1.Short title; table of
contents
(a)This Act may be cited as the Youth Prevention and Tobacco Harm Reduction
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.
Sec. 6. Effective date.
Title I—AUTHORITY OF THE TOBACCO HARM REDUCTION
CENTER
Sec. 100. Definitions.
Sec. 101. Center authority over tobacco products.
Sec. 102. Exclusion of other regulatory programs.
Sec. 103. Existing Federal statutes maintained.
Sec. 104. Proceedings in the name of the United States;
subpoenas; preemption of State and local law; no private right of
action.
Sec. 105. Illicit trade.
Sec. 106. Adulterated tobacco products.
Sec. 107. Misbranded tobacco products.
Sec. 108. Submission of health information to the
Administrator.
Sec. 109. Registration and listing.
Sec. 110. General provisions respecting control of tobacco
products.
Sec. 111. Smoking article standards.
Sec. 112. Notification and other remedies.
Sec. 113. Records and reports on tobacco products.
Sec. 114. Application for review of certain smoking
articles.
Sec. 115. Modified risk tobacco products.
Sec. 116. Judicial review.
Sec. 117. Jurisdiction of and coordination with the Federal
Trade Commission.
Sec. 118. Regulation requirement.
Sec. 119. Preservation of State and local
authority.
Sec. 120. Tobacco Products Scientific Advisory
Committee.
Sec. 121. Drug products used to treat tobacco
dependence.
Sec. 122. Advertising and marketing of tobacco
products.
Title II—TOBACCO PRODUCTS WARNINGS; CONSTITUENT AND SMOKE
CONSTITUENT DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Smokeless tobacco labels and advertising
warnings.
Title III—PUBIC DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS
Sec. 301. Disclosures on packages of tobacco
products.
Sec. 302. Disclosures on packages of smokeless
tobacco.
Sec. 303. Public disclosure of ingredients.
Title IV—PREVENTION OF ILLICIT TRADE IN TOBACCO
PRODUCTS
Sec. 401. Study and report on illicit trade.
Sec. 402. Amendment to section 1926 of the Public Health
Service Act.
Sec. 403. Establishment of rankings.
Title V—ENFORCEMENT PROVISIONS
Sec. 501. Prohibited acts.
Sec. 502. Injunction proceedings.
Sec. 503. Penalties.
Sec. 504. Seizure.
Sec. 505. Report of minor violations.
Sec. 506. Inspection.
Sec. 507. Effect of compliance.
Sec. 508. Imports.
Sec. 509. Tobacco products for export.
Title VI—MISCELLANEOUS PROVISIONS
Sec. 601. Use of payments under the master settlement agreement
and individual State settlement agreements.
Sec. 602. Preemption of State Laws Implementing Fire Safety
Standard for Cigarettes.
Sec. 603. Inspection by the alcohol and tobacco tax trade
bureau of records of certain cigarette and smokeless tobacco
sellers.
Sec. 604. Severability.
Title VII—TOBACCO GROWER PROTECTION
Sec. 701. Tobacco grower protection.
2.The Congress finds the following:
(1)Cigarette smoking
is a leading cause of preventable deaths in the United States. Cigarette
smoking significantly increases the risk of developing lung cancer, heart
disease, chronic bronchitis, emphysema and other serious diseases with adverse
health conditions.
(2)The risk for
serious diseases is significantly affected by the type of tobacco product and
the frequency, duration and manner of use.
(3)No tobacco product
has been shown to be safe and without risks. The health risks associated with
cigarettes are significantly greater than those associated with the use of
smoke-free tobacco and nicotine products.
(4)Nicotine in
tobacco products is addictive but is not considered a significant threat to
health.
(5)It is the smoke
inhaled from burning tobacco which poses the most significant risk of serious
diseases.
(6)Quitting cigarette
smoking significantly reduces the risk for serious diseases.
(7)Adult tobacco
consumers have a right to be fully and accurately informed about the risks of
serious diseases, the significant differences in the comparative risks of
different tobacco and nicotine-based products, and the benefits of quitting.
This information should be based on sound science.
(8)Governments,
public health officials, tobacco manufacturers and others share a
responsibility to provide adult tobacco consumers with accurate information
about the various health risks and comparative risks associated with the use of
different tobacco and nicotine products.
(9)Tobacco products
should be regulated in a manner that is designed to achieve significant and
measurable reductions in the morbidity and mortality associated with tobacco
use. Regulations should enhance the information available to adult consumers to
permit them to make informed choices, and encourage the development of tobacco
and nicotine products with lower risks than cigarettes currently sold in the
United States.
(10)The form of
regulation should be based on the risks and comparative risks of tobacco and
nicotine products and their respective product categories.
(11)The regulation of
marketing of tobacco products should be consistent with constitutional
protections and enhance an adult consumer’s ability to make an informed choice
by providing accurate information on the risks and comparative risks of tobacco
products.
(12)Reducing the
diseases and deaths associated with the use of cigarettes serves public health
goals and is in the best interest of consumers and society. Harm reduction
should be the critical element of any comprehensive public policy surrounding
the health consequences of tobacco use.
(13)Significant
reductions in the harm associated with the use of cigarettes can be achieved by
providing accurate information regarding the comparative risks of tobacco
products to adult tobacco consumers, thereby encouraging smokers to migrate to
the use of smoke-free tobacco and nicotine products, and by developing new
smoke-free tobacco and nicotine products and other actions.
(14)Governments,
public health officials, manufacturers, tobacco producers and consumers should
support the development, production, and commercial introduction of tobacco
leaf, and tobacco and nicotine-based products that are scientifically shown to
reduce the risks associated with the use of existing tobacco products,
particularly cigarettes.
(15)Adult tobacco
consumers should have access to a range of commercially viable tobacco and
nicotine-based products.
(16)There is
substantial scientific evidence that selected smokeless tobacco products can
satisfy the nicotine addiction of inveterate smokers while eliminating most, if
not all, risk of pulmonary and cardiovascular complications of smoking and
while reducing the risk of cancer by more than 95 percent.
(17)Transitioning
smokers to selected smokeless tobacco products will eliminate environmental
tobacco smoke and fire-related hazards.
(18)Current
abstain, quit, or die
tobacco control policies in the United
States may have reached their maximum possible public health benefit because of
the large number of cigarette smokers either unwilling or unable to discontinue
their addiction to nicotine.
(19)There is evidence
that harm reduction works and can be accomplished in a way that will not
increase initiation or impede smoking cessation.
(20)Health-related
agencies and organizations, both within the United States and abroad have
already gone on record endorsing Harm Reduction as an approach to further
reducing tobacco related illness and death.
(21)Current Federal
policy requires tobacco product labeling that leaves the incorrect impression
that all tobacco product present equal risk.
3.The purposes of this Act are—
(1)to provide authority to the Tobacco Harm
Reduction Center by recognizing it as the primary Federal regulatory authority
with respect to tobacco products as provided for in this Act;
(2)to ensure that the
Center 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
Center 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 Center
with the authority to regulate the levels of tar, nicotine, and other harmful
components of tobacco products;
(6)to ensure that
consumers are better informed regarding the relative risks for death and
disease between categories of tobacco products;
(7)to continue to
allow 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
prevention, cessation, and harm reduction policies and regulations to reduce
disease risk and the social costs associated with tobacco-related
diseases;
(10)to provide
authority to the Department of Health and Human Services to regulate tobacco
products;
(11)to establish
national policies that effectively reduce disease and death associated with
cigarette smoking and other tobacco use;
(12)to establish
national policies that encourage prevention, cessation, and harm reduction
measures regarding the use of tobacco products;
(13)to encourage
current cigarette smokers who will not quit to use noncombustible tobacco or
nicotine products that have significantly less risk than cigarettes;
(14)to establish
national policies that accurately and consistently inform adult tobacco
consumers of significant differences in risk between respective tobacco
products;
(15)to establish
national policies that encourage and assist the development and awareness of
noncombustible tobacco and nicotine products;
(16)to coordinate
national and State prevention, cessation, and harm reduction programs;
(17)to impose
measures to ensure tobacco products are not sold or accessible to underage
purchasers; and
(18)to strengthen
Federal and State legislation to prevent 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;
(2)affect any action
pending in Federal, State, or Tribal court, or any agreement, consent decree,
or contract of any kind; or
(3)be applicable to
tobacco products or component parts manufactured in the United States for
export.
(b)The provisions of this Act (or an amendment made by
this Act) which authorize the Administrator to take certain actions with regard
to tobacco and tobacco products shall not be construed to affect any authority
of the Secretary of Agriculture under existing law regarding the growing,
cultivation, or curing of raw tobacco.
(c)The provisions of this Act (or an amendment made by
this Act) which authorize the Administrator to take certain actions with regard
to tobacco products shall not be construed to affect any authority of the
Secretary of the Treasury under chapter 52 of the Internal Revenue Code of
1986.
5.If any provision of this Act, 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.
6.Except as otherwise
specifically provided, the effective date of this Act shall be the date of its
enactment.
<enum>I</enum><header>AUTHORITY OF THE
TOBACCO HARM REDUCTION CENTER</header>
<section id="H020F3E16175B4DEE9315850101971393"><enum>100.</enum><header>Definitions</header><text display-inline="no-display-inline">In this Act:</text>
<paragraph id="HB2740E9A2F56425180E36881B52BBC8D"><enum>(1)</enum><text>The term
<term>Administrator</term> means the chief executive of the Tobacco Harm
Reduction Center.</text>
</paragraph><paragraph id="H70A1A8A3FE6F454EB2FE921B32AA7E18"><enum>(2)</enum><text>The term
<term>adult</term> means any individual who has attained the minimum age under
applicable State law to be an individual to whom tobacco products may lawfully
be sold.</text>
</paragraph><paragraph id="H27632959D3CF4E7F8C955BB295E98A84"><enum>(3)</enum><text>The term
<term>adult-only facility</term> means a facility or restricted area, whether
open-air or enclosed, where the operator ensures, or has a reasonable basis to
believe, that no youth is present. A facility or restricted area need not be
permanently restricted to adults in order to constitute an adult-only facility,
if the operator ensures, or has a reasonable basis to believe, that no youth is
present during any period of operation as an adult-only facility.</text>
</paragraph><paragraph id="HAB85D50991164B25B0DC03F3DF134AE6"><enum>(4)</enum><text>The term
<term>affiliate</term> means a person that directly or indirectly owns or
controls, is owned or controlled by, or is under common ownership or control
with, another person. The terms <term>owns,</term><quote>is owned</quote>, and
<quote>ownership</quote> refer to ownership of an equity interest, or the
equivalent thereof, of 50 percent or more.</text>
</paragraph><paragraph id="HC4319F10F35543B4AC2986EF5A860960"><enum>(5)</enum><text>The term
<term>annual report</term> means a tobacco product manufacturer’s annual report
to the Center, which provides ingredient information and nicotine yield ratings
for each brand style that tobacco product manufacturer manufactures for
commercial distribution domestically.</text>
</paragraph><paragraph id="H829F570CCA1748AEBB71B57D48B5AB3A"><enum>(6)</enum><text>The term
<term>brand name</term> means a brand name of a tobacco product distributed or
sold domestically, alone, or in conjunction with any other word, trademark,
logo, symbol, motto, selling message, recognizable pattern of colors, or any
other indicium of product identification identical or similar to, or
identifiable with, those used for any domestic brand of tobacco product. The
term shall not include the corporate name of any tobacco product manufacturer
that does not, after the effective date of this Act, sell a brand style of
tobacco product in the United States that includes such corporate name.</text>
</paragraph><paragraph id="H3781CFCCC40D40E39F1E78EE5755F90B"><enum>(7)</enum><text>The term
<term>brand style</term> means a tobacco product having a brand name, and
distinguished by the selection of the tobacco, ingredients, structural
materials, format, configuration, size, package, product descriptor, amount of
tobacco, or yield of <quote>tar</quote> or nicotine.</text>
</paragraph><paragraph id="HCBC8FAA408F243CC9BB95B0DCACE8BC5"><enum>(8)</enum><text>The term
<term>Center</term> means the Tobacco Harm Reduction Center.</text>
</paragraph><paragraph id="HCC723760336146F49A0919794D4B6261"><enum>(9)</enum><text>The term
<term>cigar</term> has the meaning assigned that term by the Alcohol and
Tobacco Tax and Trade Bureau in section 40.11 of title 27, Code of Federal
Regulations.</text>
</paragraph><paragraph id="H60D6DF0A289644E1BAC5E97F24E3396A"><enum>(10)</enum><text>The term
<term>cigarette</term> means—</text>
<subparagraph id="H75AF1ED4D95C45BDB0DC11CAC87F1A33"><enum>(A)</enum><text>any roll of
tobacco wrapped in paper or in any substance not containing tobacco; or</text>
</subparagraph><subparagraph id="HC8E2658DA2A748768AD5F8BD68A5AC8A"><enum>(B)</enum><text>any roll of
tobacco wrapped in any substance containing tobacco which, because of the
appearance of the roll of tobacco, the type of tobacco used in the filler, or
its package or labeling, is likely to be offered to, or purchased by, consumers
as a cigarette described in paragraph (1).</text>
</subparagraph></paragraph><paragraph id="HE1AF46E05A944E2496DB9BB7FD9C5663"><enum>(11)</enum><text>The term
<term>competent and reliable scientific evidence</term> means evidence based on
tests, analyses, research, or studies, conducted and evaluated in an objective
manner by individuals qualified to do so, using procedures generally accepted
in the relevant scientific disciplines to yield accurate and reliable
results.</text>
</paragraph><paragraph id="HD9B898ACF0944452BCFDA4EA10BF4D29"><enum>(12)</enum><text>The term
<term>distributor</term> means any person who furthers the distribution of
tobacco products, whether domestic or imported, at any point from the original
place of manufacture to the person who sells or distributes the tobacco product
to individuals for personal consumption. Common carriers, retailers, and those
engaged solely in advertising are not considered distributors for purposes of
this Act.</text>
</paragraph><paragraph id="HF9ABD45E01B944D789F6A059575328D1"><enum>(13)</enum><text>The terms
<term>domestic</term> and <term>domestically</term> mean within the United
States, including activities within the United States involving advertising,
marketing, distribution, or sale of tobacco products that are intended for
consumption within the United States.</text>
</paragraph><paragraph id="HC7833D55847246B0938BE19F92FD2D65"><enum>(14)</enum><text>The term
<term>illicit tobacco product</term> means any tobacco product intended for use
by consumers in the United States—</text>
<subparagraph id="H24C7B12848D340AFA29DFC68A1669F2A"><enum>(A)</enum><text>as to which not
all applicable duties or taxes have been paid in full;</text>
</subparagraph><subparagraph id="HDBFBB233D32540C79EE904E3A4E8D4EF"><enum>(B)</enum><text>that has been
stolen, smuggled, or is otherwise contraband;</text>
</subparagraph><subparagraph id="HF81814904DD34712B3CF1E7D840FE76D"><enum>(C)</enum><text>that is
counterfeit; or</text>
</subparagraph><subparagraph id="HC22B117A2D974E9EB56AB1848F6F5300"><enum>(D)</enum><text>that has or had a
label, labeling, or packaging stating, or that stated, that the product is or
was for export only, or that it is or was at any time restricted by section
5704 of title 26, United States Code.</text>
</subparagraph></paragraph><paragraph id="H95FD60BA444F4215B0914F4A78099636"><enum>(15)</enum><text>The term
<term>illicit trade</term> means any transfer, distribution, or sale in
interstate commerce of any illicit tobacco product.</text>
</paragraph><paragraph id="H5FA4DD03497444C7A833D5024D71D413"><enum>(16)</enum><text>The term
<term>immediate container</term> does not include package liners.</text>
</paragraph><paragraph id="H8A376B70C47C4A61879D6F934068BFFB"><enum>(17)</enum><text>The term
<term>Indian tribe</term> has the meaning assigned that term in section 4(e) of
the Indian Self Determination and Education Assistance Act.</text>
</paragraph><paragraph id="H6536F9F70FFC46D48A98A46052E19296"><enum>(18)</enum><text>The term
<term>ingredient</term> means tobacco and any substance added to tobacco to
have an effect in the final tobacco product or when the final tobacco product
is used by a consumer.</text>
</paragraph><paragraph id="H0F79679D912D48979828ADDF2B18510A"><enum>(19)</enum><text display-inline="yes-display-inline">The term <term>International Organization
for Standardization (ISO) testing regimen</term> means the methods for
measuring cigarette smoke yields, as set forth in the most recent version of
ISO 3308, entitled <quote>Routine analytical cigarette-smoking
machine—Definition of standard conditions”; ISO 4387, entitled
“Cigarettes—Determination of total and nicotine-free dry particulate matter
using a routine analytical smoking machine</quote>; ISO 10315, entitled
<quote>Cigarettes—Determination of nicotine in smoke
condensates—Gas-chromatographic method</quote>; ISO 10362–1, entitled
<quote>Cigarettes—Determination of water in smoke condensates—Part 1:
Gas-chromatographic method</quote>; and ISO 8454, entitled
<quote>Cigarettes—Determination of carbon monoxide in the vapour phase of
cigarette smoke—NDIR method</quote>. A cigarette that does not burn down in
accordance with the testing regimen standards may be measured under the same
puff regimen using the number of puffs that such a cigarette delivers before it
extinguishes, plus an additional three puffs, or with such other modifications
as the Administrator may approve.</text>
</paragraph><paragraph id="HB31BE4453B4E48CF8A5E865428E93879"><enum>(20)</enum><text>The term
<term>interstate commerce</term> means all trade, traffic, or other
commerce—</text>
<subparagraph id="H62353ADB21974E83A00178AFDBBFCC6A"><enum>(A)</enum><text>within the
District of Columbia, or any territory or possession of the United
States;</text>
</subparagraph><subparagraph id="HAB51304395F4494487EB7629438DBE4D"><enum>(B)</enum><text>between any point
in a State and any point outside thereof;</text>
</subparagraph><subparagraph id="H0F4B823668494EB4A18E0EA1765C4B1C"><enum>(C)</enum><text>between points
within the same State through any place outside such State; or</text>
</subparagraph><subparagraph id="H07810BE0CB7E4A72B58B3D6B18627AA3"><enum>(D)</enum><text>over which the
United States has jurisdiction.</text>
</subparagraph></paragraph><paragraph id="H51ABC846AEBF489AB8A9B3974A34E553"><enum>(21)</enum><text>The term
<term>label</term> means a display of written, printed, or graphic matter upon
or applied securely to the immediate container of a tobacco product.</text>
</paragraph><paragraph id="HCB4978B94E824C02A76B6D0E2FE3B75C"><enum>(22)</enum><text>The term
<term>labeling</term> means all labels and other written, printed, or graphic
matter (1) upon or applied securely to any tobacco product or any of its
containers or wrappers, or (2) accompanying a tobacco product.</text>
</paragraph><paragraph id="H20E34A5E399A42128CEE7A763A394F07"><enum>(23)</enum><text>The term
<term>little cigar</term> has the meaning assigned that term by the Alcohol and
Tobacco Tax and Trade Bureau in section 40.11 of title 27, Code of Federal
Regulations.</text>
</paragraph><paragraph id="HC15AB6DB91964FDB943DBC994FBFD5B6"><enum>(24)</enum><text>The term
<term>loose tobacco</term> means any form of tobacco, alone or in combination
with any other ingredient or material, that, because of its appearance, form,
type, packaging, or labeling, is suitable for use and likely to be offered to,
or purchased by, consumers as tobacco for making or assembling cigarettes,
incorporation into pipes, or otherwise used by consumers to make any tobacco
product.</text>
</paragraph><paragraph id="H50ED490CAFE8453A8F66AFF44C8CAD74"><enum>(25)</enum><text>The term
<term>manufacture</term> means to design, manufacture, fabricate, assemble,
process, package, or repackage, label, or relabel, import, or hold or store in
a commercial quantity, but does not include—</text>
<subparagraph id="H718E48C030CF4C1BB105FE8C491078C0"><enum>(A)</enum><text>the growing,
curing, de-stemming, or aging of tobacco; or</text>
</subparagraph><subparagraph id="HD08804A87B93450FA0B192170EF0B709"><enum>(B)</enum><text>the holding,
storing or transporting of a tobacco product by a common carrier for hire, a
public warehouse, a testing laboratory, a distributor, or a retailer.</text>
</subparagraph></paragraph><paragraph id="HE6A0AEC19C0C475A81352D410F4C58F8"><enum>(26)</enum><text>The term
<term>nicotine-containing product</term> means a product, other than a tobacco
product, that contains added nicotine, whether or not in the form of a salt or
solvate, that has been—</text>
<subparagraph id="HC6C5F29ADE804EB8941ACE1D5F8300DE"><enum>(A)</enum><text>synthetically
produced, or</text>
</subparagraph><subparagraph id="HE280571C3B2242BC8A2B12D6CD9C256B"><enum>(B)</enum><text>obtained from
tobacco or other source of nicotine.</text>
</subparagraph></paragraph><paragraph id="HB2879DF8186B4697BE13D207DC5CD86A"><enum>(27)</enum><text>The term
<term>package</term> means a pack, box, carton, pouch, or container of any kind
in which a tobacco product or tobacco products are offered for sale, sold, or
otherwise distributed to consumers. The term <term>package</term> does not
include an outer container used solely for shipping one or more packages of a
tobacco product or tobacco products.</text>
</paragraph><paragraph id="H356DDBCF41364525858F1F45F80D88F4"><enum>(28)</enum><text>The term
<term>person</term> means any individual, partnership, corporation, committee,
association, organization or group of persons, or other legal or business
entity.</text>
</paragraph><paragraph id="H1B76762DFDDE4F08BA3B7CD190556CA3"><enum>(29)</enum><text>The term
<term>proof of age</term> means a driver’s license or other form of
identification that is issued by a governmental authority and includes a
photograph and a date of birth of the individual.</text>
</paragraph><paragraph id="HEF45F86F7871437E93CB6BC1AFE64F7C"><enum>(30)</enum><text>The term
<term>raw tobacco</term> means tobacco in a form that is received by a tobacco
product manufacturer as an agricultural commodity, whether in a form that is
natural, stem, or leaf, cured or aged, or as parts or pieces, but not in a
reconstituted form, extracted pulp form, or extract form.</text>
</paragraph><paragraph id="H272F1EE0E7E84FD086B801788A95E34A"><enum>(31)</enum><text>The term
<term>reduced-exposure claim</term> means a statement in advertising or
labeling intended for one or more consumers of tobacco products, that a tobacco
product provides a reduced exposure of users of that tobacco product to one or
more toxicants, as compared to an appropriate reference tobacco product or
category of tobacco products. A statement or representation that a tobacco
product or the tobacco in a tobacco product contains <quote>no
additives</quote> or is <quote>natural</quote> or that uses a substantially
similar term is not a reduced-exposure claim if the advertising or labeling
that contains such statement or representation also contains the disclosure
required by section 108(h) of this Act.</text>
</paragraph><paragraph id="HEE04A3F5866841389EB5469AFB0185E5"><enum>(32)</enum><text>The term
<term>reduced-risk claim</term> means a statement in advertising or labeling
intended for one or more consumers of smoking articles, that a smoking article
provides to users of that product a reduced risk of morbidity or mortality
resulting from one or more chronic diseases or serious adverse health
conditions associated with tobacco use, as compared to an appropriate reference
smoking article or category of smoking articles, even if it is not stated,
represented, or implied that all health risks associated with using that
smoking article have been reduced or eliminated. A statement or representation
that a smoking article or the tobacco in a smoking article contains <quote>no
additives,</quote> or is <quote>natural,</quote> or that uses a substantially
similar term is not a reduced-risk claim if the advertising or labeling that
contains such statement or representation also contains the disclosure required
by section 108(h).</text>
</paragraph><paragraph id="H9013CE90F2E34149A78510866D7C884C"><enum>(33)</enum><text>The term
<term>retailer</term> means any person that—</text>
<subparagraph id="HE2BA1A0D71C94B3884B87D3E75CFB29C"><enum>(A)</enum><text>sells tobacco
products to individuals for personal consumption; or</text>
</subparagraph><subparagraph id="HF822F2B57A86445C82131B67B9722F9D"><enum>(B)</enum><text>operates a
facility where the sale of tobacco products to individuals for personal
consumption is permitted.</text>
</subparagraph></paragraph><paragraph id="H9E3F49F054104CB5A112C151BFD59B9B"><enum>(34)</enum><text>The term
<term>small business</term> means a tobacco product manufacturer that—</text>
<subparagraph id="H2F14FB5674BB45F2A65C7B74FC5F1D1D"><enum>(A)</enum><text>has 150 or fewer
employees; and</text>
</subparagraph><subparagraph id="HBB946D96462440BB9513EBD19292BB92"><enum>(B)</enum><text>during the 3-year
period prior to the current calendar year, had an average annual gross revenue
from tobacco products that did not exceed $40,000,000.</text>
</subparagraph></paragraph><paragraph id="HDD4832E22C234F09933444E8DF581F9D"><enum>(35)</enum><text>The term
<term>smokeless tobacco product</term> means any form of finely cut, ground,
powdered, reconstituted, processed or shaped tobacco, leaf tobacco, or stem
tobacco, whether or not combined with any other ingredient, whether or not in
extract or extracted form, and whether or not incorporated within any carrier
or construct, that is intended to be placed in the oral or nasal cavity,
including dry snuff, moist snuff, and chewing tobacco.</text>
</paragraph><paragraph id="HB45FDF13E0A54E4F9397D4FD665D653D"><enum>(36)</enum><text>The term
<term>smoking article</term> means any tobacco-containing article that is
intended, when used by a consumer, to be burned or otherwise to employ heat to
produce a vapor, aerosol or smoke that—</text>
<subparagraph id="H5309895A9680492BACD1C21F11CE5BC4"><enum>(A)</enum><text>incorporates
components of tobacco or derived from tobacco; and</text>
</subparagraph><subparagraph id="H5AC545C9CF614C44AC2B5ED7FC7A83B8"><enum>(B)</enum><text>is intended to be
inhaled by the user.</text>
</subparagraph></paragraph><paragraph id="H464F43D4E1EE45C8AE292424D62DA91F"><enum>(37)</enum><text>The term
<term>State</term> means any State of the United States and, except as
otherwise specifically provided, includes any Indian tribe or tribal
organization, the District of Columbia, the Commonwealth of Puerto Rico, Guam,
the Virgin Islands, American Samoa, Wake Island, Midway Island, Kingman Reef,
Johnston Atoll, the Northern Marianas, and any other trust territory or
possession of the United States.</text>
</paragraph><paragraph id="HD930A1559C2C4329A843AEFAAB6E4D38"><enum>(38)</enum><text display-inline="yes-display-inline">The term <term>tar</term> means
nicotine-free dry particulate matter as defined in ISO 4387, entitled
<quote>Cigarettes—Determination of total and nicotine-free dry particulate
matter using a routine analytical smoking machine</quote>.</text>
</paragraph><paragraph id="HF3BEAAC2B7034888870C1A9111F72627"><enum>(39)</enum><text>The term
<term>tobacco</term> means a tobacco plant or any part of a harvested tobacco
plant intended for use in the production of a tobacco product, including leaf,
lamina, stem, or stalk, whether in green, cured, or aged form, whether in raw,
treated, or processed form, and whether or not combined with other materials,
including any by-product, extract, extracted pulp material, or any other
material (other than purified nicotine) derived from a tobacco plant or any
component thereof, and including strip, filler, stem, powder, and granulated,
blended, or reconstituted forms of tobacco.</text>
</paragraph><paragraph id="H5E7951B9B93E4F75A4863ECC66A28A32"><enum>(40)</enum><text>The term
<term>tobacco product</term> means—</text>
<subparagraph id="HB7CE20CC85B941C492F2D586DD9011E2"><enum>(A)</enum><text>the singular of
<quote>tobacco products</quote> as defined in section 5702(c) of the Internal
Revenue Code of 1986;</text>
</subparagraph><subparagraph id="H8B309A1F07324D8A8D0AC1E2585E2432"><enum>(B)</enum><text>any other product
that contains tobacco as a principal ingredient and that, because of its
appearance, type, or the tobacco used in the product, or its packaging and
labeling, is likely to be offered to, or purchased by, consumers as a tobacco
product as described in subparagraph (A); and</text>
</subparagraph><subparagraph id="H14E4D11F382342F48AA35E182DDF5EBF"><enum>(C)</enum><text>any form of
tobacco or any construct incorporating tobacco, intended for human consumption,
whether by—</text>
<clause id="H4427A9E838F845AF9AA467A1CBCDE2D6"><enum>(i)</enum><text>placement in the
oral or nasal cavity;</text>
</clause><clause id="H37FE9806AACE4013882D15C446D0687D"><enum>(ii)</enum><text>inhalation of
vapor, aerosol, or smoke; or</text>
</clause><clause id="H16DBD1CB71034815A97BD90769AAD14C"><enum>(iii)</enum><text>any other
means.</text>
</clause></subparagraph></paragraph><paragraph id="H8382A026E2AC467280A7AB75FF8C6C21"><enum>(41)</enum><text>The term
<term>tobacco product category</term> means a type of tobacco product
characterized by its composition, components, and intended use, and includes
tobacco products classified as cigarettes, loose tobacco for roll-your-own
tobacco products, little cigars, cigars, pipe tobacco, moist snuff, dry snuff,
chewing tobacco, and other forms of tobacco products (which are treated in this
Act collectively as a single category).</text>
</paragraph><paragraph id="H6A41EEC68247404B9FBD25DB31580568"><enum>(42)</enum><text>The term
<term>tobacco product communication</term> means any means, medium, or manner
for providing information relating to any tobacco product, including
face-to-face interaction, mailings by postal service or courier to an
individual who is an addressee, and electronic mail to an individual who is an
addressee.</text>
</paragraph><paragraph id="H2701F5A0D68C41DCA91EDE6F6C9EE32C"><enum>(43)</enum><text>The term
<term>tobacco product manufacturer</term> means an entity that directly—</text>
<subparagraph id="H47817586361A499E819AB4D0857FE03C"><enum>(A)</enum><text>manufactures
anywhere a tobacco product that is intended to be distributed commercially in
the United States, including a tobacco product intended to be distributed
commercially in the United States through an importer;</text>
</subparagraph><subparagraph id="H08CB65621AB241F3AEE0B2C2F253D6A3"><enum>(B)</enum><text>is the first
purchaser for resale in the United States of tobacco products manufactured
outside the United States for distribution commercially in the United States;
or</text>
</subparagraph><subparagraph id="H7016E3F987DC4FCD92B6B3847F036260"><enum>(C)</enum><text>is a successor or
assign of any of the foregoing.</text>
</subparagraph></paragraph><paragraph id="H25A2A99F376D404CA611358D22DB428B"><enum>(44)</enum><text>The term
<term>toxicant</term> means a chemical or physical agent that produces an
adverse biological effect.</text>
</paragraph><paragraph id="H7F581CAF7FBA4F0388E2760076E0B0AC"><enum>(45)</enum><text>The term
<term>tribal organization</term> has the meaning assigned that term in section
4(1) of the Indian Self Determination and Education Assistance Act.</text>
</paragraph><paragraph id="HF3CA0561D79943D694CA4D7F68217147"><enum>(46)</enum><text>The term
<term>United States</term> means the several States, as defined in this
Act.</text>
</paragraph><paragraph id="H5F4220C0C84B44B1BF2B78E859D1987F"><enum>(47)</enum><text>The term
<term>youth</term> means any individual who in not an adult.</text>
</paragraph></section><section id="H579522A143BA4A6886E2D9312BD6112A"><enum>101.</enum><header>Center
authority over tobacco products</header>
<subsection id="HC6B7F6FC9D78413EA2ABEE1C08300EC4"><enum>(a)</enum><header>In
general</header><text>Tobacco products, including modified risk tobacco
products for which an order has been issued in accordance with section 117,
shall be regulated by the Administrator under this Act.</text>
</subsection><subsection id="H7024203519054569AC578515A633DBFF"><enum>(b)</enum><header>Applicability</header><text display-inline="yes-display-inline">This Act shall apply to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any
other tobacco products that the Administrator by regulation deems to be subject
to this Act.</text>
</subsection><subsection id="HFBDA301535384EBD897B4C06764D1C4B"><enum>(c)</enum><header>Center</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
shall establish within the Department of Health and Human Services the Tobacco
Harm Reduction Center. The head of the Center shall be an Administrator, who
shall assume the statutory authority conferred by this Act, perform the
functions that relate to the subject matter of this Act, and have the authority
to promulgate regulations for the efficient enforcement of this Act. In
promulgating any regulations under such authority, in whole or in part or any
regulation that is likely to have an annual effect on the economy of
$50,000,000 or more or have a material adverse effect on adult users of tobacco
products, tobacco product manufacturers, distributors, or retailers, the
Administrator shall—</text>
<paragraph id="H6F4BB5761AE84B779B212ADE2183F659"><enum>(1)</enum><text>determine the
technological and economic ability of parties that would be required to comply
with the regulation to comply with it;</text>
</paragraph><paragraph id="H89986E1E9A194501B9332C748AFD814C"><enum>(2)</enum><text>consider
experience gained under any relevantly similar regulations at the Federal or
State level;</text>
</paragraph><paragraph id="H07163BB1D5224D9EA3C5C0DED02ABBFF"><enum>(3)</enum><text>determine the
reasonableness of the relationship between the costs of complying with such
regulation and the public health benefits to be achieved by such
regulation;</text>
</paragraph><paragraph id="H38DF8FFCE5EF40FBBA88C44433A9181E"><enum>(4)</enum><text>determine the
reasonable likelihood of measurable and substantial reductions in morbidity and
mortality among individual tobacco users;</text>
</paragraph><paragraph id="HE122B9842E584E85AE49982A7608A46C"><enum>(5)</enum><text>determine the
impact to United States tobacco producers and farm operations;</text>
</paragraph><paragraph id="HA9DBD8D0A1644AF7867C30F51B5D92A4"><enum>(6)</enum><text>determine the
impact on the availability and use of tobacco products by minors; and</text>
</paragraph><paragraph id="HE76B8E821EDC4C1A85DE551CADBC2A20"><enum>(7)</enum><text>determine the
impact on illicit trade of tobacco products.</text>
</paragraph></subsection><subsection id="H69C90846FBE440119A8C2F88FB072E96"><enum>(d)</enum><header>Limitation of
authority</header>
<paragraph id="H3A48AB3F95B3480DA591AE0AEEF85057"><enum>(1)</enum><header>In
general</header><text>The provisions of this Act 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 Center have any
authority to enter onto a farm owned by a producer of tobacco leaf without the
written consent of such producer.</text>
</paragraph><paragraph id="H5DBF477A14B84F3AABB0229BD7BC6DD0"><enum>(2)</enum><header>Exception</header><text>Notwithstanding
paragraph (1), 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 Act in the producer’s capacity as a manufacturer. The
exception in this subparagraph shall not apply to a producer of tobacco leaf
who grows tobacco under a contract with a tobacco product manufacturer and who
is not otherwise engaged in the manufacturing process.</text>
</paragraph><paragraph id="H1412A31F9A20415CAA66BF88B08FB667"><enum>(3)</enum><header>Rule of
construction</header><text>Nothing in this Act shall be construed to grant the
Administrator authority to promulgate regulations on any matter that involves
the production of tobacco leaf or a producer thereof.</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="HE0D15D0A89AF4DF19BC0B490BC975252"><enum>(e)</enum><header>Rulemaking
procedures</header><text display-inline="yes-display-inline">Each rulemaking
under this Act shall be in accordance with chapter 5 of title 5, United States
Code.</text>
</subsection><subsection id="HD9235D3CBBC5468FB748698F071CB3E4"><enum>(f)</enum><header>Consultation
prior to rulemaking</header><text display-inline="yes-display-inline">Prior to
promulgating rules under this Act, the Administrator shall endeavor to consult
with other Federal agencies as appropriate.</text>
</subsection></section><section id="HEDB00BD6F4094E47950859EEF0760B01"><enum>102.</enum><header>Exclusion of
other regulatory programs</header>
<subsection id="H7C3FD77BCE134BB0B43F7144DE3D9D1D"><enum>(a)</enum><header>Exclusion of
tobacco products and nicotine-containing products from the federal food, drug,
and cosmetic act</header><text>No tobacco product and no nicotine-containing
product shall be regulated as a food, drug, or device in accordance with
section 201 (f), (g) or (h) or Chapter IV or V of the Federal Food, Drug, and
Cosmetic Act, except that any tobacco product commercially distributed
domestically and any nicotine-containing product commercially distributed
domestically shall be subject to Chapter V of the Federal Food, Drug, and
Cosmetic Act if the manufacturer or a distributor of such product markets it
with an explicit claim that the product is intended for use in the cure,
mitigation, treatment, or prevention of disease in man or other animals, within
the meaning of section 201(g)(1)(C) or section 201(h)(2) of that Act.</text>
</subsection><subsection id="HA8C2F2068EA74E2A8D9B55967696F4B3"><enum>(b)</enum><header>Limitation on
effect of this act</header><text>Nothing in this Act shall be construed
to—</text>
<paragraph id="H47A754321AD04B46A182FEA883935F92"><enum>(1)</enum><text>establish a
precedent with regard to any other industry, situation, circumstance, or legal
action; or</text>
</paragraph><paragraph id="H71016D4BC89D42F7B37E60B66D476824"><enum>(2)</enum><text>affect any action
pending in any Federal, State, or Tribal court, or any agreement, consent
decree, or contract of any kind.</text>
</paragraph></subsection><subsection id="H3C99BC1C1F8948F8856BBC4972B8DBC7"><enum>(c)</enum><header>Exclusions from
authority of administrator</header><text>The authority granted to the
Administrator under this Act shall not apply to—</text>
<paragraph id="HF49035F9AA1C414D82A96B2FADEFD3AC"><enum>(1)</enum><text>raw tobacco that
is not in the possession or control of a tobacco product manufacturer;</text>
</paragraph><paragraph id="HBD46A9AF65B74639BED76EA944FDD529"><enum>(2)</enum><text>raw tobacco that
is grown for a tobacco product manufacturer by a grower, and that is in the
possession of that grower or of a person that is not a tobacco product
manufacturer and is within the scope of subparagraphs (A) through(F) of
paragraph (3); or</text>
</paragraph><paragraph id="HB183BFB608CB4FBA8E1A0E050F2DD9F2"><enum>(3)</enum><text>the activities,
materials, facilities, or practices of persons that are not tobacco product
manufacturers and that are—</text>
<subparagraph id="HC1B4583B9FAF49E28F85D0FD82AC6AE4"><enum>(A)</enum><text>producers of raw
tobacco, including tobacco growers;</text>
</subparagraph><subparagraph id="HD3B4F2B055F643639CDAA45A00AF556A"><enum>(B)</enum><text>tobacco
warehouses, and other persons that receive raw tobacco from growers;</text>
</subparagraph><subparagraph id="H82E9F7A00D834C4891284DB20E51571B"><enum>(C)</enum><text>tobacco grower
cooperatives;</text>
</subparagraph><subparagraph id="H93AD0F39A2E0495BA565B97E54673C6C"><enum>(D)</enum><text>persons that cure
raw tobacco;</text>
</subparagraph><subparagraph id="HC14B603A0E3745C4A6CDBE2A19879BA1"><enum>(E)</enum><text>persons that
process raw tobacco; and</text>
</subparagraph><subparagraph id="H4633AEB96AD048D186099FD5DC929EA6"><enum>(F)</enum><text>persons that store
raw tobacco for aging.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">If a
producer of raw tobacco is also a tobacco product manufacturer, an affiliate of
a tobacco product manufacturer, or a person producing raw tobacco for a tobacco
product manufacturer, then that producer shall be subject to this Act only to
the extent of that producer’s capacity as a tobacco product
manufacturer.</continuation-text></paragraph></subsection></section><section id="H53C5B4802A7149A0B0747D08313B7135"><enum>103.</enum><header>Existing
Federal statutes maintained</header><text display-inline="no-display-inline">Except as amended or repealed by this Act,
all Federal statutes in effect as of the effective date of this Act that
regulate tobacco, tobacco products, or tobacco product manufacturers shall
remain in full force and effect. Such statutes include, without
limitation—</text>
<paragraph id="H468404303CFB4592B454DA4DCE716CCA"><enum>(1)</enum><text>the Federal
Cigarette Labeling and Advertising Act, sections 1331–1340 of title 15, United
States Code, except that section 1335 of title 15, United States Code, is
repealed;</text>
</paragraph><paragraph id="H1B6B9E4AAB7E4FBC8D7582DDBD98C217"><enum>(2)</enum><text>the Comprehensive
Smokeless Tobacco Health Education Act of 1986, sections 4401–4408 of title 15,
United States Code, except that section 4402(f) of title 15, United States
Code, is repealed;</text>
</paragraph><paragraph id="H18E590B7082F47ADA1E78D39781626E7"><enum>(3)</enum><text>section 300x–26 of
title 42, United States Code; and</text>
</paragraph><paragraph id="H3E67BBACF7BF4F93BFFCCA4BB1D76D90"><enum>(4)</enum><text>those statutes
authorizing regulation of tobacco, tobacco products, or tobacco product
manufacturers by the Federal Trade Commission, the Department of Agriculture,
the Environmental Protection Agency, the Internal Revenue Service, and the
Alcohol and Tobacco Tax and Trade Bureau of the Department of the
Treasury.</text>
</paragraph></section><section id="HE369AC4460B2415FBF549A381187E578"><enum>104.</enum><header>Proceedings in
the name of the United States; subpoenas; preemption of State and local law; no
private right of action</header><text display-inline="no-display-inline">In
furtherance of this Act:</text>
<paragraph id="HA8FC7F7BE6B04C50928438EA5F0A40AE"><enum>(1)</enum><text>All proceedings
for the enforcement, or to restrain violations, of this Act shall be by and in
the name of the United States. Subpoenas for witnesses who are required to
attend a court of the United States, in any district, may run into any other
district in any proceeding under this section. No State, or political
subdivision thereof, may proceed or intervene in any Federal or State court
under this Act or under any regulation promulgated under it, or allege any
violation thereof except a violation by the Administrator. Nothing in this Act
shall be construed to create a right of action by any private person for any
violation of any provision of this Act or of any regulation promulgated under
it.</text>
</paragraph><paragraph id="HDC1331C5063C44688223EE3AFCEF185C"><enum>(2)</enum><text>With respect to
any subject matter addressed by this Act or by any regulation promulgated under
it, no requirement or prohibition shall be imposed under State or local law
upon any tobacco product manufacturer or distributor.</text>
</paragraph><paragraph id="H0F620E1F048545369C245911BF6710AD"><enum>(3)</enum><text>Paragraph (2)
shall not apply to any requirement or prohibition imposed under State or local
law before the date of introduction of the bill that was enacted as this
Act.</text>
</paragraph></section><section id="H4EBCBB39FF3748A6923578F7365F6129"><enum>105.</enum><header>Illicit
trade</header><text display-inline="no-display-inline">The Administrator shall
not promulgate any regulation or take any other action that has the effect
of—</text>
<paragraph id="H770B5670E3934920A4E97C3FB947A2A9"><enum>(1)</enum><text>increasing illicit
trade involving tobacco or any tobacco product, or</text>
</paragraph><paragraph id="HB47C5FDECED3468DB2B314EF8D68FFC0"><enum>(2)</enum><text>making affected
tobacco products unacceptable to a substantial number of then current users of
such products, thereby creating a substantial risk that such users will resort
to illicit tobacco products, or tobacco products that are otherwise
noncompliant or unlawful.</text>
</paragraph></section><section id="H041A64DEF3AF4E4D8482DDBAB43764EE"><enum>106.</enum><header>Adulterated
tobacco products</header><text display-inline="no-display-inline">A tobacco
product shall be deemed to be adulterated—</text>
<paragraph id="HE8E4CD0385284360BB24300D7DA0F87F"><enum>(1)</enum><text>if it bears or
contains any poisonous or deleterious substance other than—</text>
<subparagraph id="H025B16B11BC74F209165D6D8B351CD13"><enum>(A)</enum><text>tobacco;</text>
</subparagraph><subparagraph id="H67E0A7074F9444D091D6303CB9AF3794"><enum>(B)</enum><text>a substance
naturally present in tobacco;</text>
</subparagraph><subparagraph id="HE519039FAF1C44FB93E115F9B75F5BF3"><enum>(C)</enum><text>a pesticide or
fungicide chemical residue in or on tobacco if such pesticide or fungicide
chemical is registered by the Environmental Protection Agency for use on
tobacco in the United States; or</text>
</subparagraph><subparagraph id="HD15906B6C217467C87E8FFA26F002BF6"><enum>(D)</enum><text>in the case of
imported tobacco, a residue of a pesticide or fungicide chemical that—</text>
<clause id="H66E0AC16ECD248A789F4671B7BE513CE"><enum>(i)</enum><text>is
approved for use in the country of origin of the tobacco; and</text>
</clause><clause id="HCD608B74E63F4DB482F9066AD731ACAE"><enum>(ii)</enum><text>has
not been banned, and the registration of which has not been canceled, by the
Environmental Protection Agency for use on tobacco in the United States) that
may render it injurious to health; but, in case the substance is not an added
substance, such tobacco product shall not be considered adulterated under this
subsection if the quantity of such substance in such tobacco product does not
ordinarily render it injurious to health;</text>
</clause></subparagraph></paragraph><paragraph id="H6980995A47C54F168E01FE50A03BE43C"><enum>(2)</enum><text>if there is
significant scientific agreement that, as a result of the tobacco it contains,
the tobacco product presents a risk to human health that is materially higher
than the risk presented by—</text>
<subparagraph id="H324B7210BE9E471E8455FF7C6134C4CA"><enum>(A)</enum><text>such product on
the effective date of this Act; or</text>
</subparagraph><subparagraph id="H6CC367EFCBAA4B43BCCFAE1A7DD02BBA"><enum>(B)</enum><text>if such product
was not distributed commercially domestically on that date, by comparable
tobacco products of the same style and within the same category that were
commercially distributed domestically on that date;</text>
</subparagraph></paragraph><paragraph id="HC44A3A2E0BF846C8BAA6B6AAC9806ACE"><enum>(3)</enum><text>if it has been
prepared, packed, or held under unsanitary conditions whereby it may have
become contaminated with filth;</text>
</paragraph><paragraph id="H41F99F6C8FD44091AB5B28690A39D95F"><enum>(4)</enum><text>if its package is
composed, in whole or in part, of any poisonous or deleterious substance that
may render the contents injurious to health; or</text>
</paragraph><paragraph id="H54DF0F5B8F814067B19CC94280815AE2"><enum>(5)</enum><text>if its
<quote>tar</quote> yield is in violation of section 111.</text>
</paragraph></section><section id="HDFF37104B3034128BDD03EDE59A5E5B0"><enum>107.</enum><header>Misbranded
tobacco products</header><text display-inline="no-display-inline">A tobacco
product shall be deemed to be misbranded—</text>
<paragraph id="H21A0FAAD1E0442A880711A88C91D3924"><enum>(1)</enum><text>if its labeling is
false or misleading in any particular;</text>
</paragraph><paragraph id="HF89C7EFAC70744B3814162285FE1B25A"><enum>(2)</enum><text>if in package form
unless it bears a label containing—</text>
<subparagraph id="H8D5053C0264241A192B19527B7C0D9AA"><enum>(A)</enum><text>an identification
of the type of product it is, by the common or usual name of such type of
product;</text>
</subparagraph><subparagraph id="H2E70CAA960F5451CAC24C4B190D75C9E"><enum>(B)</enum><text>an accurate
statement of the quantity of the contents in the package in terms of weight,
measure, or numerical count, except that reasonable variations shall be
permitted, and exemptions as to small packages shall be established by
regulations promulgated by the Administrator;</text>
</subparagraph><subparagraph id="H41228682AFC54C88A28F3066C33E6130"><enum>(C)</enum><text>the name and place
of business of the tobacco product manufacturer, packer, or distributor;
and</text>
</subparagraph><subparagraph id="H4F8AF2FECF72498E8AF880446907EC9A"><enum>(D)</enum><text>the information
required by section 201(c) and (e) or section 202(c) and (e), as
applicable;</text>
</subparagraph></paragraph><paragraph id="H26AC8D936CC7464C9FCC6ACFEC42C55A"><enum>(3)</enum><text>if any word,
statement, or other information required by or under authority of this Act to
appear on the label, labeling, or advertising is not prominently placed thereon
with such conspicuousness (as compared with other words, statements, or designs
on the label, labeling, or advertising, as applicable) and in such terms as to
render it reasonably likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;</text>
</paragraph><paragraph id="H1F9FF76E979642AFB3FEE8DB381F298C"><enum>(4)</enum><text>if any word,
statement, or other information is required by or under this Act to appear on
the label, unless such word, statement, or other information also appears on
the outside container or wrapper, if any, of the retail package of such tobacco
product, or is easily legible through the outside container or wrapper;</text>
</paragraph><paragraph id="H0D3DAC26F37D4978829924437C07976E"><enum>(5)</enum><text>if it was
manufactured, prepared, or processed in an establishment not duly registered
under section 109, if it was not included in a list required by section 109, or
if a notice or other information respecting it was not provided as required by
section 109;</text>
</paragraph><paragraph id="HCAF91081DFA34278B567358F9E4990B8"><enum>(6)</enum><text>if its packaging,
labeling, or advertising is in violation of this Act or of an applicable
regulation promulgated in accordance with this Act;</text>
</paragraph><paragraph id="H8FD20B0029974BB98A8A19880B182C31"><enum>(7)</enum><text>if it contains
tobacco or another ingredient as to which a required disclosure under this Act
was not made;</text>
</paragraph><paragraph id="HD1F91CB093214FAEA69E2BD8A0309227"><enum>(8)</enum><text>if it is labeled
or advertised, or the tobacco contained in it is advertised, as—</text>
<subparagraph id="HE8259E6D8301421B86014E250C4002A2"><enum>(A)</enum><text>containing
<quote>no additives,</quote> or any substantially similar term, unless the
labeling or advertising, as applicable, also contains, clearly and prominently,
the following disclosure: <quote>No additives in our tobacco does NOT mean
safer.</quote>; or</text>
</subparagraph><subparagraph id="HD9B045CDE3074063A9F6726077B4F3D1"><enum>(B)</enum><text>being
<quote>natural,</quote> or any substantially similar term, unless the labeling
or advertising, as applicable, also contains, clearly and prominently, the
following disclosure: <quote>Natural does NOT mean safer.</quote>;</text>
</subparagraph></paragraph><paragraph id="H1ACEF12036E043CB9469CA0A644D5905"><enum>(9)</enum><text>if in its labeling
or advertising a term descriptive of the tobacco in the tobacco product is used
otherwise than in accordance with a sanction or approval granted by a Federal
agency;</text>
</paragraph><paragraph id="H1A51230A569C4AC79BE4B04BBFBFD65C"><enum>(10)</enum><text>if with respect
to such tobacco product a disclosure required by section 603 was not
made;</text>
</paragraph><paragraph id="H88973C06DA6843FE8A3C72DDB16B26A9"><enum>(11)</enum><text>if with respect
to such tobacco product a certification required by section 803 was not
submitted or is materially false or misleading; or</text>
</paragraph><paragraph id="H7C87C8EF070C41A985A6A9721CBB6E2F"><enum>(12)</enum><text>if its
manufacturer or distributor made with respect to it a claim prohibited by
section 115.</text>
</paragraph></section><section id="H82E6D853814B4888A2AC538EED1AC547"><enum>108.</enum><header>Submission of
health information to the Administrator</header>
<subsection id="H1BDAB685C1004528AA98491568D43068"><enum>(a)</enum><header>Requirement</header><text>Each
tobacco product manufacturer or importer, or agents thereof, shall submit to
the Administrator the following information:</text>
<paragraph id="H86DFACEBD7B74870BDC51C3D17547944"><enum>(1)</enum><text>Not later than 18
months after the date of enactment of the Act, a listing of all ingredients,
including tobacco, substances, compounds, and additives that are, as of such
date, added by the manufacturer to the tobacco, paper, filter, or other part of
each tobacco product by brand and by quantity in each brand and brand
style.</text>
</paragraph><paragraph id="H515751B57A4E43AE89F386009C091744"><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 Administrator in accordance with section 4(e) of the Federal
Cigarette Labeling and Advertising Act.</text>
</paragraph><paragraph id="H16ED5645D50240F698E28569AD1F3A9D"><enum>(3)</enum><text>Beginning 4 years
after the date of enactment of this Act, a listing of all constituents,
including smoke constituents as applicable, identified by the Administrator as
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.</text>
</paragraph></subsection><subsection id="H0155E9E9706247A8BA929FDB29F8C04E"><enum>(b)</enum><header>Data
Submission</header><text>At the request of the Administrator, each tobacco
product manufacturer or importer of tobacco products, or agents thereof, shall
submit the following:</text>
<paragraph id="H38227C2EB03A4B41A8CC726085F90F75"><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, or physiologic
effects of tobacco products and their constituents (including smoke
constituents), ingredients, components, and additives.</text>
</paragraph><paragraph id="H9C64D844802E460788C85A9914521C56"><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
significant reduction in risk to health from tobacco products can occur upon
the employment of technology available to the manufacturer.</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="HCE4DCCCCCEE149DCBD209E9885D9EA27"><enum>(c)</enum><header>Data
List</header>
<paragraph id="H3BC13F30050147FBB316D06873950085"><enum>(1)</enum><header>In
general</header><text>Not later than 4 years after the date of enactment of the
Act, and annually thereafter, the Administrator 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 Administrator) the list established
under subsection (d).</text>
</paragraph><paragraph id="HCF7371A2FD19473FB1C5F4033C2CFAFA"><enum>(2)</enum><header>Consumer
research</header><text>The Administrator 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 Act, the Administrator 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="HE9CBD9525956445A9888EC43E5EAA000"><enum>(d)</enum><header>Data
Collection</header><text>Not later than 36 months after the date of enactment
of this Act, the Administrator shall establish, and periodically revise as
appropriate, a list of harmful constituents, including smoke constituents, to
health in each tobacco product by brand and by quantity in each brand and
subbrand.</text>
</subsection></section><section id="HF0ADF115743741C4A65120008A2A4F30"><enum>109.</enum><header>Registration
and listing</header>
<subsection id="H25ED659E93714F6DA9B5DA8F3B3FB691"><enum>(a)</enum><header>Definitions</header><text>As
used in this section:</text>
<paragraph id="HE578DD6EC6174A588D14D79F54EC2EE9"><enum>(1)</enum><text>The term
<term>manufacture, preparation, or processing</term> shall include repackaging
or otherwise changing the container, wrapper, or label of any tobacco product
package other than the carton in furtherance of the distribution of the tobacco
product from the original place of manufacture to the person that makes final
delivery or sale to the ultimate consumer or user, but shall not include the
addition of a tax marking or other marking required by law to an already
packaged tobacco product.</text>
</paragraph><paragraph id="HBC46938BCD7B45D391EDEDE375AFEE5C"><enum>(2)</enum><text>The term
<term>name</term> shall include in the case of a partnership the name of the
general partner and, in the case of a privately held corporation, the name of
the chief executive officer of the corporation and the State of
incorporation.</text>
</paragraph></subsection><subsection id="H63764C5B0A024FF6A12D0CB7C5985266"><enum>(b)</enum><header>Annual
registration</header><text>Commencing one year after enactment, on or before
December 31 of each year, every person that owns or operates any establishment
in any State engaged in the manufacture, preparation, or processing of a
tobacco product or products for commercial distribution domestically shall
register with the Administrator its name, places of business, and all such
establishments.</text>
</subsection><subsection id="H79ABAB4EF87D4EF6BD958DA0EFE28DE7"><enum>(c)</enum><header>New
producers</header><text>Every person upon first engaging, for commercial
distribution domestically, in the manufacture, preparation, or processing of a
tobacco product or products in any establishment that it owns or operates in
any State shall immediately register with the Administrator its name, places of
business, and such establishment.</text>
</subsection><subsection id="H66787E7D7B75413DB4080229FAB28435"><enum>(d)</enum><header>Registration of
foreign establishments</header>
<paragraph id="HD7A29BAC253F4E38A186A7C1EEFED26B"><enum>(1)</enum><text>Commencing one
year after enactment of this Act, on or before December 31 of each year, the
person that, within any foreign country, owns or operates any establishment
engaged in the manufacture, preparation, or processing of a tobacco product
that is imported or offered for import into the United States shall, through
electronic means or other means permitted by the Administrator, register with
the Administrator the name and place of business of each such establishment,
the name of the United States agent for the establishment, and the name of each
importer of such tobacco product in the United States that is known to such
person.</text>
</paragraph><paragraph id="H691D7CE08B414CEB9C731DE599A70032"><enum>(2)</enum><text>Such person also
shall provide the information required by subsection (j), including sales made
by mail, or through the Internet, or other electronic means.</text>
</paragraph><paragraph id="H24B4557D90E14C50AC3F3EA133F8D02B"><enum>(3)</enum><text>The Administrator
is authorized to enter into cooperative arrangements with officials of foreign
countries to ensure that adequate and effective means are available for
purposes of determining, from time to time, whether tobacco products
manufactured, prepared, or processed by an establishment described in paragraph
(1), if imported or offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 708.</text>
</paragraph></subsection><subsection id="HC5E6A61D48884D5DA00CCA1317723DCD"><enum>(e)</enum><header>Additional
establishments</header><text>Every person duly registered in accordance with
the foregoing subsections of this section shall immediately register with the
Administrator any additional establishment that it owns or operates and in
which it begins the manufacture, preparation, or processing of a tobacco
product or products for commercial distribution domestically or for import into
the United States.</text>
</subsection><subsection id="HE4E5850577C445ECA26448E90100F409"><enum>(f)</enum><header>Exclusions from
application of this section</header><text>The foregoing subsections of this
section shall not apply to—</text>
<paragraph id="H7C5B03DE09BC4048B55440092D338865"><enum>(1)</enum><text>persons that
manufacture, prepare, or process tobacco products solely for use in research,
teaching, chemical or biological analysis, or export; or</text>
</paragraph><paragraph id="H995647F1D44D4840B6B1CA4987DF49C4"><enum>(2)</enum><text>such other classes
of persons as the Administrator may by regulation exempt from the application
of this section upon a finding that registration by such classes of persons in
accordance with this section is not necessary for the protection of the public
health.</text>
</paragraph></subsection><subsection id="HFC292B33830443B397F82AFF7FA9996D"><enum>(g)</enum><header>Inspection of
premises</header><text>Every establishment registered with the Administrator
pursuant to this section shall be subject to inspection pursuant to section
706; and every such establishment engaged in the manufacture, preparation, or
processing of a tobacco product or products shall be so inspected by one or
more officers or employees duly designated by the Administrator at least once
in the two-year period beginning with the date of registration of such
establishment pursuant to this section and at least once in every successive
two-year period thereafter, except that inspection of establishments outside
the United States may be conducted by other personnel pursuant to a cooperative
arrangement under subsection (d)(3).</text>
</subsection><subsection id="HC495D58D78A24ED2A8E773E7F06CBDF7"><enum>(h)</enum><header>Filing of lists
of tobacco products manufactured, prepared, or processed by registrants;
statements; accompanying disclosures</header>
<paragraph id="H8A7F79D2A0C94AEAA7EDF9FB03229CD9"><enum>(1)</enum><text>Every person that
registers with the Administrator under subsection (b), (c), (d), or (e) shall,
at the time of registration under any such subsection, file with the
Administrator a list of all brand styles (with each brand style in each list
listed by the common or usual name of the tobacco product category to which it
belongs and by any proprietary name) that are being manufactured, prepared, or
processed by such person for commercial distribution domestically or for import
into the United States, and that such person has not included in any list of
tobacco products filed by such person with the Administrator under this
paragraph or paragraph (2) before such time of registration. Such list shall be
prepared in such form and manner as the Administrator may prescribe, and shall
be accompanied by the label for each such brand style and a representative
sampling of any other labeling and advertising for each;</text>
</paragraph><paragraph id="HADA2C038536E447DA139929490B364B6"><enum>(2)</enum><text>Each person that
registers with the Administrator under this section shall report to the
Administrator each August for the preceding six-month period from January
through June, and each February for the preceding six-month period form July
through December, following information:</text>
<subparagraph id="HA06A00985474487991A91C7F10160EF9"><enum>(A)</enum><text>A list of each
brand style introduced by the registrant for commercial distribution
domestically or for import into the United States that has not been included in
any list previously filed by such registrant with the Administrator under this
subparagraph or paragraph (1). A list under this subparagraph shall list a
brand style by the common or usual name of the tobacco product category to
which it belongs and by any proprietary name, and shall be accompanied by the
other information required by paragraph (1).</text>
</subparagraph><subparagraph id="H021C59DD791F4EF6999D6C2F4F12F1FC"><enum>(B)</enum><text>If since the date
the registrant last made a report under this paragraph (or if such registrant
has not previously made a report under this paragraph, since the effective date
of this Act) such registrant has discontinued the manufacture, preparation, or
processing for commercial distribution domestically or for import into the
United States of a brand style included in a list filed by such registrant
under subparagraph (A) or paragraph (1), notice of such discontinuance, the
date of such discontinuance, and the identity (by the common or usual name of
the tobacco product category to which it belongs and by any proprietary name)
of such tobacco product.</text>
</subparagraph><subparagraph id="HED4FC3BC0D3F4D339A79B4AF40368BF1"><enum>(C)</enum><text>If, since the date
the registrant reported pursuant to subparagraph (B) a notice of discontinuance
of a tobacco product, the registrant has resumed the manufacture, preparation,
or processing for commercial distribution domestically or for import into the
United States of that brand style, notice of such resumption, the date of such
resumption, the identity of such brand style (by the common or usual name of
the tobacco product category to which it belongs and by any proprietary name),
and the other information required by paragraph (1), unless the registrant has
previously reported such resumption to the Administrator pursuant to this
subparagraph.</text>
</subparagraph><subparagraph id="HB6A1C9F880504C62BC55CC2168D756EE"><enum>(D)</enum><text>Any material
change in any information previously submitted pursuant to this paragraph (2)
or paragraph (1).</text>
</subparagraph></paragraph></subsection><subsection id="HDE1E736B6DBB46498F0BD3CE9154FED3"><enum>(i)</enum><header>Electronic
registration</header><text>Registrations under subsections (b), (c), (d), and
(e) (including the submission of updated information) shall be submitted to the
Administrator by electronic means, unless the Administrator grants a request
for waiver of such requirement because use of electronic means is not
reasonable for the person requesting such waiver.</text>
</subsection></section><section id="H46C14CA7A2B942028D6DA0B8B05CC9FC"><enum>110.</enum><header>General
provisions respecting control of tobacco products</header>
<subsection id="H706BD766791A462880A5EBB9C1808702"><enum>(a)</enum><header>In
General</header><text>Any requirement established by or under section 106, 107,
or 113 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 111, section 114, section 115, or
subsection (d) of this section, and any requirement established by or under
section 106, 107, or 113 which is inconsistent with a requirement imposed on
such tobacco product under section 111, section 114, section 115, or subsection
(d) of this section shall not apply to such tobacco product.</text>
</subsection><subsection id="HE692BC9817E942209E7F2231C747E856"><enum>(b)</enum><header>Information on
Public Access and Comment</header><text>Each notice of proposed rulemaking or
other notification under section 111, 112, 113, 114, or 115 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="HAC97CF186891414A96D7B44DB69411B9"><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="H38F9898B57CF4FDDB5251E9D7C246EB4"><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
Administrator by a notice published in the Federal Register stating good cause
therefore.</text>
</paragraph></subsection><subsection id="H783BB8AF90C04745B1CB916D1CC580B0"><enum>(c)</enum><header>Limited
Confidentiality of Information</header><text>Any information reported to or
otherwise obtained by the Administrator or the Administrator’s representative
under section 107, 108, 111, 112, 113, 114, 115, or 504, 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 Act, or when relevant in any
proceeding under this Act.</text>
</subsection><subsection id="H0E1A10EC057744AAAA2BD0A5D8E16078"><enum>(d)</enum><header>Restrictions</header>
<paragraph id="H7A088FED86D8476C9E307B07002908BB"><enum>(1)</enum><header>In
general</header><text>The Administrator may issue regulations, consistent with
this Act, regarding tobacco products if the Administrator determines that such
regulation would be appropriate for the protection of the public health. 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 users of the tobacco product, and taking into account that the standard
is reasonably likely to result in measurable and substantial reductions in
morbidly and mortality among individual tobacco users.</text>
</paragraph><paragraph id="H70A7FC3D4ACA48D5919697DFF85E9208"><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 Administrator may in such regulation prescribe.</text>
</paragraph></subsection><subsection id="H90DC2E7F746C41108140EFEBF36D986C"><enum>(e)</enum><header>Good
Manufacturing Practice Requirements</header>
<paragraph id="HE844E545908D4974A2BF5BFE5585C46D"><enum>(1)</enum><header>Methods,
facilities, and controls to conform</header>
<subparagraph id="HE905BE95B67A481380827762A766ECAB"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">In applying
manufacturing restrictions to tobacco, the Administrator shall, in accordance
with subparagraph (B), prescribe regulations (which may differ based on the
type of tobacco product involved) requiring that the methods used in, and the
facilities and controls used for, the manufacture, preproduction design
validation (including a process to assess the performance of a tobacco
product), packing, and storage of a tobacco product conform to current good
manufacturing practice, or hazard analysis and critical control point
methodology, as prescribed in such regulations to assure that the public health
is protected and that the tobacco product is in compliance with this Act. Such
regulations may provide for the testing of raw tobacco for pesticide chemical
residues after a tolerance for such chemical residues has been
established.</text>
</subparagraph><subparagraph id="HE32D7E4C5050449E878403712C966039"><enum>(B)</enum><header>Requirements</header><text>The
Administrator shall—</text>
<clause id="H5464697380C74219957F4009E6ACD426"><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="H7341DB9E76B8493494059A105C98A1A1"><enum>(ii)</enum><text>before
promulgating any regulation under subparagraph (A), afford opportunity for an
oral hearing;</text>
</clause><clause id="HFCCF2500CF9843EAA1277B7968B5C568"><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="H4D1DE85DB27E46B4B29E54D2511E4636"><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 but no earlier than four years from date of
enactment.</text>
</clause></subparagraph><subparagraph id="H19D4EA31997140209634DDC9AA2D35E6"><enum>(C)</enum><header>Additional
special rule</header><text>A tobacco product manufactured in or imported into
the United States shall not contain foreign-grown flue-cured or burley tobacco
that—</text>
<clause id="H22D6D6111D2B49E69C1AEC5786BBB09C"><enum>(i)</enum><text>was
knowingly grown or processed using a pesticide chemical that is not approved
under applicable Federal law for use in domestic tobacco farming and
processing; or</text>
</clause><clause id="H3B4B8B5C695941589404B1778A1A692D"><enum>(ii)</enum><text>in
the case of a pesticide chemical that is so approved, was grown or processed
using the pesticide chemical in a manner inconsistent with the approved
labeling for use of the pesticide chemical in domestic tobacco farming and
processing.</text>
</clause></subparagraph><subparagraph id="H6265C33B523D4BD9A977C3899389BBF1"><enum>(D)</enum><header>Exclusion</header><text>Subparagraph
(C)(ii) shall not apply to tobacco products manufactured with foreign-grown
flue-cured or burley tobacco so long as that foreign grown tobacco was
either—</text>
<clause id="H0884FD3E311F4DD1B8C07129C73211B6"><enum>(i)</enum><text>in
the inventory of a manufacturer prior to the effective date, or</text>
</clause><clause id="H20AF3D65B4AD4B7AB7525B6B0A2C4289"><enum>(ii)</enum><text>planted by the
farmer prior to the effective date of this Act and utilized by the manufacturer
no later than 3 years after the effective date.</text>
</clause></subparagraph><subparagraph id="HB98D56A6EAC7446E976520FA848BCB12"><enum>(E)</enum><header>Setting of
maximum residue limits</header><text>The Administrator shall adopt the
following pesticide residue standards:</text>
<list level="subsection" list-type="none">
<list-item>Pesticide residue standards</list-item>
<list-item>The maximum concentration of residues of the following
pesticides allowed in flue-cured or burley tobacco, expressed as parts by
weight of the residue per one million parts by weight of the tobacco (PPM)
are:</list-item>
<list-item>CHLORDANE.....3.0 </list-item>
<list-item>DIBROMOCHLOROPROPANE (DBCP).....1.0
</list-item>
<list-item>DICAMBA (Temporary).... 5.0</list-item>
<list-item>ENDRIN....0.1</list-item>
<list-item>ETHYLENE DIBROMIDE (EDB)....0.1</list-item>
<list-item>FORMOTHION.....0.5 </list-item>
<list-item>HEXACHLOROBENZENE (HCB)....0.1 </list-item>
<list-item>METHOXYCHLOR.....0.1</list-item>
<list-item>TOXAPHENE.....0.3 </list-item>
<list-item>2,4-D (Temporary).....5.0 </list-item>
<list-item>2,4,5-T.....0.1</list-item>
<list-item>Sum of ALDRIN and DIELDRIN.....0.1</list-item>
<list-item>Sum of CYPERMETHRIN and PERMETHRIN
(Temporary).....3.0</list-item>
<list-item>Sum of DDT, TDE (DDD), and DDE
.....0.4</list-item>
<list-item>Sum of HEPTACHLOR and HEPTACHLOR EPOXIDE.....0.1
</list-item></list>
</subparagraph><subparagraph id="H229803113F43424B950EEEA49E2A087D"><enum>(F)</enum><header>Maximum residue
limits</header><text display-inline="yes-display-inline">The Administrator
shall adopt regulations within one year of the effective date of this Act to
establish maximum residue limits for pesticides identified under subparagraph
(E) but not included in the table of such subparagraph to account for the fact
that weather and agronomic conditions will cause pesticides identified in
subparagraph (E) to be detected in foreign-grown tobacco even where the farmer
has not knowingly added such pesticide.</text>
</subparagraph></paragraph><paragraph id="HA41372A9A59E432E85927E76FCC07ABE"><enum>(2)</enum><header>Exemptions;
variances</header>
<subparagraph id="H97FF8B7C61144A2B9FB6D4A12AE8DAF8"><enum>(A)</enum><header>Petition</header><text>Any
person subject to any requirement prescribed under paragraph (1) may petition
the Administrator for a permanent or temporary exemption or variance from such
requirement. Such a petition shall be submitted to the Administrator in such
form and manner as the Administrator shall prescribe and shall—</text>
<clause id="H6D3BD6E6814E4049A254BD7258C9FEC6"><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
Act;</text>
</clause><clause id="HB7A6C0708D89434F8BFFE4613FA26157"><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="HB2EC955BC7304E29946C757507F4FCD9"><enum>(iii)</enum><text>contain such
other information as the Administrator shall prescribe.</text>
</clause></subparagraph><subparagraph id="H14396E12E7F140A78EE7E62B110283BA"><enum>(B)</enum><header>Referral to the
tobacco products scientific advisory committee</header><text>The Administrator
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 Administrator 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="HC6F20A1E3E3E41CBBEBBE7A83B2006E9"><enum>(i)</enum><text>the
date the petition was submitted to the Administrator under subparagraph (A);
or</text>
</clause><clause id="H314F693E6AD74E4E82026F1FDA4E66D9"><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 Administrator shall by order either deny the petition or
approve it.</continuation-text></subparagraph><subparagraph id="HCBEC374FB7CF40C28359E48F967055ED"><enum>(C)</enum><header>Approval</header><text>The
Administrator may approve—</text>
<clause id="H999A38A46D294629A1A2D043F1DCC5C7"><enum>(i)</enum><text>a
petition for an exemption for a tobacco product from a requirement if the
Administrator determines that compliance with such requirement is not required
to assure that the tobacco product will be in compliance with this Act;
and</text>
</clause><clause id="HB32F92A0A7C64E28A643D204687520E1"><enum>(ii)</enum><text>a
petition for a variance for a tobacco product from a requirement if the
Administrator determines that the methods to be used in, and the facilities and
controls to be used for, the manufacture, packing, and storage of the tobacco
product in lieu of the methods, facilities, and controls prescribed by the
requirement are sufficient to assure that the tobacco product will be in
compliance with this Act.</text>
</clause></subparagraph><subparagraph id="HA89BD8387E044A4CA6215C9482A63D66"><enum>(D)</enum><header>Conditions</header><text>An
order of the Administrator 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 Act.</text>
</subparagraph><subparagraph id="H6F315B7F3433446F8FA30B9F6C7F5733"><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="H8D9433975B8F46CC9807AABDEE8E71C4"><enum>(3)</enum><header>Compliance</header><text display-inline="yes-display-inline">Compliance with requirements under this
subsection shall not be required before the end of the 3-year period following
the date of enactment of this Act.</text>
</paragraph></subsection><subsection id="H6B58170E7FC64277AE296F30DDF5626E"><enum>(f)</enum><header>Research and
Development</header><text>The Administrator may enter into contracts for
research, testing, and demonstrations respecting tobacco products and may
obtain tobacco products for research, testing, and demonstration
purposes.</text>
</subsection></section><section id="H90CE4F14CF214346859F9ABE4FB67DB0"><enum>111.</enum><header>Smoking article
standards</header>
<subsection id="HA128D7F7A1A1428CBE58CA17F6FDB0B4"><enum>(a)</enum><header>In
general</header>
<paragraph commented="no" id="H1A0974AB36634C62ADBB49463AEFAB54"><enum>(1)</enum><header>Restrictions on
descriptors used in marketing of cigarettes</header>
<subparagraph commented="no" id="H069EE4686FAC4B3C83F60FE7F71C4DBF"><enum>(A)</enum><header>In
General</header><text>Except as provided in subparagraph (B), no person shall
use, with respect to any cigarette brand style commercially distributed
domestically, on the portion of the package of such cigarette brand style that
customarily is visible to consumers before purchase, or in advertising of such
cigarette brand style any of the following as a descriptor of any cigarette
brand style—</text>
<clause commented="no" id="H93D895CAE08E46319B79A42ED69FBEDB"><enum>(i)</enum><text>the name of any
candy or fruit;</text>
</clause><clause commented="no" id="H27E4A4CECE3A422CA0A30937811DE07B"><enum>(ii)</enum><text>the word
<quote>candy,</quote><quote>citrus,</quote><quote>cream,</quote><quote>fruit,</quote><quote>sugar,</quote><quote>sweet,</quote><quote>tangy,</quote>
or <quote>tart,</quote>; or</text>
</clause><clause commented="no" id="H5DF4A2A37751403497B9F5A1EE32669C"><enum>(iii)</enum><text>any extension or
variation of any of the words
<quote>candy,</quote><quote>citrus,</quote><quote>cream,</quote><quote>fruit,</quote><quote>sugar,</quote><quote>sweet,</quote><quote>tangy,</quote>
or <quote>tart,</quote> including but not limited to <quote>creamy,</quote> or
<quote>fruity.</quote></text>
</clause></subparagraph><subparagraph commented="no" id="HC26770E2CA2645F7B49A4011E2B168D8"><enum>(B)</enum><header>Limitation</header><text>Subparagraph
(A) shall not apply to the use of the following words or to any extension or
variation of any of them: <quote>coffee,</quote><quote>mint,</quote> and
<quote>menthol</quote>.</text>
</subparagraph><subparagraph commented="no" id="H82D367FF66AE462EB4749A804E73A773"><enum>(C)</enum><header>Scented
materials</header><text>No person shall use, in the advertising or labeling of
any cigarette commercially distributed domestically, any scented materials,
except in an adult-only facility.</text>
</subparagraph><subparagraph commented="no" id="H9C36333838324A8C8FCAE5F6C2CE4C45"><enum>(D)</enum><header>Definitions</header><text>In
this section:</text>
<clause commented="no" id="H7EE5BACBC22142B1A2F5A6B029091740"><enum>(i)</enum><text>The term
<term>candy</term> means a confection made from sugar or sugar substitute,
including any confection identified generically or by brand, and shall include
the words
<quote>cacao,</quote><quote>chocolate,</quote><quote>cinnamon,</quote><quote>cocoa,</quote><quote>honey,</quote><quote>licorice,</quote><quote>maple,</quote><quote>mocha,</quote>
and <quote>vanilla.</quote></text>
</clause><clause commented="no" id="HC6C71DECBDC041BF9590439188287651"><enum>(ii)</enum><text>The term
<term>fruit</term> means any fruit identified by generic name, type, or
variety, including but not limited to
<quote>apple,</quote><quote>banana,</quote><quote>cherry,</quote> and
<quote>orange.</quote> The term <term>fruit</term> does not include words that
identify seeds, nuts or peppers, or types or varieties thereof or words that
are extensions or variations of such words.</text>
</clause></subparagraph></paragraph><paragraph id="HB9156A01BBB34CD58D4E070CB1BB1C98"><enum>(2)</enum><header>Smoking article
standards</header>
<subparagraph id="H68A005C971BB43A2B7FD9236187A0328"><enum>(A)</enum><header>In
general</header><text>The Administrator may adopt smoking article standards in
addition to those in paragraph (1) if the Administrator finds that a smoking
article standard is appropriate for the protection of the public health.</text>
</subparagraph><subparagraph id="H33B10C11D2A245E6864F2DC23A1DEF92"><enum>(B)</enum><header>Determinations</header>
<clause id="H29EAAC5D313B4DD2BD812384FEBB38C2"><enum>(i)</enum><header>Considerations</header><text display-inline="yes-display-inline">In making a finding described in
subparagraph (A), the Administrator shall consider scientific evidence
concerning—</text>
<subclause id="H99F5DF8EF326463CB3E912FFBA98C631"><enum>(I)</enum><text>the risks and
benefits to the users of smoking articles of the proposed standard; and</text>
</subclause><subclause id="HC6FEB48E95CA4B5D8BA51748340DF01B"><enum>(II)</enum><text>that the standard
is reasonably likely to result in measurable and substantial reductions in
morbidity and mortality among individual tobacco users.</text>
</subclause></clause><clause display-inline="no-display-inline" id="HFB87BC3F34F64E7B95D573E6C3E8CDB9"><enum>(ii)</enum><header>Additional
considerations</header><text display-inline="yes-display-inline">In the event
that the Administrator makes a determination, set forth in a proposed smoking
article standard in a proposed rule, that it is appropriate for the protection
of public health to require the reduction or elimination of an additive,
constituent (including a smoke constituent), or other component of a smoking
article because the Administrator has found that the additive, constituent, or
other component is harmful, any party objecting to the proposed standard on the
ground that the proposed standard will not reduce or eliminate the risk of
illness or injury may provide for the Administrator’s consideration scientific
evidence that demonstrates that the proposed standard will not reduce or
eliminate the risk of illness or injury.</text>
</clause></subparagraph></paragraph><paragraph id="HA83CBA1559BA45FB808DD95DCE1840CD"><enum>(3)</enum><header>Content of
smoking article standards</header><text>A smoking article standard established
under this section for a smoking article—</text>
<subparagraph id="HDFF224DC361D4AED8AFA8BACE76CD7CD"><enum>(A)</enum><text>may include
provisions that are appropriate for the protection of the public health,
including provisions, where appropriate—</text>
<clause id="H5E006D23DB934D21AA880851201F354C"><enum>(i)</enum><text>for
<quote>tar</quote> and nicotine yields of the product;</text>
</clause><clause id="H304F7EE4757E49779ACAF63D8A8A835B"><enum>(ii)</enum><text>for
the reduction of other constituents, including smoke constituents, or harmful
components of the product; or</text>
</clause><clause id="H597255BBBD1546E48DA14DC72647BCBC"><enum>(iii)</enum><text>relating to any
other requirement under subparagraph (B); and</text>
</clause></subparagraph><subparagraph id="H276B3645F0F9418A9B02D7BAE26D7312"><enum>(B)</enum><text>may, where
appropriate for the protection of the public health, include—</text>
<clause id="H55EB892F165349A5B0495571E0195BE8"><enum>(i)</enum><text>provisions
respecting the construction, components, ingredients, additives, constituents,
including smoke constituents, and properties of the smoking article;</text>
</clause><clause id="HC6F843D3A1EA40D88A23EA2B9C8848F0"><enum>(ii)</enum><text>provisions for
the testing (on a sample basis or, if necessary, on an individual basis) of the
smoking article;</text>
</clause><clause id="H7826EA8D62714CF8A28559366E2284CD"><enum>(iii)</enum><text>provisions for
the measurement of the smoking article characteristics of the smoking article;
and</text>
</clause><clause id="H44A9F669074A4F72A2422A67ACA61EED"><enum>(iv)</enum><text>provisions
requiring that the results of each or of certain of the tests of the smoking
article required to be made under clause (ii) show that the smoking article is
in conformity with the portions of the standard for which the test or tests
were required.</text>
</clause></subparagraph></paragraph><paragraph id="H99173772A32B4792AAC8206EDB9B3DAB"><enum>(4)</enum><header>Periodic
reevaluation of smoking article standards</header><text>The Administrator may
provide for periodic evaluation of smoking article standards established under
this section to determine whether such standards should be changed to reflect
new medical, scientific, or other technological data.</text>
</paragraph><paragraph id="H0DBE2A7E0C924CB793B73CF1BB467083"><enum>(5)</enum><header>Cigarette
<quote>tar</quote> limits</header>
<subparagraph id="H303071FBADC24323AF72DAE9880932E0"><enum>(A)</enum><header>No increase in
<quote>tar</quote> yields</header><text>No cigarette manufacturer shall
distribute for sale domestically a brand style of cigarettes that generates a
<quote>tar</quote> yield greater than the <quote>tar</quote> yield of that
brand style of cigarettes on the date of introduction of this Act, as
determined by the ISO smoking regimen and its associated tolerances. The
<quote>tar</quote> tolerances for cigarettes with ISO <quote>tar</quote> yields
in the range of 1 to 20 milligrams per cigarette, based on variations arising
from sampling procedure, test method, and sampled product, itself, are the
greater of plus or minus—</text>
<clause id="HF0DB363B40D4489186199A0D0F9809B8"><enum>(i)</enum><text>15
percent; or</text>
</clause><clause id="HEC5314014867467E8EA5A489F3A3687E"><enum>(ii)</enum><text>1
milligram per cigarette.</text>
</clause></subparagraph><subparagraph id="H6F3BD4DFBB164E9DB38B673A13641867"><enum>(B)</enum><header>Limit on new
cigarettes</header><text>After the effective date of this Act, no cigarette
manufacturer shall manufacture for commercial distribution domestically a brand
style of cigarettes that both—</text>
<clause id="H1EF156F7520C419DA81311DCFD8EC17B"><enum>(i)</enum><text>was
not in commercial distribution domestically on the effective date of this Act,
and</text>
</clause><clause id="HEF6914C0878F4D69A3F2D2D6A6E79B7F"><enum>(ii)</enum><text>generates a
<quote>tar</quote> yield of greater than 20 milligrams per cigarette as
determined by the ISO smoking regimen and its associated tolerances.</text>
</clause></subparagraph><subparagraph id="HD5DC6358C57249DA933AEEED2ADFA6BB"><enum>(C)</enum><header>Limit on all
cigarettes</header><text>After December 31, 2010, no cigarette manufacturer
shall manufacture for commercial distribution domestically a brand style of
cigarettes that generates a <quote>tar</quote> yield greater than 20 milligrams
per cigarette as determined by the ISO smoking regimen and its associated
tolerances.</text>
</subparagraph><subparagraph id="HD0EE185D58014290BB2E806AF611E744"><enum>(D)</enum><header>Review by
Administrator</header><text>After the effective date of this Act, the
Administrator shall evaluate the available scientific evidence addressing the
potential relationship between historical <quote>tar</quote> yield values and
risk of harm to smokers. If upon a review of that evidence, and after
consultation with technical experts of the Tobacco Harm Reduction Center and
the Centers for Disease Control and Prevention and notice and an opportunity
for public comment, the Administrator determines, that a reduction in
<quote>tar</quote> yield may reasonably be expected to provide a meaningful
reduction of the risk or risks of harm to smokers, the Administrator shall
issue an order that—</text>
<clause id="H9CE07E3034BD47D890035F2861DF76A6"><enum>(i)</enum><text>provides that no
cigarette manufacturer shall manufacture for commercial distribution
domestically a cigarette that generates a <quote>tar</quote> yield that exceeds
14 milligrams as determined by the ISO smoking regimen and its associated
tolerances; and</text>
</clause><clause id="H84C5446CDED147D9AEE7D7C7058053D1"><enum>(ii)</enum><text>provides a
reasonable time for manufacturers to come into compliance with such
prohibition.</text>
</clause></subparagraph></paragraph><paragraph id="H40CF5E0C36974590B1CAB46CE7E59440"><enum>(6)</enum><header>Involvement of
other agencies; informed persons</header><text>In carrying out duties under
this section, the Administrator shall endeavor to—</text>
<subparagraph id="HBB6067E87447471196AE7771CA268656"><enum>(A)</enum><text>use personnel,
facilities, and other technical support available in other Federal
agencies;</text>
</subparagraph><subparagraph id="H06CC99B7FD72470C91D3D59BB46FD592"><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="HADAAD38857DD4C459C7B03A781D6D1F7"><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 Administrator’s judgment can
make a significant contribution.</text>
</subparagraph></paragraph></subsection><subsection display-inline="no-display-inline" id="H10ACD633178C4A56A1C92BB316D259E5"><enum>(b)</enum><header>Considerations
by Administrator</header>
<paragraph id="HAB777E186CCA45BDBA89166BF92F9964"><enum>(1)</enum><header>Technical
achievability</header><text display-inline="yes-display-inline">The
Administrator shall consider information submitted in connection with a
proposed standard regarding the technical achievability of compliance with such
standard.</text>
</paragraph><paragraph id="H2FAA41C46F3140FE9753F2C5910842DA"><enum>(2)</enum><header>Other
considerations</header><text>The Administrator shall consider all other
information submitted in connection with a proposed standard, such as the
creation of a significant demand for contraband or other tobacco products that
do not meet the requirements of this Act and the significance of such
demand.</text>
</paragraph></subsection><subsection id="H22E4DC4A9F774FC8AA1DCE9211D60496"><enum>(c)</enum><header>Proposed
standards</header>
<paragraph id="HA01AB75D5CB34A12A46568F7646CEA93"><enum>(1)</enum><header>In
general</header><text>The Administrator shall publish in the Federal Register a
notice of proposed rulemaking for the establishment, amendment, or revocation
of any smoking article standard.</text>
</paragraph><paragraph id="H4DD237B2175B4E12B340A712D53A005C"><enum>(2)</enum><header>Requirements of
notice</header><text>A notice of proposed rulemaking for the establishment or
amendment of a smoking article standard shall—</text>
<subparagraph id="H2509B5DB9CF142C494F6279D02397695"><enum>(A)</enum><text>set forth a
finding with supporting justification that the smoking article standard is
appropriate for the protection of the public health;</text>
</subparagraph><subparagraph id="HD9EDF42733CB4D7BA410B21E133757AC"><enum>(B)</enum><text display-inline="yes-display-inline">invite interested persons to submit a draft
or proposed smoking article standard for consideration by the
Administrator;</text>
</subparagraph><subparagraph id="HE285FB6C27D141BA80B6862BF1624030"><enum>(C)</enum><text display-inline="yes-display-inline">invite interested persons to submit
comments on structuring the standard so that it does not advantage
foreign-grown tobacco over domestically grown tobacco; and</text>
</subparagraph><subparagraph id="H35743D56F4714839A03F332B35B2BD6E"><enum>(D)</enum><text display-inline="yes-display-inline">invite the Secretary of Agriculture to
provide any information or analysis which the Secretary of Agriculture believes
is relevant to the proposed smoking article standard.</text>
</subparagraph></paragraph><paragraph id="HC10E31957AA54F179F4A7A93D9D5F659"><enum>(3)</enum><header>Finding</header><text display-inline="yes-display-inline">A notice of proposed rulemaking for the
revocation of a smoking article standard shall set forth a finding with
supporting justification that the smoking article standard is no longer
appropriate for the protection of the public health.</text>
</paragraph><paragraph id="H5E29F59E42C640149F688B6B7712D81B"><enum>(4)</enum><header>Comment</header><text>The
Administrator shall provide for a comment period of not less than 90
days.</text>
</paragraph></subsection><subsection id="H178A279D974D48E49B0851BBC9076AA4"><enum>(d)</enum><header>Promulgation</header>
<paragraph id="H170487B3D8B74F598688D4BC0C87A2BB"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">After the expiration
of the period for comment on a notice of proposed rulemaking published under
subsection (c) respecting a standard and after consideration of comments
submitted under subsections (b) and (c) and any report from the Tobacco
Products Scientific Advisory Committee, if the Administrator determines that
the standard would be appropriate for the protection of the public health, the
Administrator shall—</text>
<subparagraph id="H526FD6FD612A4279BA76E9FB72A4608A"><enum>(A)</enum><text display-inline="yes-display-inline">promulgate a regulation establishing a
smoking article standard and publish in the Federal Register findings on the
matters referred to in subsection (c); or</text>
</subparagraph><subparagraph id="H4046A7EE54EF4A168295A9E89586127F"><enum>(B)</enum><text>publish a notice
terminating the proceeding for the development of the standard together with
the reasons for such termination.</text>
</subparagraph></paragraph><paragraph id="HFA1A3DD27C074F78AD7B78509553BB5B"><enum>(2)</enum><header>Effective
date</header><text display-inline="yes-display-inline">A regulation
establishing a smoking article 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 Administrator
determines that an earlier effective date is necessary for the protection of
the public health. Such date or dates shall be established so as to minimize,
consistent with the public health, economic loss to, and disruption or
dislocation of, domestic and international trade. In establishing such
effective date or dates, the Administrator shall consider information submitted
in connection with a proposed product standard by interested parties, including
manufacturers and tobacco growers, regarding the technical achievability of
compliance with the standard, and including information concerning the
existence of patents that make it impossible to comply in the timeframe
envisioned in the proposed standard.</text>
</paragraph><paragraph id="H31B49ABA2FBB4854A8C855FEC3F9CBCA"><enum>(3)</enum><header>Limitation on
power granted</header><text>Because of the importance of a decision of the
Administrator to issue a regulation—</text>
<subparagraph id="H870F5E86CE6E41E284B396A9791FA313"><enum>(A)</enum><text>banning
cigarettes, smokeless smoking articles, little cigars, cigars other than little
cigars, pipe tobacco, or roll-your-own smoking articles;</text>
</subparagraph><subparagraph id="H5D12844652D440B1870A6CEDA2358139"><enum>(B)</enum><text>requiring the
reduction of <quote>tar</quote> or nicotine yields of a smoking article to
zero;</text>
</subparagraph><subparagraph commented="no" id="H0BDCD8CD8F9443668D669E69E19D4F4E"><enum>(C)</enum><text>prohibiting the
sale of any smoking article in face-to-face transactions by a specific category
of retail outlets;</text>
</subparagraph><subparagraph commented="no" id="HB82DAD4F06644BB897C72B3AE076AC64"><enum>(D)</enum><text>establishing a
minimum age of sale of smoking articles to any person older than 18 years of
age; or</text>
</subparagraph><subparagraph id="HAF0A559573FD4E6ABE3D1C597A20F3A1"><enum>(E)</enum><text display-inline="yes-display-inline">requiring that the sale or distribution of
a smoking article be limited to the written or oral authorization of a
practitioner licensed by law to prescribe medical products,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">the
Administrator is prohibited from taking such actions under this Act.</continuation-text></paragraph><paragraph commented="no" id="HF2A8E17734DE49B29F8DA692F9E2360E"><enum>(4)</enum><header>Matchbooks</header><text>For
purposes of any regulations issued by the Administrator under this Act,
matchbooks of conventional size containing not more than 20 paper matches, and
which are customarily given away for free with the purchase of smoking
articles, shall be considered as adult-written publications which shall be
permitted to contain advertising.</text>
</paragraph><paragraph id="H815D3ADAAC7045F1A9179867B4AB885C"><enum>(5)</enum><header>Amendment;
revocation</header>
<subparagraph id="H4894A0E60DD84DBC8B7F2CD07F1733C7"><enum>(A)</enum><header>Authority</header><text display-inline="yes-display-inline">The Administrator, upon the Administrator’s
own initiative or upon petition of an interested person, may by a regulation,
promulgated in accordance with the requirements of subsection (c) and paragraph
(2), amend or revoke a smoking article standard.</text>
</subparagraph><subparagraph id="HFB9E864231C646A0980DCF68772FE360"><enum>(B)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The Administrator may
declare a proposed amendment of a smoking article 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 Administrator determines
that making it so effective is in the public interest.</text>
</subparagraph></paragraph><paragraph id="H9E237848C7E147349929BA7344074582"><enum>(6)</enum><header>Referral to
advisory committee</header>
<subparagraph id="HE2B64BD70CE94F468D0E8109DDF38AD0"><enum>(A)</enum><header>In
general</header><text>The Administrator shall refer a proposed regulation for
the establishment, amendment, or revocation of a smoking article standard to
the Tobacco Products Scientific Advisory Committee for a report and
recommendation with respect to any matter involved in the proposed regulation
which requires the exercise of scientific judgment.</text>
</subparagraph><subparagraph id="H855BF22F342446BCB574AADB5B21B579"><enum>(B)</enum><header>Initiation of
referral</header><text>The Administrator shall make a referral under this
paragraph—</text>
<clause id="H301AD1A73D8C484A9354D9874681EDC0"><enum>(i)</enum><text>on
the Administrator’s own initiative; or</text>
</clause><clause id="H96147692823846A08196197F56D7CE67"><enum>(ii)</enum><text>upon the request
of an interested person that—</text>
<subclause id="H9C5AC266348449F58DF4DD2D63B85CF7"><enum>(I)</enum><text>demonstrates good
cause for the referral; and</text>
</subclause><subclause id="H1BBD670A12A742B7AFD67ACAAB50F721"><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="H9FBD18953130447AA5AE11EAFF2DF1C6"><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 Administrator shall
provide the Advisory Committee with the data and information on which such
proposed regulation is based.</text>
</subparagraph><subparagraph id="HF55DC7D111064249B90D903419CEFDCC"><enum>(D)</enum><header>Report and
recommendation</header><text>The Tobacco Products Scientific Advisory Committee
shall, within 90 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 Administrator and other data and information before it, submit to the
Administrator 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="HB0CB904A049645A7AD3EAD57F32C19A4"><enum>(E)</enum><header>Public
availability</header><text>The Administrator shall make a copy of each report
and recommendation under subparagraph (D) publicly available.</text>
</subparagraph></paragraph></subsection></section><section id="HF1FB3B75EC33498FBDE9E853E4F0793D"><enum>112.</enum><header>Notification
and other remedies</header>
<subsection id="HE7A370D0196C4888944B99E6C7724620"><enum>(a)</enum><header>Notification</header><text>If
the Administrator determines that—</text>
<paragraph id="H1C72C2F0931C4467855F1F238D056B94"><enum>(1)</enum><text display-inline="yes-display-inline">a tobacco product which is introduced or
delivered for introduction into interstate commerce for commercial distribution
presents an unreasonable risk of substantial harm materially above the risk for
death and disease of tobacco products currently in interstate commerce, to the
public health; and</text>
</paragraph><paragraph id="HBCF81DD07B02450199CB4029D7BEC987"><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 Act
(other than this section) to eliminate such risk,</text>
</paragraph><continuation-text continuation-text-level="subsection">the
Administrator 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 Administrator
may order notification by any appropriate means, including public service
announcements. Before issuing an order under this subsection, the Administrator
shall consult with the persons who are to give notice under the order.</continuation-text></subsection><subsection id="H69959C3369644DE8AC9FD48C8D0EF50E"><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="HF725C83D870942CCA646CFDBF668DA37"><enum>(c)</enum><header>Recall
Authority</header>
<paragraph id="H72C4DE4986CE45F18BCA933501CCC604"><enum>(1)</enum><header>In
general</header><text>If the Administrator 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, acute adverse health consequences or death, the Administrator 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 Administrator determines that inadequate grounds exist
to support the actions required by the order, the Administrator shall vacate
the order.</text>
</paragraph><paragraph id="H8BE84B2CABF14162B61D4273612BE974"><enum>(2)</enum><header>Amendment of
order to require recall</header>
<subparagraph id="H4A3C39A8E3014047B5ACC9486621F994"><enum>(A)</enum><header>In
general</header><text>If, after providing an opportunity for an informal
hearing under paragraph (1), the Administrator determines that the order should
be amended to include a recall of the tobacco product with respect to which the
order was issued, the Administrator shall, except as provided in subparagraph
(B), amend the order to require a recall. The Administrator shall specify a
timetable in which the tobacco product recall will occur and shall require
periodic reports to the Administrator describing the progress of the
recall.</text>
</subparagraph><subparagraph id="H80E65B1DC54D4074AE4D03C0691926A7"><enum>(B)</enum><header>Notice</header><text>An
amended order under subparagraph (A)—</text>
<clause id="H810BF262E7CE447E823D436706F8C7EB"><enum>(i)</enum><text>shall not include
recall of a tobacco product from individuals; and</text>
</clause><clause id="H990E58B67D214CC19EFEA700120BDFD9"><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 Administrator 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 Administrator
shall notify such persons under section 705(b).</continuation-text></subparagraph></paragraph><paragraph id="H4E215E9E7A9941DF85B2F6DB845E81E3"><enum>(3)</enum><header>Remedy not
exclusive</header><text>The remedy provided by this subsection shall be in
addition to remedies provided by subsection (a).</text>
</paragraph></subsection></section><section id="HD10B3584C2594E768DD364E26228DC0A"><enum>113.</enum><header>Records and
reports on tobacco products</header><text display-inline="no-display-inline">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 Administrator
may by regulation reasonably require to assure that such tobacco product is not
adulterated or misbranded.</text>
</section><section id="H27C0338B5FF5476ABDAC6682FAE74738"><enum>114.</enum><header>Application for
review of certain smoking articles</header>
<subsection id="H746A2BF6FD5E48259821315296AA0D5A"><enum>(a)</enum><header>In
general</header>
<paragraph id="HF1D192385A9346A6B62539E70091092E"><enum>(1)</enum><header>New smoking
article defined</header><text>For purposes of this section the term <term>new
smoking article</term> means—</text>
<subparagraph id="H984356CF545743C1AE1013D487715AC5"><enum>(A)</enum><text display-inline="yes-display-inline">any smoking article that was not
commercially marketed in the United States as of the date of enactment of this
Act; and</text>
</subparagraph><subparagraph id="H7EEC581DC9F84818A5E26DAD2D815AFE"><enum>(B)</enum><text display-inline="yes-display-inline">any smoking article that incorporates a
significant modification (including changes in design, component, part, or
constituent, including a smoke constituent, or in the content, delivery or form
of nicotine, or other additive or ingredient) of a smoking article where the
modified product was commercially marketed in the United States after the date
of enactment of this Act.</text>
</subparagraph></paragraph><paragraph id="HAF783B6E484B495EADCAFCCB9D4F6AEF"><enum>(2)</enum><header>Premarket review
required</header>
<subparagraph id="H1188055CC2B94F31B4810C0FB4C44EA9"><enum>(A)</enum><header>New
products</header><text>An order under subsection (c)(1)(A) for a new smoking
article is required unless the product—</text>
<clause id="HE76A16B8C4EF4320A5CC1DDD894AE141"><enum>(i)</enum><text display-inline="yes-display-inline">is substantially equivalent to a smoking
article commercially marketed in the United States as of date of enactment of
this Act; and</text>
</clause><clause id="H3C3A871C8D294B649BB49BCD2C740558"><enum>(ii)</enum><text>is
in compliance with the requirements of this Act.</text>
</clause></subparagraph><subparagraph id="HC9FD73DB656D4C3A9CEC63781BBAC0F5"><enum>(B)</enum><header>Consumer
testing</header><text display-inline="yes-display-inline">This section shall
not apply to smoking articles that are provided to adult tobacco consumers for
purposes of consumer testing. For purposes of this section, the term
<term>consumer testing</term> means an assessment of smoking articles that is
conducted by or under the control and direction of a manufacturer for the
purpose of evaluating consumer acceptance of such smoking articles, utilizing
only the quantity of cigarettes that is reasonably necessary for such
assessment</text>
</subparagraph></paragraph><paragraph id="H215F63FA363C4E86B0C38F3CBC17DB3E"><enum>(3)</enum><header>Substantially
equivalent defined</header>
<subparagraph id="H76BE6A0118E04875A0025B7C728D343F"><enum>(A)</enum><header>In
general</header><text>In this section, the term <term>substantially
equivalent</term> or <term>substantial equivalence</term> means, with respect
to the smoking article being compared to the predicate smoking article, that
the Administrator by order has found that the smoking article—</text>
<clause id="H661836DCDD8444038F9AE5D7F14CE335"><enum>(i)</enum><text>has
the same general characteristics as the predicate smoking article; or</text>
</clause><clause id="HEC3955622C8C43398661D69752756B0D"><enum>(ii)</enum><text>has
different characteristics and the information submitted contains information,
including clinical data if deemed necessary by the Administrator, 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
for the consumer of the product.</text>
</clause></subparagraph><subparagraph id="H0C3B61C83A2D4C0EAB9167568FFB0C5E"><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
smoking article.</text>
</subparagraph><subparagraph id="H271FFCCF0E304F6E98BB8D7DBA11C7EA"><enum>(C)</enum><header>Limitation</header><text>A
smoking article may not be found to be substantially equivalent to a predicate
smoking article that has been removed from the market at the initiative of the
Administrator or that has been determined by a judicial order to be misbranded
or adulterated.</text>
</subparagraph></paragraph><paragraph id="H5358938E97894398AAF1007D26497FA4"><enum>(4)</enum><header>Health
information</header><text display-inline="yes-display-inline">As part of a
submission respecting a smoking article, the person required to file a
premarket notification shall provide an adequate summary of any health
information related to the smoking article or state that such information will
be made available upon request by any person.</text>
</paragraph></subsection><subsection id="HDC1501674C004D9B96C2FADCFCBD3427"><enum>(b)</enum><header>Application</header>
<paragraph id="H797325E20D4F41FB99099EB8AC34F9AD"><enum>(1)</enum><header>Contents</header><text>An
application under this section shall contain—</text>
<subparagraph id="HE9A82B24ACBC4920BBA0551F645907E0"><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 smoking article and whether such smoking article presents
less risk than other smoking articles;</text>
</subparagraph><subparagraph id="H53D555D8A60343408AA61AE20E0FFDFD"><enum>(B)</enum><text>a full statement
of the components, ingredients, additives, and properties, and of the principle
or principles of operation, of such smoking article;</text>
</subparagraph><subparagraph id="HF00E684E35554D149DA81F5E0E41A5FB"><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
smoking article;</text>
</subparagraph><subparagraph id="H2A0C7A1157A74EC799F47BAA1368071B"><enum>(D)</enum><text>an identifying
reference to any smoking article standard under section 111 which would be
applicable to any aspect of such smoking article, and either adequate
information to show that such aspect of such smoking article fully meets such
smoking article standard or adequate information to justify any deviation from
such standard;</text>
</subparagraph><subparagraph id="HF91B61F26FA14AA4A21CF6CB94E1A306"><enum>(E)</enum><text>such samples of
such smoking article and of components thereof as the Administrator may
reasonably require;</text>
</subparagraph><subparagraph id="H476E67BCBA824BB1AD0FEEEF73F1A0F4"><enum>(F)</enum><text>specimens of the
labeling proposed to be used for such smoking article; and</text>
</subparagraph><subparagraph id="H1F5128A54C7C46E198BE4BBDEDF3B568"><enum>(G)</enum><text>such other
information relevant to the subject matter of the application as the
Administrator may require.</text>
</subparagraph></paragraph><paragraph id="HD3BD86EFADC14FB5A5AD117B2D463A90"><enum>(2)</enum><header>Referral to
tobacco products scientific advisory committee</header><text>Upon receipt of an
application meeting the requirements set forth in paragraph (1), the
Administrator—</text>
<subparagraph id="H952A8C1CE86D4E02B2C83AC62A877D18"><enum>(A)</enum><text>may, on the
Administrator’s own initiative; or</text>
</subparagraph><subparagraph id="HED2318CF8B454BB9BB45F25C2C0FF9A7"><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 Administrator may establish) of a
report and recommendation respecting the application, together with all
underlying data and the reasons or basis for the recommendation.</continuation-text></paragraph></subsection><subsection id="H8442B3DFCABF42AEA3E5D97B63B62C3D"><enum>(c)</enum><header>Action on
Application</header>
<paragraph id="H28CA199A6EFA4922849131A0F2648C0B"><enum>(1)</enum><header>Deadline</header><text display-inline="yes-display-inline">As promptly as possible, but in no event
later than 90 days after the receipt of an application under subsection (b),
the Administrator, after considering the report and recommendation submitted
under subsection (b)(2), shall—</text>
<subparagraph id="HAD18544DE46742208236780FFE4C8E33"><enum>(A)</enum><text>issue an order
that the new product may be introduced or delivered for introduction into
interstate commerce if the Administrator finds that none of the grounds
specified in paragraph (2) of this subsection applies; or</text>
</subparagraph><subparagraph id="HA2685B8165784F31B385DAF4B64FC9D4"><enum>(B)</enum><text>issue an order
that the new product may not be introduced or delivered for introduction into
interstate commerce if the Administrator 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>
</subparagraph></paragraph><paragraph id="HD791201DC26549E4B836B715985F96A2"><enum>(2)</enum><header>Denial of
application</header><text>The Administrator shall deny an application submitted
under subsection (b) if, upon the basis of the information submitted to the
Administrator as part of the application and any other information before the
Administrator with respect to such smoking article, the Administrator finds
that—</text>
<subparagraph id="HB37081AAC5694E68934E68ABE7C9E8F4"><enum>(A)</enum><text>there is a lack of
a showing that permitting such smoking article to be marketed would be
appropriate for the protection of the public health;</text>
</subparagraph><subparagraph id="H43960BD657214A4CAD66C798D3DA61EC"><enum>(B)</enum><text>the methods used
in, or the facilities or controls used for, the manufacture, processing, or
packing of such smoking article do not conform to the requirements of section
110(e);</text>
</subparagraph><subparagraph id="H8E9C56DDBCA44BDC8F2A0393E2199024"><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="H9F93B56B47864CB08FA1B2B5303C4E66"><enum>(D)</enum><text>such smoking
article is not shown to conform to a smoking article standard in effect under
section 111, and there is a lack of adequate information to justify the
deviation from such standard.</text>
</subparagraph></paragraph><paragraph id="H3F8B72FB790A40829412D123B2F04CB5"><enum>(3)</enum><header>Denial
information</header><text>Any denial of an application shall, insofar as the
Administrator determines to be practicable, be accompanied by a statement
informing the applicant of the measures required to remove such application
from deniable form (which measures may include further research by the
applicant in accordance with 1 or more protocols prescribed by the
Administrator).</text>
</paragraph><paragraph id="H9905DFC11F034A82A97D291D6D7CFB3B"><enum>(4)</enum><header>Basis for
finding</header><text>For purposes of this section, the finding as to whether
the commercial introduction of a smoking article for which an application has
been submitted is appropriate for the protection of the public health shall be
determined with respect to the risks and benefits to the users of the smoking
article, and taking into account whether such commercial introduction is
reasonably likely to increase the morbidly and mortality among individual
tobacco users.</text>
</paragraph></subsection><subsection id="HD490D46E738F468A91227873B3ABF121"><enum>(d)</enum><header>Withdrawal and
Temporary Suspension</header>
<paragraph id="H8FF93EF2C37D41198535F53ADC9FE6A4"><enum>(1)</enum><header>In
general</header><text>The Administrator shall, upon obtaining, where
appropriate, advice on scientific matters from the Tobacco Products Scientific
Advisory Committee, and after due notice and opportunity for informal hearing
for a smoking article for which an order was issued under subsection (c)(1)(A),
issue an order withdrawing the order if the Administrator finds—</text>
<subparagraph id="H7B1883FC271A447C8B3876EDCECF2C65"><enum>(A)</enum><text>that the continued
marketing of such smoking article no longer is appropriate for the protection
of the public health;</text>
</subparagraph><subparagraph id="H30B0390A47C74686BF49224A18B95738"><enum>(B)</enum><text>that the
application contained or was accompanied by an untrue statement of a material
fact;</text>
</subparagraph><subparagraph id="H829FCA9A430C42DEA8C35F6F6644E1ED"><enum>(C)</enum><text>that the
applicant—</text>
<clause id="HC2319BDE4CBB473BBB9550F12D84B8BE"><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 113; or</text>
</clause><clause id="H5A8617DB968A4378A4F9EC01808AAD66"><enum>(ii)</enum><text>has
refused to permit access to, or copying or verification of, such records as
required by section 110; or</text>
</clause></subparagraph><subparagraph id="HAFA6DA6A72474F3A969AF8A9E97E8E20"><enum>(D)</enum><text>on the basis of
new information before the Administrator with respect to such smoking article,
evaluated together with the evidence before the Administrator when the
application was reviewed, that the methods used in, or the facilities and
controls used for, the manufacture, processing, packing, or installation of
such smoking article do not conform with the requirements of section 110(e) and
were not brought into conformity with such requirements within a reasonable
time after receipt of written notice from the Administrator of
nonconformity;</text>
</subparagraph><subparagraph id="H2624D67BBDC3474FBC557884D503B3E0"><enum>(E)</enum><text>on the basis of
new information before the Administrator, evaluated together with the evidence
before the Administrator when the application was reviewed, that the labeling
of such smoking article, 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 Administrator of such fact;
or</text>
</subparagraph><subparagraph id="H73F0A2F6C2924591A1ABDFC9C81CFD35"><enum>(F)</enum><text>on the basis of
new information before the Administrator, evaluated together with the evidence
before the Administrator when such order was issued, that such smoking article
is not shown to conform in all respects to a smoking article standard which is
in effect under section 111, compliance with which was a condition to the
issuance of an order relating to the application, and that there is a lack of
adequate information to justify the deviation from such standard.</text>
</subparagraph></paragraph><paragraph id="H263B635AB68B43318C4FC7BEB6BF192C"><enum>(2)</enum><header>Appeal</header><text>The
holder of an application subject to an order issued under paragraph (1)
withdrawing an order issued pursuant to subsection (c)(1)(A) 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
116.</text>
</paragraph><paragraph id="HA977FFD4C7654E5F82ABF587F9B7CC99"><enum>(3)</enum><header>Temporary
suspension</header><text>If, after providing an opportunity for an informal
hearing, the Administrator determines there is reasonable probability that the
continuation of distribution of a smoking article under an order would cause
serious, adverse health consequences or death, that is greater than ordinarily
caused by smoking articles on the market, the Administrator shall by order
temporarily suspend the authority of the manufacturer to market the product. If
the Administrator issues such an order, the Administrator shall proceed
expeditiously under paragraph (1) to withdraw such application.</text>
</paragraph></subsection><subsection id="H477EBE763AA54D948F149962936A5B15"><enum>(e)</enum><header>Service of
Order</header><text>An order issued by the Administrator under this section
shall be served—</text>
<paragraph id="H5168FFC0A7B34DA5854C82E99AB63CCC"><enum>(1)</enum><text>in person by any
officer or employee of the department designated by the Administrator;
or</text>
</paragraph><paragraph id="H90B53600688D4525889B6CA80B4F4DE1"><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 Administrator.</text>
</paragraph></subsection><subsection id="H11D516DBC6C64352AF6E87CF09DA2F1E"><enum>(f)</enum><header>Records</header>
<paragraph id="HF2A8E5B488A24739AF8E97804831211C"><enum>(1)</enum><header>Additional
information</header><text>In the case of any smoking article for which an order
issued pursuant to subsection (c)(1)(A) for an application filed under
subsection (b) is in effect, the applicant shall establish and maintain such
records, and make such reports to the Administrator, as the Administrator 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 Administrator to determine, or facilitate a determination of,
whether there is or may be grounds for withdrawing or temporarily suspending
such order.</text>
</paragraph><paragraph id="H768B85844AC14AB482414AE45D05D880"><enum>(2)</enum><header>Access to
records</header><text>Each person required under this section to maintain
records, and each person in charge of custody thereof, shall, upon request of
an officer or employee designated by the Administrator, permit such officer or
employee at all reasonable times to have access to and copy and verify such
records.</text>
</paragraph></subsection><subsection id="HA7015698BE754BA0A0E387A4E3A8BE28"><enum>(g)</enum><header>Investigational
smoking article Exemption for Investigational Use</header><text>The
Administrator may exempt smoking articles intended for investigational use from
the provisions of this Act under such conditions as the Administrator may by
regulation prescribe.</text>
</subsection></section><section id="H169BCD624CDD4997BDB9C2A2F2BE4E57"><enum>115.</enum><header>Modified risk
tobacco products</header>
<subsection id="H8C05740023F64594BF40D9FEE2819D88"><enum>(a)</enum><header>In
General</header><text>No person may introduce or deliver for introduction into
interstate commerce any modified risk tobacco product unless an order issued
pursuant to subsection (g) is effective with respect to such product.</text>
</subsection><subsection id="H11781D4F72F74B4A8A4A998430FCB41D"><enum>(b)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="H4070D39B98E046218452758D0CCCE8E9"><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="HECC9DBA059504C3C845BBBF8CC266C5A"><enum>(2)</enum><header>Sold or
distributed</header>
<subparagraph id="HB1BA2E7ED15E4274BD00E8A64F4CC0BD"><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="HA218BB66F1A348F59D465C7AD97CA02D"><enum>(i)</enum><text>the
label, labeling, or advertising of which represents explicitly or implicitly
that—</text>
<subclause id="H6B4C5ED7E32E40E2ADFCA86F8D7C59AE"><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="H540061D6FCC74900B0BEAEC407F3E07C"><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="H7BE1809120B4483DB9620FFED3C41F44"><enum>(III)</enum><text>the tobacco
product or its smoke does not contain or is free of a substance;</text>
</subclause></clause><clause id="H0A766230DF664D12A803929967BAF5CE"><enum>(ii)</enum><text>the
label, labeling, or advertising of which uses the descriptors
<quote>light</quote>, <quote>mild</quote>, <quote>low</quote>,
<quote>medium</quote>, <quote>ultra light</quote>, <quote>low tar</quote> or
<quote>ultra low tar</quote>; or</text>
</clause><clause id="HBE3F40710C6740C08DED8516E4A5C949"><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 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="H1476AD29456441D79A9671573B4E25E4"><enum>(B)</enum><header>Limitation</header><text>No
tobacco product shall be considered to be <quote>sold or distributed for use to
reduce harm or the risk of tobacco-related disease associated with commercially
marketed tobacco products</quote>, except as described in subparagraph
(A).</text>
</subparagraph><subparagraph id="H8C7B651D08004131BCCB734CC6F76FFD"><enum>(C)</enum><header>Smokeless
tobacco product</header><text display-inline="yes-display-inline">No smokeless
tobacco product shall be considered to be <quote>sold or distributed for use to
reduce harm or the risk of tobacco-related disease associated with commercially
marketed tobacco products</quote>.</text>
</subparagraph></paragraph><paragraph id="H36533E3C7F984619867819D2870FA741"><enum>(3)</enum><header>Effective
date</header><text>The provisions of paragraph (2)(A)(ii) shall take effect 12
months after the date of enactment of the Act.</text>
</paragraph></subsection><subsection id="H190AED5ECD3248489DA040DD9A40D8A5"><enum>(c)</enum><header>Tobacco
dependence products</header><text>A product that is intended to be used for the
treatment of tobacco dependence, including smoking cessation, is not a modified
risk tobacco product under this section if it has been approved as a drug or
device by the Center and is subject to the requirements of chapter V.</text>
</subsection><subsection id="H21EDC84FEB354BB489051ABD3D9C13C6"><enum>(d)</enum><header>Filing</header><text>Any
person may file with the Administrator an application for a modified risk
tobacco product. Such application shall include—</text>
<paragraph id="H0C00F6456D55431792F8F5F877820847"><enum>(1)</enum><text>a
description of the proposed product and any proposed advertising and
labeling;</text>
</paragraph><paragraph id="H0389AF002AF140968F562470411A9FDF"><enum>(2)</enum><text>the conditions for
using the product;</text>
</paragraph><paragraph id="HAEB93C0955C744FC95D69E64C0F4E282"><enum>(3)</enum><text>the formulation of
the product;</text>
</paragraph><paragraph id="HEE16049BE8984D22830707FECE83B252"><enum>(4)</enum><text>sample product
labels and labeling;</text>
</paragraph><paragraph id="H006F33DC20E6435EB41D13D59CEDFD23"><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="HCCD6B4CBE4EC4918AE175555AC248A89"><enum>(6)</enum><text display-inline="yes-display-inline">data and information on how consumers
actually use the tobacco product; and</text>
</paragraph><paragraph id="H692F9AC0A95849FDB0EE5408E034D292"><enum>(7)</enum><text>such other
information as the Administrator may require.</text>
</paragraph></subsection><subsection id="HCBC4FF395B914E29AB16D56CC4A85666"><enum>(e)</enum><header>Public
availability</header><text>The Administrator 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="H90B81821F58948889E41531640DDC83E"><enum>(f)</enum><header>Advisory
committee</header>
<paragraph id="HF0D3412639CE4C3EABC9EE4FD52EB69B"><enum>(1)</enum><header>In
general</header><text>The Administrator shall refer to the Tobacco Products
Scientific Advisory Committee any application submitted under this
section.</text>
</paragraph><paragraph id="H40A6DA3D4047406FAE533879014972C5"><enum>(2)</enum><header>Recommendations</header><text>Not
later than 60 days after the date an application is referred to the Tobacco
Products Scientific Advisory Committee under paragraph (1), the Advisory
Committee shall report its recommendations on the application to the
Administrator.</text>
</paragraph></subsection><subsection id="H4F57FAB7363E4D0DA59C1B3ACD58C98B"><enum>(g)</enum><header>Marketing</header>
<paragraph id="H3DA579FF5A60466AB10EBE4D3005BD97"><enum>(1)</enum><header>Modified risk
products</header><text>Except as provided in paragraph (2), the Administrator
shall, with respect to an application submitted under this section, issue an
order that a modified risk product may be commercially marketed only if the
Administrator determines that the applicant has demonstrated that such product,
as it is actually used by consumers, will—</text>
<subparagraph id="HE6935B8301054DFCAE273DE9E8A535D3"><enum>(A)</enum><text>significantly
reduce harm and the risk of tobacco-related disease to individual tobacco
users; and</text>
</subparagraph><subparagraph id="H5AE74D8433CD464EBD53BC434297B007"><enum>(B)</enum><text>is reasonably
likely to result in measurable and substantial reductions in morbidity and
mortality among individual tobacco users.</text>
</subparagraph></paragraph><paragraph id="H18B225A81D454885BE92736F27012945"><enum>(2)</enum><header>Special rule for
certain products</header>
<subparagraph id="H2259CDF76EB446AFA768A89FF85537C7"><enum>(A)</enum><header>In
general</header><text>The Administrator may issue an order that a tobacco
product may be introduced or delivered for introduction into interstate
commerce, pursuant to an application under this section, with respect to a
tobacco product that may not be commercially marketed under paragraph (1) if
the Secretary makes the findings required under this paragraph and determines
that the applicant has demonstrated that—</text>
<clause id="HF5BD58E4B2D24A2D82DC3605D0E3E466"><enum>(i)</enum><text>such
order would be appropriate to promote the public health;</text>
</clause><clause id="H58CE2D087A7D4427A5DEAC00540397A8"><enum>(ii)</enum><text>any
aspect of the label, labeling, and advertising for such product that would
cause the tobacco product to be a modified risk tobacco product under
subsection (b) is limited to an explicit or implicit representation that such
tobacco product or its smoke does not contain or is free of a substance or
contains a reduced level of a substance, or presents a reduced exposure to a
substance in tobacco smoke;</text>
</clause><clause id="HA51CD9F90C7A4DC2BDF2DB04C1432363"><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="HDA29CB0780BE402CA990BEF7CDDB89EE"><enum>(iv)</enum><text>the
scientific evidence that is available without conducting long-term
epidemiological studies demonstrates that a measurable and substantial
reduction in morbidity or mortality among individual tobacco users is
reasonably likely in subsequent studies.</text>
</clause></subparagraph><subparagraph id="H9F708F547829453B9B39ACAE99323D5E"><enum>(B)</enum><header>Additional
findings required</header><text>To issue an order under subparagraph (A) the
Administrator must also find that the applicant has demonstrated that—</text>
<clause id="H354A056A72B64EAE9D0BB155C4729B8C"><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="H652158AF92C349B5B0316893BD62830D"><enum>(ii)</enum><text>the
product as actually used by consumers will not expose them to higher levels of
other harmful substances compared to the similar types of tobacco products then
on the market unless such increases are minimal and the reasonably likely
overall impact of use of the product remains a substantial and measurable
reduction in overall morbidity and mortality among individual tobacco
users;</text>
</clause><clause id="HFA4FEE073BBE4F208A7C3A7BC823CF1E"><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="H7AED239E38A549F9A2E4620FE2CC0B6C"><enum>(I)</enum><text>is or has been
demonstrated to be significantly less harmful; or</text>
</subclause><subclause id="HE405E1DC04B44E24BB92FF5891DFBE6F"><enum>(II)</enum><text>presents or has
been demonstrated to present significant less of a risk of disease than other
commercially marketed tobacco products; and</text>
</subclause></clause><clause id="HA0FD763730634D478250C75029625748"><enum>(iv)</enum><text display-inline="yes-display-inline">issuance of an order with respect to the
application is expected to benefit the health of users of tobacco
products.</text>
</clause></subparagraph></paragraph><paragraph id="HF65D0B05B6B64977962D5700C55E8343"><enum>(3)</enum><header>Basis</header><text>The
determinations under paragraphs (1) and (2) shall be based on—</text>
<subparagraph id="H2CCDB282A5154D699D39F9C87CD5407B"><enum>(A)</enum><text>the scientific
evidence submitted by the applicant; and</text>
</subparagraph><subparagraph id="HA259018B30C240228F1E94E1083FB59A"><enum>(B)</enum><text>scientific
evidence and other information that is made available to the
Administrator.</text>
</subparagraph></paragraph></subsection><subsection id="H2F156351311843DAB7C75FCE5E666B13"><enum>(h)</enum><header>Additional
Conditions for Marketing</header>
<paragraph id="H8E12492040F74135993B12E65C29E394"><enum>(1)</enum><header>Modified risk
products</header><text>The Administrator shall require for the marketing of a
product under this section that any advertising or labeling concerning modified
risk products enable the public to comprehend the information concerning
modified risk and to understand the relative significance of such information
in the context of total health and in relation to all of the diseases and
health-related conditions associated with the use of tobacco products.</text>
</paragraph><paragraph id="H593A285F856D4FDE96CB241CBB8A382E"><enum>(2)</enum><header>Comparative
claims</header>
<subparagraph id="HAB11E9137AB842EBBC981B78F463C93A"><enum>(A)</enum><header>In
general</header><text>The Administrator may require for the marketing of a
product under this subsection that a claim comparing a tobacco product to 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="H9CF29B079947419882908C2B8AA0B5F9"><enum>(B)</enum><header>Quantitative
comparisons</header><text>The Administrator 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></subsection><subsection id="HA16432E025D54CCAB87E953706E3B9BE"><enum>(i)</enum><header>Postmarket
Surveillance and Studies</header>
<paragraph id="H2094CA7CB6F64B02A8F720898E53E269"><enum>(1)</enum><header>In
general</header><text>The Administrator shall require, with respect to a
product for which an applicant obtained an order under subsection (g)(1), that
the applicant conduct postmarket surveillance and studies for such a tobacco
product to determine the impact of the order issuance on consumer perception,
behavior, and health, to enable the Administrator to review the accuracy of the
determinations upon which the order was based, and to provide information that
the Administrator determines is otherwise necessary regarding the use or health
risks involving the tobacco product. The results of postmarket surveillance and
studies shall be submitted to the Administrator on an annual basis.</text>
</paragraph><paragraph id="H7B7CBA7AFEE14C6E8E103DDA0E0095BF"><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 Administrator, a protocol for the required surveillance.
The Administrator, within 30 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 Administrator as necessary to protect the public
health.</text>
</paragraph></subsection><subsection id="H02E7A6DDFCA840EC9B702F18364E83A3"><enum>(j)</enum><header>Withdrawal of
Authorization</header><text>The Administrator, after an opportunity for an
informal hearing, shall withdraw an order under subsection (g) if the
Administrator determines that—</text>
<paragraph id="H7DE7A06420644AC98B2875CE39B184CD"><enum>(1)</enum><text>the applicant,
based on new information, can no longer make the demonstrations required under
subsection (g), or the Administrator can no longer make the determinations
required under subsection (g);</text>
</paragraph><paragraph id="HFC10A3CC166E4EFE99C0660853190B1E"><enum>(2)</enum><text>the application
failed to include material information or included any untrue statement of
material fact;</text>
</paragraph><paragraph id="H734C5DA0CC6149368C35E113DFA1DAEB"><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="HCF6E9550D18C4AFCB539C19822ABAFD8"><enum>(A)</enum><text>a tobacco product
standard is established pursuant to section 111;</text>
</subparagraph><subparagraph id="H1D70C2CE60CD4F76A1E6B0063C991A50"><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="H78B5A6F7EF954794B66763A4B685E245"><enum>(C)</enum><text>any postmarket
surveillance or studies reveal that the order is no longer consistent with the
protection of the public health;</text>
</subparagraph></paragraph><paragraph id="HC910A255F59949CCBAB3B47370918550"><enum>(4)</enum><text>the applicant
failed to conduct or submit the postmarket surveillance and studies required
under subsection (g)(2)(C)(ii) or subsection (i); or</text>
</paragraph><paragraph id="HAC25B2DF1EBC4E4BAD908A3A2D673A6F"><enum>(5)</enum><text>the applicant
failed to meet a condition imposed under subsection (h).</text>
</paragraph></subsection><subsection id="H3508E6087D0F4634A70BF533C82444FA"><enum>(k)</enum><header>Chapter IV or
V</header><text>A product for which the Administrator has issued an order
pursuant to subsection (g) shall not be subject to chapter IV or V of the
Federal Food, Drug, and Cosmetic Act.</text>
</subsection><subsection id="H30BD9453FEDC4B72951F1FE0F0C0D4AE"><enum>(l)</enum><header>Implementing
Regulations or Guidance</header>
<paragraph id="H3C18D705E9F543798267770F8E66C513"><enum>(1)</enum><header>Scientific
evidence</header><text>Not later than 2 years after the date of enactment of
the Act, the Administrator 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="HC8DA2E7B251B457C860EA1C7E5863E50"><enum>(A)</enum><text>to the extent that
adequate scientific evidence exists, establish minimum standards for scientific
studies needed prior to issuing an order under subsection (g) to show a
reasonable likelihood that a substantial reduction in morbidity or mortality
among individual tobacco users occurs for products described in subsection
(g)(1) or is reasonably likely for products described in subsection
(g)(2);</text>
</subparagraph><subparagraph id="HA9B4D6F266774C3DB124BBDF7096A723"><enum>(B)</enum><text>include validated
biomarkers, intermediate clinical endpoints, and other feasible outcome
measures, as appropriate;</text>
</subparagraph><subparagraph id="HC2877740B0504C23B85769B296D3969A"><enum>(C)</enum><text>establish minimum
standards for postmarket studies, that shall include regular and long-term
assessments of health outcomes and mortality, intermediate clinical endpoints,
consumer perception of harm reduction, and the impact on quitting behavior and
new use of tobacco products, as appropriate;</text>
</subparagraph><subparagraph id="HA3DEF0A0B24E404E9E3086829E6DE827"><enum>(D)</enum><text>establish minimum
standards for required postmarket surveillance, including ongoing assessments
of consumer perception; and</text>
</subparagraph><subparagraph id="H4FEF9B63E66A4765A20EE19259C342A4"><enum>(E)</enum><text display-inline="yes-display-inline">establish a reasonable timetable for the
Administrator to review an application under this section.</text>
</subparagraph></paragraph><paragraph id="H5ACFB6A90CFC4AB6BAC5C2B2FFF62D59"><enum>(2)</enum><header>Consultation</header><text>The
regulations or guidance issued under paragraph (1) may 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="HBFE4B00A9F554E9692D0322EB76BCE7D"><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="HDB46723F296B4488B161B8BDCF3E6A76"><enum>(4)</enum><header>New tobacco
products</header><text>Not later than 2 years after the date of enactment of
the Act, the Administrator 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 114 and which the applicant seeks to commercially
market under this section.</text>
</paragraph></subsection></section><section id="H819A79072DC4417CBCF470518CE614E9"><enum>116.</enum><header>Judicial
review</header>
<subsection id="H553AF8DF6188455284B31644CA1A3200"><enum>(a)</enum><header>Right To
Review</header>
<paragraph id="H93730D5FF64141F9971A85A9251A323F"><enum>(1)</enum><header>In
general</header><text>Not later than 60 days after—</text>
<subparagraph id="H0ABDD1872690433691D9FB211A33AF5C"><enum>(A)</enum><text>the promulgation
of a regulation under section 111 establishing, amending, or revoking a tobacco
product standard; or</text>
</subparagraph><subparagraph id="H9490642A2B284F9EBF17E61EAB480570"><enum>(B)</enum><text>a denial of an
application under section 114(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="H698F0876DB48498CBDF2D950610F3C56"><enum>(2)</enum><header>Requirements</header>
<subparagraph id="HE0F5A1DDE2D142E0B65A848B03DB4B3D"><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 Administrator.</text>
</subparagraph><subparagraph id="H3F0F01A8A64649E9AA3D3559E8B46376"><enum>(B)</enum><header>Record of
proceedings</header><text>On receipt of a petition under subparagraph (A), the
Administrator shall file in the court in which such petition was filed—</text>
<clause id="HCEE018A905E145E5BF546F78A49B3925"><enum>(i)</enum><text>the
record of the proceedings on which the regulation or order was based;
and</text>
</clause><clause id="H4049364502014159B434F56C093D6E98"><enum>(ii)</enum><text>a
statement of the reasons for the issuance of such a regulation or order.</text>
</clause></subparagraph><subparagraph id="HD0CED5DE01FB49178ED08AF0A14601F7"><enum>(C)</enum><header>Definition of
record</header><text>In this section, the term <term>record</term>
means—</text>
<clause id="HBA470A96BC80450AA280EF58EBC48854"><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="H8B536EA80D464B938FAA94CC68F6E97B"><enum>(ii)</enum><text>all
information submitted to the Administrator with respect to such regulation or
order;</text>
</clause><clause id="H175F13EDC7C4450C92C6D8CAAFAA211C"><enum>(iii)</enum><text>proceedings of
any panel or advisory committee with respect to such regulation or
order;</text>
</clause><clause id="H6F92A80461F34AEE8029D48C449AF24F"><enum>(iv)</enum><text>any
hearing held with respect to such regulation or order; and</text>
</clause><clause id="H895B85E2ACAE48198C3D5EE5B15BA8E2"><enum>(v)</enum><text>any
other information identified by the Administrator, 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="H09164204E2FA40F397F590AFB1102E76"><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="HBD0891B738FC4690B54B1B3FB98A60AE"><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="H60C167ABB48544CC95F8F273DC0F4997"><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="HBD59CC0EC5FE403884A1633E09ACF489"><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 110, 111, 112, 113, 114, or 119
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="H3A0DF26CAFFF48DCA78EE8614D703885"><enum>117.</enum><header>Jurisdiction of
and coordination with the Federal Trade Commission</header><text display-inline="no-display-inline">Except
where expressly provided in this Act, nothing in this Act 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>
</section><section id="HBA840BBEF009423BBB973BD762981049"><enum>118.</enum><header>Regulation
requirement</header>
<subsection id="HB255F8A20EAB4779839A9DF6FDCB4371"><enum>(a)</enum><header>Testing,
Reporting, and Disclosure</header><text>Not later than 36 months after the date
of enactment of the Act, the Administrator shall promulgate regulations under
this Act that meet the requirements of subsection (b).</text>
</subsection><subsection id="H0703667C3CF74B5B8C0F6A780E02C922"><enum>(b)</enum><header>Contents of
Rules</header><text>The regulations promulgated under subsection (a)—</text>
<paragraph id="HBBF62181438E41F6BB6D991BD44BEBD5"><enum>(1)</enum><text display-inline="yes-display-inline">shall require annual testing and reporting
of tobacco product constituents, ingredients, and additives, including smoke
constituents, by brand style that the Administrator determines should be tested
to protect the public health, provided that, for purposes of the testing
requirements of this paragraph, tobacco products manufactured and sold by a
single tobacco product manufacturer that are identical in all respects except
the labels, packaging design, logo, trade dress, trademark, brand name, or any
combination thereof, shall be considered as a single brand style; and</text>
</paragraph><paragraph id="HB5BFDA3916234382A9705F1AB6360CD7"><enum>(2)</enum><text>may require that
tobacco product manufacturers, packagers, or importers make disclosures
relating to the results of the testing of tar and nicotine through labels or
advertising.</text>
</paragraph></subsection><subsection id="HEAD5CE1E4EF3475ABC759B7F5425FAC7"><enum>(c)</enum><header>Authority</header><text>The
Administrator shall have the authority under this Act to conduct or to require
the testing, reporting, or disclosure of tobacco product constituents,
including smoke constituents.</text>
</subsection><subsection commented="no" id="H5728A9AB3608401EB4086526FCFFB4C6"><enum>(d)</enum><header>Joint laboratory
testing services</header><text display-inline="yes-display-inline">The
Administrator shall allow any 2 or more tobacco product manufacturers to join
together to purchase laboratory testing services required by this section on a
group basis in order to ensure that such manufacturers receive access to, and
fair pricing of, such testing services.</text>
</subsection><subsection id="H0CE231E7CB1745A1AA24CEC40AB8CD73"><enum>(e)</enum><header>Extensions for
limited laboratory capacity</header>
<paragraph id="H0D6C5C9FA2D942F3B6C83341A0170D90"><enum>(1)</enum><header>In
general</header><text>The regulations promulgated under subsection (a) shall
provide that a tobacco product manufacturer shall not be considered to be in
violation of this section before the applicable deadline, if—</text>
<subparagraph id="H6C255D2BDE134801BFF6792FB122242F"><enum>(A)</enum><text>the tobacco
products of such manufacturer are in compliance with all other requirements of
this Act; and</text>
</subparagraph><subparagraph id="HB411EF8FEB7042F8B6FD82EF89DD6DDD"><enum>(B)</enum><text>the conditions
described in paragraph (2) are met.</text>
</subparagraph></paragraph><paragraph id="H57A0B687829843629ABBA431D9526599"><enum>(2)</enum><header>Conditions</header><text display-inline="yes-display-inline">Notwithstanding the requirements of this
section, the Administrator may delay the date by which a tobacco product
manufacturer must be in compliance with the testing and reporting required by
this section until such time as the testing is reported if, not later than 90
days before the deadline for reporting in accordance with this section, a
tobacco product manufacturer provides evidence to the Administrator
demonstrating that—</text>
<subparagraph id="HD36DE186EF744680A4E146A5DFEE696D"><enum>(A)</enum><text display-inline="yes-display-inline">the manufacturer has submitted the required
products for testing to a laboratory and has done so sufficiently in advance of
the deadline to create a reasonable expectation of completion by the
deadline;</text>
</subparagraph><subparagraph id="HE2B8737F828649CB8501190B78BBE6AF"><enum>(B)</enum><text>the products
currently are awaiting testing by the laboratory; and</text>
</subparagraph><subparagraph id="H8FC745658265424D96A7903051D0AC16"><enum>(C)</enum><text display-inline="yes-display-inline">neither that laboratory nor any other
laboratory is able to complete testing by the deadline at customary,
nonexpedited testing fees.</text>
</subparagraph></paragraph><paragraph id="HDFA0F618A2F4407FA7A6781C3693B182"><enum>(3)</enum><header>Extension</header><text>The
Administrator, taking into account the laboratory testing capacity that is
available to tobacco product manufacturers, shall review and verify the
evidence submitted by a tobacco product manufacturer in accordance with
paragraph (2). If the Administrator finds that the conditions described in such
paragraph are met, the Administrator shall notify the tobacco product
manufacturer that the manufacturer shall not be considered to be in violation
of the testing and reporting requirements of this section until the testing is
reported or until 1 year after the reporting deadline has passed, whichever
occurs sooner. If, however, the Administrator has not made a finding before the
reporting deadline, the manufacturer shall not be considered to be in violation
of such requirements until the Administrator finds that the conditions
described in paragraph (2) have not been met, or until 1 year after the
reporting deadline, whichever occurs sooner.</text>
</paragraph><paragraph id="HECB6328A4A5C4B1ABDEE3BAADE8992CD"><enum>(4)</enum><header>Additional
extension</header><text display-inline="yes-display-inline">In addition to the
time that may be provided under paragraph (3), the Administrator may provide
further extensions of time, in increments of no more than 1 year, for required
testing and reporting to occur if the Administrator determines, based on
evidence properly and timely submitted by a tobacco product manufacturer in
accordance with paragraph (2), that a lack of available laboratory capacity
prevents the manufacturer from completing the required testing during the
period described in paragraph (3).</text>
</paragraph></subsection><subsection display-inline="no-display-inline" id="H3601AEC73DE54944A90CBCA479C5E058"><enum>(f)</enum><header>Rule of
construction</header><text display-inline="yes-display-inline">Nothing in
subsection (d) or (e) shall be construed to authorize the extension of any
deadline, or to otherwise affect any timeframe, under any provision of this Act
other than this section.</text>
</subsection></section><section id="H430413F7EADE4FECB556B9631C659916"><enum>119.</enum><header>Preservation of
State and local authority</header>
<subsection id="H68F52413DA8C475084ACB389C9FA9649"><enum>(a)</enum><header>In
General</header>
<paragraph id="HC6EDDE3EA3A54FE6B1CAECE02B7DF5D0"><enum>(1)</enum><header>Preservation</header><text>Except
as provided in paragraph (2)(A), nothing in this Act, or rules promulgated
under this Act, 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 requirements established under this Act, including a law,
rule, regulation, or other measure relating to or prohibiting the sale,
distribution, possession, or use of tobacco products by individuals of any age,
information reporting to the State. No provision of this Act shall limit or
otherwise affect any State, Tribal, or local taxation of tobacco
products.</text>
</paragraph><paragraph id="H2E9EC9227BF64BBB887AD5C69C66AB23"><enum>(2)</enum><header>Preemption of
certain state and local requirements</header>
<subparagraph id="H46E039A26CF94DC9883D010C2F2D37F1"><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 Act relating to tobacco product standards, premarket
review, adulteration, misbranding, labeling, registration, good manufacturing
standards, or modified risk tobacco products.</text>
</subparagraph><subparagraph id="H5788395D8ACE4C2DB3ED4056EC79486F"><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, use of, tobacco product by
individuals of any age. 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="H9E41C02C2CB74653BF627172B80DB1A1"><enum>(b)</enum><header>Rule of
Construction Regarding Product Liability</header><text>No provision of this Act
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="H2532E80E65FB45CA8ECA4E968E6618EE"><enum>120.</enum><header>Tobacco
Products Scientific Advisory Committee</header>
<subsection id="H51F70BF7297D4EF9B36EB72491C440EE"><enum>(a)</enum><header>Establishment</header><text>Not
later than 6 months after the date of enactment of this Act, the Administrator
shall establish a 16-member advisory committee, to be known as the Tobacco
Products Scientific Advisory Committee (in this section referred to as the
<quote>Advisory Committee</quote>).</text>
</subsection><subsection id="H1E28A099674A42E4B56E4B02AE550BA5"><enum>(b)</enum><header>Membership</header>
<paragraph id="H825900F6E5324C47A9ABB14E3FDA4A72"><enum>(1)</enum><header>In
general</header>
<subparagraph id="H2F072E6495544231B01E3F0EEC20DA19"><enum>(A)</enum><header>Members</header><text display-inline="yes-display-inline">The Administrator shall appoint as members
of the Tobacco Harm Reduction Advisory Committee individuals who are
technically qualified by training and experience in medicine, medical ethics,
science, or technology involving the manufacture, evaluation, or use of tobacco
products, who are of appropriately diversified professional backgrounds. The
committee shall be composed of—</text>
<clause id="HFC388D34DEE24DA581966939E14D1764"><enum>(i)</enum><text>6
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="HBCFA5FFDAFDF4EF69F4A96D1CCEA3A3A"><enum>(ii)</enum><text>2
individuals who are an officer or employee of a State or local government or of
the Federal Government;</text>
</clause><clause id="HFFE4DBB320A7408896E2254FAE46DFC9"><enum>(iii)</enum><text>2
representatives of the general public;</text>
</clause><clause id="H948719FC43F24AF0B5FF54840699F506"><enum>(iv)</enum><text>2
representatives of the interests of the tobacco manufacturing industry;</text>
</clause><clause id="HCFCB587A10B542D1B875BD682E66EBC0"><enum>(v)</enum><text display-inline="yes-display-inline">1 representative of the interests of the
small business tobacco manufacturing industry, which position may be filled on
a rotating, sequential basis by representatives of different small business
tobacco manufacturers based on areas of expertise relevant to the topics being
considered by the Advisory Committee;</text>
</clause><clause id="H7FC2828083874801B791EE9B233041C4"><enum>(vi)</enum><text>1
individual as a representative of the interests of the tobacco growers;
and</text>
</clause><clause id="H6D9228ABBBD6436A9D9FC76BA65A1C6D"><enum>(vii)</enum><text>1
individual who is an expert in illicit trade of tobacco products.</text>
</clause></subparagraph><subparagraph id="H14DD1141F20847C4886A88C1EC71051C"><enum>(B)</enum><header>Conflicts of
interest</header><text display-inline="yes-display-inline">No members of the
committee, other than members appointed pursuant to clauses (iv), (v), and (vi)
of subparagraph (A) shall, during the member’s tenure on the committee or for
the 18-month period prior to becoming such a member, receive any salary,
grants, or other payments or support from any business that manufactures,
distributes, markets, or sells cigarettes or other tobacco products or
government agency with any form of jurisdiction over tobacco products.</text>
</subparagraph></paragraph><paragraph id="H98614469DED0444EBE301F8D2F03E0B4"><enum>(2)</enum><header>Limitation</header><text>The
Administrator may not appoint to the Advisory Committee any individual who is
in the regular full-time employ of the Tobacco Harm Reduction Center or any
agency responsible for the enforcement of this Act. The Administrator may
appoint Federal officials as ex officio members.</text>
</paragraph><paragraph id="H035DEA34A8B742048BFE3F7F13C52B18"><enum>(3)</enum><header>Chairperson</header><text>The
Administrator shall designate 1 of the members appointed under clauses (i),
(ii), and (iii) of paragraph (1)(A) to serve as chairperson.</text>
</paragraph></subsection><subsection id="H3C2FB922A5A743DEBD6433B4B005B55A"><enum>(c)</enum><header>Duties</header><text>The
Tobacco Products Scientific Advisory Committee shall provide advice,
information, and recommendations to the Administrator—</text>
<paragraph id="H23AF151EAC2B4E31AA18CE1DF098E3B3"><enum>(1)</enum><text>as provided in
this Act;</text>
</paragraph><paragraph id="HA9B21FF3D6734C679BD3F2F8E817B03E"><enum>(2)</enum><text>on the
implementation of prevention, cessation, and harm reduction policies;</text>
</paragraph><paragraph id="H535A302C23C9473A83D8BC5A8E5A23ED"><enum>(3)</enum><text>on implementation
of policies and programs to fully inform consumers of the respective risks of
tobacco products; and</text>
</paragraph><paragraph id="H2542621703FC45399979E1CE77339B75"><enum>(4)</enum><text>on its review of
other safety, dependence, or health issues relating to tobacco products as
requested by the Administrator.</text>
</paragraph></subsection><subsection id="HAF56C986BEF643F48C6C612C87DB1767"><enum>(d)</enum><header>Compensation;
Support; FACA</header>
<paragraph id="HAB4CEE59A78A461BBE5A8305BAD4E7EC"><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 Administrator, 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="H763CDF7B1FB846B2A1DB61DF80375853"><enum>(2)</enum><header>Administrative
support</header><text>The Administrator shall furnish the Advisory Committee
clerical and other assistance.</text>
</paragraph><paragraph id="H4BDCAA64545246A1971FCC442420F932"><enum>(3)</enum><header>Nonapplication
of FACA</header><text>Section 14 of the Federal Advisory Committee Act does not
apply to the Advisory Committee.</text>
</paragraph></subsection><subsection id="HCAA086D096374A2BACC463814946E25E"><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="H0D58A9AD1DFD4546A8248E4E05908C8D"><enum>121.</enum><header>Drug products
used to treat tobacco dependence</header>
<subsection id="H573169BD7D0C4FF688A6812964EA3B51"><enum>(a)</enum><header>Report on
innovative products</header>
<paragraph id="HAEBD937313EB4B1EB35BEB0C96EB14F9"><enum>(1)</enum><header>In
general</header><text>Not later than 3 years after the date of enactment of
this Act, the Administrator, after consultation with recognized scientific,
medical, and public health experts (including both Federal agencies and
nongovernmental entities, the Institute of Medicine of the National Academy of
Sciences, and the Society for Research on Nicotine and Tobacco), shall submit
to the Congress a report that examines how best to promote, and encourage the
development and use by current tobacco users of innovative tobacco and nicotine
products and treatments (including nicotine-based and non-nicotine-based
products and treatments) to better achieve, in a manner that best protects and
promotes the public health—</text>
<subparagraph id="HDECF5D85A37A4A7489E8385CA148ECA5"><enum>(A)</enum><text>total abstinence
from tobacco use;</text>
</subparagraph><subparagraph id="H4FACDCA4A477475BA8D4270E10828D70"><enum>(B)</enum><text>reductions in
consumption of tobacco; and</text>
</subparagraph><subparagraph id="H00A16770CF2C41C0B01DF1ABDCDAE696"><enum>(C)</enum><text>reductions in the
harm associated with continued tobacco use by moving current users to
noncombustible tobacco products.</text>
</subparagraph></paragraph><paragraph id="H9CD96795A5FB4F1785E5A22FCD8A1F6B"><enum>(2)</enum><header>Recommendations</header><text>The
report under paragraph (1) shall include the recommendations of the
Administrator on how the Tobacco Harm and Reduction Center should coordinate
and facilitate the exchange of information on such innovative products and
treatments among relevant offices and centers within the Center and within the
National Institutes of Health, the Centers for Disease Control and Prevention,
and other relevant Federal and State agencies.</text>
</paragraph></subsection></section><section id="H5E362EDD423A4117B17566A4DB00DAC7"><enum>122.</enum><header>Advertising and
marketing of tobacco products</header>
<subsection id="HDF193A7384A94FFEAD95D5E33196D546"><enum>(a)</enum><text>Within 18 months
of enactment of the Act, the Administrator shall report to Congress on the
benefits to public health of imposing restrictions or prohibitions on the
advertising and marketing, consistent with or in addition to such restrictions
or prohibitions contained in the Master Settlement Agreement, on tobacco
products.</text>
</subsection><subsection id="HBB71D4A9809D41049EC64603D522E9DB"><enum>(b)</enum><text>The Administrator
shall specify in the report constitutional free speech implications for each
recommended restriction or prohibition.</text>
</subsection><subsection id="H9B44608EF2934FE500BDF910B823569D"><enum>(c)</enum><text>The Administrator
shall also specify the class of tobacco products to which the prohibition or
restriction would be applicable and the impact of such actions on harm
reduction policies, practices, and accurate information available to tobacco
users.</text>
</subsection><subsection id="H41A4A786557B42D2B404C2646567DB57"><enum>(d)</enum><text>The Administrator
shall establish and consult with an advisory committee consisting of experts in
constitutional law, harm reduction policies, marketing practices, and consumer
behavior in preparing this report.</text>
</subsection></section><enum>II</enum><header>TOBACCO PRODUCTS
WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT DISCLOSURE</header>
<section id="H0CEF338C565F4B3488C5D0EF4641A1E1"><enum>201.</enum><header>Cigarette label
and advertising warnings</header>
<subsection id="HFFF9388A905643B3AF8E7F1A9A33A3B2"><enum>(a)</enum><header>Amendment</header><text display-inline="yes-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 display-inline="no-display-inline" id="HD58B8943DF484006A0A44288D89693DC" style="OLC">
<section id="H037435FB39A740DF8973912246CAE5E7"><enum>4.</enum><header>Labeling</header>
<subsection id="H47B292082B9542979B50369DA48CB6E4"><enum>(a)</enum><header>Label
Requirements</header>
<paragraph id="H3761A6CBA6E44A21B631B040E6E54EFE"><enum>(1)</enum><header>In
general</header><text>It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or distribution
within the United States any cigarettes the package of which fails to bear, in
accordance with the requirements of this section, one of the following
labels:</text>
<list level="subparagraph">
<list-item>WARNING: Cigarettes are
addictive.</list-item>
<list-item>WARNING: Tobacco smoke can harm your
children.</list-item>
<list-item>WARNING: Cigarettes cause fatal lung
disease.</list-item>
<list-item>WARNING: Cigarettes cause cancer.</list-item>
<list-item>WARNING: Cigarettes cause strokes and heart
disease.</list-item>
<list-item>WARNING: Smoking during pregnancy can harm your
baby.</list-item>
<list-item>WARNING: Smoking can kill you.</list-item>
<list-item>WARNING: Tobacco smoke causes fatal lung disease in
nonsmokers.</list-item>
<list-item>WARNING: Quitting smoking now greatly reduces
serious risks to your health.</list-item></list>
</paragraph><paragraph id="HA83DFE5ECAC94DA0B17466D7012D50C5"><enum>(2)</enum><header>Placement;
typography; etc</header><text>Each label statement required by paragraph (1)
shall be located in the lower portion of the front panel of the package,
directly on the package underneath the cellophane or other clear wrapping. Each
label statement shall comprise at least the bottom 25 percent of the front
panel of the package. The word <quote>WARNING</quote> shall appear in capital
letters and all text shall be in conspicuous and legible 17-point type, unless
the text of the label statement would occupy more than 70 percent of such area,
in which case the text may be in a smaller conspicuous and legible type size,
provided that at least 60 percent of such area is occupied by required text.
The text shall be black on a white background, or white on a black background,
in a manner that contrasts, by typography, layout, or color, with all other
printed material on the package, in an alternating fashion under the plan
submitted under subsection (c).</text>
</paragraph><paragraph id="H9D28FF798D024BF4B29D00E822788962"><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="HD6FF9A7D86A44C8EA34A58837F5002E3"><enum>(4)</enum><header>Applicability to
retailers</header><text>A retailer of cigarettes shall not be in violation of
this subsection for packaging that—</text>
<subparagraph id="H6B64BC6150F1426D979EC8AA5BC3089E"><enum>(A)</enum><text>contains a warning
label;</text>
</subparagraph><subparagraph id="H0924E5D1B2DB44BA81FA090DC4F14A64"><enum>(B)</enum><text display-inline="yes-display-inline">is supplied to the retailer by a license-
or permit-holding smoking article manufacturer, importer, or distributor;
and</text>
</subparagraph><subparagraph id="H30C8730B818A4CED85F33B470238633D"><enum>(C)</enum><text>is not altered by
the retailer in a way that is material to the requirements of this
subsection.</text>
</subparagraph></paragraph></subsection><subsection id="HDFE40F3DD51C48199CE55B88EF4C1B22"><enum>(b)</enum><header>Advertising
requirements</header>
<paragraph id="HB841CA758B32409FB9908178637CE081"><enum>(1)</enum><header>In
general</header><text>It shall be unlawful for any tobacco product
manufacturer, importer, distributor, or retailer of cigarettes to advertise or
cause to be advertised within the United States any cigarette unless its
advertising bears, in accordance with the requirements of this section, one of
the labels specified in subsection (a).</text>
</paragraph><paragraph id="H1AA9F1C229B14BE4853F3B20D33CA385"><enum>(2)</enum><header>Typography,
etc</header><text>Each label statement required by subsection (a) in cigarette
advertising shall comply with the standards set forth in this paragraph. For
press and poster advertisements, each such statement and (where applicable) any
required statement relating to tar, nicotine, or other constituent (including a
smoke constituent) yield shall comprise at least 20 percent of the area of the
advertisement and shall appear in a conspicuous and prominent format and
location at the bottom of each advertisement within the trim area. The word
<quote>WARNING</quote> shall appear in capital letters, and each label
statement shall appear in conspicuous and legible type. The text of the label
statement shall be black if the background is white and white if the background
is black, under the plan submitted under subsection (c). The label statements
shall be enclosed by a rectangular border that is the same color as the letters
of the statements and that is the width of the first downstroke of the capital
<quote>W</quote> of the word <quote>WARNING</quote> in the label statements.
The text of such label statements shall be in a typeface pro rata to the
following requirements: 45-point type for a whole-page broadsheet newspaper
advertisement; 39-point type for a half-page broadsheet newspaper
advertisement; 39-point type for a whole-page tabloid newspaper advertisement;
27-point type for a half-page tabloid newspaper advertisement; 31.5-point type
for a double page spread magazine or whole-page magazine advertisement;
22.5-point type for a 28 centimeter by 3 column advertisement; and 15-point
type for a 20 centimeter by 2 column advertisement. The label statements shall
be in English, except that—</text>
<subparagraph id="H3C7646287305465EB6CB6F0D20B81185"><enum>(A)</enum><text>in the case of an
advertisement that appears in a newspaper, magazine, periodical, or other
publication that is not in English, the statements shall appear in the
predominant language of the publication; and</text>
</subparagraph><subparagraph id="HB0E7A705DAB5493AAD593FDC04CF5697"><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="HFB62F22B790C43E7BD92A40E9754062A"><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 smokeless tobacco products, each
label statement required by subsection (a) may be printed on the inside cover
of the matchbook.</text>
</paragraph></subsection><subsection id="HAA7F29ECB9B24CD3838B9873193F40E4"><enum>(c)</enum><header>Marketing
requirements</header>
<paragraph id="H0BFB595094DE455B904B5895ED33E5A2"><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 smokeless tobacco product manufacturer, importer,
distributor, or retailer and approved by the Secretary.</text>
</paragraph><paragraph id="H5E735E252C4748D58ABA8F17B3DE4AE5"><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 smokeless tobacco product manufacturer,
importer, distributor, or retailer to, and approved by, the Secretary.</text>
</paragraph><paragraph id="H1158534776FA4A0FB41B8C8B4808A5A9"><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="H2ED33E43F61942D389819396E5059EB1"><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="H6594EC770B534CA89D7F57040D1D3FB1"><enum>(B)</enum><text>assures that all
of the labels required under this section will be displayed by the smokeless
tobacco product manufacturer, importer, distributor, or retailer at the same
time.</text>
</subparagraph></paragraph><paragraph id="HD6256DBBFB5E4197B1F484670745C6F8"><enum>(4)</enum><header>Applicability to
retailers</header><text display-inline="yes-display-inline">This subsection and
subsection (b) apply to a retailer only if that retailer is responsible for or
directs the label statements required under this section except that this
paragraph shall not relieve a retailer of liability if the retailer displays,
in a location open to the public, an advertisement that does not contain a
warning label or has been altered by the retailer in a way that is material to
the requirements of this subsection and subsection
(b).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H63778217FE1C49FC9D8EBB7CAFBE4FB6"><enum>(b)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) shall take effect 24 months after the date of enactment of this
Act. Such effective date shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such effective date, a
manufacturer shall not introduce into the domestic commerce of the United
States any product, irrespective of the date of manufacture, that is not in
conformance with section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333), as amended by subsection (a).</text>
</subsection></section><section id="HFF4E849BEBE743DF8FB872A260230DE7"><enum>202.</enum><header>Smokeless
tobacco labels and advertising warnings</header>
<subsection id="HD3A49689234E4A19B5180EDAD05A69A2"><enum>(a)</enum><header>Amendment</header><text display-inline="yes-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 display-inline="no-display-inline" id="H205CEFC8FAC843628ADA7D427CF14215" style="OLC">
<section id="H7CA5A0199276476A8F302935DD94415D"><enum>3.</enum><header>Smokeless tobacco
warning</header>
<subsection id="HCB1BB06FCF454A0DBC762B75A50BF7B7"><enum>(a)</enum><header>General
rule</header>
<paragraph id="H1A176EDA6A5B4CEA9D7A960CBEA8CF59"><enum>(1)</enum><text>It shall be
unlawful for any person to manufacture, package, sell, offer to sell,
distribute, or import for sale or distribution within the United States any
smokeless tobacco product unless the product package bears, in accordance with
the requirements of this Act, one of the following labels:</text>
<list level="subparagraph">
<list-item>WARNING: This product can cause mouth
cancer.</list-item>
<list-item>WARNING: This product can cause gum disease and
tooth loss.</list-item>
<list-item>WARNING: This product has significantly lower risks
for diseases associated with cigarettes.</list-item>
<list-item>WARNING: Smokeless tobacco is
addictive.</list-item></list>
</paragraph><paragraph id="H301D1F772FEE4036ABAA1B8422099BE3"><enum>(2)</enum><text>The label
statements required by paragraph (1) shall be introduced by each smokeless
tobacco product manufacturer, packager, importer, distributor, or retailer of
smokeless tobacco products concurrently into the distribution chain of such
products.</text>
</paragraph><paragraph id="H5210BBB272F547578A0F0D1184504C2A"><enum>(3)</enum><text>The provisions of
this subsection do not apply to a smokeless 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="H1030F8DFACA541CD874F8EC554A09FF3"><enum>(4)</enum><text>A retailer of
smokeless tobacco products shall not be in violation of this subsection for
packaging that—</text>
<subparagraph id="HC26BA6F4608F485595D4B60B16158744"><enum>(A)</enum><text display-inline="yes-display-inline">contains a warning label;</text>
</subparagraph><subparagraph id="HCFB0A490FFE84D97A06122A90B241179"><enum>(B)</enum><text>is supplied to the
retailer by a license- or permit-holding smokeless tobacco product
manufacturer, importer, or distributor; and</text>
</subparagraph><subparagraph id="HCA51CE2DA99243618BA3291442FD6CFD"><enum>(C)</enum><text>is not altered by
the retailer in a way that is material to the requirements of this
subsection.</text>
</subparagraph></paragraph></subsection><subsection id="HFB1817EC7CAD4C17AB27A0DFDE6B6221"><enum>(b)</enum><header>Required
labels</header>
<paragraph id="HA1259D3A01A849E187002E6B8ACD4B18"><enum>(1)</enum><text>It shall be
unlawful for any smokeless tobacco product manufacturer, packager, importer,
distributor, or retailer of smokeless tobacco products to advertise or cause to
be advertised within the United States any smokeless tobacco product unless its
advertising bears, in accordance with the requirements of this section, one of
the labels specified in subsection (a).</text>
</paragraph><paragraph commented="no" id="HB68878D6C08B48B9942610105484C718"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H7BFBBABDF52C4944A3E0F130240D3BD2"><enum>(A)</enum><text>Each label statement
required by subsection (a) in smokeless tobacco advertising shall comply with
the standards set forth in this paragraph.</text>
</subparagraph><subparagraph commented="no" id="HA339D1C228FC443CB8D1C054E4BBDBFB" indent="up1"><enum>(B)</enum><text>For press and poster advertisements,
each such statement and (where applicable) any required statement relating to
nicotine, or other constituent yield shall comprise at least 20 percent of the
area of the advertisement.</text>
</subparagraph><subparagraph commented="no" id="H1027393D2D8A4E96B679B2E275A60ADC" indent="up1"><enum>(C)</enum><text>The word <quote>WARNING</quote> shall
appear in capital letters, and each label statement shall appear in conspicuous
and legible type.</text>
</subparagraph><subparagraph commented="no" id="HA1E08915F1494568A32E672EB382B5BA" indent="up1"><enum>(D)</enum><text>The text of the label statement shall
be black on a white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph (3).</text>
</subparagraph><subparagraph commented="no" id="H747321D044064B4685F875A9E72FF926" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">The label statements shall be enclosed by a
rectangular border that is the same color as the letters of the statements and
that is the width of the first downstroke of the capital <quote>W</quote> of
the word <quote>WARNING</quote> in the label statements.</text>
</subparagraph><subparagraph commented="no" id="H8C9CD6EF59264D45A26AC3783D846185" indent="up1"><enum>(F)</enum><text display-inline="yes-display-inline">The text of such label statements shall be
in a typeface pro rata to the following requirements: 45-point type for a
whole-page broadsheet newspaper advertisement; 39-point type for a half-page
broadsheet newspaper advertisement; 39-point type for a whole-page tabloid
newspaper advertisement; 27-point type for a half-page tabloid newspaper
advertisement; 31.5-point type for a double page spread magazine or whole-page
magazine advertisement; 22.5-point type for a 28 centimeter by 3 column
advertisement; and 15-point type for a 20 centimeter by 2 column
advertisement.</text>
</subparagraph><subparagraph commented="no" id="H3D061BB19F9E409C99C932755DFDE159" indent="up1"><enum>(G)</enum><text>The label statements shall be in
English, except that—</text>
<clause commented="no" id="H4342039DDF4343A499E1C99BE50D4A6A"><enum>(i)</enum><text>in the case of an advertisement
that appears in a newspaper, magazine, periodical, or other publication that is
not in English, the statements shall appear in the predominant language of the
publication; and</text>
</clause><clause commented="no" id="H00CE92B779A949E89FFA28F487812481"><enum>(ii)</enum><text>in the case of any other
advertisement that is not in English, the statements shall appear in the same
language as that principally used in the advertisement.</text>
</clause></subparagraph></paragraph><paragraph id="H2FC8F360DF5746BEA85803B754EC03C1"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H9A59F028E24B4ACEADC521D3E0096C65"><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 smokeless
tobacco product manufacturer, importer, distributor, or retailer and approved
by the Secretary.</text>
</subparagraph><subparagraph id="H66AB66BEFEB349C3AF00F0910D26396A" 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 smokeless tobacco product manufacturer, importer,
distributor, or retailer to, and approved by, the Secretary.</text>
</subparagraph><subparagraph id="H26D50897BBD14471A132D3F5FB283E28" indent="up1"><enum>(C)</enum><text>The Secretary shall review each plan
submitted under subparagraphs (A) and (B) and approve it if the plan—</text>
<clause id="H3EDC748EBDEC408EB6735947F3D38108"><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="H0CECB0B43EE241D28F7BE51EED0A708A"><enum>(ii)</enum><text>assures that all of the labels
required under this section will be displayed by the smokeless tobacco product
manufacturer, importer, distributor, or retailer at the same time.</text>
</clause></subparagraph><subparagraph id="H0E681A333ADA42C1B5CD0C80B4D2BF5C" indent="up1"><enum>(D)</enum><text display-inline="yes-display-inline">This paragraph applies to a retailer only
if that retailer is responsible for or directs the label statements under this
section, unless the retailer displays, in a location open to the public, an
advertisement that does not contain a warning label or has been altered by the
retailer in a way that is material to the requirements of this
subsection.</text>
</subparagraph></paragraph></subsection><subsection id="H5C993C10F84645FE90191A4EEEB8607F"><enum>(c)</enum><header>Television and
radio advertising</header><text>It is unlawful to advertise smokeless tobacco
on any medium of electronic communications subject to the jurisdiction of the
Federal Communications
Commission.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H8E0C431F34EF4349A8C65AC0510A492D"><enum>(b)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The amendment made by
subsection (a) shall take effect 24 months after the date of enactment of this
Act. Such effective date shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such effective date, a
manufacturer shall not introduce into the domestic commerce of the United
States any product, irrespective of the date of manufacture, that is not in
conformance with section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (15 U.S.C. 4402), as amended by subsection (a).</text>
</subsection></section><enum>III</enum><header>PUBIC
DISCLOSURES BY TOBACCO PRODUCTS MANUFACTURERS </header>
<section id="H125D144F8CF84C3C96AF2DE5D7139F89"><enum>301.</enum><header>Disclosures on
packages of tobacco products</header>
<subsection id="HE6A8232EF3BE4820B8BAAA00351DACA6"><enum>(a)</enum><header>Back face for
required disclosures</header><text>For purposes of this section—</text>
<paragraph id="HD2CD31E9D8444D76B6259BB407D46C0"><enum>(1)</enum><text>the principal face
of a package of a tobacco product is the face that has the largest surface area
or, for faces with identical surface areas, any of the faces that have the
largest surface area; a package shall not be characterized as having more than
2 principal faces;</text>
</paragraph><paragraph id="HF75F9DA0BF5F4000BFC22E8064349D1C"><enum>(2)</enum><text>the front face
shall be the principal face of the package;</text>
</paragraph><paragraph id="H8B0B9F6A76894D39B711321D24588298"><enum>(3)</enum><text>if the front and
back faces are of different sizes in terms of area, then the larger face shall
be the front face;</text>
</paragraph><paragraph id="H63BCD79B2D744B919777B44753EEF52"><enum>(4)</enum><text>the back face shall
be the principal face of a package that is opposite the front face of the
package;</text>
</paragraph><paragraph id="HD7FABFC45A7846719DCB8DB05DA9E6A4"><enum>(5)</enum><text>the bottom 50
percent of the back face of the package shall be allocated for required package
disclosures in accordance with this section; and</text>
</paragraph><paragraph id="HB9701E480D124B04A322AE48B9760125"><enum>(6)</enum><text>if a package of a
tobacco product is cylindrical, a contiguous area constituting 30 percent of
the total surface area of the cylinder shall be deemed the back face.</text>
</paragraph></subsection><subsection id="H40ABD9B562BA4C88AF008CBDB700DA00"><enum>(b)</enum><header>Required
information on back face</header><text>Not later than 24 months after the
effective date of this Act, the bottom 50 percent of the back face of a package
of a tobacco product shall be available solely for disclosures required by or
under this Act, the Federal Cigarette Labeling and Advertising Act, sections
1331–1340 of title 15, United States Code, and any other Federal statute. Such
disclosures shall include—</text>
<paragraph id="H818ED81DD499472E93B996F4D0122BB"><enum>(1)</enum><text>the printed name
and address of the manufacturer, packer, or distributor, and any other
identification associated with the manufacturer, packer, or distributor or with
the tobacco product that the Administrator may require;</text>
</paragraph><paragraph id="H7F491981A9984C1F960000CEAAF5E3B8"><enum>(2)</enum><text>a
list of ingredients as required by subsection (e); and</text>
</paragraph><paragraph id="HEFE64D58E784430E83A2586B45B7A215"><enum>(3)</enum><text>the appropriate
tax registration number.</text>
</paragraph></subsection><subsection id="H240AF9328BE347CA91609C875F67F6A6"><enum>(c)</enum><header>Package
disclosure of ingredients</header><text>Not later than 24 months after the
effective date of this Act, the package of a tobacco product shall bear a list
of the common or usual names of the ingredients present in the tobacco product
in an amount greater than 0.1 percent of the total dry weight of the tobacco
(including all ingredients), that shall comply with the following:</text>
<paragraph id="HFA74A34A243042E3B3D7227CC4E5CF46"><enum>(1)</enum><text>Such listing of
ingredients shall appear under, or be conspicuously accompanied by, the heading
<quote>Tobacco and principal tobacco ingredients</quote>.</text>
</paragraph><paragraph id="H56B590E8BBA2421E8600423FE47B41DD"><enum>(2)</enum><text>Tobacco may be
listed as <quote>tobacco,</quote> and shall be the first listed
ingredient.</text>
</paragraph><paragraph id="H469BB428528544BCBB75008C21185CAC"><enum>(3)</enum><text>After tobacco, the
ingredients shall be listed in descending order of predominance, by
weight.</text>
</paragraph><paragraph id="H913E2107F4D44A68AE43CB568B2EB708"><enum>(4)</enum><text>Spices and natural
and artificial flavors may be listed, respectively, as <quote>spices</quote>
and <quote>natural and artificial flavors</quote> without naming each.</text>
</paragraph><paragraph id="H078AACFCC32F48C4A8002F09FBE2DFF"><enum>(5)</enum><text>Preservatives may
be listed as <quote>preservatives</quote> without naming each.</text>
</paragraph><paragraph id="H98F950FB264843A7B7D033B349F803C"><enum>(6)</enum><text>The disclosure of
any ingredient in accordance with this section may, at the option of the
tobacco product manufacturer, designate the functionality or purpose of that
ingredient.</text>
</paragraph><paragraph id="HCC168F1D2A5844D283E547F68B2B61B0"><enum>(7)</enum><text>The package say
state <quote>Not for sale to minors</quote>.</text>
</paragraph><paragraph commented="no" id="H35C33E831CD84590001FB98126E76210"><enum>(8)</enum><text>In the case of a
package of cigarettes, the package shall state that smokeless tobacco has
significantly lower risks for disease and death than cigarettes.</text>
</paragraph></subsection></section><section id="H461D5F9281C64DBC896E300070B58E61"><enum>302.</enum><header>Disclosures on
packages of smokeless tobacco</header>
<subsection id="H51C2550755894F4FB02F4D413158FAF2"><enum>(a)</enum><header>Back face for
required disclosures</header><text>For purposes of this section—</text>
<paragraph id="H4268CA39F232441CAF9E63CFCE00EF5F"><enum>(1)</enum><text>the principal face
of a package of smokeless tobacco is the face that has the largest surface area
or, for faces with identical surface areas, any of the faces that have the
largest surface area; a package shall not be characterized as having more than
two principal faces;</text>
</paragraph><paragraph id="H5BD461EE04B2405E95C53BDAD863E0CB"><enum>(2)</enum><text>the front or top
face shall be the principal face of the package;</text>
</paragraph><paragraph id="H50C6835DE9F447EB94AE4B4CC263C72"><enum>(3)</enum><text>if
the front or top and back or bottom faces are of different sizes in terms of
area, then the larger face shall be the front or top face;</text>
</paragraph><paragraph id="H325B43E0254D41BE97A5A12865937B57"><enum>(4)</enum><text>the back or bottom
face of the package shall be the principal face of a package that is opposite
the front or top face of the package;</text>
</paragraph><paragraph id="H23F26C5C596D4857AA833D1B7D726CE"><enum>(5)</enum><text>beginning 24 months
after the effective date of this Act, 50 percent of the back or bottom face of
the package shall be allocated for required package disclosures in accordance
with this section; and</text>
</paragraph><paragraph id="H4C6C3768018A49CF85D6E4BFCBAEE6E0"><enum>(6)</enum><text>if the package is
cylindrical, a contiguous area constituting 30 percent of the total surface
area of the cylinder shall be deemed the back face.</text>
</paragraph></subsection><subsection id="H8D4AB616ABFF4897B58FD0CF6BB2FB76"><enum>(b)</enum><header>Required
information on back or bottom face</header><text>50 percent of the back or
bottom face of a package of smokeless tobacco shall be available solely for
disclosures required by or under this Act, the Comprehensive Smokeless Tobacco
Health Education Act of 1986, sections 4401–4408 of title 15, United States
Code, and any other Federal statute. Such disclosures shall include a list of
ingredients as required by subsection (e).</text>
</subsection><subsection id="H5275849FEC9F4327B1B86EEB13E3E6AA"><enum>(c)</enum><header>Package
disclosure of ingredients</header><text>Commencing 24 months after the
effective date of this Act, a package of smokeless tobacco shall bear a list of
the common or usual names of the ingredients present in the smokeless tobacco
in an amount greater than 0.1 percent of the total dry weight of the tobacco
(including all ingredients).</text>
<paragraph id="H3660C3CFFA6F4AF590E918C9CAB2FA95"><enum>(1)</enum><text>Such listing of
ingredients shall appears under, or be conspicuously accompanied by, the
heading <quote>Tobacco and principal tobacco ingredients</quote>.</text>
</paragraph><paragraph id="HA526BC24445E457FA16F9CC36D39C04E"><enum>(2)</enum><text>Tobacco may be
listed as <quote>tobacco,</quote> and shall be the first listed
ingredient.</text>
</paragraph><paragraph id="HCFE28E73BFAE4DF0A647F2122F519CAB"><enum>(3)</enum><text>After tobacco, the
ingredients shall be listed in descending order of predominance, by
weight.</text>
</paragraph><paragraph id="H3DD8F7094B76446F9E919E5E5DF0009E"><enum>(4)</enum><text>Spices and natural
and artificial flavors may be listed, respectively, as <quote>spices</quote>
and <quote>natural and artificial flavors</quote> without naming each.</text>
</paragraph><paragraph id="HD1BD978B4E434EC2BBBE9B2157E9288E"><enum>(5)</enum><text>Preservatives may
be listed as <quote>preservatives</quote> without naming each.</text>
</paragraph><paragraph id="H3A868CEE4257484E90CF9B3DFA701C6E"><enum>(6)</enum><text>The disclosure of
any ingredient in accordance with this section may, at the option of the
tobacco product manufacturer, designate the functionality or purpose of that
ingredient.</text>
</paragraph><paragraph id="H78615F98F5494C80874BE7DC511278"><enum>(7)</enum><text>Not
for sale to minors.</text>
</paragraph></subsection></section><section id="HC655762A68624A2CB11B43F87FFAA45E"><enum>303.</enum><header>Public
disclosure of ingredients</header>
<subsection id="H0143E2DC135B4832ABEFDFBDE700089D"><enum>(a)</enum><header>Regulations</header><text>Not
later than 24 months after the effective date of this Act, the Administrator
shall, by regulation, establish standards under which each tobacco product
manufacturer shall disclose publicly, and update at least annually—</text>
<paragraph id="H71771CCE02834A54B96BE398901C4E6D"><enum>(1)</enum><text>a
list of the ingredients it uses in each brand style it manufactures for
commercial distribution domestically, as provided in subsection (b); and</text>
</paragraph><paragraph id="H9FF4654695AD41D49500418236EFA5DF"><enum>(2)</enum><text>a
composite list of all the ingredients it uses in any of the brand styles it
manufactures for commercial distribution domestically, as provided in
subsection (c).</text>
</paragraph></subsection><subsection id="HE6ABC5FECD3F41788B52553EC5486593"><enum>(b)</enum><header>Ingredients To
be disclosed as to each brand style</header>
<paragraph id="HBFE1941074104FA2B3729CC76F00D2E3"><enum>(1)</enum><header>In
general</header><text>With respect to the public disclosure required by
subsection (a)(1), as to each brand style, the tobacco product manufacture
shall disclose the common or usual name of each ingredient present in the brand
style in an amount greater than 0.1 percent of the total dry weight of the
tobacco (including all ingredients).</text>
</paragraph><paragraph id="HD87CEE8E987E4750BE70AED6862B8A8"><enum>(2)</enum><header>Requirements</header><text>Disclosure
under paragraph (1) shall comply with the following:</text>
<subparagraph id="HAB6358AEA17F4E65ACA51E7D17E48F64"><enum>(A)</enum><text>Tobacco may be
listed as <quote>tobacco,</quote> and shall be the first listed
ingredient.</text>
</subparagraph><subparagraph id="H4312AA484A5946E0B7A9D3C28745CCFF"><enum>(B)</enum><text>After tobacco, the
ingredients shall be listed in descending order of predominance, by
weight.</text>
</subparagraph><subparagraph id="HA60792B26112468B8F364CFB3E99880"><enum>(C)</enum><text>Spices and natural
and artificial flavors may be listed, respectively, as <quote>spices</quote>
and <quote>natural and artificial flavors</quote> without naming each.</text>
</subparagraph><subparagraph id="H9231837C53C948FC81A9AB2514B30054"><enum>(D)</enum><text>Preservatives may
be listed as <quote>preservatives</quote> without naming each.</text>
</subparagraph><subparagraph id="HA3A0443105E546ED83E0E43128FDE947"><enum>(E)</enum><text>The disclosure of
any ingredient in accordance with this section may, at the option of the
tobacco product manufacturer, designate the functionality or purpose of that
ingredient.</text>
</subparagraph></paragraph></subsection><subsection id="H8620B59F362D4DB6B8D16FBD19C46E77"><enum>(c)</enum><header>Aggregate
disclosure of ingredients</header>
<paragraph id="H30C3406B48174EC7A3D813DAB8A5F758"><enum>(1)</enum><header>In
general</header><text>The public disclosure required of a tobacco product
manufacturer by subsection (a)(2) shall consist of a single list of all
ingredients used in any brand style a tobacco product manufacturer manufactures
for commercial distribution domestically, without regard to the quantity used,
and including, separately, each spice, each natural or artificial flavoring,
and each preservative.</text>
</paragraph><paragraph id="HA9C37795321F407C9CAC328FE56F3016"><enum>(2)</enum><header>Listing</header><text>The
ingredients shall be listed by their respective common or usual names in
descending order of predominance by the total weight used annually by the
tobacco product manufacturer in manufacturing tobacco products for commercial
distribution domestically.</text>
</paragraph></subsection><subsection id="H5638EF5D69CF42469B25A5F5ABA002C9"><enum>(d)</enum><header>No required
disclosure of quantities</header><text>The Administrator shall not require any
public disclosure of quantitative information about any ingredient in a tobacco
product.</text>
</subsection><subsection id="H5D110415E40D4851BEEE95F5B8E904E4"><enum>(e)</enum><header>Disclosure on
website</header><text>The public disclosures required by subsection (a) of this
section may be by posting on an Internet-accessible website, or other location
electronically accessible to the public, which is identified on all packages of
a tobacco product manufacturer’s tobacco products.</text>
</subsection><subsection id="HE2ADA24FD8FC402188B836D88CCDB9EE"><enum>(f)</enum><header>Timing of
initial required disclosures</header><text>No disclosure pursuant to this
section shall be required to commence until the regulations under subsection
(a) have been in effect for not less than 1 year.</text>
</subsection></section><enum>IV</enum><header>PREVENTION OF
ILLICIT TRADE IN TOBACCO PRODUCTS</header>
<section id="H42FF83F4C96C40D98766F762096CE891"><enum>401.</enum><header>Study and
report on illicit trade</header>
<subsection id="HDD1DE0D254C54AE08900FA3542672EA6"><enum>(a)</enum><text>The Administrator
shall, after consultation with other relevant agencies including Customs and
Tobacco Tax Bureau, conduct a study of trade in tobacco products that involves
passage of tobacco products either between the States or from or to any other
country across any border of the United States to—</text>
<paragraph id="H765001B4D2DB48F0AFF07BD9FACEE3E"><enum>(1)</enum><text>collect data on
such trade in tobacco products, including illicit trade involving tobacco
products, and make recommendations on the monitoring and enforcement of such
trade;</text>
</paragraph><paragraph id="H74730C78AD3F4A76A449116271891D54"><enum>(2)</enum><text>collect data on
any advertising intended to be broadcast, transmitted, or distributed from or
to the United States from or to another country and make recommendations on how
to prevent or eliminate, and what technologies could help facilitate the
elimination of, such advertising; and</text>
</paragraph><paragraph id="HB5C40C6FB6AD4C7C864595F16E427D1F"><enum>(3)</enum><text>collect data on
such trade in tobacco products by person that is not—</text>
<subparagraph id="H18C64A1A4E564B60BAC68E8B0AA802B"><enum>(A)</enum><text>a participating
manufacturer (as that term is defined in section II(jj) of the Master
Settlement Agreement of November 23, 1998, between certain of the States and
certain tobacco product manufacturers); or</text>
</subparagraph><subparagraph id="H2EE15DE3FDF7430A8C5B5276921F6B71"><enum>(B)</enum><text>an affiliate or
subsidiary of a participating manufacturer.</text>
</subparagraph></paragraph></subsection><subsection id="H5588502DBC904EFBAF341C6B63BECB5"><enum>(b)</enum><text>Not later than 18
months after the effective date of this Act, the Administrator shall submit to
the Secretary, and committees of relevant jurisdiction in Congress, a report
the recommendations of the study conducted under subsection (a).</text>
</subsection></section><section id="H904229DD6A2D4F10AA5006F9977050A2"><enum>402.</enum><header>Amendment to
section 1926 of the Public Health Service Act</header><text display-inline="no-display-inline">Section 1926 of the Public Health Service
Act (42 U.S.C. § 300x–26) is amended by adding at the end thereof the
following:</text>
<quoted-block id="H8112557B89C44F5FA100C81CECDF8E2E" style="OLC">
<subsection id="H4CABA9A5D79E4C71B91D90B71F006133"><enum>(e)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H63C54AE348C343C2B1A5165CEBA3CADD"><enum>(1)</enum><text>Subject to paragraphs
(2) and (3), for the first fiscal year after enactment and each subsequent
fiscal year, the Secretary shall reduce, as provided in subsection (h), the
amount of any grant under section 300x–21 of this title for any State that does
not have in effect a statute with substantially the following
provisions:</text>
<quoted-block display-inline="no-display-inline" id="HDF42BC9F6F8E4726B6B4DA6A2F2DBA9" style="OLC">
<section id="HDCCA1A47C5994AE4970799ADA2D052A5"><enum>1.</enum><header>Distribution to
minors</header>
<subsection id="HAC47167E389A43BAA2771D5FD29618AA"><enum>(a)</enum><text>No person shall
distribute a tobacco product to an individual under 18 years of age or a
different minimum age established under State law. A person who violates this
subsection is liable for a civil money penalty of not less than $25 nor more
than $125 for each violation of this subsection;</text>
</subsection><subsection id="HDC3F79C74C964B3097DDD7A2E7AA4569"><enum>(b)</enum><text>The employer of an
employee who has violated subsection (a) twice while in the employ of such
employer is liable for a civil money penalty of $125 for each subsequent
violation by such employee.</text>
</subsection><subsection id="H54150F3A64F6493A85225EBCE0E10088"><enum>(c)</enum><text>It shall be a
defense to a charge brought under subsection (a) that—</text>
<paragraph id="H92E8458FA6064FC7994C11EB3E9FE1EE"><enum>(1)</enum><text>the
defendant—</text>
<subparagraph id="HEF0CE41E6BE1411696BD5B87F9D8902C"><enum>(A)</enum><text>relied upon proof
of age that appeared on its face to be valid in accordance with the Federal
Tobacco Act of 2007;</text>
</subparagraph><subparagraph id="H7A136C25088C4360AFD581A8CD7F64B"><enum>(B)</enum><text>had complied with
the requirements of section 5 and, if applicable, section 7; or</text>
</subparagraph><subparagraph id="HFE7F19C4D1B0478CA08C854026AE8FD"><enum>(C)</enum><text>relied upon a
commercially available electronic age verification service to confirm that the
person was an age-verified adult; or</text>
</subparagraph></paragraph><paragraph id="H8319012DA4864D4589CF4E422E42B5A2"><enum>(2)</enum><text>the individual to
whom the tobacco product was distributed was at the time of the distribution
used in violation of subsection 8(b).</text>
</paragraph></subsection></section><section id="H6EEFA1E10DB248428C26ABE92030D476"><enum>2.</enum><header>Purchase,
receipt, or possession by minors prohibited</header>
<subsection id="H4F17A3CA9F894C0494BC51B71EC0515"><enum>(a)</enum><text>An individual under
18 years of age or a different minimum age established under State law shall
not purchase or attempt to purchase, receive or attempt to receive, possess or
attempt to possess, a tobacco product. An individual who violates this
subsection is liable for a civil money penalty of not less than $25 nor more
than $125 for each such violation, and shall be required to perform not less
than four hours nor more than ten hours of community service. Upon the second
or each subsequent violation of this subsection, such individual shall be
required to perform not less than eight hours nor more than twenty hours of
community service.</text>
</subsection><subsection id="H76AE99519DC14AD5B6DEE0491B55BFAC"><enum>(b)</enum><text>A law enforcement
agency, upon determining that an individual under 18 years of age or a
different minimum age established under State law allegedly purchased,
received, possessed, or attempted to purchase, receive, or possess, a tobacco
product in violation of subsection (a) shall notify the individual’s parent or
parents, custodian, or guardian as to the nature of the alleged violation if
the name and address of a parent or parents, guardian, or custodian is
reasonably ascertainable by the law enforcement agency. The notice required by
this subsection shall be made not later than 48 hours after the individual who
allegedly violated subsection (a) is cited by such agency for the violation.
The notice may be made by any means reasonably calculated to give prompt actual
notice, including notice in person, by telephone, or by first-class
mail.</text>
</subsection><subsection id="HD4C243B79E2B4B0C979C0871DF58BF12"><enum>(c)</enum><text>Subsection (a)
does not prohibit an individual under 18 years of age or a different minimum
age established under State law from possessing a tobacco product during
regular working hours and in the course of such individual’s employment if the
tobacco product is not possessed for such individual’s consumption.</text>
</subsection></section><section id="H1349ADE3D2D549B4AED7B2107FE4D771"><enum>3.</enum><header>Out-of-package
distribution</header><text display-inline="no-display-inline">It shall be
unlawful for any person to distribute cigarettes or a smokeless tobacco product
other than in an unopened package that complies in full with section 108 of the
Federal Tobacco Act of 2007. A person who distributes a cigarette or a
smokeless tobacco product in violation of this section is liable for a civil
money penalty of not less than $25 nor more than $125 for each such
violation.</text>
</section><section id="HC445071B84CD4412A87E14981EE1C1B1"><enum>4.</enum><header>Signage</header><text display-inline="no-display-inline">It shall be unlawful for any person who
sells tobacco products over-the-counter to fail to post conspicuously on the
premises where such person sells tobacco products over-the-counter a sign
communicating that—</text>
<paragraph id="HFD6A4469A1D544439022044498FF53F9"><enum>(1)</enum><text>the sale of
tobacco products to individuals under 18 years of age or a different minimum
age established under State law is prohibited by law;</text>
</paragraph><paragraph id="H62ABC753CCBE4657A28CB8D487217D02"><enum>(2)</enum><text>the purchase of
tobacco products by individuals under 18 years of age or a different minimum
age established under State law is prohibited by law; and</text>
</paragraph><paragraph id="H53616329FD8E4A9A90BE4CACC0ADE9C2"><enum>(3)</enum><text>proof of age may
be demanded before tobacco products are sold.</text>
</paragraph><continuation-text continuation-text-level="section">A person
who fails to post a sign that complies fully with this section is liable for a
civil money penalty of not less than $25 nor more than $125.</continuation-text></section><section id="H10F92E7E4D1C449E91F6D5E00586CE6"><enum>5.</enum><header>Notification of
employees</header>
<subsection id="H5AAB43F4B19A4067B4A28257D4D66618"><enum>(a)</enum><text>Within 180 days of
the effective date of the <short-title>Youth Prevention
and Tobacco Harm Reduction Act</short-title>, every person engaged in the
business of selling tobacco products at retail shall implement a program to
notify each employee employed by that person who sells tobacco products at
retail that—</text>
<paragraph id="H156BA41DFAA14B9482CE2CB28EE987CC"><enum>(1)</enum><text>the sale or other
distribution of tobacco products to any individual under 18 years of age or a
different minimum age established under State law, and the purchase, receipt,
or possession of tobacco products in a place open to the public by any
individual under 18 years of age or a different minimum age established under
State law, is prohibited; and</text>
</paragraph><paragraph id="H15AA2BBA61A24917ABB230125CAD7B2F"><enum>(2)</enum><text>out-of-package
distribution of cigarettes and smokeless tobacco products is prohibited.</text>
</paragraph><continuation-text continuation-text-level="subsection">Any
employer failing to provide the required notice to any employee shall be liable
for a civil money penalty of not less than $25 nor more than $125 for each such
violation.</continuation-text></subsection><subsection id="H27C79D8CD22C4F73A5C100FBB55BDEAE"><enum>(b)</enum><text>It shall be a
defense to a charge that an employer violated subsection (a) of this section
that the employee acknowledged receipt, either in writing or by electronic
means, prior to the alleged violation, of a statement in substantially the
following form:</text>
<quoted-block id="HFB0EDD9A19994C3DB22E5D232B8622B9" style="OLC">
<text display-inline="no-display-inline">I understand that State law prohibits the
distribution of tobacco products to individuals under 18 years of age or a
different minimum age established under State law and out-of-package
distribution of cigarettes and smokeless tobacco products, and permits a
defense based on evidence that a prospective purchaser’s proof of age was
reasonably relied upon and appeared on its face to be valid. I understand that
if I sell, give, or voluntarily provide a tobacco product to an individual
under 18 years of age or a different minimum age established under State law, I
may be found responsible for a civil money penalty of not less than $25 nor
more than $125 for each violation. I promise to comply with this
law.”</text>
<after-quoted-block></after-quoted-block></quoted-block>
</subsection><subsection id="HDCAE1DEAE8594DA6BB2600CCFD991115"><enum>(c)</enum><text>If an employer is
charged with a violation of subsection (a) and the employer uses as a defense
to such charge the defense provided by subsection (b), the employer shall be
deemed to be liable for such violation if such employer pays the penalty
imposed on the employee involved in such violation or in any way reimburses the
employee for such penalty.</text>
</subsection></section><section id="H6FBA287548F148B7886E33DA16A4E3E8"><enum>6.</enum><header>Self-service
displays</header>
<subsection id="H2915FF0FAC0D4F39B36C004FCF897628"><enum>(a)</enum><text>It shall be
unlawful for any person who sells tobacco products over-the-counter at retail
to maintain packages of such products in any location accessible to customers
that is not under the control of a cashier or other employee during regular
business hours. This subsection does not apply to any adult-only
facility.</text>
</subsection><subsection id="HA4F022E5E19F46AF8D73F51649A100D9"><enum>(b)</enum><text>Any person who
violates subsection (a) is liable for a civil money penalty of not less than
$25 nor more than $125 for each such violation, except that no person shall be
responsible for more than one violation per day at any one retail store.</text>
</subsection></section><section id="HF32F15F7DCA64100A292D303D3F500F3"><enum>7.</enum><header>Distribution by
mail or courier</header>
<subsection id="HD47D99E29B3E47AD819F94AB83A4FB8C"><enum>(a)</enum><text>It shall be
unlawful to distribute or sell tobacco products directly to consumers by mail
or courier, unless the person receiving purchase requests for tobacco products
takes reasonable action to prevent delivery to individuals who are not adults
by—</text>
<paragraph id="H3BF0CF3BB84A44BB8F61A2D2BCB621D1"><enum>(1)</enum><text>requiring that
addressees of the tobacco products be age-verified adults;</text>
</paragraph><paragraph id="H38FEC97BAED14F9194A553F860D36100"><enum>(2)</enum><text>making good faith
efforts to verify that such addressees have attained the minimum age for
purchase of tobacco products established by the respective States wherein the
addresses of the addressees are located; and</text>
</paragraph><paragraph id="H9EA5054969914C388459F500DE386576"><enum>(3)</enum><text>addressing the
tobacco products delivered by mail or courier to a physical addresses and not
to post office boxes.</text>
</paragraph></subsection><subsection id="H4A07AE94E2FB47B3A7B852B924F8662F"><enum>(b)</enum><text>Any person who
violates subsection (a) is liable for a civil money penalty of not less than
$25 nor more than $125 for each such violation.</text>
</subsection></section><section id="H618F7C7377D048B68CBED1D44C60E1A4"><enum>8.</enum><header>Random
unannounced inspections; reporting; and compliance</header>
<subsection id="H3C272B99C1D44119AB509C75BEB70079"><enum>(a)</enum><text>The State Police,
or a local law enforcement authority duly designated by the State Police, shall
enforce this Act in a manner that can reasonably be expected to reduce the
extent to which tobacco products are distributed to individuals under 18 years
of age or a different minimum age established under State law and shall conduct
random, unannounced inspections in accordance with the procedures set forth in
this Act and in regulations issued under section 1926 of the Federal Public
Health Service Act (42 U.S.C. § 300x–26).</text>
</subsection><subsection id="H834FF812FF97438198CA283FEE4BA8FC"><enum>(b)</enum><text>The State may
engage an individual under 18 years of age or a different minimum age
established under State law to test compliance with this Act, except that such
an individual may be used to test compliance with this Act only if the testing
is conducted under the following conditions:</text>
<paragraph id="HDC3C828363274EF19F1DAC58BA23027"><enum>(1)</enum><text>Prior to use of any
individual under 18 years of age or a different minimum age established under
State law in a random, unannounced inspection, written consent shall be
obtained from a parent, custodian, or guardian of such individual;</text>
</paragraph><paragraph id="HBFF27406579940DC8B29A4969C283B1F"><enum>(2)</enum><text>An individual
under 18 years of age or a different minimum age established under State law
shall act solely under the supervision and direction of the State Police or a
local law enforcement authority duly designated by the State Police during a
random, unannounced inspection;</text>
</paragraph><paragraph id="H6662D57F478A4CEAA4CC04103CF8CF15"><enum>(3)</enum><text>An individual
under 18 years of age or a different minimum age established under State law
used in random, unannounced inspections shall not be used in any such
inspection at a store in which such individual is a regular customer;
and</text>
</paragraph><paragraph id="HC84E26DF53C34AEDAC17A9EADA6E6B61"><enum>(4)</enum><text>If an individual
under 18 years of age or a different minimum age established under State law
participating in random, unannounced inspections is questioned during such an
inspection about such individual’s age, such individual shall state his or her
actual age and shall present a true and correct proof of age if requested at
any time during the inspection to present it.</text>
</paragraph></subsection><subsection id="H2FC70A5E696B4DDBA450B15F5DC58426"><enum>(c)</enum><text>Any person who
uses any individual under 18 years of age or a different minimum age
established under State law, other than as permitted by subsection (b), to test
compliance with this Act, is liable for a civil money penalty of not less than
$25 nor more than $125 for each such violation.</text>
</subsection><subsection id="H0DA8383C9D6E4F4E876D582C521BA334"><enum>(d)</enum><text>Civil money
penalties collected for violations of this Act and fees collected under section
9 shall be used only to defray the costs of administration and enforcement of
this Act.</text>
</subsection></section><section id="HC1ECFF87D9784FFAA9C838CBB5971D77"><enum>9.</enum><header>Licensure</header>
<subsection id="HC27C9B08822044C28BC9EBD24B996DD9"><enum>(a)</enum><text>Each person
engaged in the over-the-counter distribution at retail of tobacco products
shall hold a license issued under this section. A separate license shall be
required for each place of business where tobacco products are distributed at
retail. A license issued under this section is not assignable and is valid only
for the person in whose name it is issued and for the place of business
designated in the license.</text>
</subsection><subsection id="H136C03D98D41409299FCB5A4704DF44C"><enum>(b)</enum><text>The annual license
fee is $25 for each place of business where tobacco products are distributed at
retail.</text>
</subsection><subsection id="HA7D6A6A2DE774CD4BE28D53FFFBB51E3"><enum>(c)</enum><text display-inline="yes-display-inline">Every application for a license, including
renewal of a license, under this section shall be made upon a form provided by
the appropriate State agency or department, and shall set forth the name under
which the applicant transacts or intends to transact business, the location of
the place of business for which the license is to be issued, the street address
to which all notices relevant to the license are to be sent (in this Act
referred to as <quote>notice address</quote>), and any other identifying
information that the appropriate State agency or department may require.</text>
</subsection><subsection id="HA2C557399C8F4EC89C226EF7324E8E6C"><enum>(d)</enum><text display-inline="yes-display-inline">The appropriate State agency or department
shall issue or renew a license or deny an application for a license or the
renewal of a license within 30 days of receiving a properly completed
application and the license fee. The appropriate State agency or department
shall provide notice to an applicant of action on an application denying the
issuance of a license or refusing to renew a license.</text>
</subsection><subsection id="H54441C72374B4E82845DEDFF6DF6004B"><enum>(e)</enum><text display-inline="yes-display-inline">Every license issued by the appropriate
State agency or department pursuant to this section shall be valid for 1 year
from the date of issuance and shall be renewed upon application except as
otherwise provided in this Act.</text>
</subsection><subsection id="H76BCE35CB08C4509BD00E1CF61F81733"><enum>(f)</enum><text>Upon notification
of a change of address for a place of business for which a license has been
issued, a license shall be reissued for the new address without the filing of a
new application.</text>
</subsection><subsection id="H90DD5D94AD6C484ABE925B85DA29B88"><enum>(g)</enum><text display-inline="yes-display-inline">The appropriate State agency or department
shall notify every person in the State who is engaged in the distribution at
retail of tobacco products of the license requirements of this section and of
the date by which such person should have obtained a license.</text>
</subsection><subsection id="HBA08EFD057FA4863A3E0F7211687FDE"><enum>(h)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HD0FB5EF02D4F49D8AD40C400C4B7BAA"><enum>(1)</enum><text>Except as provided in
paragraph (2), any person who engages in the distribution at retail of tobacco
products without a license required by this section is liable for a civil money
penalty in an amount equal to (i) two times the applicable license fee, and
(ii) $50 for each day that such distribution continues without a
license.</text>
</paragraph><paragraph id="HA0334FE6DEE4440BA784FB00181E7930"><enum>(2)</enum><text>Any person who
engages in the distribution at retail of tobacco products after a license
issued under this section has been suspended or revoked is liable for a civil
money penalty of $100 per day for each day on which such distribution continues
after the date such person received notice of such suspension or
revocation.</text>
</paragraph></subsection><subsection id="HC73D4A6597734E3A93FDE4FDCF8204B0"><enum>(i)</enum><text>No person shall
engage in the distribution at retail of tobacco products on or after 180 days
after the date of enactment this Act unless such person is authorized to do so
by a license issued pursuant to this section or is an employee or agent of a
person that has been issued such a license.</text>
</subsection></section><section id="H2EEFF8308B3246CF877FCFB26D59C6D4"><enum>10.</enum><header>Suspension,
revocation, denial, and nonrenewal of licenses</header>
<subsection id="H7B56F7BF99EF475D97EFFCDB0400CE00"><enum>(a)</enum><text>Upon a finding
that a licensee has been determined by a court of competent jurisdiction to
have violated this Act during the license term, the State shall notify the
licensee in writing, served personally or by registered mail at the notice
address, that any subsequent violation of this Act at the same place of
business may result in an administrative action to suspend the license for a
period determined by the specify the appropriate State agency or
department.</text>
</subsection><subsection id="H1E67BA26DEBF4A88B8252DB74EA888EE"><enum>(b)</enum><text>Upon finding that
a further violation by this Act has occurred involving the same place of
business for which the license was issued and the licensee has been served
notice once under subsection (a), the appropriate State agency or department
may initiate an administrative action to suspend the license for a period to be
determined by the appropriate State agency or department but not to exceed six
months. If an administrative action to suspend a license is initiated, the
appropriate State agency or department shall immediately notify the licensee in
writing at the notice address of the initiation of the action and the reasons
therefor and permit the licensee an opportunity, at least 30 days after written
notice is served personally or by registered mail upon the licensee, to show
why suspension of the license would be unwarranted or unjust.</text>
</subsection><subsection id="H9E822BD53405485DADB0D7DA9CCD3191"><enum>(c)</enum><text>The appropriate
State agency or department may initiate an administrative action to revoke a
license that previously has been suspended under subsection (b) if, after the
suspension and during the one-year period for which the license was issued, the
licensee committed a further violation of this Act, at the same place of
business for which the license was issued. If an administrative action to
revoke a license is initiated, the appropriate State agency or department shall
immediately notify the licensee in writing at the notice address of the
initiation of the action and the reasons therefor and permit the licensee an
opportunity, at least 30 days after written notice is served personally or by
registered mail upon the licensee, to show why revocation of the license would
be unwarranted or unjust.</text>
</subsection><subsection id="H3F94F09597BA46C7B197F2043468B245"><enum>(d)</enum><text>A person whose
license has been suspended or revoked with respect to a place of business
pursuant to this section shall pay a fee of $50 for the renewal or reissuance
of the license at that same place of business, in addition to any applicable
annual license fees.</text>
</subsection><subsection id="H45BCAE0DC5E046CDBDB88488919603FC"><enum>(e)</enum><text>Revocation of a
license under subsection (c) with respect to a place of business shall not be
grounds to deny an application by any person for a new license with respect to
such place of business for more than 12 months subsequent to the date of such
revocation. Revocation or suspension of a license with respect to a particular
place of business shall not be grounds to deny an application for a new
license, to refuse to renew a license, or to revoke or suspend an existing
license at any other place of business.</text>
</subsection><subsection id="H97D1C836C44A4585A2CD2D3E3287B4A9"><enum>(f)</enum><text>A licensee may
seek judicial review of an action of the appropriate State agency or department
suspending, revoking, denying, or refusing to renew a license under this
section by filing a complaint in a court of competent jurisdiction. Any such
complaint shall be filed within 30 days after the date on which notice of the
action is received by the licensee. The court shall review the evidence de
novo.</text>
</subsection><subsection id="H526FD1E83651473A8080A6A5A5AF526C"><enum>(g)</enum><text>The State shall
not report any action suspending, revoking, denying, or refusing to renew a
license under this section to the Federal Secretary of Health and Human
Services, unless the opportunity for judicial review of the action pursuant to
subsection (f), if any, has been exhausted or the time for seeking such
judicial review has expired.</text>
</subsection></section><section id="H3A76513173D5452396469EE5A41400F"><enum>11.</enum><header>No private right
of action</header><text display-inline="no-display-inline">Nothing in this Act
shall be construed to create a right of action by any private person for any
violation of any provision of this Act.</text>
</section><section id="HBDA13A1F4C95413381C5F6ED7106DEA4"><enum>12.</enum><header>Jurisdiction and
venue</header><text display-inline="no-display-inline">Any action alleging a
violation of this Act may be brought only in a court of general jurisdiction in
the city or county where the violation is alleged to have occurred.</text>
</section><section id="HAEFF1E5D8CF84083B3004000A59423A0"><enum>13.</enum><header>Report</header><text display-inline="no-display-inline">The appropriate State agency or department
shall prepare for submission annually to the Federal Secretary of Health and
Human Services the report required by section 1926 of the Federal Public Health
Service Act (42 U.S.C.
300x–26).</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H87338551D1E442B2B2FE46068D00A78B"><enum>(2)</enum><text>In the case of a
State whose legislature does not convene a regular session in fiscal year 2007,
and in the case of a State whose legislature does not convene a regular session
in fiscal year 2008, the requirement described in subsection (e)(1) as a
condition of a receipt of a grant under section 300x–21 of this title shall
apply only for fiscal year 2009 and subsequent fiscal years.</text>
</paragraph><paragraph id="H63E4830EC8EB4BD9AD1F1CD9843579F4"><enum>(3)</enum><text>Subsection (e)(1)
shall not affect any State or local law that (A) was in effect on the date of
introduction of the Federal Tobacco Act of 2007, and (B) covers the same
subject matter as the law described in subsection (e)(1). Any State law that
meets the conditions of this paragraph shall also be deemed to meet the
requirement described in subsection (e)(1) as a condition of a receipt of a
grant under section 300x–21 of this title, if such State law is at least as
stringent as the law described in subsection (e)(1).</text>
</paragraph></subsection><subsection id="H14FA8AED970B4146B9CF3B75276928BF"><enum>(f)</enum><paragraph commented="no" display-inline="yes-display-inline" id="HF4B10912D49049D9B518E0A674B812BB"><enum>(1)</enum><text>For the first applicable
fiscal year and for each subsequent fiscal year, a funding agreement for a
grant under section 300x–21 of this title is a funding agreement under which
the State involved will enforce the law described in subsection (e)(1) of this
section in a manner that can reasonably be expected to reduce the extent to
which tobacco products are available to individuals under the age of 18 or a
different minimum age established under State law for the purchase of tobacco
products.</text>
</paragraph><paragraph id="HD107DD6EC246402092A0F8AC1C483281" indent="up1"><enum>(2)</enum><text>For the first applicable fiscal year
and for each subsequent fiscal year, a funding agreement for a grant under
section 300x–21 of this title is a funding agreement under which the State
involved will—</text>
<subparagraph id="H3AE9DC3682894C1FA4B723C1CF37ADB6"><enum>(A)</enum><text>conduct random, unannounced
inspections to ensure compliance with the law described in subsection (e)(1);
and</text>
</subparagraph><subparagraph id="HB47F236EEDBF412E80D0996500A82818"><enum>(B)</enum><text>annually submit to the Secretary a
report describing—</text>
<clause id="HBB4F44941CA24D01A119B2EEC7AA4C13"><enum>(i)</enum><text>the activities carried out by the
State to enforce such law during the fiscal year preceding the fiscal year for
which the State is seeking the grant;</text>
</clause><clause id="H674D01B8CF6C4738B61F49506BC8FDAF"><enum>(ii)</enum><text>the extent of success the State
has achieved in reducing the availability of tobacco products to individuals
under 18 years of age or a different minimum age established under State law,
including the results of the inspections conducted under subparagraph (A);
and</text>
</clause><clause id="H92B3C9E0D89C493484AA94B5165F03A3"><enum>(iii)</enum><text>the strategies to be utilized by
the State for enforcing such law during the fiscal year for which the grant is
sought.</text>
</clause></subparagraph></paragraph></subsection><subsection id="H61623D84D2C24F4E89F8FB6DEB3DC0B6"><enum>(g)</enum><text>The law specified
in subsection (e)(1) may be administered and enforced by a State using—</text>
<paragraph id="HE3CBD8EC5A614963B6EB10D844E625DE"><enum>(1)</enum><text>any amounts made
available to the State through a grant under section 300x–21 of this
title;</text>
</paragraph><paragraph id="H2081E74503D04454ACA376853E18A2B1"><enum>(2)</enum><text>any amounts made
available to the State under section 300w of this title;</text>
</paragraph><paragraph id="H1F0E81D8781B4C80B140529831EAC171"><enum>(3)</enum><text>any fees collected
for licenses issued pursuant to the law described in subsection (e)(1);</text>
</paragraph><paragraph id="H1B4C43FD3D4E4D8C9955A392A4BFBBF1"><enum>(4)</enum><text>any fines or
penalties assessed for violations of the law specified in subsection (e)(1);
or</text>
</paragraph><paragraph id="HC120576579574A1499F4BA829BE222AB"><enum>(5)</enum><text>any other funding
source that the legislature of the State may prescribe by statute.</text>
</paragraph></subsection><subsection id="HCACA572230754A459126E9BBD011F4DD"><enum>(h)</enum><text>Before making a
grant under section 300x–21 of this title to a State for the first applicable
fiscal year or any subsequent fiscal year, the Secretary shall make a
determination of whether the State has maintained compliance with subsections
(e) and (f) of this section. If, after notice to the State and an opportunity
for a hearing, the Secretary determines that the State is not in compliance
with such subsections, the Secretary shall reduce the amount of the allotment
under section 300x–21 of this title for the State for the fiscal year involved
by an amount equal to—</text>
<paragraph id="H39B3A7DE9AC74B949F4400E2C743F736"><enum>(1)</enum><text>In the case of the
first applicable fiscal year, 10 percent of the amount determined under section
300x–33 for the State for the fiscal year;</text>
</paragraph><paragraph id="HA52AC25C5DF84E429E8088C69033253C"><enum>(2)</enum><text>In the case of the
first fiscal year following such applicable fiscal year, 20 percent of the
amount determined under section 300x–33 for the State for the fiscal
year;</text>
</paragraph><paragraph id="HF3A381AB43674AE98D53608926158B61"><enum>(3)</enum><text>In the case of the
second such fiscal year, 30 percent of the amount determined under section
300x–33 for the State for the fiscal year; and</text>
</paragraph><paragraph id="H0A5A1EC17A8B46F19841BE52F57D84DA"><enum>(4)</enum><text>In the case of the
third such fiscal year or any subsequent fiscal year, 40 percent of the amount
determined under section 300x–33 for the State for the fiscal year.</text>
</paragraph><continuation-text continuation-text-level="subsection">The
Secretary shall not have authority or discretion to grant to any State a waiver
of the terms and requirements of this subsection or subsection (e) or
(f).</continuation-text></subsection><subsection id="H6739897E772841D2AE68A3D6B541BC4"><enum>(i)</enum><text>For the purposes of
subsections (e) through (h) of this section the term <term>first applicable
fiscal year</term> means—</text>
<paragraph id="H2CB3AA0C1CCA46FE8480EF7BA547AB00"><enum>(1)</enum><text>fiscal year 2009,
in the case of any State described in subsection (e)(2) of this section;
and</text>
</paragraph><paragraph id="HD3623123A27E407E8603F968596189A1"><enum>(2)</enum><text>fiscal year 2008,
in the case of any other State.</text>
</paragraph></subsection><subsection id="HB82B40FD7D5841E9930523270058FCDB"><enum>(j)</enum><text>For purposes of
subsections (e) through (h) of this section, references to section 300x–21
shall include any successor grant programs.<quote></quote></text>
</subsection><subsection id="HBF04D64E008E4FE7AD303B9C9521EB24"><enum>(k)</enum><text>As required by
paragraph (1), and subject to paragraph (4), an Indian tribe shall satisfy the
requirements of subsection (e)(1) of this section by enacting a law or
ordinance with substantially the same provisions as the law described in
subsection (e)(1).</text>
<paragraph id="HE30380E23F714B39B0DD195358B110F4"><enum>(1)</enum><text>An Indian tribe
shall comply with subsection (e)(1) of this section within 180 days after the
Administrator finds, in accordance with this paragraph, that—</text>
<subparagraph id="HDCFC2F79A49D4AADB100AE3310A09F99"><enum>(A)</enum><text>the Indian tribe
has a governing body carrying out substantial governmental powers and
duties;</text>
</subparagraph><subparagraph id="HDC8BE6915F644C1F0005D6C0C8D8D919"><enum>(B)</enum><text>the functions to
be exercised by the Indian tribe under this Act pertain to activities on trust
land within the jurisdiction of the tribe; and</text>
</subparagraph><subparagraph id="H80507ACC49B04BB78B034C5019C2FAA1"><enum>(C)</enum><text>the Indian tribe
is reasonably expected to be capable of carrying out the functions required
under this section.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">Within 2
years of the date of enactment of the Federal Tobacco Act of 2007, as to each
Indian tribe in the United States, the Administrator shall make the findings
contemplated by this paragraph or determine that such findings cannot be made,
in accordance with the procedures specified in paragraph (4).</continuation-text></paragraph><paragraph id="HAB90BF3535864B56AABE31941F00C0C6"><enum>(2)</enum><text>As to Indian
tribes subject to subsection (e)(1) of this section, the Administrator shall
promulgate regulations that—</text>
<subparagraph id="HC698AE7644ED43CC8F83D9A03BF8BCF"><enum>(A)</enum><text>provide whether and
to what extent, if any, the law described in subsection (e)(1) may be modified
as adopted by Indian tribes; and</text>
</subparagraph><subparagraph id="H7229BE91FD1744188E96EE7530E36874"><enum>(B)</enum><text>ensure, to the
extent possible, that each Indian tribe’s retailer licensing program under
subsection (e)(1) is no less stringent than the program of the State or States
in which the Indian tribe is located.</text>
</subparagraph></paragraph><paragraph id="HD65071FFE74D4C21B72F90EBA7F5BD19"><enum>(3)</enum><text>If with respect to
any Indian tribe the Administrator determines that compliance with the
requirements of subsection (e)(1) is inappropriate or administratively
infeasible, the Administrator shall specify other means for the Indian tribe to
achieve the purposes of the law described in subsection (e)(1) with respect to
persons who engage in the distribution at retail of tobacco products on tribal
lands.</text>
</paragraph><paragraph id="HC0D9E39E584E45F98093229D6E46004B"><enum>(4)</enum><text>The findings and
regulations promulgated under paragraphs (1) and (2) shall be promulgated in
conformance with section 553 of title 5, United States Code, and shall comply
with the following provisions:</text>
<subparagraph id="H826DEAA6725B4EB18BB8A90AE130949"><enum>(A)</enum><text>In making findings
as provided in paragraph (1), and in drafting and promulgating regulations as
provided in paragraph (2) (including drafting and promulgating any revised
regulations), the Administrator shall confer with, and allow for active
participation by, representatives and members of Indian tribes, and tribal
organizations.</text>
</subparagraph><subparagraph id="HA12070AAA3AF48AAB4D7690C2D0D49"><enum>(B)</enum><text>In carrying out
rulemaking processes under this subsection, the Administrator shall follow the
guidance of subchapter III of chapter 5 of title 5, United States Code,
commonly known as the <quote>Negotiated Rulemaking Act of 1990.</quote></text>
</subparagraph><subparagraph id="HE0971967598F4F3A9D5E1FABA0B319D"><enum>(C)</enum><text>The tribal
participants in the negotiation process referred to in subparagraph (B) shall
be nominated by and shall represent the groups described in this subsection and
shall include tribal representatives from all geographic regions.</text>
</subparagraph><subparagraph id="H6E9E9D6E700940CEA6F907461BD1A6E0"><enum>(D)</enum><text>The negotiations
conducted under this paragraph (4) shall be conducted in a timely
manner.</text>
</subparagraph><subparagraph id="HB93BE4EF24074A7EBF9F033746D3F13D"><enum>(E)</enum><text>If the
Administrator determines that an extension of the deadlines under subsection
(k)(1) of this section is appropriate, the Secretary may submit proposed
legislation to Congress for the extension of such deadlines.</text>
</subparagraph></paragraph><paragraph id="HE0B047D32DDB4BE7927B33E2D48BC3B1"><enum>(5)</enum><text>This subsection
shall not affect any law or ordinance that (A) was in effect on tribal lands on
the date of introduction of the <short-title>Youth
Prevention and Tobacco Harm Reduction Act</short-title>, and (B) covers the
same subject matter as the law described in subsection (e)(1). Any law or
ordinance that meets the conditions of this paragraph shall also be deemed to
meet the requirement described in subsection (k)(1), if such law or ordinance
is at least as stringent as the law described in subsection (e)(1).</text>
</paragraph><paragraph id="H44077EF1F5264D4CB8439FCF20B25799"><enum>(6)</enum><text>For purposes of
this subsection—</text>
<subparagraph id="H08C3046A2B574D6F88D069F0B5FDAE09"><enum>(A)</enum><text><quote>Administrator</quote>
means the Administrator of the Tobacco Harm Reduction Center.</text>
</subparagraph><subparagraph id="HE616CE1EB126478B858C2D4231F08DA3"><enum>(B)</enum><text><quote>Indian
tribe</quote> has the meaning assigned that term in section 4(e) of the Indian
Self Determination and Education Assistance Act, section 450b(e) of title 25,
United States Code.</text>
</subparagraph><subparagraph id="HA3836B6EB5CC43149C0355006FF7583E"><enum>(C)</enum><text><quote>Tribal
lands</quote> means all lands within the exterior boundaries of any Indian
reservation, all lands the title to which is held by the United States in trust
for an Indian tribe, or lands the title to which is held by an Indian tribe
subject to a restriction by the United States against alienation, and all
dependent Indian communities.</text>
</subparagraph><subparagraph id="H3302A0ADC8D543F39E3401A585110043"><enum>(D)</enum><text><quote>tribal
organization</quote> has the meaning assigned that term in section 4(l) of the
Indian Self Determination and Education Assistance Act, section 450b(l) of
title 25, United States
Code.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HCF6E1BD1E8F54E02B0AA7D04587C55EE"><enum>403.</enum><header>Establishment
of rankings</header>
<subsection id="HA3F5F042592E49B58B768DAC6B6E213E"><enum>(a)</enum><header>Standards and
procedures for rankings</header><text>Within 24 months after the effective date
of this Act, the Administrator shall, by regulation, after consultation with an
Advisory Committee established for such purpose, establish the standards and
procedures for promulgating rankings, comprehensible to consumers of tobacco
products, of the following categories of tobacco products and also
nicotine-containing products on the basis of the relative risks of serious or
chronic tobacco-related diseases and adverse health conditions those categories
of tobacco products and also nicotine-containing products respectively
present—</text>
<paragraph id="HFD254CFAD10742F798FCEDC956423BFB"><enum>(1)</enum><text>cigarettes;</text>
</paragraph><paragraph id="H50A6063941A14A12BF6660B25F85224B"><enum>(2)</enum><text>loose tobacco for
roll-your-own tobacco products;</text>
</paragraph><paragraph id="H9EF862214E7E4787003BDEC83219E0C5"><enum>(3)</enum><text>little
cigars;</text>
</paragraph><paragraph id="HD90D6B2CC45E45359040C946D6E02BF6"><enum>(4)</enum><text>cigars;</text>
</paragraph><paragraph id="HA1225F0CA97942C6AECB2FDDD0626600"><enum>(5)</enum><text>pipe
tobacco;</text>
</paragraph><paragraph id="H1DCE643D7B2449AEB2AD1446910328CB"><enum>(6)</enum><text>moist
snuff;</text>
</paragraph><paragraph id="HC83741B143EE481B873DD6A700D16C15"><enum>(7)</enum><text>dry snuff;</text>
</paragraph><paragraph id="HF267491065834F1E87FB0012F012E705"><enum>(8)</enum><text>chewing
tobacco;</text>
</paragraph><paragraph id="H5CFE032204884336B461D3B2BC1B7632"><enum>(9)</enum><text>other forms of
tobacco products, including pelletized tobacco and compressed tobacco, treated
collectively as a single category; and</text>
</paragraph><paragraph id="H8E4A7F5BD5CC44629DF2C9B16456E2E"><enum>(10)</enum><text>other
nicotine-containing products, treated collectively as a single category.</text>
</paragraph><continuation-text continuation-text-level="subsection">The
Administrator shall not have authority or discretion to establish a
relative-risk ranking of any category or subcategory of tobacco products or any
category or subcategory of nicotine-containing products other than the ten
categories specified in this subsection.</continuation-text></subsection><subsection id="H4896C7693D8C4B51AC537DF426B021D6"><enum>(b)</enum><header>Considerations
in promulgating regulations</header><text>In promulgating regulations under
this section, the Administrator—</text>
<paragraph id="H34662D04CDED4C35B8A523354EB2B829"><enum>(1)</enum><text>shall take into
account relevant epidemiologic studies and other relevant competent and
reliable scientific evidence; and</text>
</paragraph><paragraph id="H7D9909F4926F42D492F49194CDF98B81"><enum>(2)</enum><text>in assessing the
risks of serious or chronic tobacco-related diseases and adverse health
conditions presented by a particular category, shall consider the range of
tobacco products or nicotine-containing products within the category, and shall
give appropriate weight to the market shares of the respective products in the
category.</text>
</paragraph></subsection><subsection id="H347C12C0BE0146F996BCBE604DFA5CF"><enum>(c)</enum><header>Promulgation of
rankings of categories</header><text>Once the initial regulations required by
subsection (a) are in effect, the Administrator shall promptly, by order, after
notice and an opportunity for comment, promulgate to the general public
rankings of the categories of tobacco products and nicotine-containing products
in accordance with those regulations. The Administrator shall promulgate the
initial rankings of those categories of tobacco products and
nicotine-containing products to the general public not later than January 1,
2010. Thereafter, on an annual basis, the Administrator shall, by order,
promulgate to the general public updated rankings that are (1) in accordance
with those regulations, and (2) reflect the scientific evidence available at
the time of promulgation. The Administrator shall open and maintain an ongoing
public docket for receipt of data and other information submitted by any person
with respect to such annual promulgation of rankings.</text>
</subsection></section><enum>V</enum><header>ENFORCEMENT
PROVISIONS</header>
<section id="H00B0E565D0AB4F0F8DAFF13453EE72D6"><enum>501.</enum><header>Prohibited
acts</header><text display-inline="no-display-inline">The following acts and
the causing thereof are hereby prohibited—</text>
<paragraph id="H26F55687FF3A43F7AD3D35121E32674E"><enum>(1)</enum><text>the introduction
or delivery for introduction into interstate commerce of any tobacco product
that is adulterated or misbranded;</text>
</paragraph><paragraph id="HB3AF540EAA634C46AC57DDE24B10CD45"><enum>(2)</enum><text>the adulteration
or misbranding of any tobacco product in interstate commerce;</text>
</paragraph><paragraph id="H05AF3C0CEAAF453500000308F57400E7"><enum>(3)</enum><text>the receipt in
interstate commerce of any tobacco product that is known to be adulterated or
misbranded, and the delivery or proffered delivery thereof for pay or
otherwise;</text>
</paragraph><paragraph id="HA2FEF557FC1046CEAC3665D9A6D0094D"><enum>(4)</enum><text>the failure to
establish or maintain any record, or make any report or other submission, or to
provide any notice required by or under this Act; or the refusal to permit
access to, verification of, or copying of any record as required by this
Act;</text>
</paragraph><paragraph id="HC80437E371D7470BA7AE007F6C44B755"><enum>(5)</enum><text>the refusal to
permit entry or inspection as authorized by this Act;</text>
</paragraph><paragraph id="H2D97C78AE44B44928DC2C0532DADD47B"><enum>(6)</enum><text>the making to the
Administrator of a statement, report, certification or other submission
required by this Act, with knowledge that such statement, report,
certification, or other submission is false in a material aspect;</text>
</paragraph><paragraph id="H6B50ECCCD75242E09DBD7E9B7678C9EA"><enum>(7)</enum><text>the manufacturing,
shipping, receiving, storing, selling, distributing, possession, or use of any
tobacco product with knowledge that it is an illicit tobacco product;</text>
</paragraph><paragraph id="HBD0BC8ABA7864ED39E75C8728D05D4AA"><enum>(8)</enum><text>the forging,
simulating without proper permission, falsely representing, or without proper
authority using any brand name;</text>
</paragraph><paragraph id="H6FE9CB736E594E1C94B315D03C006E57"><enum>(9)</enum><text>the using by any
person to his or her own advantage, or revealing, other than to the
Administrator or officers or employees of the Agency, or to the courts when
relevant in any judicial proceeding under this Act, any information acquired
under authority of this Act concerning any item which as a trade secret is
entitled to protection; except that the foregoing does not authorize the
withholding of information from either House of Congress or from, to the extent
of matter within its jurisdiction, any committee or subcommittee of such
committee or any joint committee of Congress or any subcommittee of such joint
committee;</text>
</paragraph><paragraph id="HD47E4263F67C4FD99FC87BA450ED402E"><enum>(10)</enum><text>the alteration,
mutilation, destruction, obliteration, or removal of the whole or any part of
the labeling of, or the doing of any other act with respect to, a tobacco
product, if such act is done while such tobacco product is held for sale
(whether or not the first sale) after shipment in interstate commerce, and
results in such tobacco product being adulterated or misbranded;</text>
</paragraph><paragraph id="H39D372BE11694B42A7421F9750377D90"><enum>(11)</enum><text>the importation
of any tobacco product that is adulterated, misbranded, or otherwise not in
compliance with this Act; and</text>
</paragraph><paragraph id="HC90C132022BE49D4943588F837E9BEAA"><enum>(12)</enum><text>the commission of
any act prohibited by section 201 of this Act.</text>
</paragraph></section><section id="H6E852CD917604837B27F0112262F937F"><enum>502.</enum><header>Injunction
proceedings</header>
<subsection id="HCDEFB42B76924719B96572324BF4EFA9"><enum>(a)</enum><text>The district
courts of the United States shall have jurisdiction, for cause shown, to
restrain violations of this Act, except for violations of section
701(k).</text>
</subsection><subsection id="H9F2C5DE87F9248D6B092EF3D579274E9"><enum>(b)</enum><text>In case of an
alleged violation of an injunction or restraining order issued under this
section, which also constitutes a violation of this Act, trial shall be by the
court, or upon demand of the defendant, by a jury.</text>
</subsection></section><section id="H9D27EF1275644B37BF0139313F9797BD"><enum>503.</enum><header>Penalties</header>
<subsection id="H7504CF6FB09A469AA4E09CBB94234C6D"><enum>(a)</enum><header>Criminal
penalties</header><text>Any person who willfully violates a provision of
section 501 of this Act shall be imprisoned for not more than one year or fined
not more than $25,000, or both.</text>
</subsection><subsection id="H1405398BF5B14BFC9BA48573FC535130"><enum>(b)</enum><header>Civil penalties
for violation of Section 803</header>
<paragraph id="HB9F8639043CB49359C72031DDF0328EA"><enum>(1)</enum><text>Any person who
knowingly distributes or sells, other than through retail sale or retail offer
for sale, any cigarette brand style in violation of section 803(a)—</text>
<subparagraph id="H76B082FD330642740014BFFC93A28D"><enum>(A)</enum><text>for a first offense
shall be liable for a civil penalty not to exceed $10,000 for each distribution
or sale, or</text>
</subparagraph><subparagraph id="HA999B239FFEC4236ADB3AEAD8802BC9"><enum>(B)</enum><text>for a second
offense shall be liable for a civil penalty not to exceed $25,000 for each
distribution or sale,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">except that
the penalty imposed against any person with respect to violations during any
30-day period shall not exceed $100,000.</continuation-text></paragraph><paragraph id="HE24E22A6940D4D2B85EBBF8D5F8FE7C"><enum>(2)</enum><text>Any retailer who
knowingly distributes, sells or offers for sale any cigarette brand style in
violation of section 803(a) shall—</text>
<subparagraph id="H661678FC052A45EC81BB50BFB23344DE"><enum>(A)</enum><text>for a first
offense for each sale or offer for sale of cigarettes, if the total number of
packages of cigarettes sold or offered for sale—</text>
<clause id="HCD1DFF4C103C4628B847D571A8F4E08"><enum>(i)</enum><text>does
not exceed 50 packages of cigarettes, be liable for a civil penalty not to
exceed $500 for each sale or offer for sale, and</text>
</clause><clause id="H2CCE095F916945328EAAF1181E7DEBC6"><enum>(ii)</enum><text>exceeds 50
packages of cigarettes, be liable for a civil penalty not to exceed $1,000 for
each sale or offer for sale;</text>
</clause></subparagraph><subparagraph id="H78683536A0134BE4BACF7C004577F2D9"><enum>(B)</enum><text>for each
subsequent offense for each sale or offer for sale of cigarettes, if the total
number of cigarettes sold or offered for sale—</text>
<clause id="HF519DC34D9C04FD9B1DC1BC55B161F8"><enum>(i)</enum><text>does
not exceed 50 packages of cigarettes, be liable for a civil penalty not to
exceed $2,000 for each sale or offer for sale, and</text>
</clause><clause id="H043BD7D63E3D4D5FADA320AD4DFB4FB"><enum>(ii)</enum><text>exceeds 50
packages of cigarettes, be liable for a civil penalty not to exceed $5,000 for
each sale or offer for sale;</text>
</clause><continuation-text continuation-text-level="subparagraph">except
that the penalty imposed against any person during any 30-day period shall not
exceed $25,000.</continuation-text></subparagraph></paragraph></subsection></section><section id="H5890E2451B6D43CE9643B7E3ECF3F92"><enum>504.</enum><header>Seizure</header>
<subsection id="H3366A54DA71C4976A34550F46ECF999C"><enum>(a)</enum><header>Articles subject
to seizure</header>
<paragraph id="H9C1D07E6417843D680B7918ED42D1FDE"><enum>(1)</enum><text>Any tobacco
product that is adulterated or misbranded when introduced into or while in
interstate commerce or while held for sale (whether or not the first sale)
after shipment in interstate commerce, or which may not, under the provisions
of this Act, be introduced into interstate commerce, shall be liable to be
proceeded against while in interstate commerce, or at any time thereafter, on
libel of information and condemned in any district court of the United States
within the jurisdiction of which the tobacco product is found. No libel for
condemnation shall be instituted under this Act for any alleged misbranding if
there is pending in any court a libel for condemnation proceeding under this
Act based upon the same alleged misbranding, and not more than one such
proceeding shall be instituted if no such proceeding is so pending, except that
such limitations shall not apply—</text>
<subparagraph id="HAE73D42FB8AC4D8198066475DBEA5FF9"><enum>(A)</enum><text>when such
misbranding has been the basis of a prior judgment in favor of the United
States, in a criminal, injunction, or libel for condemnation proceeding under
this Act, or</text>
</subparagraph><subparagraph id="H7DEDCBE631654B5484E5098E06003B3C"><enum>(B)</enum><text>when the
Administrator has probable cause to believe from facts found, without hearing,
by the Administrator or any officer or employee of the Agency that the
misbranded tobacco product is dangerous to health beyond the inherent danger to
health posed by tobacco, or that the labeling of the misbranded tobacco product
is fraudulent, or would be in a material respect misleading to the injury or
damage of the purchaser or consumer. In any case where the number of libel for
condemnation proceedings is limited as above provided, the proceeding pending
or instituted shall, on application of the claimant, seasonably made, be
removed for trial to any district agreed upon by stipulation between the
parties, or, in case of failure to so stipulate within a reasonable time, the
claimant may apply to the court of the district in which the seizure has been
made, and such court (after giving the United States attorney for such district
reasonable notice and opportunity to be heard) shall by order, unless good
cause to the contrary is shown, specify a district of reasonable proximity to
the claimant’s principal place of business, to which the case shall be removed
for trial.</text>
</subparagraph></paragraph><paragraph id="H708035E49BA743E287DBAB15D37D5B6"><enum>(2)</enum><text>The following shall
be liable to be proceeded against at any time on libel of information and
condemned in any district court of the United States within the jurisdiction of
which they are found—</text>
<subparagraph id="H7BA4EA0783C247D8882BDE60F7FC605F"><enum>(A)</enum><text>any tobacco
product that is an illicit tobacco product;</text>
</subparagraph><subparagraph id="HED8EC5D0CA7A4849BC9C9B6F7B49E2D4"><enum>(B)</enum><text>any container of
an illicit tobacco product;</text>
</subparagraph><subparagraph id="H7D6E8F4DFEC14E01AFDC515551C89006"><enum>(C)</enum><text>any equipment or
thing used in making an illicit tobacco product; and</text>
</subparagraph><subparagraph id="HC7790571C6FB44DFA4365DF4FBC5797B"><enum>(D)</enum><text>any adulterated or
misbranded tobacco product.</text>
</subparagraph></paragraph><paragraph id="HA50DF77C4F7B4EB6B474C78186299287"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HB01A77D478C24A0183FC4F9219464756"><enum>(A)</enum><text>Except as provided in
subparagraph (B), no libel for condemnation may be instituted under paragraph
(1) or (2) against any tobacco product which—</text>
<clause id="H745765DF59544BFD9F71473D6BB1D73B"><enum>(i)</enum><text>is
misbranded under this Act because of its advertising, and</text>
</clause><clause id="H3D64953E05404B9DB97048F00788861"><enum>(ii)</enum><text>is
being held for sale to the ultimate consumer in an establishment other than an
establishment owned or operated by a manufacturer, packer, or distributor of
the tobacco product.</text>
</clause></subparagraph><subparagraph id="H318E6A8D4FE54B0481D149006F31BC00"><enum>(B)</enum><text>A libel for
condemnation may be instituted under paragraph (1) or (2) against a tobacco
product described in subparagraph (A) if the tobacco product’s advertising
which resulted in the tobacco product being misbranded was disseminated in the
establishment in which the tobacco product is being held for sale to the
ultimate consumer—</text>
<clause id="H5C4A6B106524483C9CDCB4C06129C0B8"><enum>(i)</enum><text>such
advertising was disseminated by, or under the direction of, the owner or
operator of such establishment, or</text>
</clause><clause id="H350DEB8D2B65403B9BBB26C2A88B334C"><enum>(ii)</enum><text>all
or part of the cost of such advertising was paid by such owner or
operator.</text>
</clause></subparagraph></paragraph></subsection><subsection id="HB0C5331DDCCD4FCD8D9C1B53665CB56E"><enum>(b)</enum><header>Procedures</header><text>The
tobacco product, equipment, or other thing proceeded against shall be liable to
seizure by process pursuant to the libel, and the procedure in cases under this
section shall conform, as nearly as may be, to the procedure in admiralty;
except that on demand of either party any issue of fact joined in any such case
shall be tried by jury. When libel for condemnation proceedings under this
section, involving the same claimant and the same issues of adulteration or
misbranding, are pending in two or more jurisdictions, such pending
proceedings, upon application of the claimant seasonably made to the court of
one such jurisdiction, shall be consolidated for trial by order of such court,
and tried in (1) any district selected by the claimant where one of such
proceedings is pending; or (2) a district agreed upon by stipulation between
the parties. If no order for consolidation is so made within a reasonable time,
the claimant may apply to the court of one such jurisdiction and such court
(after giving the United States attorney for such district reasonable notice
and opportunity to be heard) shall by order, unless good cause to the contrary
is shown, specify a district of reasonable proximity to the claimant’s
principal place of business, in which all such pending proceedings shall be
consolidated for trial and tried. Such order of consolidation shall not apply
so as to require the removal of any case the date for trial of which has been
fixed. The court granting such order shall give prompt notification thereof to
the other courts having jurisdiction of the cases covered thereby.</text>
</subsection><subsection id="H7BCA49D02C304AAABED430057D557CB1"><enum>(c)</enum><header>Samples and
analyses</header><text>The court at any time after seizure up to a reasonable
time before trial shall by order allow any party to a condemnation proceeding,
the party’s attorney or agent, to obtain a representative sample of the article
seized and a true copy of the analysis, if any, on which the proceeding is
based and the identifying marks or numbers, if any, of the packages from which
the samples analyzed were obtained.</text>
</subsection><subsection id="HB4684AB5B2BF4B7AADCEC9D53842C26D"><enum>(d)</enum><header>Disposition of
condemned tobacco products</header><paragraph commented="no" display-inline="yes-display-inline" id="HA0C0F87EF5864546AB7058AFE31200B3"><enum>(1)</enum><text>Any tobacco product
condemned under this section shall, after entry of the decree, be disposed of
by destruction or sale as the court may, in accordance with the provisions of
this section, direct; and the proceeds thereof, if sold, less the legal costs
and charges, shall be paid into the Treasury of the United States; but such
tobacco product shall not be sold under such decree contrary to the provisions
of this Act or the laws of the jurisdiction in which sold. After entry of the
decree and upon the payment of the costs of such proceedings and the execution
of a good and sufficient bond conditioned that such article shall not be sold
or disposed of contrary to the provisions of this Act or the laws of any State
in which sold, the court may by order direct that such tobacco product be
delivered to the owner thereof to be destroyed or brought into compliance with
the provisions of this Act, under the supervision of an officer or employee
duly designated by the Administrator; and the expenses of such supervision
shall be paid by the person obtaining release of the tobacco product under
bond. If the tobacco product was imported into the United States and the person
seeking its release establishes (A) that the adulteration, misbranding, or
violation did not occur after the tobacco product was imported, and (B) that
the person seeking the release of the tobacco product had no cause for
believing that it was adulterated, misbranded, or in violation before it was
released from customs custody, the court may permit the tobacco product to be
delivered to the owner for exportation under section 709 in lieu of destruction
upon a showing by the owner that there is a reasonable certainty that the
tobacco product will not be re-imported into the United States.</text>
</paragraph><paragraph id="H8C5CC8455A1A47AEB8A7099C23851800" indent="up1"><enum>(2)</enum><text>The provisions of paragraph (1) of
this subsection shall, to the extent deemed appropriate by the court, apply to
any equipment or other thing which is not otherwise within the scope of such
paragraph and which is referred to in paragraph (2) of subsection (a).</text>
</paragraph><paragraph id="HC5908C6766E14635B0AC207CA068C6D0" indent="up1"><enum>(3)</enum><text>Whenever in any proceeding under this
section, involving paragraph (2) of subsection (a), the condemnation of any
equipment or thing (other than a tobacco product) is decreed, the court shall
allow the claim of any claimant, to the extent of such claimant’s interest, for
remission or mitigation of such forfeiture if such claimant proves to the
satisfaction of the court (A) that such claimant has not caused the equipment
or thing to be within one of the categories referred to in such paragraph (2)
and has no interest in any tobacco product referred to therein, (B) that such
claimant has an interest in such equipment or other thing as owner or lienor or
otherwise, acquired by such claimant in good faith, and (C) that such claimant
at no time had any knowledge or reason to believe that such equipment or other
thing was being or would be used in, or to facilitate, the violation of laws of
the United States relating to any illicit tobacco product.</text>
</paragraph></subsection><subsection id="H5A6C9B70308A481B947F00E0498B923C"><enum>(e)</enum><header>Costs and
fees</header><text>When a decree of condemnation is entered against the tobacco
product or other article, court costs and fees, and storage and other proper
expenses shall be awarded against the person, if any, intervening as claimant
of the tobacco product or other article.</text>
</subsection><subsection id="HD84DFED21A2E4223939B5E1E48A335A3"><enum>(f)</enum><header>Removal for
trial</header><text>In the case of removal for trial of any case as provided by
subsection (a) or (b)—</text>
<paragraph id="HA56A525738254145A49200E64B90901D"><enum>(1)</enum><text>The clerk of the
court from which removal is made shall promptly transmit to the court in which
the case is to be tried all records in the case necessary in order that such
court may exercise jurisdiction.</text>
</paragraph><paragraph id="H4ED330115C2F442A801006112FBE80F7"><enum>(2)</enum><text>The court to which
such case was removed shall have the powers and be subject to the duties, for
purposes of such case, which the court from which removal was made would have
had, or to which such court would have been subject, if such case had not been
removed.</text>
</paragraph></subsection><subsection id="H3978F112BCC8432592F120714C8C21BD"><enum>(g)</enum><header>Administrative
detention of tobacco products</header>
<paragraph display-inline="no-display-inline" id="H51CD21BAC9EE4EBEAFE1EE81CFDA6516"><enum>(1)</enum><header>Detention
authority</header>
<subparagraph id="HD5F5D8BD9F304605B94986A0EC7D36A8"><enum>(A)</enum><header>In
general</header><text>An officer or qualified employee of the Agency may order
the detention, in accordance with this subsection, of any tobacco product that
is found during an inspection, examination, or investigation under this Act
conducted by such officer or qualified employee, if the officer or qualified
employee has credible evidence or information indicating that such article
presents a threat of serious adverse health consequences beyond those normally
inherent in the use of tobacco products.</text>
</subparagraph><subparagraph id="H86638DC5A9664A0C9D350501C5F2ED9"><enum>(B)</enum><header>Administrator’s
approval</header><text>A tobacco product or component thereof may be ordered
detained under subparagraph (A) if, but only if, the Administrator or an
official designated by the Administrator approves the order. An official may
not be so designated unless the official is an officer with supervisory
responsibility for the inspection, examination, or investigation that led to
the order.</text>
</subparagraph></paragraph><paragraph id="H35ADAC1B3C604A09A2B9179E321B09D2"><enum>(2)</enum><header>Period of
detention</header><text>A tobacco product may be detained under paragraph (1)
for a reasonable period, not to exceed 20 days, unless a greater period, not to
exceed 30 days, is necessary, to institute an action under subsection (a) or
section 702.</text>
</paragraph><paragraph id="H32DEDE947EE545CE9F235821686099B6"><enum>(3)</enum><header>Security of
detained tobacco product</header><text>An order under paragraph (1) may require
that the tobacco product to be detained be labeled or marked as detained, and
shall require that the tobacco product be maintained in or removed to a secure
facility, as appropriate. A tobacco product subject to such an order shall not
be transferred by any person from the place at which the tobacco product is
ordered detained, or from the place to which the tobacco product is so removed,
as the case may be, until released by the Administrator or until the expiration
of the detention period applicable under such order, whichever occurs first.
This subsection may not be construed as authorizing the delivery of the tobacco
product pursuant to the execution of a bond while the tobacco product is
subject to the order, and section 709 does not authorize the delivery of the
tobacco product pursuant to the execution of a bond while the article is
subject to the order.</text>
</paragraph><paragraph id="H2595EA140E7D4B4EA5ADC7CBAE56AB42"><enum>(4)</enum><header>Appeal of
detention order</header>
<subparagraph id="HC7BAF13CEFDC43AEA4ECB9E9F43FD2C2"><enum>(A)</enum><header>In
general</header><text>With respect to a tobacco product ordered detained under
paragraph (1), any person who would be entitled to be a claimant of such
tobacco product if the tobacco product were seized under subsection (a) may
appeal the order to the Administrator. Within five days after such an appeal is
filed, the Administrator, after providing opportunity for an informal hearing,
shall confirm or terminate the order involved, and such confirmation by the
Administrator shall be considered a final agency action for purposes of section
702 of title 5, United States Code. If during such five-day period the
Administrator fails to provide such an opportunity, or to confirm or terminate
such order, the order is deemed to be terminated.</text>
</subparagraph><subparagraph id="H3B960D52E7FF4B02A571AB1C324208BE"><enum>(B)</enum><header>Effect of
instituting court action</header><text>The process under subparagraph (A) for
the appeal of an order under paragraph (1) terminates if the Administrator
institutes an action under subsection (a) or section 702 regarding the tobacco
product involved.</text>
</subparagraph></paragraph></subsection></section><section id="H7B301F8ACE9749D88F00231E349614DE"><enum>505.</enum><header>Report of minor
violations</header><text display-inline="no-display-inline">Nothing in this Act
shall be construed as requiring the Administrator to report for prosecution, or
for institution of libel or injunction proceedings, minor violations of this
Act whenever the Administrator believes that the public interest will be
adequately served by a suitable written notice or warning.</text>
</section><section id="HD002386515C54736AB0700FB3F746700"><enum>506.</enum><header>Inspection</header>
<subsection id="H65999E581AE047C5A602697058A4CFA0"><enum>(a)</enum><header>Authority To
inspect</header><text>The Administrator shall have the power to inspect the
premises of a tobacco product manufacturer for purposes of determining
compliance with this Act, or the regulations promulgated under it. Officers of
the Agency designated by the Administrator, upon presenting appropriate
credentials and a written notice to the person in charge of the premises, are
authorized to enter, at reasonable times, without a search warrant, any
factory, warehouse, or other establishment in which tobacco products are
manufactured, processed, packaged, or held for domestic distribution. Any such
inspection shall be conducted within reasonable limits and in a reasonable
manner, and shall be limited to examining only those things, including but not
limited to records, relevant to determining whether violations of this Act, or
regulations under it, have occurred. No inspection authorized by this section
shall extend to financial data, sales data other than shipment data, pricing
data, personnel data (other than data as to qualifications of technical and
professional personnel performing functions subject to this Act), or research
data. A separate notice shall be given for each such inspection, but a notice
shall not be required for each entry made during the period covered by the
inspection. Each such inspection shall be commenced and completed with
reasonable promptness.</text>
</subsection><subsection id="HB32A89421D7D410F93A4664F00AE606B"><enum>(b)</enum><header>Report of
observations</header><text>Before leaving the premises, the officer of the
Agency who has supervised or conducted the inspection shall give to the person
in charge of the premises a report in writing setting forth any conditions or
practices that appear to manifest a violation of this Act, or the regulations
under it.</text>
</subsection><subsection id="HCC21CA563A074D42B66299BD48BC6DEE"><enum>(c)</enum><header>Samples</header><text>If
the officer has obtained any sample in the course of inspection, prior to
leaving the premises that officer shall give to the person in charge of the
premises a receipt describing the samples obtained. As to each sample obtained,
the officer shall furnish promptly to the person in charge of the premises a
copy of the sample and of any analysis made upon the sample.</text>
</subsection></section><section id="HF044FEEB7993464D86F4F2D2C88B2C5F"><enum>507.</enum><header>Effect of
compliance</header><text display-inline="no-display-inline">Compliance with the
provisions of this Act and the regulations promulgated under it shall
constitute a complete defense to any civil action, including but not limited to
any products liability action, that seeks to recover damages, whether
compensatory or punitive, based upon an alleged defect in the labeling or
advertising of any tobacco product distributed for sale domestically.</text>
</section><section id="H82C991BD765A4FA3B0A5D6071D46F4E"><enum>508.</enum><header>Imports</header>
<subsection id="H331F1229A57C4535A275C97F00399BC8"><enum>(a)</enum><header>Imports; list of
registered foreign establishments; samples from unregistered foreign
establishments; examination and refusal of admission</header><text>The
Secretary of Homeland Security shall deliver to the Administrator, upon request
by the Administrator, samples of tobacco products that are being imported or
offered for import into the United States, giving notice thereof to the owner
or consignee, who may appear before the Administrator and have the right to
introduce testimony. The Administrator shall furnish to the Secretary of
Homeland Security a list of establishments registered pursuant to subsection
(d) of section 109 of this Act, and shall request that, if any tobacco products
manufactured, prepared, or processed in an establishment not so registered are
imported or offered for import into the United States, samples of such tobacco
products be delivered to the Administrator, with notice of such delivery to the
owner or consignee, who may appear before the Administrator and have the right
to introduce testimony. If it appears from the examination of such samples or
otherwise that (1) such tobacco product is forbidden or restricted in sale in
the country in which it was produced or from which it was exported, or (2) such
tobacco product is adulterated, misbranded, or otherwise in violation of this
Act, then such tobacco product shall be refused admission, except as provided
in subsection (b) of this section. The Secretary of Homeland Security shall
cause the destruction of any such tobacco product refused admission unless such
tobacco product is exported, under regulations prescribed by the Secretary of
Homeland Security, within ninety days of the date of notice of such refusal or
within such additional time as may be permitted pursuant to such
regulations.</text>
</subsection><subsection id="H3ADB638361F14FE8005DDEBBC1933"><enum>(b)</enum><header>Disposition of
refused tobacco products</header><text>Pending decision as to the admission of
a tobacco product being imported or offered for import, the Secretary of
Homeland Security may authorize delivery of such tobacco product to the owner
or consignee upon the execution by such consignee of a good and sufficient bond
providing for the payment of such liquidated damages in the event of default as
may be required pursuant to regulations of the Secretary of Homeland Security.
If it appears to the Administrator that a tobacco product included within the
provisions of clause (3) of subsection (a) of this section can, by relabeling
or other action, be brought into compliance with this Act or rendered other
than a tobacco product, final determination as to admission of such tobacco
product may be deferred and, upon filing of timely written application by the
owner or consignee and the execution by such consignee of a bond as provided in
the preceding provisions of this subsection, the Administrator may, in
accordance with regulations, authorize the applicant to perform such relabeling
or other action specified in such authorization (including destruction or
export of rejected tobacco products or portions thereof, as may be specified in
the Administrator’s authorization). All such relabeling or other action
pursuant to such authorization shall in accordance with regulations be under
the supervision of an officer or employee of the Agency designated by the
Administrator, or an officer or employee of the Department of Homeland Security
designated by the Secretary of Homeland Security.</text>
</subsection><subsection id="H674127D073D34B0500244BB44C3663F0"><enum>(c)</enum><header>Charges
concerning refused tobacco products</header><text>All expenses (including
travel, per diem or subsistence, and salaries of officers or employees of the
United States) in connection with the destruction provided for in subsection
(a) of this section and the supervision of the relabeling or other action
authorized under the provisions of subsection (b) of this section, the amount
of such expenses to be determined in accordance with regulations, and all
expenses in connection with the storage, cartage, or labor with respect to any
tobacco product refused admission under subsection (a) of this section, shall
be paid by the owner or consignee and, in default of such payment, shall
constitute a lien against any future importations made by such owner or
consignee.</text>
</subsection></section><section id="H13A4C6AA0E214F4391A83B7B95370555"><enum>509.</enum><header>Tobacco
products for export</header>
<subsection id="HEEAACFACC8E346FCAF028166108EDFCB"><enum>(a)</enum><header>Exemption for
tobacco products exported</header><text>Except as provided in subsection (b), a
tobacco product intended for export shall be exempt from this Act if—</text>
<paragraph id="HA6693C3053A0483490A4B8D933C200A2"><enum>(1)</enum><text>it is not in
conflict with the laws of the country to which it is intended fore export, as
shown by either (A) a document issued by the government of that country or (B)
a document provided by a person knowledgeable with respect to the relevant laws
of that country and qualified by training and experience to opine on whether
the tobacco product is or is not in conflict with such laws;</text>
</paragraph><paragraph id="H89F3EA8F60A5402AAEA09F3CFA1C2800"><enum>(2)</enum><text>it is labeled on
the outside of the shipping package that it is intended for export; and</text>
</paragraph><paragraph id="H0BDDFD2972BC4504AB62319EEBB174F2"><enum>(3)</enum><text>the particular
units of tobacco product intended for export have not been sold or offered for
sale in domestic commerce.</text>
</paragraph></subsection><subsection id="H90CEC159017C4D8293A1C7A2007D298E"><enum>(b)</enum><header>Products for
U.S. armed forces overseas</header><text>A tobacco product intended for export
shall not be exempt from this Act if it is intended for sale or distribution to
members or units of the Armed Forces of the United States located outside of
the United States.</text>
</subsection><subsection id="H414F19FF451745089FC79BD4B7FF832"><enum>(c)</enum><text>This Act shall not
apply to a person that manufactures and/or distributes tobacco products solely
for export under subsection (a), except to the extent such tobacco products are
subject to subsection (b).</text>
</subsection></section><enum>VI</enum><header>MISCELLANEOUS
PROVISIONS</header>
<section id="H6AC4777466A0466CAE53E557349216C9"><enum>601.</enum><header>Use of payments
under the master settlement agreement and individual State settlement
agreements</header>
<subsection id="H291A9FDD747B46929ECC9842E684B4C0"><enum>(a)</enum><header>Reduction of
grant amounts</header><paragraph commented="no" display-inline="yes-display-inline" id="HE66B8D16CFED448E9BBCBAF43EF52C59"><enum>(1)</enum><text>For fiscal year 2010 and
each subsequent fiscal year, the Secretary shall reduce, as provided in
subsection (b), the amount of any grant under section 1921 of the Public Health
Service Act (42 U.S.C. § 300x–21) for any State that spends on tobacco control
programs from the funds received by such State pursuant to the Master
Settlement Agreement, the Florida Settlement Agreement, the Minnesota
Settlement Agreement, the Mississippi Memorandum of Understanding, or the Texas
Settlement Agreement, as applicable, less than 20 percent of the amounts
received by that State from settlement payments.</text>
</paragraph><paragraph id="HE97F5141E62F4CD19867379569B1D4D8" indent="up1"><enum>(2)</enum><text>In the case of a State whose
legislature does not convene a regular session in fiscal year 2009 or 2010, and
in the case of a State whose legislature does not convene a regular session in
fiscal year 2010, the requirement described in subsection (a)(1) as a condition
of receipt of a grant under section 1921 of the Public Health Service Act shall
apply only for fiscal year 2009 and subsequent fiscal years.</text>
</paragraph></subsection><subsection id="H282CE3FF6E3F4EEBAD2EDDF1C2D912C7"><enum>(b)</enum><header>Determination of
state spending</header><text>Before making a grant under section 1921 of the
Public Health Service Act, section 300x–21 of title 42, United States Code, to
a State for the first applicable fiscal year or any subsequent fiscal year, the
Secretary shall make a determination of whether, during the immediately
preceding fiscal year, the State has spent on tobacco control programs, from
the funds received by such State pursuant to the Master Settlement Agreement,
the Florida Settlement Agreement, the Minnesota Settlement Agreement, the
Mississippi Memorandum of Understanding, or the Texas Settlement Agreement, as
applicable, at least the amount referenced in (a)(1). If, after notice to the
State and an opportunity for a hearing, the Secretary determines that the State
has spent less than such amount, the Secretary shall reduce the amount of the
allotment under section 300x–21 of title 42, United States Code, for the State
for the fiscal year involved by an amount equal to—</text>
<paragraph id="HE9E2C071251746C7BA8252342B35EF4C"><enum>(1)</enum><text>in the case of the
first applicable fiscal year, 10 percent of the amount determined under section
300x–33 of title 42, United States Code, for the State for the fiscal
year;</text>
</paragraph><paragraph id="HD47B2D840F1A4F04B48CDE36AF789441"><enum>(2)</enum><text>in the case of the
first fiscal year following such applicable fiscal year, 20 percent of the
amount determined under section 300x–33 of title 42, United States Code, for
the State for the fiscal year;</text>
</paragraph><paragraph id="H9E468E9115124BD8B579F76411E1B7EE"><enum>(3)</enum><text>in the case of the
second such fiscal year, 30 percent of the amount determined under section
300x–33 of title 42, United States Code, for the State for the fiscal year;
and</text>
</paragraph><paragraph id="HDF4147C86A41481B9EF8040000762194"><enum>(4)</enum><text>in the case of the
third such fiscal year or any subsequent fiscal year, 40 percent of the amount
determined under section 300x–33 of title 42, United States Code, for the State
for the fiscal year.</text>
</paragraph><continuation-text continuation-text-level="subsection">The
Secretary shall not have authority or discretion to grant to any State a waiver
of the terms and requirements of this subsection or subsection (a).</continuation-text></subsection><subsection id="HBBC11B646DB042A5ACC919D516A682A6"><enum>(c)</enum><header>Definitions</header><text>For
the purposes of this section—</text>
<paragraph id="H1AD886CE8EFA4006A98E9B183C91DA90"><enum>(1)</enum><text>The term
<term>first applicable fiscal year</term> means—</text>
<subparagraph id="H913E4E2F088E4029B552127230E8202E"><enum>(A)</enum><text>fiscal year 2011,
in the case of any State described in subsection (a)(2) of this section;
and</text>
</subparagraph><subparagraph id="H080D9670E30244F998E6226E336FB821"><enum>(B)</enum><text>fiscal year 2010,
in the case of any other State.</text>
</subparagraph></paragraph><paragraph id="HC19E6E474CA041C7AE9F39BF624D4F5F"><enum>(2)</enum><text>The term
<term>Florida Settlement Agreement</term> means the Settlement Agreement,
together with the exhibits thereto, entered into on August 25, 1997, between
the State of Florida and signatory tobacco product manufacturers, as specified
therein.</text>
</paragraph><paragraph id="H38E36F87035245E2A88EFB5F7F8956FB"><enum>(3)</enum><text>The term
<term>Master Settlement Agreement</term> means the Master Settlement Agreement,
together with the exhibits thereto, entered into on November 23, 1998, between
the signatory States and signatory tobacco product manufacturers, as specified
therein.</text>
</paragraph><paragraph id="HB1815B50B69D41FDA4EF29534085CEBF"><enum>(4)</enum><text>The term
<term>Minnesota Settlement Agreement</term> means the Settlement Agreement,
together with the exhibits thereto, entered into on May 8, 1998, between the
State of Minnesota and signatory tobacco product manufacturers, as specified
therein.</text>
</paragraph><paragraph id="HCC943DB280D447BCBEA315C83733C289"><enum>(5)</enum><text>The term
<term>Mississippi Memorandum of Understanding</term> means the Memorandum of
Understanding, together with the exhibits thereto and Settlement Agreement
contemplated therein, entered into on July 2, 1997, between the State of
Mississippi and signatory tobacco product manufacturers, as specified
therein.</text>
</paragraph><paragraph id="H9BF1453E4CD94A41A977A5CA5EA0159F"><enum>(6)</enum><text>The term
<term>Secretary</term> means the Secretary of Health and Human Services.</text>
</paragraph><paragraph id="H226CDCD7B0954ED99BF019B3000026A6"><enum>(7)</enum><text>The term
<term>Texas Settlement Agreement</term> means the Settlement Agreement,
together with the exhibits thereto, entered into on January 16, 1998, between
the State of Texas and signatory tobacco product manufacturers, as specified
therein.</text>
</paragraph></subsection></section><section id="HB9425C6072B042D79CA311CF5D1407AF"><enum>602.</enum><header>Preemption of
State Laws Implementing Fire Safety Standard for Cigarettes</header>
<subsection id="HB4D29D9339DC405F83A21422B4156D16"><enum>(a)</enum><header>In
general</header><text>With respect to fire safety standards for cigarettes, no
State or political subdivision shall—</text>
<paragraph id="HF0E77E42514449BBA51580A0A7C65200"><enum>(1)</enum><text>require testing of
cigarettes that would be in addition to, or different from, the testing
prescribed in subsection (b); or</text>
</paragraph><paragraph id="H543C60C7C0A74E849E6832C22B8C1B44"><enum>(2)</enum><text>require a
performance standard that is in addition to, or different from, the performance
standard set forth in subsection (b).</text>
</paragraph></subsection><subsection id="H3C187C6F039A4DBA866941850B18206C"><enum>(b)</enum><header>Test Method and
Performance Standard</header>
<paragraph id="H65062DCEBB044E049FA71585FB360FEA"><enum>(1)</enum><text>To the extent a
State or political subdivision enacts or has enacted legislation or a
regulation setting a fire safety standard for cigarettes, the test method
employed shall be—</text>
<subparagraph id="H776F3611CFEF4025BDB699395026CAB0"><enum>(A)</enum><text>the American
Society of Testing and Materials (<quote>ASTM</quote>) standard E2187–4,
entitled <quote>Standard Test Method for Measuring the Ignition Strength of
Cigarettes</quote>;</text>
</subparagraph><subparagraph id="H2BC8A7EB03CA46298061F17A4D0CD507"><enum>(B)</enum><text>for each cigarette
on 10 layers of filter paper;</text>
</subparagraph><subparagraph id="HA5C02A5E714E49CFA8CA492BE6475466"><enum>(C)</enum><text>so that a
replicate test of 40 cigarettes for each brand style of cigarettes comprises a
complete test trial for that brand style; and</text>
</subparagraph><subparagraph id="H5CBB0EF32A274FC8865A8955AA978C59"><enum>(D)</enum><text>in a laboratory
that has been accredited in accordance with ISO/IEC 17205 of the International
Organization for Standardization (<quote>ISO</quote>) and that has an
implemented quality control and quality assurance program that includes a
procedure capable of determining the repeatability of the testing results to a
repeatability value that is no greater than 0.19.</text>
</subparagraph></paragraph><paragraph id="H770AB5939C674199AAF517F3A28C59D7"><enum>(2)</enum><text>To the extent a
State or political subdivision enacts or has enacted legislation or a
regulation setting a fire safety standard for cigarettes, the performance
standard employed shall be that no more than 25 percent of the cigarettes of
that brand style tested in a complete test in accordance with paragraph (1)
exhibit full-length burns</text>
</paragraph></subsection><subsection id="HDAB08BCA0D384BB8A4B5ECEC96102981"><enum>(c)</enum><header>Exception to
subsection <enum-in-header>(b)</enum-in-header></header><text>In the event that
a manufacturer of a cigarette that a State or political subdivision or its
respective delegated agency determines cannot be tested in accordance with the
test method prescribed in subsection (b)(1)(A), the manufacturer shall propose
a test method and performance standard for the cigarette to the State or
political subdivision. Upon approval of the proposed test method and a
determination by the State or political division that the performance standard
proposed by the manufacturer is equivalent to the performance standard
prescribed in subsection (b)(2), the manufacturer may employ such test method
and performance standard to certify such cigarette pursuant to this subsection
notwithstanding subsection (b).</text>
</subsection></section><section id="HB594784987AE45A6BA2E43C7A4362F7D"><enum>603.</enum><header>Inspection by
the alcohol and tobacco tax trade bureau of records of certain cigarette and
smokeless tobacco sellers</header>
<subsection id="HE0FED0E59CD44158969811845684513E"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Any officer of the
Bureau of the Alcohol and Tobacco Tax Trade Bureau may, during normal business
hours, enter the premises of any person described in subsection (b) for the
purposes of inspecting—</text>
<paragraph id="HADFAB6DECD9D45B0918859CF1ABF25E"><enum>(1)</enum><text>any records or
information required to be maintained by such person under the provisions of
law referred to in subsection (d); or</text>
</paragraph><paragraph id="H3E1EF34241514CFBAAFB693BA1E2505C"><enum>(2)</enum><text>any cigarettes or
smokeless tobacco kept or stored by such person at such premises.</text>
</paragraph></subsection><subsection id="H58F461914EC84CDA9402F5C81B9BB38D"><enum>(b)</enum><header>Covered
persons</header><text>Subsection (a) applies to any person who engages in a
delivery sale, and who ships, sells, distributes, or receives any quantity in
excess of 10,000 cigarettes, or any quantity in excess of 500 single-unit
consumer-sized cans or packages of smokeless tobacco, within a single
month.</text>
</subsection><subsection id="H5067C3273C4A40359373257BFAF38881"><enum>(c)</enum><header>Relief</header>
<paragraph id="H267290C583FC4468B5A14515A168DEB7"><enum>(1)</enum><header>In
general</header><text>The district courts of the United States shall have the
authority in a civil action under this subsection to compel inspections
authorized by subsection (a).</text>
</paragraph><paragraph id="H12B7E98F550D4F07945F006875DAC022"><enum>(2)</enum><header>Violations</header><text>Whoever
violates subsection (a) or an order issued pursuant to paragraph (1) shall be
subject to a civil penalty in an amount not to exceed $10,000 for each
violation.</text>
</paragraph></subsection><subsection id="HF5F5452229F04FF09D1293227010EA88"><enum>(d)</enum><header>Covered
provisions of law</header><text>The provisions of law referred to in this
subsection are—</text>
<paragraph id="H1584A96E1FB94F9AAF1D212B4374BBC8"><enum>(1)</enum><text>the Act of October
19, 1949 (15 U.S.C. 375; commonly referred to as the <quote>Jenkins
Act</quote>);</text>
</paragraph><paragraph id="HB31C7BBB4DC149BA942631CB2240021E"><enum>(2)</enum><text>chapter 114 of
title 18, United States Code; and</text>
</paragraph><paragraph id="H8E0B1B2483FB4B0FB68049249E32F1FC"><enum>(3)</enum><text>this Act.</text>
</paragraph></subsection><subsection id="H8DE88C8DB875495BBE889EBF81BB700"><enum>(e)</enum><header>Delivery sale
defined</header><text>In this section, the term <term>delivery sale</term> has
the meaning given that term in 2343(e) of title 18, United States Code, as
amended by this Act.</text>
</subsection></section><section id="H73BC574834944606A88312A997DE77C3"><enum>604.</enum><header>Severability</header><text display-inline="no-display-inline">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.</text>
</section><enum>VII</enum><header>TOBACCO GROWER
PROTECTION</header>
<section id="HC95F404B89304F2C925C65DF34734589"><enum>701.</enum><header>Tobacco grower
protection</header><text display-inline="no-display-inline">No provision in
this Act shall allow the Administrator or any other person to require changes
to traditional farming practices, including standard cultivation practices,
curing processes, seed composition, tobacco type, fertilization, soil, record
keeping, or any other requirement affecting farming practices.</text>
</section>