[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1256 Enrolled Bill (ENR)]
H.R.1256
One Hundred Eleventh Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the sixth day of January, two thousand and nine
An Act
To protect the public health by providing the Food and Drug
Administration with certain authority to regulate tobacco products, to
amend title 5, United States Code, to make certain modifications in the
Thrift Savings Plan, the Civil Service Retirement System, and the
Federal Employees' Retirement System, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
DIVISION A--FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This division may be cited as the ``Family
Smoking Prevention and Tobacco Control Act''.
(b) Table of Contents.--The table of contents of this division is
as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Modification of deadlines for Secretarial action.
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. Enforcement action plan for advertising and promotion
restrictions.
Sec. 106. Studies of progress and effectiveness.
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.
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 division.
(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) 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).
(48) 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).
(49) 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 division 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 division;
(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 division (or an amendment
made by this division) 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 division (or
an amendment made by this division) 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 division (or an
amendment made by this division) 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 division, of the amendments made by this
division, or of the regulations promulgated under this division (or
under such amendments), or the application of any such provision to any
person or circumstance is held to be invalid, the remainder of this
division, such amendments and such regulations, and the application of
such provisions to any other person or circumstance shall not be
affected and shall continue to be enforced to the fullest extent
possible.
SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION.
(a) Delayed Commencement of Dates for Secretarial Action.--
(1) In general.--Except as provided in subsection (c), with
respect to any time periods specified in this division (or in an
amendment made by this division) that begin on the date of
enactment of this Act, within which the Secretary of Health and
Human Services is required to carry out and complete specified
activities, the calculation of such time periods shall commence on
the date described in subsection (b).
(2) Limitation.--Subsection (a) shall only apply with respect
to obligations of the Secretary of Health and Human Services that
must be completed within a specified time period and shall not
apply to the obligations of any other person or to any other
provision of this division (including the amendments made by this
division) that do not create such obligations of the Secretary and
are not contingent on actions by the Secretary.
(b) Date Described.--The date described in this subsection is the
first day of the first fiscal quarter following the initial 2
consecutive fiscal quarters of fiscal year 2010 for which the Secretary
of Health and Human Services has collected fees under section 919 of
the Federal Food, Drug, and Cosmetic Act (as added by section 101).
(c) Exception.--Subsection (a) shall not apply to any time period
(or date) contained--
(1) in section 102, except that the reference to ``180 days''
in subsection (a)(1) of such section shall be deemed to be ``270
days''; and
(2) in sections 201 through 204 (or the amendments made by any
such sections).
(d) Adjustment.--The Secretary of Health and Human Services may
extend or reduce the duration of one or more time periods to which
subsection (a) applies if the Secretary determines appropriate, except
that no such period shall be extended for more than 90 days.
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 shall 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 country.--The term `Indian country' has the
meaning given such term in section 1151 of title 18, United States
Code.
``(10) 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.
``(11) 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.
``(12) 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.
``(13) 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.
``(14) 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.
``(15) 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.
``(16) 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.
``(17) 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.
``(18) 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.
``(19) State; territory.--The terms `State' and `Territory'
shall have the meanings given to such terms in section 201.
``(20) 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.
``(21) 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.
``(22) 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 the Family Smoking Prevention and Tobacco
Control Act, 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 to ensure that such statements do not violate the
misbranding provisions of subsection (a) and that such statements
comply with other provisions of the Family Smoking Prevention and
Tobacco Control Act (including the amendments made by such Act). 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 the
Family Smoking Prevention and Tobacco Control 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 such date of enactment,
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 such date of enactment 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 enactment of the Family Smoking Prevention and
Tobacco Control 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
the Family Smoking Prevention and Tobacco Control Act,
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.--Beginning 2 years after the
date of enactment of the Family Smoking Prevention and Tobacco
Control Act, a tobacco product manufacturer shall not use
tobacco, including foreign grown tobacco, that contains a
pesticide chemical residue that is at a level greater than is
specified by any tolerance applicable under Federal law to
domestically grown tobacco.
``(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, the Secretary shall--
``(A) if the Secretary determines that the standard would
be appropriate for the protection of the public health,
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 children, 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.
``(f) Dissolvable Tobacco Products.--
``(1) Referral; considerations.--The Secretary shall refer to
the Tobacco Products Scientific Advisory Committee for report and
recommendation, under section 917(c)(4), the issue of the nature
and impact of the use of dissolvable tobacco products on the public
health, including such use among children. In its review, the
Tobacco Products Scientific Advisory Committee shall address the
considerations listed in subsection (a)(3)(B)(i).
``(2) Report and recommendation.--Not later than 2 years 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 at any time
applicable to any dissolvable tobacco product.
``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
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, subject to
paragraph (2)(D). 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 (referred to
in this subsection as `tobacco regulation activities'), except
that such fees may be used for the reimbursement specified in
subparagraph (C).
``(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 tobacco regulation
activities.
``(ii) Startup costs.--Clause (i) does not apply until
October 1, 2009. Until such date, any amounts available to
the Food and Drug Administration (excluding user fees)
shall be available and allocated as needed to pay the costs
of tobacco regulation activities.
``(C) Reimbursement of start-up amounts.--
``(i) In general.--Any amounts allocated for the start-
up period pursuant to subparagraph (B)(ii) shall be
reimbursed through any appropriated fees collected under
subsection (a), in such manner as the Secretary determines
appropriate to ensure that such allocation results in no
net change in the total amount of funds otherwise
available, for the period from October 1, 2008, through
September 30, 2010, for Food and Drug Administration
programs and activities (other than tobacco regulation
activities) for such period.
``(ii) Treatment of reimbursed amounts.--Amounts
reimbursed under clause (i) shall be available for the
programs and activities for which funds allocated for the
start-up period were available, prior to such allocation,
until September 30, 2010, notwithstanding any otherwise
applicable limits on amounts for such programs or
activities for a fiscal year.
``(D) Fee collected during start-up period.--
Notwithstanding the first sentence of paragraph (1), fees under
subsection (a) may be collected through September 30, 2009
under subparagraph (B)(ii) and shall be available for
obligation and remain available until expended. Such offsetting
collections shall be credited to the salaries and expenses
account of the Food and Drug Administration.
``(E) Obligation of start-up costs in anticipation of
available fee collections.--Notwithstanding any other provision
of law, following the enactment of an appropriation for fees
under this section for fiscal year 2010, or any portion
thereof, obligations for costs of tobacco regulation activities
during the start-up period may be incurred in anticipation of
the receipt of offsetting fee collections through procedures
specified in section 1534 of title 31, United States Code.
``(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 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).''.
(c) Conforming Amendment.--Section 9(1) of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4408(i)) is
amended to read as follows:
``(1) The term `smokeless tobacco' has the meaning given such
term by section 900(18) of the Federal Food, Drug, and Cosmetic
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
division; 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 division and the amendments made by this division;
(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) include such modifications to section 897.30(b), if
any, that the Secretary determines are appropriate in light of
governing First Amendment case law, including the decision of
the Supreme Court of the United States in Lorillard Tobacco Co.
v. Reilly (533 U.S. 525 (2001));
(F) become effective on the date that is 1 year after the
date of enactment of this Act; and
(G) 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;
``(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
division, the amendments made by this division, 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 915;
``(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) Making any express or implied statement or representation
directed to consumers with respect to a tobacco product, in a label or
labeling or through the media or advertising, that either conveys, or
misleads or would mislead consumers into believing, that--
``(1) the product is approved by the Food and Drug
Administration;
``(2) the Food and Drug Administration deems the product to be
safe for use by consumers;
``(3) the product is endorsed by the Food and Drug
Administration for use by consumers; or
``(4) the product is safe or less harmful by virtue of--
``(A) its regulation or inspection by the Food and Drug
Administration; or
``(B) its compliance with regulatory requirements set by
the Food and Drug Administration;
including any such statement or representation rendering the
product misbranded under section 903.''.
(c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
(1) in paragraph (5)--
(A) by striking ``paragraph (1), (2), (3), or (4)'' each
place such appears and inserting ``paragraph (1), (2), (3),
(4), or (9)'';
(B) 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,'';
(C) 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
(D) by adding at the end the following:
``(D) The Secretary may compromise, modify, or terminate, with or
without conditions, any no-tobacco-sale order.'';
(2) 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
(3) 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.
``(9) Civil Monetary Penalties for Violation of Tobacco Product
Requirements.--
``(A) In general.--Subject to subparagraph (B), any person who
violates a requirement of this Act which relates to tobacco
products shall be liable to the United States for a civil penalty
in an amount not to exceed $15,000 for each such violation, and not
to exceed $1,000,000 for all such violations adjudicated in a
single proceeding.
``(B) Enhanced penalties.--
``(i) Any person who intentionally violates a requirement
of section 902(5), 902(6), 904, 908(c), or 911(a), shall be
subject to a civil monetary penalty of--
``(I) not to exceed $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated in a
single proceeding; or
``(II) in the case of a violation that continues after
the Secretary provides written notice to such person,
$250,000 for the first 30-day period (or any portion
thereof) that the person continues to be in violation, and
such amount shall double for every 30-day period thereafter
that the violation continues, not to exceed $1,000,000 for
any 30-day period, and not to exceed $10,000,000 for all
such violations adjudicated in a single proceeding.
``(ii) Any person who violates a requirement of section
911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil
monetary penalty of--
``(I) not to exceed $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated in a
single proceeding; or
``(II) in the case of a violation that continues after
the Secretary provides written notice to such person,
$250,000 for the first 30-day period (or any portion
thereof) that the person continues to be in violation, and
such amount shall double for every 30-day period thereafter
that the violation continues, not to exceed $1,000,000 for
any 30-day period, and not to exceed $10,000,000 for all
such violations adjudicated in a single proceeding.
``(iii) In determining the amount of a civil penalty under
clause (i)(II) or (ii)(II), the Secretary shall take into
consideration whether the person is making efforts toward
correcting the violation of the requirements of the section for
which such person is subject to such civil penalty.''.
(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 country 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 striking ``devices, or cosmetics'' each place it
appears and inserting ``devices, tobacco products, or
cosmetics'';
(B) by striking ``or restricted devices'' each place it
appears and inserting ``restricted devices, or tobacco
products''; and
(C) by striking ``and devices and subject to'' and all that
follows through ``other drugs or devices'' and inserting
``devices, and tobacco products and subject to reporting and
inspection under regulations lawfully issued pursuant to
section 505 (i) or (k), section 519, section 520(g), or chapter
IX and data relating to other drugs, devices, or tobacco
products'';
(2) in subsection (b), by inserting ``tobacco product,'' after
``device,''; and
(3) 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)--
(A) by inserting ``tobacco product'' after ``drug,
device,''; and
(B) by inserting ``, and a tobacco product intended for
export shall not be deemed to be in violation of section
906(e), 907, 911, or 920(a),'' before ``if it--''; 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 (3) and (4) of section 903(a) of the Federal Food,
Drug, and Cosmetic Act (as amended by this division) shall take
effect on the date that is 12 months after the date of enactment of
this Act. The package label requirements of paragraph (2) of such
section 903(a) for cigarettes shall take effect on the date that is
15 months after the issuance of the regulations required by section
4(d) of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333), as amended by section 201 of this division. The
package label requirements of paragraph (2) of such section 903(a)
for tobacco products other than cigarettes 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 division) 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 enactment of this
Act, submit a report to the Congress on the results of such study.
SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND PROMOTION
RESTRICTIONS.
(a) Action Plan.--
(1) Development.--Not later than 6 months after the date of
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 division, or pursuant to section
102(a) of this division, 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 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 division, or
preserved by such entities under section 916 of the Federal Food,
Drug, and Cosmetic Act, as added by section 101(b) of this
division.
(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.
SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS.
(a) FDA Report.--Not later than 3 years after the date of enactment
of this Act, and not less than every 2 years thereafter, the Secretary
of Health and Human Services 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
concerning--
(1) the progress of the Food and Drug Administration in
implementing this division, including major accomplishments,
objective measurements of progress, and the identification of any
areas that have not been fully implemented;
(2) impediments identified by the Food and Drug Administration
to progress in implementing this division and to meeting statutory
timeframes;
(3) data on the number of new product applications received
under section 910 of the Federal Food, Drug, and Cosmetic Act and
modified risk product applications received under section 911 of
such Act, and the number of applications acted on under each
category; and
(4) data on the number of full time equivalents engaged in
implementing this division.
(b) GAO Report.--Not later than 5 years after the date of enactment
of this Act, the Comptroller General of the United States shall conduct
a study of, and submit to the Committees described in subsection (a) a
report concerning--
(1) the adequacy of the authority and resources provided to the
Secretary of Health and Human Services for this division to carry
out its goals and purposes; and
(2) any recommendations for strengthening that authority to
more effectively protect the public health with respect to the
manufacture, marketing, and distribution of tobacco products.
(c) Public Availability.--The Secretary of Health and Human
Services and the Comptroller General of the United States,
respectively, shall make the reports required under subsection (a) and
(b) available to the public, including by posting such reports on the
respective Internet websites of the Food and Drug Administration and
the Government Accountability Office.
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 the top 50 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).
``(d) Graphic Label Statements.--Not later than 24 months after the
date of enactment of the Family Smoking Prevention and Tobacco Control
Act, the Secretary shall issue regulations that require color graphics
depicting the negative health consequences of smoking to accompany the
label statements specified in subsection (a)(1). The Secretary may
adjust the type size, text and format of the label statements specified
in subsections (a)(2) and (b)(2) as the Secretary determines
appropriate so that both the graphics and the accompanying label
statements are clear, conspicuous, legible and appear within the
specified area.''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect 15 months after the issuance of the regulations required by
subsection (a). 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 through a
rulemaking conducted under section 553 of title 5, United States Code,
may adjust the format, type size, color graphics, and text of any of
the label requirements, 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
other than cigarettes for introduction or delivery for introduction
into interstate commerce in the United States shall bear the
statement `sale only allowed in the United States'. Beginning 15
months after the issuance of the regulations required by section
4(d) of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1333), as amended by section 201 of Family Smoking
Prevention and Tobacco Control Act, the label, packaging, and
shipping containers of cigarettes 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 country 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.
``(e) Consultation.--In carrying out this section, the Secretary
shall consult with the Attorney General of the United States and the
Secretary of the Treasury, as appropriate.''.
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 such
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).
DIVISION B--FEDERAL RETIREMENT REFORM ACT
SEC. 100. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This division may be cited as the ``Federal
Retirement Reform Act of 2009''.
(b) Table of Contents.--The table of contents for this division is
as follows:
DIVISION B--FEDERAL RETIREMENT REFORM ACT
Sec. 100. Short title; table of contents.
TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT
Sec. 101. Short title.
Sec. 102. Automatic enrollments and immediate employing agency
contributions.
Sec. 103. Qualified Roth contribution program.
Sec. 104. Authority to establish mutual fund window.
Sec. 105. Reporting requirements.
Sec. 106. Acknowledgment of risk.
Sec. 107. Subpoena authority.
Sec. 108. Amounts in Thrift Savings Funds subject to legal proceedings.
Sec. 109. Accounts for surviving spouses.
Sec. 110. Treatment of members of the uniformed services under the
Thrift Savings Plan.
TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF
ARMED FORCES MEMBERS
Sec. 201. Increase in monthly amount of special survivor indemnity
allowance for widows and widowers of deceased members of the
Armed Forces affected by required Survivor Benefit Plan
annuity offset for dependency and indemnity compensation.
TITLE I--PROVISIONS RELATING TO FEDERAL EMPLOYEES RETIREMENT
SEC. 101. SHORT TITLE.
This title may be cited as the ``Thrift Savings Plan Enhancement
Act of 2009''.
SEC. 102. AUTOMATIC ENROLLMENTS AND IMMEDIATE EMPLOYING AGENCY
CONTRIBUTIONS.
(a) 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 Executive Director 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 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 not later than the
first full pay period following receipt of the election by the
appropriate processing entity; or
``(ii) decline automatic enrollment altogether.
``(D)(i) Except as provided in clause (ii), 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 becomes eligible to contribute to the Thrift Savings Fund.
``(ii) Members of the uniformed services shall not be eligible
individuals for purposes of this paragraph.
``(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.''.
(b) Technical Amendment.--Section 8432(b)(1) of title 5, United
States Code, is amended by striking the parenthetical matter in
subparagraph (B).
SEC. 103. 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 Executive Director 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 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. 104. AUTHORITY TO ESTABLISH MUTUAL FUND 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 service that enables participants to invest in
mutual funds, if the Board authorizes the mutual fund 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 mutual fund
window under the Thrift Savings Plan if the Board determines that such
addition would be in the best interests of participants.
``(B) The Board shall ensure that any expenses charged for use of
the mutual fund window are borne solely by the participants who use
such window.
``(C) The Board may establish such other terms and conditions for
the mutual fund window as the Board considers appropriate to protect
the interests of participants, including requirements relating to risk
disclosure.
``(D) The Board shall consult with the Employee Thrift Advisory
Council (established under section 8473) before authorizing the
addition of a mutual fund window or establishing a service that enables
participants to invest in mutual funds.''.
(c) Technical and Conforming Amendment.--Section 8438(d)(1) of
title 5, United States Code, is amended by inserting ``and options''
after ``investment funds''.
SEC. 105. 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 mutual fund 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) of title
5, United States Code, 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 Board 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. 106. ACKNOWLEDGMENT 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 acknowledgment'' 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 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); or
``(III) for allowing a participant to invest through the mutual
fund window or for establishing restrictions applicable to
participants' ability to invest through the mutual fund window.''.
SEC. 107. SUBPOENA AUTHORITY.
(a) In General.--Chapter 84 of title 5, United States Code, is
amended by inserting after section 8479 the following:
``Sec. 8480. Subpoena authority
``(a) In order to carry out the responsibilities specified in this
subchapter and subchapter III of this chapter, the Executive Director
may issue subpoenas commanding each person to whom the subpoena is
directed to produce designated books, documents, records,
electronically stored information, or tangible materials in the
possession or control of that individual.
``(b) Notwithstanding any Federal, State, or local law, any person,
including officers, agents, and employees, receiving a subpoena under
this section, who complies in good faith with the subpoena and thus
produces the materials sought, shall not be liable in any court of any
State or the United States to any individual, domestic or foreign
corporation or upon a partnership or other unincorporated association
for such production.
``(c) When a person fails to obey a subpoena issued under this
section, the district court of the United States for the district in
which the investigation is conducted or in which the person failing to
obey is found, shall on proper application issue an order directing
that person to comply with the subpoena. The court may punish as
contempt any disobedience of its order.
``(d) The Executive Director shall prescribe regulations to carry
out subsection (a).''.
(b) Technical and Conforming Amendment.--The table of sections for
chapter 84 of title 5, United States Code, is amended by inserting
after the item relating to section 8479 the following:
``8480. Subpoena authority.''.
SEC. 108. AMOUNTS IN THRIFT SAVINGS FUNDS SUBJECT TO LEGAL
PROCEEDINGS.
Section 8437(e)(3) of title 5, United States Code, is amended in
the first sentence by striking ``or relating to the enforcement of a
judgment for the physically, sexually, or emotionally abusing a child
as provided under section 8467(a)'' and inserting ``the enforcement of
an order for restitution under section 3663A of title 18, forfeiture
under section 8432(g)(5) of this title, or an obligation of the
Executive Director to make a payment to another person under section
8467 of this title''.
SEC. 109. ACCOUNTS FOR SURVIVING SPOUSES.
Section 8433(e) of title 5, United States Code, is amended--
(1) by inserting ``(1)'' after ``(e)''; and
(2) by adding at the end the following:
``(2) Notwithstanding section 8424(d), if an employee, Member,
former employee, or former Member dies and has designated as sole or
partial beneficiary his or her spouse at the time of death, or, if an
employee, Member, former employee, or former Member, dies with no
designated beneficiary and is survived by a spouse, the spouse may
maintain the portion of the employee's or Member's account to which the
spouse is entitled in accordance with the following terms:
``(A) Subject to the limitations of subparagraph (B), the
spouse shall have the same withdrawal options under subsection (b)
as the employee or Member were the employee or Member living.
``(B) The spouse may not make withdrawals under subsection (g)
or (h).
``(C) The spouse may not make contributions or transfers to the
account.
``(D) The account shall be disbursed upon the death of the
surviving spouse. A beneficiary or surviving spouse of a deceased
spouse who has inherited an account is ineligible to maintain the
inherited spousal account.
``(3) The Executive Director shall prescribe regulations to carry
out this subsection.''.
SEC. 110. TREATMENT OF MEMBERS OF THE UNIFORMED SERVICES UNDER THE
THRIFT SAVINGS PLAN.
(a) Sense of Congress.--It is the sense of Congress that--
(1) members of the uniformed services should have a retirement
system that is at least as generous as the one which is available
to Federal civilian employees; and
(2) Federal civilian employees receive matching contributions
from their employing agencies for their contributions to the Thrift
Savings Fund, but the costs of requiring such a matching
contribution from the Department of Defense could be significant.
(b) Reporting Requirement.--Not later than 180 days after the date
of the enactment of this Act, the Secretary of Defense shall report to
Congress on--
(1) the cost to the Department of Defense of providing a
matching payment with respect to contributions made to the Thrift
Savings Fund by members of the Armed Forces;
(2) the effect that requiring such a matching payment would
have on recruitment and retention; and
(3) any other information that the Secretary of Defense
considers appropriate.
TITLE II--SPECIAL SURVIVOR INDEMNITY ALLOWANCE FOR SURVIVING SPOUSES OF
ARMED FORCES MEMBERS
SEC. 201. INCREASE IN MONTHLY AMOUNT OF SPECIAL SURVIVOR INDEMNITY
ALLOWANCE FOR WIDOWS AND WIDOWERS OF DECEASED MEMBERS OF THE
ARMED FORCES AFFECTED BY REQUIRED SURVIVOR BENEFIT PLAN ANNUITY
OFFSET FOR DEPENDENCY AND INDEMNITY COMPENSATION.
(a) Payment Amount Per Fiscal Year.--Paragraph (2) of section
1450(m) of title 10, United States Code, is amended--
(1) in subparagraph (E), by striking ``and'' after the
semicolon; and
(2) by striking subparagraph (F) and inserting the following
new subparagraphs:
``(F) for months during fiscal year 2014, $150;
``(G) for months during fiscal year 2015, $200;
``(H) for months during fiscal year 2016, $275; and
``(I) for months during fiscal year 2017, $310.''.
(b) Duration.--Paragraph (6) of such section is amended--
(1) by striking ``February 28, 2016'' and inserting ``September
30, 2017''; and
(2) by striking ``March 1, 2016'' both places it appears and
inserting ``October 1, 2017''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.