1.Short title; table of
contents
(a)This Act may be cited as the Family Smoking Prevention and Tobacco Control
Act
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Title I—AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
Sec. 101. Amendment of Federal Food, Drug, and Cosmetic
Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general
provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco
products.
Sec. 105. Enforcement action plan for advertising and promotion
restrictions.
Title II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE
CONSTITUENT DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label
statements.
Sec. 203. State regulation of cigarette advertising and
promotion.
Sec. 204. Smokeless tobacco labels and advertising
warnings.
Sec. 205. Authority to revise smokeless tobacco product warning
label statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure
to the public.
Title III—PREVENTION OF ILLICIT TRADE IN TOBACCO
PRODUCTS
Sec. 301. Labeling, recordkeeping, records
inspection.
Sec. 302. Study and report.
2.The Congress finds the following:
(1)The use of tobacco
products by the Nation’s children is a pediatric disease of considerable
proportions that results in new generations of tobacco-dependent children and
adults.
(2)A
consensus exists within the scientific and medical communities that tobacco
products are inherently dangerous and cause cancer, heart disease, and other
serious adverse health effects.
(3)Nicotine is an
addictive drug.
(4)Virtually all new
users of tobacco products are under the minimum legal age to purchase such
products.
(5)Tobacco
advertising and marketing contribute significantly to the use of
nicotine-containing tobacco products by adolescents.
(6)Because past
efforts to restrict advertising and marketing of tobacco products have failed
adequately to curb tobacco use by adolescents, comprehensive restrictions on
the sale, promotion, and distribution of such products are needed.
(7)Federal and State
governments have lacked the legal and regulatory authority and resources they
need to address comprehensively the public health and societal problems caused
by the use of tobacco products.
(8)Federal and State
public health officials, the public health community, and the public at large
recognize that the tobacco industry should be subject to ongoing
oversight.
(9)Under article I,
section 8 of the Constitution, the Congress is vested with the responsibility
for regulating interstate commerce and commerce with Indian tribes.
(10)The sale,
distribution, marketing, advertising, and use of tobacco products are
activities in and substantially affecting interstate commerce because they are
sold, marketed, advertised, and distributed in interstate commerce on a
nationwide basis, and have a substantial effect on the Nation’s economy.
(11)The sale,
distribution, marketing, advertising, and use of such products substantially
affect interstate commerce through the health care and other costs attributable
to the use of tobacco products.
(12)It is in the
public interest for Congress to enact legislation that provides the Food and
Drug Administration with the authority to regulate tobacco products and the
advertising and promotion of such products. The benefits to the American people
from enacting such legislation would be significant in human and economic
terms.
(13)Tobacco use is
the foremost preventable cause of premature death in America. It causes over
400,000 deaths in the United States each year, and approximately 8,600,000
Americans have chronic illnesses related to smoking.
(14)Reducing the use
of tobacco by minors by 50 percent would prevent well over 10,000,000 of
today’s children from becoming regular, daily smokers, saving over 3,000,000 of
them from premature death due to tobacco-induced disease. Such a reduction in
youth smoking would also result in approximately $75,000,000,000 in savings
attributable to reduced health care costs.
(15)Advertising,
marketing, and promotion of tobacco products have been especially directed to
attract young persons to use tobacco products, and these efforts have resulted
in increased use of such products by youth. Past efforts to oversee these
activities have not been successful in adequately preventing such increased
use.
(16)In 2005, the
cigarette manufacturers spent more than $13,000,000,000 to attract new users,
retain current users, increase current consumption, and generate favorable
long-term attitudes toward smoking and tobacco use.
(17)Tobacco product
advertising often misleadingly portrays the use of tobacco as socially
acceptable and healthful to minors.
(18)Tobacco product
advertising is regularly seen by persons under the age of 18, and persons under
the age of 18 are regularly exposed to tobacco product promotional
efforts.
(19)Through
advertisements during and sponsorship of sporting events, tobacco has become
strongly associated with sports and has become portrayed as an integral part of
sports and the healthy lifestyle associated with rigorous sporting
activity.
(20)Children are
exposed to substantial and unavoidable tobacco advertising that leads to
favorable beliefs about tobacco use, plays a role in leading young people to
overestimate the prevalence of tobacco use, and increases the number of young
people who begin to use tobacco.
(21)The use of
tobacco products in motion pictures and other mass media glamorizes its use for
young people and encourages them to use tobacco products.
(22)Tobacco
advertising expands the size of the tobacco market by increasing consumption of
tobacco products including tobacco use by young people.
(23)Children are more
influenced by tobacco marketing than adults: more than 80 percent of youth
smoke three heavily marketed brands, while only 54 percent of adults, 26 and
older, smoke these same brands.
(24)Tobacco company
documents indicate that young people are an important and often crucial segment
of the tobacco market. Children, who tend to be more price sensitive than
adults, are influenced by advertising and promotion practices that result in
drastically reduced cigarette prices.
(25)Comprehensive
advertising restrictions will have a positive effect on the smoking rates of
young people.
(26)Restrictions on
advertising are necessary to prevent unrestricted tobacco advertising from
undermining legislation prohibiting access to young people and providing for
education about tobacco use.
(27)International
experience shows that advertising regulations that are stringent and
comprehensive have a greater impact on overall tobacco use and young people’s
use than weaker or less comprehensive ones.
(28)Text only
requirements, although not as stringent as a ban, will help reduce underage use
of tobacco products while preserving the informational function of
advertising.
(29)It is in the
public interest for Congress to adopt legislation to address the public health
crisis created by actions of the tobacco industry.
(30)The final
regulations promulgated by the Secretary of Health and Human Services in the
August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615–44618) for
inclusion as part 897 of title 21, Code of Federal Regulations, are consistent
with the first amendment to the United States Constitution and with the
standards set forth in the amendments made by this subtitle for the regulation
of tobacco products by the Food and Drug Administration, and the restriction on
the sale and distribution of, including access to and the advertising and
promotion of, tobacco products contained in such regulations are substantially
related to accomplishing the public health goals of this Act.
(31)The regulations
described in paragraph (30) will directly and materially advance the Federal
Government’s substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in preventing the
life-threatening health consequences associated with tobacco use. An
overwhelming majority of Americans who use tobacco products begin using such
products while they are minors and become addicted to the nicotine in those
products before reaching the age of 18. Tobacco advertising and promotion play
a crucial role in the decision of these minors to begin using tobacco products.
Less restrictive and less comprehensive approaches have not and will not be
effective in reducing the problems addressed by such regulations. The
reasonable restrictions on the advertising and promotion of tobacco products
contained in such regulations will lead to a significant decrease in the number
of minors using and becoming addicted to those products.
(32)The regulations
described in paragraph (30) impose no more extensive restrictions on
communication by tobacco manufacturers and sellers than are necessary to reduce
the number of children and adolescents who use cigarettes and smokeless tobacco
and to prevent the life-threatening health consequences associated with tobacco
use. Such regulations are narrowly tailored to restrict those advertising and
promotional practices which are most likely to be seen or heard by youth and
most likely to entice them into tobacco use, while affording tobacco
manufacturers and sellers ample opportunity to convey information about their
products to adult consumers.
(33)Tobacco
dependence is a chronic disease, one that typically requires repeated
interventions to achieve long-term or permanent abstinence.
(34)Because the only
known safe alternative to smoking is cessation, interventions should target all
smokers to help them quit completely.
(35)Tobacco products
have been used to facilitate and finance criminal activities both domestically
and internationally. Illicit trade of tobacco products has been linked to
organized crime and terrorist groups.
(36)It is essential
that the Food and Drug Administration review products sold or distributed for
use to reduce risks or exposures associated with tobacco products and that it
be empowered to review any advertising and labeling for such products. It is
also essential that manufacturers, prior to marketing such products, be
required to demonstrate that such products will meet a series of rigorous
criteria, and will benefit the health of the population as a whole, taking into
account both users of tobacco products and persons who do not currently use
tobacco products.
(37)Unless tobacco
products that purport to reduce the risks to the public of tobacco use actually
reduce such risks, those products can cause substantial harm to the public
health to the extent that the individuals, who would otherwise not consume
tobacco products or would consume such products less, use tobacco products
purporting to reduce risk. Those who use products sold or distributed as
modified risk products that do not in fact reduce risk, rather than quitting or
reducing their use of tobacco products, have a substantially increased
likelihood of suffering disability and premature death. The costs to society of
the widespread use of products sold or distributed as modified risk products
that do not in fact reduce risk or that increase risk include thousands of
unnecessary deaths and injuries and huge costs to our health care
system.
(38)As the National
Cancer Institute has found, many smokers mistakenly believe that low
tar
and light
cigarettes cause fewer health problems
than other cigarettes. As the National Cancer Institute has also found,
mistaken beliefs about the health consequences of smoking low
tar
and light
cigarettes can reduce the motivation to
quit smoking entirely and thereby lead to disease and death.
(39)Recent studies
have demonstrated that there has been no reduction in risk on a population-wide
basis from low tar
and light
cigarettes, and such
products may actually increase the risk of tobacco use.
(40)The dangers of
products sold or distributed as modified risk tobacco products that do not in
fact reduce risk are so high that there is a compelling governmental interest
in ensuring that statements about modified risk tobacco products are complete,
accurate, and relate to the overall disease risk of the product.
(41)As the Federal
Trade Commission has found, consumers have misinterpreted advertisements in
which one product is claimed to be less harmful than a comparable product, even
in the presence of disclosures and advisories intended to provide
clarification.
(42)Permitting
manufacturers to make unsubstantiated statements concerning modified risk
tobacco products, whether express or implied, even if accompanied by
disclaimers would be detrimental to the public health.
(43)The only way to
effectively protect the public health from the dangers of unsubstantiated
modified risk tobacco products is to empower the Food and Drug Administration
to require that products that tobacco manufacturers sold or distributed for
risk reduction be reviewed in advance of marketing, and to require that the
evidence relied on to support claims be fully verified.
(44)The Food and Drug
Administration is a regulatory agency with the scientific expertise to identify
harmful substances in products to which consumers are exposed, to design
standards to limit exposure to those substances, to evaluate scientific studies
supporting claims about the safety of products, and to evaluate the impact of
labels, labeling, and advertising on consumer behavior in order to reduce the
risk of harm and promote understanding of the impact of the product on health.
In connection with its mandate to promote health and reduce the risk of harm,
the Food and Drug Administration routinely makes decisions about whether and
how products may be marketed in the United States.
(45)The Federal Trade
Commission was created to protect consumers from unfair or deceptive acts or
practices, and to regulate unfair methods of competition. Its focus is on those
marketplace practices that deceive or mislead consumers, and those that give
some competitors an unfair advantage. Its mission is to regulate activities in
the marketplace. Neither the Federal Trade Commission nor any other Federal
agency except the Food and Drug Administration possesses the scientific
expertise needed to implement effectively all provisions of the Family Smoking
Prevention and Tobacco Control Act.
(46)If manufacturers state or imply in
communications directed to consumers through the media or through a label,
labeling, or advertising, that a tobacco product is approved or inspected by
the Food and Drug Administration or complies with Food and Drug Administration
standards, consumers are likely to be confused and misled. Depending upon the
particular language used and its context, such a statement could result in
consumers being misled into believing that the product is endorsed by the Food
and Drug Administration for use or in consumers being misled about the
harmfulness of the product because of such regulation, inspection, approval, or
compliance.
(47)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).
3.The purposes of this Act are—
(1)to provide authority to the Food and Drug
Administration to regulate tobacco products under the Federal Food, Drug, and
Cosmetic Act (21
U.S.C. 301 et seq.), by recognizing it as the primary Federal
regulatory authority with respect to the manufacture, marketing, and
distribution of tobacco products as provided for in this Act;
(2)to ensure that the
Food and Drug Administration has the authority to address issues of particular
concern to public health officials, especially the use of tobacco by young
people and dependence on tobacco;
(3)to authorize the
Food and Drug Administration to set national standards controlling the
manufacture of tobacco products and the identity, public disclosure, and amount
of ingredients used in such products;
(4)to provide new and
flexible enforcement authority to ensure that there is effective oversight of
the tobacco industry’s efforts to develop, introduce, and promote less harmful
tobacco products;
(5)to vest the Food
and Drug Administration with the authority to regulate the levels of tar,
nicotine, and other harmful components of tobacco products;
(6)in order to ensure
that consumers are better informed, to require tobacco product manufacturers to
disclose research which has not previously been made available, as well as
research generated in the future, relating to the health and dependency effects
or safety of tobacco products;
(7)to continue to
permit the sale of tobacco products to adults in conjunction with measures to
ensure that they are not sold or accessible to underage purchasers;
(8)to impose
appropriate regulatory controls on the tobacco industry;
(9)to promote
cessation to reduce disease risk and the social costs associated with
tobacco-related diseases; and
(10)to strengthen
legislation against illicit trade in tobacco products.
4.
(a)Nothing in this Act (or an amendment made by this Act)
shall be construed to—
(1)establish a
precedent with regard to any other industry, situation, circumstance, or legal
action; or
(2)affect any action
pending in Federal, State, or tribal court, or any agreement, consent decree,
or contract of any kind.
(b)The provisions of this Act (or an amendment made by
this Act) which authorize the Secretary to take certain actions with regard to
tobacco and tobacco products shall not be construed to affect any authority of
the Secretary of Agriculture under existing law regarding the growing,
cultivation, or curing of raw tobacco.
(c)The provisions of this Act (or an amendment made by
this Act) which authorize the Secretary to take certain actions with regard to
tobacco products shall not be construed to affect any authority of the
Secretary of the Treasury under
chapter 52 of the Internal
Revenue Code of 1986.
5.If any provision of this Act, of the
amendments made by this Act, or of the regulations promulgated under this Act
(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 Act, 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.
<enum>I</enum><header>AUTHORITY OF THE
FOOD AND DRUG ADMINISTRATION</header>
<section id="H940B6A0F8D40459AB87E7D34BFDD3C99"><enum>101.</enum><header>Amendment of
Federal Food, Drug, and Cosmetic Act</header>
<subsection id="H0093AB1EF4A44B7DB497A6E2352EAC33"><enum>(a)</enum><header>Definition of
Tobacco Products</header><text>Section 201 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21
U.S.C. 321</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block id="H5ABE0F68B15A46499C0CE30EC1A7C3AE" style="OLC">
<subsection id="HA2A09E892EEA4892B3C11A4C1B8A5D74"><enum>(rr)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HABAA4E6D2230480094F90623F5B44B99"><enum>(1)</enum><text>The term <term>tobacco
product</term> 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).</text>
</paragraph><paragraph id="H1DBD249476F2402CAC76EAABC75D4547" indent="up1"><enum>(2)</enum><text>The term <term>tobacco product</term>
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).</text>
</paragraph><paragraph id="HCF8DE5F4B853404D91C546FE06111921" indent="up1"><enum>(3)</enum><text>The products described in paragraph
(2) shall be subject to chapter V of this Act.</text>
</paragraph><paragraph id="H96EF0E99453F4B86B4BC43DB19BD1BC7" indent="up1"><enum>(4)</enum><text>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).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H0C2E2A9E269A4EF188AF6C784B82134A"><enum>(b)</enum><header>FDA Authority
Over Tobacco Products</header><text>The Federal Food, Drug, and Cosmetic Act
(<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et
seq.</external-xref>) is amended—</text>
<paragraph id="HC0FD72C960DC493D8508CD8931ABC1B2"><enum>(1)</enum><text>by redesignating
chapter IX as chapter X;</text>
</paragraph><paragraph id="HC048664E168F483C8DA802D38581E8E9"><enum>(2)</enum><text>by redesignating
sections 901 through 910 as sections 1001 through 1010; and</text>
</paragraph><paragraph id="H91C138DBB7144FCAAC43BC896F3E9899"><enum>(3)</enum><text>by inserting after
chapter VIII the following:</text>
<quoted-block display-inline="no-display-inline" id="HA0186428023E4C06867A02947E304AFA" style="OLC">
<chapter id="H9B1FD77BD73845308943A61248D24049"><enum>IX</enum><header>TOBACCO
PRODUCTS</header>
<section id="HC4ADF5E236D3486A9DE2C097D1AE00E5"><enum>900.</enum><header>Definitions</header><text display-inline="no-display-inline">In this chapter:</text>
<paragraph id="H8E51E530D8CF4F29826F477B14835138"><enum>(1)</enum><header>Additive</header><text>The
term <term>additive</term> 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.</text>
</paragraph><paragraph id="H844C7C52A4034B62AF329B3E3E90293B"><enum>(2)</enum><header>Brand</header><text>The
term <term>brand</term> 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.</text>
</paragraph><paragraph id="HE4EB79E7D807472298B02527407DE77F"><enum>(3)</enum><header>Cigarette</header><text>The
term <term>cigarette</term>—</text>
<subparagraph id="H15AEA7CAC8624D59A88AE16FA97C14A9"><enum>(A)</enum><text display-inline="yes-display-inline">means a product that—</text>
<clause id="H34CD940DC2514EB49EF82247F6DCAA0A"><enum>(i)</enum><text>is
a tobacco product; and</text>
</clause><clause id="HE983C90097F442E2A4152EA0DBFA5199"><enum>(ii)</enum><text>meets the
definition of the term <term>cigarette</term> in section 3(1) of the Federal
Cigarette Labeling and Advertising Act; and</text>
</clause></subparagraph><subparagraph id="HDF366FDDC6C54E36B91E0A9FD9635CCB"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H44F570347FE94420AFDFE4C6D94A7341"><enum>(4)</enum><header>Cigarette
tobacco</header><text>The term <term>cigarette tobacco</term> 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.</text>
</paragraph><paragraph id="HB0DA58A7E2DF4B6994604CC96E5E7198"><enum>(5)</enum><header>Commerce</header><text>The
term <term>commerce</term> has the meaning given that term by section 3(2) of
the Federal Cigarette Labeling and Advertising Act.</text>
</paragraph><paragraph id="H048EE11AF0C94DDC8734ED1F9BBD260B"><enum>(6)</enum><header>Counterfeit
tobacco product</header><text>The term <term>counterfeit tobacco product</term>
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).</text>
</paragraph><paragraph id="H7802581092BB4E07A60E4C1EC5BB7681"><enum>(7)</enum><header>Distributor</header><text>The
term <term>distributor</term> 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.</text>
</paragraph><paragraph id="HA180332C68CB4419B1F8ACACE34E5C2D"><enum>(8)</enum><header>Illicit
trade</header><text>The term <term>illicit trade</term> 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.</text>
</paragraph><paragraph id="H38C95AF1C40F4D038AA287554060012C"><enum>(9)</enum><header>Indian
country</header><text>The term <term>Indian country</term> has the meaning
given such term in <external-xref legal-doc="usc" parsable-cite="usc/18/1151">section 1151</external-xref> of title 18, United
States Code.</text>
</paragraph><paragraph id="HC0F61D5C1B404BB094C4A800B47BF8CC"><enum>(10)</enum><header>Indian
tribe</header><text>The term <term>Indian tribe</term> has the meaning given
such term in section 4(e) of the Indian Self-Determination and Education
Assistance Act.</text>
</paragraph><paragraph id="H9D3E4CC6AB104A9D870B5984EBF094E2"><enum>(11)</enum><header>Little
cigar</header><text>The term <term>little cigar</term> means a product
that—</text>
<subparagraph id="HB7E878CA487640D4A9402953DAE82CC9"><enum>(A)</enum><text>is a tobacco
product; and</text>
</subparagraph><subparagraph id="H0BB9E7D127AC48CBBE532D6CB5807213"><enum>(B)</enum><text>meets the
definition of the term <term>little cigar</term> in section 3(7) of the Federal
Cigarette Labeling and Advertising Act.</text>
</subparagraph></paragraph><paragraph id="H84019C7487B74F359B0690589F89362C"><enum>(12)</enum><header>Nicotine</header><text>The
term <term>nicotine</term> 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.</text>
</paragraph><paragraph id="HD6869EE3A7384CB3BBA75ED78C3C5026"><enum>(13)</enum><header>Package</header><text>The
term <term>package</term> 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.</text>
</paragraph><paragraph id="HEDF78271C092461CBC6BD7F840C502CA"><enum>(14)</enum><header>Retailer</header><text display-inline="yes-display-inline">The term <term>retailer</term> 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.</text>
</paragraph><paragraph id="H88AD6E9119964D509DFD5876CA54AE2C"><enum>(15)</enum><header>Roll-your-own
tobacco</header><text>The term <term>roll-your-own tobacco</term> 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.</text>
</paragraph><paragraph display-inline="no-display-inline" id="H1BEBE1BC9F444BDE807FEB830C572E18"><enum>(16)</enum><header>Small tobacco
product manufacturer</header><text display-inline="yes-display-inline">The term
<term>small tobacco product manufacturer</term> 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.</text>
</paragraph><paragraph id="H2509017E6C174A8AB0E84EDA72F89D0D"><enum>(17)</enum><header>Smoke
constituent</header><text>The term <term>smoke constituent</term> 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.</text>
</paragraph><paragraph id="H84B05F1E1BFC41349AA9E66EAD815B1A"><enum>(18)</enum><header>Smokeless
tobacco</header><text>The term <term>smokeless tobacco</term> 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.</text>
</paragraph><paragraph id="H5E636A9ED651493187BB77FC02BA4A93"><enum>(19)</enum><header>State;
Territory</header><text>The terms <term>State</term> and <term>Territory</term>
shall have the meanings given to such terms in section 201.</text>
</paragraph><paragraph id="HE120FDCC7BEA458DB60A53CF24DD9F3F"><enum>(20)</enum><header>Tobacco product
manufacturer</header><text>The term <term>tobacco product manufacturer</term>
means any person, including any repacker or relabeler, who—</text>
<subparagraph id="H3BCAC4E7B0254C4B8153A6AE55C6A0B5"><enum>(A)</enum><text>manufactures,
fabricates, assembles, processes, or labels a tobacco product; or</text>
</subparagraph><subparagraph id="HD0F2A3EA0EE64C1AB3F1D534A28C9511"><enum>(B)</enum><text>imports a finished
tobacco product for sale or distribution in the United States.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H3C6F95E5B4D94CF8B01EA23142187BF1"><enum>(21)</enum><header>Tobacco
warehouse</header>
<subparagraph id="H1653C42FCE9D4D4E8046A99C571E819F"><enum>(A)</enum><text>Subject to
subparagraphs (B) and (C), the term <term>tobacco warehouse</term> includes any
person—</text>
<clause id="HB6026520E28D48068D02F165D00D34C3"><enum>(i)</enum><text>who—</text>
<subclause id="HCDBC696A3F2642FEBFEC1BB0C6830387"><enum>(I)</enum><text>removes foreign
material from tobacco leaf through nothing other than a mechanical
process;</text>
</subclause><subclause id="H594298FC43F44F6ABBDF706405A66788"><enum>(II)</enum><text>humidifies
tobacco leaf with nothing other than potable water in the form of steam or
mist; or</text>
</subclause><subclause id="HC5583FF1E02B43289BC0C500741B0FF7"><enum>(III)</enum><text display-inline="yes-display-inline">de-stems, dries, and packs tobacco leaf for
storage and shipment;</text>
</subclause></clause><clause id="HBCA3ECA792F04C448326D80FB780B872"><enum>(ii)</enum><text>who performs no
other actions with respect to tobacco leaf; and</text>
</clause><clause id="H5C4371A35F2245D1B903DF5B1899FC42"><enum>(iii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph id="HBD3CD76AE073412F83B8BA12CE7A8436"><enum>(B)</enum><text>The term
<term>tobacco warehouse</term> excludes any person who—</text>
<clause id="H6B1664AEED2446199A320A7AD3566645"><enum>(i)</enum><text>reconstitutes
tobacco leaf;</text>
</clause><clause id="H5EB9B50AF6744300BED2962A8B5B013B"><enum>(ii)</enum><text>is a
manufacturer, distributor, or retailer of a tobacco product; or</text>
</clause><clause id="H110ACF46F1A74578BC530ECF91E885AB"><enum>(iii)</enum><text>applies any
chemical, additive, or substance to the tobacco leaf other than potable water
in the form of steam or mist.</text>
</clause></subparagraph><subparagraph id="H738D24FCF5A4478C8F8A0BF2414B2DD4"><enum>(C)</enum><text>The definition of
the term <term>tobacco warehouse</term> 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.</text>
</subparagraph></paragraph><paragraph id="H42A90B136CDE46D8BCCD89F43B9E11EF"><enum>(22)</enum><header>United
states</header><text>The term <term>United States</term> 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.</text>
</paragraph></section><section id="H62308DED23484F8BB05A73912F0060F8"><enum>901.</enum><header>FDA authority
over tobacco products</header>
<subsection id="HB39E8A85DE354A5B8C56DD4CF919D503"><enum>(a)</enum><header>In
general</header><text>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.</text>
</subsection><subsection id="HB03F91A462524D90B837724323885471"><enum>(b)</enum><header>Applicability</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection id="HB525E195F54B476480EC7F2056BBA9D0"><enum>(c)</enum><header>Scope</header>
<paragraph id="HF8FB5B6B85CB4A8DBF95FC96EA003323"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="HCEC88D10905040269425D4BDCC2A03B9"><enum>(2)</enum><header>Limitation of
authority</header>
<subparagraph id="H8FE643E8EC7F4CD9A3378A72CA08319F"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="HCAB0E6721C9142AE81771B41375112A7"><enum>(B)</enum><header>Exception</header><text>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.</text>
</subparagraph><subparagraph id="H2547C0F3197941C9ACDC4BAECEE5C3D6"><enum>(C)</enum><header>Rule of
construction</header><text>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.</text>
</subparagraph></paragraph></subsection><subsection display-inline="no-display-inline" id="HBFCA65248A5844649058E0259D2C6EBF"><enum>(d)</enum><header>Rulemaking
procedures</header><text display-inline="yes-display-inline">Each rulemaking
under this chapter shall be in accordance with
<external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter
5</external-xref> 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.</text>
</subsection><subsection id="H1B6B1A6C014A4A80B4CC3ED43F45022C"><enum>(e)</enum><header>Center for
Tobacco Products</header><text>Not later than 90 days after the date of
enactment of the <short-title>Family Smoking Prevention
and Tobacco Control Act</short-title>, 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.</text>
</subsection><subsection id="HCDAE7E2C20FF4FF4BF4873BB626BED93"><enum>(f)</enum><header>Office To assist
small tobacco product manufacturers</header><text>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.</text>
</subsection><subsection id="H7D96D8EEBCC140BEA71982078B7E592B"><enum>(g)</enum><header>Consultation
prior to rulemaking</header><text display-inline="yes-display-inline">Prior to
promulgating rules under this chapter, the Secretary shall endeavor to consult
with other Federal agencies as appropriate.</text>
</subsection></section><section id="H36BB43E8CD0D43B09BF1E1146B268B25"><enum>902.</enum><header>Adulterated
tobacco products</header><text display-inline="no-display-inline">A tobacco
product shall be deemed to be adulterated if—</text>
<paragraph id="HC2884B8A7D8B4C5EB1BE329602B5D13E"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="H517635931DCD44D5BBE6093FF9E6A506"><enum>(2)</enum><text>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;</text>
</paragraph><paragraph id="HE0947F6CC6A04887AB3917134A9CA46F"><enum>(3)</enum><text>its package is
composed, in whole or in part, of any poisonous or deleterious substance which
may render the contents injurious to health;</text>
</paragraph><paragraph id="HFC602F090A0C442B978B5DFC5BF2DCC7"><enum>(4)</enum><text>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;</text>
</paragraph><paragraph id="H1263DF2F7B2B4B1EB8524A58B79E9684"><enum>(5)</enum><text>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;</text>
</paragraph><paragraph id="HD3280410A9C644CDA29C90725D41FF36"><enum>(6)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HD5B5B2F50EFE4FA49F2F3F5B3A1F2D86"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H2A4496453AE34CF08E9F195C24F0A852" indent="up1"><enum>(B)</enum><text>it is in violation of an order under
section 910(c)(1)(A);</text>
</subparagraph></paragraph><paragraph id="HF3E1CC537BFE4D6BA7E029A9EDB5111A"><enum>(7)</enum><text>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</text>
</paragraph><paragraph id="H7F95CE33B76D4D96B4EC68BA9A6C9EEA"><enum>(8)</enum><text>it is in violation
of section 911.</text>
</paragraph></section><section id="HB33C246DD97740FD8D36D6EBB9B84208"><enum>903.</enum><header>Misbranded
tobacco products</header>
<subsection id="H181EAA95584C40FCBE35D3851D90ECC7"><enum>(a)</enum><header>In
General</header><text>A tobacco product shall be deemed to be
misbranded—</text>
<paragraph id="H8F521E4A3B174C33902ECE36DD5D79F3"><enum>(1)</enum><text>if its labeling is
false or misleading in any particular;</text>
</paragraph><paragraph id="HC660DA1D2E494CC5A4B7F3DDE1208136"><enum>(2)</enum><text>if in package form
unless it bears a label containing—</text>
<subparagraph id="HD6120CB83B5048CB8D2F4BCA2F41F71D"><enum>(A)</enum><text>the name and place
of business of the tobacco product manufacturer, packer, or distributor;</text>
</subparagraph><subparagraph id="H9CB1034DA2ED43DFB174CD0B2AFE0506"><enum>(B)</enum><text>an accurate
statement of the quantity of the contents in terms of weight, measure, or
numerical count;</text>
</subparagraph><subparagraph id="HB95CF56D46B84F4FA728A410AFA661DB"><enum>(C)</enum><text>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</text>
</subparagraph><subparagraph id="H44E8D49077864CB6A94B4391EDDDA79A"><enum>(D)</enum><text>the statement
required under section 920(a),</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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;</continuation-text></paragraph><paragraph id="H75D6AA30078E4801A0332F80AAA3DF3D"><enum>(3)</enum><text>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;</text>
</paragraph><paragraph id="HF7C8D0C6C3D84143B181E0DB33543C77"><enum>(4)</enum><text>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;</text>
</paragraph><paragraph id="H290DDCFDC0E54D42B9E6FEB220230EC5"><enum>(5)</enum><text>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;</text>
</paragraph><paragraph id="HA8B74E5703054B5381FA74112E416214"><enum>(6)</enum><text>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;</text>
</paragraph><paragraph id="H268BFD323906463FAB7A7BD4C92D8A00"><enum>(7)</enum><text>if, in the case of
any tobacco product distributed or offered for sale in any State—</text>
<subparagraph id="H488770774ADB45A8B05403BC227C2291"><enum>(A)</enum><text>its advertising is
false or misleading in any particular; or</text>
</subparagraph><subparagraph id="H6B2CB8F433F044148345C37DEEE3EA18"><enum>(B)</enum><text>it is sold or
distributed in violation of regulations prescribed under section 906(d);</text>
</subparagraph></paragraph><paragraph id="H0AE6CCAB274745E7803FD872BA01679D"><enum>(8)</enum><text>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—</text>
<subparagraph id="H36BA5CDA254147388F90FDB59AE6DC04"><enum>(A)</enum><text>a true statement
of the tobacco product’s established name as described in paragraph (4),
printed prominently; and</text>
</subparagraph><subparagraph id="HCC8417046D9D43F38327A1ABB5B6535A"><enum>(B)</enum><text>a brief statement
of—</text>
<clause id="H003F0EB521874D63AAFE84768B7188F2"><enum>(i)</enum><text>the uses of the
tobacco product and relevant warnings, precautions, side effects, and
contraindications; and</text>
</clause><clause id="H4599CC76C0E042CF8E913A5C1026776B"><enum>(ii)</enum><text>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;</text>
</clause></subparagraph></paragraph><paragraph id="H8F5A958585524EE0ADEE8504DC8DA089"><enum>(9)</enum><text>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</text>
</paragraph><paragraph id="HE0CB5B70D69A4F73AC2DC7143E898307"><enum>(10)</enum><text>if there was a
failure or refusal—</text>
<subparagraph id="H1285166E52E949B4AE1197364EA755FC"><enum>(A)</enum><text>to comply with any
requirement prescribed under section 904 or 908; or</text>
</subparagraph><subparagraph id="HA12FFE868C3547CF8E4487618BCC8992"><enum>(B)</enum><text>to furnish any
material or information required under section 909.</text>
</subparagraph></paragraph></subsection><subsection id="H2A6673166C4C477FB73B2A89139EE8CB"><enum>(b)</enum><header>Prior Approval
of Label Statements</header><text>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
<short-title>Family Smoking Prevention and Tobacco Control
Act</short-title> (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.</text>
</subsection></section><section id="H763BA718FC014EFE90086A517292CA88"><enum>904.</enum><header>Submission of
health information to the Secretary</header>
<subsection id="HC126CC5255EC4AA68F0BB1B87E47AF5E"><enum>(a)</enum><header>Requirement</header><text>Each
tobacco product manufacturer or importer, or agents thereof, shall submit to
the Secretary the following information:</text>
<paragraph id="H06CE8EC83D454B1D8A0A85789721CA65"><enum>(1)</enum><text>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.</text>
</paragraph><paragraph id="H89A04ECCF82E497E8367DF47D0210BE9"><enum>(2)</enum><text>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.</text>
</paragraph><paragraph id="H915936F45CF14EEF95B07D8D35477900"><enum>(3)</enum><text>Beginning 3 years
after the date of enactment of the <short-title>Family
Smoking Prevention and Tobacco Control Act</short-title>, 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.</text>
</paragraph><paragraph id="HDA184CCCB3D74DFDA584175588D633FF"><enum>(4)</enum><text>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.</text>
</paragraph></subsection><subsection id="HED3C5A713AB540A892E6414910548376"><enum>(b)</enum><header>Data
Submission</header><text>At the request of the Secretary, each tobacco product
manufacturer or importer of tobacco products, or agents thereof, shall submit
the following:</text>
<paragraph id="H75770B23F344498FB52F56E8F5058866"><enum>(1)</enum><text>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.</text>
</paragraph><paragraph id="HB39D127704604A9B8E9B7F1752C2F0A3"><enum>(2)</enum><text>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.</text>
</paragraph><paragraph id="H06A15487BACF42D59288417985E66945"><enum>(3)</enum><text>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.</text>
</paragraph><continuation-text continuation-text-level="subsection">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.</continuation-text></subsection><subsection id="HC124A121F65048D587601FA66E1A8EBF"><enum>(c)</enum><header>Time for
Submission</header>
<paragraph id="H038969CA02E7470BBFDC1F96D6EE2FA8"><enum>(1)</enum><header>In
general</header><text>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).</text>
</paragraph><paragraph id="HC5B6E0922A574272A57B108CFD0F7768"><enum>(2)</enum><header>Disclosure of
additive</header><text>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.</text>
</paragraph><paragraph id="H026191B98FE746BE9AE16B9B9031964E"><enum>(3)</enum><header>Disclosure of
other actions</header><text>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.</text>
</paragraph></subsection><subsection id="H86CC83610E3B406087FBCD794D7D0B88"><enum>(d)</enum><header>Data
List</header>
<paragraph id="H3C8A96BBF7D542C4A81C073E0CF50F6B"><enum>(1)</enum><header>In
general</header><text>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).</text>
</paragraph><paragraph id="H02C968CEA4A149F39E5B84821D77C00D"><enum>(2)</enum><header>Consumer
research</header><text>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.</text>
</paragraph></subsection><subsection id="H2C1DCBD85B2F409D909241A2C36290E4"><enum>(e)</enum><header>Data
Collection</header><text>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.</text>
</subsection></section><section id="H3493C8B7F2D24AC3ACEBD3B9550E9ABF"><enum>905.</enum><header>Annual
registration</header>
<subsection id="H983BC2EF21094A81BF593A4D9F8EB99D"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="HEB7F27417C464EB286F0AC7C72FA2D87"><enum>(1)</enum><header>Manufacture,
preparation, compounding, or processing</header><text>The term
<term>manufacture, preparation, compounding, or processing</term> 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.</text>
</paragraph><paragraph id="HE41E6E4C72C84403AEE6C9B19E7071A8"><enum>(2)</enum><header>Name</header><text>The
term <term>name</term> 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.</text>
</paragraph></subsection><subsection id="HD7E059316F524EC1AF2EB8591F070D80"><enum>(b)</enum><header>Registration by
owners and operators</header><text>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
<short-title>Family Smoking Prevention and Tobacco Control
Act</short-title> 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.</text>
</subsection><subsection id="H82CC4CA8D74849709C096C97C9CF14D5"><enum>(c)</enum><header>Registration by
new owners and operators</header><text>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.</text>
</subsection><subsection id="HC050C4AE83B8433EB07852A6552F9981"><enum>(d)</enum><header>Registration of
added establishments</header><text>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.</text>
</subsection><subsection id="H875A43FD3E2F4EDDAFD4CDBC746EAFB7"><enum>(e)</enum><header>Uniform product
identification system</header><text>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.</text>
</subsection><subsection id="H384051E0D0EB464E84CDB4B8DB7FD127"><enum>(f)</enum><header>Public access to
registration information</header><text>The Secretary shall make available for
inspection, to any person so requesting, any registration filed under this
section.</text>
</subsection><subsection id="H3B2E2AE3350D4ACBB7CB021E4F62C1E0"><enum>(g)</enum><header>Biennial
inspection of registered establishments</header><text>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.</text>
</subsection><subsection id="HCA701FF6994D4253B5A4D1883939CBA6"><enum>(h)</enum><header>Registration by
Foreign Establishments</header><text>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).</text>
</subsection><subsection id="H21ED572BD5DC4040BE306393F12EC1F6"><enum>(i)</enum><header>Registration
information</header>
<paragraph id="H576DDF1C500B44DDB7DD1CB5E5B6A21F"><enum>(1)</enum><header>Product
list</header><text>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—</text>
<subparagraph id="H7ADD2335828A4D7CB3A4DC0466D91B66"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="H57D9B81B88234FDEB87758A3C7AA5F59"><enum>(B)</enum><text>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</text>
</subparagraph><subparagraph id="HB57616B76AD64170825AF803F4AFAABA"><enum>(C)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="HED1E710ECFE343C6A6FD369ED76FA5E5"><enum>(2)</enum><header>Consultation
with respect to forms</header><text>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.</text>
</paragraph><paragraph id="HC0195851CAA1446F80935B9C2A75F443"><enum>(3)</enum><header>Biannual report
of any change in product list</header><text>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:</text>
<subparagraph id="HD6CAD71279FD4D249B52ED87AC8CBD22"><enum>(A)</enum><text>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).</text>
</subparagraph><subparagraph id="H5F2BB2AA7B1945CE836A83E29BDA1C33"><enum>(B)</enum><text>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.</text>
</subparagraph><subparagraph id="H5324B2E1642544F5BE9CA7CD759BCC2F"><enum>(C)</enum><text>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.</text>
</subparagraph><subparagraph id="H761A0E63B7264F52889E05A4BC2D78F1"><enum>(D)</enum><text>Any material
change in any information previously submitted under this paragraph or
paragraph (1).</text>
</subparagraph></paragraph></subsection><subsection id="HB39F4FEB8808407AADF05C66F827030C"><enum>(j)</enum><header>Report Preceding
Introduction of Certain Substantially Equivalent Products Into Interstate
Commerce</header>
<paragraph id="H0C735ABC28E6483C97C3FB0CCFE1A355"><enum>(1)</enum><header>In
general</header><text>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)—</text>
<subparagraph id="HDAE7C7778E4C430BA5815E00F73A330E"><enum>(A)</enum><text>the basis for such
person’s determination that—</text>
<clause id="HE542B6A471B148EE91B247D7F4F91905"><enum>(i)</enum><text>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</text>
</clause><clause commented="no" id="H9DB4A42011664F1084519A7165D85DDD"><enum>(ii)</enum><text>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</text>
</clause></subparagraph><subparagraph id="H586ECD3D3DC445AEA5534F58ABE44090"><enum>(B)</enum><text>action taken by
such person to comply with the requirements under section 907 that are
applicable to the tobacco product.</text>
</subparagraph></paragraph><paragraph id="H26F545FBE6B0488695093138D6C89141"><enum>(2)</enum><header>Application to
certain post-February 15, 2007, products</header><text>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.</text>
</paragraph><paragraph id="HE333BA209CEA42BEB8623169B09A40D4"><enum>(3)</enum><header>Exemptions</header>
<subparagraph id="H81198F093F64458E8A5BD4C759389A39"><enum>(A)</enum><header>In
general</header><text>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—</text>
<clause id="H73CBE9EEBF4C469192AB281823E51E98"><enum>(i)</enum><text>such modification
would be a minor modification of a tobacco product that can be sold under this
Act;</text>
</clause><clause id="HE790621AD44F4280860431C27E78D676"><enum>(ii)</enum><text>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</text>
</clause><clause id="H21B5460E5BF14D6596FE04D146F265DA"><enum>(iii)</enum><text>an exemption is
otherwise appropriate.</text>
</clause></subparagraph><subparagraph id="HCFC94EF7AD61498BBB6BA22510E71C3E"><enum>(B)</enum><header>Regulations</header><text>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.</text>
</subparagraph></paragraph></subsection></section><section id="H3EAFF13BF60F4C1CA764E7BB15404DD4"><enum>906.</enum><header>General
provisions respecting control of tobacco products</header>
<subsection id="H87193F08BE47462A976011AA31AD2903"><enum>(a)</enum><header>In
General</header><text>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.</text>
</subsection><subsection id="H9D3E0DE424C4491A85897F25C7A4F465"><enum>(b)</enum><header>Information on
Public Access and Comment</header><text>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—</text>
<paragraph id="HBD849495E6294C7BB661F7E2E3915B3A"><enum>(1)</enum><text>the manner in
which interested persons may examine data and other information on which the
notice or findings is based; and</text>
</paragraph><paragraph id="HABEC8339C86B435D8C39C80A102B53A3"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><subsection id="H41CA87C926504A668EFCAD69D4DB1CF1"><enum>(c)</enum><header>Limited
Confidentiality of Information</header><text>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
<external-xref legal-doc="usc" parsable-cite="usc/5/552">section
552</external-xref> 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.</text>
</subsection><subsection id="H1FCAFA5919314AE98017393E51D823FC"><enum>(d)</enum><header>Restrictions</header>
<paragraph id="H2C1B9CE085AC4D66B533FE85D3B601CA"><enum>(1)</enum><header>In
general</header><text>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—</text>
<subparagraph id="H166D2C52081A419FBBCD766849E8D735"><enum>(A)</enum><text>the increased or
decreased likelihood that existing users of tobacco products will stop using
such products; and</text>
</subparagraph><subparagraph id="HA3070C39AA414774B8DE4FF5B989A8E8"><enum>(B)</enum><text>the increased or
decreased likelihood that those who do not use tobacco products will start
using such products.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph id="H4131C7724082444B92877789A47F47D0"><enum>(2)</enum><header>Label
statements</header><text>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.</text>
</paragraph><paragraph id="HDDF37EDE4C2843ADA8428593F9321168"><enum>(3)</enum><header>Limitations</header>
<subparagraph id="H89E7792C2AD940C3BAE0BF6ACC6F1735"><enum>(A)</enum><header>In
general</header><text>No restrictions under paragraph (1) may—</text>
<clause id="H264794388960463BA272D1E4950D8F1C"><enum>(i)</enum><text>prohibit the sale
of any tobacco product in face-to-face transactions by a specific category of
retail outlets; or</text>
</clause><clause id="H71EE7104203F4E0FBA928856CC03732B"><enum>(ii)</enum><text>establish a
minimum age of sale of tobacco products to any person older than 18 years of
age.</text>
</clause></subparagraph><subparagraph id="H15A5026FCF134CD585E4F1B91E93BDBA"><enum>(B)</enum><header>Matchbooks</header><text>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.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H3228458194814E6FBFC82F500A5D6629"><enum>(4)</enum><header>Remote
sales</header>
<subparagraph id="H0FDB0FF17F7347CA9B017DAB1B129E57"><enum>(A)</enum><header>In
general</header><text>The Secretary shall—</text>
<clause id="HFD90FE6E89644E6A8A47C469C59E8589"><enum>(i)</enum><text display-inline="yes-display-inline">within 18 months after the date of
enactment of the <short-title>Family Smoking Prevention
and Tobacco Control Act</short-title>, 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</text>
</clause><clause id="HE3A3153440E2461E9C4A95BC7BF51597"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph id="H1DB52F505EEC4E2EB4D25533F64893C2"><enum>(B)</enum><header>Relation to
other authority</header><text display-inline="yes-display-inline">Nothing in
this paragraph limits the authority of the Secretary to take additional actions
under the other paragraphs of this subsection.</text>
</subparagraph></paragraph></subsection><subsection id="H85C4E65547AD42808F6B4C2DF369F446"><enum>(e)</enum><header>Good
Manufacturing Practice Requirements</header>
<paragraph id="HD5C8A9B386B64C6886E3FD0C8644B23B"><enum>(1)</enum><header>Methods,
facilities, and controls to conform</header>
<subparagraph id="HA563059DD1E848B894F9DDE3DD598B35"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph id="H7996B2E86F9440758DA14BD5CE5C43ED"><enum>(B)</enum><header>Requirements</header><text>The
Secretary shall—</text>
<clause id="H86195DB2A3AE4F82BF767F4259DB99CA"><enum>(i)</enum><text>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;</text>
</clause><clause id="H78E95D485200458192A1ED29616FB2A6"><enum>(ii)</enum><text>before
promulgating any regulation under subparagraph (A), afford opportunity for an
oral hearing;</text>
</clause><clause id="H6CB4BC74EA624744B59029C54EF43861"><enum>(iii)</enum><text>provide the
Tobacco Products Scientific Advisory Committee a reasonable time to make its
recommendation with respect to proposed regulations under subparagraph
(A);</text>
</clause><clause id="HE600796AC274433F9D03FB858D9EE2CE"><enum>(iv)</enum><text>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</text>
</clause><clause id="HB0011D52274B4CDABD8C55A18659E8B0"><enum>(v)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph><paragraph id="H4EACB02595CC46808C80BBD0CABB9509"><enum>(2)</enum><header>Exemptions;
variances</header>
<subparagraph id="H48766F5596774F54B176633B1145CEE3"><enum>(A)</enum><header>Petition</header><text>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—</text>
<clause id="HA2FE49FD7BB64AA58AC5E19EED38A6E9"><enum>(i)</enum><text>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;</text>
</clause><clause id="H6BDD387BBA8344F79A38B6B9C034136F"><enum>(ii)</enum><text>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</text>
</clause><clause id="H07D64CBFA619456E8208ACF2E5E21CE3"><enum>(iii)</enum><text>contain such
other information as the Secretary shall prescribe.</text>
</clause></subparagraph><subparagraph id="HC7209FD1034F4D31AE5E14BDC20D336A"><enum>(B)</enum><header>Referral to the
tobacco products scientific advisory committee</header><text>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—</text>
<clause id="HDA5EAE5563AA44568B98E85654CEC83D"><enum>(i)</enum><text>the date the
petition was submitted to the Secretary under subparagraph (A); or</text>
</clause><clause id="HE8BB03DFF71445079E66AB928A2B5F15"><enum>(ii)</enum><text>the day after the
petition was referred to the Tobacco Products Scientific Advisory
Committee,</text>
</clause><continuation-text continuation-text-level="subparagraph">whichever occurs later, the
Secretary shall by order either deny the petition or approve it.</continuation-text></subparagraph><subparagraph id="HE97F035AA8B34781B58D045D733ABA34"><enum>(C)</enum><header>Approval</header><text>The
Secretary may approve—</text>
<clause id="H30C6F08DF93445EFA00D0710EDE6DB78"><enum>(i)</enum><text>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</text>
</clause><clause id="H067DE27C15BD4D9280E370CC40FB65D2"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="H6F1256DDD700405F83BFA768695E09A5"><enum>(D)</enum><header>Conditions</header><text>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.</text>
</subparagraph><subparagraph id="H4F1743443C644F0F8D44DBE88EBFD261"><enum>(E)</enum><header>Hearing</header><text>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.</text>
</subparagraph></paragraph><paragraph id="HE6688B4588DD479482C532986D591754"><enum>(3)</enum><header>Compliance</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection id="H55AFD21831FB43728ED39F044BBE6B83"><enum>(f)</enum><header>Research and
Development</header><text>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.</text>
</subsection></section><section id="H5E418EB7E1A94343A83B07904F4EF45F"><enum>907.</enum><header>Tobacco product
standards</header>
<subsection id="H456B15A49C5445108DFD15CBFDCC7DDC"><enum>(a)</enum><header>In
general</header>
<paragraph id="HEF97B5C3FCB141F6954B04CDB16226B2"><enum>(1)</enum><header>Special
rules</header>
<subparagraph id="HF39F509854A641D2B5A86660CE670F19"><enum>(A)</enum><header>Special rule for
cigarettes</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph id="H558CB0FE23754FE5A3F34D41F902358C"><enum>(B)</enum><header>Additional
special rule</header><text>Beginning 2 years after the date of enactment of the
<short-title>Family Smoking Prevention and Tobacco Control
Act</short-title>, 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.</text>
</subparagraph></paragraph><paragraph id="H2A56070270554EE0B68A0147C67A048F"><enum>(2)</enum><header>Revision of
tobacco product standards</header><text>The Secretary may revise the tobacco
product standards in paragraph (1) in accordance with subsection (c).</text>
</paragraph><paragraph id="H222FF90E69C5418EB19FA56895445643"><enum>(3)</enum><header>Tobacco product
standards</header>
<subparagraph id="HFB80714E30694758BF8618FA83E5CE2B"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="HBDEBD28D2E2D48E1A134E06F31BAAE89"><enum>(B)</enum><header>Determinations</header>
<clause id="H52E7E6B8D83842DBA5F5E8CFF517EBDD"><enum>(i)</enum><header>Considerations</header><text display-inline="yes-display-inline">In making a finding described in
subparagraph (A), the Secretary shall consider scientific evidence
concerning—</text>
<subclause id="H613D764BA4ED4C4F99769E7333F25B28"><enum>(I)</enum><text>the risks and
benefits to the population as a whole, including users and nonusers of tobacco
products, of the proposed standard;</text>
</subclause><subclause id="HF470399577D3467DB6C57B6D8E9E8278"><enum>(II)</enum><text>the increased or
decreased likelihood that existing users of tobacco products will stop using
such products; and</text>
</subclause><subclause id="HE7DF10DC07FD4829898B8E3892FF3298"><enum>(III)</enum><text>the increased or
decreased likelihood that those who do not use tobacco products will start
using such products.</text>
</subclause></clause><clause display-inline="no-display-inline" id="H80CB15AF197243A491149320E947BBB8"><enum>(ii)</enum><header>Additional
considerations</header><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph></paragraph><paragraph id="H6082C17669AE472C8F73101717BB86EB"><enum>(4)</enum><header>Content of
tobacco product standards</header><text>A tobacco product standard established
under this section for a tobacco product—</text>
<subparagraph id="H45D7B95DC89947D493DFD66E43EECAE8"><enum>(A)</enum><text>shall include
provisions that are appropriate for the protection of the public health,
including provisions, where appropriate—</text>
<clause id="HA280DE768CEB489599104DADDD0F2B4C"><enum>(i)</enum><text>for nicotine
yields of the product;</text>
</clause><clause id="HA1E29B2035D64F358AAC74A3438EFA37"><enum>(ii)</enum><text>for the reduction
or elimination of other constituents, including smoke constituents, or harmful
components of the product; or</text>
</clause><clause id="H957FE7EC47604EADB213AD4B24A61D74"><enum>(iii)</enum><text>relating to any
other requirement under subparagraph (B);</text>
</clause></subparagraph><subparagraph id="H59A59E4825BA4D01B98DA0C331C69D04"><enum>(B)</enum><text>shall, where
appropriate for the protection of the public health, include—</text>
<clause id="H26C93DD905244BAC92E3DC5F700A185E"><enum>(i)</enum><text>provisions
respecting the construction, components, ingredients, additives, constituents,
including smoke constituents, and properties of the tobacco product;</text>
</clause><clause id="H92E067CFD6FE41108EBF0777220A053A"><enum>(ii)</enum><text>provisions for
the testing (on a sample basis or, if necessary, on an individual basis) of the
tobacco product;</text>
</clause><clause id="H4E857770A2A1479AB562075BDF5C1690"><enum>(iii)</enum><text>provisions for
the measurement of the tobacco product characteristics of the tobacco
product;</text>
</clause><clause id="H709403E3A1F24685A77B6003D184AAB3"><enum>(iv)</enum><text>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</text>
</clause><clause id="H4FA5D05A873D4CF387E3CD97C9F9E3DD"><enum>(v)</enum><text>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);</text>
</clause></subparagraph><subparagraph id="H967D8FAEF68645138DC5494FB80CFBCA"><enum>(C)</enum><text>shall, where
appropriate, require the use and prescribe the form and content of labeling for
the proper use of the tobacco product; and</text>
</subparagraph><subparagraph id="H420E29A299A040139634765C3103B5B3"><enum>(D)</enum><text display-inline="yes-display-inline">shall require tobacco products containing
foreign-grown tobacco to meet the same standards applicable to tobacco products
containing domestically grown tobacco.</text>
</subparagraph></paragraph><paragraph id="HA0EBE818841D411E83845CB6A9C8DC3A"><enum>(5)</enum><header>Periodic
reevaluation of tobacco product standards</header><text>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.</text>
</paragraph><paragraph id="H3062BB85EB444393836D89A209613C25"><enum>(6)</enum><header>Involvement of
other agencies; informed persons</header><text>In carrying out duties under
this section, the Secretary shall endeavor to—</text>
<subparagraph id="HA92E0979A0274481A7CC8378486B2CB7"><enum>(A)</enum><text>use personnel,
facilities, and other technical support available in other Federal
agencies;</text>
</subparagraph><subparagraph id="HF53863C19D224FA9B54FAFA4EE3BAC17"><enum>(B)</enum><text>consult with other
Federal agencies concerned with standard setting and other nationally or
internationally recognized standard-setting entities; and</text>
</subparagraph><subparagraph id="HCD3463609219437899C2DD3DBDC5F9C7"><enum>(C)</enum><text>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.</text>
</subparagraph></paragraph></subsection><subsection display-inline="no-display-inline" id="H3F9C47C23A50482FA498FC2250F171C6"><enum>(b)</enum><header>Considerations
by Secretary</header>
<paragraph id="HDD42B28C874A43D78CFD5A5595D06F34"><enum>(1)</enum><header>Technical
achievability</header><text display-inline="yes-display-inline">The Secretary
shall consider information submitted in connection with a proposed standard
regarding the technical achievability of compliance with such standard.</text>
</paragraph><paragraph id="HFC83A2700FBD439291C2401F971846AE"><enum>(2)</enum><header>Other
considerations</header><text>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.</text>
</paragraph></subsection><subsection id="HDCFA9F5E434E4876992AC4D580523D4B"><enum>(c)</enum><header>Proposed
standards</header>
<paragraph id="H97A59DA15E254567A17E6C0171333153"><enum>(1)</enum><header>In
general</header><text>The Secretary shall publish in the Federal Register a
notice of proposed rulemaking for the establishment, amendment, or revocation
of any tobacco product standard.</text>
</paragraph><paragraph id="H318F243987B343CAAF561B9712B1DF00"><enum>(2)</enum><header>Requirements of
notice</header><text>A notice of proposed rulemaking for the establishment or
amendment of a tobacco product standard for a tobacco product shall—</text>
<subparagraph id="HF081C377A6F3434C9F4F223C80BF59E9"><enum>(A)</enum><text>set forth a
finding with supporting justification that the tobacco product standard is
appropriate for the protection of the public health;</text>
</subparagraph><subparagraph id="HE4197B3C9A65428A84F4BC21F84ED6FE"><enum>(B)</enum><text>invite interested
persons to submit a draft or proposed tobacco product standard for
consideration by the Secretary;</text>
</subparagraph><subparagraph id="HC15A3435CE7847BF9639F3E62E230E46"><enum>(C)</enum><text display-inline="yes-display-inline">invite interested persons to submit
comments on structuring the standard so that it does not advantage
foreign-grown tobacco over domestically grown tobacco; and</text>
</subparagraph><subparagraph id="H7FC57D4483484BCFAC7578C4780E540D"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph id="H4CF1FD7D040548609B7211E4B611530C"><enum>(3)</enum><header>Finding</header><text>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.</text>
</paragraph><paragraph id="HBF91E46F3E4F41E895EABFCC3670EAB7"><enum>(4)</enum><header>Comment</header><text>The
Secretary shall provide for a comment period of not less than 60 days.</text>
</paragraph></subsection><subsection id="H0425F4FB6D1346809C3BC7607CC68717"><enum>(d)</enum><header>Promulgation</header>
<paragraph id="H5CAA963FE4784B0B9E05CCEC5BCE824E"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">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—</text>
<subparagraph id="H15FDD57E181C42CE9E5D2D4653E58747"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph id="H3B1AC5D70C8E4E278CCD0096126EA154"><enum>(B)</enum><text>publish a notice
terminating the proceeding for the development of the standard together with
the reasons for such termination.</text>
</subparagraph></paragraph><paragraph id="HAF08408003BD4073A6638F0DE5DDBC9F"><enum>(2)</enum><header>Effective
date</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph id="HE40B735D653E4FA18AE05B556E9CD424"><enum>(3)</enum><header>Limitation on
power granted to the Food and Drug Administration</header><text>Because of the
importance of a decision of the Secretary to issue a regulation—</text>
<subparagraph id="H6B15C5E41E194EA1B512E709C44087B9"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H169EDE1ACC6C4A47955EAE83BAEC2027"><enum>(B)</enum><text>requiring the
reduction of nicotine yields of a tobacco product to zero,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">the
Secretary is prohibited from taking such actions under this Act.</continuation-text></paragraph><paragraph id="HD46D1B3E00094AA6A02E4492FB51C7F5"><enum>(4)</enum><header>Amendment;
revocation</header>
<subparagraph id="H00BCD1243E054E11B0154C19D51B2734"><enum>(A)</enum><header>Authority</header><text>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.</text>
</subparagraph><subparagraph id="H3841670094D74AE7A6C3B15DF9931EDF"><enum>(B)</enum><header>Effective
date</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H59019FA50BC44AA7A9235F96CFE180BF"><enum>(5)</enum><header>Referral to
advisory committee</header>
<subparagraph id="H775324A46A1F4314BD6ADE64AB3F886A"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="H53DFA79198404B8C836EE4740FC02AB0"><enum>(B)</enum><header>Initiation of
referral</header><text>The Secretary may make a referral under this
paragraph—</text>
<clause id="HED83CBEACE4640588B8D76826D25BDEF"><enum>(i)</enum><text>on
the Secretary’s own initiative; or</text>
</clause><clause id="H1CD8C6CA190B408E893E9FF96A996E25"><enum>(ii)</enum><text>upon the request
of an interested person that—</text>
<subclause id="HC05B2EE8A4374ACC9269967E7D1E05FF"><enum>(I)</enum><text>demonstrates good
cause for the referral; and</text>
</subclause><subclause id="HD10D703353EB47F18209C90C6C4BA979"><enum>(II)</enum><text>is made before
the expiration of the period for submission of comments on the proposed
regulation.</text>
</subclause></clause></subparagraph><subparagraph id="H2A6364EFD0764194B9CA2150355647DB"><enum>(C)</enum><header>Provision of
data</header><text>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.</text>
</subparagraph><subparagraph id="HDABA0B9EB8DF41E28518096F62F932CB"><enum>(D)</enum><header>Report and
recommendation</header><text>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.</text>
</subparagraph><subparagraph id="H5F234925796E46E6933A937F31EA409A"><enum>(E)</enum><header>Public
availability</header><text>The Secretary shall make a copy of each report and
recommendation under subparagraph (D) publicly available.</text>
</subparagraph></paragraph></subsection><subsection display-inline="no-display-inline" id="HD5159628C90847E3A16B06AB22F82F60"><enum>(e)</enum><header>Menthol
cigarettes</header>
<paragraph id="HDE45D35531074330BBF114CEA516CF77"><enum>(1)</enum><header>Referral;
considerations</header><text>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).</text>
</paragraph><paragraph id="HCC3559C5F40844C485482A832542E248"><enum>(2)</enum><header>Report and
recommendation</header><text>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).</text>
</paragraph><paragraph id="H4DDEFAABCB0A4F6EB0E2A6DDE8AAD78C"><enum>(3)</enum><header>Rule of
construction</header><text>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.</text>
</paragraph></subsection></section><section id="H3744DDFB1D834E609984946AC0206D24"><enum>908.</enum><header>Notification
and other remedies</header>
<subsection id="HC83900756E874D0080AB2289525C0036"><enum>(a)</enum><header>Notification</header><text>If
the Secretary determines that—</text>
<paragraph id="H4CFBCF82EAB7429ABD77059683BEFBDC"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="H15D8B75DF8B444F68F397CE37E4BE86F"><enum>(2)</enum><text>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,</text>
</paragraph><continuation-text continuation-text-level="subsection">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.</continuation-text></subsection><subsection id="H5DB9542323614C82946600EE582E5E74"><enum>(b)</enum><header>No Exemption
From Other Liability</header><text>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.</text>
</subsection><subsection id="HB0AB5B22ED5E4571B8393CE8265CCFE9"><enum>(c)</enum><header>Recall
Authority</header>
<paragraph id="H5B93E523FFED4E35B369B6F9765C0150"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="HEEDD35B484AB462BB94E9432BD25EDDB"><enum>(2)</enum><header>Amendment of
order to require recall</header>
<subparagraph id="H72E4F753735E482FBE627E5CF65AF562"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="H2047F20E099540FBB757FF760842BB9F"><enum>(B)</enum><header>Notice</header><text>An
amended order under subparagraph (A)—</text>
<clause id="H01374E2F26A94F9690A472AF817CC887"><enum>(i)</enum><text>shall not include
recall of a tobacco product from individuals; and</text>
</clause><clause id="HEB1B69E18F684E549FEA694ED074BB9B"><enum>(ii)</enum><text>shall provide for
notice to persons subject to the risks associated with the use of such tobacco
product.</text>
</clause><continuation-text continuation-text-level="subparagraph">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).</continuation-text></subparagraph></paragraph><paragraph id="HDE6F0957E47749D18F7FD94F71BDF8A7"><enum>(3)</enum><header>Remedy not
exclusive</header><text>The remedy provided by this subsection shall be in
addition to remedies provided by subsection (a).</text>
</paragraph></subsection></section><section id="HB5209BB736534AD9A4005760FA7F9238"><enum>909.</enum><header>Records and
reports on tobacco products</header>
<subsection id="H7559BEDA05A84DB6A4DFB2908AD0D4C5"><enum>(a)</enum><header>In
General</header><text>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—</text>
<paragraph id="HBCAE0A2105D84295889629019926EDE4"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="H75D257A8014B437FBE5F17C869C86957"><enum>(2)</enum><text>shall require
reporting of other significant adverse tobacco product experiences as
determined by the Secretary to be necessary to be reported;</text>
</paragraph><paragraph id="H7F0482F4730240FA94D99925F8160708"><enum>(3)</enum><text>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;</text>
</paragraph><paragraph id="H26E8181294DC470788E6C774FF0E8237"><enum>(4)</enum><text>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;</text>
</paragraph><paragraph id="H3E36D6A7350A494980CCDF49AC5F3D07"><enum>(5)</enum><text>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</text>
</paragraph><paragraph id="H804B619B16B6468CAADC0515CED753FF"><enum>(6)</enum><text>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.</text>
</paragraph><continuation-text continuation-text-level="subsection">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.</continuation-text></subsection><subsection id="HF3B874F0B31C415F879F1E07BB9CB0F0"><enum>(b)</enum><header>Reports of
Removals and Corrections</header>
<paragraph id="H9EA52E4DC9BC4967BC3A1AA10690C43E"><enum>(1)</enum><header>In
general</header><text>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—</text>
<subparagraph id="HEDFE535D3F9547D59FC1BC7706927027"><enum>(A)</enum><text>to reduce a risk
to health posed by the tobacco product; or</text>
</subparagraph><subparagraph id="H136EAA04938A48A1B9B10D7B8DE3E648"><enum>(B)</enum><text>to remedy a
violation of this chapter caused by the tobacco product which may present a
risk to health.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph id="H620403485B724BEFB3C3F962F9F4C850"><enum>(2)</enum><header>Exception</header><text>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).</text>
</paragraph></subsection></section><section id="H2E45800389734E4FA9A288002C212B0E"><enum>910.</enum><header>Application for
review of certain tobacco products</header>
<subsection id="H6A06B70A2590473AA711E33FC5B285B9"><enum>(a)</enum><header>In
general</header>
<paragraph id="HE39A23FB62F142D69AA97EFA37107826"><enum>(1)</enum><header>New tobacco
product defined</header><text>For purposes of this section the term <term>new
tobacco product</term> means—</text>
<subparagraph id="HEA5F564841064B62A18F3B823A78F679"><enum>(A)</enum><text>any tobacco
product (including those products in test markets) that was not commercially
marketed in the United States as of February 15, 2007; or</text>
</subparagraph><subparagraph id="HD8354973FB7C411FA74161BCD99269C8"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="HED62365A71C34EFEACF8F74FABEEF8C2"><enum>(2)</enum><header>Premarket review
required</header>
<subparagraph id="H72CDC6BD94354C8F8C8D94F5E0DEED41"><enum>(A)</enum><header>New
products</header><text>An order under subsection (c)(1)(A)(i) for a new tobacco
product is required unless—</text>
<clause id="H03B6D380694943C0A6A7C837DA4AE2EC"><enum>(i)</enum><text>the manufacturer
has submitted a report under section 905(j); and the Secretary has issued an
order that the tobacco product—</text>
<subclause id="H3367956F59FA4A808AF1573101097D7F"><enum>(I)</enum><text>is substantially
equivalent to a tobacco product commercially marketed (other than for test
marketing) in the United States as of February 15, 2007; and</text>
</subclause><subclause id="HB1640B5603EA404CA97CB8E67708127F"><enum>(II)</enum><text>is in compliance
with the requirements of this Act; or</text>
</subclause></clause><clause id="H667B77A4A6B74B3DA11D2DA331693657"><enum>(ii)</enum><text>the tobacco
product is exempt from the requirements of section 905(j) pursuant to a
regulation issued under section 905(j)(3).</text>
</clause></subparagraph><subparagraph id="HD8B70E66BEEC4736B633C852F7FEDF0F"><enum>(B)</enum><header>Application to
certain post-February 15, 2007, products</header><text>Subparagraph (A) shall
not apply to a tobacco product—</text>
<clause id="H3B0F0C2FEE564544AEF80A8B5B08B7A2"><enum>(i)</enum><text>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</text>
</clause><clause id="H99696B4FA0E54E78BCE686AE9EFEFB83"><enum>(ii)</enum><text>for which a
report was submitted under section 905(j) within such 21-month period,</text>
</clause><continuation-text continuation-text-level="subparagraph">except
that subparagraph (A) shall apply to the tobacco product if the Secretary
issues an order that the tobacco product is not substantially
equivalent.</continuation-text></subparagraph></paragraph><paragraph id="HDB3855A72D2D4415B41E34A72F939EDE"><enum>(3)</enum><header>Substantially
equivalent defined</header>
<subparagraph id="H52F836CFC3604FFFA8F5A1864B11C55B"><enum>(A)</enum><header>In
general</header><text>In this section and section 905(j), the term
<term>substantially equivalent</term> or <term>substantial equivalence</term>
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—</text>
<clause id="H8E16160E455B4B35AAF833D78DB7F6AF"><enum>(i)</enum><text>has the same
characteristics as the predicate tobacco product; or</text>
</clause><clause id="H4F7DFBFCC66841E5970F1A55B5953E88"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="H2EC2A5C2DFA94DC4A855EAC525C3DEC1"><enum>(B)</enum><header>Characteristics</header><text>In
subparagraph (A), the term <term>characteristics</term> means the materials,
ingredients, design, composition, heating source, or other features of a
tobacco product.</text>
</subparagraph><subparagraph id="H8BA0BAA5DC834A14B1993F9F0811AFB1"><enum>(C)</enum><header>Limitation</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H759A6CCAA912466984DB2F579DBC5CAB"><enum>(4)</enum><header>Health
information</header>
<subparagraph id="H3731B07D483A4046BEDF6D437F308DAF"><enum>(A)</enum><header>Summary</header><text>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.</text>
</subparagraph><subparagraph id="H3BD10B4E26C64C55AEF6B32011A36DA8"><enum>(B)</enum><header>Required
information</header><text>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.</text>
</subparagraph></paragraph></subsection><subsection id="H057466C66B1F486EA86E473E4E349EE9"><enum>(b)</enum><header>Application</header>
<paragraph id="H06ED59E960DE4189A34AC706E7FDC2A1"><enum>(1)</enum><header>Contents</header><text>An
application under this section shall contain—</text>
<subparagraph id="H52AB291366B8411BAD7EB8B291FCB6E4"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="HD680D16B334B426EA96E8BEDCB6144C6"><enum>(B)</enum><text>a full statement
of the components, ingredients, additives, and properties, and of the principle
or principles of operation, of such tobacco product;</text>
</subparagraph><subparagraph id="H6EA95A1A188C4B94B3885A17390AECAC"><enum>(C)</enum><text>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;</text>
</subparagraph><subparagraph id="H4CEDDBCB130D406ABF24F9F7ECD03061"><enum>(D)</enum><text>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;</text>
</subparagraph><subparagraph id="H1FAFF0054C9B4DBC93B3CFFDD151F15A"><enum>(E)</enum><text>such samples of
such tobacco product and of components thereof as the Secretary may reasonably
require;</text>
</subparagraph><subparagraph id="HC042A18F8CCB4C3EA427680F3CE97468"><enum>(F)</enum><text>specimens of the
labeling proposed to be used for such tobacco product; and</text>
</subparagraph><subparagraph id="H7E691C4B52A144C3BD88431794649562"><enum>(G)</enum><text>such other
information relevant to the subject matter of the application as the Secretary
may require.</text>
</subparagraph></paragraph><paragraph id="H0FAC1F6E81C24B2BB0569BF445A03051"><enum>(2)</enum><header>Referral to
tobacco products scientific advisory committee</header><text>Upon receipt of an
application meeting the requirements set forth in paragraph (1), the
Secretary—</text>
<subparagraph id="HD8B4F12C8B6F4D2DB9F047B8B0048C69"><enum>(A)</enum><text>may, on the
Secretary’s own initiative; or</text>
</subparagraph><subparagraph id="H617E871884264D2DB26CCFBBBAD74BA9"><enum>(B)</enum><text>may, upon the
request of an applicant,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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.</continuation-text></paragraph></subsection><subsection id="H4995792E57A4479E80F09978B53CCBA2"><enum>(c)</enum><header>Action on
Application</header>
<paragraph id="H93936953265644DDA1FA7EE6B7D70819"><enum>(1)</enum><header>Deadline</header>
<subparagraph id="H77C3980EF6A04CE183787744740FE13C"><enum>(A)</enum><header>In
general</header><text>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—</text>
<clause id="H8F84B689343643429454179B0D2128D3"><enum>(i)</enum><text>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</text>
</clause><clause id="H83B8CAF1FA5B491BBA3B5C9F71D46099"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="H6E2B78F230C4428BBDE7DFF9A61759B1"><enum>(B)</enum><header>Restrictions on
sale and distribution</header><text>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).</text>
</subparagraph></paragraph><paragraph id="HA3AD9FB84B1341CD88F0962539044FD9"><enum>(2)</enum><header>Denial of
application</header><text>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—</text>
<subparagraph id="HDFD3CCE2133A4E229AF3D3A0A2EE66F5"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="HDCC1F56CC2EB43C29603DE66C5665BAD"><enum>(B)</enum><text>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);</text>
</subparagraph><subparagraph id="H45853F0BDC4845488A2AEF3198761CCC"><enum>(C)</enum><text>based on a fair
evaluation of all material facts, the proposed labeling is false or misleading
in any particular; or</text>
</subparagraph><subparagraph id="HAE4AA1A3968F4CA5AF268159241EF3D8"><enum>(D)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H1FB27E068494490D94C2CE65EC2DD3FD"><enum>(3)</enum><header>Denial
information</header><text>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).</text>
</paragraph><paragraph id="H4E0F694428B64CA4BC801195940C9F98"><enum>(4)</enum><header>Basis for
finding</header><text>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—</text>
<subparagraph id="H65F8399B9DBF4287A85E87F5479913D2"><enum>(A)</enum><text>the increased or
decreased likelihood that existing users of tobacco products will stop using
such products; and</text>
</subparagraph><subparagraph id="H6E1CDFA5EE87412F90618D415ED5BF5A"><enum>(B)</enum><text>the increased or
decreased likelihood that those who do not use tobacco products will start
using such products.</text>
</subparagraph></paragraph><paragraph id="HF28E591EAB144D85A4D4F17D33F68973"><enum>(5)</enum><header>Basis for
action</header>
<subparagraph id="H33858AA06737449CAA5248DEDB03F445"><enum>(A)</enum><header>Investigations</header><text>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.</text>
</subparagraph><subparagraph id="HB9059D0FC8E84549B11B27C8839E46FD"><enum>(B)</enum><header>Other
evidence</header><text>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.</text>
</subparagraph></paragraph></subsection><subsection id="HD65AF09938C344D9A2A1DB792F83D52A"><enum>(d)</enum><header>Withdrawal and
Temporary Suspension</header>
<paragraph id="H846EF5EC4FD847939AE8A4C7394FD9D9"><enum>(1)</enum><header>In
general</header><text>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—</text>
<subparagraph id="HE849181C2EE142DC87DD12DC3C3CD8EC"><enum>(A)</enum><text>that the continued
marketing of such tobacco product no longer is appropriate for the protection
of the public health;</text>
</subparagraph><subparagraph id="H9ED6DDB0E28E4299AB5CAAC9D3B2F4CF"><enum>(B)</enum><text>that the
application contained or was accompanied by an untrue statement of a material
fact;</text>
</subparagraph><subparagraph id="HF2DD2221814341299AA2402D48543F6D"><enum>(C)</enum><text>that the
applicant—</text>
<clause id="H2AA380A485A74E02AC6A4D9FAE1BD7D5"><enum>(i)</enum><text>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;</text>
</clause><clause id="H69F0BFAA364D412195F97CB14462AC2E"><enum>(ii)</enum><text>has refused to
permit access to, or copying or verification of, such records as required by
section 704; or</text>
</clause><clause id="H80CB0E6320224AEF981939E1B1243567"><enum>(iii)</enum><text>has not complied
with the requirements of section 905;</text>
</clause></subparagraph><subparagraph id="HC095B70E76C2469484F1ECFB9C35BAFB"><enum>(D)</enum><text>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;</text>
</subparagraph><subparagraph id="HD083F59BC8D246179BDBC4D6F5A795D3"><enum>(E)</enum><text>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</text>
</subparagraph><subparagraph id="H3710AC74EB3745ABBFB9534007326FCC"><enum>(F)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H6CFDDE5859D7404AB66BE71E7F3F8CF3"><enum>(2)</enum><header>Appeal</header><text>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.</text>
</paragraph><paragraph id="H8B4D53B553DD486388090E07B267FA71"><enum>(3)</enum><header>Temporary
suspension</header><text>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.</text>
</paragraph></subsection><subsection id="H7C712AAFEAC54ABC80440A0BB45B374F"><enum>(e)</enum><header>Service of
Order</header><text>An order issued by the Secretary under this section shall
be served—</text>
<paragraph id="HE5E0DFB3138643269BD49FD9521E7F41"><enum>(1)</enum><text>in person by any
officer or employee of the department designated by the Secretary; or</text>
</paragraph><paragraph id="H26ADD6B929324CB8843497F750984417"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><subsection id="H0041DD5422A84B6085B9D5F82D03A2BD"><enum>(f)</enum><header>Records</header>
<paragraph id="HB1B611D162E04585A2C23172F3BA9A61"><enum>(1)</enum><header>Additional
information</header><text>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.</text>
</paragraph><paragraph id="HA301C9009C4E4CB68B75E890A628BB30"><enum>(2)</enum><header>Access to
records</header><text>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.</text>
</paragraph></subsection><subsection id="H4DBF74E81A754A16A83580F7A34B833D"><enum>(g)</enum><header>Investigational
Tobacco Product Exemption for Investigational Use</header><text>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.</text>
</subsection></section><section id="H28936061C0984835B0DAE571C040D347"><enum>911.</enum><header>Modified risk
tobacco products</header>
<subsection id="H07669AAF4B99440994975379D711A3FA"><enum>(a)</enum><header>In
General</header><text>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.</text>
</subsection><subsection id="H7E874D29E1F7429780344C094AA8DB22"><enum>(b)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="H54FF8BE5DFC44680A3A3C73137668966"><enum>(1)</enum><header>Modified risk
tobacco product</header><text>The term <term>modified risk tobacco
product</term> 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.</text>
</paragraph><paragraph id="HE0D10C53FFEC4D8FB0DA007E5A856774"><enum>(2)</enum><header>Sold or
distributed</header>
<subparagraph id="H78A58573B9CD45C99D32ED75D5D7DF37"><enum>(A)</enum><header>In
general</header><text>With respect to a tobacco product, the term <term>sold or
distributed for use to reduce harm or the risk of tobacco-related disease
associated with commercially marketed tobacco products</term> means a tobacco
product—</text>
<clause id="HA4B1E3D18D2A499C8045D627C8B07127"><enum>(i)</enum><text>the label,
labeling, or advertising of which represents explicitly or implicitly
that—</text>
<subclause id="HD798A7D970AA4ABCAFD49679B568CBB3"><enum>(I)</enum><text>the tobacco
product presents a lower risk of tobacco-related disease or is less harmful
than one or more other commercially marketed tobacco products;</text>
</subclause><subclause id="HC4A9CD3361904254878C0BA1208265E6"><enum>(II)</enum><text>the tobacco
product or its smoke contains a reduced level of a substance or presents a
reduced exposure to a substance; or</text>
</subclause><subclause id="HAB38167771294B5F9CF338672AE1F12A"><enum>(III)</enum><text>the tobacco
product or its smoke does not contain or is free of a substance;</text>
</subclause></clause><clause id="HF7FFDD132B7B475EBA5716C8C0A26384"><enum>(ii)</enum><text>the label,
labeling, or advertising of which uses the descriptors <quote>light</quote>,
<quote>mild</quote>, or <quote>low</quote> or similar descriptors; or</text>
</clause><clause id="H836C0F42A93C4D71A6AB7C063479A52E"><enum>(iii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="HA33CDF40830B456FAF7E58894C4F747C"><enum>(B)</enum><header>Limitation</header><text>No
tobacco product shall be considered to be <quote>sold or distributed for use to
reduce harm or the risk of tobacco-related disease associated with commercially
marketed tobacco products</quote>, except as described in subparagraph
(A).</text>
</subparagraph><subparagraph id="HD57B32833BC443548B33909F8E5A0747"><enum>(C)</enum><header>Smokeless
tobacco product</header><text display-inline="yes-display-inline">No smokeless
tobacco product shall be considered to be <quote>sold or distributed for use to
reduce harm or the risk of tobacco-related disease associated with commercially
marketed tobacco products</quote> solely because its label, labeling, or
advertising uses the following phrases to describe such product and its use:
<quote>smokeless tobacco</quote>, <quote>smokeless tobacco product</quote>,
<quote>not consumed by smoking</quote>, <quote>does not produce smoke</quote>,
<quote>smokefree</quote>, <quote>smoke-free</quote>, <quote>without
smoke</quote>, <quote>no smoke</quote>, or <quote>not smoke</quote>.</text>
</subparagraph></paragraph><paragraph id="H7663CB7757B246E9BD5FBFE46055DF1B"><enum>(3)</enum><header>Effective
date</header><text>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).</text>
</paragraph></subsection><subsection id="HA4E9AC62050E41C3851A9CAB3511179C"><enum>(c)</enum><header>Tobacco
dependence products</header><text>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.</text>
</subsection><subsection id="HCC1FE668BCCA4F46BE6CB2E794F0D06B"><enum>(d)</enum><header>Filing</header><text>Any
person may file with the Secretary an application for a modified risk tobacco
product. Such application shall include—</text>
<paragraph id="HC43F3C1187D543B3A73FFB982B0B3ABE"><enum>(1)</enum><text>a description of
the proposed product and any proposed advertising and labeling;</text>
</paragraph><paragraph id="HF61031D5ACD842B59089E2710224A8F8"><enum>(2)</enum><text>the conditions for
using the product;</text>
</paragraph><paragraph id="HBF56B98AE6B54C778D132DC19164EE80"><enum>(3)</enum><text>the formulation of
the product;</text>
</paragraph><paragraph id="H0B623DBE0C224FA2A2934B8E9BCD1AA4"><enum>(4)</enum><text>sample product
labels and labeling;</text>
</paragraph><paragraph id="HADAE467A963D4D03836F56FCA4A9F2B7"><enum>(5)</enum><text>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;</text>
</paragraph><paragraph id="HD5EE11C6E05A4906960743E7AE000A10"><enum>(6)</enum><text>data and
information on how consumers actually use the tobacco product; and</text>
</paragraph><paragraph id="HC6BF7F3621CF4625B30EC2081448BA16"><enum>(7)</enum><text>such other
information as the Secretary may require.</text>
</paragraph></subsection><subsection id="H62267526155E42D3A9D829EE7A4BA909"><enum>(e)</enum><header>Public
availability</header><text>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.</text>
</subsection><subsection id="H533CBB63F7704733887604B6E3E60EA5"><enum>(f)</enum><header>Advisory
committee</header>
<paragraph id="HDA01C75F6C784EB3B19A2A9C3345E12D"><enum>(1)</enum><header>In
general</header><text>The Secretary shall refer to the Tobacco Products
Scientific Advisory Committee any application submitted under this
section.</text>
</paragraph><paragraph id="H0578763A19B44862B4BDD7C758C5DC72"><enum>(2)</enum><header>Recommendations</header><text>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.</text>
</paragraph></subsection><subsection id="H1DE34A7F4990489EA0931BE0C3F2ABD3"><enum>(g)</enum><header>Marketing</header>
<paragraph id="H4A3740F2DB6A483BB11C9F59D2392445"><enum>(1)</enum><header>Modified risk
products</header><text>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—</text>
<subparagraph id="H0E518B8AE6F344E4A9052E2E8B7A5553"><enum>(A)</enum><text>significantly
reduce harm and the risk of tobacco-related disease to individual tobacco
users; and</text>
</subparagraph><subparagraph id="H10F2F276306D443DB9E0AABB51B49825"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H1732C7779B5C4AA898598AA2D6DBC9F5"><enum>(2)</enum><header>Special rule for
certain products</header>
<subparagraph id="HFAEFB9DDF167422ABD730F2EDC01CFF5"><enum>(A)</enum><header>In
general</header><text>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—</text>
<clause id="HFD6E9374BB1D439BBC5FBF005FB95360"><enum>(i)</enum><text>such order would
be appropriate to promote the public health;</text>
</clause><clause id="HE2C81BB5A2DA44E4A162769D683A30C5"><enum>(ii)</enum><text>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;</text>
</clause><clause id="HB5E2C8865B0E4409A20041AE03F68B7B"><enum>(iii)</enum><text>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</text>
</clause><clause id="H7648D9F7FAD9462E952BFCA60F0D57E7"><enum>(iv)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="HC3BFC7D9DBC94F86BFE0C9685FE7A1CB"><enum>(B)</enum><header>Additional
findings required</header><text>To issue an order under subparagraph (A) the
Secretary must also find that the applicant has demonstrated that—</text>
<clause id="H429CDD155D0544BCA204E25943024526"><enum>(i)</enum><text>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;</text>
</clause><clause id="H558E5C73FBDC4B30A7D57862C0088921"><enum>(ii)</enum><text>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;</text>
</clause><clause id="HC255CCC0609F47A29853A1F327B1F6D0"><enum>(iii)</enum><text>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—</text>
<subclause id="HC68DEA64492B47FCA47EDE0E8AFEC677"><enum>(I)</enum><text>is or has been
demonstrated to be less harmful; or</text>
</subclause><subclause id="HCBAFBE12914C4785BE403FF287557169"><enum>(II)</enum><text>presents or has
been demonstrated to present less of a risk of disease than 1 or more other
commercially marketed tobacco products; and</text>
</subclause></clause><clause id="HC3FF5F229B6B4F4BA1F1B439134AB91B"><enum>(iv)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="HE651640335D043B38E94416B3AAB3C13"><enum>(C)</enum><header>Conditions of
marketing</header>
<clause id="H3D3D49FD13CC41F2A366BABD16077C7F"><enum>(i)</enum><header>In
general</header><text>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.</text>
</clause><clause id="H125736DBCD2849D4B1D55BC4621005EB"><enum>(ii)</enum><header>Agreements by
applicant</header><text>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.</text>
</clause><clause id="HCDE8CCE282C74ABFB7574192F5CECE62"><enum>(iii)</enum><header>Annual
submission</header><text>The results of such postmarket surveillance and
studies described in clause (ii) shall be submitted annually.</text>
</clause></subparagraph></paragraph><paragraph id="H7C3A3EA821E74A44A2DF86624BDEE03A"><enum>(3)</enum><header>Basis</header><text>The
determinations under paragraphs (1) and (2) shall be based on—</text>
<subparagraph id="HB1B952E810434E0388D4B7103A694BAA"><enum>(A)</enum><text>the scientific
evidence submitted by the applicant; and</text>
</subparagraph><subparagraph id="HF39FBFC1BCEA4C9EBAC580AD72828F5F"><enum>(B)</enum><text>scientific
evidence and other information that is made available to the Secretary.</text>
</subparagraph></paragraph><paragraph id="HD5018D06BCA24595BF202F1503452D29"><enum>(4)</enum><header>Benefit to
health of individuals and of population as a whole</header><text>In making the
determinations under paragraphs (1) and (2), the Secretary shall take into
account—</text>
<subparagraph id="H41DD8550C76F4D86A3DABB945A89A7FA"><enum>(A)</enum><text>the relative
health risks to individuals of the tobacco product that is the subject of the
application;</text>
</subparagraph><subparagraph id="HAA1BAD9D691748BE9507754E827328C8"><enum>(B)</enum><text>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;</text>
</subparagraph><subparagraph id="H57ADECE993D54FA08C4C7176C3B55ACF"><enum>(C)</enum><text>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;</text>
</subparagraph><subparagraph id="H34BA1D5DAE3E4A8A888BBAAAA7FFB70A"><enum>(D)</enum><text>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</text>
</subparagraph><subparagraph id="H5FD4B766ECD545FC9D8331764FD85A34"><enum>(E)</enum><text>comments, data,
and information submitted by interested persons.</text>
</subparagraph></paragraph></subsection><subsection id="H206485359EC94EBAA81F19DD184EE61C"><enum>(h)</enum><header>Additional
Conditions for Marketing</header>
<paragraph id="H22FA85F36FAA44A997286BB2ABB398F1"><enum>(1)</enum><header>Modified risk
products</header><text>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.</text>
</paragraph><paragraph id="HBD6DF1859BA646F0AEBB57BAA851912B"><enum>(2)</enum><header>Comparative
claims</header>
<subparagraph id="H22AA0A9CD4C44432803D73F63B0ED3D8"><enum>(A)</enum><header>In
general</header><text>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).</text>
</subparagraph><subparagraph id="H886AF08BD3DB4E838F76294CCA58747D"><enum>(B)</enum><header>Quantitative
comparisons</header><text>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.</text>
</subparagraph></paragraph><paragraph id="HA3E44F0A51F44057B11C7F2D24EA2655"><enum>(3)</enum><header>Label
disclosure</header>
<subparagraph id="H6EE180C6C391455CBFD9B700A82CBDB7"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="HE5D1B95AC862444EA6DC3777F1333360"><enum>(B)</enum><header>Conditions of
use</header><text>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.</text>
</subparagraph></paragraph><paragraph id="HAAD552AE968B4377B4A839EB38D821F4"><enum>(4)</enum><header>Time</header><text>An
order issued under subsection (g)(1) shall be effective for a specified period
of time.</text>
</paragraph><paragraph id="HC73E241C92604C6094BF63E419FCB09E"><enum>(5)</enum><header>Advertising</header><text>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.</text>
</paragraph></subsection><subsection id="HCB437915C10D4420B36E2E6EED1A44A3"><enum>(i)</enum><header>Postmarket
Surveillance and Studies</header>
<paragraph id="H3CF6111E70124E9198C77051B8E675E7"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="HC4B7BB7FC7B540159478322F43BCCFB4"><enum>(2)</enum><header>Surveillance
protocol</header><text>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.</text>
</paragraph></subsection><subsection id="HBD3B2ECA65AE4FB0A626CCAB5B93134D"><enum>(j)</enum><header>Withdrawal of
Authorization</header><text>The Secretary, after an opportunity for an informal
hearing, shall withdraw an order under subsection (g) if the Secretary
determines that—</text>
<paragraph id="H942DB2E2974F46E980EAF76BB122C08F"><enum>(1)</enum><text>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);</text>
</paragraph><paragraph id="HBA298ECFD08E449C9D440E64EF29FACB"><enum>(2)</enum><text>the application
failed to include material information or included any untrue statement of
material fact;</text>
</paragraph><paragraph id="HE32F3D6AA7234F58AF20EE3F94986CF5"><enum>(3)</enum><text>any explicit or
implicit representation that the product reduces risk or exposure is no longer
valid, including if—</text>
<subparagraph id="HC8E066BF07DA48DEBC7EE41831D0504F"><enum>(A)</enum><text>a tobacco product
standard is established pursuant to section 907;</text>
</subparagraph><subparagraph id="H61D2C2819EDF4D198E2B25B753410D28"><enum>(B)</enum><text>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</text>
</subparagraph><subparagraph id="H9574731849FB41DEA65780E5EC0668C6"><enum>(C)</enum><text>any postmarket
surveillance or studies reveal that the order is no longer consistent with the
protection of the public health;</text>
</subparagraph></paragraph><paragraph id="HD621EF073F9A41DCB6F35817B32C204F"><enum>(4)</enum><text>the applicant
failed to conduct or submit the postmarket surveillance and studies required
under subsection (g)(2)(C)(ii) or subsection (i); or</text>
</paragraph><paragraph id="HFA4C80F0F2274AF48C40B4F1B2A5C8A2"><enum>(5)</enum><text>the applicant
failed to meet a condition imposed under subsection (h).</text>
</paragraph></subsection><subsection id="H0D16904A42B042FD96BB2B1157305110"><enum>(k)</enum><header>Chapter IV or
V</header><text>A product for which the Secretary has issued an order pursuant
to subsection (g) shall not be subject to chapter IV or V.</text>
</subsection><subsection id="HA4D06C925F1C4A7C8CFD89AB2E42584B"><enum>(l)</enum><header>Implementing
Regulations or Guidance</header>
<paragraph id="H3BF40F8D499A4A36BC4DF8662BADECC5"><enum>(1)</enum><header>Scientific
evidence</header><text>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—</text>
<subparagraph id="H0771AC770B01469A92AE3A21A9C29A3D"><enum>(A)</enum><text>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);</text>
</subparagraph><subparagraph id="H31FBBC7B781D484FB1373458C65900F8"><enum>(B)</enum><text>include validated
biomarkers, intermediate clinical endpoints, and other feasible outcome
measures, as appropriate;</text>
</subparagraph><subparagraph id="H82EFA85C54354D449C5E315276617C0F"><enum>(C)</enum><text>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;</text>
</subparagraph><subparagraph id="H3CE9B552189946E38A2A7EB0854A7319"><enum>(D)</enum><text>establish minimum
standards for required postmarket surveillance, including ongoing assessments
of consumer perception;</text>
</subparagraph><subparagraph id="H2B737DC015934AFAA795A6C7829F69B1"><enum>(E)</enum><text>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</text>
</subparagraph><subparagraph id="H035312325D6F4E56A3E79B442387E01C"><enum>(F)</enum><text display-inline="yes-display-inline">establish a reasonable timetable for the
Secretary to review an application under this section.</text>
</subparagraph></paragraph><paragraph id="HFDA73C34D5EA4CA9AB12DA981B053A8C"><enum>(2)</enum><header>Consultation</header><text>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.</text>
</paragraph><paragraph id="H8128DC3C03254362A176495622CF237C"><enum>(3)</enum><header>Revision</header><text>The
regulations or guidance under paragraph (1) shall be revised on a regular basis
as new scientific information becomes available.</text>
</paragraph><paragraph id="H5A280A537C9841AA95E2A9A8CE43A2CF"><enum>(4)</enum><header>New tobacco
products</header><text>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.</text>
</paragraph></subsection><subsection id="H022A8CE2B06847268EA4CBBA45BF79BC"><enum>(m)</enum><header>Distributors</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section id="H6DB31540213649339F7E137C77CF16ED"><enum>912.</enum><header>Judicial
review</header>
<subsection id="H9F69F2D70E824BB79AC9D9513EFAFA54"><enum>(a)</enum><header>Right To
Review</header>
<paragraph id="H9EE1599E2C4943E8A08A4277D166F5D1"><enum>(1)</enum><header>In
general</header><text>Not later than 30 days after—</text>
<subparagraph id="H89B5C4DE8C174ED0B396FEA4E20E0A26"><enum>(A)</enum><text>the promulgation
of a regulation under section 907 establishing, amending, or revoking a tobacco
product standard; or</text>
</subparagraph><subparagraph id="H79D6706E8B5B47C5956AE26CA0893D8E"><enum>(B)</enum><text>a denial of an
application under section 910(c),</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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.</continuation-text></paragraph><paragraph id="H2C402D4A030F42B8A4F30B7D2FB61C74"><enum>(2)</enum><header>Requirements</header>
<subparagraph id="H607B60FE2593406D8898D332A9B9D1A0"><enum>(A)</enum><header>Copy of
petition</header><text>A copy of the petition filed under paragraph (1) shall
be transmitted by the clerk of the court involved to the Secretary.</text>
</subparagraph><subparagraph id="H81FDBF1231A34CEC856C65B21139D08F"><enum>(B)</enum><header>Record of
proceedings</header><text>On receipt of a petition under subparagraph (A), the
Secretary shall file in the court in which such petition was filed—</text>
<clause id="H56B277ED96E840A3A685BB7B463F724B"><enum>(i)</enum><text>the record of the
proceedings on which the regulation or order was based; and</text>
</clause><clause id="H62434E405BAF4A7F8CBCDA3587F941C7"><enum>(ii)</enum><text>a
statement of the reasons for the issuance of such a regulation or order.</text>
</clause></subparagraph><subparagraph id="H2702693BDF0C43A6AFD704D93917E3A1"><enum>(C)</enum><header>Definition of
record</header><text>In this section, the term <term>record</term>
means—</text>
<clause id="H1789573BF53740C0AB7891A0C0FF9972"><enum>(i)</enum><text>all notices and
other matter published in the Federal Register with respect to the regulation
or order reviewed;</text>
</clause><clause id="H27028EAB53D543498FDCD54A4CE49ADA"><enum>(ii)</enum><text>all information
submitted to the Secretary with respect to such regulation or order;</text>
</clause><clause id="HF8E8992C2D9E4D45BB7F931A09531D2C"><enum>(iii)</enum><text>proceedings of
any panel or advisory committee with respect to such regulation or
order;</text>
</clause><clause id="H84102AE0115D48AE8440BA104A887B2C"><enum>(iv)</enum><text>any hearing held
with respect to such regulation or order; and</text>
</clause><clause id="H09A6DBC0578F43668AC541C59EAF4632"><enum>(v)</enum><text>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.</text>
</clause></subparagraph></paragraph></subsection><subsection id="HF23D7E43404D496581624B544DEDA529"><enum>(b)</enum><header>Standard of
Review</header><text>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
<external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/7">chapter
7</external-xref> 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
<external-xref legal-doc="usc" parsable-cite="usc/5/706">section
706(2)(A)</external-xref> of title 5, United States Code.</text>
</subsection><subsection id="H6C7D96A66B7944BFBD1CE8CEA164C6A5"><enum>(c)</enum><header>Finality of
Judgment</header><text>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 <external-xref legal-doc="usc" parsable-cite="usc/28/1254">section
1254</external-xref> of title 28, United States Code.</text>
</subsection><subsection id="H9BAF6A69128E43698DF6155878EE5D90"><enum>(d)</enum><header>Other
Remedies</header><text>The remedies provided for in this section shall be in
addition to, and not in lieu of, any other remedies provided by law.</text>
</subsection><subsection id="H013A54056CDA4AE4BB59639161A8092D"><enum>(e)</enum><header>Regulations and
Orders Must Recite Basis in Record</header><text>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.</text>
</subsection></section><section id="HCD6B3F2E469C44DA83436BF16182977C"><enum>913.</enum><header>Equal treatment
of retail outlets</header><text display-inline="no-display-inline">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.</text>
</section><section id="H86C656CBB9D94E5FAA965C377BEA9D13"><enum>914.</enum><header>Jurisdiction of
and coordination with the federal trade commission</header>
<subsection id="H3BE181DEDBB94783B32091E32202B985"><enum>(a)</enum><header>Jurisdiction</header>
<paragraph id="H6D5EFF5E5C0845AD9D9D1A9B89D4C9B2"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="H47ECA679C21D40C992A7434C1CA79544"><enum>(2)</enum><header>Enforcement</header><text>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.</text>
</paragraph></subsection><subsection id="H0DC19988ABD74AE999AA132E7D0CD03C"><enum>(b)</enum><header>Coordination</header><text>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—</text>
<paragraph id="H5566E19B558D4B0CBD8CA7449924598B"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="H2D1966946D9A476D801344C5323EA993"><enum>(2)</enum><text>the Secretary
shall consult with the Chairman of such Commission in revising the label
statements and requirements under such sections.</text>
</paragraph></subsection></section><section id="H24AD8C896A35498C94428B4057EAFB73"><enum>915.</enum><header>Regulation
requirement</header>
<subsection id="HF426BF3666484A7288EE43AD19AD6552"><enum>(a)</enum><header>Testing,
Reporting, and Disclosure</header><text>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).</text>
</subsection><subsection id="H7097FD2D46E145468AD918A8932F6401"><enum>(b)</enum><header>Contents of
Rules</header><text>The regulations promulgated under subsection (a)—</text>
<paragraph id="H9C1E0D0350D944F994C3EB54D46EC0B3"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph id="H0A3FC5E226AF4E8AA3C37EE464BE8A89"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><subsection id="H4D27B74B9AA64EBDB2F46F01A5D0DC4B"><enum>(c)</enum><header>Authority</header><text>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.</text>
</subsection><subsection id="H22ECAC54C0B54B9898B4D71070C6641F"><enum>(d)</enum><header>Small tobacco
product manufacturers</header>
<paragraph id="H4482B9E7D28442C39C1050E25FBE101C"><enum>(1)</enum><header>First compliance
date</header><text display-inline="yes-display-inline">The initial regulations
promulgated under subsection (a) shall not impose requirements on small tobacco
product manufacturers before the later of—</text>
<subparagraph id="H62A9E8C951C64245B72D6FA27ECFE6E3"><enum>(A)</enum><text>the end of the
2-year period following the final promulgation of such regulations; and</text>
</subparagraph><subparagraph id="HCEEEBE209F7544C78494C33BC5C91FF1"><enum>(B)</enum><text display-inline="yes-display-inline">the initial date set by the Secretary for
compliance with such regulations by manufacturers that are not small tobacco
product manufacturers.</text>
</subparagraph></paragraph><paragraph id="HA6C701BBEBA74CAC92C647DA4B6017CE"><enum>(2)</enum><header>Testing and
reporting initial compliance period</header>
<subparagraph id="H3C2FDEFCE2514D1696B4EB6DF243676A"><enum>(A)</enum><header>4-year
period</header><text display-inline="yes-display-inline">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—</text>
<clause id="H8E0A6C3BC7584E789075D791A2724739"><enum>(i)</enum><text display-inline="yes-display-inline">to conduct such testing and reporting for
25 percent of its tobacco products during each year of such 4-year period;
and</text>
</clause><clause id="HC36AB1D587C347B08A29D40F0F284E92"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><subparagraph id="H09036914CACC44F6ADF2E4EC9E0E8DEA"><enum>(B)</enum><header>Case-by-case
delay</header><text>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.</text>
</subparagraph></paragraph><paragraph commented="no" id="H656FCBB198C247AF8F5CE149506B6A97"><enum>(3)</enum><header>Subsequent and
additional testing and reporting</header><text display-inline="yes-display-inline">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.</text>
</paragraph><paragraph id="HF43B4016038C431984CA001C484B9D06"><enum>(4)</enum><header>Joint laboratory
testing services</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection id="H619CD02889D7494D88B814594F5D0888"><enum>(e)</enum><header>Extensions for
limited laboratory capacity</header>
<paragraph id="H33DFCC34F88D47799C6108074B32BD92"><enum>(1)</enum><header>In
general</header><text>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—</text>
<subparagraph id="H5F1DD21DD74A49C58C27F39CB6C658AF"><enum>(A)</enum><text>the tobacco
products of such manufacturer are in compliance with all other requirements of
this chapter; and</text>
</subparagraph><subparagraph id="H84E57AD1E7E949C8AB16CA36B18D372B"><enum>(B)</enum><text>the conditions
described in paragraph (2) are met.</text>
</subparagraph></paragraph><paragraph id="H5B8BF158F4F949C8BB8E88BECAA55F02"><enum>(2)</enum><header>Conditions</header><text display-inline="yes-display-inline">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—</text>
<subparagraph id="H61DE21DE2F3D4314BA4BC77DDB04CB1F"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph id="HE3A2C70A42D440CA820A006BB37E59EA"><enum>(B)</enum><text>the products
currently are awaiting testing by the laboratory; and</text>
</subparagraph><subparagraph id="H4861BE5C86C24B0C8318CD991A7C1E32"><enum>(C)</enum><text display-inline="yes-display-inline">neither that laboratory nor any other
laboratory is able to complete testing by the deadline at customary,
nonexpedited testing fees.</text>
</subparagraph></paragraph><paragraph id="H87C33BAC64424E8CBBA1F58FEAFD4163"><enum>(3)</enum><header>Extension</header><text>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.</text>
</paragraph><paragraph id="H74114D41658346AEB1FF7992FE5C208B"><enum>(4)</enum><header>Additional
extension</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="H40A26EEC182243E4959F801E87EC8A16"><enum>(f)</enum><header>Rule of
construction</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section id="HDEED50E963B34E8C860EB35F8B926A34"><enum>916.</enum><header>Preservation of
state and local authority</header>
<subsection id="HDD973E7544C848D08964C3A68AF9BAF3"><enum>(a)</enum><header>In
General</header>
<paragraph id="HE90F78EE776D4417948FC677146EACE2"><enum>(1)</enum><header>Preservation</header><text>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.</text>
</paragraph><paragraph id="H48E81524527D46B99D8F4D5A5E1BBB8A"><enum>(2)</enum><header>Preemption of
certain state and local requirements</header>
<subparagraph id="HBC090EA74E2A4B67AE78989F701BBEFC"><enum>(A)</enum><header>In
general</header><text>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.</text>
</subparagraph><subparagraph id="HFE262DD28E9F4E3898A2EABE721A76FE"><enum>(B)</enum><header>Exception</header><text>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 <external-xref legal-doc="usc" parsable-cite="usc/5/552">section
552(b)(4)</external-xref> of title 5, United States Code, shall be treated as a
trade secret and confidential information by the State.</text>
</subparagraph></paragraph></subsection><subsection id="H71C91389673049FE8829FAD174238BBD"><enum>(b)</enum><header>Rule of
Construction Regarding Product Liability</header><text>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.</text>
</subsection></section><section id="HE2B58E4FEC1349D19FE78CB9FE3FA480"><enum>917.</enum><header>Tobacco
products scientific advisory committee</header>
<subsection id="H461534819519478A81DE84C828F97BC9"><enum>(a)</enum><header>Establishment</header><text>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 <quote>Advisory
Committee</quote>).</text>
</subsection><subsection id="H979CE6B6F26A492F8EE9F744E26606E4"><enum>(b)</enum><header>Membership</header>
<paragraph id="HA96915C023704CA59CD3CE6BADA440DA"><enum>(1)</enum><header>In
general</header>
<subparagraph id="H925F7B40476B430D81D20BF2B6279B4B"><enum>(A)</enum><header>Members</header><text>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—</text>
<clause id="H3B8C67414A61460B97E5590C9193DB99"><enum>(i)</enum><text>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;</text>
</clause><clause id="H24B5F511025E4FB095928E28678EA018"><enum>(ii)</enum><text>1
individual who is an officer or employee of a State or local government or of
the Federal Government;</text>
</clause><clause id="HDEA5A4947DC04AF98FF6F909576A8E80"><enum>(iii)</enum><text>1 individual as
a representative of the general public;</text>
</clause><clause id="HB62E3B52B6574C02B92450D0C7FAF8B0"><enum>(iv)</enum><text>1
individual as a representative of the interests of the tobacco manufacturing
industry;</text>
</clause><clause id="H1348C5ACDB894AD595DBD2CF5D35DAD7"><enum>(v)</enum><text display-inline="yes-display-inline">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</text>
</clause><clause id="H4F29C45AB6FF40819D1527CEA3A14E24"><enum>(vi)</enum><text>1
individual as a representative of the interests of the tobacco growers.</text>
</clause></subparagraph><subparagraph id="H92B73A1A5DE6478F93C3257361ACC102"><enum>(B)</enum><header>Nonvoting
members</header><text>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.</text>
</subparagraph><subparagraph id="H80AC719B1D6F42C4A81952F2D3205CBD"><enum>(C)</enum><header>Conflicts of
interest</header><text>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.</text>
</subparagraph></paragraph><paragraph id="H02F85DFC22BD45A8A21C0D2224735615"><enum>(2)</enum><header>Limitation</header><text>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.</text>
</paragraph><paragraph id="HB5679188C43D476195851043E60960E9"><enum>(3)</enum><header>Chairperson</header><text>The
Secretary shall designate 1 of the members appointed under clauses (i), (ii),
and (iii) of paragraph (1)(A) to serve as chairperson.</text>
</paragraph></subsection><subsection id="H94814EED30B5462994FD0BF5FF9B0469"><enum>(c)</enum><header>Duties</header><text>The
Tobacco Products Scientific Advisory Committee shall provide advice,
information, and recommendations to the Secretary—</text>
<paragraph id="HF7E62AC023A74ED5B792882C7FBE2D25"><enum>(1)</enum><text>as provided in
this chapter;</text>
</paragraph><paragraph id="HABA78550F64F454DAED33D0519E8B1BC"><enum>(2)</enum><text>on the effects of
the alteration of the nicotine yields from tobacco products;</text>
</paragraph><paragraph id="H21643055828B47FDB194F17835C9B85B"><enum>(3)</enum><text>on whether there
is a threshold level below which nicotine yields do not produce dependence on
the tobacco product involved; and</text>
</paragraph><paragraph id="HDA19226E081642BA9C8D0327C7EB5CC9"><enum>(4)</enum><text>on its review of
other safety, dependence, or health issues relating to tobacco products as
requested by the Secretary.</text>
</paragraph></subsection><subsection id="H9BDD91CA0ADB445CA47542C0C02CCFCD"><enum>(d)</enum><header>Compensation;
Support; FACA</header>
<paragraph id="H747D60DBC9C6454A981170625207C3D7"><enum>(1)</enum><header>Compensation and
travel</header><text>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 <external-xref legal-doc="usc" parsable-cite="usc/5/5382">section
5382</external-xref> 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
<external-xref legal-doc="usc" parsable-cite="usc/5/5703">section
5703</external-xref> of title 5, United States Code, for persons in the
Government service employed intermittently.</text>
</paragraph><paragraph id="HEB662C5013A244F5ADE256FAE8B49812"><enum>(2)</enum><header>Administrative
support</header><text>The Secretary shall furnish the Advisory Committee
clerical and other assistance.</text>
</paragraph><paragraph id="H34600FCD5DEC48BA9310E259938CD9E8"><enum>(3)</enum><header>Nonapplication
of FACA</header><text>Section 14 of the Federal Advisory Committee Act does not
apply to the Advisory Committee.</text>
</paragraph></subsection><subsection id="HD46FFEE9D2064D0AAEB7967068F8A2B8"><enum>(e)</enum><header>Proceedings of
Advisory Panels and Committees</header><text>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
<external-xref legal-doc="usc" parsable-cite="usc/5/552">section
552(b)</external-xref> of title 5, United States Code.</text>
</subsection></section><section id="H02DA0C240B3D4523927F19BE5A3C5108"><enum>918.</enum><header>Drug products
used to treat tobacco dependence</header>
<subsection id="H8C1B0876DDE242228E54C60C8A166904"><enum>(a)</enum><header>In
general</header><text>The Secretary shall—</text>
<paragraph id="H77B11DAB6F274015844F5628ECF44DEE"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="H0DB3C1516B3E48C59C2AE9956509B9FE"><enum>(2)</enum><text>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</text>
</paragraph><paragraph id="H19D4B0EB2D864980B773B6661F17CCA7"><enum>(3)</enum><text>review and
consider the evidence for additional indications for nicotine replacement
products, such as for craving relief or relapse prevention.</text>
</paragraph></subsection><subsection id="H8FF0931F86D84E7D9C96F4F47441A785"><enum>(b)</enum><header>Report on
innovative products</header>
<paragraph id="HFFD9A02E6C4B43B4BCBF4D113DCBB9E4"><enum>(1)</enum><header>In
general</header><text>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—</text>
<subparagraph id="HFE4FFE4909764245B420439D2DB49145"><enum>(A)</enum><text>total abstinence
from tobacco use;</text>
</subparagraph><subparagraph id="H660D0C750E7C4592973B9DF7AF35810F"><enum>(B)</enum><text>reductions in
consumption of tobacco; and</text>
</subparagraph><subparagraph id="H44E97DCCD77E4ED380057BBAF1568700"><enum>(C)</enum><text>reductions in the
harm associated with continued tobacco use.</text>
</subparagraph></paragraph><paragraph id="H044AEBC939B34F2CBD3FE84194C62B7B"><enum>(2)</enum><header>Recommendations</header><text>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.</text>
</paragraph></subsection></section><section commented="no" id="H5CB665E9F39C41C8BC2DA66F0588ABBC"><enum>919.</enum><header>User
fees</header>
<subsection commented="no" id="H72963C1E3C924679A0CBDAB52D50A2A3"><enum>(a)</enum><header>Establishment of
quarterly fee</header><text display-inline="yes-display-inline">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).</text>
</subsection><subsection commented="no" id="H75CF0D4C8DA5485F905BAB357C9727A0"><enum>(b)</enum><header>Assessment of
user fee</header>
<paragraph commented="no" id="H15AD34D572D94F7EB9D85457D1659285"><enum>(1)</enum><header>Amount of
assessment</header><text>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:</text>
<subparagraph commented="no" id="H6CAD3A4B48534A01B7B2C82913DB15F8"><enum>(A)</enum><text display-inline="yes-display-inline">For fiscal year 2009, $85,000,000 (subject
to subsection (e)).</text>
</subparagraph><subparagraph commented="no" id="H64CFCFBA19F241609FCE2C2C776DECDA"><enum>(B)</enum><text>For fiscal year
2010, $235,000,000.</text>
</subparagraph><subparagraph commented="no" id="HA386FB8A7C0A42E98DDC055708499A21"><enum>(C)</enum><text>For fiscal year
2011, $450,000,000.</text>
</subparagraph><subparagraph commented="no" id="H03F3F48F64D74B5C8DB456FB20E2D6ED"><enum>(D)</enum><text>For fiscal year
2012, $477,000,000.</text>
</subparagraph><subparagraph commented="no" id="HF542986E71B34A3FA4CD477A1C085C55"><enum>(E)</enum><text>For fiscal year
2013, $505,000,000.</text>
</subparagraph><subparagraph commented="no" id="HF0E34A8C822045B1BEE708068EBA0F84"><enum>(F)</enum><text>For fiscal year
2014, $534,000,000.</text>
</subparagraph><subparagraph commented="no" id="HA6B7E9CB18BA4C3D983402F0D75617F1"><enum>(G)</enum><text>For fiscal year
2015, $566,000,000.</text>
</subparagraph><subparagraph commented="no" id="H9CF42C35AA32444787CD4593D516C38D"><enum>(H)</enum><text>For fiscal year
2016, $599,000,000.</text>
</subparagraph><subparagraph commented="no" id="H3DA23E5499DA433A8DDA76CFF26DA721"><enum>(I)</enum><text>For fiscal year
2017, $635,000,000.</text>
</subparagraph><subparagraph commented="no" id="H3427B59838E3438C9F1A154F2B236877"><enum>(J)</enum><text>For fiscal year
2018, $672,000,000.</text>
</subparagraph><subparagraph commented="no" id="H53123024DEBC4CD5B8FFD2A0098A4F3D"><enum>(K)</enum><text>For fiscal year
2019 and each subsequent fiscal year, $712,000,000.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF3F3D07220F84D25809D77DC774A29D3"><enum>(2)</enum><header>Allocations of
assessment by class of tobacco products</header>
<subparagraph commented="no" id="H26338B365E4E4C8198AAF2235759DEAF"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" id="HC135E2C7FE6A413B9725451A8AD716EB"><enum>(B)</enum><header>Applicable
percentage</header>
<clause commented="no" id="H89A99F3E82F748918FB926B3366EDB00"><enum>(i)</enum><header>In
general</header><text>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):</text>
<subclause commented="no" id="HDE3DF3B920FD4A6CB6472650683C331B"><enum>(I)</enum><text>Cigarettes.</text>
</subclause><subclause commented="no" id="HE9F5401BB7F24FA0A95D8E88622BA941"><enum>(II)</enum><text>Cigars, including
small cigars and cigars other than small cigars.</text>
</subclause><subclause commented="no" id="H246576A30292448B97C0993994A84501"><enum>(III)</enum><text>Snuff.</text>
</subclause><subclause commented="no" id="H91D1DA2FCE9A4E5AA4A52E0F68F9894D"><enum>(IV)</enum><text>Chewing
tobacco.</text>
</subclause><subclause commented="no" id="HB7B24CA94AB74EDA985405220CCEF2AF"><enum>(V)</enum><text>Pipe
tobacco.</text>
</subclause><subclause commented="no" id="H373F5382664A4D47824E9151BFA38480"><enum>(VI)</enum><text>Roll-your-own
tobacco.</text>
</subclause></clause><clause commented="no" id="H8841AD4DB9264628B0542A539A6EB0BC"><enum>(ii)</enum><header>Allocations</header><text display-inline="yes-display-inline">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
<external-xref legal-doc="public-law" parsable-cite="pl/108/357">Public Law
108–357</external-xref> for each such class of product for such fiscal
year.</text>
</clause><clause commented="no" id="H413BF680558E4B83A5807451D8FE336E"><enum>(iii)</enum><header>Requirement of
regulations</header><text>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.</text>
</clause><clause commented="no" id="HC2BE2F7D6C2F40EAA22FB6552AE3E8AB"><enum>(iv)</enum><header>Reallocations</header><text display-inline="yes-display-inline">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).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF244046600464495AF487DAD432825B5"><enum>(3)</enum><header>Determination of
user fee by company</header>
<subparagraph commented="no" id="H767C39303D5942CE9B6F2B409B7501B7"><enum>(A)</enum><header>In
general</header><text>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—</text>
<clause commented="no" id="H863B80E337D542E0AD678261ED68D4B0"><enum>(i)</enum><text>such
manufacturer’s or importer’s percentage share as determined under paragraph
(4); by</text>
</clause><clause commented="no" id="HC5A81D6F4E9E43548C5E962E1EB8D41F"><enum>(ii)</enum><text>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).</text>
</clause></subparagraph><subparagraph commented="no" id="HD8CF34037CDC461D928729672AE395E9"><enum>(B)</enum><header>No fee in excess
of percentage share</header><text>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.</text>
</subparagraph></paragraph><paragraph commented="no" id="HE1F9ED8C23A345E3B26B5726C6CADF9B"><enum>(4)</enum><header>Allocation of
assessment within each class of tobacco product</header><text display-inline="yes-display-inline">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
<external-xref legal-doc="public-law" parsable-cite="pl/108/357">Public Law
108–357</external-xref>.</text>
</paragraph><paragraph commented="no" id="HCC79B9509DB6455D8677EB1E4C27F456"><enum>(5)</enum><header>Allocation for
cigars</header><text>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.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF4DCBB4FD3BD43A99A1F5F33820727B7"><enum>(6)</enum><header>Timing of
assessment</header><text>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.</text>
</paragraph><paragraph commented="no" id="HFBD589E6A42140F2A48D2E597F7DEC43"><enum>(7)</enum><header>Memorandum of
understanding</header>
<subparagraph commented="no" id="H86833B84487244ADAA99473922AA40C5"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" id="H04E04B7CA8F34631BABE357641340ADC"><enum>(B)</enum><header>Assurances</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="HFC7FE5936E0B4DC7A3FCAE97AF74BBA8"><enum>(c)</enum><header>Crediting and
availability of fees</header>
<paragraph commented="no" id="HA2E346BA51BB4F59AE4E5EC55DF1B99C"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">Fees authorized under
subsection (a) shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations Acts. Such fees
are authorized to remain available until expended. Such sums as may be
necessary may be transferred from the Food and Drug Administration salaries and
expenses appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such fiscal year
limitation.</text>
</paragraph><paragraph commented="no" id="HF64902B4C1DC4A23A99B53948CB44808"><enum>(2)</enum><header>Availability</header>
<subparagraph commented="no" id="H874196EAC22041ED8CB665D23071D0AE"><enum>(A)</enum><header>In
general</header><text>Fees appropriated under paragraph (3) are available only
for the purpose of paying the costs of the activities of the Food and Drug
Administration related to the regulation of tobacco products under this chapter
and the Family Smoking Prevention and Tobacco Control Act. No fees collected
under subsection (a) may be used for any other costs.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="H24F987CF0A844855A16D99ED259EFC40"><enum>(B)</enum><header>Prohibition
against use of other funds</header>
<clause commented="no" id="HBC1F5D984754461A87926BDD2FBFB78D"><enum>(i)</enum><header>In
general</header><text>Except as provided in clause (ii), fees collected under
subsection (a) are the only funds authorized to be made available for the
purpose described in subparagraph (A).</text>
</clause><clause commented="no" id="H2D59389BA8AE4C3C94119DC7E7423952"><enum>(ii)</enum><header>Startup
costs</header><text display-inline="yes-display-inline">Clause (i) does not
apply until the date on which the Secretary has collected fees under subsection
(a) for 2 fiscal year quarters. Any amounts provided to pay the costs described
in subparagraph (A) prior to the date described in the previous sentence shall
be reimbursed through fees collected under subsection (a).</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="HC67255174D3A465CBCCDDB28B985FE89"><enum>(3)</enum><header>Authorization of
appropriations</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection commented="no" id="HA31B37F069414972B80BA66047B625BE"><enum>(d)</enum><header>Collection of
unpaid fees</header><text display-inline="yes-display-inline">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
<external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31,
United States Code.</text>
</subsection><subsection commented="no" id="HA2D158FE21054FE7B5641888F9BE82B5"><enum>(e)</enum><header>Applicability to
fiscal year <enum-in-header>2009</enum-in-header></header><text>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):</text>
<paragraph commented="no" id="HD9E7C4352C4044E0B46B9388457BDC29"><enum>(1)</enum><text>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
<quote>quarterly fee amounts</quote>).</text>
</paragraph><paragraph commented="no" id="H87A067FE874E4FD9BC3F27C6AD4D1733"><enum>(2)</enum><text>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.</text>
</paragraph><paragraph commented="no" id="H3674AD57685B412E9D3720E84F803645"><enum>(3)</enum><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection></section></chapter><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="id0B9638ED4FAB4870A11B48D4C4F39F27"><enum>(c)</enum><header>Conforming
amendment</header><text>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:</text>
<quoted-block display-inline="no-display-inline" id="idAEB94367BD2742FFA91CEFE5A276CE15" style="OLC">
<paragraph id="id4FDBD47A86F4482D8518117E02BD8D5E"><enum>(1)</enum><text>The term
<term>smokeless tobacco</term> has the meaning given such term by section
900(18) of the Federal Food, Drug, and Cosmetic
Act.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="HFF1BE34E126E47FDBE7B1083E4347CC2" section-type="subsequent-section"><enum>102.</enum><header>Final rule</header>
<subsection commented="no" id="HC18D7C3ED4F34E6E894A5AED2508DD52"><enum>(a)</enum><header>Cigarettes and
Smokeless Tobacco</header>
<paragraph commented="no" id="HCF81C81424D2444D9DB879E26F280727"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">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—</text>
<subparagraph commented="no" id="H6F112DEC263B467F8A6E0E1916AC28F4"><enum>(A)</enum><text>is deemed to be
issued under chapter 9 of the Federal Food, Drug, and Cosmetic Act, as added by
section 101 of this Act; and</text>
</subparagraph><subparagraph id="HF8F9DC1FF36742D49D87744DBC1587E6"><enum>(B)</enum><text display-inline="yes-display-inline">shall be deemed to be in compliance with
all applicable provisions of
<external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter
5</external-xref> of title 5, United States Code, and all other provisions of
law relating to rulemaking procedures.</text>
</subparagraph></paragraph><paragraph commented="no" id="H8B0066FE827E4BF4AB8135BDAAB34179"><enum>(2)</enum><header>Contents of
rule</header><text>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—</text>
<subparagraph commented="no" id="HA5C7F49BC367467DA8660510BB104847"><enum>(A)</enum><text>provide for the
designation of jurisdictional authority that is in accordance with this
subsection in accordance with this Act and the amendments made by this
Act;</text>
</subparagraph><subparagraph commented="no" id="H9871BCEF1B194C09AA2528204691F902"><enum>(B)</enum><text>strike Subpart
C—Labels and section 897.32(c);</text>
</subparagraph><subparagraph commented="no" id="H3D0B13DDF9B34CBDBD72C8A1CB9DE9D3"><enum>(C)</enum><text>strike paragraphs
(a), (b), and (i) of section 897.3 and insert definitions of the terms
<term>cigarette</term>, <term>cigarette tobacco</term>, and <term>smokeless
tobacco</term> as defined in section 900 of the Federal Food, Drug, and
Cosmetic Act;</text>
</subparagraph><subparagraph commented="no" id="HD6896FB714074B5392A11B38DB0A0B5F"><enum>(D)</enum><text>insert <quote>or
roll-your-own paper</quote> in section 897.34(a) after <quote>other than
cigarettes or smokeless tobacco</quote>;</text>
</subparagraph><subparagraph commented="no" id="id373A63343E274AE3A90264ACC3AA0B7A"><enum>(E)</enum><text>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 (2201));</text>
</subparagraph><subparagraph commented="no" id="H7D475033D2934C04BEC35EBD1E59D486"><enum>(F)</enum><text>become effective
on the date that is 1 year after the date of enactment of this Act; and</text>
</subparagraph><subparagraph commented="no" id="H05320B9FDAFE4DB0A18C2CC100B139F0"><enum>(G)</enum><text display-inline="yes-display-inline">amend paragraph (d) of section 897.16 to
read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H95DB57ACF2C5499A8E95B85A36DFEAE2" style="OLC">
<subsection id="H1113F920BF68493FAA5FF2D778A5B4DB"><enum>(d)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H0845CF508970445A9359EB2CA80B97AE"><enum>(1)</enum><text>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).</text>
</paragraph><paragraph id="H0BEB7DE15C7D4474A7A3A57659C5B5C3" indent="up1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HF759254A4C274DA394056C4F71B08260"><enum>(A)</enum><text>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.</text>
</subparagraph><subparagraph id="H7C21A5636E12469ABF5FFCFE4A80117F" indent="up1"><enum>(B)</enum><text>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.</text>
</subparagraph><subparagraph id="HA906207CEBA24BE792B6482A4A07AD6C" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">For purposes of this paragraph, the term
<term>qualified adult-only facility</term> means a facility or restricted area
that—</text>
<clause id="HF6CAC0A304654318BB4D0CBA6695FFE2"><enum>(i)</enum><text>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;</text>
</clause><clause id="H097A9012B1F24594BFF5B0368C9FBE4F"><enum>(ii)</enum><text>does not sell, serve, or distribute
alcohol;</text>
</clause><clause id="H14504A5E98594C5F9CE3D6CA06ADB38C"><enum>(iii)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause id="HCDA6F4B5350547429C4D635A090CB15B"><enum>(iv)</enum><text display-inline="yes-display-inline">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;</text>
</clause><clause id="H5ED8E89DBAE642A3A0119DFB3C39B537"><enum>(v)</enum><text>is enclosed by a barrier that—</text>
<subclause id="HDFCDEFAD2088425BB273108310CC13AA"><enum>(I)</enum><text>is constructed of, or covered with,
an opaque material (except for entrances and exits);</text>
</subclause><subclause id="HE20A822262584937B149DDD6349F5DF2"><enum>(II)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause id="H0B36529467EB4DDC84BDB415CDEEE89E"><enum>(III)</enum><text>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</text>
</subclause></clause><clause id="HEA7B6659184B458889D86C213BCD8275"><enum>(vi)</enum><text>does not display on its
exterior—</text>
<subclause id="HC1B3FFA37DAA444C9148E182305CA4CD"><enum>(I)</enum><text>any tobacco product
advertising;</text>
</subclause><subclause id="H10167F5A8B594A1399C888259868120D"><enum>(II)</enum><text>a brand name other than in
conjunction with words for an area or enclosure to identify an adult-only
facility; or</text>
</subclause><subclause id="HB5FA00B6069D45A290051C08D5EA5B38"><enum>(III)</enum><text>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).</text>
</subclause></clause></subparagraph><subparagraph id="H5F92E18D0BD541E5ACE1C23FED40E19C" indent="up1"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph id="HACA21BE55CDB46CE8F99000EA4310EDB" indent="up1"><enum>(3)</enum><text>Notwithstanding subparagraph (2), no
manufacturer, distributor, or retailer may distribute or cause to be
distributed any free samples of smokeless tobacco—</text>
<subparagraph id="HF03885CD98724DEBA281AB851AC5FC62"><enum>(A)</enum><text>to a sports team or entertainment
group; or</text>
</subparagraph><subparagraph id="HFD1287CD683E4840A901ED4447BDE2AC"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph id="H7644064829F94DB2B164F49B232C7D9C" indent="up1"><enum>(4)</enum><text>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.</text>
</paragraph><paragraph id="H5BC4C0A7F9514BB8AD9D4557E6969262" indent="up1"><enum>(5)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="H1C6DC4AF6C3D43F39C808C78635D2921"><enum>(3)</enum><header>Amendments to
rule</header><text>Prior to making amendments to the rule published under
paragraph (1), the Secretary shall promulgate a proposed rule in accordance
with <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter 5</external-xref> of title 5, United
States Code.</text>
</paragraph><paragraph commented="no" id="HD4292871E098457895E38736B08ECC3A"><enum>(4)</enum><header>Rule of
construction</header><text>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
<external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter
5</external-xref> 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.</text>
</paragraph><paragraph display-inline="no-display-inline" id="H2F83F3BF93FE44C9A3DD422CA7382A42"><enum>(5)</enum><header>Enforcement of
retail sale provisions</header><text display-inline="yes-display-inline">The
Secretary of Health and Human Services shall ensure that the provisions of this
Act, the amendments made by this Act, and the implementing regulations
(including such provisions, amendments, and regulations relating to the retail
sale of tobacco products) are enforced with respect to the United States and
Indian tribes.</text>
</paragraph><paragraph display-inline="no-display-inline" id="HBFD257E176884F4DA51CEEA915C11E59"><enum>(6)</enum><header>Qualified
adult-only facility</header><text>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.</text>
</paragraph><paragraph id="H63F67640B6D84C588B2F0044A49E7B44"><enum>(7)</enum><header>Congressional
review provisions</header><text><external-xref legal-doc="usc" parsable-cite="usc/5/801">Section 801</external-xref> of title 5, United States
Code, shall not apply to the final rule published under paragraph (1).</text>
</paragraph></subsection><subsection commented="no" id="H6D5DA93D940443D28C49E97006803EC8"><enum>(b)</enum><header>Limitation on
Advisory Opinions</header><text>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
<external-xref legal-doc="regulation" parsable-cite="cfr/21/10.85">section
10.85(d)(1)</external-xref> 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:</text>
<paragraph commented="no" id="H8868B4DFC2554DE58E3F7230FCD681A3"><enum>(1)</enum><text>The preamble to
the proposed rule in the document titled <quote>Regulations Restricting the
Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect
Children and Adolescents</quote> (60 Fed. Reg. 41314–41372 (August 11,
1995)).</text>
</paragraph><paragraph commented="no" id="H957C59DB68384C0EA53AA07326217E3A"><enum>(2)</enum><text>The document
titled <quote>Nicotine in Cigarettes and Smokeless Tobacco Products is a Drug
and These Products Are Nicotine Delivery Devices Under the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name></quote> (60 Fed. Reg. 41453–41787 (August 11, 1995)).</text>
</paragraph><paragraph commented="no" id="H589A4F53E870448DB6A8313CE316B3E1"><enum>(3)</enum><text>The preamble to
the final rule in the document titled <quote>Regulations Restricting the Sale
and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents</quote> (61 Fed. Reg. 44396–44615 (August 28, 1996)).</text>
</paragraph><paragraph commented="no" id="H16111E8897C14A0390D7F7B5F54FF1E7"><enum>(4)</enum><text>The document
titled <quote>Nicotine in Cigarettes and Smokeless Tobacco is a Drug and These
Products are Nicotine Delivery Devices Under the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>; Jurisdictional Determination</quote> (61 Fed. Reg. 44619–45318
(August 28, 1996)).</text>
</paragraph></subsection></section><section id="H2FE477B493E94DD2BB3831560F25820E"><enum>103.</enum><header>Conforming and
other amendments to general provisions</header>
<subsection id="HCF14768B4B0543508815A1BA26402DBA"><enum>(a)</enum><header>Amendment of
Federal Food, Drug, and Cosmetic Act</header><text>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
(<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et
seq.</external-xref>).</text>
</subsection><subsection id="H90351893149C4ED5B96EC985A9207AB8"><enum>(b)</enum><header>Section
301</header><text>Section 301 (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended—</text>
<paragraph id="H3CC4DCF034C94893B522E5FEF1CED8A3"><enum>(1)</enum><text>in subsection (a),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="HCDF61E08EC0442498269F485384595D3"><enum>(2)</enum><text>in subsection (b),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H9FD5CFA871524AAF91CA224A9A34E6C4"><enum>(3)</enum><text>in subsection (c),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H7453A0B6F19E437790EB545C9BF2CE20"><enum>(4)</enum><text>in subsection
(e)—</text>
<subparagraph id="H443C61413CC4402DB82076A777B0F7B3"><enum>(A)</enum><text>by striking the
period after <quote>572(i)</quote>; and</text>
</subparagraph><subparagraph id="H408747B0D0FE4F1398F15DD175DDA78D"><enum>(B)</enum><text>by striking
<quote>or 761 or the refusal to permit access to</quote> and inserting
<quote>761, 909, or 920 or the refusal to permit access to</quote>;</text>
</subparagraph></paragraph><paragraph id="HD48F750F46C44B95A607C7A371D21DAA"><enum>(5)</enum><text>in subsection (g),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H61A2E8842251411A8DB4DD5838389378"><enum>(6)</enum><text>in subsection (h),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="HFD4946B287CE44889832FB4620EA9C57"><enum>(7)</enum><text>in subsection
(j)—</text>
<subparagraph id="H43DCA28C625143BC9B0E02FCD69442E9"><enum>(A)</enum><text>by striking the
period after <quote>573</quote>; and</text>
</subparagraph><subparagraph id="H702A9FCD011A46BE87DA671D6D07FB9F"><enum>(B)</enum><text>by striking
<quote>708, or 721</quote> and inserting <quote>708, 721, 904, 905, 906, 907,
908, 909, or 920(b)</quote>;</text>
</subparagraph></paragraph><paragraph id="HA6877523114343EB92CD49884B8E0E26"><enum>(8)</enum><text>in subsection (k),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H71CBB3CA688E433F9448DE7580CD7F68"><enum>(9)</enum><text>by striking
subsection (p) and inserting the following:</text>
<quoted-block id="H224CAAA865564D908D8843A2C18FF27E" style="OLC">
<subsection id="HF5FBAD2DCE044B97884EE3C28358340A"><enum>(p)</enum><text>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).</text>
</subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="HC535EC11B9044351B0F8243A2FA65513"><enum>(10)</enum><text>by striking
subsection (q)(1) and inserting the following:</text>
<quoted-block id="H4B02499AA4BA4C9B917949ECF50BDBC1" style="OLC">
<subsection id="HE44A5A8E2A97479FAA9F8B01ABAF4B83"><enum>(q)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H9655E8E016974A7D80A8E2E2C4A54DD7"><enum>(1)</enum><text>The failure or
refusal—</text>
<subparagraph id="H7B033272514846769FEFC2998E7BF17F" indent="up1"><enum>(A)</enum><text>to comply with any requirement
prescribed under section 518, 520(g), 903(b), 907, 908, or 916;</text>
</subparagraph><subparagraph id="H398D0BDE05B44040BE886CDC7D027329" indent="up1"><enum>(B)</enum><text>to furnish any notification or other
material or information required by or under section 519, 520(g), 904, 909, or
920; or</text>
</subparagraph><subparagraph id="HABE5065482B74584B58929C2253F445A" indent="up1"><enum>(C)</enum><text>to comply with a requirement under
section 522 or
913.</text>
</subparagraph></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="H78C12D24D12B4D8AABB1D7748A658C4B"><enum>(11)</enum><text>in subsection
(q)(2), by striking <quote>device,</quote> and inserting <quote>device or
tobacco product,</quote>;</text>
</paragraph><paragraph id="HF7F434F61BB24E71AA0D94E13EE0166E"><enum>(12)</enum><text>in subsection
(r), by inserting <quote>or tobacco product</quote> after the term
<term>device</term> each time that such term appears; and</text>
</paragraph><paragraph id="HF8E61609307E43FD9379BBF99EAECB6C"><enum>(13)</enum><text>by adding at the
end the following:</text>
<quoted-block id="HE9E921D9070D4B4D84BFDAFE6BA9E1F8" style="OLC">
<subsection id="HE0CC2CBF0F2C426699E7F8482DAA0000"><enum>(oo)</enum><text>The sale of
tobacco products in violation of a no-tobacco-sale order issued under section
303(f).</text>
</subsection><subsection id="HC4B2E73CBC2B4EFA98E580FD39C07188"><enum>(pp)</enum><text>The introduction
or delivery for introduction into interstate commerce of a tobacco product in
violation of section 911.</text>
</subsection><subsection id="H623582C100CF40F8ADF8894FD2D1369C"><enum>(qq)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H69EB394BF3DA4B17B8AB7E2B145BCA69"><enum>(1)</enum><text>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.</text>
</paragraph><paragraph id="H54C850094C85469AB65715AC5EBD4D2A" indent="up1"><enum>(2)</enum><text>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.</text>
</paragraph><paragraph id="HB5E55DF480C64153BFED706627589E51" indent="up1"><enum>(3)</enum><text>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.</text>
</paragraph></subsection><subsection id="HC74848EED79941848C77A61D169CC5FB"><enum>(rr)</enum><text>The charitable
distribution of tobacco products.</text>
</subsection><subsection id="H63C76FDCA750407B9BD8C972CD6736C9"><enum>(ss)</enum><text>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.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idE0D34A15764646CEBFD48FD5977B3BAA"><enum>(tt)</enum><text display-inline="yes-display-inline">With respect to a tobacco product, any
statement or representation, express or implied, directed to consumers through
the media or through the label, labeling, or advertising that is false or would
reasonably be expected to mislead consumers into believing that the product is
approved by the Food and Drug Administration, or that the Food and Drug
Administration deems the product to be safe for use by consumers, or that the
product is endorsed by the Food and Drug Administration for use by consumers,
or that is false or would reasonably be expected to mislead consumers regarding
the harmfulness of the product because of the Food and Drug Administration's
regulation or inspection of it or because of its compliance with regulatory
requirements set by the Food and Drug
Administration.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HE3AE834415A44E3AA38212B754D4F993"><enum>(c)</enum><header>Section
303</header><text>Section 303(f) (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)</external-xref>) is amended—</text>
<paragraph id="H2CBAB206EB9E45B0B04A994346104CC7"><enum>(1)</enum><text>in paragraph
(1)(A), by inserting <quote>or tobacco products</quote> after the term
<term>devices</term> each place such term appears;</text>
</paragraph><paragraph id="HB0EE255D4B534024BE90D518A0E231DB"><enum>(2)</enum><text>in paragraph
(5)—</text>
<subparagraph id="HCD5376E6A67D4F94A607225727090872"><enum>(A)</enum><text>in subparagraph
(A)—</text>
<clause id="H4ADCF66C40D0401FB12B1D947225E541"><enum>(i)</enum><text>by
striking <quote>assessed</quote> the first time it appears and inserting
<quote>assessed, or a no-tobacco-sale order may be imposed,</quote>; and</text>
</clause><clause id="H1F6AC81B3A0D4A0F97C2C5CECBD72E1F"><enum>(ii)</enum><text>by
striking <quote>penalty</quote> the second time it appears and inserting
<quote>penalty, or upon whom a no-tobacco-sale order is to be
imposed,</quote>;</text>
</clause></subparagraph><subparagraph id="H88A8139999914C1CA32613B3FFA534AD"><enum>(B)</enum><text>in subparagraph
(B)—</text>
<clause id="HF4776E6BC5EF437E9E9374622722D3C3"><enum>(i)</enum><text>by
inserting after <quote>penalty,</quote> the following: <quote>or the period to
be covered by a no-tobacco-sale order,</quote>; and</text>
</clause><clause id="HBDFD2F1A9A6E4365B9E79844328CCBA9"><enum>(ii)</enum><text>by
adding at the end the following: <quote>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.</quote>;
and</text>
</clause></subparagraph><subparagraph id="H161A900ED80244B59EDF3E18CBA78E18"><enum>(C)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H4D7D5FABD04548F6B7D1220A15F47B9C" style="OLC">
<subparagraph id="H095FAABEE7B94025B0966038DCE52504" indent="up2"><enum>(D)</enum><text>The Secretary may compromise, modify,
or terminate, with or without conditions, any no-tobacco-sale
order.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="H05F2C6DF75D64E05A841DF5E2D4471EA"><enum>(3)</enum><text>in paragraph
(6)—</text>
<subparagraph id="H61E3B7035B2245208D14DA9BC6585400"><enum>(A)</enum><text>by inserting
<quote>or the imposition of a no-tobacco-sale order</quote> after the term
<term>penalty</term> each place such term appears; and</text>
</subparagraph><subparagraph id="H7978AC2DB4474D65B6DEA6E38CB4C9DA"><enum>(B)</enum><text>by striking
<quote>issued.</quote> and inserting <quote>issued, or on which the
no-tobacco-sale order was imposed, as the case may be.</quote>; and</text>
</subparagraph></paragraph><paragraph id="H867725062826449C88ECCB49198E94A6"><enum>(4)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H2A8730CCAA6C46B9971F13C9CE1CEB8C" style="OLC">
<subsection id="HB5B07E57330841A78FD705FB366662F5"><enum>(8)</enum><text>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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HE115DE1E38C2487490565C34B0151468"><enum>(d)</enum><header>Section
304</header><text>Section 304 (<external-xref legal-doc="usc" parsable-cite="usc/21/334">21 U.S.C. 334</external-xref>) is amended—</text>
<paragraph id="H626A4C95ED4E46EAA4DAA14757518B16"><enum>(1)</enum><text>in subsection
(a)(2)—</text>
<subparagraph id="HCDE3D667F6794AB180A94402B01D17FD"><enum>(A)</enum><text>by striking
<quote>and</quote> before <quote>(D)</quote>; and</text>
</subparagraph><subparagraph id="HBC71EDEAEE2343A086B918E5221B85C3"><enum>(B)</enum><text>by striking
<quote>device.</quote> and inserting the following: <quote>device, and (E) Any
adulterated or misbranded tobacco product.</quote>;</text>
</subparagraph></paragraph><paragraph id="H4D48AE48B15041DCA0CA466380A5052C"><enum>(2)</enum><text>in subsection
(d)(1), by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H353C7B44CC7A4AD198A66751C678432A"><enum>(3)</enum><text>in subsection
(g)(1), by inserting <quote>or tobacco product</quote> after the term
<term>device</term> each place such term appears; and</text>
</paragraph><paragraph id="H6521E3B2E06E45BFA59564742DFB4662"><enum>(4)</enum><text>in subsection
(g)(2)(A), by inserting <quote>or tobacco product</quote> after
<quote>device</quote>.</text>
</paragraph></subsection><subsection id="H777D53043C264B34B17580F4176561B6"><enum>(e)</enum><header>Section
505</header><text>Section 505(n)(2) (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(n)(2)</external-xref>) is amended by
striking <quote>section 904</quote> and inserting <quote>section
1004</quote>.</text>
</subsection><subsection id="HFC3B011DE18B4AD1B66D41AEEBC722EA"><enum>(f)</enum><header>Section
523</header><text>Section 523(b)(2)(D) (<external-xref legal-doc="usc" parsable-cite="usc/21/360m">21 U.S.C. 360m(b)(2)(D)</external-xref>) is amended
by striking <quote>section 903(g)</quote> and inserting <quote>section
1003(g)</quote>.</text>
</subsection><subsection display-inline="no-display-inline" id="H99A2F468FA2F47B588EF0595CA82B18F"><enum>(g)</enum><header>Section
702</header><text display-inline="yes-display-inline">Section 702(a)(1) (U.S.C.
372(a)(1)) is amended—</text>
<paragraph id="H0B71FBAB54C245A5A376CE09EC0E27A5"><enum>(1)</enum><text>by striking
<quote>(a)(1)</quote> and inserting <quote>(a)(1)(A)</quote>; and</text>
</paragraph><paragraph id="H6105678E01D4474BAEB71F27F25F207D"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H152B3E13A7F24007824D5A12D2A61BC0" style="traditional">
<subparagraph id="H8E9CBBB26BA246B1AD7D803E5D7C9F5B" indent="up2"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="HAC30D9F26896401A8461EE15F76F7DC1"><enum>(i)</enum><text display-inline="yes-display-inline">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.</text>
</clause><clause id="H3C4681A1A3994F4C900F8FF21BD7B50F" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H3DBC3DEBF4654A2B8C8328BB2981802B"><enum>(h)</enum><header>Section
703</header><text>Section 703 (<external-xref legal-doc="usc" parsable-cite="usc/21/373">21 U.S.C. 373</external-xref>) is amended—</text>
<paragraph id="H909B24A325E64D9A95D3433E43F6D353"><enum>(1)</enum><text>by inserting
<quote>tobacco product,</quote> after the term <term>device,</term> each place
such term appears; and</text>
</paragraph><paragraph id="H6186A816B5AB4DA9AA5199904E9C4034"><enum>(2)</enum><text>by inserting
<quote>tobacco products,</quote> after the term <term>devices,</term> each
place such term appears.</text>
</paragraph></subsection><subsection id="HBC7D2099B070406D8BF5B06C3083325A"><enum>(i)</enum><header>Section
704</header><text>Section 704 (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374</external-xref>) is amended—</text>
<paragraph id="H521207C3F41540F18D0C48C2372E54D6"><enum>(1)</enum><text>in subsection
(a)(1)—</text>
<subparagraph id="H7AE5604D4C924786B2681A8FA28ADB66"><enum>(A)</enum><text>by striking
<quote>devices, or cosmetics</quote> each place it appears and inserting
<quote>devices, tobacco products, or cosmetics</quote>;</text>
</subparagraph><subparagraph id="H7B2F0D016A2045A3AEED66952B449394"><enum>(B)</enum><text>by striking
<quote>or restricted devices</quote> each place it appears and inserting
<quote>restricted devices, or tobacco products</quote>; and</text>
</subparagraph><subparagraph id="H6A8F6B1146384FF0AC292CB13E26A0A7"><enum>(C)</enum><text>by striking
<quote>and devices and subject to</quote> and all that follows through
<quote>other drugs or devices</quote> and inserting <quote>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</quote>;</text>
</subparagraph></paragraph><paragraph id="H2BDE0C48697942D29AAB51942510D125"><enum>(2)</enum><text>in subsection (b),
by inserting <quote>tobacco product,</quote> after <quote>device,</quote>;
and</text>
</paragraph><paragraph id="HE4D25E94ABE14CF48DC045B742770517"><enum>(3)</enum><text>in subsection
(g)(13), by striking <quote>section 903(g)</quote> and inserting <quote>section
1003(g)</quote>.</text>
</paragraph></subsection><subsection id="HEFDA9CDF650A43AC8CFA7E3851A240A6"><enum>(j)</enum><header>Section
705</header><text>Section 705(b) (<external-xref legal-doc="usc" parsable-cite="usc/21/375">21 U.S.C. 375(b)</external-xref>) is amended by
inserting <quote>tobacco products,</quote> after
<quote>devices,</quote>.</text>
</subsection><subsection id="H91A3334616384FF4B8486394C5D37C9F"><enum>(k)</enum><header>Section
709</header><text>Section 709 (<external-xref legal-doc="usc" parsable-cite="usc/21/379a">21 U.S.C. 379a</external-xref>) is amended by
inserting <quote>tobacco product,</quote> after <quote>device,</quote>.</text>
</subsection><subsection id="HDEBBF910CF814295894C123E63646D2E"><enum>(l)</enum><header>Section
801</header><text>Section 801 (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C. 381</external-xref>) is amended—</text>
<paragraph id="H5DE2FE9F37AE481499C5033BF78A4979"><enum>(1)</enum><text>in subsection
(a)—</text>
<subparagraph id="HB990309AAEB54FA89403872CD9D75927"><enum>(A)</enum><text>by inserting
<quote>tobacco products,</quote> after the term <term>devices,</term>;</text>
</subparagraph><subparagraph id="HA74F003B195D4E18BA8F0A44F3D36CA9"><enum>(B)</enum><text>by inserting
<quote>or section 905(h)</quote> after <quote>section 510</quote>; and</text>
</subparagraph><subparagraph id="H93A20093482B40E88AB1885CFE422120"><enum>(C)</enum><text>by striking the
term <term>drugs or devices</term> each time such term appears and inserting
<quote>drugs, devices, or tobacco products</quote>;</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="HE2FBB1FBFBCC4AE7BA4FFC7C3A165D2B"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (e)(1)—</text>
<subparagraph id="H1C1B495774614A5FBD9559CBA38C13D5"><enum>(A)</enum><text>by inserting
<quote>tobacco product</quote> after <quote>drug, device,</quote>; and</text>
</subparagraph><subparagraph id="H8F0C08015E39497E83EC877EA7CE2AA9"><enum>(B)</enum><text>by inserting
<quote>, and a tobacco product intended for export shall not be deemed to be in
violation of section 906(e), 907, 911, or 920(a),</quote> before <quote>if
it—</quote>; and</text>
</subparagraph></paragraph><paragraph id="HD121B45D3EF44A01BD1E34A4BFAD846B"><enum>(3)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H7C60B08A7DFA45ECAD61735C4595C80B" style="OLC">
<subsection id="H3AD9FB7BCACC4A64A2BAD0EBC5E37B8E"><enum>(p)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H979AFC57B7E0432F8C6C8AF9D25669F6"><enum>(1)</enum><text>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—</text>
<subparagraph id="H81B9791E5AFD499F8F10EBB50847A8A5" indent="up1"><enum>(A)</enum><text>the nature, extent, and destination of
United States tobacco product exports that do not conform to tobacco product
standards established pursuant to this Act;</text>
</subparagraph><subparagraph id="HDFBFD9599D5946A0A0B2457FD8063F7E" indent="up1"><enum>(B)</enum><text>the public health implications of such
exports, including any evidence of a negative public health impact; and</text>
</subparagraph><subparagraph id="H353D962AC2E54958B548C287F125031F" indent="up1"><enum>(C)</enum><text>recommendations or assessments of
policy alternatives available to Congress and the executive branch to reduce
any negative public health impact caused by such exports.</text>
</subparagraph></paragraph><paragraph id="H84EF920C6D80444D8A6269F0AD992317" indent="up1"><enum>(2)</enum><text>The Secretary is authorized to
establish appropriate information disclosure requirements to carry out this
subsection.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H82229D21E75C4E528B283A88CB18C7F9"><enum>(m)</enum><header>Section
1003</header><text>Section 1003(d)(2)(C) (as redesignated by section 101(b)) is
amended—</text>
<paragraph id="H210BF14CC4524F258B1EF4001D4C0EE1"><enum>(1)</enum><text>by striking
<quote>and</quote> after <quote>cosmetics,</quote>; and</text>
</paragraph><paragraph id="H2976CD98A9DE40B684BEF8D60EBA59DE"><enum>(2)</enum><text>inserting <quote>,
and tobacco products</quote> after <quote>devices</quote>.</text>
</paragraph></subsection><subsection id="HED11F125897B4A81B39F67E381873157"><enum>(n)</enum><header>Section
1009</header><text display-inline="yes-display-inline">Section 1009(b) (as
redesignated by section 101(b)) is amended by striking <quote>section
908</quote> and inserting <quote>section 1008</quote>.</text>
</subsection><subsection id="H24F6AE6193CE4295A981DA47AF589C7D"><enum>(o)</enum><header>Section 409 of
the Federal Meat Inspection Act</header><text>Section 409(a) of the Federal
Meat Inspection Act (<external-xref legal-doc="usc" parsable-cite="usc/21/679">21 U.S.C. 679(a)</external-xref>) is amended by
striking <quote>section 902(b)</quote> and inserting <quote>section
1002(b)</quote>.</text>
</subsection><subsection id="H1E04FB2F60C84B6CBAFE1076DD20609E"><enum>(p)</enum><header>Rule of
construction</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection id="H26A3F4CB0DA844CCAF82E8274819E939"><enum>(q)</enum><header>Guidance and
Effective Dates</header>
<paragraph id="HBD1BEA9C2A5A40D6BB206354E2501FED"><enum>(1)</enum><header>In
general</header><text>The Secretary of Health and Human Services shall issue
guidance—</text>
<subparagraph id="HA18EF12B3B4E4EB987CFFE56FBFC0AB5"><enum>(A)</enum><text>defining the term
<term>repeated violation</term>, as used in section 303(f)(8) of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)(8)</external-xref>) 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);</text>
</subparagraph><subparagraph id="HF1ACCE70538145588FC2077FDFE1852A"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph id="HF9E508D7C4B4413BB0AEB6870E760A8A"><enum>(C)</enum><text>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;</text>
</subparagraph><subparagraph commented="no" id="HEF52273428204A2A8ADE60C45E647B80"><enum>(D)</enum><text>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;</text>
</subparagraph><subparagraph id="HCA70F710D3B5465B93819F8B3DA8B810"><enum>(E)</enum><text>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;</text>
</subparagraph><subparagraph id="H5FFB8C137E1E484187F6CDA9B150F39F"><enum>(F)</enum><text>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—</text>
<clause id="HAA6EDE293CBF43BB90DFB1FC8B20393F"><enum>(i)</enum><text>adopting and
enforcing a written policy against sales to minors;</text>
</clause><clause id="H0CD57C9BA98D47A9B228498FE79B8C3F"><enum>(ii)</enum><text>informing its
employees of all applicable laws;</text>
</clause><clause id="H45BBD6CCD49E45878A1BCEF86EEDFE08"><enum>(iii)</enum><text>establishing
disciplinary sanctions for employee noncompliance; and</text>
</clause><clause id="H155140CD3E5C4CE480929F07AEAAAAAB"><enum>(iv)</enum><text>requiring its
employees to verify age by way of photographic identification or electronic
scanning device; and</text>
</clause></subparagraph><subparagraph display-inline="no-display-inline" id="HC6F711873E554F998DE9125929C0AA95"><enum>(G)</enum><text display-inline="yes-display-inline">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).</text>
</subparagraph></paragraph><paragraph id="HF286A36DC26944139BD05F60E080E79F"><enum>(2)</enum><header>Penalties for
violations</header>
<subparagraph id="H20D7D3A4144F40FE8C7FC4BA35B0AAC1"><enum>(A)</enum><header>In
general</header><text>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:</text>
<clause id="H514A3B840882412F80081F7E74F1EBF2"><enum>(i)</enum><text>With
respect to a retailer with an approved training program, the amount of the
civil penalty shall not exceed—</text>
<subclause id="H21C0B76F10C247B38602ECBDDDD91912"><enum>(I)</enum><text>in the case of the
first violation, $0.00 together with the issuance of a warning letter to the
retailer;</text>
</subclause><subclause id="HCFA6A8C7822448FBAABEEFB754764A39"><enum>(II)</enum><text>in the case of a
second violation within a 12-month period, $250;</text>
</subclause><subclause id="H2B33E8B2976D4182872EB7ED22C535A1"><enum>(III)</enum><text>in the case of a
third violation within a 24-month period, $500;</text>
</subclause><subclause id="H33A83977D6AB499CA200B16741C07FF7"><enum>(IV)</enum><text>in the case of a
fourth violation within a 24-month period, $2,000;</text>
</subclause><subclause id="H5F8D373224E04085ABA2D5636D3DFD46"><enum>(V)</enum><text>in the case of a
fifth violation within a 36-month period, $5,000; and</text>
</subclause><subclause id="H38C9EC2E587C498BA32D2376DE678D19"><enum>(VI)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause><clause id="H855C98B180EA4EE982D80CFEA1CEFD83"><enum>(ii)</enum><text>With respect to a
retailer that does not have an approved training program, the amount of the
civil penalty shall not exceed—</text>
<subclause id="H7058DCB8ABF54478878F1B9F822342D1"><enum>(I)</enum><text>in the case of the
first violation, $250;</text>
</subclause><subclause id="H8D5C00B824154A82B28E6D58D7B04CEC"><enum>(II)</enum><text>in the case of a
second violation within a 12-month period, $500;</text>
</subclause><subclause id="H73AA8E782A584DCEBC8D5AA86181F0D0"><enum>(III)</enum><text>in the case of a
third violation within a 24-month period, $1,000;</text>
</subclause><subclause id="HB3B152DF54484699B412BE63C26AEC5A"><enum>(IV)</enum><text>in the case of a
fourth violation within a 24-month period, $2,000;</text>
</subclause><subclause id="H1524878419D14365A8934E976F318FE5"><enum>(V)</enum><text>in the case of a
fifth violation within a 36-month period, $5,000; and</text>
</subclause><subclause id="HE7389944FAEA4DDE91C2FCCAE9DD0E41"><enum>(VI)</enum><text display-inline="yes-display-inline">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.</text>
</subclause></clause></subparagraph><subparagraph id="HD249361CFB7D4DB8817CCFC59FED64E8"><enum>(B)</enum><header>Training
program</header><text>For purposes of subparagraph (A), the term <term>approved
training program</term> means a training program that complies with standards
developed by the Food and Drug Administration for such programs.</text>
</subparagraph><subparagraph id="HADC9F4CCDC934F4D9492FDF6E85F1803"><enum>(C)</enum><header>Consideration of
State penalties</header><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph id="H134852DBA4814AB58C326CC773AF96CE"><enum>(3)</enum><header>General
effective date</header><text>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.</text>
</paragraph><paragraph id="H3294E5706DBB40D48EE3A977FF53811F"><enum>(4)</enum><header>Special
effective date</header><text>The amendment made by subsection (c)(1) shall take
effect on the date of enactment of this Act.</text>
</paragraph><paragraph id="HA941EB105DD44A159CD19B964166856A"><enum>(5)</enum><header>Package label
requirements</header><text>The package label requirements of paragraphs (2),
(3), and (4) of section 903(a) of the Federal Food, Drug, and Cosmetic Act (as
amended by this Act) shall take effect on the date that is 12 months after the
date of enactment of this Act. The effective date shall be with respect to the
date of manufacture, provided that, in any case, beginning 30 days after such
effective date, a manufacturer shall not introduce into the domestic commerce
of the United States any product, irrespective of the date of manufacture, that
is not in conformance with section 903(a) (2), (3), and (4) and section 920(a)
of the Federal Food, Drug, and Cosmetic Act.</text>
</paragraph><paragraph id="H9B5B0E18F0C84DD9A89CE80BA08559F5"><enum>(6)</enum><header>Advertising
requirements</header><text>The advertising requirements of section 903(a)(8) of
the Federal Food, Drug, and Cosmetic Act (as amended by this Act) shall take
effect on the date that is 12 months after the date of enactment of this
Act.</text>
</paragraph></subsection></section><section display-inline="no-display-inline" id="H75B23BC376C14AD681EA7566CBEBA904" section-type="subsequent-section"><enum>104.</enum><header>Study on raising the
minimum age to purchase tobacco products</header><text display-inline="no-display-inline">The Secretary of Health and Human Services
shall—</text>
<paragraph id="H0FDF7B2DC3E84A0D82D8EBB2F0366404"><enum>(1)</enum><text>convene an expert
panel to conduct a study on the public health implications of raising the
minimum age to purchase tobacco products; and</text>
</paragraph><paragraph id="H444BF430FD9047E7A81BBCB992A1AEDF"><enum>(2)</enum><text>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.</text>
</paragraph></section><section display-inline="no-display-inline" id="H8B702AF0871B4B788F12E45D7CC0A688" section-type="subsequent-section"><enum>105.</enum><header>Enforcement action
plan for advertising and promotion restrictions</header>
<subsection id="H9C4F95D1E3844A01A615BC1D45F2571F"><enum>(a)</enum><header>Action
plan</header>
<paragraph id="H69E659363E1A49BFA47C07A4075BEE12"><enum>(1)</enum><header>Development</header><text>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
<quote>Secretary</quote>) shall develop and publish an action plan to enforce
restrictions adopted pursuant to section 906 of the Federal Food, Drug, and
Cosmetic Act, as added by section 101(b) of this Act, or pursuant to section
102(a) of this Act, on promotion and advertising of menthol and other
cigarettes to youth.</text>
</paragraph><paragraph id="H09D97DBA1FC84084B32856439FFC71BC"><enum>(2)</enum><header>Consultation</header><text>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.</text>
</paragraph><paragraph id="H5E8E37B7B3304F6B83BA15C0DF825B79"><enum>(3)</enum><header>Priority</header><text>The
action plan required by paragraph (1) shall include provisions designed to
ensure enforcement of the restrictions described in paragraph (1) in minority
communities.</text>
</paragraph></subsection><subsection id="H2569B3E9E1D54314808950C7FDC4FC8A"><enum>(b)</enum><header>State and local
activities</header>
<paragraph id="HC2DB1962A5B94778A25FAEE3B01E62C9"><enum>(1)</enum><header>Information on
authority</header><text display-inline="yes-display-inline">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 Act, or preserved by such entities under section
916 of the Federal Food, Drug, and Cosmetic Act, as added by section 101(b) of
this Act.</text>
</paragraph><paragraph id="H4E2B330471B741B98DC6E9ECC4BD8170"><enum>(2)</enum><header>Community
assistance</header><text>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.</text>
</paragraph></subsection></section><enum>II</enum><header>TOBACCO PRODUCT
WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT DISCLOSURE</header>
<section id="HE621B22A288445E1BD3CCCD83E56965F"><enum>201.</enum><header>Cigarette label
and advertising warnings</header>
<subsection id="HDC0D72E83A5B404CAAF347945DD62E70"><enum>(a)</enum><header>Amendment</header><text display-inline="yes-display-inline">Section 4 of the Federal Cigarette Labeling
and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C. 1333</external-xref>) is amended to read
as follows:</text>
<quoted-block display-inline="no-display-inline" id="H9F44AE76D6B34B76B1CD1EF1A9F34FC7" style="OLC">
<section id="H782D12C4A1A34A769A4AAD804FB054F4"><enum>4.</enum><header>Labeling</header>
<subsection id="HBC92D41E0B074475B9CAFF1040CFE256"><enum>(a)</enum><header>Label
Requirements</header>
<paragraph id="HF7B9ECE037334059ABE305A278EE565E"><enum>(1)</enum><header>In
general</header><text>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:</text>
<list level="subparagraph">
<list-item>WARNING: Cigarettes are
addictive.</list-item>
<list-item>WARNING: Tobacco smoke can harm your
children.</list-item>
<list-item>WARNING: Cigarettes cause fatal lung
disease.</list-item>
<list-item>WARNING: Cigarettes cause cancer.</list-item>
<list-item>WARNING: Cigarettes cause strokes and heart
disease.</list-item>
<list-item>WARNING: Smoking during pregnancy can harm your
baby.</list-item>
<list-item>WARNING: Smoking can kill you.</list-item>
<list-item>WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.</list-item>
<list-item>WARNING: Quitting smoking now greatly reduces
serious risks to your health.</list-item></list>
</paragraph><paragraph id="H710C36CD17964183BF048FC8F0DE4631"><enum>(2)</enum><header>Placement;
typography; etc</header><text>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 <quote>WARNING</quote> 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).</text>
</paragraph><paragraph id="H1337289EA08C415DA363448995823001"><enum>(3)</enum><header>Does not apply
to foreign distribution</header><text>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.</text>
</paragraph><paragraph id="H508B46C974ED41BC9A24A5938546304A"><enum>(4)</enum><header>Applicability to
retailers</header><text>A retailer of cigarettes shall not be in violation of
this subsection for packaging that—</text>
<subparagraph id="H933EB45D3C564D738E8CFF6BC6566647"><enum>(A)</enum><text>contains a warning
label;</text>
</subparagraph><subparagraph id="HDFCD055649A641AD89A40F32CFB1B1D3"><enum>(B)</enum><text display-inline="yes-display-inline">is supplied to the retailer by a license-
or permit-holding tobacco product manufacturer, importer, or distributor;
and</text>
</subparagraph><subparagraph id="H2021B872D4FD45FE849579D53D25697D"><enum>(C)</enum><text>is not altered by
the retailer in a way that is material to the requirements of this
subsection.</text>
</subparagraph></paragraph></subsection><subsection id="H45BEEF07D9384FEEA0514D2CC270ECB6"><enum>(b)</enum><header>Advertising
requirements</header>
<paragraph id="HC5ECCD446BDB49EC9F953217FE33A2F6"><enum>(1)</enum><header>In
general</header><text>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).</text>
</paragraph><paragraph id="HFC21477E2F854A5380FB609692FFBC95"><enum>(2)</enum><header>Typography,
etc</header><text>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 <quote>WARNING</quote> 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 <quote>W</quote> of the word <quote>WARNING</quote>
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—</text>
<subparagraph id="HEC9DDA37FC654209BB58DC04E2F91845"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="H752715299FDB4C369A7669BDF3707860"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="HBB828D18FCF94A0DAA2CDF075A3B8CCA"><enum>(3)</enum><header>Matchbooks</header><text>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.</text>
</paragraph><paragraph id="HF2BAF38D12874EC89104112D312B37C2"><enum>(4)</enum><header>Adjustment by
Secretary</header><text>The Secretary may, through a rulemaking under
<external-xref legal-doc="usc" parsable-cite="usc/5/553">section
553</external-xref> 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.</text>
</paragraph></subsection><subsection id="H3982ACDB6FC84413A9C9DEBA40E45206"><enum>(c)</enum><header>Marketing
requirements</header>
<paragraph id="H292A0E72E40B4BA5B977E93FD24E951F"><enum>(1)</enum><header>Random
display</header><text>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.</text>
</paragraph><paragraph id="H78996C005BD64F3F9C84A0A8E6170410"><enum>(2)</enum><header>Rotation</header><text>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.</text>
</paragraph><paragraph id="HD60B5F11EF2C4CF887431CA447B7E582"><enum>(3)</enum><header>Review</header><text>The
Secretary shall review each plan submitted under paragraph (2) and approve it
if the plan—</text>
<subparagraph id="HB54323C276ED4518A3F33FAD131A52FF"><enum>(A)</enum><text>will provide for
the equal distribution and display on packaging and the rotation required in
advertising under this subsection; and</text>
</subparagraph><subparagraph id="HDF977CDFF3074F95BBF5D9439E4FB57C"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H3F8858658CA5455DB699745FF9638EF8"><enum>(4)</enum><header>Applicability to
retailers</header><text display-inline="yes-display-inline">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).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H9BC254766738493CB33B72301A9309F7"><enum>(b)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) shall take effect 12 months after the date of enactment of this
Act. Such effective date shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such effective date, a
manufacturer shall not introduce into the domestic commerce of the United
States any product, irrespective of the date of manufacture, that is not in
conformance with section 4 of the Federal Cigarette Labeling and Advertising
Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C.
1333</external-xref>), as amended by subsection (a).</text>
</subsection></section><section id="H2F93A810FC5546759F8408C2E6D72DB8"><enum>202.</enum><header>Authority to
revise cigarette warning label statements</header>
<subsection id="H2C6832D0EE5E4336841F05D0AFB11D6B"><enum>(a)</enum><header>Preemption</header><text display-inline="yes-display-inline">Section 5(a) of the Federal Cigarette
Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1334">15 U.S.C. 1334(a)</external-xref>) is amended by
striking <quote>No</quote> and inserting <quote>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</quote>.</text>
</subsection><subsection id="HA506CC8242E84696A285D64031D77696"><enum>(b)</enum><header>Change in
required statements</header><text display-inline="yes-display-inline">Section 4
of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C. 1333</external-xref>), as amended by
section 201, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idEDC073F8E2424932B53B053CD4DF4F13" style="OLC">
<subsection id="ID85a357933bf44dd6a5489bdcde7fbe30"><enum>(d)</enum><header>Change in
required statements</header><text>The Secretary through a rulemaking conducted
under section 553 of title 5, United States Code—</text>
<paragraph id="IDa14412e24cf7416cb28869165cd0dae6"><enum>(1)</enum><text>shall issue
regulations within 24 months of the date of enactment of the Family Smoking
Prevention and Tobacco Control Act that require color graphics depicting the
negative health consequences of smoking to accompany label requirements;
and</text>
</paragraph><paragraph id="IDe7896248dab34299bd9f7dabab5bc939"><enum>(2)</enum><text>may thereafter
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.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="HC27B608DACFB4841A0790AEE789A062E"><enum>203.</enum><header>State
regulation of cigarette advertising and promotion</header><text display-inline="no-display-inline">Section 5 of the Federal Cigarette Labeling
and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1334">15 U.S.C. 1334</external-xref>) is amended by
adding at the end the following:</text>
<quoted-block id="H09C489F0C8A34F5485F543F17DAF8383" style="OLC">
<subsection id="H529E4606F5DB49D19015A6D34CD1BC5E"><enum>(c)</enum><header>Exception</header><text>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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H6EEB5382E27146949E45B1D2D63635AF"><enum>204.</enum><header>Smokeless
tobacco labels and advertising warnings</header>
<subsection id="H9B166972B02542629AFDBA84E2FDD972"><enum>(a)</enum><header>Amendment</header><text display-inline="yes-display-inline">Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (<external-xref legal-doc="usc" parsable-cite="usc/15/4402">15 U.S.C. 4402</external-xref>) is amended to read
as follows:</text>
<quoted-block display-inline="no-display-inline" id="H21935BC969744EF88E088CFCF565527C" style="OLC">
<section id="H4ABE2E831CBE43739E88F419467C5A8C"><enum>3.</enum><header>Smokeless tobacco
warning</header>
<subsection id="H6DD76A7ABEC244A2B7C68D0F72B8322B"><enum>(a)</enum><header>General
rule</header>
<paragraph id="H1D51DC4DA7584DC8933C8A4DE4A782CC"><enum>(1)</enum><text>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:</text>
<list level="subparagraph">
<list-item>WARNING: This product can cause mouth
cancer.</list-item>
<list-item>WARNING: This product can cause gum disease and
tooth loss.</list-item>
<list-item>WARNING: This product is not a safe alternative to
cigarettes.</list-item>
<list-item>WARNING: Smokeless tobacco is
addictive.</list-item></list>
</paragraph><paragraph id="HBCD12806AEB641618952A59E82DA50C0"><enum>(2)</enum><text>Each label
statement required by paragraph (1) shall be—</text>
<subparagraph id="HE583E51051CE461B948611AC289D9E32"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="HE56400FE094149A08E3DB07D52883275"><enum>(B)</enum><text>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.</text>
</subparagraph></paragraph><paragraph id="H46644C247E4C4C25A6C625E4B383B8B1"><enum>(3)</enum><text>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.</text>
</paragraph><paragraph id="HFE6A7734062148D7974043D9B90C8D67"><enum>(4)</enum><text>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.</text>
</paragraph><paragraph id="H6BD6F083E1FA448A8729CA4AD9D0E6D3"><enum>(5)</enum><text>A retailer of
smokeless tobacco products shall not be in violation of this subsection for
packaging that—</text>
<subparagraph id="H6151F2C6AF36441397A8D051F491748F"><enum>(A)</enum><text display-inline="yes-display-inline">contains a warning label;</text>
</subparagraph><subparagraph id="HC34DEE11F9874C6C94BC9AFFBCDF6477"><enum>(B)</enum><text>is supplied to the
retailer by a license- or permit-holding tobacco product manufacturer,
importer, or distributor; and</text>
</subparagraph><subparagraph id="H33F7AB31A8F3483383AD48B7B3CE3282"><enum>(C)</enum><text>is not altered by
the retailer in a way that is material to the requirements of this
subsection.</text>
</subparagraph></paragraph></subsection><subsection id="H051F42E2C3C54EB99E2CA56C7A351B4E"><enum>(b)</enum><header>Required
labels</header>
<paragraph id="HFF0ECE5B53684BBC84F46890F558049D"><enum>(1)</enum><text>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).</text>
</paragraph><paragraph commented="no" id="H42E435344A9F4C4B8BC724532D9441E2"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HA46126DE8A604E7BB24DE0D90ACE8F8D"><enum>(A)</enum><text>Each label statement
required by subsection (a) in smokeless tobacco advertising shall comply with
the standards set forth in this paragraph.</text>
</subparagraph><subparagraph commented="no" id="H79918214E5454B58AAFE9F0E1E147974" indent="up1"><enum>(B)</enum><text>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.</text>
</subparagraph><subparagraph commented="no" id="HCB65C7440450438CBE59BC2AF758C903" indent="up1"><enum>(C)</enum><text>The word <quote>WARNING</quote> shall
appear in capital letters, and each label statement shall appear in conspicuous
and legible type.</text>
</subparagraph><subparagraph commented="no" id="HF86AE9CC1D774EFDB9997C1C266A11A1" indent="up1"><enum>(D)</enum><text>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).</text>
</subparagraph><subparagraph commented="no" id="HA08A8A11643547BEA5BC97607CAE17A3" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">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 <quote>W</quote> of
the word <quote>WARNING</quote> in the label statements.</text>
</subparagraph><subparagraph commented="no" id="H56AB05EA1166473C84A6EED12F7D986E" indent="up1"><enum>(F)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph commented="no" id="HD0296C27EBC14B8EAB5191DEB7A25638" indent="up1"><enum>(G)</enum><text>The label statements shall be in
English, except that—</text>
<clause commented="no" id="H4CF13AF852BE4C6FBB0D7AB9B7A95E0A"><enum>(i)</enum><text>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</text>
</clause><clause commented="no" id="H210261AB1048400BBED5984BB73A4AA2"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph></paragraph><paragraph id="HF0D572E9DE9C46B3A04FBE129AF288A3"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H8C7F12CF03274A098B88E7A9927901C3"><enum>(A)</enum><text>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.</text>
</subparagraph><subparagraph id="H1455917B8FF04D919654D8926002BBDD" indent="up1"><enum>(B)</enum><text>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.</text>
</subparagraph><subparagraph id="HD47D9A45A380488D8C5B4F6BD722FDD3" indent="up1"><enum>(C)</enum><text>The Secretary shall review each plan
submitted under subparagraphs (A) and (B) and approve it if the plan—</text>
<clause id="H52E2AA50BB0443E9832681A001C1897C"><enum>(i)</enum><text>will provide for the equal
distribution and display on packaging and the rotation required in advertising
under this subsection; and</text>
</clause><clause id="H61389E1A9F1A451F9160F8D5E602954F"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph><subparagraph id="H377ED61D0E1D4FB394997C63E02AF9F9" indent="up1"><enum>(D)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="HEBB44F87A6A142E88386D2EBCDB7EDA6"><enum>(4)</enum><text>The Secretary may,
through a rulemaking under
<external-xref legal-doc="usc" parsable-cite="usc/5/553">section
553</external-xref> 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.</text>
</paragraph></subsection><subsection id="H074B8B1BDB424EAB9B5113FA5C594B4C"><enum>(c)</enum><header>Television and
radio advertising</header><text>It is unlawful to advertise smokeless tobacco
on any medium of electronic communications subject to the jurisdiction of the
Federal Communications
Commission.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H9C600DAF4B82450196025621D61115B0"><enum>(b)</enum><header>Effective
date</header><text display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/15/4402">15 U.S.C. 4402</external-xref>), as amended by
subsection (a).</text>
</subsection></section><section id="H5E1AD529C63A48CA81FB7501DE147893"><enum>205.</enum><header>Authority to
revise smokeless tobacco product warning label statements</header>
<subsection id="H236C056A199E442790239BB7D828D84F"><enum>(a)</enum><header>In
general</header><text>Section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (<external-xref legal-doc="usc" parsable-cite="usc/15/4402">15 U.S.C. 4402</external-xref>), as amended by
section 204, is further amended by adding at the end the following:</text>
<quoted-block id="HF2C111FDD32645689B12DE6EF67BCC1E" style="OLC">
<subsection id="H1151D6FF07774710A86A56A24FDF1140"><enum>(d)</enum><header>Authority To
Revise Warning Label Statements</header><text>The Secretary may, by a
rulemaking conducted under
<external-xref legal-doc="usc" parsable-cite="usc/5/553">section
553</external-xref> 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.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HCDF15EC4289B4098A29770708411D165"><enum>(b)</enum><header>Preemption</header><text>Section
7(a) of the Comprehensive Smokeless Tobacco Health Education Act of 1986
(<external-xref legal-doc="usc" parsable-cite="usc/15/4406">15 U.S.C.
4406(a)</external-xref>) is amended by striking <quote>No</quote> and inserting
<quote>Except as provided in the Family Smoking Prevention and Tobacco Control
Act (and the amendments made by that Act), no</quote>.</text>
</subsection></section><section id="H6D34FF128F1B45CB8DBFB8EB1DC7E7A9"><enum>206.</enum><header>Tar, nicotine,
and other smoke constituent disclosure to the public</header><text display-inline="no-display-inline">Section 4 of the Federal Cigarette Labeling
and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C. 1333</external-xref>), as amended by
sections 201 and 202, is further amended by adding at the end the
following:</text>
<quoted-block id="H85D013D230C449E294874015836EB766" style="OLC">
<subsection id="HB352FAC385334796AC850353977BF932"><enum>(e)</enum><header>Tar, Nicotine,
and Other Smoke Constituent Disclosure</header>
<paragraph id="H22A10EEFA710481F90BDE6A0F179D5BF"><enum>(1)</enum><header>In
general</header><text>The Secretary shall, by a rulemaking conducted under
<external-xref legal-doc="usc" parsable-cite="usc/5/553">section
553</external-xref> 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.</text>
</paragraph><paragraph id="HB33B52C2E4EF4BC1943042975CB3322E"><enum>(2)</enum><header>Resolution of
differences</header><text>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.</text>
</paragraph><paragraph id="H06892910569C44C680EC3D97A45302D0"><enum>(3)</enum><header>Cigarette and
other tobacco product constituents</header><text>In addition to the disclosures
required by paragraph (1), the Secretary may, under a rulemaking conducted
under <external-xref legal-doc="usc" parsable-cite="usc/5/553">section
553</external-xref> 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.</text>
</paragraph><paragraph id="HB3FE16BE7F874945936682B6A9EBF725"><enum>(4)</enum><header>Retailers</header><text>This
subsection applies to a retailer only if that retailer is responsible for or
directs the label statements required under this
section.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>III</enum><header>PREVENTION OF
ILLICIT TRADE IN TOBACCO PRODUCTS</header>
<section id="HA4C2F58192DA4C50859C6909992FE99F"><enum>301.</enum><header>Labeling,
recordkeeping, records inspection</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="HF93243AB922A40A29FD1AB8485E6573C" style="OLC">
<section id="H40B13A13CFF945AD98618B734359B35C"><enum>920.</enum><header>Labeling,
recordkeeping, records inspection</header>
<subsection commented="no" id="HA1641C0E088243A5B36E38C647E53807"><enum>(a)</enum><header>Origin
Labeling</header>
<paragraph commented="no" id="HB7C79AD59CB041529AECF2DCFC2A5EB4"><enum>(1)</enum><header>Requirement</header><text>Beginning
1 year after the date of enactment of the Family Smoking Prevention and Tobacco
Control Act, the label, packaging, and shipping containers of tobacco products
for introduction or delivery for introduction into interstate commerce in the
United States shall bear the statement <quote>sale only allowed in the United
States</quote>.</text>
</paragraph><paragraph commented="no" id="H07261ECD3E0641B5A8D4C5289BF56DC7"><enum>(2)</enum><header>Effective
date</header><text display-inline="yes-display-inline">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.</text>
</paragraph></subsection><subsection id="HF17E3C4F99CA4516A441FFA907665E8E"><enum>(b)</enum><header>Regulations
Concerning Recordkeeping for Tracking and Tracing</header>
<paragraph commented="no" id="HD14CD1077FEE4922B6E4CBA5FA14D944"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="HB3F54A3980E542AFA3EE0509473A0FD3"><enum>(2)</enum><header>Inspection</header><text>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.</text>
</paragraph><paragraph id="H4EABCF044EA64DB7BA715930DD69BB5D"><enum>(3)</enum><header>Codes</header><text>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.</text>
</paragraph><paragraph id="HDF118B926BA14D65A61951FAFFBC5EE6"><enum>(4)</enum><header>Size of
business</header><text>The Secretary shall take into account the size of a
business in promulgating regulations under this section.</text>
</paragraph><paragraph id="H614C179CDD9849CD872CC9FD92AE345D"><enum>(5)</enum><header>Recordkeeping by
retailers</header><text>The Secretary shall not require any retailer to
maintain records relating to individual purchasers of tobacco products for
personal consumption.</text>
</paragraph></subsection><subsection id="HADC56D3DC3F243FEAE3BF8397A262823"><enum>(c)</enum><header>Records
Inspection</header><text>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.</text>
</subsection><subsection id="H9FC9A7CF49294011A296A57A121A5B75"><enum>(d)</enum><header>Knowledge of
Illegal Transaction</header>
<paragraph id="H485098916622406794489FE69879161B"><enum>(1)</enum><header>Notification</header><text>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—</text>
<subparagraph id="HB43CB395EAB54FCBABA3F03D0ACF53D1"><enum>(A)</enum><text>imported,
exported, distributed, or offered for sale in interstate commerce by a person
without paying duties or taxes required by law; or</text>
</subparagraph><subparagraph id="HF1064D8C732445B29970557187CE1BD2"><enum>(B)</enum><text>imported,
exported, distributed, or diverted for possible illicit marketing,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">the
manufacturer or distributor shall promptly notify the Attorney General and the
Secretary of the Treasury of such knowledge.</continuation-text></paragraph><paragraph id="HAE5661B28612402C8F9D01AFC92E9E87"><enum>(2)</enum><header>Knowledge
defined</header><text>For purposes of this subsection, the term
<term>knowledge</term> as applied to a manufacturer or distributor
means—</text>
<subparagraph id="H67779B6135D9431D9B28DB82CBCE404A"><enum>(A)</enum><text>the actual
knowledge that the manufacturer or distributor had; or</text>
</subparagraph><subparagraph id="H6171FE41D27E4337958856F76FC18BF2"><enum>(B)</enum><text>the knowledge
which a reasonable person would have had under like circumstances or which
would have been obtained upon the exercise of due care.</text>
</subparagraph></paragraph></subsection><subsection id="HFA3E9FAF5492419D8D1006CFAF48D0E9"><enum>(e)</enum><header>Consultation</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H0B253C91C174479891DD273B75738781"><enum>302.</enum><header>Study and
report</header>
<subsection id="H0EB1BF8BA026495CAECFA70A10CFBC3E"><enum>(a)</enum><header>Study</header><text>The
Comptroller General of the United States shall conduct a study of cross-border
trade in tobacco products to—</text>
<paragraph id="HF1C3B23F97A6469FB52EB999A8242DC3"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="HBE06C90CF1E440C2AE6F314C31999F01"><enum>(2)</enum><text>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</text>
</paragraph><paragraph id="H788CA79D771E45DCA3D2B61920904792"><enum>(3)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph id="H9CC72B4600B348FC96439FAB8A6AF95B"><enum>(A)</enum><text>the illicit trade
of tobacco products and the trade of counterfeit tobacco products; and</text>
</subparagraph><subparagraph id="H364E0B80C7844BA096E49273E113450A"><enum>(B)</enum><text display-inline="yes-display-inline">the differing tax rates applicable to
tobacco products.</text>
</subparagraph></paragraph></subsection><subsection id="H830898E882A24DB09D2768EE1CC03D20"><enum>(b)</enum><header>Report</header><text>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).</text>
</subsection><subsection id="H8BCAA7B4FE2C402D97359E5058A4059B"><enum>(c)</enum><header>Definition</header><text>In
this section:</text>
<paragraph id="H9A20FC8692D74F5093C45AD45E04F7C2"><enum>(1)</enum><text>The term
<term>cross-border trade</term> means trade across a border of the United
States, a State or Territory, or Indian country.</text>
</paragraph><paragraph commented="no" id="HA8C4DA61BBEE4F3BBD9EC00751914BFA"><enum>(2)</enum><text>The term
<term>Indian country</term> has the meaning given to such term in
<external-xref legal-doc="usc" parsable-cite="usc/18/1151">section
1151</external-xref> of title 18, United States Code.</text>
</paragraph><paragraph id="HC11DCDC5B2B040E49EFB577F5B449A83"><enum>(3)</enum><text display-inline="yes-display-inline">The terms <term>State</term> and
<term>Territory</term> have the meanings given to those terms in section 201 of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>).</text>
</paragraph></subsection></section>