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.
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 2003, the
cigarette manufacturers spent more than $15,000,000,000 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, 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 plays
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 insuring 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 approved in advance of marketing, and to require that the
evidence relied on to support approval of these products is rigorous.
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;
(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.
5.If any provision of this Act, the amendments
made by this Act, or the application of any provision of this Act to any person
or circumstance is held to be invalid, the remainder of this Act, the
amendments made by this Act, and the application of the provisions of this Act
to any other person or circumstance shall not be affected and shall continue to
be enforced to the fullest extent possible.
<enum>I</enum><header>AUTHORITY OF THE
FOOD AND DRUG ADMINISTRATION</header>
<section id="H229983ED108447C1A9A51441F57E8D40"><enum>101.</enum><header>Amendment of
Federal food, drug, and Cosmetic Act</header>
<subsection id="H223B3B8040CF445F97B827B80196F300"><enum>(a)</enum><header>Definition of
Tobacco Products</header><text>Section 201 of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 321) is amended by adding at the end the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="HDBBDB15660EF49F1AD20E0674D0522EE" style="OLC">
<item id="HC570F5BD6FC048C5B2B0E0F84EC800FF" indent="up5"><enum>(rr)</enum><subitem commented="no" display-inline="yes-display-inline" id="H1966D83B73C441C98018CF7B10B5DB8"><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>
</subitem></item><paragraph id="HB7BB8BD679E04342B832DE95CDD92204" indent="up1"><enum>(2)</enum><text>The term <term>tobacco product</term>
does not mean—</text>
<subparagraph id="H175D19D062F34813B16342B9C771C508"><enum>(A)</enum><text>a product in the form of conventional
food (including water and chewing gum), a product represented for use as or for
use in a conventional food, or a product that is intended for ingestion in
capsule, tablet, softgel, or liquid form; or</text>
</subparagraph><subparagraph id="H3F17D9457D2B404C898D32F9B660928B"><enum>(B)</enum><text>an article that is approved or is
regulated as a drug by the Food and Drug Administration.</text>
</subparagraph></paragraph><paragraph id="H40990B3F27E14B2E81817F9819F9FCC7" indent="up1"><enum>(3)</enum><text>The products described in paragraph
(2)(A) shall be subject to chapter IV or chapter V of this Act and the articles
described in paragraph (2)(B) shall be subject to chapter V of this Act.</text>
</paragraph><paragraph id="HE9C8DBC9AC0745D49501B9C4578CDCA9" indent="up1"><enum>(4)</enum><text>A tobacco product may not be marketed
in combination with any other article or product regulated under this Act
(including a drug, biologic, food, cosmetics, medical device, or a dietary
supplement).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HF0C5AC042E1A4A709E75131C367809CF"><enum>(b)</enum><header>FDA Authority
Over Tobacco Products</header><text>The <act-name parsable-cite="FFDCA">Federal
Food, Drug, and Cosmetic Act</act-name> (21 U.S.C. 301 et seq.) is
amended—</text>
<paragraph id="H3FD113F8192240B000C0367402156107"><enum>(1)</enum><text>by redesignating
chapter IX as chapter X;</text>
</paragraph><paragraph id="HC8DE60AB094F4409ADB87E053FAB2900"><enum>(2)</enum><text>by redesignating
sections 901 through 909 as sections 1001 through 1009;</text>
</paragraph><paragraph id="H64623D68DABC426FAFE7F76C00F960BA"><enum>(3)</enum><text>in section 1009
(as so redesignated), by striking <quote>section 908</quote> and inserting
<quote>section 1008</quote>; and</text>
</paragraph><paragraph id="H21EC0049BF714ACB00B0CCDCFD42BFE7"><enum>(4)</enum><text>by inserting after
chapter VIII the following:</text>
<quoted-block id="H3C4D664E1BBD44729E78BFDEA30383CA" style="OLC">
<chapter id="HF2BD3AD60F15450EAC170008EEC2781F"><enum>IX</enum><header>TOBACCO
PRODUCTS</header>
<section id="HEB8B546F72E44F20BAB45B2843F13447"><enum>900.</enum><header>Definitions</header><text display-inline="no-display-inline">In this chapter:</text>
<paragraph id="H2E653DB96CCB47AC96743FA450166257"><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, 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="H71A5F4AC358F475000D34FD2007FDBE2"><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,
or packaging, logo, registered trademark or brand name, identifiable pattern of
colors, or any combination of such attributes.</text>
</paragraph><paragraph id="H932A8666E00C432C98395BCFA8DB20B9"><enum>(3)</enum><header>Cigarette</header><text>The
term <term>cigarette</term> has the meaning given that term by section 3(1) of
the Federal Cigarette Labeling and Advertising Act, but also 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>
</paragraph><paragraph id="HA93E6D04015349F3B7DE8F9130F942C"><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 for cigarettes shall also
apply to cigarette tobacco.</text>
</paragraph><paragraph id="H64190D6D0CE54338A81322991EDEA68B"><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="HEBA1C5A0B792419C00D9BD6FB2EADB3E"><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="H4B28F2C4788F43EB8E3851809D324D9C"><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="HEB7250955BB54201B193B74C30CB1977"><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="HABF1C8148A4E409188863B3376D53700"><enum>(9)</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="H8142AA1C6D654EA582BAAA34FD7FEFCF"><enum>(10)</enum><header>Little
cigar</header><text>The term <term>little cigar</term> has the meaning given
that term by section 3(7) of the Federal Cigarette Labeling and Advertising
Act.</text>
</paragraph><paragraph id="HD70D9720D99046DCA2AC3F00F49CE751"><enum>(11)</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="H2C241E3965664BE588DE2C4B62309EF3"><enum>(12)</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="H03FCE6EFE08E47529BFF7967CB61E494"><enum>(13)</enum><header>Retailer</header><text>The
term <term>retailer</term> means any person 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="HCA30A2FD6F9445C9A200B7D36C6B098E"><enum>(14)</enum><header>Roll-your-own
tobacco</header><text>The term <term>roll-your-own tobacco</term> means any
tobacco 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 id="H3113BC581D724B87BA4235F097C57FA9"><enum>(15)</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="H4AE2FBCD9916486DAEF31B581CE5818C"><enum>(16)</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="H683BEC32AADD4EE4ADE75F35FF989496"><enum>(17)</enum><header>State</header><text>The
term <term>State</term> means any State of the United States and, for purposes
of this chapter, includes 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><paragraph id="H9B1A8D84E7D348278E4346AAB85E855E"><enum>(18)</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="H60F02991236749BA80B9EEB121ADAE2D"><enum>(A)</enum><text>manufactures,
fabricates, assembles, processes, or labels a tobacco product; or</text>
</subparagraph><subparagraph id="H8D19B23AEA98414881D21195E4A60051"><enum>(B)</enum><text>imports a finished
cigarette or smokeless tobacco product for sale or distribution in the United
States.</text>
</subparagraph></paragraph><paragraph id="H4331011D347D482DAF280008F9F9AA81"><enum>(19)</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="HEFCD4AAAA0744A7F806FFC08ABD4ECA"><enum>901.</enum><header>FDA authority
over Tobacco products</header>
<subsection id="HDA5BFD7AB70D4898A400BDEA13BD9857"><enum>(a)</enum><header>In
General</header><text>Tobacco products shall be regulated by the Secretary
under this chapter and shall not be subject to the provisions of chapter V,
unless—</text>
<paragraph id="H2B4C394CDB554715BBED1E57DDA0C0FF"><enum>(1)</enum><text>such products are
intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease (within the meaning of section 201(g)(1)(B) or section 201(h)(2));
or</text>
</paragraph><paragraph id="HE23F4D7DFB9E41578CB842101D1BB7E5"><enum>(2)</enum><text>a claim is made
for such products under section 201(g)(1)(C) or 201(h)(3);</text>
<continuation-text continuation-text-level="paragraph">other than
modified risk tobacco products approved in accordance with section 911.</continuation-text></paragraph></subsection><subsection id="H689B1AE1496D4A3CA1B8A2F5348E9874"><enum>(b)</enum><header>Applicability</header><text>This
chapter shall apply to all tobacco products subject to the regulations referred
to in section 102 of the Family Smoking Prevention and Tobacco Control Act, and
to any other tobacco products that the Secretary by regulation deems to be
subject to this chapter.</text>
</subsection><subsection id="H83A1F064732C4D2EA068CC1235491A3"><enum>(c)</enum><header>Scope</header>
<paragraph id="H4FDD084118F1414493F1AF537D2278BD"><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="H484BF892D81B4238006B0017D2E2EAD7"><enum>(2)</enum><header>Limitation of
authority</header>
<subparagraph id="H8CECA0D0A7AC416CAA21EDF15C855BDE"><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="H5E2ADDC5DD2C4B8A9B7242BF56737BD0"><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.</text>
</subparagraph><subparagraph id="H108203610AB74191B355FF98868B9D4E"><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></section><section id="H3E72738D425D41CC87A8A2000B37C3"><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="H97541BD37A4449EBBD82952C0044CB53"><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="HB701FE1164E447DA81AFFC5E988EB453"><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="H5C9BB17376CB459A9D41AC76D7D7E500"><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="HB8A30D14C9FA47659E6C8FC794611199"><enum>(4)</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="HCD202D97E44E4E77A9F65803C5267F84"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HF21AC58D8B5D41B0B0AC77C78F62AAE1"><enum>(A)</enum><text>it is required by
section 910(a) to have premarket approval and does not have an approved
application in effect; or</text>
</subparagraph><subparagraph id="H64FD917FFD324529BA2DD747B86EAF96" indent="up1"><enum>(B)</enum><text>it is in violation of the order
approving such an application;</text>
</subparagraph></paragraph><paragraph id="H393FDEFF0F654069806EDC003B3481E2"><enum>(6)</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="H648E7920EC8548BE908FA0DCE695E315"><enum>(7)</enum><text>it is in violation
of section 911.</text>
</paragraph></section><section id="HD0DD192B0A7647DEBECAEC62EEB85B7F"><enum>903.</enum><header>Misbranded
Tobacco products</header>
<subsection id="H9D55A5845E114DFFBB2E00C679AE5C04"><enum>(a)</enum><header>In
General</header><text>A tobacco product shall be deemed to be
misbranded—</text>
<paragraph id="H86C122AD670B4E318CE2BE9D5FCDCE2"><enum>(1)</enum><text>if its labeling is
false or misleading in any particular;</text>
</paragraph><paragraph id="H0864F546A1F14897890000A2E0022182"><enum>(2)</enum><text>if in package form
unless it bears a label containing—</text>
<subparagraph id="H1DDF27F330014CDEBDFB98BB42CDAB7"><enum>(A)</enum><text>the name and place
of business of the tobacco product manufacturer, packer, or distributor;</text>
</subparagraph><subparagraph id="H37582CFFC2D44FBEAB263DA9EA1B3890"><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="HDFF27BBAC85348E2B3CE339BB6A1BC3"><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="H55A449C3547945AD9ED4104AF798DC2"><enum>(D)</enum><text>the statement
required under section 921(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="HA34BC0241B5E479690531113B078E72"><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="HD4A117CBB33C49A9A08F79E5B2988678"><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="H59C6F8BF780C403E8EA950E02B4C00A1"><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="H642C54881E7B44D5928C57A7ADCF949F"><enum>(6)</enum><text>if it was
manufactured, prepared, propagated, compounded, or processed in any State 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="H36B0CA3E30D046D6B0A608AF8BAB5694"><enum>(7)</enum><text>if, in the case of
any tobacco product distributed or offered for sale in any State—</text>
<subparagraph id="H44F0A56FB55446A89600F0BA91FD006C"><enum>(A)</enum><text>its advertising is
false or misleading in any particular; or</text>
</subparagraph><subparagraph id="H2C18A3E264064D2D00658802D6BBE12"><enum>(B)</enum><text>it is sold or
distributed in violation of regulations prescribed under section 906(d);</text>
</subparagraph></paragraph><paragraph id="HC559AF2C5C9746199F96009B877C4261"><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="H61C3019E68344A6D9394D633A7FD0773"><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="H551FAE2814B14A21B6B98FDA71F76C6"><enum>(B)</enum><text>a brief statement
of—</text>
<clause id="HC7B0EC77A2A345AC8BD5DC7149D2ABB5"><enum>(i)</enum><text>the uses of the
tobacco product and relevant warnings, precautions, side effects, and
contraindications; and</text>
</clause><clause id="HEE2849D77D1B48DCB74C8B5CB0E7D6BE"><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="HE5B651DB2B014C1FA7D82308CDBD4CB4"><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="H97578458484A404EB761F7138849ED5"><enum>(10)</enum><text>if there was a
failure or refusal—</text>
<subparagraph id="HDFC6EAA3113D4BEA99CB00ADA8C5C073"><enum>(A)</enum><text>to comply with any
requirement prescribed under section 904 or 908; or</text>
</subparagraph><subparagraph id="H2B8E7C954EC843BA8B7070BECD667F9B"><enum>(B)</enum><text>to furnish any
material or information required under section 909.</text>
</subparagraph></paragraph></subsection><subsection id="H3ED8FB7D4EAC4AB69FE9C733B26537AC"><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. 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 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 <act-name parsable-cite="FTCA">Federal Trade
Commission Act</act-name>.</text>
</subsection></section><section id="H0A4DBC198E58405B9395BE7B3195BCBB"><enum>904.</enum><header>Submission of
health information to the Secretary</header>
<subsection id="H030DCFEC0DE8463B83E6D6BBC5727753"><enum>(a)</enum><header>Requirement</header><text>Not
later than 6 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, each tobacco product manufacturer or
importer, or agents thereof, shall submit to the Secretary the following
information:</text>
<paragraph id="HB43C7F8F25284BB2A8E5AC6700480600"><enum>(1)</enum><text>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="H240470D278204867A97BF7F6CC13B1C9"><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(a)(5) of the Federal Cigarette Labeling
and Advertising Act.</text>
</paragraph><paragraph id="H156D83E0D5AF48A8A79C999FB6F4D399"><enum>(3)</enum><text>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 2 years after the date
of enactment of this chapter, the manufacturer, importer, or agent shall comply
with regulations promulgated under section 916 in reporting information under
this paragraph, where applicable.</text>
</paragraph><paragraph id="H2767E2FAA2A74E42ACEA9F00C3DBA4B6"><enum>(4)</enum><text>All documents
developed after the date of enactment of the Family Smoking Prevention and
Tobacco Control Act that relate to health, toxicological, behavioral, or
physiologic effects of current or future tobacco products, their constituents
(including smoke constituents), ingredients, components, and additives.</text>
</paragraph></subsection><subsection id="HAFD545CEA4B445E6A0913FB893F6A7A1"><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="HD1FC088391574A508408323E3D9FDC4F"><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="H04D302005C204AB4A9D5C568FAB17F13"><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="H4A389B5CFDB94AA9B1E4931C902FD57E"><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="H927927811B094A7900EA8F88EADF535"><enum>(c)</enum><header>Time for
Submission</header>
<paragraph id="H680E714BB12B4D519BAE50D3BCD2DE80"><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="H26B9D618328B47F98F992EFD621718D5"><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="HBB743DD67D9B44E2A698FC2EB52337A9"><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="HDC41527357E84B7498BB2F6B8841CD86"><enum>(d)</enum><header>Data
List</header>
<paragraph id="HDC1C16D47BDA4EC7BC00F41843B7E41C"><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="HD7234E1A89864632B461F3A1E323BC7C"><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="HCAC6DE0168194B6EB1AEDA6E95C63E17"><enum>(e)</enum><header>Data
Collection</header><text>Not later than 12 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall
establish 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="HCB1651EDDE314C1DB356285DB17C64F1"><enum>905.</enum><header>Annual
registration</header>
<subsection id="HEEA0CFFD6AA747EBBD908819F1B655E7"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="H548EC60D9F514D4595C06B00F7C5F9AC"><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="H5A479CEC58FA49DD89304BBCE656AAC9"><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="H8108CD419B88453CAD15B2243D6B6117"><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.</text>
</subsection><subsection id="HF2A5B2BD67C141F2AEF7BF741DF8C3A"><enum>(c)</enum><header>Registration of
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="HADFAF469B5DC447088B6B4733EA007D"><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="H1163728A0A094FA9A59CDB736563C35C"><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="HF0A620BC0B90436B80DB40E559CD7519"><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="H6BFC548A99254DD4BDB779821540FFDE"><enum>(g)</enum><header>Biennial
Inspection of Registered Establishments</header><text>Every establishment in
any State registered with the Secretary under this section shall be subject to
inspection under section 704, 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="H528CB12ABFFF439084001F5773D9E821"><enum>(h)</enum><header>Foreign
Establishments Shall Register</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) of this section 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="HF1C38E8EA90C4C57813F3FB40422D4C3"><enum>(i)</enum><header>Registration
Information</header>
<paragraph id="H7C324306A3604899AA767EB08FB2987D"><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 has 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="H9EAA8498B6D14ED9961BEC68DAED1CEA"><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="HCC7CEE5231FB43BDA9E4873D3D382E30"><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="H518531E251234744A5A81C71497953F8"><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="H2CABB8937871408090A8BDD12B4730FD"><enum>(2)</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="H0A078125788945F1BF4CEB67F535FA5"><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="HEE3CBC9BDE1E489B9674EFA900BCBAEE"><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="H22F7A60400E94367A3CF243CCA1BC18"><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="H4A2CF95FB26946BEADC15E8999653DB4"><enum>(D)</enum><text>Any material
change in any information previously submitted under this paragraph or
paragraph (1).</text>
</subparagraph></paragraph></subsection><subsection id="H3B6426027BA84E1FBF10C0B2FE837D00"><enum>(j)</enum><header>Report Preceding
Introduction of Certain Substantially-Equivalent Products Into Interstate
Commerce</header>
<paragraph id="H99E6620BC67344F885BEBA828F7FC43B"><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 June 1, 2003, 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="H80BB0B2199A14F48A2BA02A393E272D"><enum>(A)</enum><text>the basis for such
person’s determination that 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 June 1, 2003, that
is in compliance with the requirements of this Act; and</text>
</subparagraph><subparagraph id="H3A8933D83DA14012B107D7B8D3D2BBC7"><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="HC1F725A7518B4B01949374A0F1694004"><enum>(2)</enum><header>Application to
certain post June 1, 2003 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
June 1, 2003, and prior to the date that is 15 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act shall be
submitted to the Secretary not later than 15 months after such date of
enactment.</text>
</paragraph><paragraph id="H8DE4732D4105464888E1BCF9F67B20B3"><enum>(3)</enum><header>Exemptions</header>
<subparagraph id="H8695EC99D72E47399B61A968F5D51833"><enum>(A)</enum><header>In
general</header><text>The Secretary may by regulation, exempt from the
requirements of this subsection 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="HB6889C64F3AB4DF1A4D920D068F3611F"><enum>(i)</enum><text>such modification
would be a minor modification of a tobacco product authorized for sale under
this Act;</text>
</clause><clause id="HBE6BB0E8AD334E08BD588005E1839BB3"><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="HE2872CA70F0D4DB79F78AB5FEEAC9531"><enum>(iii)</enum><text>an exemption is
otherwise appropriate.</text>
</clause></subparagraph><subparagraph id="H8F7FF341BE724949997FC580ACAB2310"><enum>(B)</enum><header>Regulations</header><text>Not
later than 9 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="H820A849FCFC742D4A9FCC334F1EFB98F"><enum>906.</enum><header>General
provisions respecting control of Tobacco products</header>
<subsection id="H9E59A8FD890345AB9D12C3BF82522731"><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="H5BF7A3B62D6E4F13808CECB9C862C6D3"><enum>(b)</enum><header>Information on
Public Access and Comment</header><text display-inline="yes-display-inline">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="H7B88FC6DB5484D3892B3F44690FC746D"><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="H6F83CBAC713243F289BFE40881F71707"><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="HFBF2142F09DF493A8DF22BFFD444E1F"><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
section 552 of title 5, United States Code, by reason of subsection (b)(4) of
that section shall be considered confidential and shall not be disclosed,
except that the information may be disclosed to other officers or employees
concerned with carrying out this chapter, or when relevant in any proceeding
under this chapter.</text>
</subsection><subsection id="HF63AA5B2EA30473B83A22F92F435E17F"><enum>(d)</enum><header>Restrictions</header>
<paragraph id="HFC5BBC1116FB48B696AA78C2E4F533CC"><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 non-users of the
tobacco product, and taking into account—</text>
<subparagraph id="H25F67EB9FE5A406A8832F433CF998910"><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="H00B0941C9AE64465A460EFD3CB52EADE"><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="HC2728E1C82D64FA2B1C86B1263F9B803"><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="H5F9E2B2F5B1B45DB91808966582913A2"><enum>(3)</enum><header>Limitations</header>
<subparagraph id="H310636388761429FA2E569E3FE87E6F"><enum>(A)</enum><header>In
general</header><text>No restrictions under paragraph (1) may—</text>
<clause id="H0B5A84D8C26F4672913C9512BA7DFBE0"><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="H3C38343464714091B0993D2EFC06FF9C"><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="HCC0A0107DF2E490E8753C93A4981514"><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></subsection><subsection id="H44105626DFAF4F2DBD61D73F68CBB5E3"><enum>(e)</enum><header>Good
Manufacturing Practice Requirements</header>
<paragraph id="HD6B6BCACB30B46F8B739E607006BF487"><enum>(1)</enum><header>Methods,
facilities, and controls to conform</header>
<subparagraph id="HE478AEE88D324E33B6B82E3365C92153"><enum>(A)</enum><header>In
general</header><text>The Secretary may, 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, pre-production 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, as
prescribed in such regulations, to assure that the public health is protected
and that the tobacco product is in compliance with this chapter. Good
manufacturing practices may include 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="H3E928A398AC243E899F266CA3EF7C652"><enum>(B)</enum><header>Requirements</header><text>The
Secretary shall—</text>
<clause id="H79C6D80F1DF949008B4B54A831B14679"><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="H39FC74368F644107B20095F91E409F00"><enum>(ii)</enum><text>before
promulgating any regulation under subparagraph (A), afford opportunity for an
oral hearing;</text>
</clause><clause id="H33B2FE3D86944B39BFE5E56605B19B8F"><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);
and</text>
</clause><clause id="H1073848533D8431CABD3BC8F8EE21B52"><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.</text>
</clause></subparagraph></paragraph><paragraph id="H85A17616C4BD433D009FD28728319C4D"><enum>(2)</enum><header>Exemptions;
variances</header>
<subparagraph id="H23BF8F38AA344F3BADCC54E72579F37B"><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="HE699A0A5FB2748B2AA00E53F45D0CAD7"><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="HFDCD42100DE2449694536C7CCD8468DD"><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="H54317EE968E54303B52800EC18C594FD"><enum>(iii)</enum><text>contain such
other information as the Secretary shall prescribe.</text>
</clause></subparagraph><subparagraph id="H57514DDDFE0C4858AB008F0660CDE820"><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="H95C8B70AB4A74802A6DA33BC3017AD24"><enum>(i)</enum><text>the date the
petition was submitted to the Secretary under subparagraph (A); or</text>
</clause><clause id="H4F8528B193454352957EF832010016D9"><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="HBAEFD2BD787A4CFB96435468BEEC9BF0"><enum>(C)</enum><header>Approval</header><text>The
Secretary may approve—</text>
<clause id="HB7DCE1E8606E4D3D980145BBAE2DA049"><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="HCEBFF5E918F44857B7B99255D91B6D5B"><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, controls, and facilities prescribed by the
requirement are sufficient to assure that the tobacco product will be in
compliance with this chapter.</text>
</clause></subparagraph><subparagraph id="H9C06DC6E4AFD4966B6372DEA7F62CB77"><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="HEE8EC86E78C045BFBB2EAC5E7C5C176E"><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="H42067AF4DD704D78BC74ABA783160FE"><enum>(3)</enum><header>Compliance</header><text>Compliance
with requirements under this subsection shall not be required before the period
ending 3 years after the date of enactment of the Family Smoking Prevention and
Tobacco Control Act.</text>
</paragraph></subsection><subsection id="H97975A5313AD4559BF21582BBE273E74"><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 without regard to
section 3324(a) and (b) of title 31, United States Code, and section 5 of title
41, United States Code.</text>
</subsection></section><section id="H100BD805DA064830A8F56BC12CDDA64"><enum>907.</enum><header>Tobacco product
standards</header>
<subsection id="HA85B5A6FC16E48B39388BA98A1BA9750"><enum>(a)</enum><header>In
General</header>
<paragraph id="H3D690806B5AC4C3C841E123ECF17EEAA"><enum>(1)</enum><header>Special rule for
cigarettes</header><text>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 paragraph.</text>
</paragraph><paragraph id="HA8D8E91F670A4382A9A593A3FEE393D1"><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 (b).</text>
</paragraph><paragraph id="H893AA1DB7F8F47D2AD5FEC67EB36E039"><enum>(3)</enum><header>Tobacco product
standards</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. This
finding shall be determined with respect to the risks and benefits to the
population as a whole, including users and non-users of the tobacco product,
and taking into account—</text>
<subparagraph id="H3A97CD07265D4210AEDAF01E00AFA678"><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="H92987DC5A61744D89246A7CA958B25A"><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="H0B2FE866558C4D88BA7DFE32395CE0DE"><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="H0507CA15197943510045DF39347C6EF7"><enum>(A)</enum><text>shall include
provisions that are appropriate for the protection of the public health,
including provisions, where appropriate—</text>
<clause id="H230F7D7D2FEC47CDABE6A7FBF1EC9B07"><enum>(i)</enum><text>for the reduction
of nicotine yields of the product;</text>
</clause><clause id="HB1F8A9CA0E4E4C72A3008688FF7B18D5"><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="HE4CD5969EA7940B98D77F3BE1FEBA728"><enum>(iii)</enum><text>relating to any
other requirement under subparagraph (B);</text>
</clause></subparagraph><subparagraph id="HE9D583836B51430C8631523890CA4472"><enum>(B)</enum><text>shall, where
appropriate for the protection of the public health, include—</text>
<clause id="HC04A09520B14491EB783005D72BB3FFF"><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="H08352882533848E1AD51CF3313DC875B"><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="H988F4F7C498E42B18459EEB37289E439"><enum>(iii)</enum><text>provisions for
the measurement of the tobacco product characteristics of the tobacco
product;</text>
</clause><clause id="H573BE5F616D14B29A0C92611FB27C71B"><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="H246F5A3E8DF9477000D0A08130C358F8"><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); and</text>
</clause></subparagraph><subparagraph id="H505761DD1CA7444CB678D75BABB74262"><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.</text>
</subparagraph></paragraph><paragraph id="HDF8E0668B9C14AADBBF7773628B3DFD0"><enum>(5)</enum><header>Periodic
re-evaluation 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="H5FAD5BDDCE454BF992695BDAD1009B63"><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="H8946FBB4AE2A4091A316A25BE43B0097"><enum>(A)</enum><text>use personnel,
facilities, and other technical support available in other Federal
agencies;</text>
</subparagraph><subparagraph id="H1DEF7E029E6E4C29AFAD63B93F6CD592"><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="H56B63208C47B42EAA1B7705CF99CA73B"><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 id="HBB52D7E7E1984E52918430AEFFDB42E1"><enum>(b)</enum><header>Establishment of
Standards</header>
<paragraph id="H4FA2E792D5C543DAB92DABE8198626DC"><enum>(1)</enum><header>Notice</header>
<subparagraph id="HFB3676D4CE4D47CBAA874FE6EF604796"><enum>(A)</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>
</subparagraph><subparagraph id="H1365B806A10440C7BA65D4BAFFEB552B"><enum>(B)</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>
<clause id="HB8A730D6253B4AF4BFEDCFF27A8F960"><enum>(i)</enum><text>set
forth a finding with supporting justification that the tobacco product standard
is appropriate for the protection of the public health;</text>
</clause><clause id="H83E2BE223A054678B5F0C404742FB08"><enum>(ii)</enum><text>set forth proposed
findings with respect to the risk of illness or injury that the tobacco product
standard is intended to reduce or eliminate; and</text>
</clause><clause id="H456E439012BF4291A721F65C25444D4C"><enum>(iii)</enum><text>invite
interested persons to submit an existing tobacco product standard for the
tobacco product, including a draft or proposed tobacco product standard, for
consideration by the Secretary.</text>
</clause></subparagraph><subparagraph id="H35EC45C1E2F240AFAB7C4043A9DDF2BE"><enum>(C)</enum><header>Standard</header><text>Upon
a determination by the Secretary that an additive, constituent (including smoke
constituent), or other component of the product that is the subject of the
proposed tobacco product standard is harmful, it shall be the burden of any
party challenging the proposed standard to prove that the proposed standard
will not reduce or eliminate the risk of illness or injury.</text>
</subparagraph><subparagraph id="H1D78E57AC3D4456A9C0000B7FE7C2F8F"><enum>(D)</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>
</subparagraph><subparagraph id="HE224977CF5A0474AA58123619DE1396E"><enum>(E)</enum><header>Consideration by
secretary</header><text>The Secretary shall consider all 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 non-tobacco 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, and shall issue the standard if the Secretary determines that the
standard would be appropriate for the protection of the public health.</text>
</subparagraph><subparagraph id="H5EF3BC32368747FCB857E9314BBFCD52"><enum>(F)</enum><header>Comment</header><text>The
Secretary shall provide for a comment period of not less than 60 days.</text>
</subparagraph></paragraph><paragraph id="HD1851CD2B2ED48F78FD9735BE7B1698D"><enum>(2)</enum><header>Promulgation</header>
<subparagraph id="H98A72023F2C84BE1B5534782E794319E"><enum>(A)</enum><header>In
general</header><text>After the expiration of the period for comment on a
notice of proposed rulemaking published under paragraph (1) respecting a
tobacco product standard and after consideration of such comments and any
report from the Tobacco Products Scientific Advisory Committee, the Secretary
shall—</text>
<clause id="H2FF07BBCE8984BFBB98C29103E649317"><enum>(i)</enum><text>promulgate a
regulation establishing a tobacco product standard and publish in the Federal
Register findings on the matters referred to in paragraph (1); or</text>
</clause><clause id="H4DCA62DBCCAF43A1ABC5D61CF6DF8EE"><enum>(ii)</enum><text>publish a notice
terminating the proceeding for the development of the standard together with
the reasons for such termination.</text>
</clause></subparagraph><subparagraph id="HE6FCF0C9C1CD486FB72B7802D369C3C4"><enum>(B)</enum><header>Effective
date</header><text>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.</text>
</subparagraph></paragraph><paragraph id="HC3390DCEB99747F083E42FDB5E292CC"><enum>(3)</enum><header>Power reserved to
congress</header><text>Because of the importance of a decision of the Secretary
to issue a regulation establishing a tobacco product standard—</text>
<subparagraph id="H67D57DB95AB0421E949B58A625E7AA64"><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="HEF1AC02F6E7D412FAD1000BC9877AA10"><enum>(B)</enum><text>requiring the
reduction of nicotine yields of a tobacco product to zero,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">Congress
expressly reserves to itself such power.</continuation-text></paragraph><paragraph id="HCC969E8A71E3434E00E4750353A2D900"><enum>(4)</enum><header>Amendment;
revocation</header>
<subparagraph id="H572488B933AE43FB8101FCAE025C35C"><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 paragraphs (1) and (2)(B), amend or revoke a tobacco product
standard.</text>
</subparagraph><subparagraph id="HBCF8A9F1C4794629BC81E8EC957D1A3"><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 commented="no" id="H7255B3DA0D9B4931A1285469B5E6747E"><enum>(5)</enum><header>Reference to
advisory committee</header>
<subparagraph id="H61554D80798F4D8AAB663028EC54EA7"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">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 commented="no" id="HCEB300FEF52F4C87927DE12542EE6673"><enum>(B)</enum><header>Initiation of
referral</header><text>The Secretary may make a referral under this
paragraph—</text>
<clause id="H5547DF03214542F19F00E0004EE0C5F7"><enum>(i)</enum><text>on
the Secretary’s own initiative; or</text>
</clause><clause commented="no" id="H0D0E8B281C1541D4A03100CB990078EE"><enum>(ii)</enum><text display-inline="yes-display-inline">upon the request of an interested person
that—</text>
<subclause id="H18029AEA5E1A4299ABB0009903A3904B"><enum>(I)</enum><text>demonstrates good
cause for the referral; and</text>
</subclause><subclause id="HDF26C9DDB59F4557A7F30014B7F14000"><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="H3F5B762E094C4FFFA141CE995BDA751"><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="HDBFE7E4156274DBF8614A2680039A1E6"><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="H415D113A64C54C4093148399425CFDD6"><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></section><section id="HCAACC7B1E1674E7FBDE5472B74E4FE94"><enum>908.</enum><header>Notification
and other remedies</header>
<subsection id="H3E4A72705D7446A798A9EC013840DB7D"><enum>(a)</enum><header>Notification</header><text>If
the Secretary determines that—</text>
<paragraph id="HB479BA113C9445D39E68ED5BF8DA61A9"><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="H335570ACFCB04BECBCFE26F00F3202E"><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="H91AFB0DDB6B9466E95741E9ED7982D93"><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="H2F719A02623C4DE9BB4F00999075815E"><enum>(c)</enum><header>Recall
Authority</header>
<paragraph id="H77BA89A9E97C44E989129EDC6C0000CC"><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="H31F68775391247E4A22F26CF82C66CCB"><enum>(2)</enum><header>Amendment of
order to require recall</header>
<subparagraph id="H3D5AC770AC51471493418657F6BC8314"><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="HFF44AD2876C046549DD48B1C30A06300"><enum>(B)</enum><header>Notice</header><text>An
amended order under subparagraph (A)—</text>
<clause id="HC5827681DAB64ABF90AB1DA48F99C64D"><enum>(i)</enum><text>shall not include
recall of a tobacco product from individuals; and</text>
</clause><clause id="HB90794CF5EE045D1B5FAE0AE00A7E301"><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="H57FD7E2E2DCA410EA6DE90FC5C371026"><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) of this section.</text>
</paragraph></subsection></section><section id="H6BDC6D00435D433FB47B79AB83724DB"><enum>909.</enum><header>Records and
reports on Tobacco products</header>
<subsection id="H3C93267D6DDB4976A74943DC99F15503"><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="HB351E1F2050D47ED90D329FD47B02937"><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="H9E3E180D77AD4BC798745D7E5F21FDC4"><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="HE85ED76A93694063ACFDEC4E72E1D64B"><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="H2259F0B035BB4ED0B056C4EC9FAAFA2E"><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="H64FAEFE3E4544E1FB5F7090070EAF11B"><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="HDE9343BA67F74600B07624A1ACDFF8E"><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="HCF996AE840414AC9BD7464E16CC30035"><enum>(b)</enum><header>Reports of
Removals and Corrections</header>
<paragraph id="H6CFB93D0B1E24812AFFF52E0F1B5F426"><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="H3D61F6EDA87F49E5AD8FC70017680037"><enum>(A)</enum><text>to reduce a risk
to health posed by the tobacco product; or</text>
</subparagraph><subparagraph id="HD47DDFC9C39C4178A31103C35D4FAE1F"><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="HD3F8586676B5441CADD92B7E60FD30AE"><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="HFEDA7B20FBC04B8295115C5EB92D24FA"><enum>910.</enum><header>Application for
review of certain Tobacco products</header>
<subsection id="H10AF7D6B5B1D4FEB82B05C87BD279045"><enum>(a)</enum><header>In
General</header>
<paragraph id="HB67D79BB9A2745489143B953FFF66E33"><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="H9324493BD1614B28B0723E328729FF8E"><enum>(A)</enum><text>any tobacco
product (including those products in test markets) that was not commercially
marketed in the United States as of June 1, 2003; or</text>
</subparagraph><subparagraph id="HAE6B2A9DFB1948EA9538D1A0E9BF0477"><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 June 1,
2003.</text>
</subparagraph></paragraph><paragraph id="H28207F1C6C9845148368B8F9D434B44"><enum>(2)</enum><header>Premarket
approval required</header>
<subparagraph id="H85570DF05A7F407DA4214E48C04C89D1"><enum>(A)</enum><header>New
products</header><text>Approval under this section of an application for
premarket approval for any new tobacco product is required unless—</text>
<clause id="HCF3C2D46D4F94C5200F36CBFF0E281CB"><enum>(i)</enum><text>the manufacturer
has submitted a report under section 905(j); and</text>
</clause><clause id="H3ECC1E472E054129A1C18F75CFDB2E02"><enum>(ii)</enum><text>the Secretary has
issued an order that the tobacco product—</text>
<subclause id="HFE38BBA02F3A4079AA475600B29DC150"><enum>(I)</enum><text>is substantially
equivalent to a tobacco product commercially marketed (other than for test
marketing) in the United States as of June 1, 2003; and</text>
</subclause><subclause id="H6A8B42A8CA4E4D57AE1C8ED19FE8803C"><enum>(II)</enum><item commented="no" display-inline="yes-display-inline" id="H5A6D6EE4D4D74049A4F41BEAAB4F3DDB"><enum>(aa)</enum><text>is in compliance with
the requirements of this Act; or</text>
</item><item id="H7327F6E9BA57477F893C19B0009BCDEB" indent="up1"><enum>(bb)</enum><text>is exempt from the requirements of
section 905(j) pursuant to a regulation issued under section 905(j)(3).</text>
</item></subclause></clause></subparagraph><subparagraph commented="no" id="HC26F7DB357774B46BFBD00C9E068F7A4"><enum>(B)</enum><header>Application to
certain post June 1, 2003 products</header><text>Subparagraph (A) shall not
apply to a tobacco product—</text>
<clause commented="no" display-inline="no-display-inline" id="H6B998572124D459F00A0DC16DB5586A4"><enum>(i)</enum><text>that was first
introduced or delivered for introduction into interstate commerce for
commercial distribution in the United States after June 1, 2003, and prior to
the date that is 15 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act; and</text>
</clause><clause commented="no" id="HBD5A5C1577CE4556A1C26997779ED426"><enum>(ii)</enum><text>for which a
report was submitted under section 905(j) within such 15-month period,</text>
</clause><continuation-text commented="no" 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="H3B351AD77F884171935C98F81EDC00A3"><enum>(3)</enum><header>Substantially
equivalent defined</header>
<subparagraph id="H05CC13ED0C8B4D74A3B4028B974D9ED2"><enum>(A)</enum><header>In
general</header><text>In this section and section 905(j), the terms
<term>substantially equivalent</term> or <term>substantial equivalence</term>
mean, 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="H83BA60805D50468494F77F88265D8100"><enum>(i)</enum><text>has the same
characteristics as the predicate tobacco product; or</text>
</clause><clause id="H679B7C15EF304EC18482128F47475964"><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="H46575D3003934B39A5105C4B1F341D75"><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="H1FE82CC8055D4AE3A0BE75E3A671944E"><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="H3BBFC733EC9C464AB517181FE6BF3909"><enum>(4)</enum><header>Health
information</header>
<subparagraph id="HB5331BCBE59E4772BF25FDB8FEF60200"><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="HEA707A22B3B0446BADAD557185EB0088"><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="H8862152365D74B85A827E8C93C819347"><enum>(b)</enum><header>Application</header>
<paragraph id="HF30F5711A9F84B81BE57139680BB89D9"><enum>(1)</enum><header>Contents</header><text>An
application for premarket approval shall contain—</text>
<subparagraph id="HFEA9F92CB5F948E19100099BB4304106"><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="H2326565AFAAE4C11A5E751267B6D7578"><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="H02DBBFE14013465BA56BB1F817342E74"><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="HE973BC1F1C9740E794323F1572B7B955"><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="HCD8AB51ADF5B44DB9380C7832FC7F05"><enum>(E)</enum><text>such samples of
such tobacco product and of components thereof as the Secretary may reasonably
require;</text>
</subparagraph><subparagraph id="HDECD0D0F87874B93A248E6C1208C8CA3"><enum>(F)</enum><text>specimens of the
labeling proposed to be used for such tobacco product; and</text>
</subparagraph><subparagraph id="H0F6226C4941F4D3A94B169676F9C84DD"><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="H3797C49CC27C48B78EECC151555B39ED"><enum>(2)</enum><header>Reference 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="HBF517C8BE3E24A8492895F2FAD160065"><enum>(A)</enum><text>may, on the
Secretary’s own initiative; or</text>
</subparagraph><subparagraph id="H4715850439434B8C8200BE6E1CC6F484"><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 approval of the application, together with
all underlying data and the reasons or basis for the recommendation.</continuation-text></paragraph></subsection><subsection id="H402004E706E841638ED0009C69272047"><enum>(c)</enum><header>Action on
Application</header>
<paragraph id="H306C58E369E64B1A8ED2006B6D108C4E"><enum>(1)</enum><header>Deadline</header>
<subparagraph id="H52DBD4815E75445783249125139B3B13"><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 paragraph (2)
of such subsection, shall—</text>
<clause id="HB3B1EF0B05F3486E844E5740ADE3D6B"><enum>(i)</enum><text>issue an order
approving the application if the Secretary finds that none of the grounds for
denying approval specified in paragraph (2) of this subsection applies;
or</text>
</clause><clause id="H609B0053DAD741C580D85CDEABDC87FF"><enum>(ii)</enum><text>deny approval of
the application 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="HDA0A91C668A2455EA1F65058516D147E"><enum>(B)</enum><header>Restrictions on
sale and distribution</header><text>An order approving an application for a
tobacco product may require as a condition to such approval 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="HCEDB31EEC8994BDB861E200303E5049F"><enum>(2)</enum><header>Denial of
approval</header><text>The Secretary shall deny approval of an application for
a tobacco product 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="HA6AF231FA09D46D5B048EE943036D41F"><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="H6D9DD8198B804ADD8C8528F415BEC295"><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="HD3099A492DB043F8A71F0457DABFC7D5"><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="H81D6A7AA5EBE4A73AB50D01E3E7717D5"><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, compliance with which is a condition to approval
of the application, and there is a lack of adequate information to justify the
deviation from such standard.</text>
</subparagraph></paragraph><paragraph id="H4049507B6F1C45CABC3B48C61E842F45"><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 place such application in approvable
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="H10CACAB1A2BE4624A9A4BE1065DC0084"><enum>(4)</enum><header>Basis for
finding</header><text>For purposes of this section, the finding as to whether
approval of a tobacco product 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="HEA1BB35BB63F4F98AC54EA441EC165B0"><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="H4D29B3A1FD224CBB8CA86092F3F9F1FC"><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="H2AE9A3E337AE4EE38E09A0A96859EC09"><enum>(5)</enum><header>Basis for
action</header>
<subparagraph id="H78CA67FAFE424339B7EE8361EA400CD"><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="H8FB2C09F34634B4E8DB1638900694E65"><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="H4E17A2A591BD4206B6D08EF421A890F2"><enum>(d)</enum><header>Withdrawal and
Temporary Suspension</header>
<paragraph id="H90717978C7414CF78072BBEC9E99086B"><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 to the
holder of an approved application for a tobacco product, issue an order
withdrawing approval of the application if the Secretary finds—</text>
<subparagraph id="H84CA0AD115F846C9B6DA126C3800D776"><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="HF723FD2D34E846BD9FB11711A9351753"><enum>(B)</enum><text>that the
application contained or was accompanied by an untrue statement of a material
fact;</text>
</subparagraph><subparagraph id="H9B85B3D66A7C4968850259E1B3BFCCC"><enum>(C)</enum><text>that the
applicant—</text>
<clause id="HEDBB2AEB1FA5438ABEE264006497BDB7"><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="H30F1300AA46746A4A01E6C3878DA07D4"><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="H297FB3F12C10495793C228A1606E22D2"><enum>(iii)</enum><text>has not complied
with the requirements of section 905;</text>
</clause></subparagraph><subparagraph id="H513B6A75DF934CFDABAF8DB9D003096"><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 approved, 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="HE915620C72E64540B08DE7FFE5983558"><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 approved, 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="HF8CB7DB340864BF086A7CDCA8E0702BB"><enum>(F)</enum><text>on the basis of
new information before the Secretary, evaluated together with the evidence
before the Secretary when the application was approved, 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
approval of the application, and that there is a lack of adequate information
to justify the deviation from such standard.</text>
</subparagraph></paragraph><paragraph id="HA49F2724D78B4148BD85EAE1BCC0F6AF"><enum>(2)</enum><header>Appeal</header><text>The
holder of an application subject to an order issued under paragraph (1)
withdrawing approval of the application 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="HC6BBB6CC35E64E678511506697965051"><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 approved application
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 approval of the application approved under this
section. If the Secretary issues such an order, the Secretary shall proceed
expeditiously under paragraph (1) to withdraw such application.</text>
</paragraph></subsection><subsection id="H5CC6C8BCED054DAEABE97283ECF2ADB"><enum>(e)</enum><header>Service of
Order</header><text>An order issued by the Secretary under this section shall
be served—</text>
<paragraph id="H8FAB73FBCD7E4DFDA1C9AF026EED86CF"><enum>(1)</enum><text>in person by any
officer or employee of the department designated by the Secretary; or</text>
</paragraph><paragraph id="H6F2B6DF485034F64BC292343AB7A782"><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="HC66AF156658F4C649B97AE7BD1C13DF"><enum>(f)</enum><header>Records</header>
<paragraph id="HEA1C4F1172A44A77B9003D00F9D411A9"><enum>(1)</enum><header>Additional
information</header><text>In the case of any tobacco product for which an
approval of 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 approval.</text>
</paragraph><paragraph id="H25B15266B3F144E49C5F59346F1F3623"><enum>(2)</enum><header>Access to
records</header><text>Each person required under this section to maintain
records, and each person in charge or 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="H22B9B27077C44DFBA03D01165BD13E2C"><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="H95AB90233C1D419BB46815AA17856D"><enum>911.</enum><header>Modified risk
Tobacco products</header>
<subsection id="H17CAD519029B43FE98CB84E80059F527"><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 approval of an
application filed pursuant to subsection (d) is effective with respect to such
product.</text>
</subsection><subsection id="HA707412B2EA143C8BD76E6158C438F97"><enum>(b)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="H044D4901E57A4A7583C44523E03BEB"><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="HACC80D3545FC4486BCB8175640A7F533"><enum>(2)</enum><header>Sold or
distributed</header>
<subparagraph id="HBBF156C9421145B300BE1E09F8017D9B"><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="H68C335D1698644EFAEBE771E76FE8429"><enum>(i)</enum><text>the label,
labeling, or advertising of which represents explicitly or implicitly
that—</text>
<subclause id="H8CF260616F7941CEADDDECFEE6B2ABB4"><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="HE43A1D96EDC9406B841FDDE04DAFC7A6"><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="HAB4C9A101CC644C5887DF8F577BE9A1"><enum>(III)</enum><text>the tobacco
product or its smoke does not contain or is free of a substance;</text>
</subclause></clause><clause id="HE697FDC800CA41D1B0BBAF4FB838B4"><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="HEED30E2419F74CE4974FEEBD9CEBCFF9"><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="H0F4FD990FFC949BCB33DA13FDF7D6E"><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></paragraph></subsection><subsection id="HC70F0A545BA24531987EA7F414C36148"><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 and is subject to the requirements of
chapter V.</text>
</subsection><subsection id="H1AC586D1DD434F46BB4B50169057E052"><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="H29CD1B76E5534CBAA756FBBF860917A0"><enum>(1)</enum><text>a description of
the proposed product and any proposed advertising and labeling;</text>
</paragraph><paragraph id="H9C3387CF576241A8A7EE70E5DEEE3D7F"><enum>(2)</enum><text>the conditions for
using the product;</text>
</paragraph><paragraph id="HCEB087A6C7A04743B8094D8EC3D77D75"><enum>(3)</enum><text>the formulation of
the product;</text>
</paragraph><paragraph id="HD2B7F8E44E234F5D9125F1CB2C29CE24"><enum>(4)</enum><text>sample product
labels and labeling;</text>
</paragraph><paragraph id="HD0CE35CDCD7842C59620124B55739332"><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="H3000A1E651954175A053033C3545356E"><enum>(6)</enum><text>data and
information on how consumers actually use the tobacco product; and</text>
</paragraph><paragraph id="H087DCE27DB8F44BF929E2B9D067531F0"><enum>(7)</enum><text>such other
information as the Secretary may require.</text>
</paragraph></subsection><subsection id="H8ED77913D5FB4765B08E05DF458666E"><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="H808E3DCE251D4B358191DCCD5F0AB00"><enum>(f)</enum><header>Advisory
Committee</header>
<paragraph id="HAFB4AA4F63E144D99B9937F78C9EDFF9"><enum>(1)</enum><header>In
general</header><text>The Secretary shall refer to the Tobacco Products
Scientific Advisory Committee any application submitted under this
subsection.</text>
</paragraph><paragraph id="HF525792D510A498CA06B744010E82EE2"><enum>(2)</enum><header>Recommendations</header><text display-inline="yes-display-inline">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="H463DD2C88E7E4325A18019A5AE743010"><enum>(g)</enum><header>Approval</header>
<paragraph id="H7A07782AC1C24452BC8D6E216ECDBAD9"><enum>(1)</enum><header>Modified risk
products</header><text>Except as provided in paragraph (2), the Secretary shall
approve an application for a modified risk tobacco product filed under this
section only if the Secretary determines that the applicant has demonstrated
that such product, as it is actually used by consumers, will—</text>
<subparagraph id="HD6F7AB9065714078ACE5CBE4FA919CE7"><enum>(A)</enum><text>significantly
reduce harm and the risk of tobacco-related disease to individual tobacco
users; and</text>
</subparagraph><subparagraph id="HDC4257714CF24A0897C630E9701B9620"><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="H06B93F529C5C49CD98D456B333E7DBB3"><enum>(2)</enum><header>Special rule for
certain products</header>
<subparagraph id="H961FF67D45DA47659695F303684ED85C"><enum>(A)</enum><header>In
general</header><text>The Secretary may approve an application for a tobacco
product that has not been approved as a modified risk tobacco product pursuant
to paragraph (1) if the Secretary makes the findings required under this
paragraph and determines that the applicant has demonstrated that—</text>
<clause id="HA44C10AD30ED468DA98CDD8774294C03"><enum>(i)</enum><text>the approval of
the application would be appropriate to promote the public health;</text>
</clause><clause id="HCFA956DCE5824AEC94EA5CF2D623EA8D"><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)(2) is
limited to an explicit or implicit representation that such tobacco product or
its smoke contains or is free of a substance or contains a reduced level of a
substance, or presents a reduced exposure to a substance in tobacco
smoke;</text>
</clause><clause id="HCC6111055F1847C7AA62FDF6F05FA15"><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="H4FD28C3F57AD43B9BCBC9813CB788400"><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 anticipated in subsequent
studies.</text>
</clause></subparagraph><subparagraph id="HEA94F6B9A0F84AA2997000BDE2807217"><enum>(B)</enum><header>Additional
findings required</header><text>In order to approve an application under
subparagraph (A) the Secretary must also find that the applicant has
demonstrated that—</text>
<clause id="H6736F8D19E634ED3973C34874F2F9400"><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="H6DD444756F6F43279F98BDF620820005"><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 anticipated 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="H38F9DD3894A84B10B7FA284900C6EC3C"><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="HE1DBB1CD500D454F97949CE222F448D3"><enum>(I)</enum><text>is or has been
demonstrated to be less harmful; or</text>
</subclause><subclause id="HA52CD484737B487586A402C6F99DADB"><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="H4B66C136B1DC4B58AD37A2A28DADB1F"><enum>(iv)</enum><text>approval of 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="H637ED5E3979E45B4BB2400BA6CAA5E36"><enum>(C)</enum><header>Conditions of
approval</header>
<clause id="HE15F0248A1CD47629D6FCE2B8032B594"><enum>(i)</enum><header>In
general</header><text>Applications approved 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="HD5DB4DA87C6F4F10B169C52D798BDD3B"><enum>(ii)</enum><header>Agreements by
applicant</header><text>Applications approved under this paragraph shall be
conditioned on the applicant’s agreement to conduct post-market surveillance
and studies and to submit to the Secretary the results of such surveillance and
studies to determine the impact of the application approval on consumer
perception, behavior, and health and to enable the Secretary to review the
accuracy of the determinations upon which the approval was based in accordance
with a protocol approved by the Secretary.</text>
</clause><clause id="H8E6AD263D35F4ABFA9C6C846DFAF36AD"><enum>(iii)</enum><header>Annual
submission</header><text>The results of such post-market surveillance and
studies described in clause (ii) shall be submitted annually.</text>
</clause></subparagraph></paragraph><paragraph id="H81BA5D004F774DE491D0B57002EFF32"><enum>(3)</enum><header>Basis</header><text>The
determinations under paragraphs (1) and (2) shall be based on—</text>
<subparagraph id="HE9EF5C5381F4491A8CA52A6B5001C3F"><enum>(A)</enum><text>the scientific
evidence submitted by the applicant; and</text>
</subparagraph><subparagraph id="HB0AEC838BADA43A3B558865BB6007D82"><enum>(B)</enum><text>scientific
evidence and other information that is available to the Secretary.</text>
</subparagraph></paragraph><paragraph id="H80CBF7A94F034536ABDB5EA586E05B22"><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="H98A634F709F049BC9189F7AD15CC00D1"><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="HA45D3FBACA3440CD9DCF009FC35AE00"><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="HEBFCF82E0B2D401C899F58E727DD8AB"><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="H68A29B5C5132488EAFA5209200C41F9F"><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="HFEAAF2CB5A564F890080DE3D2D27C565"><enum>(E)</enum><text>comments, data,
and information submitted by interested persons.</text>
</subparagraph></paragraph></subsection><subsection id="HBBE8DD87041F499AAC1B26C855C9CB"><enum>(h)</enum><header>Additional
Conditions for Approval</header>
<paragraph id="HEE36223D41594A11ADE01F36194EBADE"><enum>(1)</enum><header>Modified risk
products</header><text>The Secretary shall require for the approval of an
application 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="H769FAE0FB4B34A2AA66EE6FDBF4D4905"><enum>(2)</enum><header>Comparative
claims</header>
<subparagraph id="H86DA7C8503BB42F3B9D76D5B3111E66D"><enum>(A)</enum><header>In
general</header><text>The Secretary may require for the approval of an
application 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="H92069B94E2C24A6194F0C5B4C4643D8"><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="HBFAB7731CE234A46B6E9906D2CF5851D"><enum>(3)</enum><header>Label
disclosure</header>
<subparagraph id="HB9ECDA2AB3294DC7AEBE00578EA14FCC"><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="HF8E707C8DC0542828772395C78905D11"><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="H066776CAF8D74D2000AFE73B63B0ED68"><enum>(4)</enum><header>Time</header><text>The
Secretary shall limit an approval under subsection (g)(1) for a specified
period of time.</text>
</paragraph><paragraph id="HC86CC67365F142CA932105DA582105C"><enum>(5)</enum><header>Advertising</header><text>The
Secretary may require that an applicant, whose application has been approved
under this subsection, comply with requirements relating to advertising and
promotion of the tobacco product.</text>
</paragraph></subsection><subsection id="H8A3A97EA06BF46B186125D1150D096AB"><enum>(i)</enum><header>Postmarket
Surveillance and Studies</header>
<paragraph id="H1ADE794275384D199D3E90FAA4408DE6"><enum>(1)</enum><header>In
general</header><text>The Secretary shall require that an applicant under
subsection (g)(1) conduct post market surveillance and studies for a tobacco
product for which an application has been approved to determine the impact of
the application approval on consumer perception, behavior, and health, to
enable the Secretary to review the accuracy of the determinations upon which
the approval 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 post-market surveillance and studies shall
be submitted to the Secretary on an annual basis.</text>
</paragraph><paragraph id="HE20D1951B07E4652AD5EBE196C318056"><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="H5C809005E4E743809ECDB79E909015E0"><enum>(j)</enum><header>Withdrawal of
Approval</header><text>The Secretary, after an opportunity for an informal
hearing, shall withdraw the approval of an application under this section if
the Secretary determines that—</text>
<paragraph id="HFEFACB679E3D44418B0666CCDD89CB7D"><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="HE6394FA13DE041AF833E53309DDEE8F"><enum>(2)</enum><text>the application
failed to include material information or included any untrue statement of
material fact;</text>
</paragraph><paragraph id="H48025B0E70AE405889452DDF5200E410"><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="HA7FE3069DF864D829F927976156E523C"><enum>(A)</enum><text>a tobacco product
standard is established pursuant to section 907;</text>
</subparagraph><subparagraph id="H4DCE2A0CFF63402A82FB6C2D6ED68DF9"><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="HE93ED887CAC24696BC2FAA9688FEC2FD"><enum>(C)</enum><text>any postmarket
surveillance or studies reveal that the approval of the application is no
longer consistent with the protection of the public health;</text>
</subparagraph></paragraph><paragraph id="H721D378795C14CB0A34FE401C61C10E2"><enum>(4)</enum><text>the applicant
failed to conduct or submit the postmarket surveillance and studies required
under subsection (g)(2)(C)(ii) or (i); or</text>
</paragraph><paragraph id="HF5BCC980FBDD4965A938C2383CBE6B9C"><enum>(5)</enum><text>the applicant
failed to meet a condition imposed under subsection (h).</text>
</paragraph></subsection><subsection id="H55090C2114CF40F3ABDCF5E70FABCB4"><enum>(k)</enum><header>Chapter IV or
V</header><text>A product approved in accordance with this section shall not be
subject to chapter IV or V.</text>
</subsection><subsection id="HD4586027E91E4231820955E0FBF19134"><enum>(l)</enum><header>Implementing
Regulations or Guidance</header>
<paragraph id="HB04CEDA48052481182CBDA891D00463E"><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="HF5ABDAA250E74DD296BF2477E5874D4"><enum>(A)</enum><text>establish minimum
standards for scientific studies needed prior to approval to show that a
substantial reduction in morbidity or mortality among individual tobacco users
is likely;</text>
</subparagraph><subparagraph id="H1E74561815194E95B3DC29FCE700C8E"><enum>(B)</enum><text>include validated
biomarkers, intermediate clinical endpoints, and other feasible outcome
measures, as appropriate;</text>
</subparagraph><subparagraph id="H944B17E37A744BE18C334ECCA67EC8C7"><enum>(C)</enum><text>establish minimum
standards for post market 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="H8352BD5651A24E9DA40089044D379351"><enum>(D)</enum><text>establish minimum
standards for required postmarket surveillance, including ongoing assessments
of consumer perception; and</text>
</subparagraph><subparagraph id="H826EB6D1A95A4C8FA2A14DF0FA38D36F"><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.</text>
</subparagraph></paragraph><paragraph id="H7587A31767454A36AD01ACCF08ABCE7"><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="H446C2F3275364FCE821E2EF71D1EC221"><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="H4B927129CBEA48EEB9003E7ED1FBC85"><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 for
which the applicant seeks approval as a modified risk tobacco product under
this section.</text>
</paragraph></subsection><subsection id="HB2591DC7E03A439AAAA7E4A93B983967"><enum>(m)</enum><header>Distributors</header><text>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="HC6B8EB100B004021943183D647811CBB"><enum>912.</enum><header>Judicial
review</header>
<subsection id="H7EE03A6405E548DE8CBFD47F49E718A3"><enum>(a)</enum><header>Right To
Review</header>
<paragraph id="HDD4E6DAC74E84E499674E235A2445ED7"><enum>(1)</enum><header>In
general</header><text>Not later than 30 days after—</text>
<subparagraph id="H52694F6A19204467A2037BBE3522C846"><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="HC69D53C58B5A43E68D9667B4DF7CDB85"><enum>(B)</enum><text>a denial of an
application for approval 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="HDA1506E245F349FBB5009319BF80ADB2"><enum>(2)</enum><header>Requirements</header>
<subparagraph id="HA317FECCAAB84AC09DA7F3B305052B6F"><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="H472E077966444907BEB1C2A60407E1B"><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="H428AAB696E264D81BCCEFB00263E105D"><enum>(i)</enum><text>the record of the
proceedings on which the regulation or order was based; and</text>
</clause><clause id="HCA2443CCDEBC49B1B0A5575B28A85500"><enum>(ii)</enum><text>a
statement of the reasons for the issuance of such a regulation or order.</text>
</clause></subparagraph><subparagraph id="H9E561E871D14494CA4244E306FF65EE"><enum>(C)</enum><header>Definition of
record</header><text>In this section, the term <term>record</term>
means—</text>
<clause id="HB573F43120A544A500E5C0DE9339DCF8"><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="HC3CF7A14214049E9A1AAD9DE32CA8757"><enum>(ii)</enum><text>all information
submitted to the Secretary with respect to such regulation or order;</text>
</clause><clause id="H2D2A87BC16434DC39169D09C5C08C8DA"><enum>(iii)</enum><text>proceedings of
any panel or advisory committee with respect to such regulation or
order;</text>
</clause><clause id="H5792279ECBD0426BAC00A7A62F938265"><enum>(iv)</enum><text>any hearing held
with respect to such regulation or order; and</text>
</clause><clause id="H1BDE2F3286E14CB29BA5B5767F7100A4"><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="HDECEAF1B304342EDB67BA5E315F95314"><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 chapter 7 of title 5, United
States Code, and to grant appropriate relief, including interim relief, as
provided for in such chapter. A regulation or denial described in subsection
(a) shall be reviewed in accordance with section 706(2)(A) of title 5, United
States Code.</text>
</subsection><subsection id="HFB1153C0F9FF473A8D9CF32100A6F400"><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 section 1254 of title 28, United States Code.</text>
</subsection><subsection id="HD05F5BC6F58D4D19962333A551A6D698"><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="HF56CCDC2AED54D70A934C48F49007B32"><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="H8B5940A4D1D84617AC3F9DEE34910030"><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="HA1F66A196F714F42ADEE2F3094646746"><enum>914.</enum><header>Jurisdiction of
and coordination with the Federal Trade Commission</header>
<subsection id="H8D61290BEDC8403AB7DAC379420042B6"><enum>(a)</enum><header>Jurisdiction</header>
<paragraph id="H5DF2701D62A24E6CAD1792302E85733F"><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="H99F32B542DE945459E16564529AF3214"><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
<act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> and
shall be considered a violation of a rule promulgated under section 18 of that
Act.</text>
</paragraph></subsection><subsection id="H001348B86BA14983BF89B0019861C094"><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="H160D63275516428EAD8E58DCCC34CE05"><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="H6AA092665D54419DB1E61EE18229B53"><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="HF64F7CC4F27148DD91250629012BD069"><enum>915.</enum><header>Congressional
review provisions</header><text display-inline="no-display-inline">In
accordance with section 801 of title 5, United States Code, Congress shall
review, and may disapprove, any rule under this chapter that is subject to
section 801. This section and section 801 do not apply to the final rule
referred to in paragraphs (1) and (2) of section 102(a) of the Family Smoking
Prevention and Tobacco Control Act.</text>
</section><section id="H72496DC951704340A2016090012999DD"><enum>916.</enum><header>Regulation
requirement</header>
<subsection id="H4BAD3B51D7B14AAA858F14002E86F6B"><enum>(a)</enum><header>Testing,
Reporting, and Disclosure</header><text>Not later than 24 months after the date
of enactment of the Family Smoking Prevention and Tobacco Control Act, the
Secretary, acting through the Commissioner of Food and Drugs, shall promulgate
regulations under this Act that meet the requirements of subsection (b).</text>
</subsection><subsection id="H582BA1DCDB934C6A95F7EA67EE00C6E8"><enum>(b)</enum><header>Contents of
Rules</header><text>The regulations promulgated under subsection (a) shall
require testing and reporting of tobacco product constituents, ingredients, and
additives, including smoke constituents, by brand and sub-brand that the
Secretary determines should be tested to protect the public health. The
regulations 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>
</subsection><subsection id="H9385133EF3624A88A2E58694E9C17F93"><enum>(c)</enum><header>Authority</header><text>The
Food and Drug Administration 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></section><section id="HEF984719543B4ABBB434B2569578624D"><enum>917.</enum><header>Preservation of
State and local authority</header>
<subsection commented="no" id="HA09C8E72E89E4323AE7BEA48D782E122"><enum>(a)</enum><header>In
General</header>
<paragraph commented="no" id="H446CEF500F3745129EA4B54EA5F055B5"><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 commented="no" id="H03F1E7A8F93744D49DF1AF9C7B4FBFEB"><enum>(2)</enum><header>Preemption of
certain state and local requirements</header>
<subparagraph commented="no" id="HC7535AB9696D43908CC723E09E422067"><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
approval, adulteration, misbranding, labeling, registration, good manufacturing
standards, or modified risk tobacco products.</text>
</subparagraph><subparagraph commented="no" id="HF76ABB1D5E2B40CB89E1CA3BF1BA1F01"><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 section 552(b)(4) 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="HC8F542C46CBA4B2F8B9765618CFF33DD"><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="HC24110391B8A4C4B8C4D65286C96A74C"><enum>918.</enum><header>Tobacco
Products Scientific Advisory Committee</header>
<subsection id="H41F4D0E41BF948F0B1E8853C85E77CD8"><enum>(a)</enum><header>Establishment</header><text>Not
later than 1 year after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, the Secretary shall establish an 11-member advisory
committee, to be known as the <quote>Tobacco Products Scientific Advisory
Committee</quote> (in this section referred to as the <quote>Advisory
Committee</quote>).</text>
</subsection><subsection id="HAB11535BA81E4BEF88B0CF237610D707"><enum>(b)</enum><header>Membership</header>
<paragraph id="H5D6316E3D4D249D69678DCD46B17F000"><enum>(1)</enum><header>In
general</header>
<subparagraph id="HE177933DD81F47A081A80000772E53D1"><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 the 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="H44AE63FA9AD44796A0B57DB47ED22005"><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="H4A28FDB41EE44ECA95A94600ADC8194E"><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="HC1971F06B209411D9B30F878E09FDCBE"><enum>(iii)</enum><text>1 individual as
a representative of the general public;</text>
</clause><clause id="HBA54A28D6C1B4EA687D8A4B6CB4CFFC7"><enum>(iv)</enum><text>1
individual as a representative of the interests in the tobacco manufacturing
industry; and</text>
</clause><clause id="HF0C639D311BD4D5A8FEA9F684941626E"><enum>(v)</enum><text>1
individual as a representative of the interests of the tobacco growers.</text>
</clause></subparagraph><subparagraph id="H9FA6B3D526B549BFA25B53FDD05DCAD9"><enum>(B)</enum><header>Nonvoting
members</header><text>The members of the committee appointed under clauses (iv)
and (v) 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></paragraph><paragraph id="HFE9A0AFDF3CB450E985BEC0458A8DBE0"><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="H106AD44D446144C1B82510360072BF69"><enum>(3)</enum><header>Chairperson</header><text>The
Secretary shall designate 1 of the members of the Advisory Committee to serve
as chairperson.</text>
</paragraph></subsection><subsection id="H42DB87AA650E475682CAC725D9B4B042"><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="H2B358CE0305647ED99DBA86F5096EBC7"><enum>(1)</enum><text>as provided in
this chapter;</text>
</paragraph><paragraph id="HEC2F2DFF50BD44B2B1AFD5417285A6C3"><enum>(2)</enum><text>on the effects of
the alteration of the nicotine yields from tobacco products;</text>
</paragraph><paragraph id="H2CE735CD223E47ABAE56C9C47301B19"><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="H5020F85C38E74B078FA1763627244901"><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="H8F71D4350F6C416F9DDFC84BA3CC0881"><enum>(d)</enum><header>Compensation;
Support; FACA</header>
<paragraph id="H332202EC97F04A37AE10D2D41CBBD25"><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 section 5382 of title 5, United States Code, for each day (including
travel time) they are so engaged; and while so serving away from their homes or
regular places of business each member may be allowed travel expenses,
including per diem in lieu of subsistence, as authorized by section 5703 of
title 5, United States Code, for persons in the Government service employed
intermittently.</text>
</paragraph><paragraph id="HD994FA593F2A4901A98204452F93C881"><enum>(2)</enum><header>Administrative
support</header><text>The Secretary shall furnish the Advisory Committee
clerical and other assistance.</text>
</paragraph><paragraph id="HADB151F4713247AD889377E27BC97404"><enum>(3)</enum><header>Nonapplication
of faca</header><text>Section 14 of the <act-name parsable-cite="FACA">Federal
Advisory Committee Act</act-name> does not apply to the Advisory
Committee.</text>
</paragraph></subsection><subsection id="H56CB0F2C087446EC95BA2900792640EB"><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 section 552(b) of
title 5, United States Code.</text>
</subsection></section><section id="H0DF9E4614E5C4C889FFE08D8D9F2C2DF"><enum>919.</enum><header>Drug products
used to treat Tobacco dependence</header><text display-inline="no-display-inline">The Secretary shall—</text>
<paragraph id="H2CC5A0B8572948F59156009EECAA5720"><enum>(1)</enum><text>at the request of
the applicant, consider designating nicotine replacement products as fast track
research and approval products within the meaning of section 506;</text>
</paragraph><paragraph id="H3BA8AF558A0C499FB6FAFE7227EF2EDE"><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="HD78F95303C1E4661A616229B08410059"><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></section><section id="HEDC71858A4564A2280E5DF4B06003950"><enum>920.</enum><header>User
fee</header>
<subsection id="H31EB00D9E17243DCA2AA519F44605571"><enum>(a)</enum><header>Establishment of
Quarterly User Fee</header><text>The Secretary shall assess a quarterly user
fee with respect to every quarter of each fiscal year commencing fiscal year
2008, calculated in accordance with this section, upon each manufacturer and
importer of tobacco products subject to this chapter.</text>
</subsection><subsection id="HBE637CD4660442128769F9BD25904E13"><enum>(b)</enum><header>Funding of FDA
Regulation of Tobacco Products</header><text>The Secretary shall make user fees
collected pursuant to this section available to pay, in each fiscal year, for
the costs of the activities of the Food and Drug Administration related to the
regulation of tobacco products under this chapter.</text>
</subsection><subsection id="HFFD4878A9BA7442192F7C71F07735D4C"><enum>(c)</enum><header>Assessment of
User Fee</header>
<paragraph id="H9A8CFE9D9A634E579B90AA4AF47F684"><enum>(1)</enum><header>Amount of
assessment</header><text>Except as provided in paragraph (4), the total user
fees assessed each year pursuant to this section shall be sufficient, and shall
not exceed what is necessary, to pay for the costs of the activities described
in subsection (b) for each fiscal year.</text>
</paragraph><paragraph id="HD70D8355225B492093804FE1F18D9FBE"><enum>(2)</enum><header>Allocation of
assessment by class of tobacco products</header>
<subparagraph id="HC62C25A6A89A4ED38CC83E00A9BE257"><enum>(A)</enum><header>In
general</header><text>Subject to paragraph (3), the total user fees assessed
each fiscal year with respect to each class of importers and manufacturers
shall be equal to an amount that is the applicable percentage of the total
costs of activities of the Food and Drug Administration described in subsection
(b).</text>
</subparagraph><subparagraph id="H42A03E6FA83D4E4ABE2000E83C149F35"><enum>(B)</enum><header>Applicable
percentage</header><text>For purposes of subparagraph (A), the applicable
percentage for a fiscal year shall be the following:</text>
<clause id="H3834F54A87C14954A3B4A754FB3919EF"><enum>(i)</enum><text>92.07 percent
shall be assessed on manufacturers and importers of cigarettes;</text>
</clause><clause id="HF9ADDBF56B044B4E86D17B69A2BF041E"><enum>(ii)</enum><text>0.05 percent
shall be assessed on manufacturers and importers of little cigars;</text>
</clause><clause id="H233A62FD6A26409387860200FBB63287"><enum>(iii)</enum><text>7.15 percent
shall be assessed on manufacturers and importers of cigars other than little
cigars;</text>
</clause><clause id="H3D11724ECC744B54AD59AD9043427E5D"><enum>(iv)</enum><text>0.43 percent
shall be assessed on manufacturers and importers of snuff;</text>
</clause><clause id="HBE6A69602ADA4A11AEB0BD006F1CA259"><enum>(v)</enum><text>0.10 percent shall
be assessed on manufacturers and importers of chewing tobacco;</text>
</clause><clause id="H66C264545AF84240AB48654837E7E37C"><enum>(vi)</enum><text>0.06 percent
shall be assessed on manufacturers and importers of pipe tobacco; and</text>
</clause><clause id="H249A313A8F8143489D5B88AB388D0514"><enum>(vii)</enum><text>0.14 percent
shall be assessed on manufacturers and importers of roll-your-own
tobacco.</text>
</clause></subparagraph></paragraph><paragraph id="H19AA8D530A37478FBAB7F00060D3FFDD"><enum>(3)</enum><header>Distribution of
fee shares of manufacturers and importers exempt from user
fee</header><text>Where a class of tobacco products is not subject to a user
fee under this section, the portion of the user fee assigned to such class
under paragraph (2) shall be allocated by the Secretary on a pro rata basis
among the classes of tobacco products that are subject to a user fee under this
section. Such pro rata allocation for each class of tobacco products that is
subject to a user fee under this section shall be the quotient of—</text>
<subparagraph id="H1128755957EE4459A55D81CB808BED53"><enum>(A)</enum><text>the percentage
assigned to such class under paragraph (2); divided by</text>
</subparagraph><subparagraph id="H149521C5CB2B43A7B8EDBDF9CFD5642"><enum>(B)</enum><text>the sum of the
percentages assigned to all classes of tobacco products subject to this
section.</text>
</subparagraph></paragraph><paragraph id="HDE4448C9317C40E79BF4B9A3A09C183B"><enum>(4)</enum><header>Annual limit on
assessment</header><text>The total assessment under this section—</text>
<subparagraph id="H335F5D1EA6EE441F99409FD7C7FD095"><enum>(A)</enum><text>for fiscal year
2008 shall be $85,000,000;</text>
</subparagraph><subparagraph id="H0BC3B84118474CBE9D2EA0469B20E6BB"><enum>(B)</enum><text>for fiscal year
2009 shall be $175,000,000;</text>
</subparagraph><subparagraph id="H3726039835DA49A09B6BA88D203748D5"><enum>(C)</enum><text>for fiscal year
2010 shall be $300,000,000; and</text>
</subparagraph><subparagraph id="H861867AAE11A4F5190D700B66756B1FE"><enum>(D)</enum><text>for each
subsequent fiscal year, shall not exceed the limit on the assessment imposed
during the previous fiscal year, as adjusted by the Secretary (after notice,
published in the Federal Register) to reflect the greater of—</text>
<clause id="H71E60D8C596E4D83960257C0AD6C8EFA"><enum>(i)</enum><text>the total
percentage change that occurred in the Consumer Price Index for all urban
consumers (all items; United States city average) for the 12-month period
ending on June 30 preceding the fiscal year for which fees are being
established; or</text>
</clause><clause id="H47D6E95DB112449A8C21731EA0454BD8"><enum>(ii)</enum><text>the total
percentage change for the previous fiscal year in basic pay under the General
Schedule in accordance with section 5332 of title 5, United States Code, as
adjusted by any locality-based comparability payment pursuant to section 5304
of such title for Federal employees stationed in the District of
Columbia.</text>
</clause></subparagraph></paragraph><paragraph id="H797BC341AC0E44CB84CE2DA000BAA706"><enum>(5)</enum><header>Timing of user
fee 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 subsection
(f) during each quarter of each fiscal year. Such notifications shall occur not
earlier than 3 months prior to the end of the quarter for which such assessment
is made, and payments of all assessments shall be made not later than 60 days
after each such notification.</text>
</paragraph></subsection><subsection id="H04915A3320FA47A7A3002C8DF404FCCA"><enum>(d)</enum><header>Determination of
User Fee by Company Market Share</header>
<paragraph id="HC63671F4566045FF98FFD22F11C3F43E"><enum>(1)</enum><header>In
general</header><text>The user fee to be paid by each manufacturer or importer
of a given class of tobacco products shall be determined in each quarter by
multiplying—</text>
<subparagraph id="HB71CD241A36641179FC5D88F80000DD"><enum>(A)</enum><text>such manufacturer’s
or importer’s market share of such class of tobacco products; by</text>
</subparagraph><subparagraph id="H2861DDBE99C742DC8E20DCDFBBD77AC"><enum>(B)</enum><text>the portion of the
user fee amount for the current quarter to be assessed on manufacturers and
importers of such class of tobacco products as determined under subsection
(e).</text>
</subparagraph></paragraph><paragraph id="HB01C1897C3A14D35B5484CE08B6C6354"><enum>(2)</enum><header>No fee in excess
of market share</header><text>No manufacturer or importer of tobacco products
shall be required to pay a user fee in excess of the market share of such
manufacturer or importer.</text>
</paragraph></subsection><subsection id="H33A9088775DB4F41ADA2094826FB44C7"><enum>(e)</enum><header>Determination of
Volume of Domestic Sales</header>
<paragraph id="H3782DE9BD1E7489BAF39B83CAE8841E2"><enum>(1)</enum><header>In
general</header><text>The calculation of gross domestic volume of a class of
tobacco product by a manufacturer or importer, and by all manufacturers and
importers as a group, shall be made by the Secretary using information provided
by manufacturers and importers pursuant to subsection (f), as well as any other
relevant information provided to or obtained by the Secretary.</text>
</paragraph><paragraph id="H480DE3D540594E7598AE6FDA940040D5"><enum>(2)</enum><header>Measurement</header><text>For
purposes of the calculations under this subsection and the information provided
under subsection (f) by the Secretary, gross domestic volume shall be measured
by—</text>
<subparagraph id="HFEA6B027B1034E29B600BEE9D634E3A5"><enum>(A)</enum><text>in the case of
cigarettes, the number of cigarettes sold;</text>
</subparagraph><subparagraph id="H03C7FEB32761417A975F32AB913E807C"><enum>(B)</enum><text>in the case of
little cigars, the number of little cigars sold;</text>
</subparagraph><subparagraph id="H56768C32A21748B1BDA6A5BD00A00000"><enum>(C)</enum><text>in the case of
large cigars, the number of cigars weighing more than 3 pounds per thousand
sold; and</text>
</subparagraph><subparagraph id="H58D86DD88A2E4EC484107100A2F33E25"><enum>(D)</enum><text>in the case of
other classes of tobacco products, in terms of number of pounds, or fraction
thereof, of these products sold.</text>
</subparagraph></paragraph></subsection><subsection id="HEA1AB3FC0FE74AB399E63EBE8C9B1BF3"><enum>(f)</enum><header>Measurement of
Gross Domestic Volume</header>
<paragraph id="H30F8C58CA94C4ED0B94BE1AE3B258803"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">Each tobacco product
manufacturer and importer shall submit to the Secretary a certified copy of
each of the returns or forms described by this paragraph that are required to
be filed with a Government agency on the same date that those returns or forms
are required to be filed with such agency. The returns and forms described by
this paragraph are those returns and forms related to the removal, as defined
by section 5702(j) of the Internal Revenue Code of 1986, of tobacco products
into domestic commerce or the payment of the taxes imposed under chapter 52 of
such Code.</text>
</paragraph><paragraph id="H0E760E0507404C169C445BC7A89BCBBF"><enum>(2)</enum><header>Penalties</header><text>Any
person that knowingly fails to provide information required under this
subsection or that provides false information under this subsection shall be
subject to the penalties described in section 1001 of title 18, United States
Code. In addition, such person may be subject to a civil penalty in an amount
not to exceed 2 percent of the value of the kind of tobacco products
manufactured or imported by such person during the applicable quarter, as
determined by the Secretary.</text>
</paragraph></subsection><subsection id="HC5B27A877B3147CFB300B74BCC69116"><enum>(g)</enum><header>Effective
Date</header><text>The user fees prescribed by this section shall be assessed
in fiscal year 2008, based on domestic sales of tobacco products during fiscal
year 2007 and shall be assessed in each fiscal year
thereafter.</text>
</subsection></section></chapter><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section id="HE4FA6CA8F85B4261827618B55395D435"><enum>102.</enum><header>Final
rule</header>
<subsection id="H2A84EC5CA42D49838CA326389C82E414"><enum>(a)</enum><header>Cigarettes and
Smokeless Tobacco</header>
<paragraph id="HB1D20C11CBA844CCB471B6ED9D155B69"><enum>(1)</enum><header>In
general</header><text>Not later than 30 days 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
is hereby deemed to be in compliance with the Administrative Procedures Act and
other applicable law.</text>
</paragraph><paragraph id="HD752CFB81F49491FB4437F871C1D981C"><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 id="H337942815786435A8639FE5B381D36B7"><enum>(A)</enum><text>provide for the
designation of jurisdictional authority that is in accordance with this
subsection;</text>
</subparagraph><subparagraph id="H464609A71A54445F82D01B93F86BA7DA"><enum>(B)</enum><text>strike Subpart
C—Labels and section 897.32(c); and</text>
</subparagraph><subparagraph id="HF71591039E37451EAE505CB907EA517E"><enum>(C)</enum><text>become effective
not later than 1 year after the date of enactment of this Act.</text>
</subparagraph></paragraph><paragraph id="H9F535BC1C6E140F5B31B14CB23D522BF"><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 the Administrative Procedures Act.</text>
</paragraph><paragraph id="H9A2FAA7DC39646D4B2FCD9816459D85"><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 the Administrative Procedures Act, the regulation promulgated
pursuant to this section.</text>
</paragraph></subsection><subsection id="H896EC62021D44CB9BAA244A0F4104000"><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 section 10.85(d)(1) of title 21, Code of
Federal Regulations, except as they apply to tobacco products, and shall not be
cited by the Secretary of Health and Human Services or the Food and Drug
Administration as binding precedent:</text>
<paragraph id="H3E67930976674C2DA7E1F877D9BAE4AA"><enum>(1)</enum><text>The preamble to
the proposed rule in the document entitled <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 id="HF8E7059DDE8945A28E02B2B2808DB922"><enum>(2)</enum><text>The document
entitled <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 id="H02412FEAC8A242E693F800AEA4D2056D"><enum>(3)</enum><text>The preamble to
the final rule in the document entitled <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 id="H249727CE74E348E8BBDF8449A864E1DD"><enum>(4)</enum><text>The document
entitled <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="HAA56EDCB5E464C6E86B600D93B23DE3"><enum>103.</enum><header>Conforming and
other amendments to general provisions</header>
<subsection id="H547989549A644D1792305FC22EA0208E"><enum>(a)</enum><header>Amendment of
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name></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 <act-name parsable-cite="FFDCA">Federal Food, Drug, and
Cosmetic Act</act-name> (21 U.S.C. 301 et seq.).</text>
</subsection><subsection id="H68617E11CDBC4B36A4BA8D734417718D"><enum>(b)</enum><header>Section
<enum-in-header>301</enum-in-header></header><text>Section 301 (21 U.S.C. 331)
is amended—</text>
<paragraph id="H4B21F807636945EEBEAE9BDD09D51D00"><enum>(1)</enum><text>in subsection (a),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="HA441C75137AE4C88B16ECC31DAFD90E7"><enum>(2)</enum><text>in subsection (b),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H89D280A32177490CBDE79788AF028B70"><enum>(3)</enum><text>in subsection (c),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H1AD3889060734C68A886CB004650C670"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (e) (as amended by sections
2(c) and 3(b) of the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (Public Law 109–462; 120 Stat. 3472)), by inserting <quote>, or
909</quote> before <quote>or the refusal to permit access to</quote>;</text>
</paragraph><paragraph id="HB33037CFD3B7409D99EBA2CF196EFB2F"><enum>(5)</enum><text>in subsection (g),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="HC86780BD42394A9F99ADDBBA1722B3C"><enum>(6)</enum><text>in
subsection (h), by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="HA7575DCA5E9B4EA2A4A6F007A68B9D93"><enum>(7)</enum><text>in subsection (j),
by striking <quote>708, or 721</quote> and inserting <quote>708, 721, 904, 905,
906, 907, 908, 909, or section 921(b)</quote>;</text>
</paragraph><paragraph id="H44B6BEFF59F3413894C25068C755AC2"><enum>(8)</enum><text>in
subsection (k), by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H0BF8046377D644BF91CCEF092056235B"><enum>(9)</enum><text>by striking
subsection (p) and inserting the following:</text>
<quoted-block id="H95E06C51A3094D1F81891121204F5B17" style="OLC">
<subsection id="H352E1B1430A94617830400B9BFFA6159"><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)(2).</text>
</subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="H888286171FFE4FA19375E64F6303EEB5"><enum>(10)</enum><text>by striking
subsection (q)(1) and inserting the following:</text>
<quoted-block id="H6088CB3BB88F464A00BEE795EF0527BA" style="OLC">
<subsection id="H2C36DDB1783347EDBAFC50BF011C1F6E"><enum>(q)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H5C4CAF8FFE1D4E5FAADE774FB63207D"><enum>(1)</enum><text>The failure or
refusal—</text>
<subparagraph id="HE52EFA7C9BA74A15B883803D49852D18" indent="up1"><enum>(A)</enum><text>to comply with any requirement
prescribed under section 518, 520(g), 903(b), or 908;</text>
</subparagraph><subparagraph id="H4CE179E8E34C4CC1AB171D00B5631E47" 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
section 921; or</text>
</subparagraph><subparagraph id="H97227F71AE2B463E942410D48C00F926" 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="H043E344712E548BEAD1E7443DDA355DF"><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="H8A26F35109814D04A2733527C07EF11D"><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="H3E3A9BB4B3114FFD9985ED3FFC724D4B"><enum>(13)</enum><text display-inline="yes-display-inline">by adding at the end (as amended by section
4(a) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act
(Public Law 109–462; 120 Stat. 3475)) the following:</text>
<quoted-block id="H9125D8A999D341F6BF75B7DF7D681E95" style="OLC">
<item id="HEA336E1BFC91465E98EFC5ED9389B941" indent="up4"><enum>(jj)</enum><text>The sale of tobacco products in
violation of a no-tobacco-sale order issued under section 303(f).</text>
</item><item id="H55C835D929BC48FA86E631611CC2331D" indent="up4"><enum>(kk)</enum><text>The introduction or delivery for
introduction into interstate commerce of a tobacco product in violation of
section 911.</text>
</item><item id="H0326167DD3394EFDB025F9389FD3D256" indent="up4"><enum>(ll)</enum><subitem commented="no" display-inline="yes-display-inline" id="HF8D59AE23C744FCF8CDF58B4DACB83F6"><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>
</subitem></item><paragraph id="H0A11B0DE6C9D42CC889EFC22163069B8"><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="H083D018761954241BB0041560002004C"><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><paragraph id="H2DF2EB827EA54864B9E48C539D894288"><enum>(mm)</enum><text>The charitable
distribution of tobacco products.</text>
</paragraph><paragraph id="HD09B7549AD834EBABF34FA93FC050163"><enum>(nn)</enum><text>The failure of a
manufacturer or distributor to notify the Attorney General of their knowledge
of tobacco products used in illicit
trade.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H3FE9288DF8C74F4B9300FA31A002E22C"><enum>(c)</enum><header>Section
<enum-in-header>303</enum-in-header></header><text>Section 303 (21 U.S.C.
333(f)) is amended by redesignating the subsection that follows subsection (e)
as subsection (f) and in subsection (f) (as so redesignated)—</text>
<paragraph id="H1C92DFB620C34595A945EB00D5B366E3"><enum>(1)</enum><text>in paragraph
(1)(A), by inserting <quote>or tobacco products</quote> after
<quote>devices</quote>;</text>
</paragraph><paragraph id="HC0F02A2AAE5144F2A716BBB538C6CB2C"><enum>(2)</enum><text>in paragraph
(2)(C), by striking <quote>paragraph (3)(A)</quote> and inserting
<quote>paragraph (4)(A)</quote>;</text>
</paragraph><paragraph id="HAA52E5C9DDE543EA823E4EE13D21150"><enum>(3)</enum><text>by
redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), and
inserting after paragraph (2) the following:</text>
<quoted-block id="H3ABF53A4234E4DF0A7A2C0000CC4EFC" style="OLC">
<paragraph id="HD698F6A65C9F47158B23119359F433EE"><enum>(3)</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).</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="H136560A48A79406C893D88B45521DBDF"><enum>(4)</enum><text>in paragraph (4)
as so redesignated—</text>
<subparagraph id="H3EDF33D474674462BDC9B4A03DDEE75"><enum>(A)</enum><text>in subparagraph
(A)—</text>
<clause id="H4116B3AFAC8B4CD2B3438825D400CD50"><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="H4D63353E02CF45A798F5951FC5A9CC05"><enum>(ii)</enum><text>by
striking <quote>penalty</quote> and inserting <quote>penalty, or upon whom a
no-tobacco-order is to be imposed,</quote>;</text>
</clause></subparagraph><subparagraph id="H54C541E7A9F24F699D794DA31ECA0331"><enum>(B)</enum><text>in subparagraph
(B)—</text>
<clause id="H9FAB420D3A824586AEEA300828AFEFB8"><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="HF6CC1E25B96D4380A1230226950066B0"><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="HA2FAF8D28ED641A5B2FE9F0661EF1351"><enum>(C)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H521FF54F9F384D3FB4EBF42C1DDEB628" style="OLC">
<subparagraph id="HAA766CA724754B130005E8C845FBB74"><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="H6EE851244FBE4FAD85F11130C8084459"><enum>(5)</enum><text>in paragraph (5)
as so redesignated—</text>
<subparagraph id="H5E694366D30D47CEA2280017AE3CE59"><enum>(A)</enum><text>by striking
<quote>(3)(A)</quote> as redesignated, and inserting
<quote>(4)(A)</quote>;</text>
</subparagraph><subparagraph id="H23A6465C4608426CA42798A99878AADD"><enum>(B)</enum><text>by inserting
<quote>or the imposition of a no-tobacco-sale order</quote> after the term
<term>penalty</term> the first 2 places such term appears; and</text>
</subparagraph><subparagraph id="HC9E04F9633584AD2937039B6AA4EC118"><enum>(C)</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="HDEB714714ED54492A8185796C500F867"><enum>(6)</enum><text>in paragraph (6),
as so redesignated, by striking the term <term>paragraph (4)</term> each place
such term appears and inserting <quote>paragraph (5)</quote>.</text>
</paragraph></subsection><subsection id="H4A6804CD6498475A00DB8E1693B52875"><enum>(d)</enum><header>Section
<enum-in-header>304</enum-in-header></header><text>Section 304 (21 U.S.C. 334)
is amended—</text>
<paragraph id="H4BFB22DF484B43E8AD749DD32257F5A3"><enum>(1)</enum><text>in subsection
(a)(2)—</text>
<subparagraph id="HF3650FF4F5BE44A486F66CC5B5299CEC"><enum>(A)</enum><text>by striking
<quote>and</quote> before <quote>(D)</quote>; and</text>
</subparagraph><subparagraph id="H8CA22C4A03474AB1A5001D1157BA8D00"><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="H17730A6B007A4590BA6CCFA57C5BF7BB"><enum>(2)</enum><text>in subsection
(d)(1), by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>;</text>
</paragraph><paragraph id="H1220B5B763874425B6968328E7C66015"><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="H037952281BBF486DA0005480DAC709BB"><enum>(4)</enum><text>in subsection
(g)(2)(A), by inserting <quote>or tobacco product</quote> after the term
<term>device</term> each place such term appears.</text>
</paragraph></subsection><subsection id="H47CEBA5E8A5E45B18677CEE2A542A2FA"><enum>(e)</enum><header>Section
<enum-in-header>702</enum-in-header></header><text>Section 702(a) (21 U.S.C.
372(a)) is amended by adding at the end of paragraph (1) the following:
<quote>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.</quote>.</text>
</subsection><subsection id="H32B5B94546E34C6BAEF50006B4CC1B1B"><enum>(f)</enum><header>Section
<enum-in-header>703</enum-in-header></header><text>Section 703 (21 U.S.C. 373)
is amended—</text>
<paragraph id="HAF965754C4004E10BCCA4FAE4F89D972"><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="H36599EFEDEEA4D0196FC006DAE7BA52B"><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="H68A317EA58DC4869BFDDD2DA56E31C5D"><enum>(g)</enum><header>Section
<enum-in-header>704</enum-in-header></header><text>Section 704 (21 U.S.C. 374)
is amended—</text>
<paragraph id="H5F89BA5DACA141CDAC914CDD5EE8CA4F"><enum>(1)</enum><text>in subsection
(a)(1)(A), by inserting <quote>tobacco products,</quote> after the term
<term>devices,</term> each place such term appears;</text>
</paragraph><paragraph id="H1206C41EB2C0409387C17C135EB0DD5F"><enum>(2)</enum><text>in subsection
(a)(1)(B), by inserting <quote>or tobacco product</quote> after the term
<term>restricted devices</term> each place such term appears; and</text>
</paragraph><paragraph id="H150ED1302D7C495C8BB139E6D77B4228"><enum>(3)</enum><text>in subsection (b),
by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>.</text>
</paragraph></subsection><subsection id="H283F6FE90BED48218E0081EEA8C647E5"><enum>(h)</enum><header>Section
<enum-in-header>705</enum-in-header></header><text>Section 705(b) (21 U.S.C.
375(b)) is amended by inserting <quote>tobacco products,</quote> after
<quote>devices,</quote>.</text>
</subsection><subsection id="H4817C7FF01B84C8DA5A364EAA3CBF200"><enum>(i)</enum><header>Section
<enum-in-header>709</enum-in-header></header><text>Section 709 (21 U.S.C. 379)
is amended by inserting <quote>tobacco product, </quote> after
<quote>device,</quote>.</text>
</subsection><subsection id="H48904F4A243A4167BBA71650D9080942"><enum>(j)</enum><header>Section
<enum-in-header>801</enum-in-header></header><text>Section 801 (21 U.S.C. 381)
is amended—</text>
<paragraph id="HE7571166452545329CE92B6829662B61"><enum>(1)</enum><text>in subsection
(a)—</text>
<subparagraph id="H7BC32303B5B34FB0854C4372A0000682"><enum>(A)</enum><text>by inserting
<quote>tobacco products,</quote> after the term <term>devices,</term> the first
time such term appears;</text>
</subparagraph><subparagraph id="H7F5B5EB6EC7B4F33A98422C900D0B9ED"><enum>(B)</enum><text>by inserting
<quote>or section 905(j)</quote> after <quote>section 510</quote>; and</text>
</subparagraph><subparagraph id="H71A72EE5279F4A65BCB408FE426CCCD9"><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 id="HD9347FDBB51D469A88E43C8D9D463004"><enum>(2)</enum><text>in subsection
(e)(1), by inserting <quote>tobacco product,</quote> after
<quote>device,</quote>; and</text>
</paragraph><paragraph id="H980D9277556B43E197DE4EE71F41A3A8"><enum>(3)</enum><text>by adding at the
end the following:</text>
<quoted-block id="H26B3099ADA034A068775A060C117FA1" style="OLC">
<subsection id="H3D5FD5F6A6BE48ABAB9CE1E63038C261"><enum>(p)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HA47E54E734E4401C82F9EC4147D7F2C2"><enum>(1)</enum><text>Not later than 2 years
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="H519F71ED7CFD48299686139C193E4841" 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="H6F74432701B9470E9B3366245971A92F" 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="HE0B25041E9174A2B8679AD11DE907E60" 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="H216DEA4AE72E48CA9D2CD396D7925076" 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="HE9DDF32D1CA1424CA713004492C61C73"><enum>(k)</enum><header>Section
<enum-in-header>1003</enum-in-header></header><text>Section 1003(d)(2)(C) (as
redesignated by section 101(b)) is amended—</text>
<paragraph id="HFB47B51FF5394218ACCA45706C08C299"><enum>(1)</enum><text>by striking
<quote>and</quote> after <quote>cosmetics,</quote>; and</text>
</paragraph><paragraph id="HFBD06C16C5E044918B7569145B9C99B3"><enum>(2)</enum><text>inserting <quote>,
and tobacco products</quote> after <quote>devices</quote>.</text>
</paragraph></subsection><subsection id="HAE521C9CFD4444A3BB002966C08D9723"><enum>(l)</enum><header>Guidance and
Effective Dates</header>
<paragraph id="HA4B18254BF0F4EDB9FAA99B196C8268"><enum>(1)</enum><header>In
general</header><text>The Secretary of Health and Human Services shall issue
guidance—</text>
<subparagraph id="H1FD40798B47F40BDBB2EEFA701E8FED"><enum>(A)</enum><text>defining the term
<term>repeated violation</term>, as used in section 303(f) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(21 U.S.C. 333(f)) as amended by subsection (c), by identifying the number of
violations of particular requirements over a specified period of time at a
particular retail outlet that constitute a repeated violation;</text>
</subparagraph><subparagraph id="HFA35137D88C34625BE8599082500A64B"><enum>(B)</enum><text>providing for
timely and effective notice to the retailer of each alleged violation at a
particular retail outlet;</text>
</subparagraph><subparagraph id="HD5C855485B294AA3ABC7598D86FCC2E7"><enum>(C)</enum><text>providing for an
expedited procedure for the administrative appeal of an alleged
violation;</text>
</subparagraph><subparagraph id="HCA4FCC96E37448D98E7E53BEF12E2079"><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="H89D9C688DFBC4B950082EB8D7B04CA1F"><enum>(E)</enum><text>establishing a
period of time during which, if there are no violations by a particular retail
outlet, that outlet will not be considered to have been the site of repeated
violations when the next violation occurs; and</text>
</subparagraph><subparagraph id="H082BF3C3A8E646818D076D5D2768A43B"><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="HEE4971E0EFA349618863DCB5AEA121CA"><enum>(i)</enum><text>adopting and
enforcing a written policy against sales to minors;</text>
</clause><clause id="HFC3EC83E7D434FEF80273400ED6CE923"><enum>(ii)</enum><text>informing its
employees of all applicable laws;</text>
</clause><clause id="H797B7B0B447541B3A9A2EBBAF7A90628"><enum>(iii)</enum><text>establishing
disciplinary sanctions for employee noncompliance; and</text>
</clause><clause id="H4419D10C27D1454EA3F1C1E172B1E6B7"><enum>(iv)</enum><text>requiring its
employees to verify age by way of photographic identification or electronic
scanning device.</text>
</clause></subparagraph></paragraph><paragraph id="H7E00875CDC024F0993945773059695E9"><enum>(2)</enum><header>General
effective date</header><text>The amendments made by subsection (c), other than
the amendment made by paragraph (2) of such subsection, shall take effect upon
the issuance of guidance described in paragraph (1).</text>
</paragraph><paragraph id="HDFF2594B4E294F5B84B7DA8BFF48F775"><enum>(3)</enum><header>Special
effective date</header><text>The amendments made by paragraph (2) of subsection
(c) shall take effect on the date of enactment of this Act.</text>
</paragraph></subsection></section><enum>II</enum><header>TOBACCO PRODUCT
WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT DISCLOSURE</header>
<section id="HBF452BA37C1F4058B6294B040091366E"><enum>201.</enum><header>Cigarette label
and advertising warnings</header><text display-inline="no-display-inline">Section 4 of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333) is amended to read as follows:</text>
<quoted-block id="HFD4B3F2D43D245298C532176C2C8E170" style="OLC">
<section id="HE7E6E82A0B9D44A295D2C89C3FA9A32C"><enum>4.</enum><header>Labeling</header>
<subsection id="H7803EF63521941AA9CF3DCCE0D66EE"><enum>(a)</enum><header>Label
Requirements</header>
<paragraph id="HA3A4C8E946D743E1A3177700D82BE300"><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>
</paragraph><paragraph id="H09EFE56932444B38808B93784C289E77"><enum></enum><text><quote>WARNING:
Cigarettes are addictive</quote>.</text>
</paragraph><paragraph id="H667716C2C24248FE84C361C76F83DAB"><enum></enum><text><quote>WARNING:
Tobacco smoke can harm your children</quote>.</text>
</paragraph><paragraph id="H1BD5979A0AE74D4F9179E3C2576CBB80"><enum></enum><text><quote>WARNING:
Cigarettes cause fatal lung disease</quote>.</text>
</paragraph><paragraph id="H598AA7254904477887F448B74D272B70"><enum></enum><text><quote>WARNING:
Cigarettes cause cancer</quote>.</text>
</paragraph><paragraph id="HB55692E738764AE8A8D5311D72FC12A1"><enum></enum><text><quote>WARNING:
Cigarettes cause strokes and heart disease</quote>.</text>
</paragraph><paragraph id="H2655024738084378AE040033D4DBADCE"><enum></enum><text><quote>WARNING:
Smoking during pregnancy can harm your baby</quote>.</text>
</paragraph><paragraph id="H60EAC5CD98C341CAA890B0450041BB90"><enum></enum><text><quote>WARNING:
Smoking can kill you</quote>.</text>
</paragraph><paragraph id="HB3E2BA220806473FA532D8407EB3E62E"><enum></enum><text><quote>WARNING:
Tobacco smoke causes fatal lung disease in non-smokers</quote>.</text>
</paragraph><paragraph id="HA9D22011E8B648D583855962CEF5415E"><enum></enum><text><quote>WARNING:
Quitting smoking now greatly reduces serious risks to your
health</quote>.</text>
</paragraph><paragraph id="H9688E19A4DF64BA682B5F20029DCD8E0"><enum>(2)</enum><header>Placement;
typography; etc</header>
<subparagraph id="H6C07D8E7A2B54B99B85B423573691D3C"><enum>(A)</enum><header>In
general</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.
Except as provided in subparagraph (B), each label statement shall comprise at
least the top 30 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
(b)(4).</text>
</subparagraph><subparagraph id="HC97826B3E2AC4CB6BF8FCA3EC299AE9D"><enum>(B)</enum><header>Hinged lid
boxes</header><text>For any cigarette brand package manufactured or distributed
before January 1, 2000, which employs a hinged lid style (if such packaging was
used for that brand in commerce prior to June 21, 1997), the label statement
required by paragraph (1) shall be located on the hinged lid area of the
package, even if such area is less than 25 percent of the area of the front
panel. Except as provided in this paragraph, the provisions of this subsection
shall apply to such packages.</text>
</subparagraph></paragraph><paragraph id="H1B23CAC25A304A7C84DE00C4C007CB39"><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="HE5E13B53ECC0442000DE90B3B85413E"><enum>(4)</enum><header>Applicability to
retailers</header><text>A retailer of cigarettes shall not be in violation of
this subsection for packaging that is supplied to the retailer by a tobacco
product manufacturer, importer, or distributor and is not altered by the
retailer in a way that is material to the requirements of this subsection
except that this paragraph shall not relieve a retailer of liability if the
retailer sells or distributes tobacco products that are not labeled in
accordance with this subsection.</text>
</paragraph></subsection><subsection id="H0D4F579F54B340E2BF477274ED29CBD2"><enum>(b)</enum><header>Advertising
Requirements</header>
<paragraph id="H375733E9723F49489522A7066F92122F"><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) of this section.</text>
</paragraph><paragraph id="H1FBAC8D485844A65B6C8ABFAAD0000"><enum>(2)</enum><header>Typography,
etc</header><text>Each label statement required by subsection (a) of this
section 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 paragraph (4) of this subsection. 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 in the case of—</text>
<subparagraph id="H5177FB83D2D24C2183CBE3E1C80773D5"><enum>(A)</enum><text>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="H3511705F2C614503929C4DEF4F8E2C47"><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="H17BEDB639A9D42B0BA530200003E095E"><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="H3BB00308CE504EE2AECCE0965526FD95"><enum>(4)</enum><header>Adjustment by
secretary</header><text>The Secretary may, through a rulemaking under section
553 of title 5, United States Code, adjust the format and type sizes for the
label statements required by this section or the text, format, and type sizes
of any required tar, nicotine yield, or other constituent (including smoke
constituent) disclosures, or to establish the text, format, and type sizes for
any other disclosures required under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>. 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) of this subsection. 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="H17C583632FD0427B888009A7578B8CEA"><enum>(c)</enum><header>Marketing
Requirements</header>
<paragraph id="HE986695D1FED4A83872FCCD26030B5ED"><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="HD04D1A7E08EF47DCB940C9DC1F32D4AA"><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="H74A77183AE2445D180852505E405CAD2"><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="HA9BB5001B8BB4E349D91D02E00697742"><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="HAB24BD18C4EE4A4D96B3986566053C93"><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="H4576CE7B6DA44D6EACDECAC00AE9091"><enum>(4)</enum><header>Applicability to
retailers</header><text>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 is not labeled in accordance with the
requirements of this subsection and subsection
(b).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HD59722B3876D45AC865CCCBDBE743829"><enum>202.</enum><header>Authority to
revise cigarette warning label statements</header><text display-inline="no-display-inline">Section 4 of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333), as amended by section 201, is further
amended by adding at the end the following:</text>
<quoted-block id="H7650624AB5164AADACCD33BA9FB851FB" style="OLC">
<subsection id="H546AAF103CFC4B8FB030FE009D6769D"><enum>(d)</enum><header>Change in
Required Statements</header><text>The Secretary may, by a rulemaking conducted
under section 553 of title 5, United States Code, adjust the format, type size,
and text of any of the label requirements, require color graphics to accompany
the text, increase the required label area from 30 percent up to 50 percent of
the front and rear panels of the package, or establish the format, type size,
and text of any other disclosures required under the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, if the Secretary finds that such a change would promote greater
public understanding of the risks associated with the use of tobacco
products.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H2634E0D31D124D0E96E273B7C95FEA58"><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 (15 U.S.C. 1334) is amended by adding at the end the
following:</text>
<quoted-block id="H9276FE0DC97A44BB9F1FF2C0A666BF1F" style="OLC">
<subsection id="HBBEF5A6BBBA3440A0047B39CD66CA754"><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="H74DD09F0D1114723879CDF7000886106"><enum>204.</enum><header>Smokeless
Tobacco labels and advertising warnings</header><text display-inline="no-display-inline">Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402) is amended to read as
follows:</text>
<quoted-block id="HEFEC937ED470474B828C05096E1CCE5" style="OLC">
<section id="HF2F3A9485B114AE6AFBE076D2B981675"><enum>3.</enum><header>Smokeless Tobacco
warning</header>
<subsection id="H3D11A898A3B3466FA4163E00B88C96FB"><enum>(a)</enum><header>General
Rule</header>
<paragraph id="HCC0922216D8E4DBEBC9DB3EC91BE993E"><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>
</paragraph><paragraph id="HD9ECA926ED684CB994A9531DC6BC26BC"><enum></enum><text><quote>WARNING:
This product can cause mouth cancer</quote>.</text>
</paragraph><paragraph id="HD16921EF094A444E856F357BBFD27800"><enum></enum><text><quote>WARNING:
This product can cause gum disease and tooth loss</quote>.</text>
</paragraph><paragraph id="HDBA80D87A62B494EBE81984C0030AAD3"><enum></enum><text><quote>WARNING:
This product is not a safe alternative to cigarettes</quote>.</text>
</paragraph><paragraph id="H22388E378E9E4F83BECCF2FDFDC92536"><enum></enum><text><quote>WARNING:
Smokeless tobacco is addictive</quote>.</text>
</paragraph><paragraph id="HD2A3FF07118B4388B37111E1A7BE9242"><enum>(2)</enum><text>Each label
statement required by paragraph (1) shall be—</text>
<subparagraph id="HC0635B3724254D8AA5566FD6DE1BB376"><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="H621A57A6EFA74CD693F8AA80293C00BF"><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="HF6228C06875D4311AE8CEC7B0689E15"><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="HA00FD40DCECD4170BA1747228C7C9551"><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="HE3D058BFAE93441100F798C53D88D395"><enum>(5)</enum><text>A retailer of
smokeless tobacco products shall not be in violation of this subsection for
packaging that is supplied to the retailer by a tobacco products manufacturer,
importer, or distributor and that is not altered by the retailer unless the
retailer offers for sale, sells, or distributes a smokeless tobacco product
that is not labeled in accordance with this subsection.</text>
</paragraph></subsection><subsection id="H3C7EEFE40A854AAFA29DAF035DD471D"><enum>(b)</enum><header>Required
Labels</header>
<paragraph id="HB27958B78817491EA5520077E1F33A6"><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 id="H6404A5B3008E40400027A7395929FDE2"><enum>(2)</enum><text>Each label
statement required by subsection (a) in smokeless tobacco 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 yield shall—</text>
<subparagraph id="HD307BA68980E4852BE68C9CEA342763"><enum>(A)</enum><text>comprise at least
20 percent of the area of the advertisement, and the warning area shall be
delineated by a dividing line of contrasting color from the advertisement;
and</text>
</subparagraph><subparagraph id="H94B06291D89942C29F01E755D0050080"><enum>(B)</enum><text>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 on a white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph (3).</text>
</subparagraph></paragraph><paragraph id="H1B110EC289814AB600ED4D5917956B76"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H0666DACEFA11466EB6F8D2C3922C3B25"><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="H1EBAC904412242D6A8AF151BD4641916" 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="H58D4B2FF43FF45F883D857DA980576E9" indent="up1"><enum>(C)</enum><text>The Secretary shall review each plan
submitted under subparagraph (B) and approve it if the plan—</text>
<clause id="H553F9074888C4777BB31EEAFB4DD42AF"><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="H9EB7EEB5214B4F21A3E6A0A4F4EBD13B"><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="HE853D94EED874132AE2FE377AD316DBD" indent="up1"><enum>(D)</enum><text>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 is not labeled in accordance with the requirements of this
subsection.</text>
</subparagraph></paragraph></subsection><subsection id="H5FB4800D7336427C93D8833BFAA100A2"><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>
</section><section id="HA14B34A5932E49F5BC151EA0378C432E"><enum>205.</enum><header>Authority to
revise Smokeless Tobacco product warning label statements</header><text display-inline="no-display-inline">Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as amended by section
204, is further amended by adding at the end the following:</text>
<quoted-block id="H3E1B6B410C8744288010D0E46B9DF152" style="OLC">
<subsection id="HB28D7DDA8EB04F4D918D422DBF00F2E"><enum>(d)</enum><header>Authority To
Revise Warning Label Statements</header><text>The Secretary may, by a
rulemaking conducted under section 553 of title 5, United States Code, adjust
the format, type size, and text of any of the label requirements, require color
graphics to accompany the text, increase the required label area from 30
percent up to 50 percent of the front and rear panels of the package, or
establish the format, type size, and text of any other disclosures required
under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, 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>
</section><section id="H3997786BD65C4E91AA372361A1F8E25E"><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 (15 U.S.C. 1333), as amended by sections 201 and 202, is
further amended by adding at the end the following:</text>
<quoted-block id="HF1D1F5DB669140FCB79431B13462891F" style="OLC">
<subsection id="HA7639A5EAD3A40FCBCF91845AD0404AC"><enum>(e)</enum><header>Tar, nicotine,
and other smoke constituent disclosure</header>
<paragraph display-inline="no-display-inline" id="H174A1D66C3824EEB8E97C08004663F0"><enum>(1)</enum><header>In
general</header><text>The Secretary shall, by a rulemaking conducted under
section 553 of title 5, United States Code, determine (in the Secretary’s sole
discretion) whether cigarette and other tobacco product manufacturers shall be
required to include in the area of each cigarette advertisement specified by
subsection (b) of this section, or on the package label, or both, the tar and
nicotine yields of the advertised or packaged brand. Any such disclosure shall
be in accordance with the methodology established under such regulations, shall
conform to the type size requirements of subsection (b) of this section, and
shall appear within the area specified in subsection (b) of this
section.</text>
</paragraph><paragraph id="idAE7F536E19554F3CAB1EE221E0E7BDD9"><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="id39A0088BC3A346ADB73377EA79486607"><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 section 553 of title 5, United States Code, prescribe disclosure
requirements regarding the level of any cigarette or other tobacco product
constituent including any smoke constituent. Any such disclosure may be
required if the Secretary determines that disclosure would be of benefit to the
public health, or otherwise would increase consumer awareness of the health
consequences of the use of tobacco products, except that no such prescribed
disclosure shall be required on the face of any cigarette package or
advertisement. Nothing in this section shall prohibit the Secretary from
requiring such prescribed disclosure through a cigarette or other tobacco
product package or advertisement insert, or by any other means under the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>.</text>
</paragraph><paragraph id="id0726AD12ACF04486A96C540D6BC6B303"><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, except that this
subsection shall not relieve a retailer of liability if the retailer sells or
distributes tobacco products that are not labeled in accordance with the
requirements of subsection
(a).</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="H106C8BA9F61F442694F7D6011479CB2E"><enum>301.</enum><header>Labeling,
recordkeeping, records inspection</header><text display-inline="no-display-inline">Chapter IX of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, as added by section 101, is further amended by adding at the
end the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H9E532997688C4A4EAF56C4E742843749" style="OLC">
<section id="HEAFD24D5234C41C7B6DC670023F7B475"><enum>921.</enum><header>Labeling,
recordkeeping, records inspection</header>
<subsection id="H03D02FE0E65C445AA26B2300EE4C6BA0"><enum>(a)</enum><header>Origin
Labeling</header><text>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>
</subsection><subsection id="H442AAA8781F44EADB800FBED9D70A91D"><enum>(b)</enum><header>Regulations
Concerning Recordkeeping for Tracking and Tracing</header>
<paragraph id="H2061B05A59A44CBDBF42F4BB428D8EC"><enum>(1)</enum><header>In
general</header><text>Not later than 9 months after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act, 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="H2F1C0846549C43178B2FC523A2F6ED9"><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="H7737A3F0575C457C83AB00B8CCA618F1"><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="HD1AAC328286C4094B5398D2239A4797D"><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="HA7681925D7414E20A189FD41EBDC32B2"><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="H4A1B9181F6D84675ADBF851ECF712D48"><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.</text>
</subsection><subsection id="H06DA82A61ED7465392ED388D897466"><enum>(d)</enum><header>Knowledge of
Illegal Transaction</header>
<paragraph display-inline="no-display-inline" id="H3C9E4566A0144113AAD550EDCE2D9DD0"><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="HD0C9FD71E9624E6000245DD672056B92"><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="H485CB5FDD9C2419CB2B871FADA6C941D"><enum>(B)</enum><text>imported,
exported, distributed or diverted for possible illicit marketing,</text>
</subparagraph></paragraph><continuation-text continuation-text-level="subsection">the
manufacturer or distributor shall promptly notify the Attorney General of such
knowledge.</continuation-text><paragraph id="HB1B50670A16B4AB48222984307D900B2"><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="HE3D7472CFD644841B9A087D061E79186"><enum>(A)</enum><text>the actual
knowledge that the manufacturer or distributor had; or</text>
</subparagraph><subparagraph id="HB7F95095081D467DBBC5F6C94350CFEA"><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></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H3DB06D1520AE4FE4BB822CE397511BBE"><enum>302.</enum><header>Study and
report</header>
<subsection id="HEEC83FC3E3864F4D9B00CDAFB62D2468"><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="HF4535954D32344318DC9626F2E7BBE6"><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="H6654641D41CF4FCA8765AFD8F3B80633"><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.</text>
</paragraph></subsection><subsection id="HA88E3DA4E626438187FE16839B1A464"><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></section>