
any such decision and the breadth of authority to make adjustments as
new information emerges and the impact of different choices is better
and better evaluated.
The danger of making such a determination based on incomplete
information in the absence of a comprehensive regulatory mechanism,
such as that proposed by S. 625, is seen by what happened with
``light'' and ``low tar'' and by the even more recent experience in the
European Union. When the FTC permitted tobacco companies to include tar
and nicotine figures in their marketing as a result of the very simple
testing system that produced those numbers, it was believed that there
would be a benefit to consumers if they smoked products that reduced
their exposure to toxic substances and ``tar'' was selected as the
measure. It failed for a number of reasons. No agency controlled how
tobacco companies altered ``tar'' levels so the tobacco companies were
able to design their cigarettes to produce a level of ``tar'' on the
FTC machine method that bore no relationship to the actual level of
``tar'' that consumers received. Further, the overly simple system did
not recognize that not all ``tar'' is equal. Later research showed that
even as ``tar'' levels went down on the machine test, levels of certain
toxic substances in the ``tar'' actually went up. In addition, the
simple machine test did not look at other variables such as the impact
of the particle size of the constituents that make up ``tar,'' the
ability of the tobacco companies through chemical manipulation to alter
the impact of the different components of the constituents of ``tar''
and ``nicotine'' or even technology that altered where the different
constituents found in tobacco smoke lodged in the lungs of
consumers.\40\
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\40\ National Cancer Institute. Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
Chapter One: Public Health Implications of Changes in Cigarette Design
and Marketing Smoking and Tobacco Control Monograph No. 13. Bethesda,
MD: U.S. Department of Health and Human Services, National Institutes
of Health, National Cancer Institute, NIH Pub. No. 02-5074, October
2001; Tobacco Control Legal Consortium, The Verdict Is In: Findings
From United States v. Philip Morris, Light Cigarettes (2006).
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Even more recently, the European Union sought to reduce the harm
caused by tobacco products based on very incomplete information and
without any kind of meaningful regulatory controls over the product.
The EU set standards for ``tar'' and ``nicotine'' levels in cigarettes.
Yet, already research has shown that the tobacco companies were able to
design their cigarettes in such a way that consumers of products that
met these standards were actually not getting less ``tar'' or
``nicotine.'' \41\
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\41\ O'Connor RJ and Cummings MK et al., ``How did UK cigarette
makers reduce tar to 10 mg or less? British Medical Journal,
2006;332:302 (4 February), doi:10.1136/bmj.332.7536.302.
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We must be careful not to misinterpret these experiences. As NCI
Monograph 13 in 2001 concluded, our experience to date does not
demonstrate that if cigarettes actually deliver fewer and lower levels
of toxic substances, they are not likely to produce less disease. The
experience to date is that in the absence of a comprehensive regulatory
system able to base decisions on sound science and monitor cigarette
design, the impact of prior efforts have not produced meaningful
differences of actual exposure by consumers. There continues to be
widespread belief among the best available independent scientists that
if tobacco companies could be compelled to produce products with
dramatically lower levels of toxic substances in ways that resulted in
a major reduction of exposure to consumers, those products would still
remain deadly but would be likely to produce less disease.
This should not be surprising. Tobacco smoke contains over 4,000
chemicals, more than 200 of which are toxic and nearly 70 of which are
known or suspected human carcinogens. \42\ However, today, there is no
Federal agency that has authority to require tobacco companies to
identify what toxic chemicals appear in what products or brands or in
what quantity. Nor is there any requirement of the tobacco companies to
detail the testing they have conducted to test the health impact of
different toxic substances in different brands/products. This
legislation will give the FDA the authority to get this information,
marry it with the best available science, and then determine the most
appropriate action to take regarding these harmful substances both in
terms of recommending changes to the product (e.g., performance
standards) and informing consumers of the contents of these products
and the risks associated with their use.
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\42\ National Cancer Institute. Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
Department of Health and Human Services, National Institutes of Health,
National Cancer Institute, NIH Pub. No. 02-5074, October 2001.
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Therefore, any decision about what constituents should be lowered
or eliminated needs to be made by an agency: able to control how the
tobacco companies redesign their cigarettes to adjust to the new
standard; able to monitor the impact of any such decision on the other
components of the tobacco product and should be made with more
information about current cigarette technology. FDA will be able to do
that if this legislation is enacted and rigorously enforced. The
attempt to simply identify specific components to be eliminated in the
absence of the kind of authority to be given to FDA is far less likely
to produce a meaningful public health impact.
Question 2. How will smokers alter their behavior in response to
the introduction of cigarettes with new tobacco product standards? That
is, what will be the effect on cigarette consumption of smokers now
knowing that the FDA is tightly regulating all the constituents and
ingredients in cigarettes?
Answer 2. Tobacco products are among the most unregulated consumer
products on the market today and are exempt from important consumer
protections such as ingredient disclosure and product testing. In this
unregulated environment, tobacco companies are free to manipulate their
products in ways that can make them more addictive and/or more harmful.
Consumers have absolutely no knowledge of these changes, although these
changes have been shown to impact consumer behavior. As the recent
study from the Harvard School of Public Health demonstrates, tobacco
companies have secretly and significantly increased the levels of
nicotine in cigarette smoke over time.\43\ We have no idea how this
change has impacted consumers. We also know too little about other
changes the tobacco industry has made (and continues to make) to their
products to make them more appealing to current users, easier to use,
and harder to quit. Regulatory oversight is essential if we are ever
going to fully understand tobacco products and how changes to these
products effects initiation and use.
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\43\ Connolly, Gregory N., et al., ``Trends in Smoke Nicotine Yield
and Relationship to Design Characteristics Among Popular U.S. Cigarette
Brands 1997-2005.'' Tobacco Research Program, Harvard School of Public
Health, January, 2007.
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A few other examples of what happens in the absence of regulation
of the type proposed by this legislation also helps put this
legislation in context. After the 1964 Report of the Surgeon General,
millions of people switched to light and low tar cigarettes believing
that such cigarettes exposed them to lower levels of toxic substances
and reduced their risk of disease. As the National Cancer Institute
Monograph 13 in 2001 found, these perceptions turned out to be
inaccurate, in part because in the absence of regulation the tobacco
companies were able to make design changes to cigarettes so that they
produced low test results on the FTC testing machine that bore no
relationship to the actual exposure consumers received.\44\
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\44\ National Cancer Institute. Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
Department of Health and Human Services, National Institutes of Health,
National Cancer Institute, NIH Pub. No. 02-5074, October 2001, http://
cancercontrol.cancer.gov/tcrb/monographs/13/.
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Another good example is what happened with nitrosamine levels in
cigarettes after the introduction of light and low tar products.
Nitrosamines are one of the potent carcinogens that have been
identified in the smoke of tobacco products. Much to the surprise of
many scientists, research conducted many years after the introduction
of light and low tar tobacco products demonstrated that even as tar
ratings on the FTC testing machine dropped, nitrosamine levels in
cigarettes rose dramatically. In the absence of regulation, consumers
did not know this potentially important fact. Indeed, the Government
did not know this fact and as a result, government was not in a
position to prevent the tobacco companies from allowing nitrosamine
levels to rise.
Later after at least one major tobacco company said publicly that
it was reducing nitrosamine levels, research demonstrated that
nitrosamine levels in the products of this manufacturer as well as
others remained high. Once again consumers were misinformed because no
governmental agency regulated these products or had this information
and no one was in a position to require the tobacco companies to lower
the level of this carcinogen as well as others.
Other studies have subsequently shown that design changes in
tobacco products have increased the potency of the nicotine in these
products without the knowledge of either consumers or the Government
and other studies have shown that design changes have altered levels of
nicotine in other ways that the Federal Government did not know about.
With a product almost always first used by children, there is good
scientific reason to be concerned that changes to these products that
increase the potency or level of the prime addiction causing agent
increase the speed with which children become addicted and make it
harder for tobacco users to quit.
S. 625 gives the FDA the clear authority to prevent these types of
abuses by requiring tobacco companies to disclose for the first time
the type of information that would prevent the tobacco companies from
hiding this kind of information from consumers and to prevent a tobacco
company from making product changes in secret that could make the
product more harmful and more addictive. By helping to create a market
place where consumers and the Government are better informed, we give
consumers new tools to take steps to protect their own health and give
government new tools to prevent the tobacco industry from continuing
its current harmful practices.
Your question is: How will consumers respond? The evidence from our
experience after the Surgeon General's 1964 is clear. Faced with new
information about the health hazards of tobacco products, consumers in
very large numbers quit or switched to products that they believed
reduced their risk of disease. The problem was that those products did
not actually reduce their risk of disease, tobacco marketing misled
those consumers and no Federal agency had the power to intervene to
make sure that the market place was filled with truthful and complete
information. Unfortunately, many consumers already believe that
cigarettes and other tobacco products--and the claims being made in
their advertising--are already regulated and approved by the Federal
Government.\45\ The evidence is strong that consumers will benefit and
be better able to take steps to alter their behavior if this
legislation passes, even before FDA is able to initiate the processes
that could lead to the elimination and/or reduction of toxic substances
in tobacco products or changes in nicotine delivery.
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\45\ ``Smokers' responses to advertisements for regular and light
cigarettes and potential reduced-exposure tobacco products,'' Nicotine
& Tobacco, Volume 6, Supplement 3 (December 2004) S353-S362.
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S. 625 also gives FDA, for the first time, authority to require
companies to make changes in existing products, including the removal
of harmful ingredients. Under this legislation, FDA would determine
whether an action regarding a tobacco product will ``protect the public
health.'' This standard would require consideration of whether a
product change would reduce the overall harm caused by tobacco use,
including the harm caused to individual tobacco users and the impact on
the population as a whole.
Importantly, the legislation enables FDA to require changes in
nicotine based on the best available science for the purpose of
reducing the number of people who die from tobacco. The key is that the
science will dictate the best approach. In evaluating the impact of
different possible changes in the levels of nicotine, FDA will be able
to assess the impact on current smokers, smokers trying to quit and
non-
tobacco users and make its decision about what steps will be most
effective in reducing the number of people who die from tobacco. It
will be a broad multi-focused analysis that only an agency with broad
authority, adequate information, significant scientific expertise and a
focus on public health can achieve.
Question 3. In what way will reducing the nicotine levels in
cigarettes improve the public's health, since we know that when
nicotine levels are reduced, smokers compensate by smoking more? Won't
this approach in fact hurt the public's health?
Answer 3. This legislation does not prejudge the best way to
control nicotine to reduce the death and disease caused by tobacco.
Instead, it gives the FDA the authority to examine what to do about
nicotine based upon the best available science taking into account the
impact of any such change on both individual smokers and the population
as a whole. Thus, this legislation recognizes the important role played
by nicotine, but also recognizes that what changes should be made
require the FDA to look broadly and to examine carefully the best and
newest science on the impact of different proposed changes.
In the absence of effective legislation to regulate the tobacco
industry and their products and marketing, nicotine levels in tobacco
products have been intentionally changed by the tobacco companies
(unbeknownst to consumers or the Government) to make them more
addictive and to deliver more rapid doses of nicotine. As concluded by
Judge Kessler in her August 2006 ruling in the Department of Justice
lawsuit against the tobacco industry:
``The Defendants have repeatedly made vigorous and
impassioned public denials--before congressional committees, in
advertisements in the national print media, and on television--
that neither smoking nor nicotine is addictive, and that they
do not manipulate, alter, or control the amount of nicotine
contained in the cigarettes they manufacture. The Findings of
Fact contained in this section and section V(B), supra, provide
overwhelming evidence that those statements are false.'' [Judge
Kessler's Final Opinion, page 653]
``In sum, the evidence as presented in these Findings of Fact
is overwhelming that Defendants have, over the course of many
years, time and again--and with great self-righteousness--
denied that they manipulated the nicotine in cigarettes so as
to increase the addiction and dependence of smokers. Those
denials were false.'' [Judge Kessler's Final Opinion, page 654]
The legislation before the committee would provide FDA with the
authority to evaluate the nicotine content of all tobacco products
(along with other chemical and design features of tobacco products that
may impact addiction). Through this grant of authority, FDA would be
able to determine, based on the best available science, what decision
is in the best interest of public health, weighing both the individual
risks and the population-level impact, that changes in the nicotine
yields of tobacco products, up or down (but not down to ``zero''),
would generate.
As crafted, this legislation's approach maximizes the likelihood
that any change in nicotine levels prompted by the FDA will in fact
improve the public health because it will be able to force the tobacco
companies to control other changes in the tobacco product, monitor
closely the impact of any proposed change after it takes effect, take
into consideration the impact of any proposed change on non-smokers, as
well as on smokers attempting to quit or interested in quitting.
Tobacco smoke contains over 4,000 chemicals, more than 200 of which
are toxic and nearly 70 of which are known or suspected human
carcinogens.\46\ However, today, there is no Federal agency that has
authority to require tobacco companies to identify what toxic chemicals
appear in what products or brands or in what quantity. Nor is there any
requirement of the tobacco companies to detail the testing they have
conducted to test the health impact of different toxic substances in
different brands/products. One of the central goals of this legislation
is to give the FDA the authority to get this information, marry it with
the best available science, and then determine the most appropriate
action to take regarding these harmful substances both in terms of
recommending changes to the product (e.g., performance standards) and
informing consumers of the contents of these products and the risks
associated with their use.
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\46\ National Cancer Institute. Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.
Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S.
Department of Health and Human Services, National Institutes of Health,
National Cancer Institute, NIH Pub. No. 02-5074, October 2001.
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Response to Questions of Senator Enzi, Senator Burr, Senator Hatch, and
Senator Coburn by Elmer Huerta, M.D., M.P.H.
questions of senator enzi
Question 1. FDA is the gold standard amongst public health
regulators. I worry that under this bill, the public would interpret
FDA regulation as an endorsement that the product was safe for
consumption, when we know that tobacco is unsafe. I think tobacco
companies, not public health, would benefit from the FDA ``stamp of
approval.'' How can you ensure that FDA regulation of tobacco will not
lead to greater consumer acceptance of tobacco?
Answer 1. Meaningful FDA regulation of tobacco is not an
endorsement that a tobacco product is safe for consumption. It is
important that no tobacco company be permitted to claim that a product
is in any way approved or endorsed by the FDA. To the contrary, the FDA
regulatory process will ensure that the public finally has access to
information about the harmful ingredients in tobacco products,
including cigarette smoke constituents, and the horrendous impact they
have on public health. Under the proposed legislation, the FDA would be
granted the authority to stop tobacco companies from lying to and
misleading the public with its false advertising and unsubstantiated
health claims. FDA regulation of tobacco would also include direct
reminders to the public about the dangers of smoking with significantly
larger health warnings that tobacco products cause death and disease.
As you put it so well, FDA is the gold standard and with its scientific
expertise, it is the best agency to inform the public about the harms
of tobacco products.
Question 2. This bill sets a very high bar for the introduction of
reduced-risk products. In fact, I read it as possibly requiring
randomized, controlled clinical trials before a product can be
approved. In addition, the use of the ``public health'' standard makes
showing evidence of an improved product more difficult than the normal
Food, Drug and Cosmetic Act standard of ``safe and effective.'' I worry
that this means we will ossify the makeup of tobacco products on the
market where they are, and make it harder to market a safer product. I
assume this is not what you intended. Why do you believe that this bill
will favor the introduction of safer products?
Answer 2. First, tobacco products can never be ``safe or
effective,'' and that is why a new public health standard is
established in the proposed legislation to regulate tobacco products.
FDA regulation of tobacco would allow tobacco companies to continue to
develop new products, but would require that any health claim attached
to a product is based on sound science. The tobacco companies already
market products as less hazardous or safer without having to verify
these claims. We need only look at the experience of ``light'' and
``low tar'' to see how the tobacco industry developed a new product and
then used false and deceptive labeling and advertising to mislead
smokers into thinking they were consuming a safer product. Existing
products and new products would both have to conform to the FDA
performance standards. Tobacco companies that want to create products
that are actually less hazardous should welcome this standard.
Question 3. Philip Morris supports the bill. Philip Morris
management has an obligation to its shareholders to maximize profits.
These two things together mean that the company believes it can sell
more cigarettes for a longer time under this bill than if there were
not a bill. How can you then be confident that the bill, as written,
really will serve the public health in the long run?
Answer 3. We have conducted a thorough and independent analysis of
the proposed legislation. The American Cancer Society is an evidence-
based organization and a nationally trusted source of information on
cancer and its causes and the American Cancer Society Cancer Action
Network bases its legislative work on the evidence-based judgments of
the Society. We have concluded that the proposed legislation will
protect the public health and ultimately, save lives. The proposed
legislation would provide the FDA with the authority and resources to
effectively regulate the manufacturing, marketing, labeling,
distribution and sale of tobacco products. The FDA would be authorized
to restrict tobacco advertising and marketing, especially those aimed
at children, including banning candy-flavored cigarettes. It would also
require the tobacco companies to disclose the ingredients of tobacco
products and cigarette smoke constituents. The FDA would have the
authority to prohibit unsubstantiated health claims, and require
larger, more informative health warnings on tobacco products. The
proposed legislation would also grant the FDA the authority to take
further action to ensure that tobacco products are not illegally sold
to children. The public health would be much better protected with FDA
regulation of tobacco than the status quo.
Question 4. Shouldn't we focus on better enforcing the dozens of
tobacco regulations already on the books instead of burdening an
overworked and underfunded FDA?
Answer 4. Despite the fact that tobacco kills more than 400,000
Americans each year, tobacco is the least regulated consumer product on
the market today. The FDA is the only government regulatory agency that
combines the public health mission with the scientific and health
expertise needed to effectively regulate the tobacco industry. The
manufacturing and marketing restrictions currently in place are
completely inadequate, and there are no restrictions on additives or
other ingredients that tobacco companies can add to the content of
tobacco products. The tobacco companies market their products with
unsubstantiated health claims, and mislead the public using terms such
as ``light'' and ``low tar.'' Furthermore, there is no mechanism for
identifying misleading or fraudulent labeling or advertising claims or
holding tobacco product manufacturers accountable. The proposed
legislation effectively places tobacco companies under the same
regulatory rubric of every other consumer product. Finally, the
proposed legislation would provide funding to the FDA through a user
fee paid by the tobacco industry, and will not negatively impact the
other critical functions of the FDA.
question of senator burr
Question. How is keeping tobacco products on the market in the best
interest of the public's health? Please provide a direct answer to this
question.
Answer. Keeping tobacco products on the market clearly is not in
the best interest of the public health. Unfortunately, there is no
effective way to eliminate these products. As we learned during
Prohibition, an outright ban would lead to the creation of a black
market and all of the undesirable social side effects that black
markets create. The fact is 45 million Americans are currently addicted
to tobacco. The critical effort is to stop new smokers, who are mostly
kids, from starting, to increase the access and affordability of
cessation services and to give the public objectively-reviewed, factual
information about tobacco products. We also must stop the tobacco
industry's misleading labeling and advertising, unsubstantiated health
claims, and manipulation of their product in order to keep smokers
smoking and getting new users to start. The proposed legislation is
critically needed to protect the public health from the harms of
tobacco.
questions of senator hatch
Question 1. Dr. Huerta, what percentage of lung cancer is caused by
tobacco usage? The reason I ask is that I am aware of a few cases where
someone has been diagnosed with terminal lung cancer and never smoked a
cigarette in his or her life. I was very interested in your statistics
about the decrease in cancer deaths and the decrease in mortality rates
and incidence from lung cancer in men. Could you please talk about this
in more detail? These numbers are very encouraging news to those who
have loved ones suffering from lung cancer.
Answer 1. Approximately 87 percent of all lung cancer deaths are
attributable to tobacco use and smoking accounts for at least 30
percent of all cancer deaths. So while there are cases of lung cancer
in nonsmokers, the vast majority are associated with tobacco use. The
risk of developing lung cancer is about 23 times higher in male smokers
and 13 times higher in female smokers compared to lifelong non-smokers.
Lung cancer accounts for the most cancer-related deaths in both men and
women. Death rates from lung cancer for men have declined significantly
from 1991 to 2003, although there is still great variation between
racial and ethnic groups. After increasing for several decades, lung
cancer death rates for women are approaching a plateau, but still have
yet to decline. Women lagged behind men in picking up smoking, so it is
not surprising we see the same lag with disease. Since 1987, more women
have died each year from lung cancer than from breast cancer. This is
an extremely deadly type of cancer with only a 16 percent 5-year
survival rate. In 2007, an estimated 213,380 new cases of lung cancer
and 160,390 deaths from lung cancer are expected.
In addition to lung cancer, smoking is associated with an increased
risk of at least 14 types of cancer, including nasopharynx, nasal
cavity and paranasal sinuses, lip, oral cavity, pharynx, larynx,
esophagus, pancreas, uterine cervix, kidney, bladder, stomach, and
acute myeloid leukemia. Smoking is a major cause of other diseases too,
including heart disease, cerebrovascular disease, chronic bronchitis,
and emphysema, and is associated with gastric ulcers. The health care
costs associated with smoking-related diseases and deaths are
astronomical. The CDC estimates that over $96 billion in direct medical
expenditures are caused by tobacco each year, with an additional $97
billion lost in productivity.
Question 2. Why do you believe that the Food and Drug
Administration is the proper agency to regulate tobacco? I am just not
convinced that the FDA is the appropriate agency to regulate tobacco.
Personally, I believe that the FDA, currently, has tremendous
responsibilities imposed upon it compared to other health agencies and
adding another major responsibility like the regulation of tobacco is
just too much. We hear complaints all the time about the FDA not being
able to do its current job and here we are, through this legislation,
imposing additional responsibilities on the agency. So I'd be
interested in your opinion--why is the FDA the best agency to oversee
the regulation of tobacco? And please know, I do not disagree with you
about the need for tobacco to be better regulated--I just don't know if
the FDA is the right agency to do the job.
Answer 2. The FDA is the only government agency with the scientific
expertise and enforcement power necessary to effectively regulate
tobacco products and health-related claims made by the tobacco
companies. The FDA can evaluate the veracity of tobacco industry claims
about their products and has the ability to swiftly modify its
regulations to respond to new scientific information or changes in the
tobacco industry's tactics. I agree that resources for the FDA have
struggled to keep pace with its critical functions. The proposed
legislation ensures that the FDA regulatory functions for tobacco will
be paid for by means of a user fee levied on the tobacco industry. The
proposed legislation places tobacco on the same regulatory level of
food and drugs, and is critically important to protect the public
health.
Question 3. There has been a growing tendency both at the Federal
and at the State level to use monies generated from tobacco taxes for a
variety of legislative purposes that are not directly connected to
anti-smoking campaigns, some of which are very legitimate initiatives.
Let's assume two scenarios. First, Congress bans cigarettes tomorrow
and the ban works. We are no longer able to rely upon any revenues,
either at the Federal or the State level, from the sale of tobacco. If
such a ban took place, what would be the budgetary shortfall that we
would have to make up? Second, let's assume the legislation before the
committee is enacted, which is intended, among other things, to result
in a reduction of the sale of cigarettes. What is the budgetary
shortfall we can expect if the current bill is enacted at both the
Federal and State level?
Answer 3. Tobacco use costs our Nation over $96 billion each year
on direct health care costs and over $97 billion each year in lost
productivity, not to mention the over 400,000 lives lost. In the
unlikely scenario that a complete ban was to be enacted, the billions
of dollars in public health savings would offset any loss of tax
revenue by many orders of magnitude.
Question 4. Unfortunately, one of the consequences of the increased
regulation of cigarettes, as well as an increase in the cost, has been
a burgeoning black market in cigarettes. Again, the legislation is
intended, among other things, to discourage smoking, as well as the
smoking of cigarettes at current levels of nicotine. What provisions
are included in the bill that will enable the FDA to combat not only
the illegal sale of cigarettes in general but the possibility of a rise
in the illegal shipment of cigarettes into this country?
Answer 4. The proposed legislation imposes strong, new requirements
regarding the prevention and monitoring of potential black market sales
and provides for a congressionally mandated study of illicit trade
issues, the biggest black market threat. In addition, the user fee
imposed on the tobacco companies to fund FDA regulation would amount to
less than 1\1/2\ cents per pack of cigarettes, a virtually
inconsequential increase. Black market sales are driven by price across
State and national boundaries. The proposed legislation places
restrictions on the advertising, marketing, promotion, labeling and
sale of tobacco products, which should not impact the price of tobacco
products.
questions of senator coburn
Question 1. What constituents would you recommend that the FDA
require to be eliminated or reduced in cigarettes, and by how much
would that reduction or elimination reduce the relative risk of
tobacco-related diseases?
Answer 1. This is exactly what we want to give the FDA authority to
determine. The proposed legislation would allow the FDA to use existing
science and new science to identify changes to existing and new
products that would reduce their harm. The tobacco companies would
still be prohibited from making any unsubstantiated health claims based
on any change to their product. We know the tobacco companies
manipulate their products in order to keep their customers addicted and
to encourage new ones to start, and we see variations in the same brand
sold in different countries. The FDA is the only government agency with
the resources and scientific expertise to determine what ingredients in
tobacco products or cigarette smoke constituents should be reduced or
eliminated in order to protect the public health.
Question 2. How will smokers alter their behavior in response to
the introduction of cigarettes with new tobacco product standards? That
is, what will be the effect on cigarette consumption of smokers now
knowing that the FDA is tightly regulating all the constituents and
ingredients in cigarettes?
Answer 2. First of all, the new marketing and advertising
restrictions would stop allowing the tobacco companies to target our
youth and other vulnerable populations. These restrictions would
decrease the number of new tobacco users, particularly children, since
the vast majority of smokers start before they turn 18. In addition,
the larger health warnings, as have been used in other countries, and
the elimination of false and misleading health claims would encourage
more people to quit. Product disclosure would allow the public, for the
first time, to understand how tobacco companies manipulate the
ingredients and additives in their product in order to increase
addiction without regard for the harm of the user. Overall, the
proposed legislation will help discourage new users, encourage quitting
and ultimately save lives. Tobacco use is the most preventable cause of
death and disease in this country and granting the FDA the authority to
regulate tobacco is the key prevention measure missing in order to
reduce tobacco's deadly toll on our Nation.
Question 3. In what way will reducing the nicotine levels in
cigarettes improve the public's health, since we know that when
nicotine levels are reduced, smokers compensate by smoking more? Won't
this approach in fact hurt the public's health?
Answer 3. Most tobacco cessation products rely on the principle of
weaning the tobacco user away from nicotine addiction by reducing the
dosage level over time, and therefore have been effective for so many
people. Reducing the addictive nicotine levels in cigarettes improves
an individual's chance at stopping smoking. We know that tobacco
companies have purposefully manipulated nicotine levels in order to
prevent smokers from quitting. The proposed legislation would permit
the FDA to determine the level of and way nicotine is introduced in
tobacco products, as well as create new standards, based on the overall
impact on public health. These performance standards would be the
primary way in which the FDA would require tobacco products to be less
harmful and less addictive. Without the proposed legislation, the
tobacco companies will continue to manipulate nicotine levels to
encourage new, young smokers to start and keep current smokers from
quitting.
Response to Questions of Senator Enzi, Senator Burr, Senator Hatch,
and Senator Coburn by Richard Land, D.Phil.
questions of senator enzi
Question 1. The content of the bill before us has seen little if
any change over the years, and I think we can do better. Do you have
any suggestions for how the bill could be made even more effective in
preventing youth smoking and helping current smokers to quit?
Answer 1. We believe S. 625, in its present form, includes the
necessary tools to significantly reduce tobacco consumption among our
youth and help addicted smokers break their habit. The fact that the
bill has few substantive changes from versions introduced in previous
Congresses does not necessitate that it be modified. Congress simply
has not given the FDA opportunity to prove the effectiveness of the
bill. If the bill had been enacted into law several years ago and
little progress had been made in efforts to prevent or curb the use of
tobacco among Americans, particularly our youth, then Congress would
have legitimate reason to revisit the legislation and determine what
provisions need to be strengthened, added, or removed. While probably
every member of Congress would like to reduce tobacco use among
children, we cannot fall prey to the trap of making the perfect enemy
of the good. We believe the current provisions would provide sufficient
means to scale back tobacco use significantly, especially among youth.
Question 2. Certain brands are especially preferred by youth
smokers, even though most advertising to children is prohibited. I can
imagine that even with further restrictions on advertising as proposed
in this bill, kids will still prefer certain brands, because that's the
nature of fads and trends. This could further consolidate the market in
the hands of the biggest players, who would then be even more well-
known among youth, perpetuating the brand preferences. How does this
bill address that market consolidation and youth smoking spiral?
Answer 2. While the companies that signed the Master Settlement
Agreement agreed not to market to kids, there are actually few
restrictions on advertising to children or anyone else in the MSA.
Analysis of the MSA reveals that less than 20 percent of the marketing
and promotional expenditures of the tobacco companies were affected at
all. The major cigarette companies have more than doubled their
marketing and promotional expenditures in the years since the MSA to an
annual total of more than $15 billion,\47\ or more than $40 million
each day, and much of it still reaches kids. Tobacco advertising in
youth-oriented magazines actually increased by more than 30 percent in
the year after the MSA was signed,\48\ and tobacco companies continue
to reach kids through magazines, retail point-of-sale marketing, sports
sponsorship, and other venues. It's no wonder that kids are almost
twice as likely as adults to recall tobacco advertising.\49\ Even the
so-called youth prevention campaigns by tobacco companies have been
shown to encourage kids to smoke.\50\
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\47\ U.S. Federal Trade Commission (FTC), Cigarette Report for
2003, 2005 [data for top six manufacturers only].
\48\ Bowker, D & M Hamilton, ``Cigarette Advertising Expenditures
Before and After the Master Settlement Agreement: Preliminary
Findings.'' May 15, 2000; and Fairclough, G., ``Are Cigarette Ads in
Magazines Angling for Teens?'' The Wall Street Journal (May 15, 2000).
\49\ National telephone survey of 510 teens aged 12 to 17 and 1,012
adults conducted by International Communications Research (ICR), March
2007.
\50\ Wakefield, M., et al., ``Effect of Televised, Tobacco Company-
Funded Smoking Prevention Advertising on Youth Smoking-Related Beliefs,
Intentions, and Behavior,'' American Journal of Public Health
96(12):2154-2164, December 2006.
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S. 625 will actually subject all tobacco companies and all brands
to the same marketing restrictions, whereas that is not the case under
the MSA, as not all companies are parties to the agreement. While this
should create a level playing field across all manufacturers, our real
concern should not be what brands kids smoke but how many kids smoke at
all. Twenty-three percent of high school kids still smoke.\51\ While
this represents more than a 35 percent decline in high school smoking
since 1997, largely brought about by price increases (due to increased
tobacco taxes and MSA costs passed on to smokers) and the impact of
State tobacco prevention programs, this decline has slowed or stalled
in recent years, and the most recent data show a small increase in
youth smoking. This stalled progress no doubt reflects the aggressive
marketing by the tobacco companies.
---------------------------------------------------------------------------
\51\ U.S. Centers for Disease Control and Prevention (CDC), ``Youth
Risk Behavior Surveillance, United States, 2005,'' Morbidity and
Mortality Weekly Report (MMWR), June 9, 2006 55 SS-5.
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The evidence is very clear, despite industry claims to the
contrary, that tobacco marketing affects not only brand choice but
initiation of smoking. A 2002 monograph by the National Cancer
Institute, which reviewed the research on tobacco advertising and
promotion and its impact on youth smoking, found that tobacco
advertising and promotional activities are important catalysts in the
smoking initiation process. The NCI report also found, based on a
review of the extant research, that ``the conclusion that there is a
causal relationship between tobacco marketing and smoking initiation
seems unassailable.'' \52\ The marketing restrictions in S. 625 are
designed to reduce youth exposure to the kind of marketing that leads
to increased smoking among kids.
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\52\ National Cancer Institute, Changing Adolescent Smoking
Prevalence, Smoking and Tobacco Control Monograph No. 14, NH Pub. No.
02-5086, November 2001.
Question 3. You indicate that your support for this bill comes from
a desire to treat tobacco no differently than other consumer products.
Yet this bill sets up a radically different set of standards and
regulations for FDA authorities over tobacco. Can you explain to me how
you believe the proposed standards for tobacco regulation are the same
as for other consumer products?
Answer 3. The Southern Baptist Ethics & Religious Liberty
Commission believes FDA regulation of tobacco products is long overdue.
Astonishingly, tobacco products remain the most deadly but least
regulated of all consumer products. The FDA can ensure the safety of
everyday items, but has no authority over tobacco, a product that
causes more preventable deaths than any other. Tobacco products are the
only consumer products that, when used as directed by the manufacturer,
kill half of their users. Thus, the standard used by the FDA to
evaluate tobacco products cannot be the same standard it uses to
evaluate other consumer products. S. 625 recognizes the uniquely lethal
nature of tobacco products and that these products can never be ``safe
and effective.'' Instead, S. 625 appropriately applies a ``public
health'' standard, which allows the Secretary to take actions it
believes will protect the public health and reduce the number of people
who suffer and die from tobacco.
Although the FDA will apply a different standard to evaluate
tobacco products, it will rely on the same procedures, staff expertise,
and experience to analyze and evaluate tobacco products that it uses to
evaluate the health impact of other products on consumers.
The ``public health'' standard used in this legislation will
protect consumers. It will reduce smoking, especially among children,
and reduce the tremendous toll of tobacco on our families. We fully
support these goals.
question of senator burr
Question. How is keeping tobacco products on the market in the best
interest of the public's health? Please provide a direct answer to this
question.
Answer. We do not advocate removal of tobacco from the market, but
instead believe FDA regulation is the most significant means to protect
public health. A tobacco ban could prompt contraband trafficking and
black market sales of the prohibited tobacco products. Additionally, a
tobacco ban lacks sufficient congressional and public support, partly
due to our Nation's experience with a ban on alcohol. History shows
that Prohibition in the 1920s and early 1930s was not sustainable
largely because alcohol consumption was a personal habit very
widespread among adults. Outlawing tobacco, also a widely used product,
would receive a similar negative reaction from a minority of the
public. Additionally, while tobacco is an incredibly destructive
product, it does not debilitate the user in the same way that illicit
drugs do. A person can still perform his or her job and function safely
while using tobacco. Instead, we want to find ways for people who
choose to use tobacco to experience less harm from and less
dependability on the product. We also want to help safeguard children
from being targeted by tobacco marketing.
questions of senator hatch
Question 1. There has been a growing tendency both at the Federal
and at the State level to use monies generated from tobacco taxes for a
variety of legislative purposes that are not directly connected to
anti-smoking campaigns, some of which are very legitimate initiatives.
Let's assume two scenarios. First, Congress bans cigarettes tomorrow
and the ban works. We are no longer able to rely upon any revenues,
either at the Federal or the State level, from the sale of tobacco. If
such a ban took place, what would be the budgetary shortfall that we
would have to make up? Second, let's assume the legislation before the
committee is enacted, which is intended, among other things, to result
in a reduction of the sale of cigarettes. What is the budgetary
shortfall we can expect if the current bill is enacted at both the
Federal and State level?
Answer 1. The Southern Baptist Ethics & Religious Liberty
Commission does not possess the expertise to answer the question of
revenue effects as a result of FDA regulation of tobacco. We feel
confident, however, that the loss of revenue would be offset to some
extent by a reduction in demand for State-funded public health and
other services. Healthier people will cost the State less to care for.
A healthier workforce will also lead to greater productivity, which
will generate more tax revenue for the State. Additionally, families
will be strengthened. More children will experience the positive
benefit of having two healthy parents over the entire course of their
childhood. More children in single-parent homes will experience the
positive benefit of living with that parent their entire childhood.
These healthier parents will have greater opportunity to provide for
the financial wellbeing of their families, reducing the demand on the
public welfare system. Children raised in these more stable
environments will be less likely to live in poverty, and will
subsequently be less likely to exhibit the effects of poverty, such as
crime, poor health, lack of education, and substance abuse. It is less
likely that these children, and the adults they will become, will
require the same degree of care by government as a result, thereby
reducing the need for tax revenue.
Question 2. Unfortunately, one of the consequences of the increased
regulation of cigarettes, as well as an increase in the cost, has been
a burgeoning black market in cigarettes. Again, the legislation is
intended, among other things, to discourage smoking, as well as the
smoking of cigarettes at current levels of nicotine. What provisions
are included in the bill that will enable the FDA to combat not only
the illegal sale of cigarettes in general but the possibility of a rise
in the illegal shipment of cigarettes into this country?
Answer 2. This legislation will not contribute to the sale of
tobacco products on the black market. Indeed, it contains provisions
expressly designed to curtail illegal tobacco product sales, including
the sale of contraband tobacco products. There is no reason to believe
that this bill will result in additional illegal sales. Further, the
legislation gives the FDA the authority to evaluate the overall impact
of any action it takes on the public health based on a population-based
analysis. Thus, it is broad enough to allow the FDA to evaluate all
factors, including black market sales, that impact the number of people
who will die from using tobacco.
What is clear is that in the absence of this legislation and
stringent regulation of tobacco products, more than 400,000 Americans
continue to die each year from tobacco use. This bill provides a
critical additional tool in the battle to reduce that number.
questions of senator coburn
Question 1. What constituents would you recommend that the FDA
require to be eliminated or reduced in cigarettes, and by how much
would that reduction or elimination reduce the relative risk of
tobacco-related diseases?
Answer 1. The Southern Baptist Ethics & Religious Liberty
Commission does not possess the expertise to recommend elimination or
reduction of the various components in cigarettes. We believe the FDA
needs to make those determinations.
Question 2. How will smokers alter their behavior in response to
the introduction of cigarettes with new tobacco product standards? That
is, what will be the effect on cigarette consumption of smokers now
knowing that the FDA is tightly regulating all the constituents and
ingredients in cigarettes?
Answer 2. FDA regulation of tobacco would likely cause smokers to
more closely evaluate their decision to smoke and prompt many of them
to abandon the habit. Most smokers have little idea of the number of
carcinogens and additives within tobacco products. Disclosure of these
substances and the addition of meaningful warning labels, however,
would awaken many people to the dangers of tobacco use. Further, the
legislation would allow the FDA to require manufacturers to adopt
feasible technologies to reduce or eliminate harmful ingredients,
thereby scaling back the health risks to those who continue to smoke.
Reductions of nicotine levels would make it easier for millions of
Americans who have tried unsuccessfully to quit smoking to actually
drop the habit. Possibly most important, the legislation would help
produce future generations of adults that are not addicted to
cigarettes. By limiting marketing and sales of tobacco to children,
countless young people will never try cigarettes and so will never
begin lives of nicotine addiction.
Question 3. In what way will reducing the nicotine levels in
cigarettes improve the public's health, since we know that when
nicotine levels are reduced, smokers compensate by smoking more? Won't
this approach in fact hurt the public's health?
Answer 3. While nicotine consumption is obviously the principle
reason that people smoke, and we are concerned about addiction to
nicotine in the same way we are concerned about any other addictions,
we believe the more important issue relates to the chemicals,
additives, and processes involved in delivering nicotine through
tobacco use. We think it should be the responsibility of the FDA to
determine the type and degree of danger to which smokers are exposed by
the various components and additives in tobacco as they try to reach a
particular level of nicotine intake.
Response to Questions of Senator Kennedy, Senator Enzi, Senator Burr,
Senator Hatch, and Senator Coburn by Jack Henningfield, Ph.D.
questions of senator kennedy
Question 1. In your testimony, you emphasize that ``FDA is the
right agency and the only agency'' with appropriate experience ``to
regulate tobacco products since cigarettes are drug delivery products
at heart.''
You contrast this with the lack of appropriate expertise at the
Federal Trade Commission that led to its adoption of a misleading
system for measuring the level of tar and other toxins in cigarettes.
Please elaborate on how FDA's expertise can be used to help protect the
public from the dangers of smoking.
Answer 1. The FDA was established for the primary purpose of
protecting the public health through regulation of a broad range of
products on the basis of their contents, designs, delivery of
substances and on health effects. Its regulation through product
performance standards, allowable ingredients, claims, branding
representations (e.g., ``fresh orange juice'') and other communications
are intended to serve public health. Major staffing of the FDA are the
many scientists and public health experts whose mission is to
contribute to the improvement of public health through science-based
product regulation. They work with communications experts, legal
counsel and others to ensure that products are appropriately labeled,
advertised and regulated so as to serve public health interests
including minimizing hazardous exposures.
In fact, historically, for most food products, FDA's role was
primarily to prevent adulterated products and reduce toxic exposures
whether or not a specific health benefit was intended. For the last 20
years, however, FDA has conducted pre-
market evaluations of proposed health claims for foods. In the case of
drug products the additional burden of beneficial health effect is
required. In virtually all cases, some level of risk is allowed to
enable benefits and/or accommodate what is feasible from a practical
and commercial perspective (e.g., level of ``purity'' or maximum
allowable standards for insect parts, pesticide residues and other
contaminants such as formaldehyde in flour). In the case of drugs, most
can incur serious adverse health consequence and are not considered
absolutely safe (e.g., OTC pain relievers may cause more than 15,000
deaths per year) but their allowance for marketing is considered on the
basis of their overall public health impact.
In sharp contrast, the FTC was established, initially as the
``Bureau of Corporations'' with a core mission--the regulation and
protection of free and fair commercial trade through support of
competitive markets and restrictions. This of course, includes
advertising, branding and product claims. Moreover, FTC regulates
marketing of many products which are also or primarily regulated by FDA
but it generally defers to FDA on aspects of those products pertaining
to health effects. In contrast to FDA's staffing by scientists and
public health experts, major staffing of FTC are economists and lawyers
who focus largely on issues such as compliance with the law and serving
to enhance free, fair, and competitive trade--not public health.
With its focus on health protection, through regulation of tobacco
products FDA will have its extensive history, expertise of its many
scientists and regulators, and decades of precedents in regulation of
foods, drugs, cosmetics and other substances that can be brought to
bear in regulating tobacco products in such a way as to lead to
decrease adverse health effects (including, in principle, addiction)
and even to decrease use of some or all products.
Question 2. Even though cigarettes will never be safe to smoke and
our primary goal is to stop people from smoking, you believe that it's
important for the FDA to have the power to set ``performance
standards'' regulating the ingredients in cigarettes and how they are
made. Over time, FDA could require many changes in the design and
contents of cigarettes currently on the market and of new brands to
make them less toxic and/or less addictive by issuing performance
standards. Please explain how these performance standards would benefit
those who do smoke, and those exposed to secondhand smoke. Give us a
few concrete examples of the type of standards that FDA might adopt.
Answer 2. The principle value of product performance standards will
be to reduce or prohibit the use of added ingredients (e.g., ammonia,
menthol, chocolate), materials in composition (e.g., glass fibers), and
design features (e.g., hidden ventilation systems) which may increase
toxicity and/or addiction. Standards may be set for ingredients in the
product as well as its emissions such as constituents of ``tar,'' and
toxic gases such as carbon monoxide.
Standards that lead to decreased smoke exposure and or toxicity
have the potential to reduce secondhand smoke exposure and/or the toxic
consequences of secondhand smoke exposure. For example, if FDA
determines that chocolate is not necessary for cigarette manufacture
and consumption but may contribute to carcinogenicity and or risk of
becoming addicted it could limit or ban chocolate. Similarly, if FDA
determined that menthol increased toxic exposures by virtue of its own
effects or by enabling deeper lung exposure of other toxins, and/or
increased liability to addiction it could restrict or ban menthol. If
FDA determined that hidden ventilation holes contributed to consume
deception and/or adverse health effects it could ban their use or
require clear demarcation and warnings. FDA could restrict nicotine
content and/or form of delivery (e.g., free-base fraction). Setting
standards for maximum allowable nicotine, perhaps based on current
product levels is consistent with other efforts to prevent products
from becoming even more toxic and/or addictive. In all of these cases,
FDA actions would be based upon its science-based assessment of the
potential for the standards to contribute to public health through
reduction of toxic exposures.
Please note two additional clarifications regarding nicotine
regulation: (1) Although it is true that nicotine is not the primary
ingredient in tobacco that causes adverse health effects (other than
addiction), nicotine is not without risk, and this is why nicotine in
medicines such as nicotine gum is carefully regulated to ensure that
levels do not exceed acceptable standards for safety. Thus, the maximum
allowable dose of nicotine in nicotine gum is 4 mg of which about 2 mg
is typically delivered. This is in contrast with a conventional
cigarette that contains about 10 mg nicotine and can easily deliver 2-3
mg of nicotine; a ``pinch'' of the most popular brands of snuff can
contain and deliver 10 mg or more of nicotine. (2) Although it is
theoretically possible to reduce tobacco and tobacco toxin exposure by
increasing nicotine levels, it is not known how much nicotine
supplementation in tobacco would be required to reduce tobacco intake
sufficiently to reduce adverse health effects of contaminants. Whether
reducing nicotine would contribute to public health has not been
determined; therefore, the bill does not compel FDA to reduce nicotine
levels but appropriately gives FDA the power to regulate nicotine
levels based on public health considerations.
Question 3. In your testimony you emphasize that ``One key feature
of the legislation is that mere compliance with a performance standard
cannot be used as the basis for product claims.'' This is extremely
important to prevent the public from being misled. What safeguards can
be implemented to prevent tobacco companies from making claims based on
compliance with these standards.
Answer 3. The FDA has a long history of preventing products from
being misbranded and marketed (including labeling and advertising) with
implicit or explicit claims that can foster inappropriate use. For
example how cholesterol levels of food are communicated, the definition
of ``cholesterol free'' and what communications are allowed in
marketing (including labeling, branding, and implicit and explicit
claims) has been extensively evaluated by FDA and is regulated so as
not to contribute to excess exposure even if a product meets the
standard for ``cholesterol free.'' To achieve these goals, FDA has a
variety of tools and precedents at its disposal: it can require
sponsors to conduct studies and present data on consumer reactions and
actual patterns of use, FDA can conduct its own consumer research to
determine how consumers interpret communications, and FDA can require
companies to collect and report findings after the product is marketed
and/or collects its own data.
Thus, for example, FDA may develop its own mandatory warning
stipulating that its allowance of the product to be marketed does not
imply safety and in fact that the product carries a very high risk of
addiction, lung cancer and heart attacks. Such a statement combined
with powerful new health warnings (that will also be regulated and
changed as necessary by FDA) should lead to appropriately increased
consumer concerns about tobacco use, not to diminished concerns. To
assure that these goals were achieved and were not undermined by
unintended consequences, FDA could obtain post-market surveillance data
through a variety of mechanisms at its disposal. This is all consistent
with FDA's increasing requirements for risk management programs, which
involve assessing potential risks, requiring marketing to be developed
so as to minimize risks, and requiring that marketing efforts be
designed to minimize the risks. Furthermore, post-marketing
surveillance could be used to detect unintended consequences in a
timely fashion so as to guide corrections in regulatory approach and
marketing.
Question 4. In your testimony, you say that without FDA regulation,
smokers who want to quit will increasingly turn to ``new tobacco
products that falsely claim (at least implicitly) to be less harmful.''
We are seeing more and more of these products making unproven claims
entering the market today. Under S. 625, no such reduced risk claims
could be made unless the FDA verified the accuracy of the claim, and
determined that it would not be misleading to consumers. That is a very
important safeguard for the public, is it not? Describe the type of
process FDA scientists would go through to determine whether a new
product really reduced the risk in a meaningful way?
Answer 4. This is among the most vital safeguards. Even though
conventional cigarettes remain the most important cause of death and
disease among all tobacco products, all of the major companies are
investigating and test marketing products that could replace
conventional cigarettes in the future. We must avoid the mistake made
with ``light'' and ``reduced tar and nicotine'' cigarettes, as well as
filters. These so-called innovations falsely reassured smokers,
undermined prevention and cessation, and ultimately escalated annual
tobacco attributed mortality, including lung cancer, in the latter
quarter of the 20th century. All of this happened even as advertised
tar levels declined. Preventing such a public health disaster from
recurring is more likely with FDA regulation than with a perpetuation
of the unregulated tobacco marketplace. This role of FDA becomes more
vital with each passing day, as new products and product claims from
the implicit (e.g. ``Marlboro Ultra Smooth'' with its ``Filter Select''
banner) to the more explicit (e.g. Eclipse, claiming that ``compared to
other cigarettes Eclipse may present smokers with less risk of cancer,
chronic bronchitis and possibly emphysema.'')
FDA can require full disclosure of data regarding ingredients and
can require both testing by sponsors and post-marketing data collection
to ensure that claims are not allowed until the agency is satisfied
that they are appropriate and justified. Equally important, if allowed
claims lead to unintended consequences the agency has a variety of
tools at its disposal such as communications to address the problem,
prohibiting sales, or immediate recall of products in the marketplace.
Questions of Senator Enzi
Question 1. You state over and over in your testimony that whatever
tests or standards there are, companies will use this as a marketing
tool. Why will FDA regulation be any different?
Answer 1. The Food and Drug Administration is charged with
protecting the public health. In its day to day regulation of a broad
range of consumable products and drugs, it does this through
coordinated regulation of both product contents, often through
performance standards, and allowable labeling and marketing. FDA can
take a wide range of actions when companies label and/or market
inappropriately. For example, FDA has recalled and taken action against
orange juice that was made from frozen concentrate but advertised as
``fresh'' and apple juice for infants that was actually artificially
flavored and colored sugar water. These are but two of thousands of
examples of FDA actions over the years to ensure that products are not
labeled, marketed or branded in misleading ways.
The examples posed by Dr. Blum of misleading advertisements using
FTC tar and nicotine ratings and descriptors such as ``lights'' are
examples of practices that occur in the absence of effective product
regulation. Under the legislation, FDA would have the power to prohibit
these practices. As this bill makes clear, FDA's regulatory tools will
include regulation of marketing, labeling, claims, and warnings to
ensure that appropriate messages are communicated. FDA can also require
post-marketing research and surveillance when it has concerns; it can
inspect production facilities, and obtain company product manufacturing
documents. Furthermore, other organizations and individuals undoubtedly
will conduct post-marketing research to determine the effectiveness and
appropriateness of messages and whether unintended consequences are
occurring. Such data can be brought to the FDA's attention in the form
of additional comments to a rulemaking record or petitions for policy
change that the agency must consider.
Question 2. You said in your testimony that performance standards
should be developed for all smoke constituents. I have heard figures
for the number of constituents that range from dozens to hundreds. That
seems like a lot of performance standards just for smoke constituents,
never mind for nicotine, filters and additives. Would the result of all
these regulations really be a safer cigarette?
Answer 2. The Food and Drug Administration has many tools at its
disposal including the establishment of advisory committees to
prioritize targets for performance standard setting, even as the World
Health Organization is presently undertaking to assist nations which
are implementing the International Framework Convention on Tobacco
Control (``Tobacco Treaty''). Performance standards are not designed to
produce a safer cigarette but to reduce the delivery of toxins in
existing and new products.
Question 3. You mention the importance of stopping tobacco sales to
children. Every State already prohibits the sale of tobacco products to
anyone under the age of 18. These laws have been effective--reducing by
half the number of children purchasing these products in the past
decade. Why is FDA the appropriate agency to enforce these laws and
what is gained by doing so? Don't we run the risk of derailing
regulations that are already working?
Answer 3. Model approaches to reduce access to tobacco products by
persons under 18 years of age were developed by FDA in the process of
its 1990s Tobacco Rule development and initial phases of
implementation. I would submit that FDA understands, better than any
agency, how to best achieve these goals, building on limited success in
recent years to achieving the level of reduction of access that is
needed in the future. An FDA program would also ensure uniform and
consistent enforcement of youth access restrictions. In the past,
consistent enforcement among States has been a problem.
Question 4. I think the bill sets an extremely high bar for the
approval of a reduced risk product. In fact, I think it might call for
clinical trials. Do you think it will be possible to get Institutional
Review Board (IRB) approval for studies to determine if a tobacco
product really represents a reduced risk? If that is not possible, how
else might an application for the approval of a reduced risk product be
supported with data?
Answer 4. Approval of a new product for marketing and/or claims for
a reduced risk product (be they new products or modifications of
existing products) should be in accordance to high standards to prevent
debacles such as occurred with so-called ``light'' and ``reduced tar''
cigarettes and the ongoing ``snake'' oil type of marketing that is
occurring with some new products absent FDA regulation.
Evaluation of such products will presumably be done on the basis of
review of actual ingredients (all ingredients and not just substances
that the tobacco industry calls ``additives'' and ingredients) as well
as emissions from the product to which the person is actually exposed
when using the product. Therefore, this will also require chemical
laboratory testing, in-vitro testing, and probably animal testing.
Actual claims should be evaluated to the greatest extent possible in
clinical trials involving human volunteers. At present, all over
America, people are volunteering for and participating in studies
involving tobacco self-administration. The studies include NIH
supported studies at universities and organizations such as Battelle,
and are subject to review and approval by human subjects review boards.
The tobacco industry has a long history of such testing and presently
supports some testing that is conducted at universities under IRB
review, at Battelle, and probably in its own laboratories, although I
have no way of knowing what sorts of human subjects protections are
being followed in their own laboratories.
Question 5. You indicate that machine testing of factors such as
nicotine yield is not an accurate indicator of what happens when a
human being smokes. If that is the case, what would a product standard
for tobacco be based upon? Or are you proposing these standards be
based on technology you believe to be flawed?
Answer 5. I concur with leading investigators and the World Health
Organization that the FTC Method and its similar international variant,
the ISO or International Standards Organization method (which was based
largely on the FTC method), are seriously flawed and should be
abandoned. Even a preliminary examination of the method by the FDA
during its Tobacco Rule development led it to the conclusion that the
FTC method was flawed but at the time it issued the Proposed and Final
Rules, the FTC had announced that it was taking actions to study the
problem and resolve it. It was not until after the FDA lost its
regulatory authority that the FTC essentially walked away from the
method with an announcement on its Web site--I believe in 2001--that it
would no longer disseminate the results. Yet, absent regulation, the
tests are still done by the tobacco industry and provided in
advertising.
New standards are under evaluation through a consortium of
approximately 30 laboratories throughout the world, including the
Centers for Disease Control and several NIH funded laboratories in the
United States. FDA, with its extensive history in performance standard
development could help ensure that new standards are accurate, fair and
viable.
Questions of Senator Burr
Question 1. How is keeping tobacco products on the market in the
best interest of the public's health? Please provide a direct answer to
this question.
Answer 1. Although few in public health would probably disagree
with the premise that the world would be better without tobacco
products as they have been made, marketed and used, we have them and
there is few viable ways to remove them in the near future. Most would
probably also agree that the status quo is unacceptable. These are my
positions as well, but what is embodied in your question is what we
must do. Here my position is clear and is consistent with other leading
health organizations in the United States and the World Health
Organization: namely to institute science-based health-focused tobacco
product regulation.
This is an effort to address the reality that at least for the
foreseeable future, I do not believe that banning tobacco is viable.
FDA came to this conclusion itself in the development of its Tobacco
Rule in the mid-1990s. These conclusions recognize that approximately
50 million Americans are current cigarette smokers. By some estimates,
nearly 40 percent of all cigarettes may be smoked by people with other
psychiatric problems including depression, anxiety, thought disorder,
and other substance dependence disorders and science-based medical
interventions for addressing their tobacco use in the context of these
other problems is in its infancy. Furthermore, for many people nicotine
withdrawal is debilitating and is not compatible with their meeting
occupational, social and family demands. This includes our military
troops and many people in sensitive occupational positions that involve
public safety. I believe that many of these people could be treated
with existing pharmacological and behavioral treatments, but
limitations in access to treatment prevent many in need of treatment
from getting it.
Many health care plans do not provide adequate coverage for
existing treatment and tobacco addiction rates are highest among the
lower income individuals who are least likely to have any health care
coverage whether they are working or not (roughly 80 percent of the
approximately 47 million person without health care do not work). For
many of those with co-occurring psychiatric disorder, there are still
unresolved questions as to how best to treat their tobacco addiction
along with other disorders. These are just the scientific, medical, and
health care delivery obstacles to attempting to ban tobacco product in
the near future. The social, political, and potential contraband market
issues that would arise are additional issues. Much of this was
discussed in a paper that was commissioned by the American Medical
Association and that I co-authored a few years ago (Henningfield, J.E.,
Benowitz, N.L., Slade, J., Houston, T.P., Davis, R.M., Deitchman, S.
Reducing the addictiveness of cigarettes. Tobacco Control, 7: 281-293,
1998). I note that the FDA, in its Tobacco Rule development came to a
similar conclusion about banning tobacco products. Further into the
future, I believe and hope that within a few decades, the cigarette as
we know it today will be a relic of the past and that we will be on our
way to seeing lung cancer rates at the end of the 21st century become
what they were at the end of the 19th century: a medical rarity.
Question 2. Did you or did you not participate in the crafting of
the World Health Organization's Framework Convention on Tobacco
Control?
Answer 2. No. I served on the World Health Organization (WHO) study
groups that provided scientific evaluation of tobacco and health issues
in the late 1990s, and I served on the WHO Scientific Advisory
Committee on Tobacco Product Regulation (SACTob) from 2000 until 2004
that was charged with providing WHO with scientific guidance on various
issues that arose over the several year process of developing the
Framework Convention on Tobacco Control (FCTC or ``Tobacco Treaty'').
After the treaty was adopted, the SACTob was reconvened with a more
substantial structure as the WHO Tobacco Regulation Study Group or
TobReg, and I have served since that occurred in 2004. All of my
participation has been in an advisory capacity. I played no role in
crafting the FCTC.
Question 3. Do you or do you not support the WHO's Framework
Convention on Tobacco Control?
Answer 3. Yes. I was encouraged that former Health and Human
Services Secretary Tommy Thompson signed the treaty on behalf of the
United States of American in 2004, and I hope that the President will
request that the Senate ratify the treaty so that the United States can
join the nearly 150 other nations, representing nearly 80 percent of
the world population, which have ratified the treaty.
Question 4. Is one of the main tenants of the WHO's Framework
Convention on Tobacco Control to create an international, secretariat
level, body that would control tobacco manufacturing, cessation
programs, and production for all participating countries?
Answer 4. No.
Question 5. During the hearing, when I asked you did you support
granting sovereign control of U.S. tobacco regulation to an
international body, what was your answer?
Answer 5. I have not seen the transcript, but I frankly did not
understand the question because it seemed that you were questioning my
support of the FCTC with a question about how the treaty operates. I do
support the treaty, but it does not ``grant sovereign control of U.S.
tobacco regulation to an international body,'' as I understand those
terms. The treaty sets goals and develops standards as appropriate but
recognizes that the more than 150 nations expected to ratify it will
each need to find ways to comply that are consistent with their own
systems of governance, commerce and regulation.
Questions of Senator Hatch
Question 1. In your testimony, you say that we have made modest
progress in reducing tobacco use and that FDA regulation of the tobacco
industry have made the ``progress significantly greater.'' Could you
elaborate on that statement?
Answer 1. I will support my position with just a few examples.
Youth access: The FDA initiated a national program to reduce
tobacco sales to minors. The program effectively coupled enforcement
with penalties for repeat violators. At its peak, I understand that
200,000 compliance checks had been conducted and in excess of $1
million collected from retailers who repeatedly and illegally sold
cigarettes to minors. This entire system was discontinued after the
2000 Supreme Court decision to remove tobacco from FDA's regulatory
authority. I do not know how many children and adolescents who could
have been prevented from developing addiction, but I believe that
smoking and other tobacco among our young would be substantially less
today had FDA been able to sustain its program.
Warning labels: Many nations, including Canada and Australia, have
adopted and evaluated much more aggressive health warnings that have
been proven more effective in discouraging use and encouraging
cessation among users than the decades-old approach that the United
States still uses.
FTC testing and the ``Light'' cigarette scam: The FTC never
discovered, on its own, that its testing method was seriously flawed.
FDA quickly determined that it was flawed in the course of its
regulation development. Furthermore it was not until the 2001
publication of National Cancer Institute Monograph 13 (Risks Associated
with Smoking Cigarettes with Low Machine-Measured Yields of Tar and
Nicotine) that our Nation formally recognized that light cigarettes
were a deadly scam today accounting for the majority of tobacco-caused
deaths. Yet nothing has been done to resolve this issue. FDA could act
as other nations are to ban descriptors such as ``lights'' and provide
strong and effective warnings.
Question 2. Why does the FDA need to be the agency to regulate
tobacco?
Answer 2. If you review my answer to your first question, and my
answers to all of Senator Kennedy's and Senator Enzi's questions, you
will see why I believe that the Food and Drug Administration is the
only agency with the technical, scientific, regulatory, and legal
experience for regulating products that deliver biological active
substances to the body and which has the improvement of health as its
primary mission. Of course it would need to coordinate various parts of
the effort with other agencies, including the Federal Trade Commission,
Centers for Disease Control, Department of Agriculture, Environmental
Protection Agency, and the National Institutes of Health. But this type
of interagency collaboration has existed for decades when it comes to
FDA's regulation of foods and drugs.
Question 3. There has been a growing tendency both at the Federal
and at the State level to use monies generated from tobacco taxes for a
variety of legislative purposes that are not directly connected to
anti-smoking campaigns, some of which are very legitimate initiatives.
Let's assume two scenarios. First, Congress bans cigarettes tomorrow
and the ban works. We are no longer able to rely upon any revenues,
either at the Federal or the State level, from the sale of tobacco. If
such a ban took place, what would be the budgetary shortfall that we
would have to make up? Second, let's assume the legislation before the
committee is enacted, which is intended, among other things, to result
in a reduction of the sale of cigarettes. That is the budgetary
shortfall we can expect if the current bill is enacted at both the
Federal and State level?
Answer 3. I have addressed why I do not believe banning cigarettes
is right or feasible in my response to Senator Burr's first question.
As to issues concerning budgetary shortfall and revenues, I simply am
not qualified to answer whether the bill is passed or not and whether
Congress attempts to ban cigarettes or not.
Question 4. Unfortunately, one of the consequences of the increased
regulation of cigarettes, as well as an increase in the cost, has been
a burgeoning black market in cigarettes. Again, the legislation is
intended, among other things, to discourage smoking, as well as the
smoking of cigarettes at current levels of nicotine. What provisions
are included in the bill that will enable the FDA to combat not only
the illegal sale of cigarettes in general but the possibility of a rise
in the illegal shipment of cigarettes into this country?
Answer 4. I will address the elements of this question where I feel
my expertise is relevant and defer to others on law enforcement and
trade monitoring where I feel I have little to offer. As I mentioned in
my explanation of why I do not support banning cigarettes and other
forms of tobacco, I am concerned that this would foster contraband or
``black market'' sales (we also discussed this in the American Medical
Association report cited above). Factors that fuel such markets are
reduced access and substantially increased cost in the open market,
while demand remains high. FDA regulation is expected to contribute to
reduced demand and reduced consumption of tobacco products because its
efforts should support prevention of initiation of use and encourage
more users to quit. This should reduce pressures that foster contraband
markets.
Questions of Senator Coburn
Question 1. What constituents would you recommend that the FDA
require to be eliminated or reduced in cigarettes, and by how much
would that reduction or elimination reduce the relative risk of
tobacco-related diseases?
Answer 1. I believe that it would be premature to make specific
recommendations for ingredient elimination, although I believe that
many toxicants should be reduced if not eliminated. In fact, today's
marketed products deliver highly toxic substances in quantities that
vary widely across cigarettes, and includes carbon monoxide gas,
tobacco specific nitrosamines, heavy metals, nitrosamines, agricultural
residues (e.g., from pesticides and fertilizers). I believe that
standards could be developed based on what the market place has already
shown to be feasible. Under FDA's direction advisory committees could
supplement internal evaluations to examine a wide range of substances.
For example, added ingredients (e.g., ammonia, menthol, chocolate),
materials in composition (e.g., glass fibers), and design features
(e.g., hidden ventilation systems) which may increase toxicity and/or
addiction should be considered. Standards may be set for ingredients in
the product as well as its emissions such as constituents of ``tar,''
and toxic gases such as carbon monoxide. Standards that lead to
decreased smoke exposure and or toxicity have the potential to reduce
secondhand smoke exposure and/or the toxic consequences of secondhand
smoke exposure. For example, if FDA determines that chocolate is not
necessary for cigarette manufacture and consumption but may contribute
to carcinogenicity and or risk of becoming addicted it could limit or
ban chocolate.
In the first few years, I would not expect to see disease risk fall
substantially, if at all, due simply to performance standards on
ingredients, and that is why this aspect of regulation should be seen
as simply one of my elements of comprehensive tobacco control that are
needed short run and long run to reduce tobacco use and associated
disease.
Question 2. How will smokers alter their behavior in response to
the introduction of cigarettes with new tobacco product standards? That
is, what will be the effect on cigarette consumption of smokers now
knowing that the FDA is tightly regulating all the constituents and
ingredients in cigarettes?
Answer 2. The effects will depend at least in part on how radically
and how quickly products are changed and the nature and effectiveness
of accompanying communications. The mid-century wholesale adoption of
the niche market for cigarettes with filters is a powerful lesson in
how quickly and massively tobacco users can adjust their behavior when
there appears to be a health benefit. Unfortunately, in that case, lack
of oversight of the health consequences (as FDA would have) meant that
the filters provided reassurance to smokers but not necessarily actual
health benefit. Fortunately the FDA has considerable experience in
health communications and marketing regulation. However, many aspects
of consumer behavior will be affected by the behavior of the tobacco
industry itself as well as other factors such as increasing adoption of
clean air laws by communities, cities and States.
Question 3. In what way will reducing the nicotine levels in
cigarettes improve the public's health, since we know that when
nicotine levels are reduced, smokers compensate by smoking more? Won't
this approach in fact hurt the public's health?
Answer 3. As discussed in the American Medical Association
commissioned paper cited above, and my testimony, I concur with the WHO
and the FDA's own conclusion, in its 1990s Tobacco Rule which does not
support near-term reduction of nicotine in cigarettes. We do not yet
have the science base, the treatment infrastructure, the education or
other elements in place to enable such action. Furthermore, with FDA
regulation AND increased commitment to comprehensive tobacco control as
outlined in reports by the Centers for Disease Control and Prevention
and the WHO, it may not be necessary to eliminate nicotine from tobacco
products. However, I believe it is vital that FDA have the power to
reduce nicotine levels to below a threshold level of addiction as one
of its regulatory approaches. But the agency will need to be in a
position to help drive the science and to monitor progress and effect
of regulation--intended and unintended--and to thereby determine if
such an approach would be warranted.
Response to Questions of Senator Kennedy, Senator Enzi, Senator Burr,
Senator Hatch, and Senator Coburn by Gregory Connolly, D.M.D., M.P.H.
question of senator kennedy
Question. You conducted a study into how consumers perceived the
implied claims tobacco companies are making about the reduced health
risks of their products. Can you elaborate on what the public
understanding is when they see these claims, and would you give use a
few examples of the types of claims currently being made.
Answer. We examined smokers' responses to advertisements for
potentially reduced exposure tobacco products (PREP), light cigarettes,
and regular cigarettes. A convenience sample of 600 adult smokers
reviewed one actual advertisement for each type of product. Smokers
ranked the products on health risk, amount of tar, and carcinogenicity,
and identified the messages they perceived the advertisements to
convey. Smokers perceived PREP products as having lower health risks
and carcinogens than Light or regular cigarettes.
Although no advertisements explicitly said that the products were
healthy or safe, advertisements for PREP products and light cigarettes
were interpreted as conveying positive messages about health and
safety. Most smokers believed that claims made in cigarette
advertisements must be approved by a government agency. The results
indicate that advertisements can and do leave consumers with
perceptions of the health and safety of tobacco products that are
contrary to the scientific evidence. Explicit and implicit advertising
messages may be strengthened by the perceived government endorsement.
This supports the Institute of Medicine's recommendation to regulate
the promotion, advertising, and labeling of PREP tobacco products and
light cigarettes. Effective regulation should focus on consumer
perceptions resulting from advertisements rather than the explicit
content of advertising text.
Example of PREP advertising we studied include Eclipse. It used the
slogan ``The best choice for smokers who worry about their health is to
quit. Here's the next best choice.'' Although this was not an explicit
claim smokers perceived it to equate with a claim for reducing their
risk of disease.
A second ad was for Omni. The slogan for this brand was ``There's
only one brand that significantly reduces carcinogens. Made you look!''
Although this ad only referenced a reduction in cancer causing agents
and not a reduction in actual cancer risk it still was perceived by
smokers as a claim of reduced cancer risk.
questions of senator enzi
Question 1. The bill assumes tobacco industry user fees will pay
for the regulation of the tobacco industry. The prescription drug user
fee program also housed at FDA levies over $300 million per year in
user fees to support over 1,500 employees. This is on top of hundreds
of millions in appropriations and appropriations-funded employees for
the drug center. A standard drug review takes 10 months. In contrast,,
this bill would require the review of a reduced risk product, with an
entirely different standard for approval, in 6 months. In addition,
there are over 5,000 brand styles on the market today. The ``health
information'' required for each brand or sub-brand under section 904 is
extensive. I think it would take a lot of FDA employees to go through
that data, never mind to do reviews of new products, otherwise it would
just get warehoused and not be of much use to anyone. What is the basis
for the user fee levels set in the bill, and how do we know if that is
enough to support what the bill requires?
Answer 1. The user fees in the bill would be used among other
things to conduct needed independent research on conventional tobacco
products and potentially reduced (tobacco) exposure products (PREPS).
The bill would ramp up user fees from the initial amount to $300
million per year, equal to the drug user fee program housed at the FDA.
This level of funding appears adequate to carry out the provisions of
the bill. This level of funding is not far different from what tobacco
manufacturers are expending for research they conduct on PREPS. If FDA
did regulate PREPs, the industry research would most likely be made
available to the FDA and complement FDA funded research. The bill would
also require the industry to conduct the bulk of testing on the design
and emissions of conventional brand styles that are in the marketplace.
There may be 5,000 brand styles in the market but realistically only
1,000 are actually sold based on certifications by the New York Fire
Prevention Office of Reduced Ignition Propensity Cigarettes in New
York.
Also, Canada requires extensive testing of toxic constituents in
the tobacco and in smoke and CDC already receives ingredient lists for
the companies as does Texas by brand. If these jurisdictions already
receive this information, it should not be burdensome for FDA.
Question 2. The data in your testimony regarding the targeting and
uptake of menthol cigarettes to African-Americans, particularly young
people, is amazing. This practice is abhorrent. However, section 909 of
the bill that you support permits menthol to remain on the market. Why
shouldn't menthol also be banned along with the rest of the flavored
additives? Would you support changing the legislation to disallow
menthol along with other flavorings? If not, why not?
Answer 2. The bill will not include menthol in the list of banned
``candy'' flavors given the long history of menthol use in tobacco
products. However, the FDA could reduce or ban menthol through a
performance standard. Menthol is in all cigarettes at some level but
only at high levels in brands that are advertised as mentholated. If
FDA found menthol alone or high levels had an adverse effect on the
public health, the Agency could reduce or ban it.
Question 3. FDA's role is to assure the safety and effectiveness of
medical products, not to tinker at the margins of regulating a product
known to be harmful. What kind of public health message would we send
if we directed FDA to regulate the tobacco industry and approve tobacco
products?
Answer 3. In our research we conducted among a panel of 600
smokers, the vast majority believed a governmental agency approved the
content of advertisements, including data on levels of toxins on PREPs.
The FDA bill would protect consumers from current applied claims for
reduced harm which they believe are explicit claims and approved by a
governmental agency. FDA regulation will be an end to such claims.
Question 4. In your testimony, you suggest that States lack the
resources to aggressively counter tobacco use. How can that be possible
given the levels of funding provided by the MSA?
Answer 4. In my testimony, I stated that States lacked the
resources and legal reach to regulate tobacco products. The resources
would be both the scientific expertise as well as financial resources.
If other States as Massachusetts did, assert FDA-like jurisdiction on
tobacco products, the industry would likely litigate. Also, it may not
be in the national interest to have 50 different approaches to tobacco
product regulation.
question of senator burr
Question. How is keeping tobacco products on the market in the best
interest of the public's health? Please provide a direct answer to this
question.
Answer. The United States banned the sale of alcohol in the early
part of the last century. The action did have a positive public health
impact but also created unintended consequences of increased crime and
other social problems. Given the fact that 45 million Americans smoke,
this history would argue against an immediate, total ban of cigarettes.
The legislation would allow FDA to gradually ``wean'' smokers off
conventional tobacco products while providing alternate nicotine
delivery devices that do not cause significant harm. This would be
considered as a possible approach for the FDA.
questions of senator hatch
Question 1. You have been repeatedly quoted as saying that the
legislation would initially give ``Philip Morris a market advantage
over its business rivals'' but eventually the bill ``could turn
Marlboro into lard: legal but no one uses it.'' (Quotes are from a
story in the Richmond-Times Dispatch, February 26, 2006.) Would you
explain what this initial, if temporary, market advantage would be?
Answer 1. The legislation empowers the FDA to curtail aggressive
marketing of tobacco products to youth. After the Master Settlement
Agreement, R.J. Reynolds Tobacco continued to advertise in magazines
popular with youth, introduced candy flavored brands popular with young
people, targeted black youth with new menthol brands and most recently
young females with brands like Camel No. 9. To the extent the FDA bill
restricts such reckless marketing, RJRT would lose market ``advantage''
to Philip Morris. However, in the long term, the FDA bill should result
in reduced sales of all brands regardless of the company and improve
the public health.
Question 2. There has been a growing tendency both at the Federal
and at the State level to use monies generated from tobacco taxes from
a variety of legislative purposes that are not directly connected to
anti-smoking campaigns, some of which are very legitimate initiatives.
Let's assume two scenarios. First, Congress bans cigarettes tomorrow
and the ban works. We are no longer able to rely upon any revenues,
either at the Federal or the State level, from the sale of tobacco. If
such a ban took place, what would be the budgetary shortfall that we
would have to make up? Second, let's assume the legislation before the
committee is enacted, which is intended, among other things, to result
in a reduction of the sale of cigarettes. What is the budgetary
shortfall we can expect if the current bill is enacted at both the
Federal and State level?
Answer 2. First, no one is advocating a ban on cigarettes tomorrow
and passage of such a law is extremely unlikely if not totally
unrealistic. Making a projection on the State budgetary impact of a ban
is equally unrealistic. If the current bill is enacted, the bill will
result in a reduction of cigarettes sales and there is no doubt that
the economic benefit in health or savings far out weight tax losses. We
do not know what the reduction would be until the final bill is enacted
and implemented. Cigarette consumption fell 50 percent between 1993-
2004 in Massachusetts. The decline in Massachusetts taxes was offset
with increases in the State tax rate and a redirection of consumer
resources from cigarettes to healthy goods and services.
Combined current Federal and State taxes are small in comparison to
the economic burden that smoking has on the U.S. economy.
Question 3. Unfortunately, one of the consequences of the increased
regulation of cigarettes, as well as an increase in the cost, has been
a burgeoning black market in cigarettes. Again, the legislation is
intended, among other things, to discourage smoking, as well as the
smoking of cigarettes at current levels of nicotine. What provisions
are included in the bill that will enable the FDA to combat not only
the illegal sale of cigarettes in general but the possibility of a rise
in the illegal shipment of cigarettes into this country?
Answer 3. There is a general provision in the bill for the FDA to
seize mis-branded cigarettes which one would assume to be smuggled
cigarettes not in compliance with standards established by the FDA. The
provision of this law could be used to address contraband cigarette
sales if the FDA law resulted in an increase in contraband sales. In
1978, Congress passed the Contraband Cigarette Act which has been
effective in reducing contraband cigarette sales. This law could be
used to address any smuggling possibly created by the bill.
Questions of Senator Coburn
Question 1. What constituents would you recommend that the FDA
require to be eliminated or reduced in cigarettes, and by how much
would that reduction or elimination reduce the relative risk of
tobacco-related diseases?
Answer 1. According to the Surgeon General's 2000 Report, tobacco
manufacturers should eliminate or reduce a toxic constituent to the
lowest level technically feasible but not make a claim that such
reductions reduce health risks unless scientific study shows this. One
example is the removal of tobacco specific nitrosamines (TSNAs) which
cause cancer. Currently, smokeless tobacco manufacturers have reduced
TSNA levels in smokeless tobacco that they promote as PREPs but don't
do so for conventional brands which have up to 20 times the level of
TSNAs than PREPs. The FDA could require them to do so for all products.
Removing or reduction in toxins could take into account a fixed
timetable for smokers to adapt to the changes.
Question 2. How will smokers alter their behavior in response to
the introduction of cigarettes with new tobacco product standards? That
is, what will be the effect on cigarette consumption of smokers now
knowing that the FDA is tightly regulating all the constituents and
ingredients in cigarettes?
Answer 2. Based on the New York experience with reduced ignition
propensity Cigarettes (fire safer cigarettes) which were the only
cigarette allowed for sale in the State as of July 2004, there will
likely be little or no effect on smoker behavior if product design is
changed. We examined cigarette consumption before and after the RIP
requirement in New York and found no difference in consumption
indicating product acceptance. FDA could take the same approach with
requirements on other design features and allow time to phase in such
changes so that consumers could adapt to the products.
Question 3. In what way will reducing the nicotine levels in
cigarettes improve the public's health, since we know that when
nicotine levels are reduced, smokers compensate by smoking more? Won't
this approach in fact hurt the public's health?
Answer 3. We do not know how increasing or decreasing nicotine will
affect the public health. As part of FDA regulation, research will be
conducted to find this answer before nicotine levels are changed.
Increasing nicotine and decreasing toxins in smoke or in the body
doesn't necessarily correlate with a reduction in disease outcomes. For
example, cardiovascular disease may be induced at very low doses of
toxins.
On the other hand, nicotine could be reduced to a level that is
non-addictive (.3mg/g of tobacco), a level found in tomatoes. This
could result in complete cessation of conventional cigarettes and a
switch to nicotine products that have been shown not to cause harm.
Response to Questions of Senator Enzi and Senator Hatch by Lisa Shames
U.S. Government Accountability Office,
Washington, DC. 20548,
March 15, 2007.
Hon. Edward M. Kennedy,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC. 20510.
Hon. Michael B. Enzi,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC. 20510.
Re: Posthearing Questions Related to the Regulation of Tobacco Products
Dear Senators: On February 27, I testified before this committee at
a hearing addressing the regulation of tobacco products. This letter
responds to your request that I provide answers to followup questions
asked after the hearing. Senator Enzi's and Senator Hatch's questions,
along with my responses, follow.
questions of senator enzi
Question 1. In 1998, as the Senate debated a major tobacco bill, I
offered an amendment that would have directed the money paid into the
National Tobacco Trust Fund by manufacturers and importers to Medicare,
Medicaid and tobacco control and prevention. Half the money would have
gone to Medicare, 25 percent to Medicaid, and 25 percent to tobacco
control and prevention activities. Although the legislation eventually
failed, I wonder what would have happened if we had applied that
breakdown to the Master Settlement Agreement (MSA) funds. Are any
States spending 25 percent of their MSA money on tobacco control and
prevention activities?
Answer 1. For fiscal year 2006, five States--Wyoming, Maine,
Arkansas, Oklahoma, and Montana--reported that they planned to allocate
over 25 percent of their MSA funds on tobacco control and prevention,
with Wyoming reporting 35.9 percent of their funds, Montana reporting
26.1 percent, and the others falling in between.
Question 2. I'm interested in determining what portion of
``health'' spending by the States under the MSA is going toward the
care of smokers and former smokers, and what portion is going to other
health priorities. Can you discuss the breakdown of the ``health''
category of State spending?
Answer 2. While States provided examples of health programs, they
generally did not provide a further breakdown of the percentages
allocated to each specific example. However, Medicaid and insurance-
related programs were two commonly-cited examples.
Question 3. I learned a lot about the MSA and how States are
spending the funds from your testimony, and much of what I learned
worries me. Can it really be true that States would actually receive a
decrease in MSA money if smoking goes down? It seems to me that is a
perverse disincentive for States to do right with this money.
Answer 3. The tobacco companies' annual payments are adjusted based
on several factors contained in the MSA, including fluctuations in the
volume of cigarette sales, inflation, and other variables, such as the
participating companies' share of the tobacco market. Declining tobacco
consumption alone would result in lower MSA payments than originally
expected. Tobacco consumption has declined since the MSA was signed in
1998--by about 6.5 percent in 1999 alone--mostly attributed to one-time
increases in cigarette prices by the tobacco companies after the
agreement took effect. Analysts project that, in the future, tobacco
consumption will decline by an average of nearly 2 percent per
year.\53\ As a result, tobacco consumption is estimated to decline by
33 percent between 1999 and 2020.
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\53\ Cigarette consumption peaked in 1981 and has been declining
since.
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However, the MSA also includes an inflation adjustment factor that
some analysts have estimated increases payments more than any decreases
caused by reduced consumption. The inflation adjustment equals the
actual percentage increase in the Consumer Price Index for the
preceding year or 3 percent, whichever is greater. The effect of these
compounding increases is potentially significant, especially given that
the payments are made in perpetuity. Assuming a 3-percent inflation
adjustment and no decline in base payments, settlement amounts States
receive would double every 24 years.
Also, several tobacco companies' interpretation of the provision
that addresses participants' market share led them to lower their
payments in 2006. Under this provision, an independent auditor
determined that participating tobacco companies lost a portion of their
market share to non-participating companies. An economic research firm
determined that the MSA was a significant factor in these market share
losses. Based on these findings, several participating companies
reduced their fiscal year 2006 payments by a total of about $800
million. Many States have filed suit to recover these funds.
In addition to the annual payments States receive, the MSA requires
that a Strategic Contribution Fund payment begin in 2008 and continue
through 2017. The base amount of each year's Strategic Contribution
Fund payment is $861 million, which will be adjusted for volume and
inflation and shared among the States. Strategic Contribution Fund
payments are intended to reflect the level of the contribution each
State made toward final resolution of their lawsuit against the tobacco
companies. They will be allocated to the States based on a separate
formula developed by a panel of former State Attorneys General.
questions of senator hatch
Question 1. There has been a growing tendency both at the Federal
and at the State level to use monies generated from tobacco taxes for a
variety of legislative purposes that are not directly connected to
anti-smoking campaigns, some of which are very legitimate initiatives.
Let's assume two scenarios. First, Congress bans cigarettes tomorrow
and the ban works. We are no longer able to rely upon any revenues,
either at the Federal or the State level, from the sale of tobacco. If
such a ban took place, what would be the budgetary shortfall that we
would have to make up? Second, let's assume the legislation before the
committee is enacted, which is intended, among other things, to result
in a reduction of the sale of cigarettes. What is the budgetary
shortfall we can expect if the current bill is enacted at both the
Federal and State level?
Answer 1. While we have not conducted an analysis of the economic
effects of a cigarette ban or of the current bill on tax revenues and
MSA payments, the revenue stream from the MSA, excluding securitized
proceeds, has been over $5 billion annually for several years.
Question 2. Unfortunately, one of the consequences of the increased
regulation of cigarettes, as well as an increase in the cost, has been
a burgeoning black market in cigarettes. Again, the legislation is
intended, among other things, to discourage smoking, as well as the
smoking of cigarettes at current levels of nicotine. What provisions
are included in the bill that will enable the FDA to combat not only
the illegal sale of cigarettes in general but the possibility of a rise
in the illegal shipment of cigarettes into this country?
Answer 2. We have not studied the provisions in this bill. However,
we reported in 2004 that cigarette smuggling, particularly of
counterfeit cigarettes, is a significant problem. However, because of
the clandestine nature, the extent of cigarette smuggling into the
United States is impossible to measure with any certainty.\54\
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\54\ GAO, Cigarette Smuggling: Federal Law Enforcement Efforts and
Seizures Increasing GAO-04-641, (Washington, DC.: May 28, 2004).
Counterfeit cigarettes are those produced without the authorization of
the trademark holder.
We appreciate the opportunity to comment and hope that these
responses are of assistance. If you have any additional questions,
please do not hesitate to call me at (202) 512-3841.
Lisa Shames,
Acting Director,
Natural Resources and Environment.
______
Response to Questions of Senator Enzi, Senator Burr, and Senator Hatch
by Alan Blum, M.D.
questions of senator enzi
Question 1. Do you think FDA regulation of tobacco lends legitimacy
to the [tobacco] industry?
Answer 1. The tobacco industry should be fully expected to take
advantage of this bill to remind all Americans through television,
radio, the print media, package inserts, the U.S. Mail, and the
internet that cigarettes are now regulated by the same agency that
ensures that food and medicines are safe.
Philip Morris is already testing the waters, and setting a new
standard for chutzpah, by attempting to enlist physicians in the
distribution of the company's propaganda to their patients. For the
first time in more than half a century, Philip Morris is communicating
directly to doctors by means of personal letters (example attached)
offering to supply unlimited copies of a booklet on stopping smoking.
If you decide to quit smoking . . . (cover attached) does not mention
the word ``addiction,'' contains a total of three sentences in its 52
pages that mention diseases caused by smoking, and is illustrated with
17 color photographs, all of healthy, smiling people and none of
persons made ill from smoking or of tobaccogenic diseases.
Philip Morris' Youth Smoking Prevention advertisements on
television and in booklets directed to parents (Raising Kids Who Don't
Smoke, cover attached) have been reviled by health organizations such
as the Campaign for Tobacco Free Kids as both ineffective and
inappropriate. The company touts this program to college students at
job fairs on university campuses across the country (as well as on its
Web site (www.cantbeattheexperience.com), even though there are no
entry-level Youth Smoking Prevention positions. To the contrary, the
jobs offered to college students are exclusively summer internships and
territory sales managerships that involve the distribution of
cigarettes to upwards of 150 convenience stores, supermarkets,
pharmacies, bars, and other retail outlets.
In half-page color advertisements in college newspapers urging
students to meet with company recruiters at career fairs, Philip Morris
boasts that it is ``unique in how we face our particular challenges and
responsibilities'' (copy of advertisement attached, from The Crimson
White, University of Alabama, February 9, 2007, page 5: `` `I want a
MARKET LEADER. An INNOVATOR. Someone who'll stretch my limits. And
you're telling me TOBACCO?' YES. And we're telling you United States.
We not only lead a major consumer products category in this country--we
do it with a brand that's recognized as one of the 10 most valuable in
the world. We're also unique in how we face our particular challenges
and responsibilities. That's why we've helped redefine how products are
marketed . . . with innovative, experiential and one-to-one programs
for our adult consumers. So now--how about telling us more about you?
See us on campus at the Career Fair Wednesday, February 14th, 9am-3pm
Bryant Conference Center.'' CANTBEATTHEEXPERIENCE.COM. PHILIP MORRIS
USA)
Such practices aimed at burnishing the company's nicotine-stained
image among physicians and parents and increasing the size of its
youthful sales force--direct mail to the medical profession, propaganda
campaigns aimed at parents, and recruitment advertisements in college
newspapers--would remain unregulated by this bill and protected by the
first amendment.
FDA regulation of tobacco products would provide an unprecedented,
unmerited, health-related legitimacy to manufacturers of cigarettes and
would send a misleading message to consumers, namely that cigarettes,
however unsafe, are government-sanctioned.
By promulgating health standards, FDA will be fostering the
perception that cigarettes are now safer to smoke. The public is not
generally aware that there are more than 4,000 solid and gaseous
poisons in tobacco smoke, including more than 40 cancer-causers. Nor
are most consumers of cigarettes likely to understand epidemiology. If
consumers are informed that nitrosamines (powerful carcinogens) have
been reduced or removed from cigarettes, then they are going to infer
that the problem is being taken care of or even solved. This ignores
the dozens of other cancer-causers. Neither the technology to remove
carcinogens from cigarette smoke nor the science to prove that the
removal of any toxin from cigarette smoke reduces mortality yet exists.
Such studies would take decades to detect any reduction of harm from
tobacco use, and the ethics of conducting such ongoing research on
persons who smoke without providing frequent cessation interventions
would be called into question. Having served as a member of the
Institutional Review Board (IRB) of the University of Alabama
(overseeing research protocols to ensure the protection of human
subjects), I cannot imagine that prospective comparison studies of
different tobacco products would be permitted by any scientific body.
Since smoking prevalence is directly proportional to the degree of
perceived harm from smoking, FDA sanction of cigarettes will lead to an
increase in smoking prevalence, compared to what would have occurred in
the absence of this legislation.
Question 2. Do you believe that getting FDA regulation of tobacco
up and running will take substantial time and commitment from HHS and
FDA leadership? What is FDA's track record when they are asked to
produce many new complex regulations simultaneously?
Answer 2. I agree with Senator Kennedy that the Food and Drug
Administration has been a model for the world to follow in ensuring the
safety and efficacy of medications. I greatly admire his longstanding
efforts, as well as those of Representative Waxman, the late Senator
Kefauver, and other legislators, to strengthen the watchdog powers of
the FDA over the pharmaceutical industry.
By all accounts, however, the FDA is in a state of turmoil.
Unprecedented bipartisan criticism has rained down on the agency for
several years, as its failings and foul-ups have mounted. These
troubles culminated in the sentencing of the most recent former FDA
Commissioner for his conviction on ethical conflict-of-interest
violations on the very day of the HELP Committee's hearing on this
bill.
The current FDA Commissioner, Dr. Andrew von Eschenbach, has
publicly questioned the wisdom of giving the FDA the power to regulate
tobacco. ``When a product, when used as intended, results in death,
it's hard for me to say how to regulate that as being safe and
effective,'' he told Bloomberg News on March 6, 2007. In an interview
on the same day with the Associated Press, Dr. von Eschenbach warned
that if the FDA were to accept the mandate of the bill to reduce
nicotine levels in cigarettes, consumers would tailor their smoking
habits to maintain current levels of the addictive drug:
``We could find ourselves in the conundrum of having made a
decision about nicotine only to have made the public health
radically worse. And that is not the position the FDA is in; we
approve products that enhance health, not destroy it,'' said
Dr. von Eschenbach, a cancer surgeon . . . ``What I don't want
to see happen is that we are in a position where we are
determining that a cigarette is safe.''
For his candor, Dr. von Eschenbach has been criticized as
``misinformed'' by the chairman/ceo of the Campaign for Tobacco-Free
Kids in a March 6, 2007 press release.
Senator Kennedy's earlier bill, The Tobacco Product Education and
Health Protection Act of 1990 (S. 2795), which I was privileged to
testify in favor of, was closer to the mark in establishing a separate
Center for Tobacco Products.
The FDA has a disappointing and alarming recent history of
compromised consumer safety. For instance, considerable shortcomings
have been exposed in the FDA's regulation of medical devices, including
artificial heart valves, coronary artery stents, heart defibrillators,
and artificial joints. FDA policy is to permit brands to be marketed
that are ``substantially equivalent'' to other models that have been
approved. As a result, failures of these less-tested brands--and
resultant fatalities--are more likely to occur. This has been the case
with defibrillators, and since only health facilities (among all sorts
of public places in which a host of cheap, shoddy models are installed)
must regularly test devices and report failures, the FDA does not even
know the magnitude of the problem.
In contrast to the time when the FDA prevented drugs like
thalidomide from reaching the market for the treatment of nausea of
pregnancy, today the pharmaceutical industry has regained the upper
hand through aggressive marketing and ineffective regulation. For
example, in 2006 two separate congressional committees examined the
FDA's handling of antidepressant medications in pediatric patients
because of an increased association between these drugs and suicide
attempts. The FDA had failed to make public the recommendation of its
own scientific reviewer that there be an intensive risk management
strategy if these drugs were to continue to be prescribed to
adolescents and children. Similarly, although some medications used for
hyperactivity in children have been removed from the market in Canada,
the FDA has been slow to restrict the use of these drugs.
In several recent instances, the failure of the FDA to obtain
complete and accurate data from companies on the incidence of adverse
effects of top-selling medications has undermined public confidence in
the impartiality of the agency. After one manufacturer, AstraZeneca,
was found to have withheld information that its cholesterol-lowering
medication Crestor may have caused a higher incidence of muscle damage,
liver damage, and kidney failure than similar drugs, the company
purchased full-page ads in major newspapers that claimed, ``The FDA has
confidence in the safety and efficacy of Crestor,'' In response,
Representative Henry Waxman wrote in a letter to the FDA, ``Either
AstraZeneca is misleading the public about Crestor's safety, or the FDA
is giving the company private assessments that conflict with the
agency's public position'' (``Crestor Ads Draw Fire; FDA Could Act.''
USA Today, December 8, 2004).
Such failures by the FDA to obtain and act on reports of adverse
drug effects may be the tip of the iceberg. The FDA's latest annual
report on mandatory monitoring of drugs approved for the market found
that 899 of 1,259 post-approval studies had not even been started.
(``Many Drug Studies Not Begun, FDA says.'' Los Angeles Times, February
2, 2007, page A20).
Similar serious post-marketing safety concerns have been raised
about medications for weight-loss (Meridia), acne (Accutane), and
asthma (Serevent).
Perhaps the most thorough failure of the FDA occurred with the COX-
2 inhibitor drugs for arthritis (Vioxx, Celebrex, Bextra), which became
the most promoted, prescribed, and consumed class of medications in
spite of the fact that they were no more effective and were far less
expensive than older, over-the-counter drugs, and in spite of the
manufacturers' knowledge of an increased incidence of cardiovascular
problems attributed to these new drugs. In this instance, in 2004 a
glaring conflict-of-interest was revealed to have occurred in the
agency, wherein an FDA scientist who worked with pharmaceutical
companies on drug approvals also had authority over FDA's drug safety
office.
Other allegations of problems at the FDA in recent years have
included rampant conflict-of-interest and pro-pharmaceutical industry
bias among scientific advisory panel members; the lack of checks on
bovine hormone and antibiotic use in cattle that has led to bacterial
contamination of meat; the failure to prevent contamination of animal
feed and the resultant increased risk of mad cow disease and Jacob-
Creutzfeld disease in humans; inadequate inspections of produce and
other food; the failure to end the practice of gifts to prescribing
physicians by pharmaceutical companies; insufficient attention to
questions about the safety of dietary supplements, sleep medications,
and hormone replacement therapy in women, among other classes of drugs;
influenza vaccine shortages due to the failure to plan for the
replacement of a contaminated facility in the United Kingdom; mixed
messages on the safety of breast implants; the relative ease with which
certain prescription drugs with potentially harmful consequences have
been able to receive over-the-counter status; and the failure to limit
off-label uses of drugs or to enforce its own rules on prescription
drug advertising.
To its credit, during the brouhaha over the COX-2 drugs, the FDA
commissioned the Institute of Medicine (IOM) to assess the drug safety
system. On the basis of its investigation, in September 2006 an IOM
committee reported on numerous serious problems at the FDA, including
the scarcity of post-approval data. Earlier in 2006, the Government
Accountability Office also found that the FDA lacks a clear and
effective process for oversight of post-market safety issues. The IOM
proposed 25 recommendations for overhauling the agency. Although the
FDA pledged to adopt the necessary reforms, the Wall Street Journal
reported on March 3, 2007 that a study commissioned by the agency
itself found that its new system for detecting adverse effects of
medications has failed. (``Report Blasts FDA's System to Track Drugs.
Wall Street Journal, March 3-4, 2007, page A1-A2).
Senator Enzi's observation that the FDA is struggling with the
challenges of regulating an expanded universe of products and threats
is accurate. The FDA is already tasked with duties related to public
health, drug importation, food safety, and bioterrorism, any of which
could ramp up demands for FDA resources. It makes no sense to give this
overextended agency yet another huge mission. I also agree that getting
FDA regulation of tobacco up and running will take substantial time.
Given its present inability to solve its own myriad problems, the FDA
would be the wrong agency at the wrong time to undertake oversight of
tobacco products.
William Godshall, a public health professional and founder of
Smokefree Pennsylvania, is a leading advocate of the harm reduction
approach to tobacco control, whereby consumers of cigarettes are
encouraged to switch to noncombustible tobacco products if they cannot
otherwise stop smoking. He sees a parallel between the hundreds of
medications overseen by the FDA and the more than 400 different brand
variations of cigarettes on the U.S. market, each containing differing
amounts of scores of chemical additives and thousands of smoke
constituents; and he therefore questions the feasibility of correlating
tobacco-related deaths and diseases with the brands of cigarettes
consumed, which the FDA would have to do if it is to make any valid
assessments and recommendations about individual tobacco products.
FDA's track record in dealing with complex and controversial
regulations is problematic at best. But this reason should not, per se,
rule out FDA regulation of tobacco if such regulation would likely
result in major reductions of tobacco-related illness and death.
Regrettably, S. 625, if enacted, would not provide this public health
benefit.
Addendum: As a former member of an FDA advisory panel (on
immunologic devices), I support the mission of this agency and
appreciate the dedication of its staff. However, a personal experience
may help to illustrate the disappointment and frustration I anticipate
would result were the FDA to undertake the regulation of tobacco
products.
In the April 3, 1981 edition of the Journal of the American Medical
Association, I wrote an editorial that was the first to state the case
for the removal from the market of phenylpropanolamine (PPA), a
stimulant with actions similar to ephedrine and the amphetamines that
was an ingredient in heavily advertised over-the-counter weight loss
remedies and cold pills (Phenylpropanolamine: An over-the-counter
amphetamine? JAMA 1981;246:1347-48). Several medical journal articles
had reported individual cases of hypertension and hemorrhagic stroke
attributed to PPA (even in small doses and even among young persons) in
Australia and the United Kingdom.
In October 1981 the Center for Science in the Public Interest, a
Washington-based nutrition education group, petitioned the FDA to ban
dietary aids containing PPA. In the mid-1980s, The Medical Letter, an
independent review of medications, joined in the call for a ban on PPA.
Ubiquitous advertising for the diet pills (e.g., Dexatrim) and
decongestants continued unabated. Not until 1991, by which time a total
of 44 cases of stroke in PPA users had been reported to the FDA, did
the agency convene a public hearing on the drug, but pressure from the
manufacturers of PPA-containing OTC products prevented any action from
being taken.
In October 2000 Public Citizen's Health Research Group, which
estimated that as many as 510 to 1,020 cases of hemorrhagic strokes had
occurred in persons using PPA-containing products, petitioned the FDA
for an immediate ban on all uses of PPA in OTC products, including
appetite suppressants and cough and cold preparations. Finally, on
December 22, 2005 the FDA reclassified PPA as not safe or effective and
ordered the removal of PPA from all drug products.
Cigarettes are already known to be responsible for an estimated
500,000 deaths each year in the United States. Yet, as Senator Coburn
points out, with enactment of this bill Congress would be sidestepping
its responsibility to take direct action against cigarettes by not
granting the FDA the authority either to remove them from the market or
otherwise seriously limit their sale. Cigarette manufacturers have far
greater financial resources and influence than makers of PPA. If it
took nearly 25 years for the FDA to heed calls for a ban on this
dangerous drug, then can we truly expect the agency to take any
immediate and decisive actions that will significantly inhibit
cigarette sales?
Question 3. [C]ould this bill serve to create a significant legal
defense by the industry to counter product liability and tort lawsuits
by plaintiffs?
Answer 3. The bill would serve to create a significant legal
defense by the tobacco industry to counter product liability and tort
lawsuits by plaintiffs. In court, the industry would remind jurors and
judges alike that tobacco products are now regulated by the same agency
that ensures the safety of food and medicines.
The bill would end the prospect of meaningful punishment of the
tobacco industry and the achievement of reform through litigation.
Punitive damages for victims, or classes of victims, of tobacco-caused
death, disease, and suffering would end due to the shield provided by
the FDA.
In previous tobacco litigation, cigarette manufacturers have
successfully argued that they are sufficiently regulated and thus there
is no need for further steps to deter future misconduct. The industry
gained considerable public relations value from the Master Settlement
Agreement (MSA) and would gain additional mileage from FDA regulation.
Analogous to its having cited the MSA numerous times in court over the
past decade, including the Department of Justice case, the industry
would claim that the Federal Government has assumed jurisdiction over
all aspects of tobacco operations, including manufacture, new product
introductions, health claims, health standards, ingredients, additives,
constituents of smoke, nicotine, advertising, access, and marketing
(which would be true) and that there is thus no need for any further
injunctive relief or punitive damages to deter future bad behavior: it
is now all under FDA's control. And from a public perception, cigarette
manufacturers would be right.
The important point is not whether the bill actually gives the
tobacco companies immunity or protection from litigation. Rather, it is
whether or not the companies can use the fact of being regulated by FDA
to achieve de facto immunity by exploiting the public perception that
the problem is being solved.
Tobacco industry investment analyst Bonnie Herzog wrote in her
March 5, 2007 report that the bill could ``prevent future litigation.''
Tobacco industry investment analyst David Adelman wrote in his February
15, 2007 report that the bill gives the industry, ``an additional and
potentially effective legal defense.'' Analysis of internal Philip
Morris documents (e.g., Bates numbers 207573345/3346 and 2081523647,
accessible at University of California, San Francisco Legacy Tobacco
Documents Library) suggests that this is a key goal the company hopes
to achieve with FDA regulation.
Question 4. Does anything in the proposed legislation address anti-
smoking programs? Does anything in the proposed legislation help
smokers quit?
Answer 4. Nothing in this legislation addresses anti-smoking
programs or encourages these programs to be offered to the public. In
fact, the bill will likely have a chilling effect on State and local
anti-smoking programs because it will shift the entire focus to the
Federal regulatory level. It will create a perception that the problem
is being handled by the Federal Government, which will deter many State
and local legislatures from taking on this issue.
In addition, there is nothing in the proposed legislation that will
help current smokers quit. In fact, the legislation will likely make it
much more difficult for smokers to quit because it will create a false
sense of security. Knowing that cigarettes are now stringently
regulated by the FDA and that the products now have an FDA seal of
approval, many smokers will be under the illusion that the product is
now somehow safer. This will result in many consumers continuing to
smoke, rather than quit. Tobacco companies have long been able to
accomplish this by marketing filtered cigarettes, then ``low-tar''
cigarettes, then ``light'' and ``ultralight'' cigarettes. These much-
touted innovations did not confer any reduction in the risk of disease.
Yet they successfully addressed the health concerns of many if not most
smokers, who would otherwise have attempted to stop smoking but who
decided to continue because of the false inference that such products
were safer.
Indeed, according to Professor Michael Siegel of Boston University
School of Public Health (personal communication, March 3, 2007), this
legislation is likely to result in increased, not decreased, deaths
from tobacco products for the following reasons:
a. The bill will make it virtually impossible to research, develop,
introduce, and market new potentially less hazardous tobacco products.
It essentially freezes the market as it is and entrenches existing
high-risk products into the market. It puts an end to any meaningful
possibility of harm reduction as a tobacco control approach.
b. It will undermine current and future litigation: the companies
will be able to argue successfully that they are already regulated to
stave off injunctive relief and substantial punitive damages in
litigation by appealing to jurors' perceptions that the problem is
being solved. The grossly exaggerated claims by health organizations
supporting this bill of the bill's positive impact on public health are
only contributing to this perception.
c. It will reduce the public's perception of the inherent
harmfulness of cigarettes. By promulgating health standards, FDA will
be giving the public the perception that cigarettes are now safer to
smoke.
d. Most importantly, there are no documented mechanisms by which
the legislation will save lives. Health groups supporting this bill
have not produced a single evidence-based argument of how it will save
lives.
Dr. Siegel points out that there are only three ways that this
could occur:
First, the bill could save lives if the performance standards
reduced the relative risk of smoking-related diseases. There is no
evidence whatsoever that this is the case.
Second, the bill could save lives if it encouraged the research,
development, and marketing of actual reduced risk products. But the
bill does the opposite by setting up an almost impossible barrier to
the creation of such products.
Third, the bill could save lives if it reduced youth smoking. It
has been well-documented that youth access restrictions, implemented in
actual widespread practice, do not reduce youth smoking. The very
access restrictions that could potentially reduce youth smoking have
been precluded by the bill (namely, raising the legal age of purchase
and restricting the types of establishments, such as pharmacies, that
sell cigarettes).
[Research has also documented that the kinds of marketing
restrictions imposed by the bill are not effective in reducing youth
exposure to cigarette advertising. There are too many avenues for the
tobacco companies to market their products, and anything short of a
near-total ban on advertising and promotion of tobacco products (which
would violate the first amendment) is unlikely to have a substantial
effect on youth smoking. Even major changes in policy, such as removing
advertisements completely from youth-oriented publications, would not
reduce youth exposure to advertising to any meaningful extent.]
Fourth, the bill could save lives if it reduced adult smoking by
reducing demand for cigarettes. The bill won't do that by increasing
competition in the marketplace, and it won't do that by increasing the
public's perception of the inherent risks of cigarettes.
Question 5. I believe that people shouldn't smoke. I also believe
that the best way to achieve this is by reducing demand, not tinkering
with the supply. We reduce demand by preventing people from smoking in
the first place, and helping current smokers quit. Do you agree with
this approach?
Answer 5. The best approach to address the smoking pandemic is to
do all we can to reduce the demand for cigarettes. The supply-side
approach makes little sense because cigarettes are an inherently
dangerous product, and there is no evidence that tinkering with the
levels of various constituents of tobacco smoke will result in a safer
product. We simply do not know the specific constituents that are
responsible for the diseases or the relative contribution of each
constituent, alone and in combination. Nor do we have any evidence for
a decreased relative risk associated with product changes that either
eliminate or reduce one or several components of tobacco smoke.
question of senator burr
Question. How is keeping tobacco products on the market in the best
interest of the public's health? Please provide a direct answer to this
question.
Answer. As former FDA Commissioner David Kessler has noted, as long
as there are 50 million Americans addicted to nicotine, taking tobacco
products off the market would not be prudent. Among other adverse
effects, such a prohibition would dramatically exacerbate the black
market.
Prevention is universally agreed upon as the answer to end the
devastating health toll caused by smoking. Reducing demand through paid
mass media education campaigns is the cornerstone of primary
prevention. Regrettably, this bill is by no means likely to reduce
consumption, since it will normalize cigarettes and create the illusion
of safety.
questions of senator hatch
Question 1. What provisions are included in the bill that will
enable the FDA to combat not only the illegal sale of cigarettes in
general but the possibility of a rise in the illegal shipment of
cigarettes into this country?
Answer 1. With regard to contraband, Professor David Sweanor of the
Faculties of Law and Medicine of the University of Ottawa notes
(personal communication, March 11, 2007) that section 921 of the bill
institutes a form of ``track and trace'' for tobacco products. Had such
a system been in place, the major tobacco companies would not have been
able to develop the infamous ``transit trade'' that allowed cigarettes
to get ``lost'' and show up untaxed in various jurisdictions. He
commends this aspect of the bill but believes this is addressing the
last war.
According to Professor Sweanor, the problem now is not cigarettes
that originate from the major cigarette manufacturers but rather from
counterfeiters and Native American reservations who can produce fake
branded cigarettes for a few cents a pack. Although the legal authority
exists to stop such practices, the bill does nothing to address these
alternative sources of contraband. Thus the growing problem of fake
Marlboros from Asia or Mexico, or anything else that enters the
pipeline other than from the major manufacturers, is not addressed. The
goal should be to anticipate where the contraband will originate and to
take measures to stop it. This bill does not do that.
Question 2. If such a ban took place, what would be the budgetary
shortfall we would have to make up? What is the budgetary shortfall we
can expect if the current bill is enacted at both the Federal and State
level?
Answer 2. Since the bill would have a negligible effect at most in
reducing smoking, the budgetary shortfall would be little to none.
A ban on cigarettes would reduce annual Federal cigarette tax
revenue by about $7.5 billion* (calculated at the Federal excise tax
rate of 39 cents a pack for 19 billion packs sold), annual State and
local cigarette tax revenue by about $13 billion, and annual tobacco
settlement payments to States by about $8 billion. Thus cigarette
prohibition could reduce Federal and State revenue by about $28.5
billion a year.
---------------------------------------------------------------------------
* Since Federal cigarette tax revenue is a small fraction of 1
percent of total Federal Government taxes ($2.5 trillion a year), it
does not have a meaningful impact on the Federal revenue situation.
---------------------------------------------------------------------------
It is possible that reduced health costs for tobaccogenic diseases
and fires might offset such lost revenue. However, since this bill is
unlikely to reduce cigarette consumption, its enactment is certain to
increase the already massive amounts of Federal and State Government
expenditures spent on the treatment of cigarette-caused disease and
disability.
[Whereupon, at 12:10 p.m., the hearing was adjourned.]