[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1108 Engrossed in House (EH)]
110th CONGRESS
2d Session
H. R. 1108
_______________________________________________________________________
AN ACT
To protect the public health by providing the Food and Drug
Administration with certain authority to regulate tobacco products.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Family Smoking
Prevention and Tobacco Control Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco
products.
Sec. 105. Tobacco industry concentration.
Sec. 106. Enforcement action plan for advertising and promotion
restrictions.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label
statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the
public.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.
TITLE IV--THRIFT SAVINGS PLAN ENHANCEMENT
Sec. 401. Short title.
Sec. 402. Automatic enrollments.
Sec. 403. Qualified Roth contribution program.
Sec. 404. Authority to establish self-directed investment window.
Sec. 405. Reporting requirements.
Sec. 406. Acknowledgement of risk.
Sec. 407. Credit for unused sick leave.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) The use of tobacco products by the Nation's children is
a pediatric disease of considerable proportions that results in
new generations of tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous and
cause cancer, heart disease, and other serious adverse health
effects.
(3) Nicotine is an addictive drug.
(4) Virtually all new users of tobacco products are under
the minimum legal age to purchase such products.
(5) Tobacco advertising and marketing contribute
significantly to the use of nicotine-containing tobacco
products by adolescents.
(6) Because past efforts to restrict advertising and
marketing of tobacco products have failed adequately to curb
tobacco use by adolescents, comprehensive restrictions on the
sale, promotion, and distribution of such products are needed.
(7) Federal and State governments have lacked the legal and
regulatory authority and resources they need to address
comprehensively the public health and societal problems caused
by the use of tobacco products.
(8) Federal and State public health officials, the public
health community, and the public at large recognize that the
tobacco industry should be subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the
Congress is vested with the responsibility for regulating
interstate commerce and commerce with Indian tribes.
(10) The sale, distribution, marketing, advertising, and
use of tobacco products are activities in and substantially
affecting interstate commerce because they are sold, marketed,
advertised, and distributed in interstate commerce on a
nationwide basis, and have a substantial effect on the Nation's
economy.
(11) The sale, distribution, marketing, advertising, and
use of such products substantially affect interstate commerce
through the health care and other costs attributable to the use
of tobacco products.
(12) It is in the public interest for Congress to enact
legislation that provides the Food and Drug Administration with
the authority to regulate tobacco products and the advertising
and promotion of such products. The benefits to the American
people from enacting such legislation would be significant in
human and economic terms.
(13) Tobacco use is the foremost preventable cause of
premature death in America. It causes over 400,000 deaths in
the United States each year, and approximately 8,600,000
Americans have chronic illnesses related to smoking.
(14) Reducing the use of tobacco by minors by 50 percent
would prevent well over 10,000,000 of today's children from
becoming regular, daily smokers, saving over 3,000,000 of them
from premature death due to tobacco-induced disease. Such a
reduction in youth smoking would also result in approximately
$75,000,000,000 in savings attributable to reduced health care
costs.
(15) Advertising, marketing, and promotion of tobacco
products have been especially directed to attract young persons
to use tobacco products, and these efforts have resulted in
increased use of such products by youth. Past efforts to
oversee these activities have not been successful in adequately
preventing such increased use.
(16) In 2005, the cigarette manufacturers spent more than
$13,000,000,000 to attract new users, retain current users,
increase current consumption, and generate favorable long-term
attitudes toward smoking and tobacco use.
(17) Tobacco product advertising often misleadingly
portrays the use of tobacco as socially acceptable and
healthful to minors.
(18) Tobacco product advertising is regularly seen by
persons under the age of 18, and persons under the age of 18
are regularly exposed to tobacco product promotional efforts.
(19) Through advertisements during and sponsorship of
sporting events, tobacco has become strongly associated with
sports and has become portrayed as an integral part of sports
and the healthy lifestyle associated with rigorous sporting
activity.
(20) Children are exposed to substantial and unavoidable
tobacco advertising that leads to favorable beliefs about
tobacco use, plays a role in leading young people to
overestimate the prevalence of tobacco use, and increases the
number of young people who begin to use tobacco.
(21) The use of tobacco products in motion pictures and
other mass media glamorizes its use for young people and
encourages them to use tobacco products.
(22) Tobacco advertising expands the size of the tobacco
market by increasing consumption of tobacco products including
tobacco use by young people.
(23) Children are more influenced by tobacco marketing than
adults: more than 80 percent of youth smoke three heavily
marketed brands, while only 54 percent of adults, 26 and older,
smoke these same brands.
(24) Tobacco company documents indicate that young people
are an important and often crucial segment of the tobacco
market. Children, who tend to be more price sensitive than
adults, are influenced by advertising and promotion practices
that result in drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will have a
positive effect on the smoking rates of young people.
(26) Restrictions on advertising are necessary to prevent
unrestricted tobacco advertising from undermining legislation
prohibiting access to young people and providing for education
about tobacco use.
(27) International experience shows that advertising
regulations that are stringent and comprehensive have a greater
impact on overall tobacco use and young people's use than
weaker or less comprehensive ones.
(28) Text only requirements, although not as stringent as a
ban, will help reduce underage use of tobacco products while
preserving the informational function of advertising.
(29) It is in the public interest for Congress to adopt
legislation to address the public health crisis created by
actions of the tobacco industry.
(30) The final regulations promulgated by the Secretary of
Health and Human Services in the August 28, 1996, issue of the
Federal Register (61 Fed. Reg. 44615-44618) for inclusion as
part 897 of title 21, Code of Federal Regulations, are
consistent with the first amendment to the United States
Constitution and with the standards set forth in the amendments
made by this subtitle for the regulation of tobacco products by
the Food and Drug Administration, and the restriction on the
sale and distribution of, including access to and the
advertising and promotion of, tobacco products contained in
such regulations are substantially related to accomplishing the
public health goals of this Act.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government's
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences associated
with tobacco use. An overwhelming majority of Americans who use
tobacco products begin using such products while they are
minors and become addicted to the nicotine in those products
before reaching the age of 18. Tobacco advertising and
promotion play a crucial role in the decision of these minors
to begin using tobacco products. Less restrictive and less
comprehensive approaches have not and will not be effective in
reducing the problems addressed by such regulations. The
reasonable restrictions on the advertising and promotion of
tobacco products contained in such regulations will lead to a
significant decrease in the number of minors using and becoming
addicted to those products.
(32) The regulations described in paragraph (30) impose no
more extensive restrictions on communication by tobacco
manufacturers and sellers than are necessary to reduce the
number of children and adolescents who use cigarettes and
smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations are
narrowly tailored to restrict those advertising and promotional
practices which are most likely to be seen or heard by youth
and most likely to entice them into tobacco use, while
affording tobacco manufacturers and sellers ample opportunity
to convey information about their products to adult consumers.
(33) Tobacco dependence is a chronic disease, one that
typically requires repeated interventions to achieve long-term
or permanent abstinence.
(34) Because the only known safe alternative to smoking is
cessation, interventions should target all smokers to help them
quit completely.
(35) Tobacco products have been used to facilitate and
finance criminal activities both domestically and
internationally. Illicit trade of tobacco products has been
linked to organized crime and terrorist groups.
(36) It is essential that the Food and Drug Administration
review products sold or distributed for use to reduce risks or
exposures associated with tobacco products and that it be
empowered to review any advertising and labeling for such
products. It is also essential that manufacturers, prior to
marketing such products, be required to demonstrate that such
products will meet a series of rigorous criteria, and will
benefit the health of the population as a whole, taking into
account both users of tobacco products and persons who do not
currently use tobacco products.
(37) Unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such risks,
those products can cause substantial harm to the public health
to the extent that the individuals, who would otherwise not
consume tobacco products or would consume such products less,
use tobacco products purporting to reduce risk. Those who use
products sold or distributed as modified risk products that do
not in fact reduce risk, rather than quitting or reducing their
use of tobacco products, have a substantially increased
likelihood of suffering disability and premature death. The
costs to society of the widespread use of products sold or
distributed as modified risk products that do not in fact
reduce risk or that increase risk include thousands of
unnecessary deaths and injuries and huge costs to our health
care system.
(38) As the National Cancer Institute has found, many
smokers mistakenly believe that ``low tar'' and ``light''
cigarettes cause fewer health problems than other cigarettes.
As the National Cancer Institute has also found, mistaken
beliefs about the health consequences of smoking ``low tar''
and ``light'' cigarettes can reduce the motivation to quit
smoking entirely and thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been
no reduction in risk on a population-wide basis from ``low
tar'' and ``light'' cigarettes, and such products may actually
increase the risk of tobacco use.
(40) The dangers of products sold or distributed as
modified risk tobacco products that do not in fact reduce risk
are so high that there is a compelling governmental interest in
ensuring that statements about modified risk tobacco products
are complete, accurate, and relate to the overall disease risk
of the product.
(41) As the Federal Trade Commission has found, consumers
have misinterpreted advertisements in which one product is
claimed to be less harmful than a comparable product, even in
the presence of disclosures and advisories intended to provide
clarification.
(42) Permitting manufacturers to make unsubstantiated
statements concerning modified risk tobacco products, whether
express or implied, even if accompanied by disclaimers would be
detrimental to the public health.
(43) The only way to effectively protect the public health
from the dangers of unsubstantiated modified risk tobacco
products is to empower the Food and Drug Administration to
require that products that tobacco manufacturers sold or
distributed for risk reduction be reviewed in advance of
marketing, and to require that the evidence relied on to
support claims be fully verified.
(44) The Food and Drug Administration is a regulatory
agency with the scientific expertise to identify harmful
substances in products to which consumers are exposed, to
design standards to limit exposure to those substances, to
evaluate scientific studies supporting claims about the safety
of products, and to evaluate the impact of labels, labeling,
and advertising on consumer behavior in order to reduce the
risk of harm and promote understanding of the impact of the
product on health. In connection with its mandate to promote
health and reduce the risk of harm, the Food and Drug
Administration routinely makes decisions about whether and how
products may be marketed in the United States.
(45) The Federal Trade Commission was created to protect
consumers from unfair or deceptive acts or practices, and to
regulate unfair methods of competition. Its focus is on those
marketplace practices that deceive or mislead consumers, and
those that give some competitors an unfair advantage. Its
mission is to regulate activities in the marketplace. Neither
the Federal Trade Commission nor any other Federal agency
except the Food and Drug Administration possesses the
scientific expertise needed to implement effectively all
provisions of the Family Smoking Prevention and Tobacco Control
Act.
(46) If manufacturers state or imply in communications
directed to consumers through the media or through a label,
labeling, or advertising, that a tobacco product is approved or
inspected by the Food and Drug Administration or complies with
Food and Drug Administration standards, consumers are likely to
be confused and misled. Depending upon the particular language
used and its context, such a statement could result in
consumers being misled into believing that the product is
endorsed by the Food and Drug Administration for use or in
consumers being misled about the harmfulness of the product
because of such regulation, inspection, approval, or
compliance.
(47) If manufacturers are permitted to state or imply in
communications directed to consumers that a tobacco product is
approved or inspected by the Food and Drug Administration or
complies with Food and Drug Administration standards, consumers
are likely to be confused and misled. Such a statement could
result in consumers being misled into believing that the
product is endorsed by the Food and Drug Administration for use
or in consumers being misled about the harmfulness of the
product because of such regulation, inspection, or compliance.
(48) In August 2006 a United States district court judge
found that the major United States cigarette companies continue
to target and market to youth. USA v Philip Morris, USA, Inc.,
et al. (Civil Action No. 99-2496 (GK), August 17, 2006).
(49) In August 2006 a United States district court judge
found that the major United States cigarette companies
dramatically increased their advertising and promotional
spending in ways that encourage youth to start smoking
subsequent to the signing of the Master Settlement Agreement in
1998. USA v Philip Morris, USA, Inc., et al. (Civil Action No.
99-2496 (GK), August 17, 2006).
(50) In August 2006 a United States district court judge
found that the major United States cigarette companies have
designed their cigarettes to precisely control nicotine
delivery levels and provide doses of nicotine sufficient to
create and sustain addiction while also concealing much of
their nicotine-related research. USA v Philip Morris, USA,
Inc., et al. (Civil Action No. 99-2496 (GK), August 17, 2006).
SEC. 3. PURPOSE.
The purposes of this Act are--
(1) to provide authority to the Food and Drug
Administration to regulate tobacco products under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by
recognizing it as the primary Federal regulatory authority with
respect to the manufacture, marketing, and distribution of
tobacco products as provided for in this Act;
(2) to ensure that the Food and Drug Administration has the
authority to address issues of particular concern to public
health officials, especially the use of tobacco by young people
and dependence on tobacco;
(3) to authorize the Food and Drug Administration to set
national standards controlling the manufacture of tobacco
products and the identity, public disclosure, and amount of
ingredients used in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco
industry's efforts to develop, introduce, and promote less
harmful tobacco products;
(5) to vest the Food and Drug Administration with the
authority to regulate the levels of tar, nicotine, and other
harmful components of tobacco products;
(6) in order to ensure that consumers are better informed,
to require tobacco product manufacturers to disclose research
which has not previously been made available, as well as
research generated in the future, relating to the health and
dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to
adults in conjunction with measures to ensure that they are not
sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the
tobacco industry;
(9) to promote cessation to reduce disease risk and the
social costs associated with tobacco-related diseases; and
(10) to strengthen legislation against illicit trade in
tobacco products.
SEC. 4. SCOPE AND EFFECT.
(a) Intended Effect.--Nothing in this Act (or an amendment made by
this Act) shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action; or
(2) affect any action pending in Federal, State, or Tribal
court, or any agreement, consent decree, or contract of any
kind.
(b) Agricultural Activities.--The provisions of this Act (or an
amendment made by this Act) which authorize the Secretary to take
certain actions with regard to tobacco and tobacco products shall not
be construed to affect any authority of the Secretary of Agriculture
under existing law regarding the growing, cultivation, or curing of raw
tobacco.
(c) Revenue Activities.--The provisions of this Act (or an
amendment made by this Act) which authorize the Secretary to take
certain actions with regard to tobacco products shall not be construed
to affect any authority of the Secretary of the Treasury under chapter
52 of the Internal Revenue Code of 1986.
SEC. 5. SEVERABILITY.
If any provision of this Act, the amendments made by this Act, or
the application of any provision of this Act to any person or
circumstance is held to be invalid, the remainder of this Act, the
amendments made by this Act, and the application of the provisions of
this Act to any other person or circumstance shall not be affected and
shall continue to be enforced to the fullest extent possible.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definition of Tobacco Products.--Section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at
the end the following:
``(rr)(1) The term `tobacco product' means any product made or
derived from tobacco that is intended for human consumption, including
any component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product).
``(2) The term `tobacco product' does not mean an article that is a
drug under subsection (g)(1), a device under subsection (h), or a
combination product described in section 503(g).
``(3) The products described in paragraph (2) shall be subject to
chapter V of this Act.
``(4) A tobacco product may not be marketed in combination with any
other article or product regulated under this Act (including a drug,
biologic, food, cosmetic, medical device, or a dietary supplement).''.
(b) FDA Authority Over Tobacco Products.--The Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 910 as sections
1001 through 1010; and
(3) by inserting after chapter VIII the following:
``CHAPTER IX--TOBACCO PRODUCTS
``SEC. 900. DEFINITIONS.
``In this chapter:
``(1) Additive.--The term `additive' means any substance
the intended use of which results or may reasonably be expected
to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristic of any tobacco
product (including any substances intended for use as a
flavoring or coloring or in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or
holding), except that such term does not include tobacco or a
pesticide chemical residue in or on raw tobacco or a pesticide
chemical.
``(2) Brand.--The term `brand' means a variety of tobacco
product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, packaging,
logo, registered trademark, brand name, identifiable pattern of
colors, or any combination of such attributes.
``(3) Cigarette.--The term `cigarette'--
``(A) means a product that--
``(i) is a tobacco product; and
``(ii) meets the definition of the term
`cigarette' in section 3(1) of the Federal
Cigarette Labeling and Advertising Act; and
``(B) includes tobacco, in any form, that is
functional in the product, which, because of its
appearance, the type of tobacco used in the filler, or
its packaging and labeling, is likely to be offered to,
or purchased by, consumers as a cigarette or as roll-
your-own tobacco.
``(4) Cigarette tobacco.--The term `cigarette tobacco'
means any product that consists of loose tobacco that is
intended for use by consumers in a cigarette. Unless otherwise
stated, the requirements applicable to cigarettes under this
chapter shall also apply to cigarette tobacco.
``(5) Commerce.--The term `commerce' has the meaning given
that term by section 3(2) of the Federal Cigarette Labeling and
Advertising Act.
``(6) Counterfeit tobacco product.--The term `counterfeit
tobacco product' means a tobacco product (or the container or
labeling of such a product) that, without authorization, bears
the trademark, trade name, or other identifying mark, imprint,
or device, or any likeness thereof, of a tobacco product listed
in a registration under section 905(i)(1).
``(7) Distributor.--The term `distributor' as regards a
tobacco product means any person who furthers the distribution
of a tobacco product, whether domestic or imported, at any
point from the original place of manufacture to the person who
sells or distributes the product to individuals for personal
consumption. Common carriers are not considered distributors
for purposes of this chapter.
``(8) Illicit trade.--The term `illicit trade' means any
practice or conduct prohibited by law which relates to
production, shipment, receipt, possession, distribution, sale,
or purchase of tobacco products including any practice or
conduct intended to facilitate such activity.
``(9) Indian tribe.--The term `Indian tribe' has the
meaning given such term in section 4(e) of the Indian Self-
Determination and Education Assistance Act.
``(10) Little cigar.--The term `little cigar' means a
product that--
``(A) is a tobacco product; and
``(B) meets the definition of the term `little
cigar' in section 3(7) of the Federal Cigarette
Labeling and Advertising Act.
``(11) Nicotine.--The term `nicotine' means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or
C[10]H[14]N[2], including any salt or complex of nicotine.
``(12) Package.--The term `package' means a pack, box,
carton, or container of any kind or, if no other container, any
wrapping (including cellophane), in which a tobacco product is
offered for sale, sold, or otherwise distributed to consumers.
``(13) Retailer.--The term `retailer' means any person,
government, or entity who sells tobacco products to individuals
for personal consumption, or who operates a facility where
self-service displays of tobacco products are permitted.
``(14) Roll-your-own tobacco.--The term `roll-your-own
tobacco' means any tobacco product which, because of its
appearance, type, packaging, or labeling, is suitable for use
and likely to be offered to, or purchased by, consumers as
tobacco for making cigarettes.
``(15) Small tobacco product manufacturer.--The term `small
tobacco product manufacturer' means a tobacco product
manufacturer that employs fewer than 350 employees. For
purposes of determining the number of employees of a
manufacturer under the preceding sentence, the employees of a
manufacturer are deemed to include the employees of each entity
that controls, is controlled by, or is under common control
with such manufacturer.
``(16) Smoke constituent.--The term `smoke constituent'
means any chemical or chemical compound in mainstream or
sidestream tobacco smoke that either transfers from any
component of the cigarette to the smoke or that is formed by
the combustion or heating of tobacco, additives, or other
component of the tobacco product.
``(17) Smokeless tobacco.--The term `smokeless tobacco'
means any tobacco product that consists of cut, ground,
powdered, or leaf tobacco and that is intended to be placed in
the oral or nasal cavity.
``(18) State; territory.--The terms `State' and `Territory'
shall have the meanings given to such terms in section 201.
``(19) Tobacco product manufacturer.--The term `tobacco
product manufacturer' means any person, including any repacker
or relabeler, who--
``(A) manufactures, fabricates, assembles,
processes, or labels a tobacco product; or
``(B) imports a finished tobacco product for sale
or distribution in the United States.
``(20) Tobacco warehouse.--
``(A) Subject to subparagraphs (B) and (C), the
term `tobacco warehouse' includes any person--
``(i) who--
``(I) removes foreign material from
tobacco leaf through nothing other than
a mechanical process;
``(II) humidifies tobacco leaf with
nothing other than potable water in the
form of steam or mist; or
``(III) de-stems, dries, and packs
tobacco leaf for storage and shipment;
``(ii) who performs no other actions with
respect to tobacco leaf; and
``(iii) who provides to any manufacturer to
whom the person sells tobacco all information
related to the person's actions described in
clause (i) that is necessary for compliance
with this Act.
``(B) The term `tobacco warehouse' excludes any
person who--
``(i) reconstitutes tobacco leaf;
``(ii) is a manufacturer, distributor, or
retailer of a tobacco product; or
``(iii) applies any chemical, additive, or
substance to the tobacco leaf other than
potable water in the form of steam or mist.
``(C) The definition of the term `tobacco
warehouse' in subparagraph (A) shall not apply to the
extent to which the Secretary determines, through
rulemaking, that regulation under this chapter of the
actions described in such subparagraph is appropriate
for the protection of the public health.
``(21) United states.--The term `United States' means the
50 States of the United States of America and the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands, American Samoa, Wake Island, Midway Islands, Kingman
Reef, Johnston Atoll, the Northern Mariana Islands, and any
other trust territory or possession of the United States.
``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
``(a) In General.--Tobacco products, including modified risk
tobacco products for which an order has been issued in accordance with
section 911, shall be regulated by the Secretary under this chapter and
shall not be subject to the provisions of chapter V.
``(b) Applicability.--This chapter shall apply to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to
any other tobacco products that the Secretary by regulation deems to be
subject to this chapter.
``(c) Scope.--
``(1) In general.--Nothing in this chapter, or any policy
issued or regulation promulgated thereunder, or in sections
101(a), 102, or 103 of title I, title II, or title III of the
Family Smoking Prevention and Tobacco Control Act, shall be
construed to affect, expand, or limit the Secretary's authority
over (including the authority to determine whether products may
be regulated), or the regulation of, products under this Act
that are not tobacco products under chapter V or any other
chapter.
``(2) Limitation of authority.--
``(A) In general.--The provisions of this chapter
shall not apply to tobacco leaf that is not in the
possession of a manufacturer of tobacco products, or to
the producers of tobacco leaf, including tobacco
growers, tobacco warehouses, and tobacco grower
cooperatives, nor shall any employee of the Food and
Drug Administration have any authority to enter onto a
farm owned by a producer of tobacco leaf without the
written consent of such producer.
``(B) Exception.--Notwithstanding subparagraph (A),
if a producer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product
manufacturer, the producer shall be subject to this
chapter in the producer's capacity as a manufacturer.
The exception in this subparagraph shall not apply to a
producer of tobacco leaf who grows tobacco under a
contract with a tobacco product manufacturer and who is
not otherwise engaged in the manufacturing process.
``(C) Rule of construction.--Nothing in this
chapter shall be construed to grant the Secretary
authority to promulgate regulations on any matter that
involves the production of tobacco leaf or a producer
thereof, other than activities by a manufacturer
affecting production.
``(d) Rulemaking Procedures.--Each rulemaking under this chapter
shall be in accordance with chapter 5 of title 5, United States Code.
This subsection shall not be construed to affect the rulemaking
provisions of section 102(a) of the Family Smoking Prevention and
Tobacco Control Act.
``(e) Center for Tobacco Products.--Not later than 90 days after
the date of enactment of this chapter, the Secretary shall establish
within the Food and Drug Administration the Center for Tobacco
Products, which shall report to the Commissioner of Food and Drugs in
the same manner as the other agency centers within the Food and Drug
Administration. The Center shall be responsible for the implementation
of this chapter and related matters assigned by the Commissioner.
``(f) Office to Assist Small Tobacco Product Manufacturers.--The
Secretary shall establish within the Food and Drug Administration an
identifiable office to provide technical and other nonfinancial
assistance to small tobacco product manufacturers to assist them in
complying with the requirements of this Act.
``(g) Consultation Prior to Rulemaking.--Prior to promulgating
rules under this chapter, the Secretary shall endeavor to consult with
other Federal agencies as appropriate.
``SEC. 902. ADULTERATED TOBACCO PRODUCTS.
``A tobacco product shall be deemed to be adulterated if--
``(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise contaminated
by any added poisonous or added deleterious substance that may
render the product injurious to health;
``(2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to
health;
``(3) its package is composed, in whole or in part, of any
poisonous or deleterious substance which may render the
contents injurious to health;
``(4) the manufacturer or importer of the tobacco product
fails to pay a user fee assessed to such manufacturer or
importer pursuant to section 919 by the date specified in
section 919 or by the 30th day after final agency action on a
resolution of any dispute as to the amount of such fee;
``(5) it is, or purports to be or is represented as, a
tobacco product which is subject to a tobacco product standard
established under section 907 unless such tobacco product is in
all respects in conformity with such standard;
``(6)(A) it is required by section 910(a) to have premarket
review and does not have an order in effect under section
910(c)(1)(A)(i); or
``(B) it is in violation of an order under section
910(c)(1)(A);
``(7) the methods used in, or the facilities or controls
used for, its manufacture, packing, or storage are not in
conformity with applicable requirements under section 906(e)(1)
or an applicable condition prescribed by an order under section
906(e)(2); or
``(8) it is in violation of section 911.
``SEC. 903. MISBRANDED TOBACCO PRODUCTS.
``(a) In General.--A tobacco product shall be deemed to be
misbranded--
``(1) if its labeling is false or misleading in any
particular;
``(2) if in package form unless it bears a label
containing--
``(A) the name and place of business of the tobacco
product manufacturer, packer, or distributor;
``(B) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical
count;
``(C) an accurate statement of the percentage of
the tobacco used in the product that is domestically
grown tobacco and the percentage that is foreign grown
tobacco; and
``(D) the statement required under section 920(a),
except that under subparagraph (B) reasonable variations shall
be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary;
``(3) if any word, statement, or other information required
by or under authority of this chapter to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements, or
designs in the labeling) and in such terms as to render it
likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
``(4) if it has an established name, unless its label
bears, to the exclusion of any other nonproprietary name, its
established name prominently printed in type as required by the
Secretary by regulation;
``(5) if the Secretary has issued regulations requiring
that its labeling bear adequate directions for use, or adequate
warnings against use by children, that are necessary for the
protection of users unless its labeling conforms in all
respects to such regulations;
``(6) if it was manufactured, prepared, propagated,
compounded, or processed in an establishment not duly
registered under section 905(b), 905(c), 905(d), or 905(h), if
it was not included in a list required by section 905(i), if a
notice or other information respecting it was not provided as
required by such section or section 905(j), or if it does not
bear such symbols from the uniform system for identification of
tobacco products prescribed under section 905(e) as the
Secretary by regulation requires;
``(7) if, in the case of any tobacco product distributed or
offered for sale in any State--
``(A) its advertising is false or misleading in any
particular; or
``(B) it is sold or distributed in violation of
regulations prescribed under section 906(d);
``(8) unless, in the case of any tobacco product
distributed or offered for sale in any State, the manufacturer,
packer, or distributor thereof includes in all advertisements
and other descriptive printed matter issued or caused to be
issued by the manufacturer, packer, or distributor with respect
to that tobacco product--
``(A) a true statement of the tobacco product's
established name as described in paragraph (4), printed
prominently; and
``(B) a brief statement of--
``(i) the uses of the tobacco product and
relevant warnings, precautions, side effects,
and contraindications; and
``(ii) in the case of specific tobacco
products made subject to a finding by the
Secretary after notice and opportunity for
comment that such action is appropriate to
protect the public health, a full description
of the components of such tobacco product or
the formula showing quantitatively each
ingredient of such tobacco product to the
extent required in regulations which shall be
issued by the Secretary after an opportunity
for a hearing;
``(9) if it is a tobacco product subject to a tobacco
product standard established under section 907, unless it bears
such labeling as may be prescribed in such tobacco product
standard; or
``(10) if there was a failure or refusal--
``(A) to comply with any requirement prescribed
under section 904 or 908; or
``(B) to furnish any material or information
required under section 909.
``(b) Prior Approval of Label Statements.--The Secretary may, by
regulation, require prior approval of statements made on the label of a
tobacco product. No regulation issued under this subsection may require
prior approval by the Secretary of the content of any advertisement,
except for modified risk tobacco products as provided in section 911.
No advertisement of a tobacco product published after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act
shall, with respect to the language of label statements as prescribed
under section 4 of the Federal Cigarette Labeling and Advertising Act
and section 3 of the Comprehensive Smokeless Tobacco Health Education
Act of 1986 or the regulations issued under such sections, be subject
to the provisions of sections 12 through 15 of the Federal Trade
Commission Act.
``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.
``(a) Requirement.--Each tobacco product manufacturer or importer,
or agents thereof, shall submit to the Secretary the following
information:
``(1) Not later than 6 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act, a
listing of all ingredients, including tobacco, substances,
compounds, and additives that are, as of such date, added by
the manufacturer to the tobacco, paper, filter, or other part
of each tobacco product by brand and by quantity in each brand
and subbrand.
``(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Secretary in accordance with section 4(e) of the Federal
Cigarette Labeling and Advertising Act.
``(3) Beginning 3 years after the date of enactment of this
Act, a listing of all constituents, including smoke
constituents as applicable, identified by the Secretary as
harmful or potentially harmful to health in each tobacco
product, and as applicable in the smoke of each tobacco
product, by brand and by quantity in each brand and subbrand.
Effective beginning 3 years after the date of enactment of this
chapter, the manufacturer, importer, or agent shall comply with
regulations promulgated under section 915 in reporting
information under this paragraph, where applicable.
``(4) Beginning 6 months after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, all
documents developed after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act that relate to
health, toxicological, behavioral, or physiologic effects of
current or future tobacco products, their constituents
(including smoke constituents), ingredients, components, and
additives.
``(b) Data Submission.--At the request of the Secretary, each
tobacco product manufacturer or importer of tobacco products, or agents
thereof, shall submit the following:
``(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) on the health, toxicological,
behavioral, or physiologic effects of tobacco products and
their constituents (including smoke constituents), ingredients,
components, and additives.
``(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) that relate to the issue of
whether a reduction in risk to health from tobacco products can
occur upon the employment of technology available or known to
the manufacturer.
``(3) Any or all documents (including underlying scientific
or financial information) relating to marketing research
involving the use of tobacco products or marketing practices
and the effectiveness of such practices used by tobacco
manufacturers and distributors.
An importer of a tobacco product not manufactured in the United States
shall supply the information required of a tobacco product manufacturer
under this subsection.
``(c) Time for Submission.--
``(1) In general.--At least 90 days prior to the delivery
for introduction into interstate commerce of a tobacco product
not on the market on the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the manufacturer of
such product shall provide the information required under
subsection (a).
``(2) Disclosure of additive.--If at any time a tobacco
product manufacturer adds to its tobacco products a new tobacco
additive or increases the quantity of an existing tobacco
additive, the manufacturer shall, except as provided in
paragraph (3), at least 90 days prior to such action so advise
the Secretary in writing.
``(3) Disclosure of other actions.--If at any time a
tobacco product manufacturer eliminates or decreases an
existing additive, or adds or increases an additive that has by
regulation been designated by the Secretary as an additive that
is not a human or animal carcinogen, or otherwise harmful to
health under intended conditions of use, the manufacturer shall
within 60 days of such action so advise the Secretary in
writing.
``(d) Data List.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act, and annually thereafter, the Secretary shall publish in a
format that is understandable and not misleading to a lay
person, and place on public display (in a manner determined by
the Secretary) the list established under subsection (e).
``(2) Consumer research.--The Secretary shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay persons. Not later
than 5 years after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary shall submit
to the appropriate committees of Congress a report on the
results of such research, together with recommendations on
whether such publication should be continued or modified.
``(e) Data Collection.--Not later than 24 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act, the
Secretary shall establish, and periodically revise as appropriate, a
list of harmful and potentially harmful constituents, including smoke
constituents, to health in each tobacco product by brand and by
quantity in each brand and subbrand. The Secretary shall publish a
public notice requesting the submission by interested persons of
scientific and other information concerning the harmful and potentially
harmful constituents in tobacco products and tobacco smoke.
``SEC. 905. ANNUAL REGISTRATION.
``(a) Definitions.--In this section:
``(1) Manufacture, preparation, compounding, or
processing.--The term `manufacture, preparation, compounding,
or processing' shall include repackaging or otherwise changing
the container, wrapper, or labeling of any tobacco product
package in furtherance of the distribution of the tobacco
product from the original place of manufacture to the person
who makes final delivery or sale to the ultimate consumer or
user.
``(2) Name.--The term `name' shall include in the case of a
partnership the name of each partner and, in the case of a
corporation, the name of each corporate officer and director,
and the State of incorporation.
``(b) Registration by Owners and Operators.--On or before December
31 of each year, every person who owns or operates any establishment in
any State engaged in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products shall register with
the Secretary the name, places of business, and all such establishments
of that person. If the enactment of this Act occurs in the second half
of the calendar year, the Secretary shall designate a date no later
than 6 months into the subsequent calendar year by which registration
pursuant to this subsection shall occur.
``(c) Registration by New Owners and Operators.--Every person upon
first engaging in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products in any
establishment owned or operated in any State by that person shall
immediately register with the Secretary that person's name, place of
business, and such establishment.
``(d) Registration of Added Establishments.--Every person required
to register under subsection (b) or (c) shall immediately register with
the Secretary any additional establishment which that person owns or
operates in any State and in which that person begins the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco
products.
``(e) Uniform Product Identification System.--The Secretary may by
regulation prescribe a uniform system for the identification of tobacco
products and may require that persons who are required to list such
tobacco products under subsection (i) shall list such tobacco products
in accordance with such system.
``(f) Public Access to Registration Information.--The Secretary
shall make available for inspection, to any person so requesting, any
registration filed under this section.
``(g) Biennial Inspection of Registered Establishments.--Every
establishment registered with the Secretary under this section shall be
subject to inspection under section 704 or subsection (h), and every
such establishment engaged in the manufacture, compounding, or
processing of a tobacco product or tobacco products shall be so
inspected by 1 or more officers or employees duly designated by the
Secretary at least once in the 2-year period beginning with the date of
registration of such establishment under this section and at least once
in every successive 2-year period thereafter.
``(h) Registration by Foreign Establishments.--Any establishment
within any foreign country engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products,
shall register under this section under regulations promulgated by the
Secretary. Such regulations shall require such establishment to provide
the information required by subsection (i) and shall include provisions
for registration of any such establishment upon condition that adequate
and effective means are available, by arrangement with the government
of such foreign country or otherwise, to enable the Secretary to
determine from time to time whether tobacco products manufactured,
prepared, compounded, or processed in such establishment, if imported
or offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 801(a).
``(i) Registration Information.--
``(1) Product list.--Every person who registers with the
Secretary under subsection (b), (c), (d), or (h) shall, at the
time of registration under any such subsection, file with the
Secretary a list of all tobacco products which are being
manufactured, prepared, compounded, or processed by that person
for commercial distribution and which have not been included in
any list of tobacco products filed by that person with the
Secretary under this paragraph or paragraph (2) before such
time of registration. Such list shall be prepared in such form
and manner as the Secretary may prescribe and shall be
accompanied by--
``(A) in the case of a tobacco product contained in
the applicable list with respect to which a tobacco
product standard has been established under section 907
or which is subject to section 910, a reference to the
authority for the marketing of such tobacco product and
a copy of all labeling for such tobacco product;
``(B) in the case of any other tobacco product
contained in an applicable list, a copy of all consumer
information and other labeling for such tobacco
product, a representative sampling of advertisements
for such tobacco product, and, upon request made by the
Secretary for good cause, a copy of all advertisements
for a particular tobacco product; and
``(C) if the registrant filing a list has
determined that a tobacco product contained in such
list is not subject to a tobacco product standard
established under section 907, a brief statement of the
basis upon which the registrant made such determination
if the Secretary requests such a statement with respect
to that particular tobacco product.
``(2) Consultation with respect to forms.--The Secretary
shall consult with the Secretary of the Treasury in developing
the forms to be used for registration under this section to
minimize the burden on those persons required to register with
both the Secretary and the Tax and Trade Bureau of the
Department of the Treasury.
``(3) Biannual report of any change in product list.--Each
person who registers with the Secretary under this section
shall report to the Secretary once during the month of June of
each year and once during the month of December of each year
the following:
``(A) A list of each tobacco product introduced by
the registrant for commercial distribution which has
not been included in any list previously filed by that
person with the Secretary under this subparagraph or
paragraph (1). A list under this subparagraph shall
list a tobacco product by its established name and
shall be accompanied by the other information required
by paragraph (1).
``(B) If since the date the registrant last made a
report under this paragraph that person has
discontinued the manufacture, preparation, compounding,
or processing for commercial distribution of a tobacco
product included in a list filed under subparagraph (A)
or paragraph (1), notice of such discontinuance, the
date of such discontinuance, and the identity of its
established name.
``(C) If since the date the registrant reported
under subparagraph (B) a notice of discontinuance that
person has resumed the manufacture, preparation,
compounding, or processing for commercial distribution
of the tobacco product with respect to which such
notice of discontinuance was reported, notice of such
resumption, the date of such resumption, the identity
of such tobacco product by established name, and other
information required by paragraph (1), unless the
registrant has previously reported such resumption to
the Secretary under this subparagraph.
``(D) Any material change in any information
previously submitted under this paragraph or paragraph
(1).
``(j) Report Preceding Introduction of Certain Substantially
Equivalent Products Into Interstate Commerce.--
``(1) In general.--Each person who is required to register
under this section and who proposes to begin the introduction
or delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for human
use that was not commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, shall,
at least 90 days prior to making such introduction or delivery,
report to the Secretary (in such form and manner as the
Secretary shall prescribe)--
``(A) the basis for such person's determination
that--
``(i) the tobacco product is substantially
equivalent, within the meaning of section 910,
to a tobacco product commercially marketed
(other than for test marketing) in the United
States as of February 15, 2007, or to a tobacco
product that the Secretary has previously
determined, pursuant to subsection (a)(3) of
section 910, is substantially equivalent and
that is in compliance with the requirements of
this Act; or
``(ii) the tobacco product is modified
within the meaning of paragraph (3), the
modifications are to a product that is
commercially marketed and in compliance with
the requirements of this Act, and all of the
modifications are covered by exemptions granted
by the Secretary pursuant to paragraph (3); and
``(B) action taken by such person to comply with
the requirements under section 907 that are applicable
to the tobacco product.
``(2) Application to certain post-february 15, 2007,
products.--A report under this subsection for a tobacco product
that was first introduced or delivered for introduction into
interstate commerce for commercial distribution in the United
States after February 15, 2007, and prior to the date that is
21 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act shall be submitted to the
Secretary not later than 21 months after such date of
enactment.
``(3) Exemptions.--
``(A) In general.--The Secretary may exempt from
the requirements of this subsection relating to the
demonstration that a tobacco product is substantially
equivalent within the meaning of section 910, tobacco
products that are modified by adding or deleting a
tobacco additive, or increasing or decreasing the
quantity of an existing tobacco additive, if the
Secretary determines that--
``(i) such modification would be a minor
modification of a tobacco product that can be
sold under this Act;
``(ii) a report under this subsection is
not necessary to ensure that permitting the
tobacco product to be marketed would be
appropriate for protection of the public
health; and
``(iii) an exemption is otherwise
appropriate.
``(B) Regulations.--Not later than 15 months after
the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, the Secretary shall issue
regulations to implement this paragraph.
``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.
``(a) In General.--Any requirement established by or under section
902, 903, 905, or 909 applicable to a tobacco product shall apply to
such tobacco product until the applicability of the requirement to the
tobacco product has been changed by action taken under section 907,
section 910, section 911, or subsection (d) of this section, and any
requirement established by or under section 902, 903, 905, or 909 which
is inconsistent with a requirement imposed on such tobacco product
under section 907, section 910, section 911, or subsection (d) of this
section shall not apply to such tobacco product.
``(b) Information on Public Access and Comment.--Each notice of
proposed rulemaking or other notification under section 907, 908, 909,
910, or 911 or under this section, any other notice which is published
in the Federal Register with respect to any other action taken under
any such section and which states the reasons for such action, and each
publication of findings required to be made in connection with
rulemaking under any such section shall set forth--
``(1) the manner in which interested persons may examine
data and other information on which the notice or findings is
based; and
``(2) the period within which interested persons may
present their comments on the notice or findings (including the
need therefore) orally or in writing, which period shall be at
least 60 days but may not exceed 90 days unless the time is
extended by the Secretary by a notice published in the Federal
Register stating good cause therefore.
``(c) Limited Confidentiality of Information.--Any information
reported to or otherwise obtained by the Secretary or the Secretary's
representative under section 903, 904, 907, 908, 909, 910, 911, or 704,
or under subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5, United
States Code, by reason of subsection (b)(4) of that section shall be
considered confidential and shall not be disclosed, except that the
information may be disclosed to other officers or employees concerned
with carrying out this chapter, or when relevant in any proceeding
under this chapter.
``(d) Restrictions.--
``(1) In general.--The Secretary may by regulation require
restrictions on the sale and distribution of a tobacco product,
including restrictions on the access to, and the advertising
and promotion of, the tobacco product, if the Secretary
determines that such regulation would be appropriate for the
protection of the public health. The Secretary may by
regulation impose restrictions on the advertising and promotion
of a tobacco product consistent with and to full extent
permitted by the first amendment to the Constitution. The
finding as to whether such regulation would be appropriate for
the protection of the public health shall be determined with
respect to the risks and benefits to the population as a whole,
including users and nonusers of the tobacco product, and taking
into account--
``(A) the increased or decreased likelihood that
existing users of tobacco products will stop using such
products; and
``(B) the increased or decreased likelihood that
those who do not use tobacco products will start using
such products.
No such regulation may require that the sale or distribution of
a tobacco product be limited to the written or oral
authorization of a practitioner licensed by law to prescribe
medical products.
``(2) Label statements.--The label of a tobacco product
shall bear such appropriate statements of the restrictions
required by a regulation under subsection (a) as the Secretary
may in such regulation prescribe.
``(3) Limitations.--
``(A) In general.--No restrictions under paragraph
(1) may--
``(i) prohibit the sale of any tobacco
product in face-to-face transactions by a
specific category of retail outlets; or
``(ii) establish a minimum age of sale of
tobacco products to any person older than 18
years of age.
``(B) Matchbooks.--For purposes of any regulations
issued by the Secretary, matchbooks of conventional
size containing not more than 20 paper matches, and
which are customarily given away for free with the
purchase of tobacco products, shall be considered as
adult-written publications which shall be permitted to
contain advertising. Notwithstanding the preceding
sentence, if the Secretary finds that such treatment of
matchbooks is not appropriate for the protection of the
public health, the Secretary may determine by
regulation that matchbooks shall not be considered
adult-written publications.
``(4) Remote sales.--
``(A) In general.--The Secretary shall--
``(i) within 18 months after the date of
enactment of this chapter, promulgate
regulations regarding the sale and distribution
of tobacco products that occur through means
other than a direct, face-to-face exchange
between a retailer and a consumer in order to
prevent the sale and distribution of tobacco
products to individuals who have not attained
the minimum age established by applicable law
for the purchase of such products, including
requirements for age verification; and
``(ii) within 2 years after such date of
enactment, issue regulations to address the
promotion and marketing of tobacco products
that are sold or distributed through means
other than a direct, face-to-face exchange
between a retailer and a consumer in order to
protect individuals who have not attained the
minimum age established by applicable law for
the purchase of such products.
``(B) Relation to other authority.--Nothing in this
paragraph limits the authority of the Secretary to take
additional actions under the other paragraphs of this
subsection.
``(e) Good Manufacturing Practice Requirements.--
``(1) Methods, facilities, and controls to conform.--
``(A) In general.--In applying manufacturing
restrictions to tobacco, the Secretary shall, in
accordance with subparagraph (B), prescribe regulations
(which may differ based on the type of tobacco product
involved) requiring that the methods used in, and the
facilities and controls used for, the manufacture,
preproduction design validation (including a process to
assess the performance of a tobacco product), packing,
and storage of a tobacco product conform to current
good manufacturing practice, or hazard analysis and
critical control point methodology, as prescribed in
such regulations to assure that the public health is
protected and that the tobacco product is in compliance
with this chapter. Such regulations may provide for the
testing of raw tobacco for pesticide chemical residues
regardless of whether a tolerance for such chemical
residues has been established.
``(B) Requirements.--The Secretary shall--
``(i) before promulgating any regulation
under subparagraph (A), afford the Tobacco
Products Scientific Advisory Committee an
opportunity to submit recommendations with
respect to the regulation proposed to be
promulgated;
``(ii) before promulgating any regulation
under subparagraph (A), afford opportunity for
an oral hearing;
``(iii) provide the Tobacco Products
Scientific Advisory Committee a reasonable time
to make its recommendation with respect to
proposed regulations under subparagraph (A);
``(iv) in establishing the effective date
of a regulation promulgated under this
subsection, take into account the differences
in the manner in which the different types of
tobacco products have historically been
produced, the financial resources of the
different tobacco product manufacturers, and
the state of their existing manufacturing
facilities, and shall provide for a reasonable
period of time for such manufacturers to
conform to good manufacturing practices; and
``(v) not require any small tobacco product
manufacturer to comply with a regulation under
subparagraph (A) for at least 4 years following
the effective date established by the Secretary
for such regulation.
``(2) Exemptions; variances.--
``(A) Petition.--Any person subject to any
requirement prescribed under paragraph (1) may petition
the Secretary for a permanent or temporary exemption or
variance from such requirement. Such a petition shall
be submitted to the Secretary in such form and manner
as the Secretary shall prescribe and shall--
``(i) in the case of a petition for an
exemption from a requirement, set forth the
basis for the petitioner's determination that
compliance with the requirement is not required
to assure that the tobacco product will be in
compliance with this chapter;
``(ii) in the case of a petition for a
variance from a requirement, set forth the
methods proposed to be used in, and the
facilities and controls proposed to be used
for, the manufacture, packing, and storage of
the tobacco product in lieu of the methods,
facilities, and controls prescribed by the
requirement; and
``(iii) contain such other information as
the Secretary shall prescribe.
``(B) Referral to the tobacco products scientific
advisory committee.--The Secretary may refer to the
Tobacco Products Scientific Advisory Committee any
petition submitted under subparagraph (A). The Tobacco
Products Scientific Advisory Committee shall report its
recommendations to the Secretary with respect to a
petition referred to it within 60 days after the date
of the petition's referral. Within 60 days after--
``(i) the date the petition was submitted
to the Secretary under subparagraph (A); or
``(ii) the day after the petition was
referred to the Tobacco Products Scientific
Advisory Committee,
whichever occurs later, the Secretary shall by order
either deny the petition or approve it.
``(C) Approval.--The Secretary may approve--
``(i) a petition for an exemption for a
tobacco product from a requirement if the
Secretary determines that compliance with such
requirement is not required to assure that the
tobacco product will be in compliance with this
chapter; and
``(ii) a petition for a variance for a
tobacco product from a requirement if the
Secretary determines that the methods to be
used in, and the facilities and controls to be
used for, the manufacture, packing, and storage
of the tobacco product in lieu of the methods,
facilities, and controls prescribed by the
requirement are sufficient to assure that the
tobacco product will be in compliance with this
chapter.
``(D) Conditions.--An order of the Secretary
approving a petition for a variance shall prescribe
such conditions respecting the methods used in, and the
facilities and controls used for, the manufacture,
packing, and storage of the tobacco product to be
granted the variance under the petition as may be
necessary to assure that the tobacco product will be in
compliance with this chapter.
``(E) Hearing.--After the issuance of an order
under subparagraph (B) respecting a petition, the
petitioner shall have an opportunity for an informal
hearing on such order.
``(3) Compliance.--Compliance with requirements under this
subsection shall not be required before the end of the 3-year
period following the date of enactment of the Family Smoking
Prevention and Tobacco Control Act.
``(f) Research and Development.--The Secretary may enter into
contracts for research, testing, and demonstrations respecting tobacco
products and may obtain tobacco products for research, testing, and
demonstration purposes.
``SEC. 907. TOBACCO PRODUCT STANDARDS.
``(a) In General.--
``(1) Special rules.--
``(A) Special rule for cigarettes.--Beginning 3
months after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, a cigarette
or any of its component parts (including the tobacco,
filter, or paper) shall not contain, as a constituent
(including a smoke constituent) or additive, an
artificial or natural flavor (other than tobacco or
menthol) or an herb or spice, including strawberry,
grape, orange, clove, cinnamon, pineapple, vanilla,
coconut, licorice, cocoa, chocolate, cherry, or coffee,
that is a characterizing flavor of the tobacco product
or tobacco smoke. Nothing in this subparagraph shall be
construed to limit the Secretary's authority to take
action under this section or other sections of this Act
applicable to menthol or any artificial or natural
flavor, herb, or spice not specified in this
subparagraph.
``(B) Additional special rule.--A tobacco product
manufactured in or imported into the United States
shall not contain foreign-grown tobacco that--
``(i) was grown or processed using a
pesticide chemical that is not approved under
applicable Federal law for use in domestic
tobacco farming and processing; or
``(ii) in the case of a pesticide chemical
that is so approved, was grown or processed
using the pesticide chemical in a manner
inconsistent with the approved labeling for use
of the pesticide chemical in domestic tobacco
farming and processing.
``(2) Revision of tobacco product standards.--The Secretary
may revise the tobacco product standards in paragraph (1) in
accordance with subsection (c).
``(3) Tobacco product standards.--
``(A) In general.--The Secretary may adopt tobacco
product standards in addition to those in paragraph (1)
if the Secretary finds that a tobacco product standard
is appropriate for the protection of the public health.
``(B) Determinations.--
``(i) Considerations.--In making a finding
described in subparagraph (A), the Secretary
shall consider scientific evidence concerning--
``(I) the risks and benefits to the
population as a whole, including users
and nonusers of tobacco products, of
the proposed standard;
``(II) the increased or decreased
likelihood that existing users of
tobacco products will stop using such
products; and
``(III) the increased or decreased
likelihood that those who do not use
tobacco products will start using such
products.
``(ii) Additional considerations.--In the
event that the Secretary makes a determination,
set forth in a proposed tobacco product
standard in a proposed rule, that it is
appropriate for the protection of public health
to require the reduction or elimination of an
additive, constituent (including a smoke
constituent), or other component of a tobacco
product because the Secretary has found that
the additive, constituent, or other component
is or may be harmful, any party objecting to
the proposed standard on the ground that the
proposed standard will not reduce or eliminate
the risk of illness or injury may provide for
the Secretary's consideration scientific
evidence that demonstrates that the proposed
standard will not reduce or eliminate the risk
of illness or injury.
``(4) Content of tobacco product standards.--A tobacco
product standard established under this section for a tobacco
product--
``(A) shall include provisions that are appropriate
for the protection of the public health, including
provisions, where appropriate--
``(i) for nicotine yields of the product;
``(ii) for the reduction or elimination of
other constituents, including smoke
constituents, or harmful components of the
product; or
``(iii) relating to any other requirement
under subparagraph (B);
``(B) shall, where appropriate for the protection
of the public health, include--
``(i) provisions respecting the
construction, components, ingredients,
additives, constituents, including smoke
constituents, and properties of the tobacco
product;
``(ii) provisions for the testing (on a
sample basis or, if necessary, on an individual
basis) of the tobacco product;
``(iii) provisions for the measurement of
the tobacco product characteristics of the
tobacco product;
``(iv) provisions requiring that the
results of each or of certain of the tests of
the tobacco product required to be made under
clause (ii) show that the tobacco product is in
conformity with the portions of the standard
for which the test or tests were required; and
``(v) a provision requiring that the sale
and distribution of the tobacco product be
restricted but only to the extent that the sale
and distribution of a tobacco product may be
restricted under a regulation under section
906(d);
``(C) shall, where appropriate, require the use and
prescribe the form and content of labeling for the
proper use of the tobacco product; and
``(D) shall require tobacco products containing
foreign-grown tobacco to meet the same standards
applicable to tobacco products containing domestically
grown tobacco.
``(5) Periodic reevaluation of tobacco product standards.--
The Secretary shall provide for periodic evaluation of tobacco
product standards established under this section to determine
whether such standards should be changed to reflect new
medical, scientific, or other technological data. The Secretary
may provide for testing under paragraph (4)(B) by any person.
``(6) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Secretary shall
endeavor to--
``(A) use personnel, facilities, and other
technical support available in other Federal agencies;
``(B) consult with other Federal agencies concerned
with standard setting and other nationally or
internationally recognized standard-setting entities;
and
``(C) invite appropriate participation, through
joint or other conferences, workshops, or other means,
by informed persons representative of scientific,
professional, industry, agricultural, or consumer
organizations who in the Secretary's judgment can make
a significant contribution.
``(b) Considerations by Secretary.--
``(1) Technical achievability.--The Secretary shall
consider information submitted in connection with a proposed
standard regarding the technical achievability of compliance
with such standard.
``(2) Other considerations.--The Secretary shall consider
all other information submitted in connection with a proposed
standard, including information concerning the countervailing
effects of the tobacco product standard on the health of
adolescent tobacco users, adult tobacco users, or nontobacco
users, such as the creation of a significant demand for
contraband or other tobacco products that do not meet the
requirements of this chapter and the significance of such
demand.
``(c) Proposed Standards.--
``(1) In general.--The Secretary shall publish in the
Federal Register a notice of proposed rulemaking for the
establishment, amendment, or revocation of any tobacco product
standard.
``(2) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a tobacco
product standard for a tobacco product shall--
``(A) set forth a finding with supporting
justification that the tobacco product standard is
appropriate for the protection of the public health;
``(B) invite interested persons to submit a draft
or proposed tobacco product standard for consideration
by the Secretary;
``(C) invite interested persons to submit comments
on structuring the standard so that it does not
advantage foreign-grown tobacco over domestically grown
tobacco; and
``(D) invite the Secretary of Agriculture to
provide any information or analysis which the Secretary
of Agriculture believes is relevant to the proposed
tobacco product standard.
``(3) Finding.--A notice of proposed rulemaking for the
revocation of a tobacco product standard shall set forth a
finding with supporting justification that the tobacco product
standard is no longer appropriate for the protection of the
public health.
``(4) Comment.--The Secretary shall provide for a comment
period of not less than 60 days.
``(d) Promulgation.--
``(1) In general.--After the expiration of the period for
comment on a notice of proposed rulemaking published under
subsection (c) respecting a tobacco product standard and after
consideration of comments submitted under subsections (b) and
(c) and any report from the Tobacco Products Scientific
Advisory Committee, if the Secretary determines that the
standard would be appropriate for the protection of the public
health, the Secretary shall--
``(A) promulgate a regulation establishing a
tobacco product standard and publish in the Federal
Register findings on the matters referred to in
subsection (c); or
``(B) publish a notice terminating the proceeding
for the development of the standard together with the
reasons for such termination.
``(2) Effective date.--A regulation establishing a tobacco
product standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation may take
effect before 1 year after the date of its publication unless
the Secretary determines that an earlier effective date is
necessary for the protection of the public health. Such date or
dates shall be established so as to minimize, consistent with
the public health, economic loss to, and disruption or
dislocation of, domestic and international trade. In
establishing such effective date or dates, the Secretary shall
consider information submitted in connection with a proposed
product standard by interested parties, including manufacturers
and tobacco growers, regarding the technical achievability of
compliance with the standard, and including information
concerning the existence of patents that make it impossible to
comply in the timeframe envisioned in the proposed standard. If
the Secretary determines, based on the Secretary's evaluation
of submitted comments, that a product standard can be met only
by manufacturers requiring substantial changes to the methods
of farming the domestically grown tobacco used by the
manufacturer, the effective date of that product standard shall
be not less than 2 years after the date of publication of the
final regulation establishing the standard.
``(3) Limitation on power granted to the food and drug
administration.--Because of the importance of a decision of the
Secretary to issue a regulation--
``(A) banning all cigarettes, all smokeless tobacco
products, all little cigars, all cigars other than
little cigars, all pipe tobacco, or all roll-your-own
tobacco products; or
``(B) requiring the reduction of nicotine yields of
a tobacco product to zero,
the Secretary is prohibited from taking such actions under this
Act.
``(4) Amendment; revocation.--
``(A) Authority.--The Secretary, upon the
Secretary's own initiative or upon petition of an
interested person, may by a regulation, promulgated in
accordance with the requirements of subsection (c) and
paragraph (2), amend or revoke a tobacco product
standard.
``(B) Effective date.--The Secretary may declare a
proposed amendment of a tobacco product standard to be
effective on and after its publication in the Federal
Register and until the effective date of any final
action taken on such amendment if the Secretary
determines that making it so effective is in the public
interest.
``(5) Referral to advisory committee.--
``(A) In general.--The Secretary may refer a
proposed regulation for the establishment, amendment,
or revocation of a tobacco product standard to the
Tobacco Products Scientific Advisory Committee for a
report and recommendation with respect to any matter
involved in the proposed regulation which requires the
exercise of scientific judgment.
``(B) Initiation of referral.--The Secretary may
make a referral under this paragraph--
``(i) on the Secretary's own initiative; or
``(ii) upon the request of an interested
person that--
``(I) demonstrates good cause for
the referral; and
``(II) is made before the
expiration of the period for submission
of comments on the proposed regulation.
``(C) Provision of data.--If a proposed regulation
is referred under this paragraph to the Tobacco
Products Scientific Advisory Committee, the Secretary
shall provide the Advisory Committee with the data and
information on which such proposed regulation is based.
``(D) Report and recommendation.--The Tobacco
Products Scientific Advisory Committee shall, within 60
days after the referral of a proposed regulation under
this paragraph and after independent study of the data
and information furnished to it by the Secretary and
other data and information before it, submit to the
Secretary a report and recommendation respecting such
regulation, together with all underlying data and
information and a statement of the reason or basis for
the recommendation.
``(E) Public availability.--The Secretary shall
make a copy of each report and recommendation under
subparagraph (D) publicly available.
``(e) Menthol Cigarettes.--
``(1) Referral; considerations.--Immediately upon the
establishment of the Tobacco Products Scientific Advisory
Committee under section 917(a), the Secretary shall refer to
the Committee for report and recommendation, under section
917(c)(4), the issue of the impact of the use of menthol in
cigarettes on the public health, including such use among
African Americans, Hispanics, and other racial and ethnic
minorities. In its review, the Tobacco Products Scientific
Advisory Committee shall address the considerations listed in
subsections (a)(3)(B)(i) and (b).
``(2) Report and recommendation.--Not later than 1 year
after its establishment, the Tobacco Product Scientific
Advisory Committee shall submit to the Secretary the report and
recommendations required pursuant to paragraph (1).
``(3) Rule of construction.--Nothing in this subsection
shall be construed to limit the Secretary's authority to take
action under this section or other sections of this Act
applicable to menthol.
``SEC. 908. NOTIFICATION AND OTHER REMEDIES.
``(a) Notification.--If the Secretary determines that--
``(1) a tobacco product which is introduced or delivered
for introduction into interstate commerce for commercial
distribution presents an unreasonable risk of substantial harm
to the public health; and
``(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that
adequate notification is provided in an appropriate form, by the
persons and means best suited under the circumstances involved, to all
persons who should properly receive such notification in order to
eliminate such risk. The Secretary may order notification by any
appropriate means, including public service announcements. Before
issuing an order under this subsection, the Secretary shall consult
with the persons who are to give notice under the order.
``(b) No Exemption From Other Liability.--Compliance with an order
issued under this section shall not relieve any person from liability
under Federal or State law. In awarding damages for economic loss in an
action brought for the enforcement of any such liability, the value to
the plaintiff in such action of any remedy provided under such order
shall be taken into account.
``(c) Recall Authority.--
``(1) In general.--If the Secretary finds that there is a
reasonable probability that a tobacco product contains a
manufacturing or other defect not ordinarily contained in
tobacco products on the market that would cause serious,
adverse health consequences or death, the Secretary shall issue
an order requiring the appropriate person (including the
manufacturers, importers, distributors, or retailers of the
tobacco product) to immediately cease distribution of such
tobacco product. The order shall provide the person subject to
the order with an opportunity for an informal hearing, to be
held not later than 10 days after the date of the issuance of
the order, on the actions required by the order and on whether
the order should be amended to require a recall of such tobacco
product. If, after providing an opportunity for such a hearing,
the Secretary determines that inadequate grounds exist to
support the actions required by the order, the Secretary shall
vacate the order.
``(2) Amendment of order to require recall.--
``(A) In general.--If, after providing an
opportunity for an informal hearing under paragraph
(1), the Secretary determines that the order should be
amended to include a recall of the tobacco product with
respect to which the order was issued, the Secretary
shall, except as provided in subparagraph (B), amend
the order to require a recall. The Secretary shall
specify a timetable in which the tobacco product recall
will occur and shall require periodic reports to the
Secretary describing the progress of the recall.
``(B) Notice.--An amended order under subparagraph
(A)--
``(i) shall not include recall of a tobacco
product from individuals; and
``(ii) shall provide for notice to persons
subject to the risks associated with the use of
such tobacco product.
In providing the notice required by clause (ii), the
Secretary may use the assistance of retailers and other
persons who distributed such tobacco product. If a
significant number of such persons cannot be
identified, the Secretary shall notify such persons
under section 705(b).
``(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a).
``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
``(a) In General.--Every person who is a tobacco product
manufacturer or importer of a tobacco product shall establish and
maintain such records, make such reports, and provide such information,
as the Secretary may by regulation reasonably require to assure that
such tobacco product is not adulterated or misbranded and to otherwise
protect public health. Regulations prescribed under the preceding
sentence--
``(1) may require a tobacco product manufacturer or
importer to report to the Secretary whenever the manufacturer
or importer receives or otherwise becomes aware of information
that reasonably suggests that one of its marketed tobacco
products may have caused or contributed to a serious unexpected
adverse experience associated with the use of the product or
any significant increase in the frequency of a serious,
expected adverse product experience;
``(2) shall require reporting of other significant adverse
tobacco product experiences as determined by the Secretary to
be necessary to be reported;
``(3) shall not impose requirements unduly burdensome to a
tobacco product manufacturer or importer, taking into account
the cost of complying with such requirements and the need for
the protection of the public health and the implementation of
this chapter;
``(4) when prescribing the procedure for making requests
for reports or information, shall require that each request
made under such regulations for submission of a report or
information to the Secretary state the reason or purpose for
such request and identify to the fullest extent practicable
such report or information;
``(5) when requiring submission of a report or information
to the Secretary, shall state the reason or purpose for the
submission of such report or information and identify to the
fullest extent practicable such report or information; and
``(6) may not require that the identity of any patient or
user be disclosed in records, reports, or information required
under this subsection unless required for the medical welfare
of an individual, to determine risks to public health of a
tobacco product, or to verify a record, report, or information
submitted under this chapter.
In prescribing regulations under this subsection, the Secretary shall
have due regard for the professional ethics of the medical profession
and the interests of patients. The prohibitions of paragraph (6)
continue to apply to records, reports, and information concerning any
individual who has been a patient, irrespective of whether or when he
ceases to be a patient.
``(b) Reports of Removals and Corrections.--
``(1) In general.--Except as provided in paragraph (2), the
Secretary shall by regulation require a tobacco product
manufacturer or importer of a tobacco product to report
promptly to the Secretary any corrective action taken or
removal from the market of a tobacco product undertaken by such
manufacturer or importer if the removal or correction was
undertaken--
``(A) to reduce a risk to health posed by the
tobacco product; or
``(B) to remedy a violation of this chapter caused
by the tobacco product which may present a risk to
health.
A tobacco product manufacturer or importer of a tobacco product
who undertakes a corrective action or removal from the market
of a tobacco product which is not required to be reported under
this subsection shall keep a record of such correction or
removal.
``(2) Exception.--No report of the corrective action or
removal of a tobacco product may be required under paragraph
(1) if a report of the corrective action or removal is required
and has been submitted under subsection (a).
``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.
``(a) In General.--
``(1) New tobacco product defined.--For purposes of this
section the term `new tobacco product' means--
``(A) any tobacco product (including those products
in test markets) that was not commercially marketed in
the United States as of February 15, 2007; or
``(B) any modification (including a change in
design, any component, any part, or any constituent,
including a smoke constituent, or in the content,
delivery or form of nicotine, or any other additive or
ingredient) of a tobacco product where the modified
product was commercially marketed in the United States
after February 15, 2007.
``(2) Premarket review required.--
``(A) New products.--An order under subsection
(c)(1)(A)(i) for a new tobacco product is required
unless--
``(i) the manufacturer has submitted a
report under section 905(j); and the Secretary
has issued an order that the tobacco product--
``(I) is substantially equivalent
to a tobacco product commercially
marketed (other than for test
marketing) in the United States as of
February 15, 2007; and
``(II) is in compliance with the
requirements of this Act; or
``(ii) the tobacco product is exempt from
the requirements of section 905(j) pursuant to
a regulation issued under section 905(j)(3).
``(B) Application to certain post-february 15,
2007, products.--Subparagraph (A) shall not apply to a
tobacco product--
``(i) that was first introduced or
delivered for introduction into interstate
commerce for commercial distribution in the
United States after February 15, 2007, and
prior to the date that is 21 months after the
date of enactment of the Family Smoking
Prevention and Tobacco Control Act; and
``(ii) for which a report was submitted
under section 905(j) within such 21-month
period,
except that subparagraph (A) shall apply to the tobacco
product if the Secretary issues an order that the
tobacco product is not substantially equivalent.
``(3) Substantially equivalent defined.--
``(A) In general.--In this section and section
905(j), the term `substantially equivalent' or
`substantial equivalence' means, with respect to the
tobacco product being compared to the predicate tobacco
product, that the Secretary by order has found that the
tobacco product--
``(i) has the same characteristics as the
predicate tobacco product; or
``(ii) has different characteristics and
the information submitted contains information,
including clinical data if deemed necessary by
the Secretary, that demonstrates that it is not
appropriate to regulate the product under this
section because the product does not raise
different questions of public health.
``(B) Characteristics.--In subparagraph (A), the
term `characteristics' means the materials,
ingredients, design, composition, heating source, or
other features of a tobacco product.
``(C) Limitation.--A tobacco product may not be
found to be substantially equivalent to a predicate
tobacco product that has been removed from the market
at the initiative of the Secretary or that has been
determined by a judicial order to be misbranded or
adulterated.
``(4) Health information.--
``(A) Summary.--As part of a submission under
section 905(j) respecting a tobacco product, the person
required to file a premarket notification under such
section shall provide an adequate summary of any health
information related to the tobacco product or state
that such information will be made available upon
request by any person.
``(B) Required information.--Any summary under
subparagraph (A) respecting a tobacco product shall
contain detailed information regarding data concerning
adverse health effects and shall be made available to
the public by the Secretary within 30 days of the
issuance of a determination that such tobacco product
is substantially equivalent to another tobacco product.
``(b) Application.--
``(1) Contents.--An application under this section shall
contain--
``(A) full reports of all information, published or
known to, or which should reasonably be known to, the
applicant, concerning investigations which have been
made to show the health risks of such tobacco product
and whether such tobacco product presents less risk
than other tobacco products;
``(B) a full statement of the components,
ingredients, additives, and properties, and of the
principle or principles of operation, of such tobacco
product;
``(C) a full description of the methods used in,
and the facilities and controls used for, the
manufacture, processing, and, when relevant, packing
and installation of, such tobacco product;
``(D) an identifying reference to any tobacco
product standard under section 907 which would be
applicable to any aspect of such tobacco product, and
either adequate information to show that such aspect of
such tobacco product fully meets such tobacco product
standard or adequate information to justify any
deviation from such standard;
``(E) such samples of such tobacco product and of
components thereof as the Secretary may reasonably
require;
``(F) specimens of the labeling proposed to be used
for such tobacco product; and
``(G) such other information relevant to the
subject matter of the application as the Secretary may
require.
``(2) Referral to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Secretary--
``(A) may, on the Secretary's own initiative; or
``(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission (within
such period as the Secretary may establish) of a report and
recommendation respecting the application, together with all
underlying data and the reasons or basis for the
recommendation.
``(c) Action on Application.--
``(1) Deadline.--
``(A) In general.--As promptly as possible, but in
no event later than 180 days after the receipt of an
application under subsection (b), the Secretary, after
considering the report and recommendation submitted
under subsection (b)(2), shall--
``(i) issue an order that the new product
may be introduced or delivered for introduction
into interstate commerce if the Secretary finds
that none of the grounds specified in paragraph
(2) of this subsection applies; or
``(ii) issue an order that the new product
may not be introduced or delivered for
introduction into interstate commerce if the
Secretary finds (and sets forth the basis for
such finding as part of or accompanying such
denial) that 1 or more grounds for denial
specified in paragraph (2) of this subsection
apply.
``(B) Restrictions on sale and distribution.--An
order under subparagraph (A)(i) may require that the
sale and distribution of the tobacco product be
restricted but only to the extent that the sale and
distribution of a tobacco product may be restricted
under a regulation under section 906(d).
``(2) Denial of application.--The Secretary shall deny an
application submitted under subsection (b) if, upon the basis
of the information submitted to the Secretary as part of the
application and any other information before the Secretary with
respect to such tobacco product, the Secretary finds that--
``(A) there is a lack of a showing that permitting
such tobacco product to be marketed would be
appropriate for the protection of the public health;
``(B) the methods used in, or the facilities or
controls used for, the manufacture, processing, or
packing of such tobacco product do not conform to the
requirements of section 906(e);
``(C) based on a fair evaluation of all material
facts, the proposed labeling is false or misleading in
any particular; or
``(D) such tobacco product is not shown to conform
in all respects to a tobacco product standard in effect
under section 907, and there is a lack of adequate
information to justify the deviation from such
standard.
``(3) Denial information.--Any denial of an application
shall, insofar as the Secretary determines to be practicable,
be accompanied by a statement informing the applicant of the
measures required to remove such application from deniable form
(which measures may include further research by the applicant
in accordance with 1 or more protocols prescribed by the
Secretary).
``(4) Basis for finding.--For purposes of this section, the
finding as to whether the marketing of a tobacco product for
which an application has been submitted is appropriate for the
protection of the public health shall be determined with
respect to the risks and benefits to the population as a whole,
including users and nonusers of the tobacco product, and taking
into account--
``(A) the increased or decreased likelihood that
existing users of tobacco products will stop using such
products; and
``(B) the increased or decreased likelihood that
those who do not use tobacco products will start using
such products.
``(5) Basis for action.--
``(A) Investigations.--For purposes of paragraph
(2)(A), whether permitting a tobacco product to be
marketed would be appropriate for the protection of the
public health shall, when appropriate, be determined on
the basis of well-controlled investigations, which may
include 1 or more clinical investigations by experts
qualified by training and experience to evaluate the
tobacco product.
``(B) Other evidence.--If the Secretary determines
that there exists valid scientific evidence (other than
evidence derived from investigations described in
subparagraph (A)) which is sufficient to evaluate the
tobacco product, the Secretary may authorize that the
determination for purposes of paragraph (2)(A) be made
on the basis of such evidence.
``(d) Withdrawal and Temporary Suspension.--
``(1) In general.--The Secretary shall, upon obtaining,
where appropriate, advice on scientific matters from the
Tobacco Products Scientific Advisory Committee, and after due
notice and opportunity for informal hearing for a tobacco
product for which an order was issued under subsection
(c)(1)(A)(i), issue an order withdrawing the order if the
Secretary finds--
``(A) that the continued marketing of such tobacco
product no longer is appropriate for the protection of
the public health;
``(B) that the application contained or was
accompanied by an untrue statement of a material fact;
``(C) that the applicant--
``(i) has failed to establish a system for
maintaining records, or has repeatedly or
deliberately failed to maintain records or to
make reports, required by an applicable
regulation under section 909;
``(ii) has refused to permit access to, or
copying or verification of, such records as
required by section 704; or
``(iii) has not complied with the
requirements of section 905;
``(D) on the basis of new information before the
Secretary with respect to such tobacco product,
evaluated together with the evidence before the
Secretary when the application was reviewed, that the
methods used in, or the facilities and controls used
for, the manufacture, processing, packing, or
installation of such tobacco product do not conform
with the requirements of section 906(e) and were not
brought into conformity with such requirements within a
reasonable time after receipt of written notice from
the Secretary of nonconformity;
``(E) on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when the application was reviewed, that
the labeling of such tobacco product, based on a fair
evaluation of all material facts, is false or
misleading in any particular and was not corrected
within a reasonable time after receipt of written
notice from the Secretary of such fact; or
``(F) on the basis of new information before the
Secretary, evaluated together with the evidence before
the Secretary when such order was issued, that such
tobacco product is not shown to conform in all respects
to a tobacco product standard which is in effect under
section 907, compliance with which was a condition to
the issuance of an order relating to the application,
and that there is a lack of adequate information to
justify the deviation from such standard.
``(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing an order issued
pursuant to subsection (c)(1)(A)(i) may, by petition filed on
or before the 30th day after the date upon which such holder
receives notice of such withdrawal, obtain review thereof in
accordance with section 912.
``(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Secretary determines
there is reasonable probability that the continuation of
distribution of a tobacco product under an order would cause
serious, adverse health consequences or death, that is greater
than ordinarily caused by tobacco products on the market, the
Secretary shall by order temporarily suspend the authority of
the manufacturer to market the product. If the Secretary issues
such an order, the Secretary shall proceed expeditiously under
paragraph (1) to withdraw such application.
``(e) Service of Order.--An order issued by the Secretary under
this section shall be served--
``(1) in person by any officer or employee of the
department designated by the Secretary; or
``(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Secretary.
``(f) Records.--
``(1) Additional information.--In the case of any tobacco
product for which an order issued pursuant to subsection
(c)(1)(A)(i) for an application filed under subsection (b) is
in effect, the applicant shall establish and maintain such
records, and make such reports to the Secretary, as the
Secretary may by regulation, or by order with respect to such
application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination of,
whether there is or may be grounds for withdrawing or
temporarily suspending such order.
``(2) Access to records.--Each person required under this
section to maintain records, and each person in charge of
custody thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee at
all reasonable times to have access to and copy and verify such
records.
``(g) Investigational Tobacco Product Exemption for Investigational
Use.--The Secretary may exempt tobacco products intended for
investigational use from the provisions of this chapter under such
conditions as the Secretary may by regulation prescribe.
``SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
``(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any modified risk tobacco product
unless an order issued pursuant to subsection (g) is effective with
respect to such product.
``(b) Definitions.--In this section:
``(1) Modified risk tobacco product.--The term `modified
risk tobacco product' means any tobacco product that is sold or
distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
``(2) Sold or distributed.--
``(A) In general.--With respect to a tobacco
product, the term `sold or distributed for use to
reduce harm or the risk of tobacco-related disease
associated with commercially marketed tobacco products'
means a tobacco product--
``(i) the label, labeling, or advertising
of which represents explicitly or implicitly
that--
``(I) the tobacco product presents
a lower risk of tobacco-related disease
or is less harmful than one or more
other commercially marketed tobacco
products;
``(II) the tobacco product or its
smoke contains a reduced level of a
substance or presents a reduced
exposure to a substance; or
``(III) the tobacco product or its
smoke does not contain or is free of a
substance;
``(ii) the label, labeling, or advertising
of which uses the descriptors `light', `mild',
or `low' or similar descriptors; or
``(iii) the tobacco product manufacturer of
which has taken any action directed to
consumers through the media or otherwise, other
than by means of the tobacco product's label,
labeling, or advertising, after the date of
enactment of the Family Smoking Prevention and
Tobacco Control Act, respecting the product
that would be reasonably expected to result in
consumers believing that the tobacco product or
its smoke may present a lower risk of disease
or is less harmful than one or more
commercially marketed tobacco products, or
presents a reduced exposure to, or does not
contain or is free of, a substance or
substances.
``(B) Limitation.--No tobacco product shall be
considered to be `sold or distributed for use to reduce
harm or the risk of tobacco-related disease associated
with commercially marketed tobacco products', except as
described in subparagraph (A).
``(C) Smokeless tobacco product.--No smokeless
tobacco product shall be considered to be `sold or
distributed for use to reduce harm or the risk of
tobacco-related disease associated with commercially
marketed tobacco products' solely because its label,
labeling, or advertising uses the following phrases to
describe such product and its use: `smokeless tobacco',
`smokeless tobacco product', `not consumed by smoking',
`does not produce smoke', `smokefree', `smoke-free',
`without smoke', `no smoke', or `not smoke'.
``(3) Effective date.--The provisions of paragraph
(2)(A)(ii) shall take effect 12 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act for those products whose label, labeling, or advertising
contains the terms described in such paragraph on such date of
enactment. The effective date shall be with respect to the date
of manufacture, provided that, in any case, beginning 30 days
after such effective date, a manufacturer shall not introduce
into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in
conformance with paragraph (2)(A)(ii).
``(c) Tobacco Dependence Products.--A product that is intended to
be used for the treatment of tobacco dependence, including smoking
cessation, is not a modified risk tobacco product under this section if
it has been approved as a drug or device by the Food and Drug
Administration and is subject to the requirements of chapter V.
``(d) Filing.--Any person may file with the Secretary an
application for a modified risk tobacco product. Such application shall
include--
``(1) a description of the proposed product and any
proposed advertising and labeling;
``(2) the conditions for using the product;
``(3) the formulation of the product;
``(4) sample product labels and labeling;
``(5) all documents (including underlying scientific
information) relating to research findings conducted,
supported, or possessed by the tobacco product manufacturer
relating to the effect of the product on tobacco-related
diseases and health-related conditions, including information
both favorable and unfavorable to the ability of the product to
reduce risk or exposure and relating to human health;
``(6) data and information on how consumers actually use
the tobacco product; and
``(7) such other information as the Secretary may require.
``(e) Public Availability.--The Secretary shall make the
application described in subsection (d) publicly available (except
matters in the application which are trade secrets or otherwise
confidential, commercial information) and shall request comments by
interested persons on the information contained in the application and
on the label, labeling, and advertising accompanying such application.
``(f) Advisory Committee.--
``(1) In general.--The Secretary shall refer to the Tobacco
Products Scientific Advisory Committee any application
submitted under this section.
``(2) Recommendations.--Not later than 60 days after the
date an application is referred to the Tobacco Products
Scientific Advisory Committee under paragraph (1), the Advisory
Committee shall report its recommendations on the application
to the Secretary.
``(g) Marketing.--
``(1) Modified risk products.--Except as provided in
paragraph (2), the Secretary shall, with respect to an
application submitted under this section, issue an order that a
modified risk product may be commercially marketed only if the
Secretary determines that the applicant has demonstrated that
such product, as it is actually used by consumers, will--
``(A) significantly reduce harm and the risk of
tobacco-related disease to individual tobacco users;
and
``(B) benefit the health of the population as a
whole taking into account both users of tobacco
products and persons who do not currently use tobacco
products.
``(2) Special rule for certain products.--
``(A) In general.--The Secretary may issue an order
that a tobacco product may be introduced or delivered
for introduction into interstate commerce, pursuant to
an application under this section, with respect to a
tobacco product that may not be commercially marketed
under paragraph (1) if the Secretary makes the findings
required under this paragraph and determines that the
applicant has demonstrated that--
``(i) such order would be appropriate to
promote the public health;
``(ii) any aspect of the label, labeling,
and advertising for such product that would
cause the tobacco product to be a modified risk
tobacco product under subsection (b) is limited
to an explicit or implicit representation that
such tobacco product or its smoke does not
contain or is free of a substance or contains a
reduced level of a substance, or presents a
reduced exposure to a substance in tobacco
smoke;
``(iii) scientific evidence is not
available and, using the best available
scientific methods, cannot be made available
without conducting long-term epidemiological
studies for an application to meet the
standards set forth in paragraph (1); and
``(iv) the scientific evidence that is
available without conducting long-term
epidemiological studies demonstrates that a
measurable and substantial reduction in
morbidity or mortality among individual tobacco
users is reasonably likely in subsequent
studies.
``(B) Additional findings required.--To issue an
order under subparagraph (A) the Secretary must also
find that the applicant has demonstrated that--
``(i) the magnitude of the overall
reductions in exposure to the substance or
substances which are the subject of the
application is substantial, such substance or
substances are harmful, and the product as
actually used exposes consumers to the
specified reduced level of the substance or
substances;
``(ii) the product as actually used by
consumers will not expose them to higher levels
of other harmful substances compared to the
similar types of tobacco products then on the
market unless such increases are minimal and
the reasonably likely overall impact of use of
the product remains a substantial and
measurable reduction in overall morbidity and
mortality among individual tobacco users;
``(iii) testing of actual consumer
perception shows that, as the applicant
proposes to label and market the product,
consumers will not be misled into believing
that the product--
``(I) is or has been demonstrated
to be less harmful; or
``(II) presents or has been
demonstrated to present less of a risk
of disease than 1 or more other
commercially marketed tobacco products;
and
``(iv) issuance of an order with respect to
the application is expected to benefit the
health of the population as a whole taking into
account both users of tobacco products and
persons who do not currently use tobacco
products.
``(C) Conditions of marketing.--
``(i) In general.--Applications subject to
an order under this paragraph shall be limited
to a term of not more than 5 years, but may be
renewed upon a finding by the Secretary that
the requirements of this paragraph continue to
be satisfied based on the filing of a new
application.
``(ii) Agreements by applicant.--An order
under this paragraph shall be conditioned on
the applicant's agreement to conduct postmarket
surveillance and studies and to submit to the
Secretary the results of such surveillance and
studies to determine the impact of the order on
consumer perception, behavior, and health and
to enable the Secretary to review the accuracy
of the determinations upon which the order was
based in accordance with a protocol approved by
the Secretary.
``(iii) Annual submission.--The results of
such postmarket surveillance and studies
described in clause (ii) shall be submitted
annually.
``(3) Basis.--The determinations under paragraphs (1) and
(2) shall be based on--
``(A) the scientific evidence submitted by the
applicant; and
``(B) scientific evidence and other information
that is made available to the Secretary.
``(4) Benefit to health of individuals and of population as
a whole.--In making the determinations under paragraphs (1) and
(2), the Secretary shall take into account--
``(A) the relative health risks to individuals of
the tobacco product that is the subject of the
application;
``(B) the increased or decreased likelihood that
existing users of tobacco products who would otherwise
stop using such products will switch to the tobacco
product that is the subject of the application;
``(C) the increased or decreased likelihood that
persons who do not use tobacco products will start
using the tobacco product that is the subject of the
application;
``(D) the risks and benefits to persons from the
use of the tobacco product that is the subject of the
application as compared to the use of products for
smoking cessation approved under chapter V to treat
nicotine dependence; and
``(E) comments, data, and information submitted by
interested persons.
``(h) Additional Conditions for Marketing.--
``(1) Modified risk products.--The Secretary shall require
for the marketing of a product under this section that any
advertising or labeling concerning modified risk products
enable the public to comprehend the information concerning
modified risk and to understand the relative significance of
such information in the context of total health and in relation
to all of the diseases and health-related conditions associated
with the use of tobacco products.
``(2) Comparative claims.--
``(A) In general.--The Secretary may require for
the marketing of a product under this subsection that a
claim comparing a tobacco product to 1 or more other
commercially marketed tobacco products shall compare
the tobacco product to a commercially marketed tobacco
product that is representative of that type of tobacco
product on the market (for example the average value of
the top 3 brands of an established regular tobacco
product).
``(B) Quantitative comparisons.--The Secretary may
also require, for purposes of subparagraph (A), that
the percent (or fraction) of change and identity of the
reference tobacco product and a quantitative comparison
of the amount of the substance claimed to be reduced
shall be stated in immediate proximity to the most
prominent claim.
``(3) Label disclosure.--
``(A) In general.--The Secretary may require the
disclosure on the label of other substances in the
tobacco product, or substances that may be produced by
the consumption of that tobacco product, that may
affect a disease or health-related condition or may
increase the risk of other diseases or health-related
conditions associated with the use of tobacco products.
``(B) Conditions of use.--If the conditions of use
of the tobacco product may affect the risk of the
product to human health, the Secretary may require the
labeling of conditions of use.
``(4) Time.--An order issued under subsection (g)(1) shall
be effective for a specified period of time.
``(5) Advertising.--The Secretary may require, with respect
to a product for which an applicant obtained an order under
subsection (g)(1), that the product comply with requirements
relating to advertising and promotion of the tobacco product.
``(i) Postmarket Surveillance and Studies.--
``(1) In general.--The Secretary shall require, with
respect to a product for which an applicant obtained an order
under subsection (g)(1), that the applicant conduct postmarket
surveillance and studies for such a tobacco product to
determine the impact of the order issuance on consumer
perception, behavior, and health, to enable the Secretary to
review the accuracy of the determinations upon which the order
was based, and to provide information that the Secretary
determines is otherwise necessary regarding the use or health
risks involving the tobacco product. The results of postmarket
surveillance and studies shall be submitted to the Secretary on
an annual basis.
``(2) Surveillance protocol.--Each applicant required to
conduct a surveillance of a tobacco product under paragraph (1)
shall, within 30 days after receiving notice that the applicant
is required to conduct such surveillance, submit, for the
approval of the Secretary, a protocol for the required
surveillance. The Secretary, within 60 days of the receipt of
such protocol, shall determine if the principal investigator
proposed to be used in the surveillance has sufficient
qualifications and experience to conduct such surveillance and
if such protocol will result in collection of the data or other
information designated by the Secretary as necessary to protect
the public health.
``(j) Withdrawal of Authorization.--The Secretary, after an
opportunity for an informal hearing, shall withdraw an order under
subsection (g) if the Secretary determines that--
``(1) the applicant, based on new information, can no
longer make the demonstrations required under subsection (g),
or the Secretary can no longer make the determinations required
under subsection (g);
``(2) the application failed to include material
information or included any untrue statement of material fact;
``(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid, including
if--
``(A) a tobacco product standard is established
pursuant to section 907;
``(B) an action is taken that affects the risks
presented by other commercially marketed tobacco
products that were compared to the product that is the
subject of the application; or
``(C) any postmarket surveillance or studies reveal
that the order is no longer consistent with the
protection of the public health;
``(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or subsection (i); or
``(5) the applicant failed to meet a condition imposed
under subsection (h).
``(k) Chapter IV or V.--A product for which the Secretary has
issued an order pursuant to subsection (g) shall not be subject to
chapter IV or V.
``(l) Implementing Regulations or Guidance.--
``(1) Scientific evidence.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue regulations or
guidance (or any combination thereof) on the scientific
evidence required for assessment and ongoing review of modified
risk tobacco products. Such regulations or guidance shall--
``(A) to the extent that adequate scientific
evidence exists, establish minimum standards for
scientific studies needed prior to issuing an order
under subsection (g) to show that a substantial
reduction in morbidity or mortality among individual
tobacco users occurs for products described in
subsection (g)(1) or is reasonably likely for products
described in subsection (g)(2);
``(B) include validated biomarkers, intermediate
clinical endpoints, and other feasible outcome
measures, as appropriate;
``(C) establish minimum standards for postmarket
studies, that shall include regular and long-term
assessments of health outcomes and mortality,
intermediate clinical endpoints, consumer perception of
harm reduction, and the impact on quitting behavior and
new use of tobacco products, as appropriate;
``(D) establish minimum standards for required
postmarket surveillance, including ongoing assessments
of consumer perception;
``(E) require that data from the required studies
and surveillance be made available to the Secretary
prior to the decision on renewal of a modified risk
tobacco product; and
``(F) establish a reasonable timetable for the
Secretary to review an application under this section.
``(2) Consultation.--The regulations or guidance issued
under paragraph (1) shall be developed in consultation with the
Institute of Medicine, and with the input of other appropriate
scientific and medical experts, on the design and conduct of
such studies and surveillance.
``(3) Revision.--The regulations or guidance under
paragraph (1) shall be revised on a regular basis as new
scientific information becomes available.
``(4) New tobacco products.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue a regulation or
guidance that permits the filing of a single application for
any tobacco product that is a new tobacco product under section
910 and which the applicant seeks to commercially market under
this section.
``(m) Distributors.--Except as provided in this section, no
distributor may take any action, after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, with respect to a
tobacco product that would reasonably be expected to result in
consumers believing that the tobacco product or its smoke may present a
lower risk of disease or is less harmful than one or more commercially
marketed tobacco products, or presents a reduced exposure to, or does
not contain or is free of, a substance or substances.
``SEC. 912. JUDICIAL REVIEW.
``(a) Right To Review.--
``(1) In general.--Not later than 30 days after--
``(A) the promulgation of a regulation under
section 907 establishing, amending, or revoking a
tobacco product standard; or
``(B) a denial of an application under section
910(c),
any person adversely affected by such regulation or denial may
file a petition for judicial review of such regulation or
denial with the United States Court of Appeals for the District
of Columbia or for the circuit in which such person resides or
has their principal place of business.
``(2) Requirements.--
``(A) Copy of petition.--A copy of the petition
filed under paragraph (1) shall be transmitted by the
clerk of the court involved to the Secretary.
``(B) Record of proceedings.--On receipt of a
petition under subparagraph (A), the Secretary shall
file in the court in which such petition was filed--
``(i) the record of the proceedings on
which the regulation or order was based; and
``(ii) a statement of the reasons for the
issuance of such a regulation or order.
``(C) Definition of record.--In this section, the
term `record' means--
``(i) all notices and other matter
published in the Federal Register with respect
to the regulation or order reviewed;
``(ii) all information submitted to the
Secretary with respect to such regulation or
order;
``(iii) proceedings of any panel or
advisory committee with respect to such
regulation or order;
``(iv) any hearing held with respect to
such regulation or order; and
``(v) any other information identified by
the Secretary, in the administrative proceeding
held with respect to such regulation or order,
as being relevant to such regulation or order.
``(b) Standard of Review.--Upon the filing of the petition under
subsection (a) for judicial review of a regulation or order, the court
shall have jurisdiction to review the regulation or order in accordance
with chapter 7 of title 5, United States Code, and to grant appropriate
relief, including interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be reviewed in
accordance with section 706(2)(A) of title 5, United States Code.
``(c) Finality of Judgment.--The judgment of the court affirming or
setting aside, in whole or in part, any regulation or order shall be
final, subject to review by the Supreme Court of the United States upon
certiorari or certification, as provided in section 1254 of title 28,
United States Code.
``(d) Other Remedies.--The remedies provided for in this section
shall be in addition to, and not in lieu of, any other remedies
provided by law.
``(e) Regulations and Orders Must Recite Basis in Record.--To
facilitate judicial review, a regulation or order issued under section
906, 907, 908, 909, 910, or 916 shall contain a statement of the
reasons for the issuance of such regulation or order in the record of
the proceedings held in connection with its issuance.
``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.
``The Secretary shall issue regulations to require that retail
establishments for which the predominant business is the sale of
tobacco products comply with any advertising restrictions applicable to
retail establishments accessible to individuals under the age of 18.
``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL TRADE
COMMISSION.
``(a) Jurisdiction.--
``(1) In general.--Except where expressly provided in this
chapter, nothing in this chapter shall be construed as limiting
or diminishing the authority of the Federal Trade Commission to
enforce the laws under its jurisdiction with respect to the
advertising, sale, or distribution of tobacco products.
``(2) Enforcement.--Any advertising that violates this
chapter or a provision of the regulations referred to in
section 102 of the Family Smoking Prevention and Tobacco
Control Act, is an unfair or deceptive act or practice under
section 5(a) of the Federal Trade Commission Act and shall be
considered a violation of a rule promulgated under section 18
of that Act.
``(b) Coordination.--With respect to the requirements of section 4
of the Federal Cigarette Labeling and Advertising Act and section 3 of
the Comprehensive Smokeless Tobacco Health Education Act of 1986--
``(1) the Chairman of the Federal Trade Commission shall
coordinate with the Secretary concerning the enforcement of
such Act as such enforcement relates to unfair or deceptive
acts or practices in the advertising of cigarettes or smokeless
tobacco; and
``(2) the Secretary shall consult with the Chairman of such
Commission in revising the label statements and requirements
under such sections.
``SEC. 915. REGULATION REQUIREMENT.
``(a) Testing, Reporting, and Disclosure.--Not later than 36 months
after the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall promulgate regulations under
this Act that meet the requirements of subsection (b).
``(b) Contents of Rules.--The regulations promulgated under
subsection (a)--
``(1) shall require testing and reporting of tobacco
product constituents, ingredients, and additives, including
smoke constituents, by brand and subbrand that the Secretary
determines should be tested to protect the public health,
provided that, for purposes of the testing requirements of this
paragraph, tobacco products manufactured and sold by a single
tobacco product manufacturer that are identical in all respects
except the labels, packaging design, logo, trade dress,
trademark, brand name, or any combination thereof, shall be
considered as a single brand; and
``(2) may require that tobacco product manufacturers,
packagers, or importers make disclosures relating to the
results of the testing of tar and nicotine through labels or
advertising or other appropriate means, and make disclosures
regarding the results of the testing of other constituents,
including smoke constituents, ingredients, or additives, that
the Secretary determines should be disclosed to the public to
protect the public health and will not mislead consumers about
the risk of tobacco-related disease.
``(c) Authority.--The Secretary shall have the authority under this
chapter to conduct or to require the testing, reporting, or disclosure
of tobacco product constituents, including smoke constituents.
``(d) Small Tobacco Product Manufacturers.--
``(1) First compliance date.--The initial regulations
promulgated under subsection (a) shall not impose requirements
on small tobacco product manufacturers before the later of--
``(A) the end of the 2-year period following the
final promulgation of such regulations; and
``(B) the initial date set by the Secretary for
compliance with such regulations by manufacturers that
are not small tobacco product manufacturers.
``(2) Testing and reporting initial compliance period.--
``(A) 4-year period.--The initial regulations
promulgated under subsection (a) shall give each small
tobacco product manufacturer a 4-year period over which
to conduct testing and reporting for all of its tobacco
products. Subject to paragraph (1), the end of the
first year of such 4-year period shall coincide with
the initial date of compliance under this section set
by the Secretary with respect to manufacturers that are
not small tobacco product manufacturers or the end of
the 2-year period following the final promulgation of
such regulations, as described in paragraph (1)(A). A
small tobacco product manufacturer shall be required--
``(i) to conduct such testing and reporting
for 25 percent of its tobacco products during
each year of such 4-year period; and
``(ii) to conduct such testing and
reporting for its largest-selling tobacco
products (as determined by the Secretary)
before its other tobacco products, or in such
other order of priority as determined by the
Secretary.
``(B) Case-by-case delay.--Notwithstanding
subparagraph (A), the Secretary may, on a case-by-case
basis, delay the date by which an individual small
tobacco product manufacturer must conduct testing and
reporting for its tobacco products under this section
based upon a showing of undue hardship to such
manufacturer. Notwithstanding the preceding sentence,
the Secretary shall not extend the deadline for a small
tobacco product manufacturer to conduct testing and
reporting for all of its tobacco products beyond a
total of 5 years after the initial date of compliance
under this section set by the Secretary with respect to
manufacturers that are not small tobacco product
manufacturers.
``(3) Subsequent and additional testing and reporting.--The
regulations promulgated under subsection (a) shall provide
that, with respect to any subsequent or additional testing and
reporting of tobacco products required under this section, such
testing and reporting by a small tobacco product manufacturer
shall be conducted in accordance with the timeframes described
in paragraph (2)(A), except that, in the case of a new product,
or if there has been a modification described in section
910(a)(1)(B) of any product of a small tobacco product
manufacturer since the last testing and reporting required
under this section, the Secretary shall require that any
subsequent or additional testing and reporting be conducted in
accordance with the same timeframe applicable to manufacturers
that are not small tobacco product manufacturers.
``(4) Joint laboratory testing services.--The Secretary
shall allow any 2 or more small tobacco product manufacturers
to join together to purchase laboratory testing services
required by this section on a group basis in order to ensure
that such manufacturers receive access to, and fair pricing of,
such testing services.
``(e) Extensions for Limited Laboratory Capacity.--
``(1) In general.--The regulations promulgated under
subsection (a) shall provide that a small tobacco product
manufacturer shall not be considered to be in violation of this
section before the deadline applicable under paragraphs (3) and
(4), if--
``(A) the tobacco products of such manufacturer are
in compliance with all other requirements of this
chapter; and
``(B) the conditions described in paragraph (2) are
met.
``(2) Conditions.--Notwithstanding the requirements of this
section, the Secretary may delay the date by which a small
tobacco product manufacturer must be in compliance with the
testing and reporting required by this section until such time
as the testing is reported if, not later than 90 days before
the deadline for reporting in accordance with this section, a
small tobacco product manufacturer provides evidence to the
Secretary demonstrating that--
``(A) the manufacturer has submitted the required
products for testing to a laboratory and has done so
sufficiently in advance of the deadline to create a
reasonable expectation of completion by the deadline;
``(B) the products currently are awaiting testing
by the laboratory; and
``(C) neither that laboratory nor any other
laboratory is able to complete testing by the deadline
at customary, nonexpedited testing fees.
``(3) Extension.--The Secretary, taking into account the
laboratory testing capacity that is available to tobacco
product manufacturers, shall review and verify the evidence
submitted by a small tobacco product manufacturer in accordance
with paragraph (2). If the Secretary finds that the conditions
described in such paragraph are met, the Secretary shall notify
the small tobacco product manufacturer that the manufacturer
shall not be considered to be in violation of the testing and
reporting requirements of this section until the testing is
reported or until 1 year after the reporting deadline has
passed, whichever occurs sooner. If, however, the Secretary has
not made a finding before the reporting deadline, the
manufacturer shall not be considered to be in violation of such
requirements until the Secretary finds that the conditions
described in paragraph (2) have not been met, or until 1 year
after the reporting deadline, whichever occurs sooner.
``(4) Additional extension.--In addition to the time that
may be provided under paragraph (3), the Secretary may provide
further extensions of time, in increments of no more than 1
year, for required testing and reporting to occur if the
Secretary determines, based on evidence properly and timely
submitted by a small tobacco product manufacturer in accordance
with paragraph (2), that a lack of available laboratory
capacity prevents the manufacturer from completing the required
testing during the period described in paragraph (3).
``(f) Rule of Construction.--Nothing in subsection (d) or (e) shall
be construed to authorize the extension of any deadline, or to
otherwise affect any timeframe, under any provision of this Act or the
Family Smoking Prevention and Tobacco Control Act other than this
section.
``SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY.
``(a) In General.--
``(1) Preservation.--Except as provided in paragraph
(2)(A), nothing in this chapter, or rules promulgated under
this chapter, shall be construed to limit the authority of a
Federal agency (including the Armed Forces), a State or
political subdivision of a State, or the government of an
Indian tribe to enact, adopt, promulgate, and enforce any law,
rule, regulation, or other measure with respect to tobacco
products that is in addition to, or more stringent than,
requirements established under this chapter, including a law,
rule, regulation, or other measure relating to or prohibiting
the sale, distribution, possession, exposure to, access to,
advertising and promotion of, or use of tobacco products by
individuals of any age, information reporting to the State, or
measures relating to fire safety standards for tobacco
products. No provision of this chapter shall limit or otherwise
affect any State, Tribal, or local taxation of tobacco
products.
``(2) Preemption of certain state and local requirements.--
``(A) In general.--No State or political
subdivision of a State may establish or continue in
effect with respect to a tobacco product any
requirement which is different from, or in addition to,
any requirement under the provisions of this chapter
relating to tobacco product standards, premarket
review, adulteration, misbranding, labeling,
registration, good manufacturing standards, or modified
risk tobacco products.
``(B) Exception.--Subparagraph (A) does not apply
to requirements relating to the sale, distribution,
possession, information reporting to the State,
exposure to, access to, the advertising and promotion
of, or use of, tobacco products by individuals of any
age, or relating to fire safety standards for tobacco
products. Information disclosed to a State under
subparagraph (A) that is exempt from disclosure under
section 552(b)(4) of title 5, United States Code, shall
be treated as a trade secret and confidential
information by the State.
``(b) Rule of Construction Regarding Product Liability.--No
provision of this chapter relating to a tobacco product shall be
construed to modify or otherwise affect any action or the liability of
any person under the product liability law of any State.
``SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
``(a) Establishment.--Not later than 6 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act, the
Secretary shall establish a 12-member advisory committee, to be known
as the Tobacco Products Scientific Advisory Committee (in this section
referred to as the `Advisory Committee').
``(b) Membership.--
``(1) In general.--
``(A) Members.--The Secretary shall appoint as
members of the Tobacco Products Scientific Advisory
Committee individuals who are technically qualified by
training and experience in medicine, medical ethics,
science, or technology involving the manufacture,
evaluation, or use of tobacco products, who are of
appropriately diversified professional backgrounds. The
committee shall be composed of--
``(i) 7 individuals who are physicians,
dentists, scientists, or health care
professionals practicing in the area of
oncology, pulmonology, cardiology, toxicology,
pharmacology, addiction, or any other relevant
specialty;
``(ii) 1 individual who is an officer or
employee of a State or local government or of
the Federal Government;
``(iii) 1 individual as a representative of
the general public;
``(iv) 1 individual as a representative of
the interests of the tobacco manufacturing
industry;
``(v) 1 individual as a representative of
the interests of the small business tobacco
manufacturing industry, which position may be
filled on a rotating, sequential basis by
representatives of different small business
tobacco manufacturers based on areas of
expertise relevant to the topics being
considered by the Advisory Committee; and
``(vi) 1 individual as a representative of
the interests of the tobacco growers.
``(B) Nonvoting members.--The members of the
committee appointed under clauses (iv), (v), and (vi)
of subparagraph (A) shall serve as consultants to those
described in clauses (i) through (iii) of subparagraph
(A) and shall be nonvoting representatives.
``(C) Conflicts of interest.--No members of the
committee, other than members appointed pursuant to
clauses (iv), (v), and (vi) of subparagraph (A) shall,
during the member's tenure on the committee or for the
18-month period prior to becoming such a member,
receive any salary, grants, or other payments or
support from any business that manufactures,
distributes, markets, or sells cigarettes or other
tobacco products.
``(2) Limitation.--The Secretary may not appoint to the
Advisory Committee any individual who is in the regular full-
time employ of the Food and Drug Administration or any agency
responsible for the enforcement of this Act. The Secretary may
appoint Federal officials as ex officio members.
``(3) Chairperson.--The Secretary shall designate 1 of the
members appointed under clauses (i), (ii), and (iii) of
paragraph (1)(A) to serve as chairperson.
``(c) Duties.--The Tobacco Products Scientific Advisory Committee
shall provide advice, information, and recommendations to the
Secretary--
``(1) as provided in this chapter;
``(2) on the effects of the alteration of the nicotine
yields from tobacco products;
``(3) on whether there is a threshold level below which
nicotine yields do not produce dependence on the tobacco
product involved; and
``(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the
Secretary.
``(d) Compensation; Support; FACA.--
``(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which may not exceed the daily equivalent of the
rate in effect under the Senior Executive Schedule under
section 5382 of title 5, United States Code, for each day
(including travel time) they are so engaged; and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per diem
in lieu of subsistence, as authorized by section 5703 of title
5, United States Code, for persons in the Government service
employed intermittently.
``(2) Administrative support.--The Secretary shall furnish
the Advisory Committee clerical and other assistance.
``(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act does not apply to the Advisory
Committee.
``(e) Proceedings of Advisory Panels and Committees.--The Advisory
Committee shall make and maintain a transcript of any proceeding of the
panel or committee. Each such panel and committee shall delete from any
transcript made under this subsection information which is exempt from
disclosure under section 552(b) of title 5, United States Code.
``SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
``(a) In General.--The Secretary shall--
``(1) at the request of the applicant, consider designating
products for smoking cessation, including nicotine replacement
products as fast track research and approval products within
the meaning of section 506;
``(2) consider approving the extended use of nicotine
replacement products (such as nicotine patches, nicotine gum,
and nicotine lozenges) for the treatment of tobacco dependence;
and
``(3) review and consider the evidence for additional
indications for nicotine replacement products, such as for
craving relief or relapse prevention.
``(b) Report on Innovative Products.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act, the Secretary, after consultation with recognized
scientific, medical, and public health experts (including both
Federal agencies and nongovernmental entities, the Institute of
Medicine of the National Academy of Sciences, and the Society
for Research on Nicotine and Tobacco), shall submit to the
Congress a report that examines how best to regulate, promote,
and encourage the development of innovative products and
treatments (including nicotine-based and non-nicotine-based
products and treatments) to better achieve, in a manner that
best protects and promotes the public health--
``(A) total abstinence from tobacco use;
``(B) reductions in consumption of tobacco; and
``(C) reductions in the harm associated with
continued tobacco use.
``(2) Recommendations.--The report under paragraph (1)
shall include the recommendations of the Secretary on how the
Food and Drug Administration should coordinate and facilitate
the exchange of information on such innovative products and
treatments among relevant offices and centers within the
Administration and within the National Institutes of Health,
the Centers for Disease Control and Prevention, and other
relevant agencies.
``SEC. 919. USER FEES.
``(a) Establishment of Quarterly Fee.--Beginning on the date of the
enactment of the Family Smoking Prevention and Tobacco Control Act, the
Secretary shall in accordance with this section assess user fees on,
and collect such fees from, each manufacturer and importer of tobacco
products subject to this chapter. The fees shall be assessed and
collected with respect to each quarter of each fiscal year, and the
total amount assessed and collected for a fiscal year shall be the
amount specified in subsection (b)(1) for such year, subject to
subsection (c).
``(b) Assessment of User Fee.--
``(1) Amount of assessment.--The total amount of user fees
authorized to be assessed and collected under subsection (a)
for a fiscal year is the following, as applicable to the fiscal
year involved:
``(A) For fiscal year 2009, $85,000,000 (subject to
subsection (e)).
``(B) For fiscal year 2010, $235,000,000.
``(C) For fiscal year 2011, $450,000,000.
``(D) For fiscal year 2012, $477,000,000.
``(E) For fiscal year 2013, $505,000,000.
``(F) For fiscal year 2014, $534,000,000.
``(G) For fiscal year 2015, $566,000,000.
``(H) For fiscal year 2016, $599,000,000.
``(I) For fiscal year 2017, $635,000,000.
``(J) For fiscal year 2018, $672,000,000.
``(K) For fiscal year 2019 and each subsequent
fiscal year, $712,000,000.
``(2) Allocations of assessment by class of tobacco
products.--
``(A) In general.--The total user fees assessed and
collected under subsection (a) each fiscal year with
respect to each class of tobacco products shall be an
amount that is equal to the applicable percentage of
each class for the fiscal year multiplied by the amount
specified in paragraph (1) for the fiscal year.
``(B) Applicable percentage.--
``(i) In general.--For purposes of
subparagraph (A), the applicable percentage for
a fiscal year for each of the following classes
of tobacco products shall be determined in
accordance with clause (ii):
``(I) Cigarettes.
``(II) Cigars, including small
cigars and cigars other than small
cigars.
``(III) Snuff.
``(IV) Chewing tobacco.
``(V) Pipe tobacco.
``(VI) Roll-your-own tobacco.
``(ii) Allocations.--The applicable
percentage of each class of tobacco product
described in clause (i) for a fiscal year shall
be the percentage determined under section
625(c) of Public Law 108-357 for each such
class of product for such fiscal year.
``(iii) Requirement of regulations.--
Notwithstanding clause (ii), no user fees shall
be assessed on a class of tobacco products
unless such class of tobacco products is listed
in section 901(b) or is deemed by the Secretary
in a regulation under section 901(b) to be
subject to this chapter.
``(iv) Reallocations.--In the case of a
class of tobacco products that is not listed in
section 901(b) or deemed by the Secretary in a
regulation under section 901(b) to be subject
to this chapter, the amount of user fees that
would otherwise be assessed to such class of
tobacco products shall be reallocated to the
classes of tobacco products that are subject to
this chapter in the same manner and based on
the same relative percentages otherwise
determined under clause (ii).
``(3) Determination of user fee by company.--
``(A) In general.--The total user fee to be paid by
each manufacturer or importer of a particular class of
tobacco products shall be determined for each quarter
by multiplying--
``(i) such manufacturer's or importer's
percentage share as determined under paragraph
(4); by
``(ii) the portion of the user fee amount
for the current quarter to be assessed on all
manufacturers and importers of such class of
tobacco products as determined under paragraph
(2).
``(B) No fee in excess of percentage share.--No
manufacturer or importer of tobacco products shall be
required to pay a user fee in excess of the percentage
share of such manufacturer or importer.
``(4) Allocation of assessment within each class of tobacco
product.--The percentage share of each manufacturer or importer
of a particular class of tobacco products of the total user fee
to be paid by all manufacturers or importers of that class of
tobacco products shall be the percentage determined for
purposes of allocations under subsections (e) through (h) of
section 625 of Public Law 108-357.
``(5) Allocation for cigars.--Notwithstanding paragraph
(4), if a user fee assessment is imposed on cigars, the
percentage share of each manufacturer or importer of cigars
shall be based on the excise taxes paid by such manufacturer or
importer during the prior fiscal year.
``(6) Timing of assessment.--The Secretary shall notify
each manufacturer and importer of tobacco products subject to
this section of the amount of the quarterly assessment imposed
on such manufacturer or importer under this subsection for each
quarter of each fiscal year. Such notifications shall occur not
later than 30 days prior to the end of the quarter for which
such assessment is made, and payments of all assessments shall
be made by the last day of the quarter involved.
``(7) Memorandum of understanding.--
``(A) In general.--The Secretary shall request the
appropriate Federal agency to enter into a memorandum
of understanding that provides for the regular and
timely transfer from the head of such agency to the
Secretary of the information described in paragraphs
(2)(B)(ii) and (4) and all necessary information
regarding all tobacco product manufacturers and
importers required to pay user fees. The Secretary
shall maintain all disclosure restrictions established
by the head of such agency regarding the information
provided under the memorandum of understanding.
``(B) Assurances.--Beginning not later than fiscal
year 2015, and for each subsequent fiscal year, the
Secretary shall ensure that the Food and Drug
Administration is able to determine the applicable
percentages described in paragraph (2) and the
percentage shares described in paragraph (4). The
Secretary may carry out this subparagraph by entering
into a contract with the head of the Federal agency
referred to in subparagraph (A) to continue to provide
the necessary information.
``(c) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations
Acts. Such fees are authorized to remain available until
expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation.
``(2) Availability.--
``(A) In general.--Fees appropriated under
paragraph (3) are available only for the purpose of
paying the costs of the activities of the Food and Drug
Administration related to the regulation of tobacco
products under this chapter and the Family Smoking
Prevention and Tobacco Control Act. No fees collected
under subsection (a) may be used for any other costs.
``(B) Prohibition against use of other funds.--
``(i) In general.--Except as provided in
clause (ii), fees collected under subsection
(a) are the only funds authorized to be made
available for the purpose described in
subparagraph (A).
``(ii) Startup costs.--Clause (i) does not
apply until the date on which the Secretary has
collected fees under subsection (a) for 2
fiscal year quarters. Until such date, other
amounts available to the Food and Drug
Administration (excluding fees collected under
subsection (a)) are authorized to be made
available to pay the costs described in
subparagraph (A), provided that such amounts
are reimbursed through fees collected under
subsection (a).
``(3) Authorization of appropriations.--For fiscal year
2009 and each subsequent fiscal year, there is authorized to be
appropriated for fees under this section an amount equal to the
amount specified in subsection (b)(1) for the fiscal year.
``(d) Collection of Unpaid Fees.--In any case where the Secretary
does not receive payment of a fee assessed under subsection (a) within
30 days after it is due, such fee shall be treated as a claim of the
United States Government subject to subchapter II of chapter 37 of
title 31, United States Code.
``(e) Applicability to Fiscal Year 2009.--If the date of the
enactment of the Family Smoking Prevention and Tobacco Control Act
occurs during fiscal year 2009, the following applies, subject to
subsection (c):
``(1) The Secretary shall determine the fees that would
apply for a single quarter of such fiscal year according to the
application of subsection (b) to the amount specified in
paragraph (1)(A) of such subsection (referred to in this
subsection as the `quarterly fee amounts').
``(2) For the quarter in which such date of enactment
occurs, the amount of fees assessed shall be a pro rata amount,
determined according to the number of days remaining in the
quarter (including such date of enactment) and according to the
daily equivalent of the quarterly fee amounts. Fees assessed
under the preceding sentence shall not be collected until the
next quarter.
``(3) For the quarter following the quarter to which
paragraph (2) applies, the full quarterly fee amounts shall be
assessed and collected, in addition to collection of the pro
rata fees assessed under paragraph (2).
``(f) Study by GAO.--
``(1) In general.--The Comptroller General of the United
States shall conduct a study on--
``(A) the prevalence of youth tobacco use and the
brands and subbrands that individuals under the age of
18 consume;
``(B) the feasibility of structuring the user fees
or a portion of the user fees collected under this
section on the youth market share of a manufacturer or
year to year changes in a manufacturer's share of youth
market; and
``(C) the potential effects of tobacco marketing to
youth audiences if user fees were calculated in whole
or in part on youth market share.
``(2) Report.--The Comptroller General shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report on the study conducted
under paragraph (1) by not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act.''.
SEC. 102. FINAL RULE.
(a) Cigarettes and Smokeless Tobacco.--
(1) In general.--On the first day of publication of the
Federal Register that is 180 days or more after the date of
enactment of this Act, the Secretary of Health and Human
Services shall publish in the Federal Register a final rule
regarding cigarettes and smokeless tobacco, which--
(A) is deemed to be issued under chapter 9 of the
Federal Food, Drug, and Cosmetic Act, as added by
section 101 of this Act; and
(B) shall be deemed to be in compliance with all
applicable provisions of chapter 5 of title 5, United
States Code, and all other provisions of law relating
to rulemaking procedures.
(2) Contents of rule.--Except as provided in this
subsection, the final rule published under paragraph (1), shall
be identical in its provisions to part 897 of the regulations
promulgated by the Secretary of Health and Human Services in
the August 28, 1996, issue of the Federal Register (61 Fed.
Reg., 44615-44618). Such rule shall--
(A) provide for the designation of jurisdictional
authority that is in accordance with this subsection in
accordance with this Act and the amendments made by
this Act;
(B) strike Subpart C--Labels and section 897.32(c);
(C) strike paragraphs (a), (b), and (i) of section
897.3 and insert definitions of the terms
``cigarette'', ``cigarette tobacco,'', and ``smokeless
tobacco'' as defined in section 900 of the Federal
Food, Drug, and Cosmetic Act;
(D) insert ``or roll-your-own paper'' in section
897.34(a) after ``other than cigarettes or smokeless
tobacco'';
(E) become effective on the date that is 1 year
after the date of enactment of this Act; and
(F) amend paragraph (d) of section 897.16 to read
as follows:
``(d)(1) Except as provided in subparagraph (2), no manufacturer,
distributor, or retailer may distribute or cause to be distributed any
free samples of cigarettes, smokeless tobacco, or other tobacco
products (as such term is defined in section 201 of the Federal Food,
Drug, and Cosmetic Act).
``(2)(A) Subparagraph (1) does not prohibit a manufacturer,
distributor, or retailer from distributing or causing to be distributed
free samples of smokeless tobacco in a qualified adult-only facility.
``(B) This subparagraph does not affect the authority of a State or
local government to prohibit or otherwise restrict the distribution of
free samples of smokeless tobacco.
``(C) For purposes of this paragraph, the term `qualified adult-
only facility' means a facility or restricted area that--
``(i) requires each person present to provide to a law
enforcement officer (whether on or off duty) or to a security
guard licensed by a governmental entity government-issued
identification showing a photograph and at least the minimum
age established by applicable law for the purchase of smokeless
tobacco;
``(ii) does not sell, serve, or distribute alcohol;
``(iii) is not located adjacent to or immediately across
from (in any direction) a space that is used primarily for
youth-oriented marketing, promotional, or other activities;
``(iv) is a temporary structure constructed, designated,
and operated as a distinct enclosed area for the purpose of
distributing free samples of smokeless tobacco in accordance
with this subparagraph; and
``(v) is enclosed by a barrier that--
``(I) is constructed of, or covered with, an opaque
material (except for entrances and exits);
``(II) extends from no more than 12 inches above
the ground or floor (which area at the bottom of the
barrier must be covered with material that restricts
visibility but may allow airflow) to at least 8 feet
above the ground or floor (or to the ceiling); and
``(III) prevents persons outside the qualified
adult-only facility from seeing into the qualified
adult-only facility, unless they make unreasonable
efforts to do so; and
``(vi) does not display on its exterior--
``(I) any tobacco product advertising;
``(II) a brand name other than in conjunction with
words for an area or enclosure to identify an adult-
only facility; or
``(III) any combination of words that would imply
to a reasonable observer that the manufacturer,
distributor, or retailer has a sponsorship that would
violate section 897.34(c).
``(D) Distribution of samples of smokeless tobacco under this
subparagraph permitted to be taken out of the qualified adult-only
facility shall be limited to 1 package per adult consumer containing no
more than 0.53 ounces (15 grams) of smokeless tobacco. If such package
of smokeless tobacco contains individual portions of smokeless tobacco,
the individual portions of smokeless tobacco shall not exceed 8
individual portions and the collective weight of such individual
portions shall not exceed 0.53 ounces (15 grams). Any manufacturer,
distributor, or retailer who distributes or causes to be distributed
free samples also shall take reasonable steps to ensure that the above
amounts are limited to one such package per adult consumer per day.
``(3) Notwithstanding subparagraph (2), no manufacturer,
distributor, or retailer may distribute or cause to be distributed any
free samples of smokeless tobacco--
``(A) to a sports team or entertainment group; or
``(B) at any football, basketball, baseball, soccer, or
hockey event or any other sporting or entertainment event
determined by the Secretary to be covered by this subparagraph.
``(4) The Secretary shall implement a program to ensure compliance
with this paragraph and submit a report to the Congress on such
compliance not later than 18 months after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act.
``(5) Nothing in this paragraph shall be construed to authorize any
person to distribute or cause to be distributed any sample of a tobacco
product to any individual who has not attained the minimum age
established by applicable law for the purchase of such product.''.
(3) Amendments to rule.--Prior to making amendments to the
rule published under paragraph (1), the Secretary shall
promulgate a proposed rule in accordance with chapter 5 of
title 5, United States Code.
(4) Rule of construction.--Except as provided in paragraph
(3), nothing in this section shall be construed to limit the
authority of the Secretary to amend, in accordance with chapter
5 of title 5, United States Code, the regulation promulgated
pursuant to this section, including the provisions of such
regulation relating to distribution of free samples.
(5) Enforcement of retail sale provisions.--The Secretary
of Health and Human Services shall ensure that the provisions
of this Act, the amendments made by this Act, and the
implementing regulations (including such provisions,
amendments, and regulations relating to the retail sale of
tobacco products) are enforced with respect to the United
States and Indian tribes.
(6) Qualified adult-only facility.--A qualified adult-only
facility (as such term is defined in section 897.16(d) of the
final rule published under paragraph (1)) that is also a
retailer and that commits a violation as a retailer shall not
be subject to the limitations in section 103(q) and shall be
subject to penalties applicable to a qualified adult-only
facility.
(7) Congressional review provisions.--Section 801 of title
5, United States Code, shall not apply to the final rule
published under paragraph (1).
(b) Limitation on Advisory Opinions.--As of the date of enactment
of this Act, the following documents issued by the Food and Drug
Administration shall not constitute advisory opinions under section
10.85(d)(1) of title 21, Code of Federal Regulations, except as they
apply to tobacco products, and shall not be cited by the Secretary of
Health and Human Services or the Food and Drug Administration as
binding precedent:
(1) The preamble to the proposed rule in the document
titled ``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco Products to Protect Children
and Adolescents'' (60 Fed. Reg. 41314-41372 (August 11, 1995)).
(2) The document titled ``Nicotine in Cigarettes and
Smokeless Tobacco Products is a Drug and These Products Are
Nicotine Delivery Devices Under the Federal Food, Drug, and
Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
(3) The preamble to the final rule in the document titled
``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
(4) The document titled ``Nicotine in Cigarettes and
Smokeless Tobacco is a Drug and These Products are Nicotine
Delivery Devices Under the Federal Food, Drug, and Cosmetic
Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318
(August 28, 1996)).
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.
(a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as
otherwise expressly provided, whenever in this section an amendment is
expressed in terms of an amendment to, or repeal of, a section or other
provision, the reference is to a section or other provision of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
(1) in subsection (a), by inserting ``tobacco product,''
after ``device,'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (c), by inserting ``tobacco product,''
after ``device,'';
(4) in subsection (e)--
(A) by striking the period after ``572(i)''; and
(B) by striking ``or 761 or the refusal to permit
access to'' and inserting ``761, 909, or 920 or the
refusal to permit access to'';
(5) in subsection (g), by inserting ``tobacco product,''
after ``device,'';
(6) in subsection (h), by inserting ``tobacco product,''
after ``device,'';
(7) in subsection (j)--
(A) by striking the period after ``573''; and
(B) by striking ``708, or 721'' and inserting
``708, 721, 904, 905, 906, 907, 908, 909, or 920(b)'';
(8) in subsection (k), by inserting ``tobacco product,''
after ``device,'';
(9) by striking subsection (p) and inserting the following:
``(p) The failure to register in accordance with section 510 or
905, the failure to provide any information required by section 510(j),
510(k), 905(i), or 905(j), or the failure to provide a notice required
by section 510(j)(2) or 905(i)(3).'';
(10) by striking subsection (q)(1) and inserting the
following:
``(q)(1) The failure or refusal--
``(A) to comply with any requirement prescribed under
section 518, 520(g), 903(b), 907, 908, or 916;
``(B) to furnish any notification or other material or
information required by or under section 519, 520(g), 904, 909,
or 920; or
``(C) to comply with a requirement under section 522 or
913.'';
(11) in subsection (q)(2), by striking ``device,'' and
inserting ``device or tobacco product,'';
(12) in subsection (r), by inserting ``or tobacco product''
after the term ``device'' each time that such term appears; and
(13) by adding at the end the following:
``(oo) The sale of tobacco products in violation of a no-tobacco-
sale order issued under section 303(f).
``(pp) The introduction or delivery for introduction into
interstate commerce of a tobacco product in violation of section 911.
``(qq)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp
(including tax stamp), tag, label, or other identification device upon
any tobacco product or container or labeling thereof so as to render
such tobacco product a counterfeit tobacco product.
``(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate, stone, or
other item that is designed to print, imprint, or reproduce the
trademark, trade name, or other identifying mark, imprint, or device of
another or any likeness of any of the foregoing upon any tobacco
product or container or labeling thereof so as to render such tobacco
product a counterfeit tobacco product.
``(3) The doing of any act that causes a tobacco product to be a
counterfeit tobacco product, or the sale or dispensing, or the holding
for sale or dispensing, of a counterfeit tobacco product.
``(rr) The charitable distribution of tobacco products.
``(ss) The failure of a manufacturer or distributor to notify the
Attorney General and the Secretary of the Treasury of their knowledge
of tobacco products used in illicit trade.
``(tt) With respect to a tobacco product, any statement directed to
consumers through the media or through the label, labeling, or
advertising that would reasonably be expected to result in consumers
believing that the product is regulated, inspected or approved by the
Food and Drug Administration, or that the product complies with the
requirements of the Food and Drug Administration, including a statement
or implication in the label, labeling, or advertising of such product,
and that could result in consumers believing that the product is
endorsed for use by the Food and Drug Administration or in consumers
being misled about the harmfulness of the product because of such
regulation, inspection, or compliance.''.
(c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
(1) in paragraph (1)(A), by inserting ``or tobacco
products'' after the term ``devices'' each place such term
appears;
(2) in paragraph (5)--
(A) in subparagraph (A)--
(i) by striking ``assessed'' the first time
it appears and inserting ``assessed, or a no-
tobacco-sale order may be imposed,''; and
(ii) by striking ``penalty'' the second
time it appears and inserting ``penalty, or
upon whom a no-tobacco-sale order is to be
imposed,'';
(B) in subparagraph (B)--
(i) by inserting after ``penalty,'' the
following: ``or the period to be covered by a
no-tobacco-sale order,''; and
(ii) by adding at the end the following:
``A no-tobacco-sale order permanently
prohibiting an individual retail outlet from
selling tobacco products shall include
provisions that allow the outlet, after a
specified period of time, to request that the
Secretary compromise, modify, or terminate the
order.''; and
(C) by adding at the end the following:
``(D) The Secretary may compromise, modify, or terminate, with or
without conditions, any no-tobacco-sale order.'';
(3) in paragraph (6)--
(A) by inserting ``or the imposition of a no-
tobacco-sale order'' after the term ``penalty'' each
place such term appears; and
(B) by striking ``issued.'' and inserting ``issued,
or on which the no-tobacco-sale order was imposed, as
the case may be.''; and
(4) by adding at the end the following:
``(8) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph (1).
Prior to the entry of a no-sale order under this paragraph, a
person shall be entitled to a hearing pursuant to the
procedures established through regulations of the Food and Drug
Administration for assessing civil money penalties, including
at a retailer's request a hearing by telephone, or at the
nearest regional or field office of the Food and Drug
Administration, or at a Federal, State, or county facility
within 100 miles from the location of the retail outlet, if
such a facility is available.''.
(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and'' before ``(D)''; and
(B) by striking ``device.'' and inserting the
following: ``device, and (E) Any adulterated or
misbranded tobacco product.'';
(2) in subsection (d)(1), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (g)(1), by inserting ``or tobacco
product'' after the term ``device'' each place such term
appears; and
(4) in subsection (g)(2)(A), by inserting ``or tobacco
product'' after ``device''.
(e) Section 505.--Section 505(n)(2) (21 U.S.C. 355(n)(2)) is
amended by striking ``section 904'' and inserting ``section 1004''.
(f) Section 523.--Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is
amended by striking ``section 903(g)'' and inserting ``section
1003(g)''.
(g) Section 702.--Section 702(a)(1) (U.S.C. 372(a)(1)) is amended--
(1) by striking ``(a)(1)'' and inserting ``(a)(1)(A)''; and
(2) by adding at the end the following:
``(B)(i) For a tobacco product, to the extent feasible, the
Secretary shall contract with the States in accordance with this
paragraph to carry out inspections of retailers within that State in
connection with the enforcement of this Act.
``(ii) The Secretary shall not enter into any contract under clause
(i) with the government of any of the several States to exercise
enforcement authority under this Act on Indian lands without the
express written consent of the Indian tribe involved.''.
(h) Section 703.--Section 703 (21 U.S.C. 373) is amended--
(1) by inserting ``tobacco product,'' after the term
``device,'' each place such term appears; and
(2) by inserting ``tobacco products,'' after the term
``devices,'' each place such term appears.
(i) Section 704.--Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)(A), by inserting ``tobacco
products,'' after the term ``devices,'' each place such term
appears;
(2) in subsection (a)(1)(B), by inserting ``or tobacco
products'' after the term ``restricted devices'' each place
such term appears;
(3) in subsection (b), by inserting ``tobacco product,''
after ``device,''; and
(4) in subsection (g)(13), by striking ``section 903(g)''
and inserting ``section 1003(g)''.
(j) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by
inserting ``tobacco products,'' after ``devices,''.
(k) Section 709.--Section 709 (21 U.S.C. 379a) is amended by
inserting ``tobacco product,'' after ``device,''.
(l) Section 801.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``tobacco products,'' after the
term ``devices,'' ;
(B) by inserting ``or section 905(h)'' after
``section 510''; and
(C) by striking the term ``drugs or devices'' each
time such term appears and inserting ``drugs, devices,
or tobacco products'';
(2) in subsection (e)(1), by inserting ``tobacco product,''
after ``device,''; and
(3) by adding at the end the following:
``(p)(1) Not later than 36 months after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act, and annually
thereafter, the Secretary shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives, a report
regarding--
``(A) the nature, extent, and destination of United States
tobacco product exports that do not conform to tobacco product
standards established pursuant to this Act;
``(B) the public health implications of such exports,
including any evidence of a negative public health impact; and
``(C) recommendations or assessments of policy alternatives
available to Congress and the executive branch to reduce any
negative public health impact caused by such exports.
``(2) The Secretary is authorized to establish appropriate
information disclosure requirements to carry out this subsection.''.
(m) Section 1003.--Section 1003(d)(2)(C) (as redesignated by
section 101(b)) is amended--
(1) by striking ``and'' after ``cosmetics,''; and
(2) inserting ``, and tobacco products'' after ``devices''.
(n) Section 1009.--Section 1009(b) (as redesignated by section
101(b)) is amended by striking ``section 908'' and inserting ``section
1008''.
(o) Section 409 of the Federal Meat Inspection Act.--Section 409(a)
of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by
striking ``section 902(b)'' and inserting ``section 1002(b)''.
(p) Rule of Construction.--Nothing in this section is intended or
shall be construed to expand, contract, or otherwise modify or amend
the existing limitations on State government authority over tribal
restricted fee or trust lands.
(q) Guidance and Effective Dates.--
(1) In general.--The Secretary of Health and Human Services
shall issue guidance--
(A) defining the term ``repeated violation'', as
used in section 303(f)(8) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by
subsection (c), as including at least 5 violations of
particular requirements over a 36-month period at a
particular retail outlet that constitute a repeated
violation and providing for civil penalties in
accordance with paragraph (2);
(B) providing for timely and effective notice by
certified or registered mail or personal delivery to
the retailer of each alleged violation at a particular
retail outlet prior to conducting a followup compliance
check, such notice to be sent to the location specified
on the retailer's registration or to the retailer's
registered agent if the retailer has provider such
agent information to the Food and Drug Administration
prior to the violation;
(C) providing for a hearing pursuant to the
procedures established through regulations of the Food
and Drug Administration for assessing civil money
penalties, including at a retailer's request a hearing
by telephone or at the nearest regional or field office
of the Food and Drug Administration, and providing for
an expedited procedure for the administrative appeal of
an alleged violation;
(D) providing that a person may not be charged with
a violation at a particular retail outlet unless the
Secretary has provided notice to the retailer of all
previous violations at that outlet;
(E) establishing that civil money penalties for
multiple violations shall increase from one violation
to the next violation pursuant to paragraph (2) within
the time periods provided for in such paragraph;
(F) providing that good faith reliance on the
presentation of a false government-issued photographic
identification that contains a date of birth does not
constitute a violation of any minimum age requirement
for the sale of tobacco products if the retailer has
taken effective steps to prevent such violations,
including--
(i) adopting and enforcing a written policy
against sales to minors;
(ii) informing its employees of all
applicable laws;
(iii) establishing disciplinary sanctions
for employee noncompliance; and
(iv) requiring its employees to verify age
by way of photographic identification or
electronic scanning device; and
(G) providing for the Secretary, in determining
whether to impose a no-tobacco-sale order and in
determining whether to compromise, modify, or terminate
such an order, to consider whether the retailer has
taken effective steps to prevent violations of the
minimum age requirements for the sale of tobacco
products, including the steps listed in subparagraph
(F).
(2) Penalties for violations.--
(A) In general.--The amount of the civil penalty to
be applied for violations of restrictions promulgated
under section 906(d), as described in paragraph (1),
shall be as follows:
(i) With respect to a retailer with an
approved training program, the amount of the
civil penalty shall not exceed--
(I) in the case of the first
violation, $0.00 together with the
issuance of a warning letter to the
retailer;
(II) in the case of a second
violation within a 12-month period,
$250;
(III) in the case of a third
violation within a 24-month period,
$500;
(IV) in the case of a fourth
violation within a 24-month period,
$2,000;
(V) in the case of a fifth
violation within a 36-month period,
$5,000; and
(VI) in the case of a sixth or
subsequent violation within a 48-month
period, $10,000 as determined by the
Secretary on a case-by-case basis.
(ii) With respect to a retailer that does
not have an approved training program, the
amount of the civil penalty shall not exceed--
(I) in the case of the first
violation, $250;
(II) in the case of a second
violation within a 12-month period,
$500;
(III) in the case of a third
violation within a 24-month period,
$1,000;
(IV) in the case of a fourth
violation within a 24-month period,
$2,000;
(V) in the case of a fifth
violation within a 36-month period,
$5,000; and
(VI) in the case of a sixth or
subsequent violation within a 48-month
period, $10,000 as determined by the
Secretary on a case-by-case basis.
(B) Training program.--For purposes of subparagraph
(A), the term ``approved training program'' means a
training program that complies with standards developed
by the Food and Drug Administration for such programs.
(C) Consideration of state penalties.--The
Secretary shall coordinate with the States in enforcing
the provisions of this Act and, for purposes of
mitigating a civil penalty to be applied for a
violation by a retailer of any restriction promulgated
under section 906(d), shall consider the amount of any
penalties paid by the retailer to a State for the same
violation.
(3) General effective date.--The amendments made by
paragraphs (2), (3), and (4) of subsection (c) shall take
effect upon the issuance of guidance described in paragraph (1)
of this subsection.
(4) Special effective date.--The amendment made by
subsection (c)(1) shall take effect on the date of enactment of
this Act.
(5) Package label requirements.--The package label
requirements of paragraphs (2), (3), and (4) of section 903(a)
of the Federal Food, Drug, and Cosmetic Act (as amended by this
Act) shall take effect on the date that is 12 months after the
date of enactment of this Act. The effective date shall be with
respect to the date of manufacture, provided that, in any case,
beginning 30 days after such effective date, a manufacturer
shall not introduce into the domestic commerce of the United
States any product, irrespective of the date of manufacture,
that is not in conformance with section 903(a)(2), (3), and (4)
and section 920(a) of the Federal Food, Drug, and Cosmetic Act.
(6) Advertising requirements.--The advertising requirements
of section 903(a)(8) of the Federal Food, Drug, and Cosmetic
Act (as amended by this Act) shall take effect on the date that
is 12 months after the date of enactment of this Act.
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE TOBACCO
PRODUCTS.
The Secretary of Health and Human Services shall--
(1) convene an expert panel to conduct a study on the
public health implications of raising the minimum age to
purchase tobacco products; and
(2) not later than 5 years after the date of the enactment
of this Act, submit a report to the Congress on the results of
such study.
SEC. 105. TOBACCO INDUSTRY CONCENTRATION.
(a) Study.--The Federal Trade Commission shall conduct a study on
the causes and effects of concentration in the tobacco industry.
(b) Public Report.--The Federal Trade Commission shall transmit to
Congress a report not later than 5 years after the date of enactment of
this Act, and a subsequent report on the date that is 10 years after
the date of enactment of this Act. Such reports shall include--
(1) an analysis of trends in the market share of any
dominant tobacco product manufacturer in any class of tobacco
products; or
(2) an analysis of trends in competition or the emergence
of a monopoly; and
(3) recommendations to Congress on any corrective actions
that should be taken to address tobacco industry concentration.
SEC. 106. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND PROMOTION
RESTRICTIONS.
(a) Action Plan.--
(1) Development.--Not later than 6 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall develop and publish an action plan to enforce
restrictions adopted pursuant to section 906 of the Federal
Food, Drug, and Cosmetic Act, as added by section 101(b) of
this Act, or pursuant to section 102(a) of this Act, on
promotion and advertising of menthol and other cigarettes to
youth.
(2) Consultation.--The action plan required by paragraph
(1) shall be developed in consultation with public health
organizations and other stakeholders with demonstrated
expertise and experience in serving minority communities.
(3) Priority.--The action plan required by paragraph (1)
shall include provisions designed to ensure enforcement of the
restrictions described in paragraph (1) in minority
communities.
(b) State and Local Activities.--
(1) Information on authority.--Not later than 3 months
after the date of the enactment of this Act, the Secretary
shall inform State, local, and tribal governments of the
authority provided to such entities under section 5(c) of the
Federal Cigarette Labeling and Advertising Act, as added by
section 203 of this Act, or preserved by such entities under
section 916 of the Federal Food, Drug, and Cosmetic Act, as
added by section 101(b) of this Act.
(2) Community assistance.--At the request of communities
seeking assistance to prevent underage tobacco use, the
Secretary shall provide such assistance, including assistance
with strategies to address the prevention of underage tobacco
use in communities with a disproportionate use of menthol
cigarettes by minors.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
(a) Amendment.--Section 4 of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333) is amended to read as follows:
``SEC. 4. LABELING.
``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States any
cigarettes the package of which fails to bear, in accordance
with the requirements of this section, one of the following
labels:
``WARNING: Cigarettes are addictive.
``WARNING: Tobacco smoke can harm your children.
``WARNING: Cigarettes cause fatal lung disease.
``WARNING: Cigarettes cause cancer.
``WARNING: Cigarettes cause strokes and heart
disease.
``WARNING: Smoking during pregnancy can harm your
baby.
``WARNING: Smoking can kill you.
``WARNING: Tobacco smoke causes fatal lung disease
in nonsmokers.
``WARNING: Quitting smoking now greatly reduces
serious risks to your health.
``(2) Placement; typography; etc.--Each label statement
required by paragraph (1) shall be located in the upper portion
of the front and rear panels of the package, directly on the
package underneath the cellophane or other clear wrapping. Each
label statement shall comprise at least the top 30 percent of
the front and rear panels of the package. The word `WARNING'
shall appear in capital letters and all text shall be in
conspicuous and legible 17-point type, unless the text of the
label statement would occupy more than 70 percent of such area,
in which case the text may be in a smaller conspicuous and
legible type size, provided that at least 60 percent of such
area is occupied by required text. The text shall be black on a
white background, or white on a black background, in a manner
that contrasts, by typography, layout, or color, with all other
printed material on the package, in an alternating fashion
under the plan submitted under subsection (c).
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco product
manufacturer or distributor of cigarettes which does not
manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(4) Applicability to retailers.--A retailer of cigarettes
shall not be in violation of this subsection for packaging
that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or
permit-holding tobacco product manufacturer, importer,
or distributor; and
``(C) is not altered by the retailer in a way that
is material to the requirements of this subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a).
``(2) Typography, etc.--Each label statement required by
subsection (a) in cigarette advertising shall comply with the
standards set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable) any
required statement relating to tar, nicotine, or other
constituent (including a smoke constituent) yield shall
comprise at least 20 percent of the area of the advertisement
and shall appear in a conspicuous and prominent format and
location at the top of each advertisement within the trim area.
The Secretary may revise the required type sizes in such area
in such manner as the Secretary determines appropriate. The
word `WARNING' shall appear in capital letters, and each label
statement shall appear in conspicuous and legible type. The
text of the label statement shall be black if the background is
white and white if the background is black, under the plan
submitted under subsection (c). The label statements shall be
enclosed by a rectangular border that is the same color as the
letters of the statements and that is the width of the first
downstroke of the capital `W' of the word `WARNING' in the
label statements. The text of such label statements shall be in
a typeface pro rata to the following requirements: 45-point
type for a whole-page broadsheet newspaper advertisement; 39-
point type for a half-page broadsheet newspaper advertisement;
39-point type for a whole-page tabloid newspaper advertisement;
27-point type for a half-page tabloid newspaper advertisement;
31.5-point type for a double page spread magazine or whole-page
magazine advertisement; 22.5-point type for a 28 centimeter by
3 column advertisement; and 15-point type for a 20 centimeter
by 2 column advertisement. The label statements shall be in
English, except that--
``(A) in the case of an advertisement that appears
in a newspaper, magazine, periodical, or other
publication that is not in English, the statements
shall appear in the predominant language of the
publication; and
``(B) in the case of any other advertisement that
is not in English, the statements shall appear in the
same language as that principally used in the
advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of tobacco products,
each label statement required by subsection (a) may be printed
on the inside cover of the matchbook.
``(4) Adjustment by secretary.--The Secretary may, through
a rulemaking under section 553 of title 5, United States Code,
adjust the format and type sizes for the label statements
required by this section; the text, format, and type sizes of
any required tar, nicotine yield, or other constituent
(including smoke constituent) disclosures; or the text, format,
and type sizes for any other disclosures required under the
Federal Food, Drug, and Cosmetic Act. The text of any such
label statements or disclosures shall be required to appear
only within the 20 percent area of cigarette advertisements
provided by paragraph (2). The Secretary shall promulgate
regulations which provide for adjustments in the format and
type sizes of any text required to appear in such area to
ensure that the total text required to appear by law will fit
within such area.
``(c) Marketing Requirements.--
``(1) Random display.--The label statements specified in
subsection (a)(1) shall be randomly displayed in each 12-month
period, in as equal a number of times as is possible on each
brand of the product and be randomly distributed in all areas
of the United States in which the product is marketed in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer and approved
by the Secretary.
``(2) Rotation.--The label statements specified in
subsection (a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the plan--
``(A) will provide for the equal distribution and
display on packaging and the rotation required in
advertising under this subsection; and
``(B) assures that all of the labels required under
this section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the
same time.
``(4) Applicability to retailers.--This subsection and
subsection (b) apply to a retailer only if that retailer is
responsible for or directs the label statements required under
this section except that this paragraph shall not relieve a
retailer of liability if the retailer displays, in a location
open to the public, an advertisement that does not contain a
warning label or has been altered by the retailer in a way that
is material to the requirements of this subsection and
subsection (b).''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect 12 months after the date of enactment of this Act. Such
effective date shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such effective
date, a manufacturer shall not introduce into the domestic commerce of
the United States any product, irrespective of the date of manufacture,
that is not in conformance with section 4 of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1333), as amended by subsection
(a).
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.
(a) Preemption.--Section 5(a) of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1334(a)) is amended by striking ``No'' and
inserting ``Except to the extent the Secretary requires additional or
different statements on any cigarette package by a regulation, by an
order, by a standard, by an authorization to market a product, or by a
condition of marketing a product, pursuant to the Family Smoking
Prevention and Tobacco Control Act (and the amendments made by that
Act), or as required under section 903(a)(2) or section 920(a) of the
Federal Food, Drug, and Cosmetic Act, no''.
(b) Change in Required Statements.--Section 4 of the Federal
Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as amended by
section 201, is further amended by adding at the end the following:
``(d) Change in Required Statements.--The Secretary may, by a
rulemaking conducted under section 553 of title 5, United States Code,
adjust the format, type size, and text of any of the label
requirements, require color graphics to accompany the text, increase
the required label area from 30 percent up to 50 percent of the front
and rear panels of the package, or establish the format, type size, and
text of any other disclosures required under the Federal Food, Drug,
and Cosmetic Act, if the Secretary finds that such a change would
promote greater public understanding of the risks associated with the
use of tobacco products.''.
SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND PROMOTION.
Section 5 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1334) is amended by adding at the end the following:
``(c) Exception.--Notwithstanding subsection (b), a State or
locality may enact statutes and promulgate regulations, based on
smoking and health, that take effect after the effective date of the
Family Smoking Prevention and Tobacco Control Act, imposing specific
bans or restrictions on the time, place, and manner, but not content,
of the advertising or promotion of any cigarettes.''.
SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.
(a) Amendment.--Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402) is amended to read as
follows:
``SEC. 3. SMOKELESS TOBACCO WARNING.
``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any smokeless tobacco
product unless the product package bears, in accordance with
the requirements of this Act, one of the following labels:
``WARNING: This product can cause mouth cancer.
``WARNING: This product can cause gum disease and
tooth loss.
``WARNING: This product is not a safe alternative
to cigarettes.
``WARNING: Smokeless tobacco is addictive.
``(2) Each label statement required by paragraph (1) shall
be--
``(A) located on the 2 principal display panels of
the package, and each label statement shall comprise at
least 30 percent of each such display panel; and
``(B) in 17-point conspicuous and legible type and
in black text on a white background, or white text on a
black background, in a manner that contrasts by
typography, layout, or color, with all other printed
material on the package, in an alternating fashion
under the plan submitted under subsection (b)(3),
except that if the text of a label statement would
occupy more than 70 percent of the area specified by
subparagraph (A), such text may appear in a smaller
type size, so long as at least 60 percent of such
warning area is occupied by the label statement.
``(3) The label statements required by paragraph (1) shall
be introduced by each tobacco product manufacturer, packager,
importer, distributor, or retailer of smokeless tobacco
products concurrently into the distribution chain of such
products.
``(4) The provisions of this subsection do not apply to a
tobacco product manufacturer or distributor of any smokeless
tobacco product that does not manufacture, package, or import
smokeless tobacco products for sale or distribution within the
United States.
``(5) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that--
``(A) contains a warning label;
``(B) is supplied to the retailer by a license- or
permit-holding tobacco product manufacturer, importer,
or distributor; and
``(C) is not altered by the retailer in a way that
is material to the requirements of this subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of
smokeless tobacco products to advertise or cause to be
advertised within the United States any smokeless tobacco
product unless its advertising bears, in accordance with the
requirements of this section, one of the labels specified in
subsection (a).
``(2)(A) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph.
``(B) For press and poster advertisements, each such
statement and (where applicable) any required statement
relating to tar, nicotine, or other constituent yield shall
comprise at least 20 percent of the area of the advertisement.
``(C) The word `WARNING' shall appear in capital letters,
and each label statement shall appear in conspicuous and
legible type.
``(D) The text of the label statement shall be black on a
white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph
(3).
``(E) The label statements shall be enclosed by a
rectangular border that is the same color as the letters of the
statements and that is the width of the first downstroke of the
capital `W' of the word `WARNING' in the label statements.
``(F) The text of such label statements shall be in a
typeface pro rata to the following requirements: 45-point type
for a whole-page broadsheet newspaper advertisement; 39-point
type for a half-page broadsheet newspaper advertisement; 39-
point type for a whole-page tabloid newspaper advertisement;
27-point type for a half-page tabloid newspaper advertisement;
31.5-point type for a double page spread magazine or whole-page
magazine advertisement; 22.5-point type for a 28 centimeter by
3 column advertisement; and 15-point type for a 20 centimeter
by 2 column advertisement.
``(G) The label statements shall be in English, except
that--
``(i) in the case of an advertisement that appears
in a newspaper, magazine, periodical, or other
publication that is not in English, the statements
shall appear in the predominant language of the
publication; and
``(ii) in the case of any other advertisement that
is not in English, the statements shall appear in the
same language as that principally used in the
advertisement.
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month period, in
as equal a number of times as is possible on each brand of the
product and be randomly distributed in all areas of the United
States in which the product is marketed in accordance with a
plan submitted by the tobacco product manufacturer, importer,
distributor, or retailer and approved by the Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraphs (A) and (B) and approve it if the plan--
``(i) will provide for the equal distribution and
display on packaging and the rotation required in
advertising under this subsection; and
``(ii) assures that all of the labels required
under this section will be displayed by the tobacco
product manufacturer, importer, distributor, or
retailer at the same time.
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
under this section, unless the retailer displays, in a location
open to the public, an advertisement that does not contain a
warning label or has been altered by the retailer in a way that
is material to the requirements of this subsection.
``(4) The Secretary may, through a rulemaking under section
553 of title 5, United States Code, adjust the format and type
sizes for the label statements required by this section; the
text, format, and type sizes of any required tar, nicotine
yield, or other constituent disclosures; or the text, format,
and type sizes for any other disclosures required under the
Federal Food, Drug, and Cosmetic Act. The text of any such
label statements or disclosures shall be required to appear
only within the 20 percent area of advertisements provided by
paragraph (2). The Secretary shall promulgate regulations which
provide for adjustments in the format and type sizes of any
text required to appear in such area to ensure that the total
text required to appear by law will fit within such area.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco on any medium of electronic communications
subject to the jurisdiction of the Federal Communications
Commission.''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect 12 months after the date of enactment of this Act. Such
effective date shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such effective
date, a manufacturer shall not introduce into the domestic commerce of
the United States any product, irrespective of the date of manufacture,
that is not in conformance with section 3 of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as
amended by subsection (a)
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL
STATEMENTS.
(a) In General.--Section 3 of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402), as amended by section
204, is further amended by adding at the end the following:
``(d) Authority To Revise Warning Label Statements.--The Secretary
may, by a rulemaking conducted under section 553 of title 5, United
States Code, adjust the format, type size, and text of any of the label
requirements, require color graphics to accompany the text, increase
the required label area from 30 percent up to 50 percent of the front
and rear panels of the package, or establish the format, type size, and
text of any other disclosures required under the Federal Food, Drug,
and Cosmetic Act, if the Secretary finds that such a change would
promote greater public understanding of the risks associated with the
use of smokeless tobacco products.''.
(b) Preemption.--Section 7(a) of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4406(a)) is amended by
striking ``No'' and inserting ``Except as provided in the Family
Smoking Prevention and Tobacco Control Act (and the amendments made by
that Act), no''.
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE
PUBLIC.
Section 4 of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333), as amended by sections 201 and 202, is further amended by
adding at the end the following:
``(e) Tar, Nicotine, and Other Smoke Constituent Disclosure.--
``(1) In general.--The Secretary shall, by a rulemaking
conducted under section 553 of title 5, United States Code,
determine (in the Secretary's sole discretion) whether
cigarette and other tobacco product manufacturers shall be
required to include in the area of each cigarette advertisement
specified by subsection (b) of this section, or on the package
label, or both, the tar and nicotine yields of the advertised
or packaged brand. Any such disclosure shall be in accordance
with the methodology established under such regulations, shall
conform to the type size requirements of subsection (b) of this
section, and shall appear within the area specified in
subsection (b) of this section.
``(2) Resolution of differences.--Any differences between
the requirements established by the Secretary under paragraph
(1) and tar and nicotine yield reporting requirements
established by the Federal Trade Commission shall be resolved
by a memorandum of understanding between the Secretary and the
Federal Trade Commission.
``(3) Cigarette and other tobacco product constituents.--In
addition to the disclosures required by paragraph (1), the
Secretary may, under a rulemaking conducted under section 553
of title 5, United States Code, prescribe disclosure
requirements regarding the level of any cigarette or other
tobacco product constituent including any smoke constituent.
Any such disclosure may be required if the Secretary determines
that disclosure would be of benefit to the public health, or
otherwise would increase consumer awareness of the health
consequences of the use of tobacco products, except that no
such prescribed disclosure shall be required on the face of any
cigarette package or advertisement. Nothing in this section
shall prohibit the Secretary from requiring such prescribed
disclosure through a cigarette or other tobacco product package
or advertisement insert, or by any other means under the
Federal Food, Drug, and Cosmetic Act.
``(4) Retailers.--This subsection applies to a retailer
only if that retailer is responsible for or directs the label
statements required under this section.''.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as added by
section 101, is further amended by adding at the end the following:
``SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPECTION.
``(a) Origin Labeling.--
``(1) Requirement.--Beginning 1 year after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act, the label, packaging, and shipping containers of tobacco
products for introduction or delivery for introduction into
interstate commerce in the United States shall bear the
statement `sale only allowed in the United States'.
``(2) Effective date.--The effective date specified in
paragraph (1) shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such
effective date, a manufacturer shall not introduce into the
domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in
conformance with such paragraph.
``(b) Regulations Concerning Recordkeeping for Tracking and
Tracing.--
``(1) In general.--The Secretary shall promulgate
regulations regarding the establishment and maintenance of
records by any person who manufactures, processes, transports,
distributes, receives, packages, holds, exports, or imports
tobacco products.
``(2) Inspection.--In promulgating the regulations
described in paragraph (1), the Secretary shall consider which
records are needed for inspection to monitor the movement of
tobacco products from the point of manufacture through
distribution to retail outlets to assist in investigating
potential illicit trade, smuggling, or counterfeiting of
tobacco products.
``(3) Codes.--The Secretary may require codes on the labels
of tobacco products or other designs or devices for the purpose
of tracking or tracing the tobacco product through the
distribution system.
``(4) Size of business.--The Secretary shall take into
account the size of a business in promulgating regulations
under this section.
``(5) Recordkeeping by retailers.--The Secretary shall not
require any retailer to maintain records relating to individual
purchasers of tobacco products for personal consumption.
``(c) Records Inspection.--If the Secretary has a reasonable belief
that a tobacco product is part of an illicit trade or smuggling or is a
counterfeit product, each person who manufactures, processes,
transports, distributes, receives, holds, packages, exports, or imports
tobacco products shall, at the request of an officer or employee duly
designated by the Secretary, permit such officer or employee, at
reasonable times and within reasonable limits and in a reasonable
manner, upon the presentation of appropriate credentials and a written
notice to such person, to have access to and copy all records
(including financial records) relating to such article that are needed
to assist the Secretary in investigating potential illicit trade,
smuggling, or counterfeiting of tobacco products. The Secretary shall
not authorize an officer or employee of the government of any of the
several States to exercise authority under the preceding sentence on
Indian lands without the express written consent of the Indian tribe
involved.
``(d) Knowledge of Illegal Transaction.--
``(1) Notification.--If the manufacturer or distributor of
a tobacco product has knowledge which reasonably supports the
conclusion that a tobacco product manufactured or distributed
by such manufacturer or distributor that has left the control
of such person may be or has been--
``(A) imported, exported, distributed, or offered
for sale in interstate commerce by a person without
paying duties or taxes required by law; or
``(B) imported, exported, distributed, or diverted
for possible illicit marketing,
the manufacturer or distributor shall promptly notify the
Attorney General and the Secretary of the Treasury of such
knowledge.
``(2) Knowledge defined.--For purposes of this subsection,
the term `knowledge' as applied to a manufacturer or
distributor means--
``(A) the actual knowledge that the manufacturer or
distributor had; or
``(B) the knowledge which a reasonable person would
have had under like circumstances or which would have
been obtained upon the exercise of due care.''.
SEC. 302. STUDY AND REPORT.
(a) Study.--The Comptroller General of the United States shall
conduct a study of cross-border trade in tobacco products to--
(1) collect data on cross-border trade in tobacco products,
including illicit trade and trade of counterfeit tobacco
products and make recommendations on the monitoring of such
trade;
(2) collect data on cross-border advertising (any
advertising intended to be broadcast, transmitted, or
distributed from the United States to another country) of
tobacco products and make recommendations on how to prevent or
eliminate, and what technologies could help facilitate the
elimination of, cross-border advertising; and
(3) collect data on the health effects (particularly with
respect to individuals under 18 years of age) resulting from
cross-border trade in tobacco products, including the health
effects resulting from--
(A) the illicit trade of tobacco products and the
trade of counterfeit tobacco products; and
(B) the differing tax rates applicable to tobacco
products.
(b) Report.--Not later than 18 months after the date of enactment
of this Act, the Comptroller General of the United States shall submit
to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a report on the study described in subsection (a).
(c) Definition.--In this section:
(1) The term ``cross-border trade'' means trade across a
border of the United States, a State or Territory, or Indian
country.
(2) The term ``Indian country'' has the meaning given to
that term in section 1151 of title 18, United States Code.
(3) The terms ``State'' and ``Territory'' have the meanings
given to those terms in section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321).
TITLE IV--THRIFT SAVINGS PLAN ENHANCEMENT
SEC. 401. SHORT TITLE.
This title may be cited as the ``Thrift Savings Plan Enhancement
Act of 2008''.
SEC. 402. AUTOMATIC ENROLLMENTS.
(a) Automatic Enrollments.--
(1) In general.--Section 8432(b) of title 5, United States
Code, is amended by striking paragraphs (2) through (4) and
inserting the following:
``(2)(A) The Board shall by regulation provide for an eligible
individual to be automatically enrolled to make contributions under
subsection (a) at the default percentage of basic pay.
``(B) For purposes of this paragraph, the default percentage shall
be equal to 3 percent or such other percentage, not less than 2 percent
nor more than 5 percent, as the Board may by regulation prescribe.
``(C) The regulations shall include provisions under which any
individual who would otherwise be automatically enrolled in accordance
with subparagraph (A) may--
``(i) modify the percentage or amount to be contributed
pursuant to automatic enrollment, effective from the start of
such enrollment; or
``(ii) decline automatic enrollment altogether.
``(D) For purposes of this paragraph, the term `eligible
individual' means any individual who, after any regulations under
subparagraph (A) first take effect, is appointed, transferred, or
reappointed to a position in which that individual is eligible to
contribute to the Thrift Savings Fund.
``(E) Sections 8351(a)(1), 8440a(a)(1), 8440b(a)(1), 8440c(a)(1),
8440d(a)(1), and 8440e(a)(1) shall be applied in a manner consistent
with the purposes of this paragraph.''.
(2) Technical amendment.--Section 8432(b)(1) of title 5,
United States Code, is amended by striking the parenthetical
matter in subparagraph (B).
(b) Default Investments.--Section 8438(c)(2) of title 5, United
States Code, is amended to read as follows:
``(2) If an election has not been made with respect to any sums in
the Thrift Savings Fund which are available for investment, the
Executive Director shall invest such sums in--
``(A) the Government Securities Investment Fund; or
``(B) such alternative fund or funds (in lieu of the fund
under subparagraph (A)) as the Board may designate in
regulations.
The designation of an alternative fund by regulations under
subparagraph (B) may be made only if, in the judgment of the Board,
such designation would be in the best interests of participants. Any
decision under the preceding sentence shall be made after consultation
with the Employee Thrift Advisory Council (established under section
8473).''.
SEC. 403. QUALIFIED ROTH CONTRIBUTION PROGRAM.
(a) In General.--Subchapter III of chapter 84 of title 5, United
States Code, is amended by inserting after section 8432c the following:
``Sec. 8432d. Qualified Roth contribution program
``(a) Definitions.--For purposes of this section--
``(1) the term `qualified Roth contribution program' means
a program described in paragraph (1) of section 402A(b) of the
Internal Revenue Code of 1986 which meets the requirements of
paragraph (2) of such section; and
``(2) the terms `designated Roth contribution' and
`elective deferral' have the meanings given such terms in
section 402A of the Internal Revenue Code of 1986.
``(b) Authority To Establish.--The Board shall by regulation
provide for the inclusion in the Thrift Savings Plan of a qualified
Roth contribution program, under such terms and conditions as the Board
may prescribe.
``(c) Required Provisions.--The regulations under subsection (b)
shall include--
``(1) provisions under which an election to make designated
Roth contributions may be made--
``(A) by any individual who is eligible to make
contributions under section 8351, 8432(a), 8440a,
8440b, 8440c, 8440d, or 8440e; and
``(B) by any individual, not described in
subparagraph (A), who is otherwise eligible to make
elective deferrals under the Thrift Savings Plan;
``(2) any provisions which may, as a result of the
enactment of this section, be necessary in order to clarify the
meaning of any reference to an `account' made in section
8432(f), 8433, 8434(d), 8435, 8437, or any other provision of
law; and
``(3) any other provisions which may be necessary to carry
out this section.''.
(b) Clerical Amendment.--The analysis for chapter 84 of title 5,
United States Code, is amended by inserting after the item relating to
section 8432c the following:
``8432d. Qualified Roth contribution program.''.
SEC. 404. AUTHORITY TO ESTABLISH SELF-DIRECTED INVESTMENT WINDOW.
(a) In General.--Section 8438(b)(1) of title 5, United States Code,
is amended--
(1) in subparagraph (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the period and
inserting ``; and''; and
(3) by adding after subparagraph (E) the following:
``(F) a self-directed investment window, if the
Board authorizes such window under paragraph (5).''.
(b) Requirements.--Section 8438(b) of title 5, United States Code,
is amended by adding at the end the following:
``(5)(A) The Board may authorize the addition of a self-directed
investment window under the Thrift Savings Plan if the Board determines
that such addition would be in the best interests of participants.
``(B) The self-directed investment window shall be limited to--
``(i) low-cost, passively-managed index funds that offer
diversification benefits; and
``(ii) other investment options, if the Board determines
the options to be appropriate retirement investment vehicles
for participants.
``(C) The Board shall ensure that any administrative expenses
related to use of the self-directed investment window are borne solely
by the participants who use such window.
``(D) The Board may establish such other terms and conditions for
the self-directed investment window as the Board considers appropriate
to protect the interests of participants, including requirements
relating to risk disclosure.
``(E) The Board shall consult with the Employee Thrift Advisory
Council (established under section 8473) before establishing any self-
directed investment window.''.
SEC. 405. REPORTING REQUIREMENTS.
(a) Annual Report.--The Board shall, not later than June 30 of each
year, submit to Congress an annual report on the operations of the
Thrift Savings Plan. Such report shall include, for the prior calendar
year, information on the number of participants as of the last day of
such prior calendar year, the median balance in participants' accounts
as of such last day, demographic information on participants, the
percentage allocation of amounts among investment funds or options, the
status of the development and implementation of the self-directed
investment window, the diversity demographics of any company,
investment adviser, or other entity retained to invest and manage the
assets of the Thrift Savings Fund, and such other information as the
Board considers appropriate. A copy of each annual report under this
subsection shall be made available to the public through an Internet
website.
(b) Reporting of Fees and Other Information.--
(1) In general.--The Board shall include in the periodic
statements provided to participants under section 8439(c) the
amount of the investment management fees, administrative
expenses, and any other fees or expenses paid with respect to
each investment fund and option under the Thrift Savings Plan.
Any such statement shall also provide a statement notifying
participants as to how they may access the annual report
described in subsection (a), as well as any other information
concerning the Thrift Savings Plan that might be useful.
(2) Use of estimates.--For purposes of providing the
information required under this subsection, the Executive
Director may provide a reasonable and representative estimate
of any fees or expenses described in paragraph (1) and shall
indicate any such estimate as being such an estimate. Any such
estimate shall be based on the previous year's experience.
(c) Definitions.--For purposes of this section--
(1) the term ``Board'' has the meaning given such term by
8401(5) of title 5, United States Code;
(2) the term ``participant'' has the meaning given such
term by section 8471(3) of title 5, United States Code; and
(3) the term ``account'' means an account established under
section 8439 of title 5, United States Code.
SEC. 406. ACKNOWLEDGEMENT OF RISK.
(a) In General.--Section 8439(d) of title 5, United States Code, is
amended--
(1) by striking the matter after ``who elects to invest
in'' and before ``shall sign an acknowledgement'' and inserting
``any investment fund or option under this chapter, other than
the Government Securities Investment Fund,''; and
(2) by striking ``either such Fund'' and inserting ``any
such fund or option''.
(b) Coordination With Provisions Relating to Investments in the
Absence of an Election.--Subsection (d) of section 8439 of title 5,
United States Code (as amended by subsection (a)) is further amended--
(1) by redesignating subsection (d) as subsection (d)(1);
and
(2) by adding at the end the following:
``(2)(A) In the case of an investment made under section 8438(c)(2)
in any fund or option to which paragraph (1) would otherwise apply, the
participant involved shall, for purposes of this subsection, be
deemed--
``(i) to have elected to invest in such fund or option; and
``(ii) to have executed the acknowledgement required under
paragraph (1).
``(B)(i) The Executive Director shall prescribe regulations under
which written notice shall be provided to a participant whenever an
investment is made under section 8438(c)(2)(B) on behalf of such
participant in the absence of an affirmative election described in
section 8438(c)(1).
``(ii) The regulations shall ensure that any such notice shall be
provided to the participant within 7 calendar days after the effective
date of the default election.
``(C) For purposes of this paragraph, the term `participant' has
the meaning given such term by section 8471(3).''.
(c) Coordination With Provisions Relating to Fiduciary
Responsibilities, Liabilities, and Penalties.--Section 8477(e)(1)(C) of
title 5, United States Code, is amended--
(1) by redesignating subparagraph (C) as subparagraph
(C)(i); and
(2) by adding at the end the following:
``(ii) A fiduciary shall not be liable under subparagraph (A), and
no civil action may be brought against a fiduciary--
``(I) for providing for the automatic enrollment of a
participant in accordance with section 8432(b)(2)(A);
``(II) for enrolling a participant in a default investment
fund in accordance with section 8438(c)(2)(B); or
``(III) for allowing a participant to invest through the
self-directed investment window or for establishing
restrictions applicable to participants' ability to invest
through the self-directed investment window.''.
SEC. 407. CREDIT FOR UNUSED SICK LEAVE.
(a) In General.--Section 8415 of title 5, United States Code, is
amended--
(1) by redesignating the second subsection (k) and
subsection (l) as subsections (l) and (m), respectively; and
(2) in subsection (l) (as so redesignated by paragraph
(1))--
(A) by striking ``(l) In computing'' and inserting
``(l)(1) In computing''; and
(B) by adding at the end the following:
``(2) Except as provided in paragraph (1), in computing an annuity
under this subchapter, the total service of an employee who retires on
an immediate annuity or who dies leaving a survivor or survivors
entitled to annuity includes--
``(A) for an employee who retires within 3 years after the
date of enactment of this paragraph, \3/4\ of the days, and
``(B) for an employee who retires after 3 years after the
date of enactment of this paragraph, the days
of unused sick leave to his credit under a formal leave system, except
that these days will not be counted in determining average pay or
annuity eligibility under this subchapter. For purposes of this
subsection, in the case of any such employee who is excepted from
subchapter I of chapter 63 under section 6301(2)(x)-(xiii), the days of
unused sick leave to his credit include any unused sick leave standing
to his credit when he was excepted from such subchapter.''.
(b) Exception From Deposit Requirement.--Section 8422(d)(2) of
title 5, United States Code, is amended by striking ``section 8415(k)''
and inserting ``paragraph (1) or (2) of section 8415(l)''.
(c) Effective Date.--The amendments made by this section shall
apply with respect to annuities computed based on separations occurring
on or after the date of the enactment of this Act.
Passed the House of Representatives July 30, 2008.
Attest:
Clerk.
110th CONGRESS
2d Session
H. R. 1108
_______________________________________________________________________
AN ACT
To protect the public health by providing the Food and Drug
Administration with certain authority to regulate tobacco products.