[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: IS THE FDA TRYING TO
CHANGE THE INTENT OF CONGRESS?
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
MARCH 25, 1999
__________
Serial No. 106-13
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
57-333 WASHINGTON : 1999
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
JOE SCARBOROUGH, Florida CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South DENNIS J. KUCINICH, Ohio
Carolina ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia DANNY K. DAVIS, Illinois
DAN MILLER, Florida JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas JIM TURNER, Texas
LEE TERRY, Nebraska THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
JOHN T. DOOLITTLE, California (Independent)
HELEN CHENOWETH, Idaho
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Carla J. Martin, Chief Clerk
Phil Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on March 25, 1999................................... 1
Statement of:
Bass, I. Scott, J.D., adjunct professor, Georgetown
University; Daniel A. Kracov, J.D., attorney, Patton Boggs,
LLP; Edward M. Croom, Jr., Ph.D., Phytomedical Project,
National Center for the Development of Natural Products
Research, Institute of Pharmaceutical Sciences at the
School of Pharmacy, University of Mississippi; Robert S.
McCaleb, president, Herb Research Foundation, Boulder, CO;
James S. Turner, Citizens for Health; Annette Dickinson,
vice president, Scientific and Regulatory Affairs, Council
for Responsible Nutrition; and professor Margaret
Gilhooley, Seton Hall University School of Law............. 82
Henney, Jane, Commissioner, Food and Drug Administration,
accompanied by Joe Levitt, Director, Center for Food Safety
and Applied Nutrition, and Margaret Porter, Chief Counsel.. 28
Welch, Raquel, actress....................................... 68
Letters, statements, etc., submitted for the record by:
Bass, I. Scott, J.D., adjunct professor, Georgetown
University, prepared statement of.......................... 86
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana:
FDA topics of concern on dietary supplements............. 4
Prepared statement of.................................... 10
Chenoweth, Hon. Helen, a Representative in Congress from the
State of Idaho, prepared statement of...................... 22
Croom, Edward M., Jr., Ph.D., Phytomedical Project, National
Center for the Development of Natural Products Research,
Institute of Pharmaceutical Sciences at the School of
Pharmacy, University of Mississippi:
Botanical research priorities............................ 162
Information concerning herbal medicines.................. 153
Prepared statement of.................................... 103
Dickinson, Annette, vice president, Scientific and Regulatory
Affairs, Council for Responsible Nutrition, prepared
statement of............................................... 130
Gilhooley, Margaret, professor, Seton Hall University School
of Law:
Information concerning prescribing, administering or
dispersing amygdalin (laetrile)........................ 165
Prepared statement of.................................... 138
Gilman, Hon. Benjamin A., a Representative in Congress from
the State of New York, prepared statement of............... 23
Henney, Jane, Commissioner, Food and Drug Administration:
Information concerning health claims..................... 60
Prepared statement of.................................... 31
Kracov, Daniel A., J.D., attorney, Patton Boggs, LLP,
prepared statement of...................................... 97
Kucinich, Hon. Dennis J., a Representative in Congress from
the State of Ohio, prepared statement of................... 26
McCaleb, Robert S., president, Herb Research Foundation,
Boulder, CO, prepared statement of......................... 111
Turner, James S., Citizens for Health, prepared statement of. 121
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of the American
Dietetic Association....................................... 20
Welch, Raquel, actress, prepared statement of................ 70
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT: IS THE FDA TRYING TO
CHANGE THE INTENT OF CONGRESS?
----------
THURSDAY, MARCH 25, 1999
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:06 a.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Davis, Horn, Ros-Lehtinen,
Morella, Gilman, Biggert, Terry, Hutchinson, Sanford, Souder,
Chenoweth, Waxman, Norton, Kucinich, Tierney, and Schakowsky.
Staff present: Kevin Binger, staff director; Daniel R.
Moll, deputy staff director; Barbara Comstock, chief counsel;
David A. Kass, deputy counsel and parliamentarian; S. Elizabeth
Clay, professional staff member; Mark Corallo, director of
communications; John Williams, deputy communications director;
Carla J. Martin, chief clerk; Lisa Smith-Arafune, deputy chief
clerk; Maria Tamburri, staff assistant; Phil Schiliro, minority
staff director; Phil Barnett, minority chief counsel; Kristin
Amerling and Sarah Depres, minority counsels; and Jean Gosa and
Earley Green, minority staff assistants.
Mr. Burton. Good morning. A quorum being present, the
Committee on Government Reform will come to order.
I ask unanimous consent that all Members' and witnesses'
written opening statements be included in the record. And,
without objection, so ordered.
Today we are here to talk about the implementation of the
Dietary Supplement Health and Education Act [DSHEA], by the
Food and Drug Administration. At our hearing in February, we
heard from the delightful actress Jane Seymour about her use of
complementary and alternative medicine, including herbal
products and other dietary supplements to maintain good health
for herself and her family.
At that hearing, we also heard from Dr. Brian Berman of the
University of Maryland about the importance of research in
dietary supplements, such as glucosamine, to help Americans
with arthritis and gingko biloba in delaying the onset of
Alzheimer's disease. The potential cost savings to the Federal
Government in these two debilitating illnesses is enormous and
certainly justifies more research funding.
In our March 10 hearings on chelation therapy, we learned
from a panel of expert physicians that dietary supplements is
used in conjunction with chelation therapy to improve
circulation and cardiovascular health. In studying various
alternative systems of healing, whether it's Ayurveda, Native
American healing, or traditional Chinese medicine, two currents
run through each of these systems: the importance of
spirituality in healing and the important role of botanical
products and nutrition in healing.
The Food and Drug Administration does a very good job of
protecting the public. We are pleased that the new FDA
Commissioner is joining us today to discuss the improvements
she is making to assure that the FDA continues to protect the
public and facilitate patients' access to clinical trials.
Congress passed the Dietary Supplement Health and Education
Act in 1994. The American people demanded to be heard on this
issue and Congress listened to them. More letters and faxes
were received on this topic than any other single piece of
legislation in U.S. history.
Over 50 percent of Americans use dietary supplements on a
regular basis to improve their health. I personally began using
supplements after a telephone conversation with Nobel Prize-
winning scientist Linus Pauling, who told me that high doses of
vitamin C would help prevent cancer and other diseases.
Every Member of Congress is pulled in many directions at
once every day. We work long, exhausting hours under great
deals of stress. I was delighted to learn in our February
hearing from my colleague on the committee, Helen Chenoweth,
that she has successfully used the dietary supplement zinc in
the treatment of a rare disorder Meniere's disease. It has
helped her stay healthy and prevent brain surgery. I think that
the Office of Dietary Supplements and the Office of Rare
Diseases at the National Institutes of Health need to work
together to determine where dietary supplements can be helpful
in the treatment of rare diseases and disorders and to make
this information known to the public.
When Congress passed the Dietary Supplement Health and
Education Act, it was made very clear that Americans would have
access to these products and that information was a key factor.
Quality, accurate, useful information on the labels, in the
labeling, and in third-party literature is vital to Americans'
needs to make informed, safe choices. This is the cornerstone
of this first hearing on dietary supplements.
The committee has been in frequent contact with the FDA on
a variety of concerns about proposed rulemaking, as well as the
actions of the FDA on a variety of topics in this area. It is
particularly timely that we begin this discussion now as there
is a new Commissioner of Food and Drugs, Dr. Jane Henney, who
will testify this morning. There are several issues of concern
in this area.
We cannot address each of the topics regarding dietary
supplements in depth today. However, they do warrant
mentioning: nutritional labeling, good manufacturing practices,
the Dietary Supplement Commission on labeling, the structure
function statement and the redefinition of disease, the
authoritative statement health
claims, Pearson v. Shalala, Pharmanex's Cholestin, adverse
events reporting, ephedra, Stevia, and CODEX. And we have an
attachment to the statement which I would like to enter into
the record as well.
[The information referred to follows:]
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Mr. Burton. We have heard interviews in the media from FDA
officials that, since the passage of the Dietary Supplement
Health and Education Act, FDA has no authority to regulate
dietary supplements. This is not a factual statement. In fact,
the FDA has several specific authorities that are listed on the
poster and I think we have that poster someplace. Do you want
to put that up there? Those who are interested can take a
closer look at that. I'm sorry the print is a little bit small.
Do we have a handout? Mr. Waxman's asked for one, so if we
could get that, we would like to have it.
As for the safety of supplements, an interesting comparison
was published last year; 106,000 people die a year from
prescription drugs; 42,000 a year from automobile accidents. It
is more likely that you will be struck by lightning and die in
this country than it is that you will die from using a dietary
supplement, with just 16 deaths reported from that last year.
We wish to continue to work with the FDA to assure that these
numbers do not increase. Research to learn more about drug
interactions will help, as well as a better reporting system.
The primary focus of today's hearing with the FDA will be
the proposed rule on structure function statements. The Dietary
Supplement Health and Education Act was explicit in allowing
for manufacturers to include information on labels regarding
the benefits of a supplement on the structure or the function
of the body, while specifically not allowing for disease claims
to be made. The proposed rule does not comply with the
legislation. Instead, this proposed rule would supersede
legislation passed by the Congress and be in direct opposition
to the will of Congress and the American people.
We are delighted today to hear from Miss Raquel Welch, who
will be with us shortly. She is a lovely lady who has
entertained us in her many movie and stage performances. And
she will share with us how she uses dietary supplements to
maintain good health. And I just found out a few minutes ago
that she is one of your constituents, Mr. Waxman. It's kind of
nice to know you have one of the most beautiful women in the
world in your district, don't you think? [Laughter.]
We will also hear today from Scott Bass. I don't know how
beautiful Scott is. Where are you Scott? [Laughter.]
He is an adjunct professor at Georgetown University and an
attorney with the law firm of Sidley and Austin. Mr. Bass is a
legal expert on dietary supplements and will outline for us the
history of dietary supplement legislation and the effect of
proposed structure function regulations.
We will also hear from Daniel Kracov of Patton Boggs,
regarding one of the laws involved in the Cholestin case. I
think that was just resolved recently. He will share with us
information about Pharmanex's interactions with FDA and the
legal case.
There is an increasing amount of research being published
on the benefits of dietary supplements. A week does not go by
that the press does not report on the benefits of some of these
supplements. Dr. Edward Croom of the University of Mississippi
will discuss the role and the level of research in botanicals,
as well as outline the need for further research. Dr. Croom has
been called an advisor to many Federal agencies as well as
international organizations such as the World Health
Organization.
We will also be hearing from three members of the Dietary
Supplement Commission on Labeling. Robert McCaleb, president of
the Herb Research Foundation; Dr. Annette Dickinson, from the
Council for Responsible Nutrition; and Margaret Gilhooley, of
Seton Hall Law School.
We will also hear from Attorney James Turner, chairperson
of Citizens for Health, a consumer advocate organization. In
addition to dietary supplement issues, Mr. Turner worked with
the FDA on reclassification of acupuncture needles.
I am pleased that my colleagues in the Senate, Senators Tom
Harkin and Orrin Hatch, have been supportive of our efforts to
resolve these issues. I think we have a couple of staff people
from Senator Hatch's office with us today. Both Senator Harkin
and Senator Hatch were instrumental in passing the Dietary
Supplement Health and Education Act in 1994. Additionally,
colleagues here in the House, Congressman Dennis Kucinich, who
is on our committee, and Peter DeFazio have worked diligently
to ensure that Americans have health freedom.
We have shown that good health is not a partisan issue. We
have shown on this committee that there is interest in assuring
that Americans have the right to make their own health care
choices and have access to an integrated system of healing on
both sides of the aisle. And, toward that end, we will hold the
record open until April 8 to allow written submissions for the
record from members of the committee.
I now recognize my colleague, Mr. Waxman, for his opening
statement.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Waxman. Thank you very much, Mr. Chairman. I have a
number of remarks I want to make about the topic of dietary
supplements. But, before I do, I want to welcome FDA
Commissioner Henney.
Commissioner Henney was sworn in only a few months ago and
I understand this is the first time she has appeared before our
committee. As her written testimony indicates, she has
identified five priorities for FDA, including enhancing the
agency's science base, protecting the Nation's food and blood
supply, and reducing teen smoking. These are essential
priorities for improving and protecting the health of the
American people. It is crucial that we in Congress work with
Commissioner Henney in achieving these priorities.
Today's hearing addresses an issue that I have been
involved in for years, dietary supplements. Five years ago, I
worked with Senator Hatch and my colleagues on the Commerce
Committee in crafting the Dietary Supplement Health and
Education Act of 1994. Since I was intimately involved in the
negotiations that produced the legislation, I think I am in a
good position to address the topic of this hearing, the
``Dietary Supplement Health and Education Act: Is FDA trying to
change the intent of Congress?''
It is clear to me that the FDA is doing a good job
implementing a complex, challenging, and sometimes deliberately
ambiguous law. The law we enacted in 1994 was a series of
compromises. DSHEA allowed makers of supplements to market
their products without having to demonstrate that they are safe
or effective, but, at the time, it authorized FDA to remove
products that are later proven to be dangerous from the market.
It allowed manufacturers to claim that dietary supplements will
benefit the structure or function of the body but, at the same
time, it prohibited manufacturers from making unproven claims
that supplements will cure diseases. Our hope was that the law
would balance the goal of providing consumers with wide access
to dietary supplements and the goal of protecting consumers
from dangerous or ineffective products.
Today we will hear arguments that Congress did not intend
for the FDA to have an active role in protecting the consumer
from dangerous products being sold as dietary supplements. We
will also hear that FDA's recent efforts to protect the
consumer are inappropriate and heavy-handed intervention. This
is simply erroneous. When we passed DSHEA, we knew that many
dietary supplements, such as minerals and vitamins, can play an
important role in promoting health. But we also knew that,
without proper regulation, dietary supplements can sometimes be
lethal.
We knew that L-tryptophan, a product that was marketed in
the 1980's as a sleep aid, was linked to EMS, a painful,
debilitating, and sometimes fatal disease. At least 1,500
people were struck with this disease and at least 38 people
died from it before FDA issued regulations banning L-
tryptophan.
Events since enactment of DSHEA have confirmed the need for
an active FDA. Sometimes it seems that there is a new article
about the dangers of dietary supplements every month. For
example, in 1997, the Washington Post reported about the danger
of Nature's Nutrition Formula One, which contained a dietary
supplement called ephedra. Products like Nature's Nutrition
Formula One and other products containing ephedra like herbal
ecstasy and herbal fen-phen are marketed for weight loss,
energy boost, and natural high. But, in fact, according to the
Washington Post, these products have been linked to at least 38
deaths. FDA also received hundreds of reports of other adverse
events associated with products containing ephedra. These
adverse events included increased blood pressure, chest pains,
insomnia, heart attack, stroke, psychosis, and seizure.
More recently, in March 1998, FDA warned consumers against
Sleeping Buddha, a product being marketed as a dietary
supplement, but which actually contains a prescription-strength
drug ingredient, Estazolam, which is known to have serious side
effects, including potential damage to a fetus if consumed by a
pregnant woman. Earlier this year, FDA issued a warning against
dietary supplements containing GBL, a substance marketed as a
performance enhancer. When GBL is taken orally, it is converted
in the body to GHB, a potent and unapproved drug. GBL has been
associated with at least 55 incidents of adverse health
affects, including seizures, vomiting, comas, and death. Five
of the reported victims were children under 18 years of age.
These are not the only products that have caused problems.
For example, certain teas with plant-derived laxatives have
been associated with the deaths of four young women. And, as
Commissioner Henney states in her testimony, which we had an
opportunity to read in advance, some dietary supplements
containing the ingredient plantain were actually contaminated
with digitalis, a powerful stimulant which can cause nausea,
vomiting, dizziness, headache, confusion, low blood pressure,
vision trouble, and abnormal heart rate and heart rhythm.
I don't recite these examples in order to alarm the public
or criticize the dietary supplement industry. There are many
important and effective dietary supplements on the market. But
the purpose of DSHEA was to make these products available and
to ease the fears that many people had that the products would
be removed from the market or they would have to go to the
doctor to get a prescription simply to get a vitamin. We made
clear that we weren't going to permit that sort of practice. No
one disputes the importance of products such as calcium in
maintaining healthy bones or the link between folic acid and
the prevention of certain birth defects. Consumers need to
learn about these products.
My point is that we need an active and vigilant FDA to help
us weed out the dangerous dietary supplements and identify the
safe and effective ones. The answer isn't to attack FDA every
time the agency takes even baby steps toward regulating dietary
supplements. The answer isn't to criticize the agency for
failing to adhere to the intent of Congress when, in fact, the
agency is trying its best to implement a complex and ambiguous
law. Instead, the answer is to establish a regulatory framework
for dietary supplements at FDA that appropriately balances the
interests of consumer access and public health. This position
is supported by a variety of consumer groups, including the
American Dietetic Association, which
represents nearly 70,000 food and nutrition professionals. And
I would like, Mr. Chairman, to ask that the statement of the
American Dietetic Association be entered into the record.
Mr. Burton. Without objection.
[The prepared statement of the American Dietetic
Association follows:]
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Mr. Waxman. I have learned one thing about dietary
supplements over the years. It is that we also need to reduce
the mistrust and polarization that has surrounded this issue
for far too long. I don't think it is in the interests of those
who support dietary supplements to have products on the market
that harm people because then the public will be distrustful of
all dietary supplements. I don't think it is helpful for the
American people to allow products to be marketed with claims
that are made for which there is no substantiation and no
validity. This is going to lead to cynicism and distrust.
I believe that Commissioner Henney understands this and I
look forward to hearing her ideas and those of the other
witnesses about dietary supplements. I am pleased to welcome
Raquel Welch, who is one of my constituents, and all the other
witnesses that we have scheduled for today. This is an issue
that engenders a lot of interest because there is nothing more
important than trying to protect the health of the American
people.
Mr. Burton. I understand that Dr. Henney is under time
constraints. If any Members would like to make a brief opening
statement, we will allow it, but, otherwise, we will just have
them submitted for the record. With that, Dr. Henney, would you
like to come forward?
Mrs. Chenoweth, would you like to have your statement
submitted for the record? Without objection, so ordered.
[The prepared statements of Hon. Helen Chenoweth, Hon.
Benjamin A. Gilman, and Hon. Dennis J. Kucinich follow:]
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Mr. Burton. We will do it for everyone, yes.
Dr. Henney, would you like to come forward? You can still
stand. We normally swear in our witnesses.
[Witness sworn.]
Mr. Burton. Welcome, Dr. Henney, and congratulations on
your new appointment. We are anxious to hear what you have to
say, so you are recognized to make an opening statement.
STATEMENTS OF JANE HENNEY, COMMISSIONER, FOOD AND DRUG
ADMINISTRATION, ACCOMPANIED BY JOE LEVITT, DIRECTOR, CENTER FOR
FOOD SAFETY AND APPLIED NUTRITION, AND MARGARET PORTER, CHIEF
COUNSEL
Dr. Henney. Mr. Chairman and members of the committee, my
name is Dr. Jane Henney. I am accompanied this morning by Dr.
Joe Levitt, who is the Director of the FDA Center for Food
Safety and Applied Nutrition, and Margaret Porter, our Chief
Counsel. I am honored to address you, as the Commissioner of
Food and Drugs, and pleased to be here today to discuss the
implementation of the Dietary Supplement Health and Education
Act of 1994.
Because this is my first appearance before this committee
as Commissioner, I would like to take this opportunity to
briefly share my priorities for the FDA. I hope that they will
provide a context for our dialog today and in the future. My
first priority is the full and effective implementation of the
FDA Modernization Act. I intend to build on this collaborative,
constructive model by working closely with the Congress, the
regulated industry, patients, consumers, and health
professionals.
My second priority is enhancing the agency's science base.
To meet our statutory obligation to regulate cutting edge
scientific discovery and development, we must have cutting edge
expertise in our staff. We must also harness the scientific
expertise of those outside the agency.
My remaining three priorities are also those of the
administration, the safety of our food supply, the safety of
our blood supply, and reducing tobacco use by young people.
Beyond these priorities, the agency must use its finite
resources wisely. We must focus on those areas that maximize
public health promotion and protection. And this is the
perspective with which we approach implementation of the
Dietary Supplements Act of 1994.
I know that this statute was passed with broad, bipartisan
support. I know that you and others in Congress worked hard to
develop an appropriate statutory scheme that would facilitate
consumers' access to dietary supplements, as well as to provide
FDA with the authority to remove products from the market if
they present a significant or unreasonable risk of illness or
injury. I know that many Americans place great faith in dietary
supplements to maintain and improve their health. And I know
that the scientific evidence documenting the benefits of a
number of supplements is increasing.
With these facts in mind, I want to assure you that, as the
new Commissioner of the Food and Drug Administration, I am
focusing attention on dietary supplements. Last month, FDA's
Center for Food Safety and Applied Nutrition published a 1999
program priorities document. This document includes on its A
list for completion an overall dietary supplements strategy by
the end of the year. I am committed to developing a
comprehensive strategy for effective regulation of dietary
supplements. And in so doing, to reach out to those affected by
our regulation and to listen receptively to their views.
I am equally committed to ensuring that FDA's
implementation of the statute is true to congressional intent.
Congress has given a challenge to the FDA under this statute to
strike the right balance between preserving consumer access to
potentially health-improving supplements, while assuring the
safety and proper labeling of these products. I think it is
clear that the agency still has a way to go both in developing
a workable regulatory framework and in achieving full
implementation of the Dietary Supplement Act of 1994.
I want to take this opportunity to acknowledge our
progress, shortcomings, and remaining challenges. Let me first
note that the dietary supplement marketplace has changed
significantly since the passage of the act. The dietary
supplement industry itself has grown exponentially. So have the
number of Americans buying these products. Surveys show that
more than half of the U.S. adult population now uses dietary
supplements, spending upwards of $12 billion per year on these
products.
Access to dietary supplements also has changed. In the
past, with the exception of vitamin and mineral products,
dietary supplements were available primarily in health food
stores. Dietary supplements were marketed principally to
adults. Now a wide range of dietary supplements are available
in supermarkets and via the Internet. This makes dietary
supplements readily available to children and adolescents, as
well as to adults.
Many of these changes would appear to be consistent with
the intent of the Dietary Supplements Act of 1994. However, a
rapidly expanding industry and a changing demographic mix of
consumers eager to manage their own health care present
significant regulatory challenges, many of which were not
foreseen at the time the act was passed.
Let me turn to FDA's progress to date in implementing the
Dietary Supplements Act of 1994. Initially, the agency
concentrated on publishing the many regulations mandated by the
statute. The agency also began a number of other regulatory
actions to establish the framework for implementation of the
new law.
Since the passage of the statute, FDA has published 25
Federal Register notices regarding dietary supplements. These
notices, which are described in more detail in my written
testimony, include a final rule requiring that all dietary
supplement labels carry nutrition information in a box,
entitled ``supplement facts,'' which became effective just this
week; an advance notice of proposed rulemaking on good
manufacturing practice that would assure purity and consistency
for dietary supplements; and a proposed rule to permit health
claims on dietary supplements, based on authoritative
statements.
Notwithstanding these actions, I want to acknowledge that
FDA has a long way to go to achieve full implementation of the
Dietary Supplement Act of 1994. I mentioned earlier that the
agency intends, this year, to issue an overall strategy for
regulation of dietary supplements. The strategy will address
all of the elements of an effective dietary supplement program,
including defining the boundaries between dietary supplements
and conventional foods and between dietary supplements and
drugs; claims made for dietary supplements; good manufacturing
practice or GMP regulations; adverse event reporting, review,
and followup; laboratory capabilities; research needs;
enforcement; and, finally, resource needs.
I would like to note here that, while the agency may not
have moved quickly on this in the past, we are committed to
accelerating the development and implementation of GMP
regulations. FDA also is committed to quickly addressing safety
problems that arise with dietary supplements.
Several important regulatory challenges lie ahead for FDA
in fully implementing the Dietary Supplement Act of 1994. We
must delineate some difficult boundaries between dietary
supplements and conventional foods; and between dietary
supplements and drugs; and between dietary supplements and
cosmetics. We must clarify what types of claims may be made for
dietary supplements. And we must be sure we are able to use
efficiently the tools Congress provided to us to protect
consumers from unsafe products.
Mr. Chairman, we share the goal of making safe dietary
supplement products available to consumers who want to make
informed personal choices to improve their health. The Dietary
Supplement Act of 1994 was enacted to ensure access to those
products. I also believe the act provides FDA with the
necessary legal authority to protect the public health. We will
do our best to marshall the scientific information and
expertise necessary to exercise that authority when the public
health is threatened.
The dietary supplement industry sells products on which
millions of Americans rely. I am aware that in the past, the
relationship between FDA and some in the industry has been, at
times, antagonistic and counterproductive. I am committed to
developing a positive relationship with the industry so that we
may, together, meet our shared goal of providing safe products
to the American public. The statute is still in its early
stages of implementation and I look forward to working with
Congress and other interested parties to ensure that resource
constraints or other issues do not impede FDA's ability to use
this statutory authority most effectively. And I will be happy
to respond to any questions the committee may have.
[The prepared statement of Dr. Henney follows:]
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Mr. Burton. Thank you very much, Dr. Henney. And I want to
apologize for not recognizing Ms. Porter and Dr. Levitt when
you first came up. So welcome to both of you, as well.
First of all, I would like to congratulate you on bringing
to the consumer the supplements facts statement. I think you
sent it to us a couple of days ago. This is a good move for the
agency toward getting very accurate and good information to the
public. I really appreciate that. Under your direction, the FDA
seems to be doing a much better job with the problem products
that we have had to deal with in the past. And I think that is
a good signal to Members of Congress. So congratulations on a
good start.
First of all, let me ask you about the proposed rule on the
structure function statements. There is some question about
what the FDA and what you are going to do with that. Could you
comment?
Dr. Henney. Mr. Chairman, let me describe what the agency
has done thus far. As you know, the agency did issue a proposed
rule in that area. It is fair to say that this is a matter of
great interest because we have received over 100,000 comments
that have commented on many aspects of that proposed rule, all
of which we are obligated to take into account before we move
to final rule stage.
I would say that most of the concerns sort of center around
the issue of the disease definition used by the agency that
relied very heavily on reference books from medical
dictionaries and the like. I think that we still have a ways to
go in our evaluation of all comments on the particular
definition that we have selected and whether it was too broad
or not. So we will be working diligently on coming to closure
on that rule before we would issue it in final.
Mr. Burton. Well, there is some concern among some Members
of Congress and many in the public sector, that the law, which
was passed in 1994, 1995 would be circumvented by that
regulation. And I presume that you are going to take a hard
look at the compliance with the current statute.
Dr. Henney. I think, Mr. Chairman, it is fair to say that
it is very important that we settle on this key issue of
definition of disease because it is that definition that will
also guide that critical issue of boundary for a dietary
supplement and what happens in the drug arena. So we realize
the interest and we will want to deal with this quite
thoughtfully and deliberately.
Mr. Burton. Do you think that the FDA has enough authority
right now to deal with dietary supplements?
Dr. Henney. Mr. Chairman, I believe, as outlined in the
act, appropriate authority is either given to the agency within
the context of the Dietary Supplement Act or in the law that it
is embodied in the basic FDA act as well. However, I would say
that we are very early into the implementation of this new law.
We believe that we have the appropriate authorities that we
need. But please be assured that if we do not and find
ourselves in a situation where we do not have adequate
authority to protect the public health, we will bring it to
your attention.
Mr. Burton. How many courtesy letters has the FDA sent out
on the structure function statement? And what percentage is
that to the total number of statements that have been made?
Dr. Henney. Mr. Chairman, it is very good, as Commissioner,
to have people who know more facts than I do after only 3
months.
Mr. Burton. I couldn't agree with you more. You have got to
have good help.
Dr. Henney. Good help is hard to find. But I am told that
about 300.
Mr. Burton. About 300. Excuse me, what were the total
number of statements, do you know?
Dr. Henney. This is about 10 percent or about 3,000
statements.
Mr. Burton. About 3,000. As a physician, can you really
accept the definition of disease as the absence of a normal
state?
Dr. Henney. Mr. Chairman, I am going to be compelled to
look at this issue, both as a physician and Commissioner. I
think that, as I indicated, the definition of disease that was
drawn on in the proposed rule did come, in large part, from
reference texts, so we are having to rely on a number of
resources as look not only at what we did originally but at
what others would like us to consider now. And I have not come
to a conclusion in that matter yet.
Mr. Burton. Do you think that the FDA should create a
separate advisory committee for dietary supplements rather than
have only a subcommittee to the Foods Advisory Committee?
Dr. Henney. Mr. Chairman, the matter of having an advisory
committee in one specific area of regulation is certainly
something that we could give consideration to. The Foods
Advisory Committee itself was established during the time that
I was at the agency before, when we felt that we needed more
expertise and outside help from a variety of sources to help us
with the whole area of food. I believe that, as we move forward
into developing our framework, our regulatory framework for the
dietary supplements area, we will likely be using a wide
variety of means to garner information and expertise from
individuals outside the agency. Whether that will call for the
establishment of a permanent advisory committee, we have not
made any decision in that regard.
I would cite one case in which we have done that in the
past and it was, again, in an area that the agency was moving
into, the over-the-counter products. And an advisory committee
was established simply for that area as a drug might move from
the prescription area to over-the-counter. So it is not without
precedent that we might do something like that. But please be
assured, whether or not we have a fixed and permanent advisory
committee, both Mr. Levitt and I are very committed to seek the
outside support, help, and expertise from many as we move
forward.
Mr. Burton. Thank you very much. I will probably have a
couple more questions in the second round. Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman. Dr. Henney, this may
not be a good example. This is maybe more of a food product.
But I have a glass with some liquid in it. Let us say I wanted
to bottle this and sell it and tell people that, if they drink
this, it will cure cancer. Will FDA stop me?
Dr. Henney. Mr. Waxman, it would be a daunting challenge to
stop you from anything. [Laughter.]
However, since you would be making----
Mr. Waxman. The chairman's had some success.
Dr. Henney. Since you would clearly be making a disease
claim, which is prohibited, yes, we would stop you.
Mr. Waxman. If I sold this product and I didn't make a
disease claim but I made a claim that this could really help
improve your health, any problem with that?
Dr. Henney. We at the agency would likely have much less
problem with that because drinking water is known to help
improve an individual's health.
Mr. Waxman. When we drafted this legislation, there were
some people who argued a manufacturer ought to be able to sell
a product and make any claim that he wants to if he has some
substantiation, but it doesn't have to be a great deal. And let
the marketplace operate.
On the other hand, other people felt, well, that is just
too wide open. And we made a distinction in the law between
disease claims, claims that a product is intended to treat,
prevent, mitigate, cure, or diagnose a disease. And we said
those products are drugs and they ought to be reviewed by FDA
to be sure they are safe and effective. But if it is a product
that simply is intended to affect the structure or function of
the body, we said that the manufacturer can make claims in that
regard. Now they have to be accurate, but you wouldn't police
the accuracy of those claims, as I understand it.
Dr. Henney. Mr. Waxman, to the latter point, I think that
there is a provision that, on the label there would have to be
a disclaimer in that regard. The statement must be truthful and
not misleading, as well.
Mr. Waxman. Disclaimer, right. But the question that I
wanted to ask you--I may be not fully correct in that saying
that if there is something so outlandish, even though it wasn't
a disease claim, you still may have peripheral authority. But,
for all practical purposes, the intent of Congress was to allow
some of these claims to be made. What would happen if you
allowed something to be marketed with disease claims and what
dangers are there associated with marketing a product that
makes a disease claim, without having demonstrated scientific
substantiation for such claims? A lot of people think that
products ought to be out there. It will make it more available
to people. Give them information that is valuable. Why wouldn't
you think it would make sense to allow disease claims to be
made?
Dr. Henney. Mr. Waxman, I think that there are at least two
concerns in that regard. One is of concern to the consumer of
having a claim, particularly in terms of the treatment of
disease, that would be wrong or, at best, false and misleading
and consumers acting on that information would clearly be
misled. And so I think Congress struck a good balance in saying
disease claims could not be made.
It also, I believe, is one of those areas where there is a
definitional boundary in terms of making a drug claim, in terms
of not infringing upon a drug industry's mode of working with
the agency as well; where premarket approval clearly is
rigorous, premarket approval clearly is required.
Mr. Waxman. Well, I think there is another reason also. If
a manufacturer of a drug could just market it as a dietary
supplement without having to go through all the research, he
might start marketing a product and we wouldn't even fully know
the impact of that product because all the clinical tests might
not be completed. They can go out and market it and make a
profit and not even know whether there is going to be a full
success or other problems associated with that.
The FDA has been criticized because the line between the
structure function claim and a disease claim is not always
clear, but I don't think that is your fault. The statute forces
you to draw a distinction between the two types of claims when,
in fact, there may be no clear distinction. What is your
opinion on this? And could you also answer this question: about
if the court decision on Cholestin is not overturned, what
problems do you see with that decision in the context of our
discussion?
Dr. Henney. Mr. Waxman, to the point of structure function,
it is critical that we get this issue correct. The boundary for
a dietary supplement and drug or dietary supplement and health
claims or food claims is equally important. I think to the
specific issue of Cholestin, the issue is not so much about the
claim, but whether the product in question is really not the
original food of red yeast rice but has been converted through
a manufacturing process to the active ingredient of a drug.
Mr. Waxman. Well, if you have a product that then competes
with a drug because it has the same active ingredient yet it
doesn't go through the clinical tests and you don't know about
the whole manufacturing process, is there a concern that you
have about that?
Dr. Henney. Then there is, essentially, no protection for
those drug manufacturers who invest and go through all of the
rigors of that clinical trial and meet the standard of new drug
approval.
Mr. Waxman. And maybe they won't make that investment next
time around.
Mr. Burton. Mrs. Chenoweth.
Mrs. Chenoweth. Thank you, Mr. Chairman. Commissioner,
welcome. Is it the overall objective of the FDA to support
access to dietary supplements or try to suppress out of concern
for the purchaser?
Dr. Henney. Mrs. Chenoweth, I think that the agency is
obligated to follow the law in this regard and the law very
clearly was intended to provide access to dietary supplements
while charging the agency and giving the agency appropriate
authority that, if these products were unsafe or presented
unreasonable health risks, the agency could take action. It
also clearly wanted to provide access to a product that was
appropriately and properly labeled.
Mrs. Chenoweth. Wouldn't the FDA want the population to
have access to information that will help them to make educated
decisions about the products they use in terms of health claims
as opposed to disease claims? I ask you this because there is
evidence that the FDA is deliberately suppressing information
which could help health consumers make an educated decision
about products which could help them. The FDA limits what
producers of health supplements may say about their products.
For example, psyllium is widely known to be helpful in
lowering cholesterol which is a health claim which is a
contributing factor to heart disease. They make the distinction
there. Now this is a nutrient found in many commercial food
products; Post and Kellogg and the big companies use it on
their products, like cereal and other whole grains. But the FDA
has approved the health claim associating consumption of
psyllium in food with reduced risk of heart disease. Producers
will often print that information on the labels of their
products so consumers can make an educated choice.
But that isn't true for psyllium sold off the shelf as a
dietary supplement. In fact, if producers of psyllium as a
dietary supplement wanted to educate consumers about the
benefits of psyllium--that is the health decisions, the health
choice--the FDA would prevent it. And this is precisely the
issue at stake in the case that you just appealed to the
Supreme Court involving Pearson and Shalala, the difference
between a claim and a disease claim.
And then the second part of my question, of course, is why
can Post and Kellogg's and the big companies get by with that,
making those claims, those health claims, while the small
individual nutrition stores may not?
Dr. Henney. Mrs. Chenoweth, let me respond to you in terms
of the issue of health claims. You raise many specific items
during the course of your question and I would like the
opportunity to tease those apart and get back to you if I
could, explicitly, for the record.
[The information referred to follows:]
FDA authorizes health claims for use in food labeling under
provisions of the Nutrition Labeling and Education Act of 1990
and established requirements at 21 CFR 101.14. FDA has
authorized use of a health claim for the relationship between
soluble fiber from certain foods, including psyllium, and a
reduced risk of coronary heart disease (21 CFR 101.81).
Consequently, any food, including a dietary supplement that
meets the eligibility criteria in FDA's regulations at 21 CFR
101.14 and 21 CFR 101.81 may bear that claim in its label or
labeling. The Agency is aware that there are products marketed
as dietary supplements that bear a claim about the relationship
between psyllium and coronary heart disease.
Dr. Henney. I think to the matter of health claims, be they
for a food or a drug, if they relate specifically to a disease,
they go through a different kind of process or a
preauthorization process than those that relate to the
structure and function of the body, on dietary supplements.
With respect to psyllium, FDA has approved a health claim for
this and its relationship to coronary heart disease, but I will
be more than glad to look into other applications we might have
in hand with respect to that particular product and see if
there is anything else, in-house, that has been requested of
us.
Mrs. Chenoweth. Thank you, Doctor. You know, I know that
the Federal Government has not been entirely lax in trying to
provide information to consumers about health products. For
example, the Department of Health and Human Services in their
Dietary Guidelines for Americans publication which provides
information about the effect of the diet on health and disease.
I am sure that you are familiar with this publication. So let
us say that this publication includes a statement on the
benefits of psyllium in fighting heart disease. And let us say
I produced psyllium for sale over the counter as a supplement,
but if I quote the Dietary Guidelines for Americans directly
anywhere on the literature, prior to the change that I don't
know specifically yet what the change is in labeling associated
with marketing my product, the FDA can enjoin me and possibly
file criminal charges.
I look here at the CDC's annual review of nutrition which
claims that antioxidants, micronutrients appear to play many
important roles in protecting the body against cancer. Now that
is the CDC's own report. The USDA Human Nutrition Agriculture
Research Service Quarterly Report, fourth quarter, 1996 states,
``Antioxidants are thought to help prevent heart attack,
stroke, and cancer.'' USDA and DHHS Dietary Guidelines for
Americans states in their publication that the antioxidant
nutrients found in plant foods are presently of great interest
to scientists and the public because of their potentially
beneficial role in reducing the risk of cancer.
So, while the agency is able to make disease claims, if the
dietary supplement producers tried to make the same claims that
the agency does, they would be having to face those
consequences.
Dr. Henney. Mrs. Chenoweth, let me respond by saying that
Congress did look at this area reasonably recently when they
were considering the FDA Modernization Act. And I think that
there is provision within the context of that act to try to
clarify the issue of authoritative statement. And, at least as
we have tried to track the legislative history of the portion
of the FDA Modernization Act known as section 303 I think there
was a statement that authoritative statements such as those you
cite could be used by the agency if they represented
deliberative reviews. And so we have tried to follow the intent
and the letter with respect to that.
Sometimes when you go back to those documents or to those
bodies to see whether the body itself believes that there has
been a deliberative review for some of those statements or even
to document as to whether those statements represented
preliminary findings on their part, there is sometimes that
information that becomes available. But I believe that, if
these statements have come from such a body and do represent,
in that body's view, a deliberative review process having taken
place, that FDA can accept these types of statements. So there
is that ability to do what you are talking about. But there is
a process outlined that I believe that we have to follow.
Mr. Burton. Thank you, Mrs. Chenoweth. Ms. Schakowsky.
Ms. Schakowsky. Thank you, Mr. Chairman. Dr. Henney, I am
new at this job as well, but neither of us is really new to
these kind of issues. I started becoming active in the
community in the early 1970's on an effort to get expiration
dates on food products. As a young housewife I felt that the
more informed we were about the products we were buying, the
better choices we would be able to make. And, of course, we
have come a long way since then in terms of labeling on
products so that we can look at those and decide what is best
for us, what is safest for us.
And I think that most Americans make the assumption--it is
not always valid--that somebody is protecting us, that the
products that we buy, wouldn't be on the shelf if somebody
weren't there to make sure that they are OK. And I think we try
as best as we can to make sure that that assumption is based in
fact. And I would hope that on this issue we do that as well.
I think a large component of what we need to do, in
addition to setting rules and regulations, is getting this
information out to the public on how to use it and how to make
informed choices. What kinds of programs are there at the FDA
in terms of public health education programs so that we widely
disseminate accurate information on how to use the 1994 law and
what it really means?
Dr. Henney. Ms. Schakowsky, I very much appreciate somebody
else being new to this as well, but I also appreciate your
longstanding interest in this whole area of the informed
consumer. I think with respect to the safety issue, I think
consumers can continue to rely that, in terms of a premarketing
review of safety, that clearly is done in the area of
conventional foods, new foods, food additives that might come
to the marketplace, and drugs.
With dietary supplements, I think, embodied in this act,
was the presumption and knowledge that many of these products
have been used for years and, therefore, there was not a need
for preauthorization but an assumption of safety. And that is
some of the concept, I think, that was embodied in this act, to
have access to products that, by their history, had been
established to be safe. But when that was not the case, the
agency was given the authority to remove them from the market.
With respect to initiatives to make consumers more informed
about the products that they are using, I think that a few
years ago, under the NLEA, the Nutrition Labeling and Education
Act, the agency's first step was to develop that new food label
that we saw come onto the market in the last few years. And a
few weeks ago, we announced that a similar, very clear label, a
consistent label, a concise label would also be coming onto
over-the-counter products. And just this week, we have
finalized that issue with respect to supplements and the
supplement label. And so on dietary supplements in the future,
the elements that we will be seeing on all labels will easily
identify for the consumer the type of supplement it is; per
servings; the nutrients; other dietary ingredients that might
be in the product; and, if it is a botanical, the plant or herb
that the product comes from.
So I think that there will be a step up with these new
labels in terms of the kind of information that a consumer can
use.
Ms. Schakowsky. And when will consumers--when can they
expect to see those new labels on the products?
Dr. Henney. The final rule was published on September 23,
1997, with an effective date of March 23, 1999, giving industry
18 months to comply. Products labeled prior to March 23 can
continue to be sold until stocks are depleted. Some companies
have already introduced products with the new labels.
Ms. Schakowsky. I do have one other question, Mr. Chairman.
Can I go ahead? It is my understanding that the FDA issued
interim rules prohibiting the use of nine different health
claims on foods. We were talking about that. And that the
petitioner for these claims, the manufacturers, had submitted
statements describing those claims as authoritative and that
there has been some criticism, including that of the chairman,
that the FDA said that these statements were not, in fact,
authoritative. And you were talking about going back to these
scientific bodies that I guess were used as the basis of those
claims.
And I would like to clarify what Representative Chenoweth
was saying. On the one hand, internally, in their documents,
they seem to be making those same claims. When you go back to
them and say are those authoritative claims? Can they be used
by the manufacturers? Those same bodies are saying no. How do
we reconcile that difference?
Dr. Henney. One of the key issues, and, again, it was in
the legislative history of the FDA Modernization Act, was to
describe what authoritative meant, in that authoritative meant,
within the context of the legislative history, that the
statement had come through a deliberative review. I am told
that, as the agency and the Department face this issue, that
Secretary Shalala asked for representatives of many of those
bodies to come together to represent a liaison group from those
organizations so that----
Ms. Schakowsky. But those organizations, just to clarify,
are those like the CDC? Who are we talking about?
Dr. Henney. CDC, NIH, and National Academy of Sciences. To
establish a channel of communication. One of the key issues of
those discussions was to learn the context of the Dietary
Supplement Act of 1994 as well as the context of the FDA
Modernization Act in terms of deliberative review and to know
what we would be asking if we queried does the statement
represent that of your organization? Has it come through a
deliberative review?
And the nine statements which you referred to, I believe,
although I can't go through every one this morning, in large
part, were sent back to those bodies when they sit as
organizations and asked that question. And sometimes they said
yes or no and there are some documents, and I believe
Representative Chenoweth cited one, where the body doesn't sit
but perhaps once every 5 years. And at the time they are making
their statements, they may be preliminary, so we have no body
to go back to, so we rely on the context of the statement
within the document. And often a statement is made, an
accompanying statement might say, but these results are
preliminary. So we have to be guided by both the statement and
its context.
Mr. Burton. Thank you. Mr. Souder.
Mr. Souder. I would like to first yield to Mrs. Chenoweth.
Mrs. Chenoweth. Thank you, Mr. Souder. I do want to clarify
something, Doctor, that you just mentioned. The cites that I
made were actually public cites; they were published. And so,
therefore, they became part of the public domain. They were not
internal documents. There were actual published with page
numbers, volumes, everything. So I think that takes on an
entirely different context, once it becomes part of the public
domain, with regards to authoritative statements that can be
closely held internally.
Mr. Souder. One of the difficulties you have at FDA is if
you have products out there that are unsafe and then you are
held accountable. But I was curious also about the liability
that FDA might have if you list a company in this area as
having killed someone when they may not have manufactured the
product. And, also, if the report is incorrect, then what do
you do to correct it in the cite? In other words, what is your
liability if you have false information or information that
would say that, in effect, a distributor was responsible when
they didn't manufacture? Have you run into the liability
question?
Dr. Henney. Mr. Souder, I would love to be in a position to
answer your question, but I have a feeling that my Chief
Counsel is in a better position to answer your question about
the liability.
Ms. Porter. Mr. Souder, if you are talking legal liability
and you are referring to the agency's adverse event reporting
system, I think under ordinary circumstances, the agency's good
faith effort to receive and evaluate adverse events would be
viewed as a discretionary act and, therefore, exempt from tort
liability in the legal sense. If you are referring to the
agency's efforts to do its best to assure within its authority
and its resource constraints that the reports are correct, well
then, of course, the agency would try to do that.
Mr. Souder. And if there was a false report, would you make
an effort on your Internet site to correct that and is there
not just a legal liability, but also an ethical liability if
you have damaged a company?
Dr. Henney. Mr. Souder, when we are made aware that there
is not even the extreme of false, but information that would
appear to be not full or complete, when we are made aware of
that, we do have an ability to at least footnote those reports
in that way. We do not change in any way the original report
that we would have received, but we would footnote it as having
received information to the contrary. And that is how we would
handle that.
Ms. Porter. Mr. Souder, let me also add that the adverse
events that are reported to the agency as a general matter are
made available under the Freedom of Information Act. We try to
keep confidential the names of the reporters and the names of
the individual patients, but the rest of the report is, in
fact, legally available. So I think that would be another
reason why the agency wouldn't be held legally liable. But, as
is indicated, within our constraints, we want to be sure
consumers have accurate information.
Mr. Souder. Why, if a report is false or incorrect,
wouldn't it be deleted? Why would it just be footnoted?
Ms. Porter. I can't--I am sorry.
Mr. Souder. The response was that if the report was proven
to be false or just incorrect or you got additional
information, you would footnote it. Why wouldn't you delete the
false information?
Ms. Porter. It is part of the entire record. I think that
would be the answer.
Mr. Souder. I have some concerns about that. I am not even
familiar with the general issue, but there is, in corporate
issues, I find that that is an uncomfortable answer.
In the research area of dietary supplements, in particular,
complex herbal preparations, does the FDA have a specific team
of experts who assist researchers in getting IND clearances?
And how do dietary supplements differ from drugs in this area?
Dr. Henney. Mr. Souder, if you will permit me, I would like
Mr. Levitt to respond to that question of expertise.
Mr. Levitt. If I understand your question correctly, in
terms of if a company wants to submit an IND investigation or a
new drug application, then that would be done through the
Center for Drug Evaluation and Research. And in that case, they
have the divisions separated according to specialty, so it
would depend upon the purpose that they would be trying to
study.
Mr. Souder. So there are not or are there dramatic
differences in dietary supplements from other sorts of drugs,
whether they be prescription or over-the-counter? In other
words, you are saying there are different divisions, but they
are not necessarily treated differently? They just go to a
different place?
Mr. Levitt. I believe that all investigational new drug
applications are handled together in one unit within the agency
and that is the Center for Drug Evaluation and Research.
Mr. Souder. Thank you.
Dr. Henney. And, Mr. Souder, we may be trying to split this
hair too finely. When you used the term investigational new
drug, that definitely would put the herb into a drug category,
like a natural product category of drug, and out of the dietary
supplement area.
Mr. Souder. So you are saying it depends on the claim for
the dietary supplement as to how you would assign it?
Dr. Henney. In part, yes.
Mr. Souder. Or would it take the claim for a dietary
supplement or something you suspect that they may it?
Dr. Henney. If you had a natural product, an herb, a plant,
let us take digitalis, and you were going to develop that for
the treatment of arrhythmias for heart disease, and you wanted
to market it as a drug, you would come in through our Center
for Drugs for review. It would require clinical studies and it
would require premarket review for the safety and the efficacy
of that drug that was derived from a plant or an herb. However,
if it was an herb intended to supplement the diet in some way
and met the criteria of the Dietary Supplement Act and was not
being intended to treat a particular disease, you would come in
through the dietary supplement area which lies over in the
Center on Foods.
Mr. Souder. Thank you very much.
Mr. Burton. Mr. Kucinich, what I would like to do is finish
with Dr. Henney and her panel. We have two votes on the floor.
And then, when we come back, we will take the next panel. So,
Mr. Kucinich.
Mr. Kucinich. I will yield to Mr. Waxman. I am fine. I will
yield to Mr. Waxman.
Mr. Waxman. Well, I thank you for yielding. I appreciate it
because I did want to get another question in and take
advantage of the fact that you are here, Dr. Henney. On another
subject, I understand an FDA advisory committee is meeting
tomorrow to review the safety of Rezulin and I am concerned
that no one, not the FDA, not Warner-Lambert, not the public
knows the exact number of deaths and injuries associated with
Rezulin. What we have are voluntary adverse event reports which
we all recognize constitute only a fraction of actual deaths
and adverse events. Right now Rezulin labeling calls on
patients to be tested regularly to ensure their livers are
functioning properly, but Warner-Lambert is doing nothing to
confirm that patients are actually getting tested the way they
should.
In your February 25 letter to me, you wrote that the FDA is
conducting an observational epidemiological study on whether
Rezulin patients were getting tested in 1998. But that is a
look backward, not a way to guarantee compliance in the future.
Is the agency considering requiring the company to determine,
for certain, in the future that patients are getting tested
consistent with Rezulin's labeling?
Dr. Henney. Mr. Waxman, one of the reasons why we are
holding the advisory committee tomorrow is to get advice from
experts on exactly next steps that should be taken. I do have
with me today Janet Woodcock who is the center director for
drug evaluation and research. She might want to add additional
information, but it is just in this context that we are holding
the meeting with the advisory committee to give them an update
on where we are with this product to see if any further
monitoring, labeling, or action with respect to the drug is
warranted at this point.
Mr. Waxman. Before she comments on that question, let me
also ask you about the fact that on Monday the British FDA, the
Medicines Control Agency, decided Rezulin was unsafe to be
marketed in Britain. Has the FDA reviewed the facts and the
medical basis for their decision? And is the FDA aware of all
the same reported deaths and injuries that the British were
aware of in making their decision to ban Rezulin?
Dr. Henney. I will have to ask Dr. Woodcock to respond to
that.
Dr. Woodcock. Yes. To answer your second question first, we
have been in close contact with the British authorities and
their deliberations, so we are aware of that. As far as knowing
the exact number of deaths from the use of any drug in the
United States, that would require 100 percent registry of all
patients taking the drug and that is an extraordinary step that
FDA has taken only very rarely, such as with thalidomide. We do
believe that we have fairly good information on new deaths that
have occurred with this drug, for a variety of reasons. We will
be discussing, as Dr. Henney said, any additional steps that
should be taken and the results of the epidemiologic study on
the monitoring.
Mr. Waxman. Coming back to the subject that is not
unrelated, manufacturers are currently required to report
adverse events when it is a drug. Do you believe that dietary
supplement manufacturers should report adverse events and have
you discussed what steps FDA has taken to try to enhance its
adverse event reporting system?
Dr. Henney. Mr. Waxman, our adverse event reporting system
is open to all products that FDA regulates. We do believe that
there are enhancements to that system that certainly should
occur. We currently have before the Appropriations Committee a
request to increase the level of funding that we would have
available so we can enhance that kind of injury reporting
system so we could have a better handle on events, be they with
the devices, drugs, or dietary supplements, in terms of actions
that the agency might need to take.
Mr. Waxman. With a drug, I think there is a requirement to
report adverse events. On dietary supplements, is there any
kind of requirement or are you relying solely on----
Dr. Henney. Mr. Waxman, most of our reporting systems are
voluntary. The required reporting system that I am aware of--
within the agency there may be others--is with device
manufacturers that must report to us. But in terms of
individual physicians seeing events with their patients, we
rely heavily on a voluntary reporting system in all of our
products.
Mr. Burton. Mr. Kucinich, did you have any questions you
would like to ask? Well, do you want Dr. Henney and the
panelists to wait? If you have any questions, we have a few
minutes.
Mr. Kucinich. Well, I am going to submit some questions in
writing. OK?
Mr. Burton. Would you be willing to respond to those
questions in writing?
Dr. Henney. Oh, absolutely.
Mr. Kucinich. Thank you.
Mr. Burton. Well, I think we have concluded all of the
questions for you. I want to thank you very much. It has been
nice having you here today and we will look forward to working
with you in the future.
Dr. Henney. All right. Thank you.
Mr. Burton. Thank you very much, all of you. We stand in
recess at the call of the Chair. We will be back in about 10 or
15 minutes. We have two votes on the floor.
[Recess.]
Mr. Burton. If everybody could take their seats, we will be
prepared to start with the next panel.
Ms. Welch, you are welcome to sit right there.
Ms. Welch. OK. Thank you.
Mr. Burton. First of all, on behalf of the Congress and the
committee, we want to welcome you to the U.S. Congress. I think
everybody has been an admirer of yours for years. We have
watched you on screen and stage and we have really not only
admired your beauty, but your acting skills as well. And we are
very happy to have you here today to testify about nutrition
and supplements. So if you are prepared for an opening
statement, proceed.
Ms. Welch. Yes, I am. Thank you very much.
Mr. Gilman. Mr. Chairman, could I----
Mr. Burton. Oh, excuse me. Pardon me. Mr. Ben Gilman, our
chairman of the International Operations Committee had a brief
statement he wanted to put in the record. So----
Mr. Gilman. Thank you. We are conducting a hearing across
the hall on Russian policy and I thank you for the opportunity.
I regret I couldn't be here earlier. And I want to apologize to
our witness. But I do want to put in an opening statement.
The passage of the Dietary Supplemental Health and
Education Act of 1994 I think has brought about a number of
important improvements for millions of Americans who regularly
consume dietary supplements to protect and improve their
health. DSHEA guarantees the right of Americans to have access
to the traditional supplements that consumers have used for a
number of years and new products that are just beginning to
come into the market today and DSHEA ensures that these new
products are safe and properly labeled for sale in our Nation.
Studies and testimonial statements from consumers have
shown that supplements can and do improve good health. However,
the FDA's slow acknowledgement of the benefits of dietary
supplements has brought us here today and, without DSHEA, there
is no uniform quality of products and the lack of information
about these kind of supplements that are available to the
public. So once the regulations will be in place and practice--
and I am pleased that the Commissioner Jane Henney has
indicated that they are moving in that direction--once they are
in place and practice, consumers can be confident that
supplements will be safe and regulated.
We must make certain that the FDA implements DSHEA as
prescribed for in the act of 1994. So I am pleased the new FDA
Commissioner, Ms. Jane Henney, has testified here this morning
that she will be dedicated to help FDA fairly interpret,
implement, and enforce the provisions of this act as they were
intended when Congress initially passed the act. And while some
have argued that DSHEA is full of complex questions of fact,
policy, and law, it is the duty of FDA and its Commissioner to
enact this measure and provide the American consumers with safe
and regulated dietary supplements.
And I want to commend our witness, Raquel Welch, for coming
to us today to give us her thoughts with regard to these
supplements. Thank you, Mr. Chairman.
Mr. Burton. Well, before I yield to Ms. Welch, Mr. Waxman
is your Congressman and he would like to say a word of welcome.
And I don't blame him a bit.
Mr. Waxman. I want to tell you how pleased I am to be here
to hear your testimony and to welcome you to our committee
hearing. We came back from the vote anxious to hear your
testimony and I am going to be able to hear it, but I was also
able to hear Mr. Gilman's statement as well. Unfortunately, I
want to apologize to you because I am not going to be able to
join you and other Members for the lunch after your testimony
because I have a previous engagement with Bishop Desmond Tutu
from South Africa. But I want to welcome you here. I look
forward to your testimony. I hope I will be able to stay to ask
some questions, but I just appreciate your willingness to come
here and tell us your views.
Ms. Welch. Thank you.
Mr. Burton. OK, Ms. Welch.
STATEMENT OF RAQUEL WELCH, ACTRESS
Ms. Welch. Well, good morning, Chairman Burton, members of
the committee, and a special greeting to my Congressman, Henry
Waxman of California.
I am Raquel Welch and, before I begin, I would just like to
say that I am not a paid spokesperson for the dietary
supplement industry nor do I have any financial connections
with it. I am here today because of a statement made by former
Surgeon General C. Everett Koop, who is quoted as saying, ``If
you want to be successful in life, pursue good health.''
I am a woman who has played many roles: an actress, a wife,
a mother, and a person who made a decision some 25 years ago to
take an active role in maintaining my health and well-being. It
has been one of the most important roles of my life and, much
like a demanding role in a film or a play, it requires
preparation and study. On the screen and on stage, you prepare
with a script. If you have chosen to make dietary supplements
part of your life, as I have, you prepare by getting
information.
The availability of truthful, balanced information on the
dietary supplement labels is guaranteed now by the Dietary
Supplement Health and Education Act. Congress unanimously voted
in favor of the consumer's right to know what dietary
supplements are for and how they work. Most importantly, this
information is mandated to be where customers can look first,
on the label.
For the past 5 years, customers have had access to valuable
information on how supplements affect the structure and
function of the body. These congressionally mandated structure
function statements now appear on dietary supplement labels,
allowing customers like me to make informed choices. However, I
have recently been informed by the National Nutritional Foods
Association that the FDA has proposed rules which would
severely curtail these structure function statements. And,
therefore, restrict the information that Congress intended
these statements to impart.
Mr. Chairman, as you well know and as I have learned,
structure function statements must not say that a dietary
supplement is intended to cure, treat, prevent, or diagnose any
disease and a disclaimer to that effect must appear on the
label in conjunction with any structure function statement. My
understanding is that what the FDA proposes is to expand the
definition of disease to the point that virtually all
structural function statements would be discouraged or
outlawed.
I know that there are instances where label statements have
been made beyond the explicit limits stated in the Dietary
Supplement Act. I believe that even the FDA records will show
that these claims are found on only an infinitesimal number of
products, approximately 1 percent. As a consumer, it seems to
me that the FDA should use its enforcement powers to eliminate
these questionable and unsubstantiated claims. That would be
understandable and logical. However, instead, the agency is
proposing virtual elimination of an entire category of consumer
information with broad restrictions and confusing rules. I
would say that is like killing a flea with a cannon.
Mr. Chairman, millions of consumers like me have and will
benefit from learning more about these supplements from the
structure function statements. What the FDA is proposing seems
like a regulatory sleight-of-hand to stifle such statements. I
implore you and the members of this committee to urge the FDA
to withdraw its proposed rule. The language in the existing
Dietary Supplement Act already gives sufficient direction and
establishes explicit limitations on structure function
statements. And it gives FDA the authority it needs to chase
down delinquent companies and their products.
The FDA's proposal ignores congressional intent and flies
in the face of the best interests of the 100 million Americans
who, like me, take dietary supplements every day. We need and
ask for your help if health-conscious citizens are to continue
to be able to make informed health choices. It is, after all,
part of the American way.
I have been taking supplements since 1 million years B.C.
[Laughter.]
So please support us. Thank you very much.
[The prepared statement of Ms. Welch follows:]
[GRAPHIC] [TIFF OMITTED] T7333.044
[GRAPHIC] [TIFF OMITTED] T7333.045
[GRAPHIC] [TIFF OMITTED] T7333.046
Mr. Burton. Well, I saw ``1 Million B.C.,'' and those
supplements really work, I have got to tell you. [Laughter.]
First of all, let me thank you for coming today. You
represent, as you said, a lot of Americans who take
supplements, among which I am one. And how do you decide, as an
individual, what supplements you should take?
Ms. Welch. Well, I think I am a pretty average Joe in
regard to that. I hear that something is effective and then I
try to get the information about it. Sometimes you can work
through a distributor who you can get in touch with personally
and they can explain everything to you and ask all kinds of
questions. But most times, I have to go in to a health shop, a
health place, where they have all these supplements, and read
the labels and decide for myself what I think is the best thing
to do. But I want to just say, briefly, although you didn't ask
me, that this is always in conjunction with regular medical
check-ups.
Mr. Burton. Sure.
Ms. Welch. And, you know, under a doctor's care and
everything. But I rely heavily on the labels and on the
individual distributor who can tell me a lot about these
things.
Mr. Burton. You don't have to answer this question, but
what kind of supplements do you take?
Ms. Welch. Too many to mention. I just take supplements
every day and I take a wide variety of multivitamins and I also
take other things that I guess could be classified as women's
supplements like calcium and those kinds of things. And I also
take blue-green algae supplements.
Mr. Burton. What kind of an impact do you think these
supplements have had on your life?
Ms. Welch. Well, I have found, very specifically, that when
I have tried certain supplements, that they have helped my
energy level, which I need when I am on Broadway. For instance,
the last time I found something new in the way of a supplement
was when I was in rehearsal for Victor/Victoria and I found my
energy level, you know, sort of dropping lower and lower and I
was eating all the right foods. I don't smoke and drink. And,
as everyone knows, I am pretty much of a health creature and
fairly disciplined.
But I found myself slumping and actually my brother said to
me that he knew of a distributor that handled blue-green algae
products and that they were very effective in boosting up
energy in a very natural way, no caffeines or anything that
revs you up, you know, and makes you speed away. So I started
taking them and they were very effective and I have been taking
them still.
Mr. Burton. Well, I just have one last question and I think
you may have answered it in your opening statement. You do
believe the information that you are getting on these
supplements that you buy in the health food store is adequate
and well-enough labeled?
Ms. Welch. I believe they are. I would like more
information, but as, according to what, you know, the rules and
the laws are now, I think to have less would be a very bad
thing.
Mr. Burton. We had the Commissioner in just before you
testified and I believe they are going to try to expand the
information on the labels and in the products so that consumers
will even have more information.
Ms. Welch. I think that would be very helpful. And when I
was growing up as a young girl, there was nothing like a health
food store or a health store which you could go in and get
vitamins and supplements. That was just not in the mix at all.
And as I have come along now, this is very much an everyday
thing and everybody I know takes supplements of one kind or
another. It is interesting to note that the next generation or
certainly the generation that is, you know, out there now, you
know, is conversant with this kind of thing and they usually
hear on the grapevine that something is working well and they
go in to find out for themselves.
It would be better if we had more specific information, I
think, and more of it. Of course there are books and you can
get whole books on herbal supplements and vitamins and what
they do. Because I think most people now have an attitude about
preventative medicine trying to go to the doctor on a regular
basis, but for treatment only as a last resort if you can't
cure your malady by something that can help your immune system
or to keep you stronger and more energetic on a regular basis
so you are not going into the doctor with all kinds of small
fry stuff that really does affect the quality of your health on
an everyday basis.
Mr. Burton. Very good. Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman. Thank you very much
for your testimony. You are sure right about the idea that it
is only recently we have been learning so much about the impact
of diet and how beneficial some of these vitamins and
supplements can be. But to me the most shocking thing was that,
for so many years, doctors didn't even take classes in
nutrition in medical school. So we need to educate everybody
about the value of nutrition in our diet, whether it is from
food products themselves or from supplements that would make up
for the lack of some of the essential nutrients that we need.
Ms. Welch. I think that the stress in modern-day life makes
us not absorb some of the nutrients from our food and that is
why. And I think that the new woman--if I can call her that--of
this last 100 years has been expanding her horizons so much
that her energy is often taxed. I think men too, in modern
society, have this problem so they try to shore up their
resources as best they can in a natural way.
In defense of current physicians, I would just say that, I
guess going to medical school is a pretty barrage of so much
information that is about really serious illnesses, that it
takes a great deal of time and effort to absorb that and,
therefore, it is difficult, you know, because it isn't in our
culture, common knowledge. I would think that probably the next
generation of physicians will know more about this kind of
thing.
Mr. Waxman. Well, I certainly hope so and I think the
medical schools are trying to adapt and recognize the fact that
it would certainly be beneficial for our society if we could
prevent some of these diseases and not just deal with them
after they occur. In getting the information, we all want
accurate information. We want to know which products will be
helpful and which ones will not. And I think that sometimes I
get concerned when someone who stands to make a lot of money
wants to tell me how their product is so good for me and I want
to know that somebody is sort of watching to be sure that, when
they make those claims, there is some validity. Don't you feel
that way too?
Ms. Welch. I do feel that way. And I am certainly a
supporter of the FDA and everything that it represents and all
that it does. However, I do believe that, when we are talking
about herbs and some of these supplements, we are talking about
things that haven't just arrived yesterday. Only, perhaps, in
this culture, but in other cultures throughout the world, they
have been used for literally hundreds and thousands of years.
So there is a kind of a knowledge, if you will, that is among
kind of a--I want to say the word traditional--but historical
knowledge of these herbs and other supplements and vitamins
that is known to people and it isn't--I don't think--I don't
think it is even advertised any near as strongly or with as
much as the exploitation value as most of our other food
products are on the market, television and magazines, today.
Mr. Waxman. Well, there is a lot more advertising, a lot
more on television and newspapers and magazines for one product
or another.
Ms. Welch. Yes, it is an important thing to look out for. I
personally don't think that we are to that level yet in this
particular dietary supplement area where we are being
delinquent in our claims. But that is just my opinion as a
consumer.
Mr. Waxman. Yes, but when we passed the bill, though, some
Members advocated that we allow people to say that their
product would cure diseases without going through any FDA
review or test.
Ms. Welch. Well, that would be wrong.
Mr. Waxman. And I thought so too. So you don't want to let
them say a product cures diseases, yet the structure function
claims can get very close to saying a product cures a disease.
So it is a hard line to draw. What we want the FDA to do is to
draw that line in a way that will get the information that the
public needs to know without having people deceived with claims
that aren't accurate, that can't be checked out, and over which
FDA would no----
Ms. Welch. So I take you are in favor of this particular
FDA regulation.
Mr. Waxman. The regulations? I haven't looked at them. I
haven't looked at them specifically. I was in favor of the
structure function claims and I want structure function claims
to be permitted, but I don't want disease claims to go under
the guise of a structure function claim. You wouldn't, would
you?
Ms. Welch. No, I wouldn't. But I don't know that they are
claims as much as they are information. I mean, people have to
know what they are taking it for.
Mr. Waxman. Well, information from somebody who is trying
to sell you a product.
Ms. Welch. Well, that is the American way, isn't that
right? [Laughter.]
Mr. Waxman. Because I always get a little suspicious--I
didn't hear what you said.
Ms. Welch. I said that is the American way. We are all
selling something.
Mr. Waxman. Well, I suppose that is true, but then a lot of
times the consumers are deceived as a result of it so we want
to make sure that----
Ms. Welch. That is true, but I do think----
Mr. Waxman. When it comes to your health, people get very
anxious about it. We do live in a time when there is a lot of
anxiety, but we want people to have access to products that are
going to be helpful, not harmful.
Ms. Welch. I absolutely agree, but I think that the
statutes, as they stand now, are sufficient guidelines to have
protection for the public.
Mr. Waxman. The statute has to be implemented.
Ms. Welch. Yes.
Mr. Waxman. So they have to decide what the statute is so
they have to adopt regulations.
Ms. Welch. The regulations, yes.
Mr. Waxman. So you would prefer they draft the regulations
differently than what they have proposed and FDA is now
considering all of the comments they have received and we will
see what they come up with. But thank you very much.
Ms. Welch. Thank you.
Mr. Burton. Mrs. Chenoweth.
Mrs. Chenoweth. Thank you, Mr. Chairman. Ms. Welch, I am
just thrilled that you are here and the evidence is in the
package, I guess. I would have to say you do handle such a
tremendous schedule and, obviously, your personage speak
volumes for our concerns. Thank you very much for taking the
time out of your busy schedule to be here.
Ms. Welch. Thank you. Thank you.
Mrs. Chenoweth. You know, I guess I have the feeling, like
most Americans, that I really want to take my own health
concerns into my hands as much as possible and stay healthy,
stay energetic, ahead of the power curve of getting sick and
then having to seek medical help. And I kind of want to use an
analogy, based on what Mr. Waxman said. Every morning, I juice
up my own carrots and celery and apple and parsley. And that is
an energy drink and very good for me. It is full of vitamin A
and other vitamins. But I wouldn't want the Federal Government,
because I drink this juice that is also sold in health food
stores, because I know it gives me energy, to tell me whether
or not I can go to the grocery store, who is probably making a
small profit on those carrots that I am buying, and, you know,
because of that, I still want to be free to be able to make my
own juices or take my own supplements and take care of my own
body, ahead of the power curve.
Ms. Welch. Of course. Of course. We all need information
about that. That is the thing. Especially the new generation
who will be starting out. Let us say that there is some young
woman or young man that is--and this is, of course, totally in
agreement with what you are saying--and is going to come along
and say, you know, I want to be healthy. I want to make the
best of my life. I have this ambition and I know I am going to
need optimum health and energy, like Koop said, you know, to
make my way in life. So, you know, I have been told that if I
take some vitamin C, I am not going to get, you know, sick as
fast or if I feel the cold coming on. These kind of things will
be passed along and they will go in and they will read a label.
Now if the label doesn't say anything, they are going to be
deterred from even trying because they don't--they really
literally--don't have any information. I think that we have to
have on the labels things that help people understand.
It is up to them whether they take the vitamin C and say,
forget about it, you know. This doesn't do a thing for me. You
know, it is not like we are forcing people into this, to say,
oh, you must do it. I mean, a lot of things that some people
take don't work at all for me and I wouldn't do it, I wouldn't
have them, I wouldn't buy them. Or I returned them after having
bought them and thought, you know, this isn't for me at all.
Mrs. Chenoweth. Thank you.
Ms. Welch. Sorry to interrupt you, but I thought we were
talking about the same thing.
Mr. Burton. Thank you, Mrs. Chenoweth. Mrs. Morella.
Mrs. Morella. It is a great honor. Thank you very much for
being here. I reiterate what the committee feels about your
personal experience really enhancing the implementation of the
Dietary Supplement Health and Education Act that this Congress
passed. You know, I do look at labels of some of the
supplements when I go to a health food store and I am always
curious about what they will do and what they will not do. Do
we, as consumers, have an obligation to do studying or other
reading to help us in the decisionmaking? I always wonder, how
much am I supposed to know when I look at these items in the
health food store?
Ms. Welch. How much? I don't know, you know. I am not, you
know, an expert on this, I just can speak from my own personal
experience. I think, short of making claims to cure and do
something special for you, they just need to say, first of all,
what they contain and what they do. And then I think you have
to be deductive yourself and make your decision. And, like so
many things in this world, it does come from trial and error. I
think we are trying to save consumers from spending money
unnecessarily or giving them hopes that are not going to be----
Mrs. Morella. We have to be careful of that caveat emptor,
you know, let the buyer beware.
Ms. Welch. Yes, exactly.
Mrs. Morella. And, yet, we have an obligation--I guess that
is the balance I am trying to resolve--we have an obligation to
also look at what we know about certain products before we
automatically believe what we would like to have them be able
to do.
Ms. Welch. Well, I would agree if this was a drug we were
talking about. What I am basically saying is that I think that
there exists already all the provisions to protect the
consumer. I think to go beyond that is going over the line. It
is a fine line, but I think it is going over the line and could
possibly inhibit the taking of these things to people who do
take them now and the people who will not have access to them
in the near future.
I mean, because it takes a tremendous amount of time to go
through and test, so to speak, everything when some of these
things have literally been around as if they had never been
seen before. But since most of them have been around for, you
know, the beginning of civilization, practically. You know, it
seems to me, as I said, killing a flea with a cannon. I know
that there is an obligation, but it is almost like saying,
well, what will carrots do for you? Shall we ban carrots; they
are not right for you. I mean, herbs have been around for so
long. I mean, you either don't want carrots or you do want
carrots, you know.
Mrs. Morella. I love to believe what I see. And what I see
and I read I am never sure. I mean, like I grew up with the
idea that you take your carrots for your vision and fish was
for the brain and, you know, some of those concepts. And, yet,
I think there is a certain amount of self-education that is
important.
Ms. Welch. It is. You are right.
Mrs. Morella. You heard our new FDA Director this morning
talk about her recommendations for the implementation?
Ms. Welch. I am sorry.
Mrs. Morella. Did you hear the new Director?
Ms. Welch. No, I am sorry I did not hear it. Her
recommendations for----
Mrs. Morella. How she was going to implement this act. Did
you?
Ms. Welch. No, I am sorry. I did not hear that. I was not
aware that she was making a statement.
Mrs. Morella. It will be very interesting to, for us, it
would be our obligation, to see how she follows through on
that. But I think, Mr. Chairman, the fact that you have this
hearing makes us all very much aware and I think it helps the
FDA, to know how Congress feels and how the citizenry feel. And
your being here as a role model. We thank you very much.
Ms. Welch. Thank you.
Mrs. Morella. Thank you, Mr. Chairman.
Mr. Burton. Mrs. Biggert, do you have any comments or
questions?
Mrs. Biggert. Thank you, Mr. Chairman. Ms. Welch, when you
are talking about the diet supplements, are you talking about
something that might have been--you said this goes back for
like centuries, something like things that have been used by
like Native Americans or----
Ms. Welch. They could be, but they could be----
Mrs. Biggert. Like teas or like roots. Is this part of the
dietary supplement or----
Ms. Welch. I don't--yes, it would be part of dietary
supplements. There are a lot of teas that are very useful, I
think, for various functions, you know. The thing is that, you
know, they are not going to--one particular product, whatever
it may be, that is not a drug, is not going to work the same on
each person. You know, camomile tea is supposed to calm you
down and relax you. You can take it before sleep. I am sure
this helps many, many people. It has never helped me. But it is
not a bad tea. I am perfectly happy to have my camomile tea
from time to time because of the taste.
Mrs. Biggert. It is like some people with caffeine. They
can't drink it at night.
Ms. Welch. Caffeine is very difficult for me. That is one
of the reasons why--I mean, caffeine really causes, in my body,
a very decided reaction that is negative. And I can get
terrible migraine headaches from it and really, you know, throw
my whole nervous system off which affects other parts of my
body. It is not a nice thing. So I try to avoid that. So I am
looking for other ways that I can naturally, you know, shore up
my energy without speeding around like a Looney Tunes. I don't
like that kind of a thing at all.
Mrs. Biggert. What you are saying as far as finding the
right diet, the right nutrition, is really the responsibility
of each of us to find out what works.
Ms. Welch. Yes. I think so. As in everything in life, I
think that one of the beliefs I have is that each one of us
really does have to find in everything in life what works for
them. There are all these things available. I think that to try
to take on the responsibility for what the individual person
has to find for themselves is too much to ask of anybody, even
the government.
Mrs. Biggert. I think that we probably do that. Like with
pregnancy, years ago everybody took all the vitamins, took
everything. And then there was this big thing about not using
anything that might be harmful.
Ms. Welch. I am sure that is true. And, yet, I am sure that
pregnant mothers today would probably take a lot more vitamins
or would want to. I haven't been pregnant in many years, so I
can't tell you what they do now. [Laughter.]
Mrs. Biggert. No, I haven't either, fortunately. But thank
you very much for coming. I appreciate it.
Mr. Burton. Thank you, Ms. Welch. We are expecting Mr.
Kucinich. I think he wants to ask just a few questions before
we release you from the table. But I want to assure you that we
will be watching and working with the Food and Drug
Administration, as well as the people in the industry, to make
sure that the structure function rule doesn't change the intent
of the DSHEA law. It is extremely important, I think, that the
will of the people expressed through the legislation passed by
the Congress be followed by every bureaucracy in our
government. And if we find a bureaucracy that tries to
supersede existing law that has been passed by the Congress
with a regulation, then I think that we need to hold them and
call them to account. And we will certainly do that.
Ms. Welch. Thank you.
Mr. Burton. I will yield to Ms. Norton. Do you have any
questions?
Ms. Norton. Thank you, Mr. Chairman. As a result of hearing
Ms. Welch's testimony, I must say that she has inspired some
questions in me. The first is, Ms. Welch, have you ever heard
of the placebo effect?
Ms. Welch. Yes, I have. Isn't that where somebody takes a
substance which is being tested and it really doesn't have
anything in it, and then, because of psychological reasons, it
seems to work or not work?
Ms. Norton. Yes. It is, you know, when we take something,
we want it to work and we are all human. That is why we require
controlled studies for medicines, because it would be very
dangerous to rely on the placebo effect and so, as a matter of
the scientific method, it is understood worldwide. We normally
do not rely on anecdotal evidence for the reason that,
interestingly, you say, for the reason that something may work
on me and not work on you. Camomile tea doesn't make everyone
sleepy; it makes some people sleepy. Well, at some point, the
world wants to know whether or not it makes most people sleepy
or only some people sleepy some of the time.
The only thing that disturbs me about your testimony is
this notion that, despite all that the scientific method has
established for hundreds of years, you seem to believe that,
for something as precious as your body, how you receive it
should be the answer, even if that may be, in fact, the placebo
effect and you may be spending your good money on a placebo.
Ms. Welch. No, I don't happen to believe that is true. I
know what you are getting at, but I don't know how any study
could help every person know how it is going to work on them.
That is impossible. And----
Ms. Norton. And no study purports to do that.
Ms. Welch. And I don't think it is possible.
Ms. Norton. The studies do purport to tell us whether, in
the main, the claim to effect is valid or not. And I was
interested, as you said, people do deserve as much information
as possible. Isn't that the kind of information you would want
people to have? In the main, recognizing that there are always
some people who die of aspirin, even though most of us get our
headaches cured by it, in the main, I would want to know that a
very tiny percent die of aspirin. But I would also want to know
whether or not aspirin cures headaches.
In the same way, and I speak as somebody who, in fact,
takes all kinds of these things, so judges for herself, like
you, but the more I know whether or not somebody who I trust,
some scientific expert says it works, the more confident I am
that I am taking what is right for me. And from what I hear you
want it. I think you would feel better if you knew----
Ms. Welch. No, I don't think so.
Ms. Norton [continuing]. That somebody you trusted, in
fact, said that this substance should work this way, as opposed
to word of mouth telling you that it works this way.
Ms. Welch. Well, I can only say that about 10 million
Americans feel adequately informed at this point to take these
supplements regularly and I happen to be one of them. I respect
your disagreement with me.
Ms. Norton. I would think that for somebody like you and me
who have taken but relying on what is on the label, that what
we would want the FDA to do is not fail to tell us what works
and what doesn't work as a scientific matter. What I think we
should be pressing the FDA to do is to find some way to test
these substances faster so that we have information to rely on.
We ought to be pressing the scientific agency to do its job,
rather than saying, step back; we don't need you. Let us simply
rely on what is in our head, which may be a placebo.
Ms. Welch. I am not saying that. I am saying rely on what
is existing right now in the FDA in the rules that are existing
now. Instead of what I understand to be the idea is to take the
definition of disease and expand it to such a degree that, for
instance, pregnancy, menopause, things that like that are what
I consider normal, would not be considered normal. And you are
expanding the definition of the word disease to such a degree
that pretty soon you can't say anything. I have heard you use
the word claim many times. I didn't use the word claim in my
statement and I don't believe that the rules that are in place
now, the laws that are in place now talk about any claim. In
fact, I think it precludes making any claim. So I think we are
talking about something that really is not--I am not talking
about today. I am not talking about making a claim.
Ms. Norton. The law doesn't exist, as a practical matter,
until regulations are issued determining the law.
Ms. Welch. Yes, I know. These technicalities, you will have
to forgive me, I am not accustomed to them.
Ms. Norton. Just let me say that I join you in your
confidence in many of these substances and I think the only
thing we can say about the 10 million people who take them is
that the more information they have, the more confidence they
will have in what they are taking. Thank you, Mr. Chairman.
Mr. Burton. Thank you, Ms. Norton. I am not sure Mr.
Kucinich is going to make it. Let me just end up by saying that
I share your concerns. I share your desire for adequate
information about supplements and I share your concern that we
not allow bureaucracies to supersede the rulemaking authority
of the Congress of the United States when it passes a law. That
law to which you referred in your testimony, the DSHEA law, was
passed overwhelmingly by both the House and the Senate. And for
any agency to try to impose a regulation that supersedes the
intent of the law is just wrong. And this committee, which
oversees the entire Federal Government and every agency of the
Federal Government, will exercise its authority to make sure
that the regulatory agencies adhere to the law. Now we will try
to work with them to make sure that the consumer is protected,
as you have stated in your statement. But we are going to make
sure that the law is followed. And, toward that end, I want to
thank you very, very much for being here.
Ms. Welch. Thank you. My pleasure.
Mr. Burton. Your celebrity not only adds a great deal to
our hearing, but it adds a great deal to the American public's
awareness of how important this issue is. And I am sure people
across the country who may be watching this on television are
going to appreciate you taking the time out of your busy
schedule to come here and testify.
And, with that, let me just say that we are going to
recess. And those who will be panelists this afternoon, along
with Ms. Welch, if you would like to join us in the back for a
brief respite where we can have a bite to eat, and maybe talk
with her just a moment, I would really appreciate that. And,
once again, thank you very, very much for being here, Ms.
Welch.
Ms. Welch. Thank you.
Mr. Burton. We stand in recess until the fall of gavel,
around 1 p.m.
[Whereupon, at 12:32 p.m., the committee recessed, to
reconvene at 1:05 p.m., the same day.]
Mr. Burton [presiding]. We will reconvene the hearing, and
I would like to ask Mr. Bass, Mr. Kracov, Dr. Croom, Mr.
McCaleb, Mr. Turner, Dr. Dickinson, and Ms. Gilhooley to please
approach the table.
And, although we don't have the vast majority of media here
to hear your testimony, I want you to know that it is very
important for the record and it will help us make the proper
case to other Members of Congress about the importance of
dietary supplements. So I want you to know I really appreciate
your patience and your being here to testify. And, with that,
let me start. I will just start down at the left end by that
sexy Mr. Bass--[laughter]--who we talked to and kidded with a
little bit earlier. Didn't we, Mr. Bass? Would you like to
start and make your opening remarks?
STATEMENTS OF I. SCOTT BASS, J.D., ADJUNCT PROFESSOR,
GEORGETOWN UNIVERSITY; DANIEL A. KRACOV, J.D., ATTORNEY, PATTON
BOGGS, LLP; EDWARD M. CROOM, JR., Ph.D., PHYTOMEDICAL PROJECT,
NATIONAL CENTER FOR THE DEVELOPMENT OF NATURAL PRODUCTS
RESEARCH, INSTITUTE OF PHARMACEUTICAL SCIENCES AT THE SCHOOL OF
PHARMACY, UNIVERSITY OF MISSISSIPPI; ROBERT S. MCCALEB,
PRESIDENT, HERB RESEARCH FOUNDATION, BOULDER, CO; JAMES S.
TURNER, CITIZENS FOR HEALTH; ANNETTE DICKINSON, VICE PRESIDENT,
SCIENTIFIC AND REGULATORY AFFAIRS, COUNCIL FOR RESPONSIBLE
NUTRITION; AND PROFESSOR MARGARET GILHOOLEY, SETON HALL
UNIVERSITY SCHOOL OF LAW
Mr. Bass. Chairman Burton, thank you very much for the
opportunity to testify today with respect to the Dietary
Supplement Health and Education and, particularly, with respect
to the FDA proposed structure function regulations. The
committee has suggested that I speak from an academic legal
perspective and I appreciate that.
I am an adjunct professor at the Georgetown University
Graduate School of Public Policy and I head the Food and Drug
Law practice at Sidley and Austin in Washington, DC. I am a
graduate of the University of Michigan Law School, I have
coauthored the principal book on the Food and Drug's Dietary
Supplement Health and Education Act and was heavily in the
drafting of that act in the 3 years proceeding the October 1994
enactment. Our clients include both pharmaceutical companies
and dietary supplement companies, functional food companies as
well as the National Nutritional Foods Association. Hopefully,
then, I can bring a balanced perspective to the issues before
this committee.
The first thing I would like to discuss is, very briefly,
how dietary supplements were regulated before DSHEA, in order
to set the framework for how dietary supplements are being
treated under these structure function regulations. The main
law that applies to dietary supplements is the 1938 Federal
Food, Drug, and Cosmetic Act. Now, back then, it was quite easy
to determine the line between the function of drugs and the
function of foods. Essentially, any product that was intended
to treat, mitigate, or cure disease was a drug and anything
that was supposed to affect structure or function, except for
conventional foods, was also a drug.
By the 1960's, the dietary patterns of Americans began to
change and the demands for information about health changed.
However, FDA continued, until DSHEA, to regulate health-related
information under the 1938 act and those precepts that we
discussed earlier. It was huge public opposition in the 1970's
to FDA's attempt to limit the potencies of vitamins and
minerals that would be available to consumers that led to the
enactment of what is popularly called the Proxmire amendments
to section 411 of the act.
By the 1980's, people began to demand more and more ability
to take control of their own health. Kellogg's came out with a
campaign that fiber might lead to the prevention of certain
types of cancers. FDA opposed this and, after many years of
regulatory contention, Congress passed the Nutrition Labeling
and Education Act that carved out an exception to this 1938
food/drug distinction. They said that companies that sell foods
can make health claims.
Now that term ``health claims'' is not clearly understood
in some quarters so I am going to spend just a second
explaining that. A health claim is essentially a claim that you
will reduce the risk of a long-term disease. A drug claim is a
``treatment, cure, prevention'' of a disease. Health claims are
sort of a cut-out or carve-out from drug claims.
After FDA had essentially told the industry in its proposed
NLEA regulations that they were not going to recognize any
claims for herbs at all because they weren't nutritional
products, that they weren't going to recognize structure
function claims for dietary supplements, the type we have
today, Congress passed DSHEA and, in so passing, created a
brand-new definitional category for dietary supplements that
wasn't present in the 1938 law. This brought much more
information to consumers, but it also brought a host of
interpretational concerns.
The one thing, Mr. Chairman, that you mentioned earlier
today, which I think is probably the most important for the
public, is the conception that people have read that DSHEA took
the safety powers away from FDA. And I won't dwell on that
because I think you very articulately set that straight. But
let me say that that derives from an old theory FDA used to use
when they said, ``you can't sue a supplement because of claims,
because it doesn't have any claims,'' but--using ginseng as an
example--you have a ginseng capsule, they argued: because you
add ginseng to the ginseng capsule, the ginseng is a food
additive. Now one would say, who cares? Well, the answer was if
FDA called it a food additive, they could never lose a case
because they didn't have to prove it unsafe. All they had to do
was submit an affidavit of one FDA scientist saying that, in my
opinion, experts do not agree this is generally recognized as
safe among experts in the field and that was the end of the
case. There was no defense. As you will hear in a minute, that
is very relevant to today's proposal on structure function
claims.
We turn to claims in general, then. One of the most
important parts of the Dietary Supplement Health and Education
Act was section 6 that is before your committee today,
structure function claims. Those claims essentially allow a
company to tell how a substance beneficially affects the way in
which the body functions, how you maintain or support your
immune system or the mechanism by how that dietary ingredient
operates in your body. They can also talk about general well-
being claims.
Again, just to draw the record, a drug claim would talk
about, for example, ``fiber extract cures colon cancer.'' The
health claim would be ``eating fiber with exercise and a good
diet might reduce the incidence of certain types of cancers.''
Whereas a structure function claim would be ``a fiber
supplement can help to maintain normal and healthy digestive
systems and the functioning of your colon.'' That distinction
is very important today.
So I turn, then, to the last portion of my remarks, to the
proposals that Congress is looking at today. That is the April
28, 1998 structure function proposed regulation. I have four
points I would like to make today about that proposed
regulation. The first is that, in my opinion, it must be
withdrawn. I believe that that regulation undercuts the purpose
that Congress had in enacting section 6 of DSHEA. I believe
that FDA attempted in good faith to try to draw a line, but
that that good faith attempt went awry and went into much too
much detail and much too broad a scope to eliminate honest,
good information to consumers. If we look at the preamble to
DSHEA, the important preamble to DSHEA, where Congress said we
want healthful diets to mitigate the need for expensive medical
procedures, then look at this regulation, they contradict each
other.
Now there are some people who would say that any structure
function claim is an implied disease claim, that maintaining a
good circulatory system is really a ``wink'' way of saying
you're going to prevent a heart attack. We do not believe that
Congress should permit this government to make that claim
illegal because somebody thinks that it might be an implied
drug claim. Now there are many valid objections that have been
filed in the 100,000 comments that Dr. Henney referred to. And
I do want to say at this point that we are very encouraged that
Dr. Henney has said that she believes that FDA has sufficient
safety powers under DSHEA, a stance that contradicts her
predecessors. And we think there are people at FDA now who
exhibit the same attitude and we are hopeful that this process
can go forward in a very positive way.
But let me just bring up four basic points about the
structure function claim regs. First and foremost, FDA has put
the word ``normal'' back into section 6 by redefining disease.
They say a disease would have to be interpreted as any
interruption or impairment of normal structure or function. We
fought hard about that word, Mr. Chairman, during the drafting
of DSHEA and there were those who tried to put the word normal
into that law and Congress very definitively kept it out.
Putting the word normal in takes a broad-based health message
to the consumer and cuts it down to a narrow area that won't
allow this industry to function properly. For that reason
alone, we believe this proposed regulation is not proper.
Second, the way that ``disease claim'' is defined can make
almost any claim illegal. All the FDA has to do is get the
affidavit of one health expert who says that in the opinion of
the health expert community or the health community, this claim
implies a disease. To use an example before, maintaining good
circulatory system, it is really for people with heart attacks;
that implies a disease; this is an illegal structure function
claim. It is much too broad a definition. We don't think that
the government should live with that definition.
Third, Congress said, we don't want consumers to be fooled.
We believe consumers have brains. If you put this disclaimer on
that says this is not intended to treat, mitigate, or cure a
disease and FDA hasn't evaluated it, those words have meanings.
It is right there on the label. What this proposal does is take
away from consumers the right to make that judgment. It makes
that disclaimer meaningless. It says, essentially, to
consumers: I don't care what you say on the label, what you
read, if you have intelligence, we think if we have a health
expert who might imply a disease claim from this, you can't get
that information. We believe that is wrong as well.
Finally, this claim, this proposed reg, contradicts in its
breadth some of the recent first amendment decisions from the
D.C. Circuit, including the Washington Legal Foundation of
Pearson v. Shalala. And, for that reason as well, for first
amendment reasons, we believe there are serious issues with
this regulation.
We have two proposals to make today, as a solution. The
first is--and I have lived with this issue now for 7 years. I
am aware of the complexities and I don't treat this as a
simplistic issue--but I think that the only solution to this
issue is a simple solution. I believe that FDA should be
entitled to repropose the regulation, but it should just draw a
very simple line to begin with until Congress and FDA have more
experience. And that is, if you mention disease, it is a drug.
If you don't mention disease, it is presumably a structure
function claim. Let enforcement and an advisory body take it up
after there.
The main message that we have is that you have to retain a
line. Pharmaceutical companies must be given the opportunity to
have protection for huge, hundreds of millions of dollars in
investments, for important drugs that save lives and cure
disease. That is a very important policy of Congress. On the
other hand, Congress spoke in DSHEA that the people who want to
maintain their health, prevent disease, and stay out of the
hospital, they also need information and they are not going to
get that information if this proposed reg is enacted.
We believe, therefore, that not only should FDA draw a
simple line, but that the Congress should consider additional
funds for FDA to enforce against the outliers, the people on
the Internet you see who are committing fraud, who don't help
the good people in this industry. The mainstream of this
industry is bringing important information to consumers. They
should be allowed to continue to do that.
And, finally, Mr. Chairman, I propose that an advisory
group, modeled perhaps on the American Association of Feed
Control Officials or International Milk Shippers, groups that
contain government officials, academia, State officials, as
well as academics and lawyers and provide nonbinding guidelines
to FDA in the grey area, so that we don't have to sit here in
oversight hearings for the next 10 years worrying about whether
regulation overreaches. Thank you, Mr. Chairman.
[The prepared statement of Mr. Bass follows:]
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Mr. Burton. Thank you, Mr. Bass.
Mr. Kracov.
Mr. Kracov. Thank you, Mr. Chairman. On behalf of my
client, Pharmanex, Inc., I want to thank you for the
opportunity to provide testimony today regarding our experience
in the Cholestin matter. Our hope is that participating in this
hearing will play a constructive role in your oversight
activities and in FDA's evaluation of its policies with respect
to dietary supplement products.
Pharmanex, Inc., now a subsidiary of Nu Skin Enterprises of
Provo Utah is a science-based company providing standardized
dietary supplement products bearing substantiated claims. In
addition to assembling a first-class scientific team that
includes experts in medicine, nutrition, and natural product
chemistry, Pharmanex invested enormous sums in research and
development and put in place manufacturing facilities that
employ sophisticated quality control and quality assurance
methods. Pharmanex, in essence, represents precisely what the
Dietary Supplement Health and Education Act was intended to
promote: a responsible company providing quality products that
benefit the health and well-being of consumers.
Cholestin, one of Pharmanex's products, is a natural
dietary supplement that is composed solely of milled red yeast
rice. Red yeast rice, which is a solid fermentation of yeast on
rice, has a documented history of use as both a food and health
product going back almost a millennium. The species of yeast in
Cholestin was originally identified scientifically in 1895 and
it has a long history of use in the manufacture of red yeast
rice, red sake, and other food products that have long been
available in the United States. Indeed, the earliest reported
attempt to manufacture red yeast rice in the United States--in
1920--was undertaken by Margaret Church, an employee of the
Bureau of Chemistry, U.S. Department of Agriculture, the direct
predecessor to the Food and Drug Administration. That effort
used the very same yeast strain employed by Pharmanex in making
Cholestin.
Some traditional red yeast rice products naturally contain
a range of substances known as HMG-CoA reductase inhibitors.
These include, but are not limited to, lovastatin, as well as
other natural compounds that promote and maintain healthy
cholesterol levels. In developing Cholestin as a dietary
supplement product, Pharmanex sought to employ modern quality
control methods in the ancient recipe for red yeast rice in
order to ensure that all of the beneficial constituents are
consistently present. In addition, Pharmanex spent millions on
clinical research to ensure the product is safe and beneficial.
In spite of this, however, FDA took the position, both in
an administrative proceeding and, subsequently, in the
Pharmanex v. Shalala litigation, that Pharmanex's Cholestin red
yeast rice is a drug rather than a dietary supplement.
According to the agency, Pharmanex, ``manipulated,'' the
production process to ensure lovastatin content and,
``touted,'' the presence of lovastatin in the product. FDA did
not challenge the safety of Cholestin.
FDA's legal case was built upon construing a phrase in
section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic
Act as amended by DSHEA. This provision states that, ``an
article that is approved as a new drug under section 505,'' of
the Federal Food, Drug, and Cosmetic Act cannot be sold as a
dietary supplement unless marketed prior to that approval as a
dietary supplement or as a food. The agency's view was that
Cholestin red yeast rice, a dietary supplement form of a
traditional food, could not be marketed because a synthesized
drug product, Mevacor, contains the active ingredient
lovastatin. Notably, the agency's construction of this
statutory provision was completely at odds with its historical
interpretation of the term ``new drug approved under section
505'' including an administrative decision issued in another
matter as recently as December 1998.
The agency's theory was also at odds with the facts
regarding Cholestin. Lovastatin is 1 of 10 HMG-CoA reductase
inhibitors in Cholestin, and the company does not control or
even test for its level. Lovastatin varies from 20 to 60
percent of the total HMG-CoA reductase inhibitors in the
product, which is actually composed mostly of rice. Pharmanex
does not add or enhance any single constituent. Rather,
Pharmanex has employed quality control measures common to the
food industry to standardize the overall level of beneficial
constituents. Such standardization is precisely what Congress
sought to encourage in DSHEA. Indeed, it is worthwhile noting
that, although Cholestin is simply ground red yeast rice, DSHEA
specifically authorizes the use of metabolites, extracts, and
concentrates as dietary supplements.
Moreover, rather than touting the lovastatin content of the
product, the company has marketed the product as a natural
dietary supplement: a food. Indeed, a Federal judge in a
trademark case specifically found that Cholestin was not
marketed as a drug and did not compete with drug products. The
agency's case was built entirely upon a few Pharmanex
references to lovastatin in the context of overviews of
clinical research, and a tiny warning formerly found on the
back label of the product.
As to the historical marketing of red yeast rice containing
lovastatin, even FDA's own testing found that some other
traditional red yeast rice foods on market contained
lovastatin, including one with a lovastatin level equal to 39
percent of that found in Cholestin. Phamanex's own
comprehensive testing here and in China found traditional red
yeast rice foods with more lovastatin than in Cholestin. The
presence of lovastatin, a food product like red yeast rice, is
not that surprising. The ability to produce HMG-CoA reductase
inhibitors has been found to be widespread among fungi
originating from different taxonomic groups and habitats. For
example, lovastatin is found at high levels in a species of
mushroom widely consumed in the United States.
Fortunately, on February 16, 1999, the U.S. District Court
for the District of Utah found for Pharmanex in the Pharmanex
v. Shalala litigation, holding that Cholestin is, in fact, a
dietary supplement. Nevertheless, FDA's position with respect
to Cholestin placed an enormous burden on the company,
resulting in millions of dollars in lost equity value and
marketing investments, as well as significant litigation costs.
Indeed, but for the district court's earlier grant to Pharmanex
of a preliminary injunction preventing FDA from initiating
further detentions of Pharmanex's red yeast rice imports, it is
quite possible that the company would have gone out of business
entirely.
For Pharmanex, the FDA's position in the case has always
been puzzling in that the company thought that it was a model
for what FDA would like in a dietary supplement company: strict
quality controls, extensive efforts to understand the nature
and safety of its products, and substantial investments in
clinical studies. The company always wondered why the matter
was treated as an enforcement case with an approach of ``detain
imports and ask questions later.'' Over the many months of back
and forth with the agency, Pharmanex repeatedly suggested ways
that the matter could be resolved, but FDA seemed determined to
stick to its initial legal theory, rather than find a way to
maintain consumer access to what we believe is an important
product.
In the aftermath of this decision, we hope FDA will
reexamine its policies in light of the intent of Congress in
enacting DSHEA. That intent was quite clear: FDA should do
everything possible to ensure the availability of safe dietary
supplement products. Regulation of these products should not be
governed by a blind presumption that pharmaceuticals should be
protected at all cost. Simply put, FDA needs to take dietary
supplements seriously from a public health promotion
standpoint, and should foster companies like Pharmanex that are
willing to put funds into serious quality controls and
research.
I know that my client continues to be willing to put this
litigation behind them to work closely with the agency to
foster the growth of a research-based dietary supplement
industry. Such cooperation would be a significant step toward
promoting the public health, as Congress intended in DSHEA.
Once again, on behalf of Pharmanex, Inc., thank you for this
opportunity.
[The prepared statement of Mr. Kracov follows:]
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Mr. Burton. Thank you, Mr. Kracov. Dr. Croom.
Mr. Croom. Thank you, Mr. Chairman and members of this
committee. I am extremely honored to be given the opportunity
to provide testimony to the Committee on Government Reform.
I think, as a way to simplify this, let me say that
botanicals is what I am going to focus on, not all the things
delineated in DSHEA, because I don't know all the other things.
That is not my specialty. But let me say that my original
motivation over 20 years ago was to say what could be a safe
and effective and affordable and available part of primary
health care throughout the world. And there is only one answer
and that is botanical medicines, only one answer.
Today the other critical issue is--why my prepared
testimony discusses so much science--is that, in my experience,
for many years, that I could see traditional healers using very
safe and effective therapies, however, they can never be
translated into a broader cultural context without the
scientific validation of those. Without that scientific
validation--I will speak to a couple of issues that I heard
raised today--we don't know what is reproducible and how much
should you take, once we are beyond a mild tea. And some things
are physiologically potent; most, however, are not. As a matter
of fact, our biggest challenge is to say how can we have gentle
therapies when science, like much else in the world, rewards
quick, immediate, dramatic answers, not, I would say, wisdom
and compassion and gentleness that we all say we are about as
some of us approach middle-age crisis, but that is our real
challenge.
And our challenge that why I believe in science is to make
a reproducible product so I can believe I get consistency or
what I, too, would buy in the marketplace to treat myself, is
it can all be answered without conflict and without war if we
start having this idea that there really is some value here.
And let us study it and let us build up the foundation of not
only our health care.
But, I am being very honest, that has not been part of this
debate. The debate has always been, in recent times, the
question of regulation and of marketing and of corporate
interest. Let us broaden this whole discussion. Where is our
health, our children's health, and the world's health? With
that dedication, we can make changes. And that will come,
working together in a cooperative way.
I, too, must comment. I was glad to hear more sense of
cooperation. Because let me also say that over 20 years ago, my
major professor said there would never be another new drug,
even plant, derived, when I started graduate school. And,
within 2 years, I was fortunate enough to direct the production
of a Chinese traditional medicine anti-malarial drug for
clinical trials by World Health.
He, too, had the same debate I heard today. Was it the warm
water in the tea? Was it placebo? I had one advantage over my
major professor. It was from being a Southerner, which we
always study our ancestors. And I grew up with the knowledge
that my greatgrandfather was a founding member of the North
Carolina Pharmaceutical Association and a physician. He used
herbal medicine in his constant practice. I did not believe it
was all safe and effective. I do not still believe that. But
some of it was and it got dismissed by the quickness of time we
went for very what I would call dramatic chemistry and dramatic
physiological results is what happened historically in this
century.
So I guess if I have a message to you, it is, yes, garlic
and ginseng and saw palmetto and St. John's wort, many people
have tried these. And many people have benefited. But, really,
we have just begun. We are like children who have just begun.
So let us not ask for final answers today of where is all the
science? Let us take this challenge to say, what can we do?
And I will respond to Raquel Welch's comment. You know
science and worrying about placebos, we sometimes forget the
individual. And we all know whether it is something we eat. I
will be honest. I will leave it out so I won't have a trade
association after me. But there are some foods I can't eat that
I feel horrible after eating them and other people don't. I
don't sleep well. I don't have the same energy level. Now we
have to approach things scientifically that way to say both you
as an individual and as a group what happens.
And I will speak to that same experience with over 6 years
I worked on producing Taxol from renewable yew needles. I have
never testified before Congress, but I heard one before.
Because I started working to say how could we save the old-
growth forest and help women's lives, which is where this issue
started. And, therefore, what I found that was, after being
official, let us face it, no matter all the clinical, some
individuals that are friends of mine who have had Taxol have
been greatly helped and some have not. So let us not be naive
about our own individual health.
And my message, you can see today--which I appreciate the
faith in your staff and my colleagues here, because I can see I
didn't stick at all to my prepared testimony. But I understand
you get to say both--is that we can do this and that it is
really just a beginning. There is science--and there does need
to be more science--but science should always be in service to
our health and not seen as some kind of bar for us having good
health. Thank you.
[The prepared statement of Mr. Croom follows:]
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Mr. Burton. Thank you. Thank you, Dr. Croom.
Mr. McCaleb.
Mr. McCaleb. Thank you, Mr. Chairman, members of the
committee. I would like to thank you for the opportunity to
address you today on the FDA's handling of dietary supplement
labeling issues.
The Herb Research Foundation is a 15-year-old scientific
organization, nonprofit, tax-exempt organization, that compiles
research on botanicals and gives information for the education
of the public, the media, scientists, health professionals,
pharmacists, and so on. We have perhaps the best library of
scientific journal article collection in the country on the
subject of herbal medicine and herbs used as dietary
supplements. We have over 200,000 scientific articles in our
files and provided a lot of those articles to Members of
Congress during the debate over DSHEA. We have also provided a
lot of the substantiation information for companies who want to
make scientifically substantiated structure function claims.
I was also a member of the Commission on Dietary Supplement
Labels, as you know, and, as part of that and through my 25-
year career in herbal products, I have studied and understood
the regulation of dietary supplements and the debates over them
for years. I followed a lot of the things that Scott Bass was
talking about a moment ago.
The FDA's proposed rules under discussion today do appear
to me to be an attempt to sort of turn back the clock to
circumvent the will of Congress and of the people and to
prevent the very types of claims that DSHEA was written to
allow. I believe DSHEA has produced very impressive public
health benefits already. HRF is very aware of the increasing
volume and quality of scientific research because we track it
daily. We receive stacks of articles every week on the latest
research on botanicals used in health care.
We have also witnessed a new public awareness in health and
nutrition. Nobody wants to be a minimum-daily adult. People are
not looking for just the disease preventive effects of taking
vitamin C to prevent scurvy. In fact, I would venture to guess
that nobody takes vitamin C to prevent scurvy any more. Rather,
our concept of nutrition and health now has expanded to the
point that we understand that certain types of foods and
supplements can help maintain and promote and increase our
health and, some people would say, prevent disease. And I
understand that there is sometimes a fine line between those
types of claims.
In addition, the passage of DSHEA has increased the
sophistication in supplement formulation and created, I think,
dramatic incentives for research. We have not seen this level
of research in this country for many years on botanical
products. In addition, technologically advanced companies
created by the newly allowable supplement claims are raising
standards of quality in the industry and bringing much-needed
research funding to academic institutions for high-quality
American supplement research.
DSHEA is producing just exactly the kinds of changes that
we envisioned in supplement research, development, and use of
dietary supplements. A better-informed public is using the
best-researched supplement ingredients to produce real gains in
public health. It is time for the FDA to abandon its continuing
battle against dietary supplements and against the right of the
public to access truthful information about the known effects
of supplements.
I am disturbed by the repeated misrepresentations made by
the FDA alleging that supplements are unregulated, a word that
has appeared in nearly every magazine and newspaper story since
the passage of DSHEA on supplements. The FDA persists in
alleging that Congress jeopardized public health to appease the
so-called multibillion-dollar supplement industry and that
DSHEA exempts supplements from government oversight. As we have
heard today, none of these things is true.
My specific objections to the proposed rules: the
redefinition of disease. The FDA's proposed definition would
allow any deviation from a state of normal health to be
considered disease. Armed with that ability to broadly redefine
disease, FDA could consider any product which helps or which
claims to help maintain normal health, a drug claim. Any
deviation from perfect health could be called a disease, even
if that deviation is a normal part of aging.
The Commission on Dietary Supplement Labels spent 2 years
in careful consideration and often debate on regulation of
supplement labeling. Throughout this process, we assumed that
the definition of disease, drug, supplement, and food were not
subject to change except by Congress. Indeed, the FDA testified
before us that they were unable to change or interpret these
definitions without an act of Congress. Now it seems the agency
believes it has the power to radically alter the definition of
disease and grant itself the power to define anything as a
drug. By the FDA definition, thirst is a disease and drinking
water a drug.
Implied claims. The FDA has always wanted the authority to
decide what is implied in claims. The Commission recognized the
difficulty of determining what is implied to a consumer by a
particular statement. Regulation must be based on what is
stated on a label, not what a consumer reads into it. The FDA
endorsed in its proposal this claim, ``Helps maintain
cardiovascular function and a healthy circulatory system.'' One
consumer reading that statement may conclude this helps keep my
heart healthy, while another might think this can help me
prevent heart disease. The manufacturer cannot be held
responsible for a statement being interpreted as a wellness
claim by one and disease-prevention claim by another.
The important point is that the public has a desire and a
right to know about substances that can protect their health.
Although heart disease can only be diagnosed by a doctor, every
American wants to maintain a healthy heart.
Citation of publications. The FDA proposes the citation of
a title of a publication or other reference could cause a
supplement to be regulated as a drug if the publication or
article named a disease. This would restrict the ability of
supplement producers to inform the public of even the best
quality of research, citing even the works of the National
Cancer Institute and other health agencies, respected journals,
and other high-quality sources of consumer education.
I think the FDA's proposed rules should be withdrawn and
redrafted with the serious intent to carry out the will of
Congress and of the public. The current proposal appears to be
a stubborn attempt to reverse the major provisions of DSHEA and
prevent most statements of nutritional support. Thank you.
[The prepared statement of Mr. McCaleb follows:]
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Mr. Burton. Thank you, Mr. McCaleb.
Mr. Turner.
Mr. Turner. Thank you, Mr. Chairman. My name is James
Turner and I am the chairman of the board of Citizens for
Health. Citizens for Health generated about 1 million letters
to Congress to support DSHEA. It has also been involved as one
of the plaintiffs in the Pearson case, which was recently
decided by the court here in the District against the FDA.
Also, last September, it generated not 100, but over 175,000
letters to the FDA complaining about the structure function
regulation that was put forward by the FDA.
Our concern about the structure function claim was
underlined by the Commissioner's statements this morning. Just
as she was slightly off on the 100,000 versus 175,000 names,
she was slightly off on what the situation is with regard to
the proposed regulation. She said that the FDA wanted to look
at a bunch of medical books to find out what the definition of
disease was so that they could then decide how properly to
regulate the disease aspects of the law.
What she did not say is that FDA has in place a definition
of disease by regulation which was in place at the time that
DSHEA was passed and it is quite different than the one that
they are currently proposing. That regulation says that disease
is some damage to a bodily organ, heart, structure, or system
which impairs its function, such as cardiovascular disease. The
argument that Citizens for Health has made is that that
definition should not be changed. Changing that definition
completely essentially repeals the structure function aspects
of DSHEA. It eliminates the ability to make the kinds of claims
that the law was designed to pass.
We are prepared at Citizens for Health. We have already
mounted a campaign of 175,000 letters. That is how many they
have counted. They are still counting. We are prepared to go to
court and argue that the intent of Congress, when the bill was
passed, was to recognize by law the definition that FDA had in
place at that time, that, as a matter of law, the definition
that existed at that time was the definition that Congress put
into the act.
We have one minor recommendation to Congress in the future.
When taking an action of the kind that they did in DSHEA,
probably the exact language of such definitions should be
written into the legislation. I have been working on food and
drug law since 1968. I was involved in the passage of the
Proxmire Act, NLEA, and DSHEA. Every time Congress has moved
forward to make more information available to the public about
dietary supplements, the FDA has moved backward and tried to
undo that action by their regulatory efforts. The FDA, for some
reason, seems to be institutionally incapable of having an open
mind about the interests of the public about the consumer
having information about how to make their own health
decisions.
In pursuing this desire--wherever the desire comes from--to
keep rolling back these acts of Congress, it also--I don't want
to say misleads--but it certainly leads Congress off in
ancillary directions. This discussion, for example, this
morning about looking in medical books for the definition of
disease is completely off-point about the issue. As I have
said, the issue is that a definition exists. Congress passed a
law fully cognizant of that definition existing. And now the
FDA wants to change that definition. They have provided
absolutely zero information as to why that definition should be
changed. Incidentally, they have also provided no legal basis
upon which they could change that definition.
They have undertaken the same kinds of activities in
several other areas which are in our written testimony, which
we submit for the record, and, hopefully, it will be published
in the final document of the hearing today. Thank you very
much.
[The prepared statement of Mr. Turner follows:]
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Mr. Burton. Thank you, Mr. Turner.
Dr. Dickinson.
Ms. Dickinson. Thank you and we do appreciate the
opportunity to be here to comment on FDA's implementation of
DSHEA.
The Council for Responsible Nutrition is a trade
association representing the dietary supplement industry. Our
hundred manufacturing companies are responsible for producing
most of the dietary supplements that are currently available to
you in health food stores, supermarkets, drug stores, by direct
sales, and by mail order. We were intimately involved in the
bipartisan effort to pass DSHEA by 1994 and have been
monitoring every step of FDA and congressional implementation
of that law.
We believe that DSHEA strikes exactly the balance that Mr.
Burton and Mr. Waxman spoke of this morning, that is the
balance between protecting consumer access to products that
they want to improve their health and also allowing FDA ample
authority to enforce the requirement that the products be safe
and that the products be appropriately labeled and that any
statements on the label be substantiated. We believe DSHEA
quite intentionally allows that balance to be struck.
We think the most damaging thing that is happening today
that could endanger DSHEA and endanger the industry is the
widespread perception that is being spread by the media and,
sometimes, supported by some individuals even within the
regulatory agencies that these products are unregulated. It
would be bad for industry, it would be bad for consumers if,
indeed, these products were unregulated. But they are not. FDA
has authority over the safety of these products and DSHEA
specifically spells out procedures to be followed before a new
ingredient can be introduced in a dietary supplement. It also
gives FDA ample authority to withdraw or seize products that
are found to be unsafe and CRN supports these procedures.
We think the only thing that could be done that would be
better in terms of making DSHEA better would be for FDA to step
up to the plate to its duties in the way of enforcement. We
think that companies who are trying to do the right thing are
not well-served by an agency that does not enforce the
requirement that statements on the label be truthful, not
misleading, and substantiated. Nor are they supported, nor are
they helped by an agency that doesn't take swift action when
there are issues of safety to be addressed.
Recently FDA seems to be moving in the direction of being
somewhat more active in these areas. For example, they have
been reviewing the 75-day notices for new ingredients that are
required under DSHEA and, just this year, they moved against a
product called GBL, which they had already determined to be
unsafe, but was being marketed anyway. CRN supported that
action and we would continue to support FDA actions in the
interest of assuring the safety of products that are available
to consumers.
Our written testimony addresses other areas where CRN and
other members of the industry have supported FDA action, which
unfortunately has been slower in coming than it should be, for
example, in the area of finalizing good manufacturing
practices, which DSHEA recognized are essential to assure the
quality of products available to consumers. Also, there needs
to be extensive improvements in FDA's current handling of
adverse event reporting for nutritional supplement products.
There needs to be a dietary supplement advisory committee
established for FDA. FDA currently relies on its Food Advisory
Committee, which, unfortunately, does not have the kinds of
individuals, the kind of expertise, represented on it that it
needs in order to address dietary supplement issues.
On the issue of the current proposal of FDA on statements
of nutritional support, CRN has submitted extensive comments to
FDA criticizing virtually every element of that proposal. FDA
recognizes in its preamble that there is very little difference
between promoting health and preventing disease and that almost
any disease claim can be stated as a statement supporting
structure or function of the body. We think that this very
recognition by FDA underlines what is wrong with the current
structure function proposal.
Congress drew the only bright line that can be drawn
between permissible statements of nutritional support and
disease claims when Congress said in DSHEA that a statement of
nutritional support may not mention a disease or related
condition nor may it use the kinds of terms that are embodied
in the drug definition, such as prevent, treat, cure, mitigate.
Beyond that, the act clearly anticipates that any statement
that, on its face, is a statement about affecting structure and
function should be permitted under DSHEA. Once FDA leaves that
solid ground and launches off into trying to draw another line
between statements of nutritional support that may be implied
disease claims and statements that may not, we believe they
enter an area where there really is no logical line that can be
drawn.
For example, in the proposal, FDA says that it is quite OK
if you say, as a statement of nutritional support, that a
product maintains a healthy cholesterol level or that it
maintains a healthy heart. We would agree with that statement.
However they also say that it would not be an acceptable claim
if you say a product lowers cholesterol. What do you think
people believe maintaining a healthy cholesterol means? They
obviously think it means having a lower cholesterol. So FDA is
trying in this case to draw an indefensible line between what
they would consider to be an implied statement and a disease
claim. We believe that all of these statements should rightly
be permitted as statements of nutritional support regarding
effect on the structure and function of the body.
The FDA proposal would even prevent the provision of
adequate information to consumers regarding the research basis
for some of these statements. As Robert McCaleb mentioned, the
proposal would prevent manufacturers, in labeling--and remember
that the rule applies to labeling as well as to labels, so
informational brochures that are prepared by the company and
distributed with the product would have to comply with this
rule--it forbids the citation of articles that contain the
mention of a disease.
CRN published a statement on benefits of nutritional
supplements early last year citing almost 200 references. And
we went back and checked how many of those have the name of a
disease in the title of the article and it is more than 50
percent. One could not do a competent review of the science on
any subject related to health without mentioning such articles.
So we are very concerned about that aspect.
CRN believes that FDA would do well to follow the USDA
model in this case. When USDA published an organic rule that
was hugely opposed by consumers and on which they also got more
than 200,000 letters, the Secretary stood up to the bar and
said, OK, we got it wrong. We are going to withdraw this
regulation. We are going to go back to the drawing board and
reconsider what is needed. We think that should be FDA's
response also in this case.
In general, our philosophy in dealing with FDA is to try to
cooperate for the betterment of FDA and the industry and we are
glad to hear Dr. Henney say that, under FDAMA with its
instruction to FDA to deal more directly with its stakeholders,
that they are going to work with us more closely. We look
forward to working both with you and with FDA to resolve these
issues.
[The prepared statement of Ms. Dickinson follows:]
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Mr. Burton. Thank you, Dr. Dickinson.
Ms. Gilhooley.
Ms. Gilhooley. I am Margaret Gilhooley. I am a professor at
Seton Hall Law School and was a member of the Commission on
Dietary Supplement Labels. I appreciate the opportunity to
testify on DSHEA and whether FDA is carrying out its intent.
I will first address the criteria to identify disease
claims. DSHEA permits dietary supplements to make structure and
function claims, but not disease claims. Under FDA's proposed
rules, disease claims include references to specific diseases,
but not more general references to body systems or functions.
Thus, FDA tentatively regards as appropriate a claim that a
supplement helps maintain cardiovascular function, inhibits
platelet aggregation, and helps maintain a healthy cholesterol
level.
I believe FDA's criteria are too narrow. General references
to bodily functions can still imply usefulness to prevent
disease conditions and especially so when the claim refers to
bodily organs and functions that normally receive medical
attention. The Commission members disagreed about appropriate
claims for supplements and some of us found troubling and
problematic claims mentioning organs such as the heart or
systems such as the circulatory system associated with major
clinical conditions.
In my view, a claim to maintain normal cardiovascular
function implies a need to use the product to prevent an
abnormality, an abnormality which would be a disease. Moreover,
when a claim relates to a matter beyond the ability of the
consumer to assess from their own experience, the potential to
mislead increases. Thus, I think the FDA proposal needs to be
revised.
The FDA proposal also recognizes as an appropriate
structure and function statement a claim that a product
improves absent-mindedness. In my view, this claim should not
be viewed as an appropriate claim for a dietary ingredient.
There are no foods that affect absentmindedness and this claim
is not for the role of a dietary ingredient or a dietary
supplement in any meaningful sense. That claim should not be
permissible for the same reason that a claim of a dietary
supplement to be an oral contraceptive would not be
permissible. The claim is simply not one for the affects of a
dietary ingredient.
With respect to health claims, the Commission found that
the standard of significant scientific agreement is appropriate
and serves the public interest and that the process for
approval of health claims should be same for dietary
supplements and conventional foods. While FDA has adopted this
approach, the recent decision by the D.C. Circuit of Appeal in
Pearson v. Shalala has found constitutional and legal
difficulties with FDA's actions. Under the decision, the FDA
regulations are unconstitutional in failing to allow
supplements to make a health claim, even when there is no
significant scientific agreement to support the claim, so long
as the supplement bears a disclaimer about the inconclusiveness
or other limits of the supporting evidence and the lack of FDA
approval.
I will not comment about the constitutional law aspects of
the decision, but will point out the important decision FDA
will have to make on remand in determining what constitutes an
adequate disclaimer to inform consumers with respect to
particular health claims. In my view, in addition to the other
disclaimers, consideration needs to be given to stating on the
label that there is no significant scientific agreement to
support the claim. The difficulties of using disclaimers to
inform consumers is also illustrated by the National Cancer
Institute's study of the affects of the antioxidant supplement
beta carotene. The Institute's investigators found in two
studies that the supplements were clearly not effective to
prevent cancer or heart disease and may even be harmful.
Disclaimers may simply not be adequate to convey this
information on the label. Moreover, even under the court's
decision, preclusion of a claim, rather than a disclaimer, may
be appropriate when the weight of the evidence shows the claim
to be ineffective.
With respect to safety substantiation, consumers use
dietary supplements because they assume the supplements are
safe, as safe as foods. The supplements are not, however,
subject to the requirements for general recognition or FDA
approval that provides assurance of the safety of other
ingredients. FDA bears the burden of proof to show that the
product poses a significant risk. And the Commission report
also indicates the difficulties and resource burdens involved
in meeting that standard. In my view, supplement manufacturers
should have a legally enforceable affirmative obligation to do
the testing needed to establish that supplements are safe. I
think that responsible manufacturers will do that and it is
really only the irresponsible manufacturers who will evade that
obligation and may bring discredit to the dietary supplement
industry.
If a manufacturer does not do safety testing, the
manufacturer should put a warning on the label that the safety
of the supplement has not been substantiated. I recommended in
the Commission report that FDA require this warning to prevent
deception, but FDA has not acted on that measure.
Finally, there is debate about whether FDA is carrying out
the intent of DSHEA. But the underlying reason why it is hard
to resolve that issue is because DSHEA is an enigma. The
provisions are ambiguous and can be interpreted in various
ways. Thus, while I believe FDA can and should do more to guard
against inappropriate claims, I recognize that not all will
agree that FDA has that authority under DSHEA. And if FDA does
not have this authority, in my view, Congress should revisit
DSHEA and provide clear criteria to limit inappropriate claims
and give FDA stronger authority to assure the safety
supplements. Thank you for the opportunity to testify.
[The prepared statement of Ms. Gilhooley follows:]
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Mr. Burton. Thank you, Ms. Gilhooley. I have a number of
comments and questions. I think, Mr. Bass, you suggested that
there ought to be an advisory panel on this whole issue to at
least work with the head of the FDA. And, toward that end, we
will contact the new Commissioner and suggest that we think
that might be a good idea. It is not binding, but it would
help, maybe, illuminate some of the issues and problems so that
they could be solved without regulations being proposed before
all sides have been heard. So we will suggest that and we will
contact her by mail and in person about that.
Mr. Kracov, regarding Cholestin, you made some inferences--
I am not sure I read you correctly--but you were talking about
lovastatin and I think--was it Merck that produces lovastatin?
Mr. Kracov. That is correct.
Mr. Burton. Yes. Do you believe or did I read in your
remarks that possibly some of the pharmaceutical companies may
be involved in trying to stop some of these supplements that
may take away some of their business?
Mr. Kracov. I agree and disagree in that at least one
pharmaceutical company was interested in stopping our
particular product. But, in general, one of the ironies of the
Cholestin case is that FDA was supposedly protecting incentives
to develop pharmaceutical products, but neither the
pharmaceuticals industry association or any other
pharmaceutical company commented in the docket against
Pharmanex. And, indeed, the only other pharmaceutical company
that commented actually supported our position on cholesterol
claims for the product.
Mr. Burton. Do any of you believe that the pharmaceutical
industry has, behind the scenes, tried to influence people at
the FDA or any government agency regarding the stopping of
certain supplements from being marketed? Do you have any idea?
Mr. Turner. That is a very tough question to answer because
the evidence is not right there in the record. But I have been
involved with the herbal sweetener Stevia for a number of years
and we know that FDA has restricted its access into the United
States. We know that there has been industry complaints from
other industries about it. We don't know really who they are.
And we know that it competes directly with Nutrasweet. There is
a buzz around that there is some role that Nutrasweet plays in
helping the FDA not allow this sweetener to be widely
distributed. Now the way it works, once DSHEA was passed, the
products could continue to be sold, it could be sold, but it
just can't be labeled as a sweetener.
Mr. Burton. Do any of you have knowledge or information
that people who work at the FDA, Health and Human Services, the
National Cancer Institute, or National Institutes of Health,
have been influenced by pharmaceutical companies in their
decision or the decisionmaking process over there at any of
those institutions?
Mr. Kracov. I can comment that in the Pharmanex
administrative proceeding, there was extensive involvement by
one pharmaceutical company in particular and there was
significant----
Mr. Burton. What was that company?
Mr. Kracov. It was the maker of Mevacor, Merck.
Mr. Burton. Merck.
Mr. Kracov. And the information provided to the docket was
obviously, heavily weighted or attempted to weight the case
against Pharmanex. Fortunately, we were able to rebut that and
go to court and win. I think that is unusual. I think,
actually, if you look at the products that are on the table
here, many of those dietary supplement products are made by
pharmaceutical companies.
Mr. Burton. Oh, yes.
Mr. Kracov. And I think a lot of those companies are
actually seeing the promise of the Dietary Supplement Health
and Education Act and are taking advantage of it.
Mr. Burton. Well, you know, I know that is the case because
it is a burgeoning industry. And people are more concerned
about their health and, as a result, I think a lot of the
pharmaceutical companies are seeing additional marketing that
they can do, additional products that they can market and make
money. Which is fine.
The line of questioning I am taking right now is, I don't
believe that any industry, even though they have a lot of money
at risk because of scientific research into certain products,
should try to influence government agencies for their benefit
while, at the same time, it is to the detriment of another
industry and, ultimately, maybe, to the American people. And
that is why I asked that question.
I understand--and I think Mr. Bass mentioned this in his
comments--pharmaceutical companies invest millions, billions of
dollars, in research and we want to make sure that they don't
go out of business because they spend a lot of money on
research and then they can't recoup that by selling their
product, you know, through having control of that product for a
long period of time. But, at the same time, if somebody comes
up with a less expensive approach to, curing a form of cancer,
I think it is unseemly for the pharmaceutical industry to come
in and say, hey, we want to stop that and try to use our
influence with a governmental agency to do so. And that is why
I ask that question.
And if any of you have any indication that some person at
any of these agencies are ever being unduly influenced or
influenced at all by somebody in one of these industries or one
of these companies, I wish you would bring it to my attention
because I would certainly like to pursue that. OK?
I think, Dr. Croom, you talked about placebos and one of
the concerns that I have had, we have had a number of people
testify before our committee who have had Hodgkin's disease or
had children who were terminally ill with lymphoma or some
other disease and there have been alternative therapies that
have been proposed by certain doctors in other parts of the
country. And I believe it was Health and Human Services that
have said that, you know, these aren't proven therapies as far
as they are concerned. And, as a result, they told these
doctors, if they used their procedures on the individuals who
testified before our committee, that they could lose their
license to practice medicine.
And the ultimate result was that these people had no hope.
They had been adjudged terminally ill and the parents of the
boy that was in question and another fellow who had Hodgkin's
disease, they were told, in essence, go home and die. They
didn't say it just that callously, but they said, go home and
die. And that the possibility that these alternative therapies
used by other doctors had not yet been proven to the
satisfaction of these government agencies meant that the people
couldn't go down there and pursue that therapy.
I also was concerned because we had people who wanted to
have therapies and they were told that there was trials being
undertaken and that they had to either take a placebo or take a
product under question. And they really were terminally ill and
they didn't want to take the placebo, they wanted to try the
therapy that they thought would save their life.
So I would like you to comment on that real briefly, if you
would.
Mr. Croom. I would be glad to. I have faced those same
questions, obviously, from family and friends. I am really
hoping we are on a new beginning. And I am going to say it is--
I had a sentence written I guess I didn't read--and I say we
must ask what is the health outcome of our public policies and
scientific studies on the enhancement--and I would take it to
just what you asked. Not just botanicals.
In other words, if I say to you, I haven't studied it, but
I am not going to give you money to study it. And, believe me,
I have had people at a number of alternative cancer therapies
who have asked me, over the last year, to help them design the
clinical trials because they involved botanical products. Quite
honestly, at this point, there has not been sufficient
funding--and I am talking about--my job is not to do the
clinical trial, my job is to say what is that optimum product
you are using? What is the purity and identity and standard? We
haven't backed up and asked that question and funded that
research yet.
Because, again, of course, I want to be the same way. I
have friends who have gone to Switzerland for therapy from
Oxford, MS. I have friends who have gone to Mexico. And people
come to me and I have to say, you know, you have just pointed
out a problem. Of course, I would rather have faith that
something is happening to me. It is a well-known case that if I
tell you you are going to die, you are more likely to die if
people tell you that every day. And that is an absolute--I am
sorry--transgression of medical ethics to tell you that. To say
that is unproven, I think, is not.
In all honesty, there are so many things like this that
touch all our lives, that I am saying to you that, and I agree.
And, believe me, 16 years ago, when I became a professor and
was doing botanical medicines, I started doing the anti-
malarial and then the drug ones because no one would fund our
research and business was giving us incentive.
But you can tell me, Chairman Burton, if you would approach
it differently, but I don't have that same honest answer. I
want to know that a person is competent and compassionate about
the therapy that I can trust the results they tell me, to say
who would this help and who it would not help and know that
answer. Because, right now, I don't think, in many cases, we
know. And I think in other cases--and I will respond to some of
the things--we have asked certain high standards to just tell
you you are unproven and you are foolish to do it. And you will
never even know if it helped you, you know, even if you did it.
I think that is just arrogance. And that is my plea, is to
say let us have some humility and get the knowledge base. I
hope that is responsive to your question.
Mr. Burton. Well, I guess to a degree it is. I will yield
to my colleague in just a moment. But we have had some severe
cancer problems in my family in the last year. My mother and
father both died of cancer within a month of one another. My
wife had breast cancer 5 years ago and she was given about a 50
percent chance to survive 5 years. You know, they always use
these statistics. And we were putting her into a special cancer
program that I read about where they stimulate your immune
system. It was in Highland Park, IL. I had read about it in
Life magazine, I believe.
They were going to close that down after I brought it to
the attention of the FDA, because I thought it should be
expanded because they were only working on about 72 women. And
it really bothered me a great deal because these women were
calling me, because of my position in the Congress, in the
middle of the night, crying saying, you know, this is our only
hope.
And then these people that have testified before our
committee over the last year, who had terminal illness had been
adjudged terminal. And some of them had had miraculous results
by going to a physician who was practicing and offering
alternative therapies. And, yet, those physicians were
threatened with the loss of their licenses, as were the
physicians up in Highland Park where they were going to close
the program down, because they said that either they hadn't had
all the paperwork done or it hadn't been proven to the
satisfaction of the governing agencies.
And so I guess my concern is, if a person whose life is in
jeopardy, if their life has been threatened, if they have been
adjudged to be terminal or they have a 50-50 chance to live
over a certain period of time, shouldn't they have the
opportunity to try anything that they really want to to save
their lives? And should government agencies preclude that
possibility by saying if a doctor who has an alternative
therapy that they believe works or has worked on some patients
and hasn't been proven to the satisfaction of the government
agencies, should the government be able to stop that person
from trying that therapy? And that is, I think, something that
all Americans would really be concerned about if it was their
life.
And I will tell you--I don't want to make a big long speech
out of this--but we had the former head of HHS, who was a
friend of mine, I served with him in the Indiana General
Assembly, he was speaker of the house there, that was Dr.
Boehm. Dr. Boehm is a very fine man and a great physician. We
had alternative therapies and procedures we talked about in the
Indiana General Assembly when I was in the legislature there.
And he, supporting the AMA's position and other's positions,
was dead set against those alternatives. I understand that. We
had hundreds of cancer patients who wanted to try these
alternative therapies back in those days. His wife ultimately
became terminally ill with cancer and it is my understanding
that he tried some of the alternative therapies that had not
been proven but had been turned down and looked upon with
disdain by these agencies, the same as what we were talking
about.
The point I am trying to make is, when it is your life,
when it is your loved one's life, when it is someone else's
life in your family that is at stake, you want to do everything
you can to save them. And for a government agency to be so
callous as to say, hey, that hasn't been proven, you are
terminally ill or judged terminally ill, should that agency be
able to say, if a doctor tries to provide this alternative
therapy, we are going to take away his license, thus closing
the door to that person's only alternative to live? I
personally don't think they should.
Mr. Croom. And, because I actually live with people who are
doing this, I am trying to give you a fair answer instead of
maybe quite as direct of what I hear you saying, but let me put
it this way. Again the parallel is alternative therapy. Once I
am at a regular hospital, do you realize how much you have put
me in the fringe and I am seen as not a legitimate physician or
scientist, once you call me that? And that is why I am calling
to remove all the emotional issues and get down to the health
issues, is to say, of course, I have had friends who I won't
describe the therapies I have seen official medicine to do them
for their cancers, that were horrendous.
Mr. Burton. Sure.
Mr. Croom. That were absolutely horrendous. And, yet, the
same highest level institutions, if we go and ask this very
question you are--and I am saying the way that will turn that
around is to say, then, let us say to our most prestigious
places, we want you to evaluate this and then you remove all
the conflict. You remove all the conflict.
But my point to you is, like anything that I have found,
including in science, you need to have someone that is unbiased
and an expert, but also is enough of--I would still say--a
person who would be very careful and fair in the results. It
does not come in a priori, either way. So you can question
that. Because I have those same experiences and I guess that is
what I am pleading with you. Look, I have been asked by the
Canadian Government to evaluate ESSIAC, for example, type
therapies or Hocksy remedies in Mexico.
And I am being honest with you, I left it in the background
because I figure most people don't worry the details like I do.
I am the opposite of the don't worry, make money. I worry,
don't make money. And so, there are a huge amount of things to
actually do it right is why I left it in the checklist in the
last of my testimony. And, believe me, my personal experience
is with things like cancer. That is how thorough I want to be.
I will give you a simple answer. We could say there is this
Chinese medicinal plant that cured malaria. Isn't that enough?
And we have given it to some people and they made a tea and it
cured their malaria. Well, I am going to tell you, that is what
the army thought. And, instead, I went and collected all kinds
of plant lines, got material from where it was originally used
in China. It was only that plant material, only that genetic
line. The stuff here on the Potomac was worthless. You could
have taken the tea all day long and you would have still died,
then, from malaria.
So my point is the same with your cancer and our other
serious things. I have family members that have had Alzheimer's
or Parkinson's, all this. There is another way. We keep
debating this. But let me also say, I want to see Congress
encourage how can we have--there are actually botanicals that
should go IND NDA routes. Nothing has come out the other end of
that door. So, again, my criteria is safe, effective,
affordable, and available. And if you never make it available
to me, then, just like yours, I have created an undoable
situation. Because I believe we have things that will help on
not only cancer, but neuroprotection and other serious
diseases. And some of those, let me say, need to be under a
direct physician's care.
So I hope I am understanding your mission and I appreciate
the opportunity. That is why I am going to leave you with that.
You have many opportunities. It is a great--I would just have
to say blessing--to see what you are having this committee do.
Mr. Burton. Mr. Horn.
Mr. Horn. Thank you very much, Mr. Chairman. I commend you
for holding this series of hearings on alternative medicines
and alternative therapies and other aspects of our health care
in the Nation. Let me start with you if I might, Dr. Croom. I
am curious if you could put together a research focus, what
supplements would you feel deserve that attention at this
point, that are, perhaps, in common use and what hasn't been
done in terms of examining them along the lines you are talking
about?
Mr. Croom. I may later give you a handout I just did at
Harvard that will be there for continuing medical education, I
guess. I would say----
Mr. Horn. Well, we can put that in the record, if you would
like. Without objection, Mr. Chairman.
Mr. Croom. OK. We could do that. Miss Clay has that.
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Mr. Croom. Specifically, let me understand your question. I
must say that I refrained from this because I was getting
concerned that everybody would just want to pick my brain to
say that now if I have an enlarged prostate, is there anything
to supplement, pumpkin seed or what? But I will say, yes.
Mr. Horn. Well, I mean, you have come into contact with a
lot of people. They have a lot of suggestions. They feel some
of it has done well by them. And, in terms of the research
approach, which areas that seem to have a high demand and use
by people, is there a way you can develop a protocol that
research could be done and to see if it really is, is it
chance? Is it just psychology or what?
Mr. Croom. I think you will see there are a number of the
products I think we already know. For example, like saw
palmetto and St. John's wort, that have enough evidence that I
would say that a number of people are going to benefit, OK,
from it. And, certainly, whether you are taking it to just have
a mood elevator or for mild depression, you are going to feel
better. A lot of people have a safer therapy with that.
If you are asking how we would do a research
prioritization, actually, some of mine that I have commented on
is not just selected products. I will be glad to get that back
to you. I would love to.
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Mr. Croom. Part of my focus is to say things just as have
been addressed here. I have been on the FDA working group on
GMPs. We need to increase our knowledge of product definition
and get that over with. What are we buying? What makes good
quality and consistency products? That is the first step, I
think. I think there are a number of significant things that,
again, I would say that if we broadened it to where it was not
thought of as alternative and I am going to be involved in a
NIH conference on liver diseases, for example. It is starting
to progress.
If you as Congressmen just say to NIH, these are serious
and you help us get these answers, they are the experts that
know what are the best liver diseases or worst for retrieval
kidney. If those guys ask us that, then I say we take it one at
a time, like these come and say what are our best shots, what
do we develop? I think that is the most rational approach,
instead of giving you a total checklist. Is that all right?
Mr. Horn. Well, it is a start. I wonder if any other
members of the panel will answer that question? Mr. McCaleb.
Mr. McCaleb. Mr. Chairman, if I could comment on that
subject, I think a rational strategy for deciding what to study
first is to take those things where we have the greatest chance
of success in research, those studies that--those botanicals
that have been well-studied in European studies, but in which
American physicians are saying we need to replicate those in
American studies. I am pleased to see the NIH is doing this
with respect to St. John's wort. I think we will probably find
that is effective. A few more of those to confirm that the
results of European research are valid and maybe we can start
following the European lead in looking at the best researched
of the European phytomedicines and researching those in I would
say a priority order according to what will have the greatest
public health impact.
I appreciate your mentioning the immune stimulation
approach to treating cancer. And, for so many years, medical
science has been locked into a pattern of testing anti
substances. That is, we had antibiotics. We have antivirals. We
have antitumor agents and so on. Immune stimulants or
substances that work with our bodies to help our own immune
systems work more effectively against disease and that is a
part of a wellness approach that I think is going to yield very
great public benefits for us.
Mr. Turner. I think there is an additional point that
should be made and that is that, in addition to the scientific
strategy, there should be a legal policy strategy that goes
along with it, specifically in areas where there is not a
safety question. The period of time that it takes us to gather
the information about a new substance should be a time in which
consumers can have access to that substance while the decision
is being made. And there are many situations in which we are
held back because the FDA and other regulators take the
position that, until we know and can prove that a substance is,
``effective,'' then we should not allow consumers to have
access to it.
I believe that this is a misreading of the efficacy
amendments to the law. When they were made in 1962, it said
that there should be substantial evidence to support efficacy.
Substantial evidence traditionally means more than a scintilla,
but less than a preponderance of evidence. What the law was
designed to do was to oppose fakery or quackery and make claim
for something for which there was no evidence, for which there
was not a scintilla. The public policy change that would
address the point that you were making is to allow people to
have access to situations that are supported by emerging
science that is more than a scintilla, that is some evidence,
but not necessarily enough to establish efficacy.
My belief is that if we could establish that kind of an
approach, we would create a framework for providing social
support behind the kind of science that our two scientists here
have been describing.
Mr. Horn. Anybody else on the panel want to comment on that
question? Ms. Gilhooley.
Ms. Gilhooley. To the extent that this relates to products
that would be sold as drugs with the AIDS crisis FDA has
changed its policy and Congress has enacted a program for fast-
track approval of drugs that deal with life-threatening and
serious conditions. But the manufacturer still has to be in the
process of doing adequate, well-controlled studies and complete
them afterwards.
Mr. Horn. I think a lot of people have felt that if you are
terminally ill, what is wrong with trying it. And the people of
California showed by a majority vote that if you are terminally
ill, you have pain, in the case of many cancer victims, that
you should be allowed to use marijuana. That is a very rational
decision for people.
Ms. Gilhooley. I had a comment on the question before about
people who are terminally ill who want to use products and
maybe alternatives out of the hope that it will help them. And
maybe there really isn't any scientific evidence for it. That
came up with laetrile. It is a long-time issue. It is a very
compelling dilemma. But there is also a concern not to have
people spend all their last money and be taken in by people.
I teach a food and drug course and one of the students in
my class who is a doctor gave me a copy of New Jersey's
provision on laetrile, which is a provision to allow doctors to
administer laetrile, as long as there is a limit on their
making more money out of it and charging more than they would
for their regular payments. And I could supply that to the
committee, if you would like.
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Mr. Horn. I enjoyed reading your testimony. I have got to
ask you a personal question. I knew a Gilhooley in a previous
incarnation and are you any relation to the great Gilhooley who
was Assistant Secretary of Labor under President Eisenhower? He
was also a lawyer.
Ms. Gilhooley. I believe he might be a distant cousin. I
think all of the Gilhooley's come from Leitrim way back in
Ireland. We are all cousins.
Mr. Horn. And they all became lawyers, right? [Laughter.]
Well, I come from the Malones and the McCaffreys and the
McSherries and they all have lawyers as the second cousins
after the first cousins make it. So I just wondered. He was a
very able public servant. Thank you very much. We appreciate
all your testimony.
Mr. Burton. Thank you, Mr. Horn, for that view into your
ancestry. I really appreciate that. [Laughter.]
A lot of lawyers?
Mr. Horn. That is right. I am not one of them.
Mr. Burton. Well, how did you become a university
president?
Mr. Horn. Well, I am not one of them and my son, who
everybody expected to go to law school says, dad, if I go, I
want to just be a prosecutor. [Laughter.]
Mr. Burton. OK. Well, let me just end it by saying to all
of you I really appreciate your testimony today. I think it has
been a real service for the country and people are watching
across the country. And, hopefully, it will give us some
guidance in Congress on how to deal with these problems. And it
will also help us in our work with the Food and Drug
Administration and other health agencies in this country. And I
hope you will all stay in touch with me, even those who
disagree with me. I would really like to have as much input as
possible so that we can make sure that this committee, which
has oversight responsibilities over a lot of these areas, does
its job well.
Thank you very much. This committee stands adjourned.
[Whereupon, at 2:28 p.m., the committee was adjourned.]
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