1.Short
title; table of contents
(a)This Act may be cited
as the Federal Tobacco Act of
2009
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of
contents.
Sec. 2. Purposes.
Sec. 3. Definitions.
TITLE I—General provisions
Sec. 101. Establishment of the Tobacco Regulatory
Agency.
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. Advisory committees.
Sec. 106. Illicit trade.
Sec. 107. Adulterated tobacco products.
Sec. 108. Misbranded tobacco products.
Sec. 109. Registration and listing.
Sec. 110. Effective date.
TITLE II—Restrictions on youth access to tobacco products and
exposure of youth to tobacco product marketing and advertising
Sec. 201. Prohibitions on youth targeting.
Sec. 202. State law regarding sale of tobacco products to
individuals under age of 18.
Sec. 203. Restrictions on descriptors used in marketing of
cigarettes.
TITLE III—Reduced-exposure and reduced-risk claims for tobacco
products, and ranking of tobacco product categories
Sec. 301. Prohibition of unapproved reduced-exposure and
reduced-risk claims.
Sec. 302. Applications for approval of reduced-exposure and
reduced-risk claims.
Sec. 303. Standards for approval of applications for
reduced-exposure or reduced-risk claims.
Sec. 304. General provisions.
Sec. 305. Establishment of rankings.
Sec. 306. Compulsory licensing.
Sec. 307. Moist snuff warnings.
TITLE IV—Disclosures to the agency regarding tobacco
products
Sec. 401. Confidential disclosures to the agency.
Sec. 402. Nicotine reporting requirements for
cigarettes.
Sec. 403. Nicotine reporting requirements for smokeless tobacco
products.
TITLE V—Tar and nicotine yields
Sec. 501. Determination of tar and nicotine yields of
cigarettes.
Sec. 502. Cigarette tar limits.
Sec. 503. Prohibition of smoking article yield
terms.
Sec. 504. Disclosure of tar and nicotine yields of
cigarettes.
Sec. 505. Evaluation of tobacco smoke toxicants.
TITLE VI—Pubic disclosures by tobacco product
manufacturers
Sec. 601. Disclosures on packages of smoking
articles.
Sec. 602. Disclosures on packages of chewing tobacco and dry
snuff.
Sec. 603. Public disclosure of ingredients.
Sec. 604. Cigarette label and advertising warnings.
TITLE VII—Enforcement provisions
Sec. 701. Prohibited acts.
Sec. 702. Injunction proceedings.
Sec. 703. Penalties.
Sec. 704. Seizure.
Sec. 705. Report of minor violations.
Sec. 706. Inspection.
Sec. 707. Effect of compliance.
Sec. 708. Imports.
Sec. 709. Tobacco products for export.
TITLE VIII—Miscellaneous provisions
Sec. 801. Use of payments under the master settlement agreement
and individual State settlement agreements.
Sec. 802. User fees.
Sec. 803. Fire safety standards for cigarettes.
Sec. 804. Inspection by the alcohol and tobacco tax trade
bureau of records of certain cigarette and smokeless tobacco
sellers.
Sec. 805. Tobacco grower
protection.
Sec. 806. Severability.
2.The purposes of this Act are—
(1)to provide
Federal authority and an appropriate administrative body designed specifically
to regulate tobacco products, including smoking articles and smokeless tobacco
products;
(2)to affirm the
lawfulness of tobacco products and to ensure the ability of private
manufacturers to compete for the business of adult users of tobacco products,
including smokers and users of smokeless tobacco, in a free enterprise
system;
(3)to confirm that
cigarettes and other tobacco products, as customarily marketed, are not subject
to regulation under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 201 et
seq.), but instead are subject to regulation under this and other appropriate
Acts;
(4)to ensure that
existing Federal laws regulating certain aspects of tobacco and tobacco product
production, as well as tobacco product taxation, testing, marketing, promotion,
and advertising remain in full force and effect, except as repealed or amended
by this Act;
(5)to ensure that
tobacco products sold in the United States conform with all applicable laws and
regulations;
(6)to strengthen
enforcement against illegal sales of tobacco products, including the smuggling
of illegal cigarettes and other tobacco products into the United States;
(7)to restrict
access to tobacco products on the part of individuals younger than the minimum
age established by State law for the purchase of tobacco products, and to limit
the exposure of such individuals to tobacco product advertising, marketing, and
promotion;
(8)to continue to
permit the sale of tobacco products to adults in conjunction with measures to
ensure that tobacco products are not sold or accessible to those who have not
attained the minimum age established by State law for the purchase of tobacco
products;
(9)to allow tobacco
product manufacturers to communicate truthful and nonmisleading information, in
advertising and otherwise, concerning tobacco products to adult users of
tobacco products, including smokers and users of smokeless tobacco;
(10)to ensure that
tobacco products sold in the United States do not present adults who choose to
use those products with additional health risks beyond those inherent in
tobacco use;
(11)to establish
principles and policies governing tobacco products to promote reductions in
morbidity and mortality associated with tobacco products, to inform adult users
of tobacco products about the relative risks of chronic diseases and serious
adverse health conditions associated with tobacco use presented by different
categories of tobacco products, and to encourage manufacturers of tobacco
products to develop and introduce tobacco products that present reduced
exposure of tobacco product users to toxicants in tobacco or in tobacco smoke
and tobacco products that present a reduced risk of chronic diseases and
serious adverse health conditions associated with tobacco use;
(12)to promote the
ability of adult consumers of tobacco products to obtain truthful and
nonmisleading health-related information regarding the tobacco products that
those consumers choose to use, while protecting the trade secrets of tobacco
product manufacturers; and
(13)to establish a
comprehensive Federal program to deal with tobacco, including the subject
matters addressed in paragraphs (1) through (12), such that commerce and the
national economy may be—
(A)protected to the
maximum extent; and
(B)not impeded by
diverse, nonuniform, and confusing requirements or prohibitions.
3.In this Act:
(1)The
term Administrator means the chief executive of the Tobacco
Regulatory Agency established under section 101.
(2)The
term adult 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.
(3)The term adult-only facility 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.
(4)The
term advertising means a communication to the general public by a
tobacco product manufacturer, distributor, retailer, or its agents, which
identifies a tobacco product by brand name and is intended by such
manufacturer, distributor, retailer, or its agents to promote purchases of such
tobacco product. Such term shall not include—
(A)any advertising
or other communication in any tobacco trade publication or tobacco trade
promotional material;
(B)the content of
any scientific publication or presentation, or any patent application or other
communication to the United States Patent and Trademark Office or any similar
office in any foreign country;
(C)any corporate or
financial report or financial communication;
(D)any communication
to a lending institution or to securities holders;
(E)any communication
not intended for public display or public exposure, except that a direct
mailing or direct electronic communication of what otherwise is advertising
shall be deemed to be advertising;
(F)any communication
in, on, or within a factory, office, plant, warehouse, or other facility
related to or associated with the development, manufacture, or storage of
tobacco products;
(G)any communication
to any governmental agency, body, official, or employee;
(H)any communication
to any journalist, editor, Internet blogger, or other author;
(I)any communication
in connection with litigation, including arbitration and similar proceedings;
or
(J)any editorial
advertisement that addresses a public issue.
(5)The
term affiliate 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 owns, is owned, and
ownership mean ownership of an equity interest, or the equivalent
thereof, of 50 percent or more.
(6)The
term Agency means the Tobacco Regulatory Agency established under
section 101.
(7)The term age-verified adult means any
individual who is an adult and—
(A)who has stated or
acknowledged, after being asked, that he or she is an adult and a tobacco
product user, and has presented proof of age identifying the individual and
verifying that the individual is an adult; or
(B)whose status as
an adult has been verified by a commercially available database of such
information.
(8)The term annual report means a tobacco
product manufacturer’s annual report to the Agency, which provides ingredient
information and nicotine yield ratings for each brand style that the tobacco
product manufacturer manufactures for commercial distribution
domestically.
(9)The term brand name 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. Such 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.
(10)The term brand name sponsorship means an
athletic, musical, artistic, or other social or cultural event, series, or
tour, as to which payment is made, or other consideration is provided, in
exchange for use of a brand name or names—
(A)as part of the
name of the event; or
(B)to identify,
advertise, or promote such event or an entrant, participant, or team in such
event in any other way.
(11)The term brand style 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 tar or nicotine.
(12)The
term carton means a container into which packages of tobacco
products are directly placed for distribution or sale (such as a carton
containing 10 packages of cigarettes), but does not include cases intended for
shipping.
(13)The
term cartoon means any drawing or other depiction of an object,
person, animal, creature or any similar caricature that satisfies any of the
following criteria:
(A)The use of
comically exaggerated features.
(B)The attribution
of human characteristics to animals, plants or other objects, or the similar
use of anthropomorphic technique.
(C)The attribution
of unnatural or extrahuman abilities, such as imperviousness to pain or injury,
X-ray vision, tunneling at very high speeds, or transformation.
Such term
shall not include any drawing or other depiction that, on the effective date of
this Act, was in use in the United States in any tobacco product manufacturer’s
corporate logo or in any tobacco product manufacturer’s tobacco product
packaging.(14)The
term cigar has the meaning given such term by the Alcohol and
Tobacco Tax and Trade Bureau under section 40.11 of title 27, Code of Federal
Regulations.
(15)The
term cigarette means—
(A)any roll of
tobacco wrapped in paper or in any substance not containing tobacco; or
(B)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
of a cigarette described in subparagraph (A).
(16)Competent and
reliable scientific evidenceThe term competent and
reliable scientific evidence 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.
(17)The
term distributor 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.
(18)The terms domestic and
domestically 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.
(19)The term human image means any photograph,
drawing, silhouette, statue, model, video, likeness, or depiction of the
appearance of a human being, or the appearance of any portion of the body of a
human being.
(20)The term illicit tobacco product
means any tobacco product intended for commercial distribution for use by
consumers in the United States—
(A)with respect to
which not all applicable duties or taxes have been paid in full;
(B)that has been
stolen, smuggled, or is otherwise contraband,
(C)that is
counterfeit; or
(D)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 the Internal Revenue Code of 1986.
(21)The term illicit trade means any transfer,
distribution, or sale in interstate commerce of any illicit tobacco
product.
(22)The term immediate container shall not
include package liners.
(23)The term Indian tribe has the meaning given
such term in section 4(e) of the Indian Self Determination and Education
Assistance Act (25 U.S.C. 450b(e)).
(24)The
term ingredient 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.
(25)International
Organization for Standardization testing regimen; ISO testing regimen
(A)The terms International Organization for
Standardization testing regimen or ISO testing regimen mean
the methods for measuring cigarette smoke yields, as set forth in the most
recent versions of the following:
(i)ISO
3308, entitled Routine analytical cigarette-smoking machine—Definition
of standard conditions
.
(ii)ISO 4387,
entitled Cigarettes—Determination of total and nicotine-free dry
particulate matter using a routine analytical smoking machine
.
(iii)ISO 10315,
entitled Cigarettes—Determination of nicotine in smoke
condensates—Gas-chromatographic method
.
(iv)ISO 10362–1,
entitled Cigarettes—Determination of water in smoke condensates—Part 1:
Gas-chromatographic method
.
(v)ISO
8454, entitled Cigarettes—Determination of carbon monoxide in the vapour
phase of cigarette smoke—NDIR method
.
(B)A
cigarette that does not burn down in accordance with the testing regimen
standards described in subparagraph (A) may be measured under the same puff
regimen using the number of puffs that such a cigarette delivers before it
extinguishes, plus an additional 3 puffs, or with such other modifications as
the Administrator may approve.
(26)The term interstate commerce means all
trade, traffic, or other commerce—
(A)within the
District of Columbia, or any territory or possession of the United
States;
(B)between any point
in a State and any point outside thereof;
(C)between points
within the same State through any place outside such State; or
(D)over which the
United States has jurisdiction.
(27)The
term label means a display of written, printed, or graphic matter
upon or applied securely to the immediate container of a tobacco
product.
(28)The
term labeling means all labels and other written, printed, or
graphic matter—
(A)upon or applied
securely to any tobacco product or any of its containers or wrappers; or
(B)accompanying a
tobacco product.
(29)The term little cigar has the meaning given
such term by the Alcohol and Tobacco Tax and Trade Bureau under section 40.11
of title 27, Code of Federal Regulations.
(30)The term loose tobacco 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 smoking article.
(31)The
term manufacture means to design, manufacture, fabricate,
assemble, process, package or repackage, label or relabel, import, or hold or
store in a commercial quantity. Such term shall not include—
(A)the growing,
curing, destemming, or aging of tobacco; or
(B)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.
(32)Nicotine-containing
productThe term nicotine-containing product means a
product intended for human consumption, other than a tobacco product, that
contains added nicotine, whether or not in the form of a salt or solvate, which
nicotine has been—
(A)synthetically
produced; or
(B)obtained from
tobacco or other source of nicotine.
(33)
(A)Except as provided in subparagraph (B), the term
outdoor advertising means—
(i)a
billboard;
(ii)a
sign or placard in an arena, stadium, shopping mall, or video game arcade
(whether any of the foregoing is open air or enclosed), but not including any
such sign or placard located in an adult-only facility; and
(iii)any other
advertisement placed outdoors.
(B)The
term outdoor advertising shall not include—
(i)an
advertisement on the outside of a tobacco product manufacturing facility;
or
(ii)an
advertisement that—
(I)is inside a
retail establishment that sells tobacco products (other than solely through a
vending machine or vending machines);
(II)is placed on the
inside surface of a window facing outward; and
(III)is no larger
than 14 square feet.
(34)The
term package 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. Such term shall not include an outer
container used solely for shipping 1 or more packages of a tobacco product or
tobacco products.
(35)The
term person means any individual, partnership, corporation,
committee, association, organization or group of persons, or other legal or
business entity.
(36)The term proof of age 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.
(37)The term raw tobacco means tobacco in a form
that is received by a tobacco product manufacturer as an agricultural
commodity, whether in a form that is—
(A)natural, stem or
leaf;
(B)cured or aged;
or
(C)as parts or
pieces, but not in a reconstituted form, extracted pulp form, or extract
form.
(38)The term reduced-exposure claim means a
statement in advertising or labeling intended for 1 or more consumers of
tobacco products, that a tobacco product provides a reduced exposure of users
of that tobacco product to 1 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 no additives
or is natural
, 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).
(39)The term reduced-risk claim means a statement
in advertising or labeling intended for 1 or more consumers of tobacco
products, that a tobacco product provides to users of that product a reduced
risk of morbidity or mortality resulting from 1 or more chronic diseases or
serious adverse health conditions associated with tobacco use, as compared to
an appropriate reference tobacco product or category of tobacco products, even
if it is not stated, represented, or implied that all health risks associated
with using that tobacco product have been reduced or eliminated. A statement or
representation that a tobacco product or the tobacco in a tobacco product
contains no additives
or is natural
, 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).
(40)The
term retailer means any person that—
(A)sells tobacco
products to individuals for personal consumption; or
(B)operates a
facility where the sale of tobacco products to individuals for personal
consumption is permitted.
(41)The
term sample means a tobacco product distributed to members of the
public at no cost for the purpose of promoting the product, but excludes
tobacco products distributed—
(A)in conjunction
with the sale of other tobacco products,
(B)for market
research, medical or scientific study or testing, or teaching,
(C)to persons
employed in the tobacco industry;
(D)to adult
consumers in response to consumer complaints; or
(E)to employees of
the manufacturer of the tobacco product.
(42)The term small business means a tobacco
product manufacturer that—
(A)employs 150 or
fewer employees; and
(B)during the 3-year
period prior to the calendar year in which this Act is enacted, had an average
annual gross revenue from tobacco products that did not exceed
$40,000,000.
(43)Smokeless
tobacco productThe term smokeless tobacco product
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.
(44)The term smoking article 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—
(A)incorporates
components of tobacco or derived from tobacco; and
(B)is intended to be
inhaled by the user.
(45)The
term State 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.
(46)The
term tar means nicotine-free dry particulate matter as defined in
ISO 4387, entitled Cigarettes—Determination of total and nicotine-free
dry particulate matter using a routine analytical smoking
machine
.
(47)The
term tobacco 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.
(48)The term tobacco product means—
(A)the singular of
the term tobacco products, as defined in section 5702(c) of the
Internal Revenue Code of 1986;
(B)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
(C)any form of
tobacco or any construct incorporating tobacco, intended for human consumption,
whether by—
(i)placement in the
oral or nasal cavity;
(ii)inhalation of
vapor, aerosol, or smoke; or
(iii)any other
means.
(49)The term tobacco product category
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).
(50)Tobacco
product communicationThe term tobacco product
communication 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.
(51)Tobacco
product manufacturerThe term tobacco product
manufacturer means an entity that directly—
(A)manufactures 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;
(B)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
(C)is a successor or
assign of any of the foregoing.
(52)The
term toxicant means a chemical or physical agent that produces an
adverse biological effect.
(53)The term transit advertisements means
advertising on or within private or public vehicles and all advertisements
placed at, on, or within any bus stop, taxi stand, transportation waiting area,
train station, airport, or any similar location.
(54)The term tribal organization has the
meaning given such term by section 4(1) of the Indian Self Determination and
Education Assistance Act (25 U.S.C. 450b(l)).
(55)The term United States means the several
States, as defined in this Act.
(56)The term vending machine means any
mechanical, electric, or electronic self-service device that, upon insertion of
money, tokens, or any other form of payment, automatically dispenses tobacco
products.
(57)The term video game arcade means an
entertainment establishment primarily consisting of video games (other than
video games intended primarily for use by adults) or pinball machines.
(58)The
term youth means any individual who is not an adult.
<enum>I</enum><header>General
provisions</header>
<section id="id6A17876FE9974D9EA943F9C5A572512D"><enum>101.</enum><header>Establishment
of the Tobacco Regulatory Agency</header>
<subsection id="ID03adcb8274ac4dd194fe9fe0d51f7d5c"><enum>(a)</enum><header>Establishment
of Agency</header><text>There is established within the Department of Health
and Human Services the Tobacco Regulatory Agency. The Agency shall not be part
of the Food and Drug Administration, and shall not in any way be under the
authority of the Commissioner of Food and Drugs.</text>
</subsection><subsection id="ID01817666439b4a4d8549447a33597fb3"><enum>(b)</enum><header>Agency head;
regulations; cost-benefit analysis</header>
<paragraph id="id5D67A47511854ACCB613DC240E787268"><enum>(1)</enum><header>In
general</header><text>The Agency shall be headed by an Administrator, to be
appointed by the President with the advice and consent of the Senate, who shall
have the authority provided under 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.</text>
</paragraph><paragraph id="idC8BDC7B33800469FBE144E2BA45A0FB8"><enum>(2)</enum><header>Regulations</header><text>In
promulgating regulations under section 107, section 108, or section 502(c), 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>
<subparagraph id="IDda617b8dc0d1448b8612294354a2dc30"><enum>(A)</enum><text>determine the
technological and economic ability of parties that would be required to comply
with the regulation involved to comply with such regulation;</text>
</subparagraph><subparagraph id="ID88656a6ceaa548d0b4af3425dfec25d6"><enum>(B)</enum><text>consider
experience gained under any similar relevant regulations at the Federal or
State level; and</text>
</subparagraph><subparagraph id="IDe0c4c9dd952e4b478f3fd2736f6cd1a5"><enum>(C)</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>
</subparagraph></paragraph></subsection></section><section id="ID678f1d6ce3ab468eb13a9c735e4d8453"><enum>102.</enum><header>Exclusion of
other regulatory programs</header>
<subsection id="IDbc5370b9e57a4023a89394062f8a182e"><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 or nicotine-containing
product shall be regulated as a food, drug, or device under subsection (f),
(g), or (h) of section 201, or chapter IV or V, of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(f), (g), or (h), 341 et seq., and 351 et seq.),
except that any tobacco product commercially distributed domestically and any
nicotine-containing product commercially distributed domestically shall be
subject to chapter V of such 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
such Act.</text>
</subsection><subsection id="ID1bcce9c77cd144d293cbdfaff5f51388"><enum>(b)</enum><header>Limitation on
effect of this Act</header><text>Nothing in this Act shall be construed
to—</text>
<paragraph id="ID49831ba2270340a1843178dbbed483e1"><enum>(1)</enum><text>establish a
precedent with respect to any other industry, situation, circumstance, or legal
action; or</text>
</paragraph><paragraph id="ID6ec038d6987d4fd798fb0988963e2141"><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="IDa411d81466454329a66eb337ebbf5a5f"><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="ID2827cf50c67a4d1588e03076dc9251b9"><enum>(1)</enum><text>raw tobacco that
is not in the possession or control of a tobacco product manufacturer;</text>
</paragraph><paragraph id="IDe9b79d4eb50e4162897261340bbe47e4"><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="ID073d656d5d7a4310896db7ec72be3aba"><enum>(3)</enum><text>the activities,
materials, facilities, or practices of persons that are not tobacco product
manufacturers and that are—</text>
<subparagraph id="ID40d06a2dd5ef4f8daaaaa438e7e88745"><enum>(A)</enum><text>producers of raw
tobacco, including tobacco growers;</text>
</subparagraph><subparagraph id="IDd4ad3b2ddc9c444dad715cd228ff1978"><enum>(B)</enum><text>tobacco
warehouses, and other persons that receive raw tobacco from growers;</text>
</subparagraph><subparagraph id="ID3f7f8db18527492399c5f3aa630cbb5c"><enum>(C)</enum><text>tobacco grower
cooperatives;</text>
</subparagraph><subparagraph id="IDe28651efe92a468e9ed384e856f8cd6b"><enum>(D)</enum><text>persons that cure
raw tobacco;</text>
</subparagraph><subparagraph id="ID80a8971caef044279e711bdd197fbc8a"><enum>(E)</enum><text>persons that
process raw tobacco; and</text>
</subparagraph><subparagraph id="ID618147bc0927413ea030eb83caf3dc0f"><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="ID5ee6f2a088b148cbb830b756761b9766"><enum>103.</enum><header>Existing
Federal laws maintained</header>
<subsection id="id6F07F4179DC04346BC90D93DB0DA9853"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Except as otherwise
amended or repealed by this Act, all Federal laws in effect on the effective
date of this Act that regulate tobacco, tobacco products, or tobacco product
manufacturers shall remain in effect. Such laws shall include—</text>
<paragraph id="IDe8519abb446348c497c4fc5852bbab7b"><enum>(1)</enum><text>the Federal
Cigarette Labeling and Advertising Act (15 U.S.C. 1331 et seq.);</text>
</paragraph><paragraph id="ID4931b1daab9c44fa804fe8ebb4ecdeb2"><enum>(2)</enum><text>the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq.);</text>
</paragraph><paragraph id="ID5e444dae18b54e06921d8d1dc62c4838"><enum>(3)</enum><text>section 1926 of
the Public Health Service Act (42 U.S.C. 300x–26); and</text>
</paragraph><paragraph id="ID6b3b5f930ce747e4b9b98d6845265370"><enum>(4)</enum><text>those laws
authorizing the 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></subsection><subsection id="id0B954925A7DA4BC9AF650767D13517C5"><enum>(b)</enum><header>Repeals</header><text>The
following provisions shall be repealed—</text>
<paragraph id="id83B01AF6A975416788D84FBFF56463E9"><enum>(1)</enum><text>Section 6 of the
Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1335).</text>
</paragraph><paragraph id="idEA164D496F4A4F9981733B491AB56195"><enum>(2)</enum><text>Section 2(f) of
the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C.
4401(f)).</text>
</paragraph></subsection></section><section id="ID77a90129f61f4949886e3889beb2f437"><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
carrying out the purpose described in 2(13) the following shall apply:</text>
<paragraph id="ID0d212c4002804cad989dcda464b070bf"><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 be enforceable in 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 this Act, 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 this Act.</text>
</paragraph><paragraph id="ID1e45727040564e988486010f104ad786"><enum>(2)</enum><text>With respect to
any subject matter covered by this Act or by any regulation promulgated under
this Act, no conflicting requirement or prohibition shall be imposed under
State or local law upon any tobacco product manufacturer or distributor.</text>
</paragraph><paragraph id="IDe9f1d757c01c4ab487ef3ad6b644c29f"><enum>(3)</enum><text>Paragraph (2)
shall not apply to any requirement or prohibition imposed under State or local
law prior to December 31, 2009.</text>
</paragraph></section><section id="IDa77acb14189f4e58919a9ba71129b6b7"><enum>105.</enum><header>Advisory
committees</header>
<subsection id="IDa48cc24b00bb4b4a966df581411ff17b"><enum>(a)</enum><header>Establishment</header><text>The
Administrator shall establish advisory committees for purposes required by this
Act and otherwise as the Administrator determines appropriate.</text>
</subsection><subsection id="IDf6d1ff601eed4cb8a49c562b6b747693"><enum>(b)</enum><header>Composition</header>
<paragraph id="idDC40D25FA8D7474EB829467A5BE8B4A6"><enum>(1)</enum><header>In
general</header><text>An advisory committee established under this Act shall be
composed of 11 members, of whom—</text>
<subparagraph id="id3EC5DAB2E1104367A67B444A98D5E3CB"><enum>(A)</enum><text>3 members shall
be officers or employees of the Federal Government, or a State or local
government;</text>
</subparagraph><subparagraph id="id32EEC6CBA79747E9AFAF33177E93753B"><enum>(B)</enum><text>3 members shall
be representatives of the interests of scientific and health
professionals;</text>
</subparagraph><subparagraph id="idA38F111CBC424F8DBFD1B351DF962410"><enum>(C)</enum><text>2 members shall
be representatives of the interests of the general public; and</text>
</subparagraph><subparagraph id="id6C650C115ECD4C999D0EEC5041DC56DA"><enum>(D)</enum><text>3 members shall
be representatives of the tobacco products manufacturing industry, of which, 1
such member shall be a representative of small businesses.</text>
</subparagraph></paragraph><paragraph id="id41CBA80E97B546DA860431CE3C39A2FA"><enum>(2)</enum><header>Administrative
provisions</header><text>The Administrator shall designate the chairperson of
each advisory committee under this Act from among its members, shall furnish
any such advisory committee with clerical and other assistance, and shall
establish for all members (other than those who are employees of the Federal
Government), appropriate compensation and travel expenses, as authorized by
section 7503 of title 5, United States Code.</text>
</paragraph></subsection></section><section id="ID994f7fe2fbea4e88b76aed6baf8f9d19"><enum>106.</enum><header>Illicit
trade</header>
<subsection id="IDf937a5be07324bd2b027a6997e06d682"><enum>(a)</enum><header>No action To
increase illicit trade</header><text>The Administrator shall not promulgate any
regulation or take any other action under this Act that has the effect
of—</text>
<paragraph id="IDc4ab6f0bfcd343e983e9e7a0e49781a1"><enum>(1)</enum><text>increasing
illicit trade involving tobacco or any tobacco product; or</text>
</paragraph><paragraph id="IDee9bcf9797264b1883374928cf363e8f"><enum>(2)</enum><text>making affected
tobacco products unacceptable to a substantial number of the 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></subsection><subsection id="ID1d3711e1e94f4df9a1713bdd0b9c3bef"><enum>(b)</enum><header>Study and
report</header>
<paragraph id="ID64822a8ab6744fdd95278256f7a34e42"><enum>(1)</enum><header>Study</header><text>The
Administration shall, after consultation with other relevant agencies, conduct
a study of trade in tobacco products that involves the passage of such products
either from or to any foreign country across any border of the United States,
to—</text>
<subparagraph id="IDc0faa12bca5245aea6c7ce6675cdb5fe"><enum>(A)</enum><text>collect data on
such trade in tobacco products, including illicit trade involving tobacco
products, and make recommendations on the monitoring of such trade;</text>
</subparagraph><subparagraph id="IDbff96887ecbb4be6b1ffda0167a5ee69"><enum>(B)</enum><text>collect data on
any advertising intended to be broadcast, transmitted, or distributed from the
United States 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>
</subparagraph><subparagraph id="ID14244661764447b590c0f86ebabea027"><enum>(C)</enum><text>collect data on
such trade in tobacco products by a person that is not—</text>
<clause id="ID8f71ac66a3ac414d95bd04fa36d3c879"><enum>(i)</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>
</clause><clause id="IDd05d98ea0a3c4d838f0c801bc04ad05f"><enum>(ii)</enum><text>an
affiliate or subsidiary of a participating manufacturer.</text>
</clause></subparagraph></paragraph><paragraph id="ID6511c36d407e405cad17891c97ff8aa6"><enum>(2)</enum><header>Report</header><text>Not
later than 18 months after the effective date of this Act, the Administrator
shall submit to the Secretary, and the appropriate committees of Congress, a
report concerning the study conducted under paragraph (1).</text>
</paragraph></subsection></section><section id="ID3b4d15e4fa1848fd9e552a024f2af543"><enum>107.</enum><header>Adulterated
tobacco products</header><text display-inline="no-display-inline">A tobacco
product shall be deemed to be adulterated—</text>
<paragraph id="ID5ba015a75ad548a9811be4a51df20dd0"><enum>(1)</enum><text>if such product
bears or contains any poisonous or deleterious substance other than—</text>
<subparagraph id="IDdf007419d3774c348da25548dcd9af69"><enum>(A)</enum><text>tobacco;</text>
</subparagraph><subparagraph id="IDc49f3cad754845b9ace860e8450fa077"><enum>(B)</enum><text>a substance
naturally present in tobacco;</text>
</subparagraph><subparagraph id="IDf50d9b57f91a4435902a1061aed6d4e6"><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="ID00809ab1329442dbb1c66404f3552f9e"><enum>(D)</enum><text>in the case of
imported tobacco, a residue of a pesticide or fungicide chemical that—</text>
<clause id="ID6f5959baef13409189bce2cdd9cab9a5"><enum>(i)</enum><text>is
approved for use in the country of origin of the tobacco; or</text>
</clause><clause id="IDd1c5d20e424947ddb7989ffd048a1a5a"><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 the event that 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="ID4409fa2eb01045538714cc0af90bc8a6"><enum>(2)</enum><text>if there is
significant scientific agreement that, as a result of the tobacco that such
product contains, such product presents a risk to human health that is
materially higher than the risk presented by—</text>
<subparagraph id="IDcb550519be2c4b068e63fc902f4d0217"><enum>(A)</enum><text>such product on
the effective date of this Act; or</text>
</subparagraph><subparagraph id="IDfaea41e3e01b4e0cad110b3badecf129"><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="IDbca89042030a4349889b3e72be3b9069"><enum>(3)</enum><text>if such product
has been prepared, packed, or held under unsanitary conditions whereby it may
have become contaminated with filth;</text>
</paragraph><paragraph id="ID021f2e830d9342c782dcbcb2961cb9c2"><enum>(4)</enum><text>if the package of
such product is composed, in whole or in part, of any poisonous or deleterious
substance that may render the contents injurious to health;</text>
</paragraph><paragraph id="ID6b31a889b6d14bb4b1723eaa959e9d9b"><enum>(5)</enum><text>if the tar yield
of such product is in violation of section 502; or</text>
</paragraph><paragraph id="ID6e403a95bada42fc97e861698b3bd7c4"><enum>(6)</enum><text>if such product
is not in compliance with the standard prescribed by section 803.</text>
</paragraph></section><section id="IDb8dc035bb926404cba1b01026fda0d48"><enum>108.</enum><header>Misbranded
tobacco products</header><text display-inline="no-display-inline">A tobacco
product shall be deemed to be misbranded—</text>
<paragraph id="IDa77631aafc604e6c890e0eda667099f8"><enum>(1)</enum><text>if the labeling
of such product is false or misleading in any particular;</text>
</paragraph><paragraph id="ID6468b94329a94d308e9c32d93aee5f34"><enum>(2)</enum><text>if such product
is in package form unless the product bears a label containing—</text>
<subparagraph id="ID51f81a9d16fc4f4c958bd19b7f057511"><enum>(A)</enum><text>an identification
of the type of product, by the common or usual name of such type of
product;</text>
</subparagraph><subparagraph id="IDff857681aef1433898a7149e3dde675e"><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="ID741f8725a7d34658a33559d00e05383a"><enum>(C)</enum><text>the name and
place of business of the tobacco product manufacturer, packer, or distributor;
and</text>
</subparagraph><subparagraph id="ID13d02a5f5c9e40808d31429971f071b9"><enum>(D)</enum><text>the information
required by section 601(c) and (e) or section 602(c) and (e), as
applicable;</text>
</subparagraph></paragraph><paragraph id="IDfae333ce670e4e269898e0587c28d32c"><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 of such product 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="ID29c3aec948574c74afd61c108f835a39"><enum>(4)</enum><text>if any word,
statement, or other information is required by this Act to appear on the label
of such product, 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="ID23d71633042d42cf88b4c0177614a7d1"><enum>(5)</enum><text>if such product
was manufactured, prepared, or processed in an establishment not duly
registered under section 109, if such product was not included in a list
required by section 109, or if a notice or other information with respect to
such product was not provided as required by section 109;</text>
</paragraph><paragraph id="IDcb18eec08e7e49f49fc1c199784110a9"><enum>(6)</enum><text>if the packaging,
labeling, or advertising of such product is in violation of this Act or of an
applicable regulation promulgated in accordance with this Act;</text>
</paragraph><paragraph id="ID1123727fa4df4314bdeb79938121ac2a"><enum>(7)</enum><text>if such product
contains tobacco or another ingredient as to which a required disclosure under
this Act was not made;</text>
</paragraph><paragraph id="ID39c60312a6924e118604fb0ff4e00b31"><enum>(8)</enum><text>if such product
is labeled or advertised, or the tobacco contained in such product is
advertised, as—</text>
<subparagraph id="ID250d14f123ae4afda2dfe75362227c8a"><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: “No additives in our tobacco does NOT mean safer”;
or</text>
</subparagraph><subparagraph id="ID731f4bcfcbdb4baca9fbc3ce29cd7ef5"><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: “Natural does NOT mean safer”;</text>
</subparagraph></paragraph><paragraph id="ID356f3002866f400798e097f36d90b6cf"><enum>(9)</enum><text>if in the
labeling or advertising of such product 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="ID94a6c0ce45ea4de98820d838b97c6242"><enum>(10)</enum><text>if with respect
to such product a disclosure required by section 603 was not made;</text>
</paragraph><paragraph id="ID881ad68f4fe74524950cf917b5773d4e"><enum>(11)</enum><text>if with respect
to such product a certification required by section 803 was not submitted or is
materially false or misleading; or</text>
</paragraph><paragraph id="IDc6eabc99be3a49e684345d2a174df631"><enum>(12)</enum><text>if the
manufacturer or distributor of such product made with respect to the product a
claim prohibited by section 301.</text>
</paragraph></section><section id="ID8ea130afb3144e979299a904b9e3217a"><enum>109.</enum><header>Registration
and listing</header>
<subsection id="ID619a07082765420ca47f3ea2ee9ccde1"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="ID01fafa8cc7374366807684db01589548"><enum>(1)</enum><header>Manufacture,
preparation, or procession</header><text>The term <term>manufacture,
preparation, or processing</term> includes 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. Such term 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="ID8baef781a7524af28aafb39ac092c76b"><enum>(2)</enum><header>Name</header><text>The
term <term>name</term> includes, 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="ID81791ef1c39641db9396308fc770fa30"><enum>(b)</enum><header>Annual
registration</header><text>Not later than December 31, 2010, and December 31 of
each year thereafter, a 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="IDb5c0c2a18d5a4e6283f798ec89f3f5ee"><enum>(c)</enum><header>New
producers</header><text>A 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="IDb2f72904b3f74b44ab0096dcf1213495"><enum>(d)</enum><header>Registration of
foreign establishments</header>
<paragraph id="IDccbd0ef309df46a6b9ec63db09972998"><enum>(1)</enum><header>In
general</header><text>Not later than December 31, 2010, and December 31 of each
year thereafter, a 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 otherwise as 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="ID877a9e60f00d4bf3982134a293592efd"><enum>(2)</enum><header>Other
information</header><text>A person described in paragraph (1) shall, in
addition to the information required under paragraph (1), provide the
information required by subsection (j), including sales made by mail or through
the Internet, or other electronic means.</text>
</paragraph><paragraph id="ID21d41bd785e141dbaf6b823d14d0fb79"><enum>(3)</enum><header>Cooperative
agreements</header><text>The Administrator may 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="ID2df2d856291147cda708c6124032f9cf"><enum>(e)</enum><header>Additional
establishments</header><text>A person duly registered in accordance with the
preceding 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="IDdd49073f410e4f309230be5bc584a359"><enum>(f)</enum><header>Exclusions from
application of this section</header><text>The preceding subsections of this
section shall not apply to—</text>
<paragraph id="IDa464e3b0c1ff40ea9175b6a1d95ba6f8"><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="ID617a95e0c4f94bfbaabdb6e783f71cc0"><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="ID1d4d42a38867415bbc2aa7cf3701c341"><enum>(g)</enum><header>Inspection of
premises</header><text>An establishment registered with the Administrator
pursuant to this section shall be subject to inspection pursuant to section
706. An established described in the preceding sentence that is engaged in the
manufacture, preparation, or processing of a tobacco product or products shall
be inspected under section 706 by 1 or more officers or employees duly
designated by the Administrator at least once in the 2-year period beginning
with the date of registration of such establishment pursuant to this section
and at least once in every successive 2-year period thereafter, except that the
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="ID1f41d937d83949e486bccfdd8e492e53"><enum>(h)</enum><header>Filing of lists
of tobacco products manufactured, prepared, or processed by registrants;
statements; accompanying disclosures</header>
<paragraph id="IDde3d9d99bb5f4b28927ea48677aa64f5"><enum>(1)</enum><header>Filing of
lists</header><text>A person that registers with the Administrator under
subsection (b), (c), (d), or (e) shall, at the time of such registration, 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) prior to 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 such
brand style.</text>
</paragraph><paragraph id="IDd0b0b60599b942319ef940734718257f"><enum>(2)</enum><header>Reports of
information</header><text>A person that registers with the Administrator under
this section (referred in this paragraph as the <quote>registrant</quote>)
shall report to the Administrator, not later than August 30 the preceding
6-month period from January through June, and not later than February 28 (or 29
as applicable) for the preceding 6-month period from July through December,
each year the following information:</text>
<subparagraph id="IDcfc759a24d344580877eb025bb68b736"><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="ID7e1bfdb5e2fd4c8a886a7a30f6b01e1c"><enum>(B)</enum><text>If, subsequent to
the date on which the registrant last made a report under this paragraph (or if
such registrant has not previously made a report under this paragraph, after
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="ID7bc6df658fef4d4dad852f7fadef91c4"><enum>(C)</enum><text>If, subsequent to
the date on which 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="ID6bb38b9a38ec4d95b387cd57a985c73b"><enum>(D)</enum><text>Any material
change in any information previously submitted pursuant to this paragraph or
paragraph (1).</text>
</subparagraph></paragraph></subsection><subsection id="ID6faecdb92a6b48a6bcf14a07aac8f785"><enum>(i)</enum><header>Electronic
registration</header><text>A registration under subsection (b), (c), (d), or
(e) (including the submission of updated information) shall be submitted to the
Administrator by electronic means, unless the Administrator grants a request
for a waiver of such requirement because the use of electronic means is not
reasonable for the person requesting such waiver.</text>
</subsection></section><section id="ID0791b3e5175145caab17c26caa102d4e"><enum>110.</enum><header>Effective
date</header><text display-inline="no-display-inline">Except as otherwise
specifically provided, this Act shall be effective on the date of enactment of
this Act.</text>
</section><enum>II</enum><header>Restrictions on
youth access to tobacco products and exposure of youth to tobacco product
marketing and advertising</header>
<section id="id7E9E474BE3F14DE994C1EEBF37205604"><enum>201.</enum><header>Prohibitions
on youth targeting</header><text display-inline="no-display-inline">Effective
18 months after the date of enactment of this Act, no person shall engage in
any of the following activities or practices in the advertising, promotion, or
marketing of any tobacco product:</text>
<paragraph id="IDbf808cda9f49401485294420f6bdedcc"><enum>(1)</enum><text>The use, or
causing the use, of any cartoon in the advertising, promoting, packaging, or
labeling of any tobacco product.</text>
</paragraph><paragraph id="IDb96884d4ada5433c8aba694130a25980"><enum>(2)</enum><text>The use, or
causing the use, of any human image in the advertising, promoting, packaging,
or labeling of any tobacco product, except for the following:</text>
<subparagraph id="ID16533d6b0a1640bc918f8bf431651a86"><enum>(A)</enum><text>The use, or
continued use, in advertising, promoting, marketing, packaging, or labeling of
any human image appearing on a tobacco product package before December 31,
2009.</text>
</subparagraph><subparagraph id="ID3e9050cf748e45d5aecd44e7be9aef9c"><enum>(B)</enum><text>The use, or
continued use, of a human image in the advertising, promoting, or marketing of
a tobacco product, if conducted solely in an adult-only facility or
facilities.</text>
</subparagraph><subparagraph id="ID60ed6998c9fe464db0fe5824b6bac1f6"><enum>(C)</enum><text>The use, or
continued use, of a human image in a tobacco product communication means
directed solely to persons that the tobacco product manufacturer has a
good-faith belief are age-verified adults.</text>
</subparagraph></paragraph><paragraph id="IDc42047ec05274206a58317e49d0897b5"><enum>(3)</enum><text>The advertising
of tobacco products in any magazine or newspaper intended for distribution to
the general public.</text>
</paragraph><paragraph id="ID518137ebd7c24f76b8ce24b5907c776a"><enum>(4)</enum><text>The engaging in
any brand name sponsorship in the United States, other than a brand name
sponsorship occurring solely in an adult-only facility or facilities.</text>
</paragraph><paragraph id="IDce297de5536c4652b8e8c1df46258cb7"><enum>(5)</enum><text>The engaging in
any brand name sponsorship of any event in the United States in which any paid
participants or contestants are youth.</text>
</paragraph><paragraph id="IDd6d489a7eece469782bce12331360bd8"><enum>(6)</enum><text>The sponsoring of
any athletic event between opposing teams in any football, basketball,
baseball, soccer, or hockey league.</text>
</paragraph><paragraph id="IDe651f981cd21482aa50802e3ed02cae5"><enum>(7)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id7CFC25F3BA30413290DB933039C14982"><enum>(A)</enum><text>The securing of a
right, by agreement, to name any stadium or arena located within the United
States with a brand name; or</text>
</subparagraph><subparagraph id="id2C294FDF0B774027892651FAEE378289" indent="up1"><enum>(B)</enum><text>otherwise causing a stadium or arena
located within the United States to be named with a brand name.</text>
</subparagraph></paragraph><paragraph id="ID54bde6537a2741a8b1697a9ab58b8016"><enum>(8)</enum><text>The securing of a
right by agreement pursuant to which payment is made or other consideration is
provided to use a brand name in association with any football, basketball,
baseball, soccer, or hockey league, or any team involved in any such
league.</text>
</paragraph><paragraph id="IDa132cc48ceff435e80a1c5a99411e672"><enum>(9)</enum><text>The use of, or
causing the use of, by agreement requiring the payment of money or other
consideration, a brand name with any nationally recognized or nationally
established trade name or brand designation of any non-tobacco item or service,
or any nationally recognized or nationally established sports team,
entertainment group or individual celebrity for purposes of advertising, except
for an agreement between or among persons that enter into such agreement for
the sole purpose of avoiding infringement claims.</text>
</paragraph><paragraph id="IDed6b87d3e51c4b46a6e5298d6ca2fa03"><enum>(10)</enum><text>The license,
express authorization, or otherwise causing of any person to use or advertise
within the United States any brand name in a manner that—</text>
<subparagraph id="ID678747fdbfe44d3283cbdd97ec4a0b23"><enum>(A)</enum><text>does not pertain
to a tobacco product; or</text>
</subparagraph><subparagraph id="ID7350901eee14423dae5816ea6d453039"><enum>(B)</enum><text>causes that
person to use the brand name to advertise, promote, package or label,
distribute, or sell any product or service that is not a tobacco
product.</text>
</subparagraph></paragraph><paragraph id="ID82c7ca94d5e245a6a08ae9ea6352389c"><enum>(11)</enum><text>The marketing,
distribution, offering, selling, licensing, or authorizing of, or the causing
to be marketed, distributed, offered, sold, licensed, or authorized, any
apparel or other merchandise bearing a brand name, except—</text>
<subparagraph id="ID88d30f8a90404deb8251e1e2e5944aa0"><enum>(A)</enum><text>apparel or other
merchandise that is used by individuals representing a tobacco product
manufacturer within an adult-only facility and that is not distributed, by sale
or otherwise, to any member of the general public;</text>
</subparagraph><subparagraph id="ID164329273fee4f52844aa968981316f7"><enum>(B)</enum><text>apparel or
merchandise provided to an adult employee of a tobacco product manufacturer for
use by such employee;</text>
</subparagraph><subparagraph id="ID46cc1869e3394e068c16b4afbab40361"><enum>(C)</enum><text>items or
materials used to hold or display tobacco products at retail;</text>
</subparagraph><subparagraph id="ID04dbf8f80f164ef289be2e433c17c568"><enum>(D)</enum><text>items or
materials the sole function of which is to advertise tobacco products;</text>
</subparagraph><subparagraph id="IDc01c3d69a8934982bad25d61dac31033"><enum>(E)</enum><text>written or
electronic publications;</text>
</subparagraph><subparagraph id="IDeeb8c5f1421748b4aa40f41cb6488cd2"><enum>(F)</enum><text>coupons or other
items used by adults solely in connection with the purchase of tobacco
products;</text>
</subparagraph><subparagraph id="ID3a6cd1fa82804b799f3a3cb1c139d45a"><enum>(G)</enum><text>that the
composition, structure, form, or appearance of any tobacco product, package,
label, or labeling shall not be affected by the prohibitions of this paragraph;
and</text>
</subparagraph><subparagraph id="ID1ff51e48337a494493d4264ee98bd333"><enum>(H)</enum><text>that no person
shall be required to retrieve, collect, or otherwise recover any item or
material that was marketed, distributed, offered, sold, licensed, or caused to
be marketed, distributed, offered, sold, or licensed by such person;</text>
</subparagraph></paragraph><paragraph id="ID48c8396890d248d5a1135f0ff049134e"><enum>(12)</enum><text>The
distribution, or causing the distribution, of any free sample domestically,
except in an adult-only facility or facilities to individuals who are
age-verified adults.</text>
</paragraph><paragraph id="IDc3b4771497404c64a56ba4dfb1423536"><enum>(13)</enum><text>The making of,
or causing to be made, any payment or the payment of, or causing to be paid,
any other consideration to any other person to use, display, make reference to,
or use as a prop in any performance medium any tobacco product, tobacco product
package, advertisement for a tobacco product, or any other item bearing a brand
name. For the purposes of this paragraph, the terms <quote>performance
medium</quote> and <quote>performance media</quote> mean any motion picture,
television show, theatrical production or other live performance, live or
recorded performance of music, commercial film or video, or video game. This
paragraph shall not apply to the following:</text>
<subparagraph id="ID2644f68c3b6a4702b24fe169bb06d229"><enum>(A)</enum><text>Performance media
for which the audience or viewers are within 1 or more adult-only facilities,
if such performance media are not audible or visible to persons outside such
adult-only facility or facilities.</text>
</subparagraph><subparagraph id="IDf897baaf305543c5853ab76e9a6c73dc"><enum>(B)</enum><text>Performance media
not intended to be heard or viewed by the general public.</text>
</subparagraph><subparagraph id="IDd71477a8f93544f396066f2a154cbf4a"><enum>(C)</enum><text>Instructional
performance media that concern tobacco products and their use, and that are
intended to be heard or viewed only by, or provided only to, age-verified
adults.</text>
</subparagraph><subparagraph id="ID7a68b562ae674153b4a11bb67ffa25fa"><enum>(D)</enum><text>Performance media
used in tobacco product communications to age-verified adults.</text>
</subparagraph></paragraph><paragraph id="IDce58e5aa15c246bf92d120e0fc57c269"><enum>(14)</enum><text>Engaging in
outdoor advertising or transit advertisements of tobacco products within the
United States, except for the following:</text>
<subparagraph id="ID30598235c9a64dde964ec3c0a9e08a2d"><enum>(A)</enum><text>Advertising that
is within an adult-only facility.</text>
</subparagraph><subparagraph id="ID24138f7b0a8f42dbaa9394bf040568d2"><enum>(B)</enum><text>The use of
outdoor advertising for purposes of identification of an adult-only facility,
to the extent that such outdoor advertising is placed at the site, premises, or
location of the adult-only facility.</text>
</subparagraph><subparagraph id="ID9fb86cf1986543ed979e334bf710fcde"><enum>(C)</enum><text>The use of
outdoor advertising in identifying a brand name sponsorship at an adult-only
facility, if such outdoor advertising—</text>
<clause id="idC0E3399249964B86872D74B3E0A23EED"><enum>(i)</enum><text>is
placed at the site, premises, or location of the adult-only facility where such
brand name sponsorship will occur no more than 30 days before the start of the
initial sponsored event; and</text>
</clause><clause id="id9FA00BBC521045E9ACA7F4DEA15ECC25"><enum>(ii)</enum><text>is
removed within 10 days after the end of the last sponsored event.</text>
</clause></subparagraph></paragraph><paragraph id="IDf5a56e80d7c543f59d8d78e287f29a14"><enum>(15)</enum><text>The distribution
or sale domestically of any package or other container of cigarettes containing
fewer than 20 cigarettes.</text>
</paragraph><paragraph id="ID1f9dbb50162d4819aadeb5446fb3990e"><enum>(16)</enum><text>The advertising
of tobacco products on any broadcast, cable, or satellite transmission to a
television or radio receiver, or other medium of electronic communication
subject to the jurisdiction of the Federal Communications Commission, except
electronic communications—</text>
<subparagraph id="ID0a48c179a79049179422a735f21390a5"><enum>(A)</enum><text>contained on
log-in or home pages containing no tobacco product advertising other than brand
name identification;</text>
</subparagraph><subparagraph id="ID051ace1d6b74466fb4d3afc20bd24c00"><enum>(B)</enum><text>in an adult-only
facility or facilities;</text>
</subparagraph><subparagraph id="ID125dabc9caf14be497dbf39bd5598441"><enum>(C)</enum><text>through the
Internet or other individual user-accessible electronic communication means,
including websites accessible using the Internet, if the advertiser takes
reasonable action to restrict access to individuals who are adults by—</text>
<clause id="ID0d6e68e9367f438d932f1e2bf811a5bd"><enum>(i)</enum><text>requiring
individuals accessing such electronic communications to be age-verified adults;
and</text>
</clause><clause id="IDfb0d5e8580464bcca42990d2d59fad77"><enum>(ii)</enum><text>making
good-faith efforts to verify that such individuals are adults.</text>
</clause></subparagraph></paragraph><paragraph id="IDf34a405405384836b913d42a41b8fecb"><enum>(17)</enum><text>The distribution
or sale of 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>
<subparagraph id="ID6eb844e3091e4b4b9d405742de21f115"><enum>(A)</enum><text>requiring that
the addressees of the tobacco products be age-verified adults;</text>
</subparagraph><subparagraph id="ID129ed3b5a3a34932832639a79d66b7bf"><enum>(B)</enum><text>making good faith
efforts to verify that such addressees are adults; and</text>
</subparagraph><subparagraph id="ID8928c03867224dc8b32f1fd057320d31"><enum>(C)</enum><text>addressing the
tobacco products delivered by mail, courier or common carrier to a physical
address and not a post office box.</text>
</subparagraph></paragraph><paragraph id="ID996344b769f04efda784387980cd789d"><enum>(18)</enum><text>The providing of
any gift of a non-tobacco product, except matches, in connection with the
purchase of a tobacco product.</text>
</paragraph><paragraph id="IDc699e541ea55422285d8d28fa1c40d13"><enum>(19)</enum><text>The engaging in
the sponsorship or promotion, or causing the sponsorship or promotion, of any
consumer sweepstakes, contest, drawing, or similar activity resulting in the
award of a prize in connection with advertising.</text>
</paragraph><paragraph id="ID18920139677c4277951546bfaf5b5f27"><enum>(20)</enum><text>The offering,
promoting, conducting, or authorizing, or causing to be offered, promoted,
conducted, or authorized, any consumer sweepstakes, drawing, contest, or other
activity resulting in the awarding of a prize, based on redemption of a
proof-of-purchase, coupon, or other item awarded as a result of the purchase or
use of a tobacco product.</text>
</paragraph><paragraph id="ID03a12b06e3134bc39d0fa46efce6dc1e"><enum>(21)</enum><text>The making of,
or causing to be made, any payment or the payment of, or causing to be paid,
any other consideration, to any other person with regard to the display or
placement of any cigarettes, or any advertising for cigarettes, in any retail
establishment that is not an adult-only facility.</text>
</paragraph></section><section id="ID482c4376164843d0b206250f836bb36d"><enum>202.</enum><header>State law
regarding sale of tobacco products to individuals under age of 18</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 the following:</text>
<quoted-block display-inline="no-display-inline" id="idF1222FEA173242F990343A04B5F70057" style="OLC">
<subsection id="IDb374ffacb72a4bca8abdf9e60bb9b640"><enum>(e)</enum><header>Elements of
State distribution law</header>
<paragraph id="id148F3ECAA87E42BBB52457A8585BDF05"><enum>(1)</enum><header>In
general</header><text>Subject to paragraphs (2) and (3), for fiscal year 2010
and each subsequent fiscal year, the Secretary shall reduce, as provided for in
subsection (h), the amount of any grant under section 1921 for any State that
does not have in effect a law with substantially the following
provisions:</text>
<quoted-block display-inline="no-display-inline" id="idFEC5C2D4126745B1A382C3F31574B3A3" style="OLC">
<section id="idFA31C6D468704B0794F9154120460AD9" section-type="section-one"><enum>1.</enum><header>Distribution to
minors</header>
<subsection id="IDcf2801f9d2544f1bbfc4443f3ecd510c"><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 shall be 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="IDe25355ef0216487d9a2eaf2f83acccf5"><enum>(b)</enum><text>The employer of
an employee who has violated subsection (a) twice while in the employ of such
employer shall be liable for a civil money penalty of $125 for each subsequent
violation by such employee.</text>
</subsection><subsection id="IDe36249bb4db743e9ad889636e70179ee"><enum>(c)</enum><text>It shall be a
defense to a charge brought under subsection (a) that—</text>
<paragraph id="IDeee9a00de4d04b7290cc00225c719a17"><enum>(1)</enum><text>the
defendant—</text>
<subparagraph id="IDb7fda6f42a74414f9664e7a37ff0b76d"><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 2009;</text>
</subparagraph><subparagraph id="IDcbfc919402314fc8b507ec315413f981"><enum>(B)</enum><text>had complied with
the requirements of section 5 and, if applicable, section 7; or</text>
</subparagraph><subparagraph id="IDfb12208a357b46f0ba809182d389ba74"><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="ID4e76c1c45bdb488eb3bdc6832e6f5812"><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="IDb1649c0edb3a426ba3bd0f49802970b1"><enum>2.</enum><header>Purchase,
receipt, or possession by minors prohibited</header>
<subsection id="IDd51fbff62afb47d4a5db34cce5173987"><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 shall be 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 4 hours nor more than 10 hours of community service. Upon the
second or each subsequent violation of this subsection, such individual shall
be required to perform not less than 8 hours nor more than 20 hours of
community service.</text>
</subsection><subsection id="ID7864a52fda6e48b988a3b536a00c6d86"><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="ID2e07db527840403fbfd671f86d2f2786"><enum>(c)</enum><text>Subsection (a)
shall not be construed to 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="ID42f1372a8bf64599b0b977ee3ef87d3c"><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 2009. A person who distributes a cigarette or a
smokeless tobacco product in violation of this section shall be liable for a
civil money penalty of not less than $25 nor more than $125 for each such
violation.</text>
</section><section id="ID06b4e18fa8324d45874a2e1d3ddb1077"><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="ID0aa302df8e2443a9b93fce3c43e0f539"><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="IDc2578b6e342b4d4b91515dc39aab62ed"><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="ID9f56a2c5a875484899e3cacb9e7a93b6"><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 shall be liable
for a civil money penalty of not less than $25 nor more than $125.</continuation-text></section><section id="ID6f75fcb53bf4426db1a37398cb557a92"><enum>5.</enum><header>Notification of
employees</header>
<subsection id="ID1a78a79575b5440d84016560d1ede855"><enum>(a)</enum><text>Not later than
180 days of the effective date of this Act, a 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="ID7a1c154e040f47a796a5cdf5b3190ae8"><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="ID114e9151de524605ae75369b0ce195ad"><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="ID0853c7cb8db4457a995d616c64800c96"><enum>(b)</enum><text>It shall be a
defense to a charge that an employer violated subsection (a) 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: <quote>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</quote>.</text>
</subsection><subsection id="ID79597e2d39614295b6178291f805bbd9"><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="ID9f67b90e7f62431ab20b9a78f234d4d3"><enum>6.</enum><header>Self-service
displays</header>
<subsection id="ID5d67251bf977414e999058018fa76c44"><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 shall not apply to any adult-only
facility.</text>
</subsection><subsection id="ID32212099c80c4ff885aaee64ef89c0c5"><enum>(b)</enum><text>Any person who
violates subsection (a) shall be 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="id32498644023848CFB1F1FD3D60B7F930"><enum>7.</enum><header>Distribution by
mail or courier</header>
<subsection id="ID9449bd22303b4a56877dfdb7285d6627"><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 such purchase requests for tobacco
products takes reasonable action to prevent delivery to individuals who are not
adults by—</text>
<paragraph id="IDce70834abb68492ba0d7ad9932229e6f"><enum>(1)</enum><text>requiring that
addressees of the tobacco products be age-verified adults;</text>
</paragraph><paragraph id="ID1bda00ddcff442bf87140b47942a1756"><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="ID1e6decfb29f743c8aa05b89eb04e1ffa"><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="IDd9f26fc2b609491787dfdfc7cd24c639"><enum>(b)</enum><text>Any person who
violates subsection (a) shall be liable for a civil money penalty of not less
than $25 nor more than $125 for each such violation.</text>
</subsection></section><section id="ID992e825852b9474a9471f96694d6c45c"><enum>8.</enum><header>Random
unannounced inspections; reporting; and compliance</header>
<subsection id="ID13590c52869945c682f0e8e570502a05"><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 Public Health
Service Act (42 U.S.C. 300x–26).</text>
</subsection><subsection id="ID51b8f8c8dd1b477ab6b6deacbd81a950"><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="ID29c2916a29634abe874661510d683a9f"><enum>(1)</enum><text>Prior to the 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="IDe6de4793518246c58ef1c2da788a1da2"><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="ID8418fc3930994d9888b85184fdcab5ba"><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.</text>
</paragraph><paragraph id="IDf2feae453e714487b67bc20d5cbbde0a"><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="IDd968e324bbaa425d80dbb1c4b152a7d9"><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, shall be liable for a civil money penalty of not less
than $25 nor more than $125 for each such violation.</text>
</subsection><subsection id="ID90b0e51de84c46d6bad543c54f371d29"><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="ID2160d139aa674297b89e9c3026aae395"><enum>9.</enum><header>Licensure</header>
<subsection id="IDc054246b3f81435cba732a44d3f06793"><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="ID2346048d43ec4283acd4f1508e266941"><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="ID6afc90afe7634ebc9e70c4000ae6ce93"><enum>(c)</enum><text>Every application
for a license, including renewal of a license, under this section shall be made
upon a form provided by the Tobacco Regulatory Agency, 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 Tobacco Regulatory Agency may require.</text>
</subsection><subsection id="IDaa0c616047e5405c9abd0a6dfb00ff5c"><enum>(d)</enum><text>The Tobacco
Regulatory Agency 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 Tobacco Regulatory Agency 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="IDc5a86531c58b4e758fa61616fd98fac8"><enum>(e)</enum><text>Every license
issued by the Tobacco Regulatory Agency 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="ID37277a95b0914567bf2000b8078cdb06"><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="ID2c5240d5818a4e038c3ef7002c3f9451"><enum>(g)</enum><text>The Tobacco
Regulatory Agency 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="ID5672d630e91f4a789c37f8a2cdcb84bb"><enum>(h)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id120D45D9CFCF421B84360499D7A5BC7A"><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 shall be liable for a civil
money penalty in an amount equal to—</text>
<subparagraph id="id6AF9D36A63F04D6AB9F068DAE0A7FFDE" indent="up1"><enum>(A)</enum><text>2 times the applicable license fee;
and</text>
</subparagraph><subparagraph id="id5D2543E1F47046E2A4FA0B5B1F513790" indent="up1"><enum>(B)</enum><text>$50 for each day that such
distribution continues without a license.</text>
</subparagraph></paragraph><paragraph id="idA9360AF80C8B4A578EE6E1A178DD31C7" indent="up1"><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="id0FF84DBE1FDE4E9E9EAE81C99002CE5A"><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="ID5ddd6e4d49c342cdadf28901c0696e13"><enum>10.</enum><header>Suspension,
revocation, denial, and nonrenewal of licenses</header>
<subsection id="IDd6a32d8e102f48d385c1ad35f5cad917"><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 Tobacco Regulatory Agency.</text>
</subsection><subsection id="IDdabe8d2d9622424796d5ae1ad45b909c"><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 Tobacco Regulatory Agency may initiate an
administrative action to suspend the license for a period to be determined by
the Tobacco Regulatory Agency but not to exceed 6 months. If an administrative
action to suspend a license is initiated, the Tobacco Regulatory Agency 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="IDfeeff40618334fa4bda26b60973edd19"><enum>(c)</enum><text>The Tobacco
Regulatory Agency may initiate an administrative action to revoke a license
that previously has been suspended under subsection (b) if, after the
suspension and during the 1-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 Tobacco Regulatory Agency shall immediately
notify the licensee in writing at the notice address of the initiation of the
action and the reasons therefore 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="ID46ec633593ec4bdd939d885483137e3c"><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="IDaf94b140a52f4a3189927584c9d7486e"><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="IDb5cef4c11a284ca7bd9d567b7beefb96"><enum>(f)</enum><text>A licensee may
seek judicial review of an action of the Tobacco Regulatory Agency 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="IDe5c6c82ab82747c588ff2992bc18abaa"><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 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="IDdddfced75b104e96ab48a96f5007ad2a"><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="IDf5c2ff4c956b4d97a3cad9e6adee0407"><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="ID3c7d5d90d519496fb78edcb3ddf1e95b"><enum>13.</enum><header>Report</header><text display-inline="no-display-inline">The Tobacco Regulatory Agency shall prepare
for submission annually to the Secretary of Health and Human Services the
report required by section 1926 of the Public Health Service Act (42 U.S.C.
300x–26).</text>
</section><section id="ID5c7aee3b9e9e4156842da881224531ce"><enum>14.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this Act:</text>
<paragraph id="ID6262e1f5adcc494fae9c3c426d865822"><enum>(1)</enum><text>The term
<term>adult-only facility</term> shall have the meaning given such term in
section 3 of the Federal Tobacco Act of 2009.</text>
</paragraph><paragraph id="ID90eccaa84c8b4c498ae7b8c0eadf99e5"><enum>(2)</enum><text>The term
<term>age-verified adult</term> shall have the meaning given such term in
section 3 of the Federal Tobacco Act of 2009.</text>
</paragraph><paragraph id="ID17c8d20b74034cbab7b1ddd092fea196"><enum>(3)</enum><text>The term
<term>package</term> means a pack, box, or container of any kind or, if not a
container, any wrapping (including cellophane), in which a tobacco product or
products are offered for sale, sold, or otherwise distributed to consumers, and
includes cartons in which packages of tobacco products are contained for sale,
offer for sale, or otherwise distributed to consumers.</text>
</paragraph><paragraph id="IDe5a1897042534b0db3206f1cb4d1c058"><enum>(4)</enum><text>The term
<term>proof of age</term> shall have the meaning given such term in section 3
of the Federal Tobacco Act of 2009.</text>
</paragraph><paragraph id="ID4f39f7bb75b94ca4a68bb8d99a83c465"><enum>(5)</enum><text>The term
<term>sample</term> shall have the meaning given such term in section 3 of the
Federal Tobacco Act of 2009.</text>
</paragraph><paragraph id="IDde736ccff32847f4a3b85dea02b2d301"><enum>(6)</enum><text>The term
<term>tobacco product</term> shall have the meaning given such term in section
3 of the Federal Tobacco Act of 2009.</text>
</paragraph><paragraph id="ID946939a6fde648ae8292ff94eb734745"><enum>(7)</enum><text>The term
<term>under the control</term> means within the reach of the cashier or other
employee, or otherwise protected by security, surveillance, or detection
methods, including electronic scanners, such that the tobacco product cannot be
purchased except in a face-to-face
transaction.</text>
</paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="ID21acb6d993f74f4bb76b752c93d4a8de"><enum>(2)</enum><header>Application to
certain States</header><text>In the case of a State whose legislature does not
convene a regular session in fiscal year 2009, and in the case of a State whose
legislature does not convene a regular session in fiscal year 2010, the
requirement described in paragraph (1) as a condition of a receipt of a grant
under section 1921 shall apply only for fiscal year 2011 and subsequent fiscal
years.</text>
</paragraph><paragraph id="ID2f7c02eac68c4a2d9b0ab05f57a64bbe"><enum>(3)</enum><header>Limitation</header><text>Paragraph
(1) shall not affect any State or local law that—</text>
<subparagraph id="idB7EAEA8E1FA34C2687611241831EC760"><enum>(A)</enum><text>was in effect on
the date of enactment of the <short-title>Federal Tobacco
Act of 2009</short-title>; and</text>
</subparagraph><subparagraph id="id3C211BD31F2848408A8024578A1BF3CE"><enum>(B)</enum><text>covers the same
subject matter as the law described in paragraph (1).</text>
</subparagraph><continuation-text continuation-text-level="paragraph">Any State
law that meets the conditions of this paragraph shall also be deemed to meet
the requirement described in paragraph (1) as a condition of a receipt of a
grant under section 1921, if such State law is at least as stringent as the law
described in paragraph (1).</continuation-text></paragraph></subsection><subsection id="IDdf05fa5a69c6436f96d54f89a1a574cc"><enum>(f)</enum><header>Enforcing of
State law</header>
<paragraph id="id1ACDDC2003CB4E73875B06BD0AE99BB3"><enum>(1)</enum><header>In
general</header><text>For the first applicable fiscal year and for each
subsequent fiscal year, a funding agreement for a grant under section 1921 is a
funding agreement under which the State involved will enforce the law described
in subsection (e)(1) 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="id6572D6B094A142E7817F60FF04C76508"><enum>(2)</enum><header>Requirements</header><text>For
the first applicable fiscal year and for each subsequent fiscal year, a funding
agreement for a grant under 1921 is a funding agreement under which the State
involved will—</text>
<subparagraph id="idA52846F32B6D49C592886511EB1598DB"><enum>(A)</enum><text>conduct random,
unannounced inspections to ensure compliance with the law described in
subsection (e)(1); and</text>
</subparagraph><subparagraph id="id03F3041854ED461FA3E39EF677F35AD9"><enum>(B)</enum><text>annually submit
to the Secretary a report describing—</text>
<clause id="id6C5A78F57A67485299D05AD4D2B14D83"><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="id615C485B5EC941E5AF6D4A7DEDB4C759"><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="id375D451A24254A9F8F0307A97D93E2B5"><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="IDc32fa84952a244c0a59cbfcf431cee54"><enum>(g)</enum><header>Funding
sources</header><text display-inline="yes-display-inline">The law specified in
subsection (e)(1) may be administered and enforced by a State using—</text>
<paragraph id="ID673884a60cc34ad0b7bd4fb9390b848a"><enum>(1)</enum><text>any amounts made
available to the State through a grant under section 1921;</text>
</paragraph><paragraph id="IDfc029da3a3e24371b22879385208eff3"><enum>(2)</enum><text>any amounts made
available to the State under section 1901;</text>
</paragraph><paragraph id="ID09678d8893ad4da788755b9b4b563e36"><enum>(3)</enum><text>any fees
collected for licenses issued pursuant to the law described in subsection
(e)(1);</text>
</paragraph><paragraph id="IDae7b3b6dce5e4a10ad97af834ce24110"><enum>(4)</enum><text>any fines or
penalties assessed for violations of the law specified in subsection (e)(1);
or</text>
</paragraph><paragraph id="ID14edc9d660154cfd9192dcba485fc6dd"><enum>(5)</enum><text>any other funding
source that the legislature of the State may prescribe by law.</text>
</paragraph></subsection><subsection id="ID9a3088c158a24e7ca26527b4150666fa"><enum>(h)</enum><header>Compliance
determinations</header><text>Prior to making a grant under section 1921 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). 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 1921 for the State for the fiscal year involved by an
amount equal to—</text>
<paragraph id="ID4b6bfea3b6a241e8886962057364339f"><enum>(1)</enum><text>in the case of
the first applicable fiscal year, 10 percent of the amount determined under
section 1933 for the State for the fiscal year;</text>
</paragraph><paragraph id="ID2b4805e333b54ff79e0ea94de737ed1a"><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 1933 for the State for the fiscal year;</text>
</paragraph><paragraph id="ID4d23aba625f74853b97bf1c509ce2d19"><enum>(3)</enum><text>in the case of
the second such fiscal year, 30 percent of the amount determined under section
1933 for the State for the fiscal year; and</text>
</paragraph><paragraph id="IDd8d21d7fa2cf4a0dadaf0bcfe92e84cc"><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 1933 for the State for the fiscal year.</text>
</paragraph><continuation-text continuation-text-level="subsection">The
Secretary may not grant to any State a waiver of the terms and requirements of
this subsection or subsection (e) or (f).</continuation-text></subsection><subsection id="ID17bb47eea7c74602b6dce527cddb8706"><enum>(i)</enum><header>Definition</header><text>For
the purposes of subsections (e) through (h), the term <term>first applicable
fiscal year</term> means—</text>
<paragraph id="ID6c585c58009847138067009b66e0bea8"><enum>(1)</enum><text>fiscal year 2010,
in the case of any State described in subsection (e)(2); and</text>
</paragraph><paragraph id="ID54388ee62b1748e99c72e34353f13965"><enum>(2)</enum><text>fiscal year 2009,
in the case of any other State.</text>
</paragraph></subsection><subsection id="IDc19a5683acae486db10008fc10aa05c9"><enum>(j)</enum><header>References</header><text>For
purposes of subsections (e) through (h), references to section 1921 shall
include any successor grant programs to the programs established under section
1921.</text>
</subsection><subsection id="ID4bfb9b0296f9466f9d1ac002eb99ca6b"><enum>(k)</enum><header>Indians</header>
<paragraph id="id59948F53A4CD4DA18FC788A80FC75E2C"><enum>(1)</enum><header>In
general</header><text>As required by paragraph (2), and subject to paragraph
(5), an Indian tribe shall satisfy the requirements of subsection (e)(1) by
enacting a law or ordinance with substantially the same provisions as the law
described in subsection (e)(1).</text>
</paragraph><paragraph id="ID9b00ee70571a42ab97d4b69d30bc7501"><enum>(2)</enum><header>Compliance</header><text>An
Indian tribe shall comply with subsection (e)(1) within 180 days after the
Administrator finds, in accordance with this paragraph, that—</text>
<subparagraph id="ID1634175ff3d74a45901a7a1645c81129"><enum>(A)</enum><text>the Indian tribe
has a governing body carrying out substantial governmental powers and
duties;</text>
</subparagraph><subparagraph id="IDa1a49f0b11294ae0b597f3c4da87613a"><enum>(B)</enum><text>the functions to
be exercised by the Indian tribe under this subsection pertain to activities on
trust land within the jurisdiction of the tribe; and</text>
</subparagraph><subparagraph id="IDacbc07494de44068afb708a70939f864"><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">Not later
than 2 years of the date of enactment of the Federal Tobacco Act of 2009, with
respect 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
(5).</continuation-text></paragraph><paragraph id="ID7c9b15b096c14c16b1dc61b926a530f8"><enum>(3)</enum><header>Regulations</header><text>With
respect to an Indian tribe that is subject to subsection (e)(1), the
Administrator shall promulgate regulations that—</text>
<subparagraph id="ID087d2bd0a12d4e66b8b5adb049959b4f"><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="IDdcb454f1a6394457b0d377ddd2527a76"><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="IDd2ea550f989440dba1045fa08cb95866"><enum>(4)</enum><header>Noncompliance</header><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="ID3d43b5f628cd4dfab4ee054592d8c457"><enum>(5)</enum><header>Procedures</header><text>The
findings and regulations promulgated under paragraphs (2) and (3) shall be
promulgated in conformance with section 553 of title 5, United States Code, and
shall comply with the following provisions:</text>
<subparagraph id="IDf143d9fbc133476ea7ee4bb2253ef37c"><enum>(A)</enum><text>In making
findings as provided in paragraph (2), and in drafting and promulgating
regulations as provided in paragraph (3) (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="IDc39c07c808ba44adbf632c24648aa1fe"><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 Negotiated Rulemaking Act of 1990.</text>
</subparagraph><subparagraph id="ID7611ba4114e04b389d20f1e4acc257b3"><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="ID0502f725684b43c8a91c373d7761d9ca"><enum>(D)</enum><text>The negotiations
conducted under this paragraph shall be conducted in a timely manner.</text>
</subparagraph><subparagraph id="IDa3e9bcbba6594305ac657a98831dbb64"><enum>(E)</enum><text>If the
Administrator determines that an extension of the deadlines under subsection
(k)(1) is appropriate, the Secretary may submit proposed legislation to
Congress for the extension of such deadlines.</text>
</subparagraph></paragraph><paragraph id="ID7b0a62205bc94b5ca9691c753cfce6c3"><enum>(6)</enum><header>Limitation</header><text>This
subsection shall not affect any law or ordinance that—</text>
<subparagraph id="id20194BDD363D455583AA28EF7386341B"><enum>(A)</enum><text>was in effect on
tribal lands on <short-title>Federal Tobacco Act of
2009</short-title>; and</text>
</subparagraph><subparagraph id="idA1E92275B6B242DF940A7B7DCD90E91F"><enum>(B)</enum><text>covers the same
subject matter as the law described in subsection (e)(1).</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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).</continuation-text></paragraph><paragraph id="IDc0a1db4fd8de49c2b249a604978d99aa"><enum>(7)</enum><header>Definitions</header><text>In
this subsection:</text>
<subparagraph id="ID1b93651fe2f94649b6af43c31882cef4"><enum>(A)</enum><header>Administrator</header><text>The
term <term>Administrator</term> means the Administrator of the Tobacco
Regulatory Agency.</text>
</subparagraph><subparagraph id="ID77ada0600b694e19bb5eca0231ba42c3"><enum>(B)</enum><header>Indian
tribe</header><text>The term <term>Indian tribe</term> has the meaning given
such term in section 4(e) of the Indian Self Determination and Education
Assistance Act (25 U.S.C. 450b(e)).</text>
</subparagraph><subparagraph id="IDd4d3961a8b7a4ef48d8791fd510a874a"><enum>(C)</enum><header>Tribal
lands</header><text>The term <term>tribal lands</term> 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="IDb9cfb93960714798ae748ed732850eb5"><enum>(D)</enum><header>Tribal
organization</header><text>The term <term>tribal organization</term> has the
same meaning given such term in section 4(l) of the Indian Self Determination
and Education Assistance Act (25 U.S.C.
450b(l)).</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="IDb2099c7dcfda499db82a5396cba15833"><enum>203.</enum><header>Restrictions
on descriptors used in marketing of cigarettes</header>
<subsection id="IDa2b5242d8bc1426582f6180cc60054e1"><enum>(a)</enum><header>In
general</header><text>Except as provided in subsection (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 that is not located in an adult-only facility or is not
addressed solely to age-verified adults any of the following as a descriptor of
any cigarette brand style:</text>
<paragraph id="ID2f196b47bc42479ab995e9a00652374b"><enum>(1)</enum><text>The name of any
candy or fruit.</text>
</paragraph><paragraph id="IDea6e48ba5df941a19c1d73b62ee974fd"><enum>(2)</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>.</text>
</paragraph><paragraph id="ID5d53aad87ef14838982a91eb65cc1377"><enum>(3)</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
<quote>creamy</quote>, or <quote>fruity.</quote></text>
</paragraph></subsection><subsection id="ID8424317b6cc44555939702d293567991"><enum>(b)</enum><header>Limitation</header><text>Subsection
(a) shall not apply to the use of the following words or to any extension or
variation of any such words: <quote>clove</quote> and
<quote>menthol</quote>.</text>
</subsection><subsection id="IDf3d6b90acaf14e6d89e6105f422069e7"><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>
</subsection><subsection id="ID44bc7d0a4ba94af88eada959461aadc9"><enum>(d)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="ID99ed34440e7b4032a1c93cd53fa02765"><enum>(1)</enum><header>Candy</header><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>
</paragraph><paragraph id="ID3a7fc874839a488e92cd8f8c498bee39"><enum>(2)</enum><header>Fruit</header><text>The
term <term>fruit</term> means any fruit identified by generic name, type, or
variety, including <quote>apple</quote>, <quote>banana</quote>,
<quote>cherry</quote>, and <quote>orange</quote>. Such 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>
</paragraph></subsection></section><enum>III</enum><header>Reduced-exposure
and reduced-risk claims for tobacco products, and ranking of tobacco product
categories</header>
<section id="id81FC20A09E6C436C9B6EE861AC1C40D7"><enum>301.</enum><header>Prohibition of
unapproved reduced-exposure and reduced-risk claims</header>
<subsection id="idA882C23E19984B90B17BBD0E89C90532"><enum>(a)</enum><header>Prohibition of
unapproved reduced-exposure and reduced-risk claims</header><text display-inline="yes-display-inline">No person shall make, or cause to be made,
in any tobacco product labeling or advertising, a statement or other
representation regarding a tobacco product that is likely to be received and
understood by a significant number of objective, reasonable consumers as making
either a reduced-exposure claim or a reduced-risk claim, unless an application
regarding such claim with respect to such tobacco product has been approved in
accordance with this title and has not been withdrawn in accordance with this
title. Nothing in this Act shall be construed to restrict—</text>
<paragraph id="IDea6ddfec7e384fa8a4499f0ba30888be"><enum>(1)</enum><text>the full exchange
of scientific information concerning a tobacco product, including the
dissemination of scientific findings in scientific and lay media;</text>
</paragraph><paragraph id="ID531513606e34489e9edc9605616aa9b4"><enum>(2)</enum><text>communications
with employees, contractors, or suppliers;</text>
</paragraph><paragraph id="IDc34a4822c0054636a48f9cd71d0ae4d4"><enum>(3)</enum><text>communications to
a governmental entity, body, official, or employee;</text>
</paragraph><paragraph id="IDde43e33e187844d786a54dd106b4bae4"><enum>(4)</enum><text>communications
in, or in connection with, litigation or arbitration; or</text>
</paragraph><paragraph id="IDc1da4b81888446938525dc7cb3eb50f1"><enum>(5)</enum><text>communications to
securities holders.</text>
</paragraph><continuation-text continuation-text-level="subsection">No
liability under State law shall be imposed on the basis, wholly or in part, of
any statement or representation making a reduced-exposure claim or a
reduced-risk claim in a scientific or lay medium of communication (other than
advertising in such medium) or otherwise within the scope of paragraphs (1)
through (5).</continuation-text></subsection><subsection id="ID13db062e5b74440d928c8d5f928e3b8a"><enum>(b)</enum><header>Tobacco
products with no reduced-exposure or reduced-risk claim
unaffected</header><text>Nothing in this section shall be construed to prevent
any person from introducing into interstate commerce any tobacco product the
labeling and advertising of which do not make any statement or other
representation prohibited by subsection (a).</text>
</subsection><subsection id="ID749d011e0c7245e2bb5a0d890721c5be"><enum>(c)</enum><header>Nicotine-replacement
therapies</header><text>A product that is intended to be used as part of a
nicotine replacement therapy in the treatment of tobacco dependence, or as part
of a tobacco product cessation program, shall not be considered to be
either—</text>
<paragraph id="ID7bd1648d81f54bf586ab4005c4d21aa6"><enum>(1)</enum><text>a tobacco product
for which a reduced-exposure claim might be made; or</text>
</paragraph><paragraph id="ID3e9b55b4805441f08cf1ff0242ef73dc"><enum>(2)</enum><text>a tobacco product
for which a reduced-risk claim might be made.</text>
</paragraph></subsection></section><section id="IDe2c1b63d308c475cbc0574482124081c"><enum>302.</enum><header>Applications
for approval of reduced-exposure and reduced-risk claims</header><text display-inline="no-display-inline">A person may submit to the Administrator an
application for approval of a reduced-exposure claim or a reduced-risk claim
for a tobacco product as compared to 1 or more other reference products either
within the tobacco product category that includes the subject tobacco product
or in a tobacco product category that does not include the subject tobacco
product. Such an application shall contain the following:</text>
<paragraph id="ID2b7a98483daf4fe7ab02d1ee09edb228"><enum>(1)</enum><text>A complete
description, including the formulation, construction, and a full list of the
components, of the tobacco product for which the proposed reduced-exposure
claim or reduced-risk claim might be made.</text>
</paragraph><paragraph id="ID9663417b40454fc7aaae332563a1bff8"><enum>(2)</enum><text>The proposed
reduced-exposure or reduced-risk claim or claims for that tobacco
product.</text>
</paragraph><paragraph id="ID6911636afb1c449baa8f1edcc3b1c2a9"><enum>(3)</enum><text>Full reports of
investigations of the subject tobacco product, as compared to 1 or more other
tobacco products, with respect to—</text>
<subparagraph id="ID43a345c4775d4b2dab87df0d61d55c8c"><enum>(A)</enum><text>the chemical
compositions of the tobacco products (or of the smoke of the tobacco product if
the subject tobacco product is intended for smoking);</text>
</subparagraph><subparagraph id="IDb3644649a94e4a228ef583f6e68fa838"><enum>(B)</enum><text>the toxicological
and any other biological effects of the tobacco products (or of the smoke of
the tobacco product if the subject tobacco product is intended for smoking) in
laboratory test systems, animals, and humans; and</text>
</subparagraph><subparagraph id="id3D79885B51FE4AF28899636CA1830C46"><enum>(C)</enum><text>human behavior in
the use of the tobacco products; and</text>
</subparagraph></paragraph><paragraph id="IDe0056db7cde34faba72fc3d76962312a"><enum>(4)</enum><text>Such samples of
the tobacco product as the Administrator may request.</text>
</paragraph></section><section id="id99488E158C674912AF03531B505B69F5"><enum>303.</enum><header>Standards for
approval of applications for reduced-exposure or reduced-risk claims</header>
<subsection id="ID918de16d2e7e4fa99afdbe3d7a2be800"><enum>(a)</enum><header>Standards for
approval of reduced-exposure claims</header><text>The Administrator shall
approve an application submitted under section 302 for a reduced-exposure
claim, as originally submitted or as modified, if the Administrator finds each
of the following:</text>
<paragraph id="ID6df75e473bab41a1b01ebe79a309aeaf"><enum>(1)</enum><text>That the subject
tobacco product (or the smoke from the subject tobacco product, if the subject
tobacco product is intended for smoking, when evaluated under not more than 2
machine-smoking regimens), yields a reduced amount of 1 or more toxicants when
compared to an appropriate reference tobacco product or products.</text>
</paragraph><paragraph id="IDc95ad4907202422fa5060fc840af6d10"><enum>(2)</enum><text>That the subject
tobacco product, when evaluated under conditions of actual use by
tobacco-product users, presents a reduced exposure to 1 or more toxicants when
compared to an appropriate reference tobacco product or products, as
demonstrated by—</text>
<subparagraph id="IDe1994a64eb11430fa32c4b3d5ffcfd8c"><enum>(A)</enum><text>data on smoking
behavior or other behavior in the use of the tobacco product, as applicable, by
users of the tobacco product;</text>
</subparagraph><subparagraph id="ID85fa6e11471343c3b607b7d60702d620"><enum>(B)</enum><text>data showing a
statistically significant reduction of at least 1 toxicant biomarker, or other
scientifically validated indicator of toxicant exposure; and</text>
</subparagraph><subparagraph id="ID0f2bbbedcfe84f35a53288674e311cb3"><enum>(C)</enum><text>data showing
either—</text>
<clause id="ID014344569dd6443dabb32d70f968aaf6"><enum>(i)</enum><text>no
statistically significant increase in exposure to any toxicant or in any
biomarker of toxicant exposure; or</text>
</clause><clause id="IDa031e52389654a218260e391f0714899"><enum>(ii)</enum><text>that any
statistically significant increase in exposure to any toxicant or in any
toxicant biomarker of exposure does not pose a significant risk of increasing
morbidity or mortality of users of the tobacco product.</text>
</clause></subparagraph></paragraph><paragraph id="IDb1cb148b72284ecab6a272701c087a9e"><enum>(3)</enum><text>That there is a
sufficiently persuasive scientific rationale to justify a reasonable
expectation, among qualified experts, that the reduction in exposure to 1 or
more toxicants would result in a meaningful reduction of morbidity or
mortality, as supported by—</text>
<subparagraph id="ID38cc4e21ecf64fd98455b2cda31ecdc7"><enum>(A)</enum><text>biologically
meaningful quantitative risk assessment data;</text>
</subparagraph><subparagraph id="ID3fc5abe8ac6940a2b63fbe9a89a3277c"><enum>(B)</enum><text>biologically
meaningful pre-clinical toxicology data; or</text>
</subparagraph><subparagraph id="ID04973a7a7feb47469a5f5b6f693e9343"><enum>(C)</enum><text>biologically
meaningful data from short-term studies in users of tobacco products.</text>
</subparagraph></paragraph><paragraph id="IDa6fb3c8026dd44bd8e0aab08ba168a6a"><enum>(4)</enum><text>That there is a
sufficiently persuasive scientific rationale to justify a reasonable
expectation, among qualified experts, that use of the subject tobacco product
by tobacco-product users would not result in a statistically significant
increase in biological activity when compared to an appropriate reference
tobacco product or products, as supported by—</text>
<subparagraph id="ID9059c32310dc4332923522bc38723447"><enum>(A)</enum><text>biologically
meaningful quantitative risk assessment data;</text>
</subparagraph><subparagraph id="ID51948db322b64740a27f32d6eff6958b"><enum>(B)</enum><text>biologically
meaningful pre-clinical toxicology data; or</text>
</subparagraph><subparagraph id="IDab8f8811e53f446cbc5fde0f4ce1f84a"><enum>(C)</enum><text>biologically
meaningful data from short-term studies in users of tobacco products.</text>
</subparagraph></paragraph></subsection><subsection id="ID7fb595808af74a1588dc3acb966ded8a"><enum>(b)</enum><header>Standards for
approval of reduced-risk claims</header><text>The Administrator shall approve
an application submitted under section 302 for a reduced-risk claim, as
originally submitted or as modified, if the Administrator makes each of the
findings required by paragraphs (1) through (4) of subsection (a) and finds
that an epidemiologic study or other human studies lead to significant
scientific agreement that—</text>
<paragraph id="ID0b21ecb0ce4646b5b3aff0b9bc0b311a"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idD5EAB173E30A4D81B7F4B782CA8CD944"><enum>(A)</enum><text>the totality of
available scientific evidence warrants the conclusion that the subject tobacco
product, when compared to an appropriate reference tobacco product or products,
provides a meaningful reduction of 1 or more chronic diseases or serious
adverse health conditions associated with tobacco use; or</text>
</subparagraph><subparagraph id="ID4300e1cb4edd404388c6b2ba6c6e02cb" indent="up1"><enum>(B)</enum><text>the totality of the available
scientific evidence shows—</text>
<clause id="ID67b6472e6f4c44b09b93289916dce0f5"><enum>(i)</enum><text>that actual use of the subject
tobacco product by users of tobacco products, as compared to actual use of an
appropriate reference tobacco product or products by users of tobacco products,
results in an altered intake of an appropriately identified and measured
substance; and</text>
</clause><clause id="ID84840d088375412fa94614daed98e89c"><enum>(ii)</enum><text>that the change in intake from the
use of the subject tobacco product results in a meaningful reduction in a valid
measure of chronic disease or serious adverse health condition associated with
tobacco use; and</text>
</clause></subparagraph></paragraph><paragraph id="IDe2ff6e712cc147e0a16f1a0ca980fdb0"><enum>(2)</enum><text>the validity of
the anticipated reduction in 1 or more tobacco-related diseases or adverse
health conditions is not likely to be reversed by new and evolving
science.</text>
</paragraph></subsection></section><section id="ID9e7a4469f1744d209a6fcd033eab13db"><enum>304.</enum><header>General
provisions</header>
<subsection id="IDc434d148efb640febfb8e2209f409802"><enum>(a)</enum><header>Confidentiality
of applications</header><text>The Administrator shall treat the content of all
applications submitted under section 302 as confidential.</text>
</subsection><subsection id="IDb86a5cbf3b0f4be5bfa5e2fbc059e3c4"><enum>(b)</enum><header>Referral to
advisory committee</header><text>The Administrator may refer an application
submitted under section 302 to an Advisory Committee having expertise in 1 or
more of the fields of biological science, medicine, statistics, or other
discipline relevant to the review of the application.</text>
</subsection><subsection id="ID3a3866792bb842a9bf966c8e51cce592"><enum>(c)</enum><header>Action on an
application</header>
<paragraph id="id807D6AFAA364463B8DEBB1006F220828"><enum>(1)</enum><header>In
general</header><text>Not later than 180 days after the receipt of an
application under section 302, or such additional period as may be agreed upon
by the Administrator and the applicant, after consultation with appropriate
technical experts of the Food and Drug Administration, the Federal Trade
Commission, and the Centers for Disease Control and Prevention, the
Administrator shall—</text>
<subparagraph id="ID30495a8c19414f5fbc8ef7b8528c9305"><enum>(A)</enum><text>approve the
application as initially submitted or as modified; or</text>
</subparagraph><subparagraph id="IDaf817f1421e741eb94883215b32025c5"><enum>(B)</enum><text>refuse to approve
the application as initially submitted or as modified, provide a detailed
written statement of the reasons for such refusal, and give the applicant
notice of an opportunity for a hearing on the record before the Administrator
on the question whether such application is approvable.</text>
</subparagraph></paragraph><paragraph id="id068AE51CBE8C4F5589BA09ABD55EB918"><enum>(2)</enum><header>Hearing on
disapproval</header><text>If an applicant accepts the opportunity for a hearing
under paragraph (1)(B) by written request submitted not later than 30 days
after notice of such opportunity is received by the applicant, such hearing
shall commence not later than 90 days after the expiration of such 30-day
period unless the Administrator and the applicant otherwise agree. Any such
hearing shall thereafter be conducted on an expedited basis, and the
Administrator’s order thereon shall be issued not later than 90 days after the
date fixed by the Administrator for the filing of final briefs or for the final
hearing.</text>
</paragraph></subsection><subsection id="IDdec93de6541b4d1d8463cb2f6bba3938"><enum>(d)</enum><header>Post-market
surveillance and studies</header><text>The Administrator shall require that an
applicant under this title whose application has been approved conduct
post-market surveillance and studies of the tobacco product that is the subject
of the approved application, unless the Administrator finds that the
information likely to result from such surveillance or studies is not likely to
be useful for the protection of the public health.</text>
</subsection><subsection id="ID70974b47886f4f0d80302476057e5736"><enum>(e)</enum><header>Withdrawal of
approval</header><text>The Administrator, after due notice and an opportunity
for a hearing on the record before the Administrator, shall withdraw the
approval of an application under this title if the Administrator determines
that—</text>
<paragraph id="IDf010f8cb5c48420caffe985033263767"><enum>(1)</enum><text>new evidence not
contained in such application or not available to the Administrator until after
such application was approved, or evidence from tests by new methods, or tests
by methods not deemed reasonably applicable when such application was approved,
evaluated together with the evidence available to the Administrator when the
application was approved, demonstrates that there is a lack of adequate support
for the findings necessary for the approval of the application;</text>
</paragraph><paragraph id="IDfa58b74b577a4058830650c55eeba3f3"><enum>(2)</enum><text>the applicant
knowingly or recklessly failed to include material information in the
application, or the application included any untrue statement of material fact
by the applicant; or</text>
</paragraph><paragraph id="IDeb20a205bacf4ad287314be0b4ca3aba"><enum>(3)</enum><text>the applicant
failed to conduct, or to submit reports on, post-market surveillance or studies
as required under this section.</text>
</paragraph></subsection><subsection id="ID788e23a71fa54691928c6c9c9426961d"><enum>(f)</enum><header>Judicial
review</header>
<paragraph id="idB116DC67D09242EA93B0E60AA844EF31"><enum>(1)</enum><header>In
general</header><text>An applicant may appeal an order of the Administrator
refusing or withdrawing approval of an application under this title in
accordance with this subsection.</text>
</paragraph><paragraph id="id17B7CEADF56F4CAF87AB868F24807F28"><enum>(2)</enum><header>Filing</header><text>An
appeal under this subsection shall be make by filing in the United States court
of appeals for the circuit wherein the applicant resides or wherein the
principal place of business of such applicant is located, or in the United
States Court of Appeals for the District of Columbia Circuit, not later than 60
days after the date on which such order was entered, a written petition seeking
that the order of the Administrator be set aside. A copy of such petition shall
be transmitted forthwith by the clerk of the court to the Administrator, or any
officer designated by the Administrator for that purpose, and thereupon the
Administrator shall certify and file in the court the record upon which the
order complained of was entered, as provided in section 2112 of title 28,
United States Code.</text>
</paragraph><paragraph id="id6B8E102F51864817AE08BA78303CABC2"><enum>(3)</enum><header>Jurisdiction</header><text>Upon
the filing of a petition under paragraph (2), the court involved shall have
exclusive jurisdiction to affirm or set aside the order that is the subject of
the petition, except that until the filing of the record the Administrator may
modify or set aside the order that is being appealed.</text>
</paragraph><paragraph id="idE4A40876F97644E193827CEDC517CEBD"><enum>(4)</enum><header>Administrative
provisions</header><text>No objection to the order of the Administrator shall
be considered by the court under this subsection unless such objection shall
have been urged before the Administrator or unless there were reasonable
grounds for failure so to do. The findings of the Administrator as to the
facts, if supported by substantial evidence, shall be conclusive. If any person
shall apply to the court for leave to adduce additional evidence, and shall
show to the satisfaction of the court that such additional evidence is material
and that there were reasonable grounds for failure to adduce such evidence in
the proceeding before the Administrator, the court may order such additional
evidence to be taken before the Administrator and to be adduced upon the
hearing in such manner and upon such terms and conditions as to the court may
seem proper. The Administrator may modify his or her findings as to the facts
by reason of the additional evidence so taken, and the Administrator shall file
with the court such modified findings which, if supported by substantial
evidence, shall be conclusive, and the Administrator’s recommendation, if any,
for the setting aside of the original order.</text>
</paragraph><paragraph id="id3D482533761D4691A668B97E320FD282"><enum>(5)</enum><header>Judgment</header><text>The
judgment of the court affirming or setting aside any order of the Administrator
under this subsection shall be final, subject to review by the Supreme Court of
the United States upon certiorari or certification as provided for in section
1254 of title 28, United States Code.</text>
</paragraph><paragraph id="id82B2FCC2C53748EABD32656A86C73CCF"><enum>(6)</enum><header>Limitation</header><text>The
commencement of proceedings under this subsection shall not, unless
specifically ordered by the court to the contrary, operate as a stay of the
Administrator’s order.</text>
</paragraph></subsection><subsection id="ID19ce7ca51e7747498f6b0aed25a38a4d"><enum>(g)</enum><header>Regulations</header><text>Not
later than 24 months after the effective date of this Act, the Administrator
shall promulgate regulations governing, among other things—</text>
<paragraph id="IDd24b389e9ba74aac95707f6bef99be9a"><enum>(1)</enum><text>the content of an
application under section 302;</text>
</paragraph><paragraph id="ID33328984358b4bedb873603226eb742a"><enum>(2)</enum><text>the procedures
for amending or supplementing such an application;</text>
</paragraph><paragraph id="ID10b30ad35f2a4e3ab2d47f140fafcd25"><enum>(3)</enum><text>the procedures
for the Administrator to approve, approve with modifications, or refuse to
approve applications submitted under section 302;</text>
</paragraph><paragraph id="IDead52dde18324ec8b38fb4b6b5f22c78"><enum>(4)</enum><text>the design of,
conduct of, recordkeeping on, and reporting on post-market surveillance and
studies under this section; and</text>
</paragraph><paragraph id="IDf9f590d0fdd64ffc8711035f51f00f50"><enum>(5)</enum><text>post-approval
reporting by holders of approved applications.</text>
</paragraph></subsection><subsection id="ID0b6fbfeda8fc4dc09a9583438490ed80"><enum>(h)</enum><header>Limitation</header><text>Nothing
in this Act shall be construed to require a tobacco product manufacturer to
investigate, evaluate, develop, or pursue the marketing of any tobacco product
for which a reduced-exposure claim or a reduced-risk claim might be made.
Except as otherwise provided in this section, nothing in this Act shall be
construed to require a tobacco product manufacturer to supply any information,
data, or technology to the Administrator regarding the development or
properties of any tobacco product for which a reduced-exposure claim or
reduced-risk claim might be made.</text>
</subsection></section><section id="IDf12f3e0d4bee4938aedab8386ab4494c"><enum>305.</enum><header>Establishment
of rankings</header>
<subsection id="ID6e151b7b1d4b44199eeb23142a9c7853"><enum>(a)</enum><header>Standards and
procedures for rankings</header><text>Not later than 24 months after the
effective date of this Act, the Administrator shall, by regulation and 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 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 nicotine-containing products respectively
present:</text>
<paragraph id="IDd74fdab9801845b0ba8f8d956ce556db"><enum>(1)</enum><text>Cigarettes.</text>
</paragraph><paragraph id="ID46fe3c07bdb24f479d76f9b96f644da7"><enum>(2)</enum><text>Loose tobacco for
roll-your-own tobacco products.</text>
</paragraph><paragraph id="ID4d1ba057336b4725bdf92b69bc9e4414"><enum>(3)</enum><text>Little
cigars.</text>
</paragraph><paragraph id="ID1ff713a8c9274dd1866a90ebfe66aff4"><enum>(4)</enum><text>Cigars.</text>
</paragraph><paragraph id="IDdd05771788f94250ad45ef46c2f4b7b5"><enum>(5)</enum><text>Pipe
tobacco.</text>
</paragraph><paragraph id="ID7a3238ac151648fcaad9f408fe695219"><enum>(6)</enum><text>Moist
snuff.</text>
</paragraph><paragraph id="IDf60531e38be248dbbae40e561eed5737"><enum>(7)</enum><text>Dry snuff.</text>
</paragraph><paragraph id="IDa37d86c98c2d4ee8bdcdc28220995534"><enum>(8)</enum><text>Chewing
tobacco.</text>
</paragraph><paragraph id="ID85ea9d1c5f144021abd9f5d8cfa3ed54"><enum>(9)</enum><text>Other forms of
tobacco products, including pelletized tobacco and compressed tobacco, treated
collectively as a single category.</text>
</paragraph><paragraph id="ID210280864c424a958a9c278076612517"><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
categories specified in paragraphs (1) through (10).</continuation-text></subsection><subsection id="IDeda74aad095a49208407f79505d56e4f"><enum>(b)</enum><header>Considerations
in promulgating regulations</header><text>In promulgating regulations under
this section, the Administrator—</text>
<paragraph id="ID085c2891f3c044e8aa7c672e8b271137"><enum>(1)</enum><text>shall take into
account relevant epidemiologic studies and other relevant competent and
reliable scientific evidence; and</text>
</paragraph><paragraph id="IDd268121a4dcb49e38c1dde6c36c431a2"><enum>(2)</enum><text>shall, in
assessing the risks of serious or chronic tobacco-related diseases and adverse
health conditions presented by a particular category, consider the range of
tobacco products or nicotine-containing products within the category, and give
appropriate weight to the market shares of the respective products in the
category.</text>
</paragraph></subsection><subsection id="ID104e72da56d9451dab3ec2a05bada554"><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 such 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,
2011. Thereafter, on an annual basis, the Administrator shall, by order,
promulgate to the general public updated rankings that—</text>
<paragraph id="id9E9C868280D944B9897E10930DACD50E"><enum>(1)</enum><text>are in accordance
with such regulations; and</text>
</paragraph><paragraph id="id1C9AE070121745CD8AB961C844846C5A"><enum>(2)</enum><text>reflect the
scientific evidence available at the time of promulgation.</text>
</paragraph><continuation-text continuation-text-level="subsection">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.</continuation-text></subsection></section><section id="ID0f1858a3d14f4c59b92def4f304ea606"><enum>306.</enum><header>Compulsory
licensing</header>
<subsection id="ID790af42145124dc897f16538aab75e34"><enum>(a)</enum><header>Grant of
license</header><text>A person that owns intellectual property rights to any
technology that is the basis for the approval of a reduced-risk claim for a
brand style of cigarettes under section 304(c) shall, to the fullest extent of
such rights, license to any licensee any and all such rights to the technology
that are needed to make, use, and sell in the United States cigarettes
incorporating such technology, if the licensee—</text>
<paragraph id="ID9026d6d639e04dc0b20c946784e217f0"><enum>(1)</enum><text>is incorporated
within the United States;</text>
</paragraph><paragraph id="ID88c2de74894742bd9e08fc33e3996aa5"><enum>(2)</enum><text>requests such a
license; and</text>
</paragraph><paragraph id="IDbffd0c4538924a1b9882cc2e8e743ea6"><enum>(3)</enum><text>agrees to
commercially reasonable terms, including payment of a commercially reasonable
fee, which fee shall take into account the costs of development and testing, as
well as the value, of any associated intellectual property rights or
protection.</text>
</paragraph></subsection><subsection id="ID0798719153b24268accadaed50aeca25"><enum>(b)</enum><header>Binding
arbitration</header><text>The parties shall submit to binding arbitration any
dispute regarding the terms of a license provided under subsection (a).</text>
</subsection><subsection id="ID5ac71a9f8c9c48c7aed236ca25c30742"><enum>(c)</enum><header>Limitation on
license</header><text>This section shall not apply to any technology that is
not, in whole or in part, necessary to the approval of a reduced-risk claim for
a brand style of cigarettes under section 304(c).</text>
</subsection></section><section id="ID230303f6469b4f528cb366aab30c81e9"><enum>307.</enum><header>Moist snuff
warnings</header><text display-inline="no-display-inline">Not later than 24
months after the effective date of this Act, the Administrator, after
consultation with an Advisory Committee, shall review the warning labels
required to appear on packages of moist snuff products under section 3 of the
Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4402)
in light of current population-based science, and shall make a recommendation
to the Secretary and Congress as to whether the contents of the warning labels
are accurate and are supported by current scientific data and whether the
labels convey to users of tobacco products information that is truthful and not
misleading, and that assists users of tobacco products in comparing the health
risks presented by moist snuff products with the health risks presented by
cigarettes and other types of tobacco products.</text>
</section><enum>IV</enum><header>Disclosures to
the Agency regarding tobacco products</header>
<section id="IDf041d750efcb4c5ba58fcc11f3581c65"><enum>401.</enum><header>Confidential
disclosures to the Agency</header>
<subsection id="IDb9deb554dbec4e2cb461830bfac78691"><enum>(a)</enum><header>Annual reports
by manufacturers</header><text>Not later than September 1, 2009, and each
September 1 thereafter, each tobacco product manufacturer shall submit to the
Administrator, as to each brand style it manufactures for commercial
distribution domestically, a list of the ingredients added to tobacco in the
manufacture of that brand style, without regard to the quantity used, and
including, separately, each spice, each natural or artificial flavoring, and
each preservative used in the brand style. In each such list, each ingredient
shall be listed by its chemical name and chemical abstract service registry
number, if available, or, if not available, by its common or usual name. The
ingredients shall be listed in descending order of predominance by weight,
measure, or numerical count.</text>
</subsection><subsection id="IDce821f0158504b24a764ae75f154497d"><enum>(b)</enum><header>Evaluation by
the Administrator</header>
<paragraph id="id6277218D75B0436191AEFE2FB7D65DDE"><enum>(1)</enum><header>In
general</header><text>At such times as the Administrator considers appropriate,
the Administrator shall request that technical experts of the Food and Drug
Administration and the Centers for Disease Control and Prevention review and
comment on the information provided under subsection (a), with respect
to—</text>
<subparagraph id="idAAA64975287346AD9C69AA972EC70683"><enum>(A)</enum><text>a summary
of—</text>
<clause id="idF5F94FB4A9FB44BB8354878E7CF63E55"><enum>(i)</enum><text>current
scientific data pertaining to the health effects of the ingredients added to
tobacco in the manufacture of tobacco products; and</text>
</clause><clause id="id9C5D6D19026047589AD9E5873CD62F0D"><enum>(ii)</enum><text>any proposed
additional research activities on such health effects; and</text>
</clause></subparagraph><subparagraph id="id3D62443F4DB54D04B46B62076E7C027A"><enum>(B)</enum><text>information
pertaining to any such ingredient that in the judgment of technical experts of
the Food and Drug Administration or the Centers for Disease Control and
Prevention meaningfully increases the health risk or risks presented to users
of tobacco products containing such ingredient.</text>
</subparagraph></paragraph><paragraph id="id8EA65C6DBD01458995AA820F2AB121DD"><enum>(2)</enum><header>Confidential
information</header><text>Except for information required to be disclosed in
accordance with any of sections 601 through 603, all information submitted
under subsection (a) and provided to technical experts of the Food and Drug
Administration or to the Centers for Disease Control and Prevention shall be
treated as trade secret or confidential commercial information subject to
section 552 (b)(4) of title 5, United States Code, and section 1905 of title
18, United States Code, and shall not be revealed, to any person other than
those authorized by the Administrator in carrying out their official duties
under this section.</text>
</paragraph></subsection><subsection id="ID5dca6b3295f141f5a6d24c4a9df9210c"><enum>(c)</enum><header>Reports by the
Administrator</header>
<paragraph id="idB1154EFBEA794B8EB5562A9B85852B0F"><enum>(1)</enum><header>In
general</header><text>At such times as the Administrator considers appropriate,
the Administrator shall transmit to the Congress a report, based on the
information provided under subsection (a), containing—</text>
<subparagraph id="id957E82B2CFB24EB98304053B12CD9032"><enum>(A)</enum><text>a summary of
research activities and proposed research activities on the health effects of
ingredients added to tobacco in the manufacture of tobacco products and the
findings of such research;</text>
</subparagraph><subparagraph id="idE883A8CA0FB141FBA3BF8B28F5739AD4"><enum>(B)</enum><text>information
pertaining to any such ingredient that in the judgment of the Administrator
meaningfully increases the health risk or risks presented to users of tobacco
products containing such ingredient, and</text>
</subparagraph><subparagraph id="idDEBCCE64856C4705B2A90ED6A7493EF7"><enum>(C)</enum><text>any other
information, other than trade secrets and confidential commercial information,
the inclusion of which the Administrator determines to be in the public
interest.</text>
</subparagraph></paragraph><paragraph id="idEBCE8CDD9F1A44E99249979EAC222B06"><enum>(2)</enum><header>Confidential
information</header>
<subparagraph id="id3EDC8037E37F477CA0D19C78C5D5C9B3"><enum>(A)</enum><header>In
general</header><text>Except for information required to be disclosed in
accordance with sections 601 through 603, all information provided to the
Administrator under paragraph (1) shall be treated as trade secret or
confidential commercial information subject to section 552 (b)(4) of title 5,
United States Code, and section 1905 of title 18, United States Code, and shall
not be revealed, to any person other than those authorized by the Administrator
in carrying out their official duties under this section.</text>
</subparagraph><subparagraph id="idE2548272FCB0402792763B7D48CF5485"><enum>(B)</enum><header>Limitation</header><text>Subparagraph
(A) shall not be construed to authorize the withholding of a list provided
under subsection (a) from any duly authorized subcommittee or committee of the
Congress. If a subcommittee or committee of the Congress requests the
Administrator to provide it such a list, the Administrator shall make the list
available to the subcommittee or committee and shall, at the same time, notify
in writing the tobacco product manufacturer that provided the list of such
request.</text>
</subparagraph><subparagraph id="id30B636B08F454DF5B11F11B17FF89C27"><enum>(C)</enum><header>Procedures</header><text>The
Administrator shall establish written procedures to assure the confidentiality
of information provided under paragraph (1). Such procedures shall include the
designation of a duly authorized agent to serve as custodian of such
information. The agent shall—</text>
<clause id="id45C9881F7EAF4674B0FB9312CE560A82"><enum>(i)</enum><text>take physical
possession of the information and, when such information is not in use by a
person authorized to have access to it, shall store such information in a
locked cabinet or file; and</text>
</clause><clause id="idB9691BDEFC064619A8921F65E9D184BF"><enum>(ii)</enum><text>maintain a
complete record of all persons that inspect or use the information.</text>
</clause><continuation-text continuation-text-level="subparagraph">Such
procedures shall require that any person permitted access to the information
shall be instructed in writing not to disclose the information to anyone who is
not entitled to have access to the information.</continuation-text></subparagraph></paragraph></subsection><subsection id="IDd93c7c30706a4ee18fd3f4ca3640d638"><enum>(d)</enum><header>Inclusion of
nicotine yield ratings of cigarettes</header><text>Not later than September 1,
2009, and each September 1 thereafter, each tobacco product manufacturer of
cigarettes shall include in its annual report submitted in accordance with
subsection (a), for each brand style of cigarettes it manufactures for
commercial distribution domestically, nicotine yield ratings determined in
accordance with the standards established under section 402.</text>
</subsection><subsection id="ID89af68cac26246709a481f8807e5a7d7"><enum>(e)</enum><header>Inclusion of
nicotine information relating to smokeless tobacco products</header><text>Not
later than September 1, 2009, and each September 1 thereafter, each tobacco
product manufacturer of a smokeless tobacco product shall include in its annual
report submitted in accordance with subsection (a), for each brand style of
smokeless tobacco product it manufactures for commercial distribution
domestically, nicotine information determined in accordance with the standards
established under section 403.</text>
</subsection></section><section id="ID58fed5f8259a405db71755d5a5fc88fd"><enum>402.</enum><header>Nicotine
reporting requirements for cigarettes</header>
<subsection id="id3AE6400F1C6C43BCB5BFC2DA9530E469"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The testing of
cigarettes for purposes of this title shall comply with this section.</text>
</subsection><subsection id="ID2a5dd5ebf1e049e89fb1258076bea7c6"><enum>(b)</enum><header>Selection of
cigarettes for testing</header><text>Cigarettes of each brand style tested
shall be randomly selected from cigarette packages obtained from the
manufacturing facility of the tobacco product manufacturer.</text>
</subsection><subsection id="IDd1e215f963784e80a87cf062e216468d"><enum>(c)</enum><header>Brand styles
identical in composition</header><text>For purposes of this section, if a brand
style of cigarettes is identical to 1 or more other brand styles of cigarettes,
except for brand name designation and other aspects not affecting the physical
or chemical composition or performance of the cigarettes, then, for purposes of
this section, those brand styles shall be treated as if they were a single
brand style, and the cigarette manufacturer shall be required to test only 1 of
those brand styles in lieu of testing all such brand styles. The cigarette
manufacturer shall specify in its annual report to the Administrator under
section 401(c) the brand styles covered by the results with respect to the
brand style tested.</text>
</subsection><subsection id="IDd78d013d9728406ca44bd3789d7b42b6"><enum>(d)</enum><header>Machine-smoking
regimens</header>
<paragraph id="idC1FD117344C64CF292EF4D6F8A472739"><enum>(1)</enum><header>Regulations</header><text>Not
later than December 31, 2010, the Administrator shall, by regulation, establish
not more than 2 machine-smoking regimens for determining the yield of nicotine
from each brand style of cigarettes manufactured for commercial distribution
domestically.</text>
</paragraph><paragraph id="ID7725d3309df54dd5b1a28d76c1ad7ead"><enum>(2)</enum><header>Conditioning</header><text>Cigarettes
to be tested under this subsection shall be conditioned in accordance with ISO
3402:1999, entitled <quote>Tobacco and tobacco products—Atmosphere for
conditioning and testing.</quote></text>
</paragraph><paragraph id="IDe06559e13b484a5ab9cc725ccc09a24f"><enum>(3)</enum><header>Testing
trials</header><text>In establishing either 1 or 2 smoking regimens, the
Administrator shall mandate and coordinate interlaboratory, collaborative
testing trials to verify the suitability and ruggedness of the smoking regimen
or regimens.</text>
</paragraph><paragraph id="ID52d13451ad324c3d9149c27e2399578e"><enum>(4)</enum><header>Meaningful
change in nicotine yield</header><text>On the basis of the interlaboratory
testing trials, the Administrator shall determine, as to each regimen, the
magnitude of change in a measured value that constitutes a meaningful change in
the nicotine yield of a cigarette.</text>
</paragraph><paragraph id="ID2dfcca77a08646c19acb86e35869f0a8"><enum>(5)</enum><header>Nicotine yield
values</header><text>The regulations promulgated under this subsection shall
require that cigarette manufacturers report all nicotine yield values to a
number of decimal places consistent with the established value for a meaningful
change in the nicotine yield of a cigarette and in light of any limitations
associated with the smoking regimen.</text>
</paragraph><paragraph id="ID58dd7d96a9c84282912e956d1568884f"><enum>(6)</enum><header>Requirement of
regimen</header><text>One of the 2 smoking regimens for establishing the yield
of nicotine from each brand style of cigarettes shall be the ISO smoking
regimen. When testing a brand style with the ISO smoking regimen, 20 channels
of 5 cigarettes per channel shall be smoked using a linear smoking
machine.</text>
</paragraph><paragraph id="ID83e78ab6a7f34255b7fc9b5e17dd3d8b"><enum>(7)</enum><header>Alternative
regimen</header><text>The other regimen, if established by the Administrator,
shall be the ISO testing regimen modified as follows:</text>
<subparagraph id="ID6672e40ec0c84153a993c10028c1f806"><enum>(A)</enum><text>Puff volume shall
be adjusted to 45 milliliters.</text>
</subparagraph><subparagraph id="IDfebe440465aa40548551ff91f8efa556"><enum>(B)</enum><text>Puff interval
shall be adjusted to 30 seconds.</text>
</subparagraph><subparagraph id="ID3aadcb7a375040b6b8e782892069d9ef"><enum>(C)</enum><text>Puff duration
shall remain 2 seconds.</text>
</subparagraph><subparagraph id="IDcf71f83c73a747e2beaa58544ae08bea"><enum>(D)</enum><text>50 percent of the
ventilation holes shall be blocked by the design of the cigarette holding
device, placement of adhesive tape over 50 percent of the circumference of the
cigarette filter to block ventilation holes present, or by another method
approved by the Administrator.</text>
</subparagraph><subparagraph id="IDfa1cac31c6ea44489bd095f6bf4b3b92"><enum>(E)</enum><text>20 channels of 3
cigarettes per channel shall be smoked using a linear smoking machine.</text>
</subparagraph></paragraph></subsection><subsection id="ID84f19ef73a7b4539acfa14b6bd1cbc5b"><enum>(e)</enum><header>Aspects of
cigarettes To be determined</header><text>For each brand style of cigarettes
that is tested under this section, nicotine content and other aspects shall be
determined as follows:</text>
<paragraph id="ID80be91d0f74349e0bcef37f1281d5448"><enum>(1)</enum><text>Total nicotine
content of the cigarette, reported in milligrams of nicotine, shall be
determined using the protocol for measuring nicotine content in tobacco as
described in—</text>
<subparagraph id="ID3d19a8f7a53f494fb7fed094c1435156"><enum>(A)</enum><text>the rules
published on May 2, 1997, at pages 24115 and 24116 of volume 62 of the Federal
Register (Protocol for Analysis of Nicotine, Total Moisture, and pH in
Smokeless Tobacco Products); or</text>
</subparagraph><subparagraph id="ID6bb8688d40f64558901d4cc08456f6b8"><enum>(B)</enum><text>the colorimetric
technique identified as CORESTA Recommended Method No. 35 (Determination of
total alkaloids (as nicotine) in tobacco by continuous flow analysis).</text>
</subparagraph><continuation-text continuation-text-level="paragraph">In measuring
nicotine content, the cigarette manufacturer shall use the following sampling
method: Two cigarettes shall be randomly selected from each pack and
conditioned, the tobacco rod split open, and the cigarette tobacco mixed
thoroughly before weighing. The minimum sample size shall be 100 grams of
tobacco. If the weight of the tobacco is less than 100 grams, sufficient
additional cigarettes shall be randomly selected from each pack to achieve the
minimum sample size.</continuation-text></paragraph><paragraph id="IDf3df85abf4c340f0b222811c03cdde7b"><enum>(2)</enum><text>Percent filter
tip ventilation, defined as the amount of air dilution in the whole smoke
provided by the perforations in the cigarette filter, described in percent,
shall be determined in accordance with the current version of ISO 6565:2002,
entitled <quote>Tobacco and tobacco products—Draw resistance of cigarettes and
pressure drop of filter rods—Standard conditions and measurement</quote>. Two
cigarettes shall be randomly selected from each sampled pack, conditioned, and
tested for percent filter ventilation. The average percent filter ventilation
shall be computed for a sample of 60 cigarettes obtained in the manner
described in subsection (b).</text>
</paragraph><paragraph id="ID0ae64e55dd414b828442505f3e7bf490"><enum>(3)</enum><text>For 3 brand
styles of cigarettes selected by the Administrator from each brand family that
has a national market share of 3.0 percent or greater, as reported in the most
recent (published not later than December 31 of the year preceding the
reporting deadline) Maxwell Report, “Cigarette Brand Sales and Market Share”
published by Davenport and Company, Richmond, Virginia, or a comparable report
designated by the Administrator, pH of cigarette smoke shall be determined on a
puff-by-puff basis, in accordance with the method described in Harris, J.L.,
and Hayes, L.E., <quote>A method for measuring the pH of whole smoke</quote>,
Tobacco Science, 1977: 60: 81–83, or the method described in Sensabaugh, A.J.,
Jr., and Cundiff, R.H., <quote>A New Technique for Determining the pH of Whole
Tobacco Smoke</quote>, Tobacco Science, 1967: 11:25–30, and Brunnemann, K.D.
and Hoffmann, D., <quote>The pH of Tobacco Smoke</quote>, Food, Cosmet.
Toxical., 1974:112:115.</text>
</paragraph></subsection><subsection id="IDf9779eba954a43cf84fc3eeae55eb297"><enum>(f)</enum><header>Classification
of nicotine yield ratings</header><text>Nicotine yield ratings reported in the
annual report in accordance with section 401(a) shall be classified by the
cigarette manufacturer on the basis of the larger of the 2 nicotine yield
testing results produced under subsection (d) and in accordance with the
following standards:</text>
<paragraph id="ID44d4db4d42d640e6be33d4993a08cf9f"><enum>(1)</enum><text><quote>High
Nicotine</quote>: cigarettes yielding more than 1.2 milligrams per
cigarette.</text>
</paragraph><paragraph id="IDba50dda23d254931909b7f47cf4f7c22"><enum>(2)</enum><text><quote>Moderate
Nicotine</quote>: cigarettes yielding more than 0.2 and less than or equal to
1.2 milligrams per cigarette.</text>
</paragraph><paragraph id="ID62c47743d6f74c8e866c1d18c6dbad0e"><enum>(3)</enum><text><quote>Low
Nicotine</quote>: cigarettes yielding more than or equal to 0.01 and less than
or equal to 0.2 milligrams per cigarette.</text>
</paragraph><paragraph id="IDa1d90d25d5b64f978a9e6a5dd9d2224c"><enum>(4)</enum><text><term>Nicotine
Free</term>: cigarettes yielding less than 0.01 milligrams per
cigarette.</text>
</paragraph></subsection><subsection id="ID53fe6aa0152244e182723212717df6aa"><enum>(g)</enum><header>Accredited
Laboratory</header><text>Each test conducted in accordance with this section
shall be performed in a laboratory that has been accredited according to the
ISO 17025 standard, entitled <quote>General Requirements for the Competence of
Calibration and Testing Laboratories</quote>.</text>
</subsection><subsection id="IDdaf5c72b7bf246dc96a976bdd03a44b5"><enum>(h)</enum><header>Manner of
reporting</header><text>The Administrator shall, by regulation, specify the
manner in which the results of tests conducted under this section shall be
reported to the Administrator.</text>
</subsection></section><section id="ID70da36849b55414299ec66af2f4adee6"><enum>403.</enum><header>Nicotine
reporting requirements for smokeless tobacco products</header>
<subsection id="ID48ab56574daa42d8832d7b85fed14a3c"><enum>(a)</enum><header>Testing of
smokeless tobacco products</header><text>Unless the Administrator approves
equivalent or superior testing standards, information developed under this
section and to be included in the annual report by a manufacturer of smokeless
tobacco products under section 401(d) shall conform to testing standards
published on March 23, 1999, at pages 14085 through 14096 of volume 64 of the
Federal Register (Annual Submission of the Quantity of Nicotine Contained in
Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United
States), and, as to each brand style, except as provided in subsection (b),
shall include the following:</text>
<paragraph id="ID66bdad7267e4498994259e6ca49522ff"><enum>(1)</enum><text>The pH of the
tobacco.</text>
</paragraph><paragraph id="IDbf3a3a6b757f4eb58bd2a15fdb87cc08"><enum>(2)</enum><text>The moisture
content as a percentage of the dry weight of the tobacco.</text>
</paragraph><paragraph id="ID12136006fdbd4131967be9fc5e41e26e"><enum>(3)</enum><text>The nicotine in
milligrams per gram of tobacco.</text>
</paragraph><paragraph id="ID40eaad39b9394002a6bff15aee44a6b3"><enum>(4)</enum><text>The nicotine as a
percentage of the dry weight of the tobacco.</text>
</paragraph><paragraph id="ID564d52a284f84e3b8ab37581702962a6"><enum>(5)</enum><text>The percentage of
un-ionized (free) nicotine.</text>
</paragraph><paragraph id="ID98bba244be644c94b96d67d8089a6ff6"><enum>(6)</enum><text>The total
un-ionized (free) nicotine in milligrams per gram of tobacco.</text>
</paragraph><paragraph id="IDa4303a2ccef24270a2ded468cd58230f"><enum>(7)</enum><text>A classification
of each brand style of smokeless tobacco products for nicotine delivery, in
accordance with the following standards:</text>
<subparagraph id="ID331e2c5dd8fc48ff90ba7b0cfed960c3"><enum>(A)</enum><text><quote>High
Nicotine</quote>: smokeless tobacco product yielding more than 2.0 milligrams
of total free nicotine per gram.</text>
</subparagraph><subparagraph id="IDc2b3412ecdd34c87842864e907267b15"><enum>(B)</enum><text><quote>Moderate
Nicotine</quote>: smokeless tobacco product yielding more than 0.5 and less
than or equal to 2.0 milligrams of total free nicotine per gram.</text>
</subparagraph><subparagraph id="IDee77f3c43980496cb9cd0585d8ae64b5"><enum>(C)</enum><text><quote>Low
Nicotine</quote>: smokeless tobacco product yielding more than or equal to .01
and less than or equal to 0.5 milligrams of total free nicotine per
gram.</text>
</subparagraph><subparagraph id="IDb659ba2b08de4640ac48797a101a3d3e"><enum>(D)</enum><text><quote>Nicotine
Free</quote>: smokeless tobacco product yielding less than 0.01 milligrams of
total free nicotine per gram.</text>
</subparagraph></paragraph></subsection><subsection id="IDd250606b12ee44ca9c79cbaf194fcf4e"><enum>(b)</enum><header>Brand styles
identical in composition</header><text>For purposes of this section, if a brand
style of smokeless tobacco is identical to 1 or more other brand styles of
smokeless tobacco, except for brand name designation and other aspects not
affecting the physical or chemical composition or performance of the smokeless
tobacco, then, for purposes of this section, those brand styles shall be
treated as if they were a single brand style, and the smokeless tobacco product
manufacturer shall be required to test only 1 of those brand styles in lieu of
testing all of those brand styles. The smokeless tobacco product manufacturer
shall specify in its annual report to the Administrator under section 401(d)
the brand styles covered by the results with respect to the brand style
tested.</text>
</subsection><subsection id="ID1c80be5fd7ed4ddfa0b8899a73b585e1"><enum>(c)</enum><header>Accredited
laboratory</header><text>Each test conducted in accordance with this section
shall be performed in a laboratory that has been accredited according to the
ISO 17025 standard, entitled <quote>General Requirements for the Competence of
Calibration and Testing Laboratories</quote>.</text>
</subsection></section><enum>V</enum><header>Tar
and nicotine yields</header>
<section id="ID8a10508fe7504b4d872f11021682976a"><enum>501.</enum><header>Determination
of tar and nicotine yields of cigarettes</header>
<subsection id="IDdfe1a823bf984522997670d00ea326e8"><enum>(a)</enum><header>Machine-smoking
regimen</header><text>The testing regimen or regimens and the reporting method
established by the Administrator under section 402(c) with respect to the
determination and reporting of nicotine yields shall also be used for the
determination and disclosure of tar yields under section 504.</text>
</subsection><subsection id="ID175e5723daba4f8bb29d854407cab366"><enum>(b)</enum><header>Continued
supervision by Federal trade commission</header><text>Prior to the expiration
of a reasonable period determined by the Administrator for conducting testing
pursuant to the regulations promulgated by the Administrator under section
402(c), but in no event later than December 31, 2009, manufacturers of
cigarettes shall continue to disclose the tar and nicotine yields of their
cigarettes under the supervision of the Federal Trade Commission.</text>
</subsection><subsection id="IDd4f294a90df049e8a9f7b22ef47f56d6"><enum>(c)</enum><header>End of Federal
Trade Commission authority</header><text>After the period specified under
subsection (b), the Federal Trade Commission shall have no authority over the
testing or reporting of the tar and nicotine yields of cigarettes.</text>
</subsection><subsection id="IDba23e3228dc14bfc8762fd15a3a63573"><enum>(d)</enum><header>Accredited
laboratory</header><text>Each test conducted in accordance with this section
shall be performed in a laboratory that has been accredited according to the
ISO 17025 standard, entitled <quote>General Requirements for the Competence of
Calibration and Testing Laboratories</quote>.</text>
</subsection></section><section id="IDf45c45015e9c4b6584bf070d125d909d"><enum>502.</enum><header>Cigarette tar
limits</header>
<subsection id="ID2746c91663954837bdbd85c96b9db685"><enum>(a)</enum><header>No increase in
tar yields</header><text>No tobacco product manufacturer shall distribute for
sale domestically a brand style of cigarettes that generates a tar yield
greater than the tar yield of that brand style of cigarettes on
<short-title>Federal Tobacco Act of 2009</short-title>, as
determined by the ISO smoking regimen and its associated tolerances. The tar
tolerances for cigarettes with ISO tar 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>
<paragraph id="id5A2A6EDE2DB640AD86AA3D42EBA46F81"><enum>(1)</enum><text>15 percent;
or</text>
</paragraph><paragraph id="id645C7E2AFA444449AC2DEA05BFD4563C"><enum>(2)</enum><text>1 milligram per
cigarette.</text>
</paragraph></subsection><subsection id="IDd4b86cd6cc934019b976a110769209e5"><enum>(b)</enum><header>Limit on new
cigarettes</header><text>Beginning on the effective date of this Act, no
tobacco product manufacturer shall manufacture for commercial distribution
domestically a brand style of cigarettes that—</text>
<paragraph id="ID31dd7d2e185f434fbb496644460b3bce"><enum>(1)</enum><text>was not in
commercial distribution domestically on the effective date of this Act;
and</text>
</paragraph><paragraph id="IDdb48a141187c4e989c2565668725b0fd"><enum>(2)</enum><text>generates a tar
yield of greater than 20 milligrams per cigarette as determined by the ISO
smoking regimen and its associated tolerances.</text>
</paragraph></subsection><subsection id="IDd9b8813bcaf24bea8d5715a17ff7c698"><enum>(c)</enum><header>Limit on all
cigarettes</header><text>Beginning on January 1, 2010, no tobacco product
manufacturer shall manufacture for commercial distribution domestically a brand
style of cigarettes that generates a tar yield greater than 20 milligrams per
cigarette as determined by the ISO smoking regimen and its associated
tolerances.</text>
</subsection><subsection id="ID20173111382b42ee8b8a06d053087262"><enum>(d)</enum><header>Review by
Administrator</header><text>Beginning on the effective date of this Act, the
Administrator shall evaluate the available scientific evidence addressing the
potential relationship between historical tar yield values and the risk of harm
to smokers. If upon a review of such evidence, and after consultation with
technical experts of the Food and Drug Administration and the Centers for
Disease Control and Prevention and notice and an opportunity for public
comment, the Administrator determines that a reduction in tar 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>
<paragraph id="ID3afe3c99c5e34af995b9e6330830d13b"><enum>(1)</enum><text>provides that no
cigarette manufacturer shall manufacture for commercial distribution
domestically a cigarette that generates a tar yield that exceeds 14 milligrams
as determined by the ISO smoking regimen and its associated tolerances;
and</text>
</paragraph><paragraph id="IDac3014fac0c443e79e79bbc87ff688c9"><enum>(2)</enum><text>provides a
reasonable time for manufacturers to come into compliance with such
prohibition.</text>
</paragraph></subsection></section><section id="IDb5a68e7ee8b744d49272e595dfac0db4"><enum>503.</enum><header>Prohibition of
smoking article yield terms</header><text display-inline="no-display-inline">Beginning 24 months after the effective date
of this Act, no tobacco product manufacturer shall use in packaging, labeling,
or advertising of cigarettes any of the following terms: <quote>low
tar</quote>, <quote>medium</quote>, <quote>light</quote>, <quote>mild</quote>,
<quote>ultra light,</quote> and <quote>ultra low tar</quote>.</text>
</section><section id="ID5fe8f358238e49188379851a170577f1"><enum>504.</enum><header>Disclosure of
tar and nicotine yields of cigarettes</header><text display-inline="no-display-inline">A tobacco product manufacturer shall include
prominently in all advertising for each brand style of cigarettes it
manufactures for commercial distribution domestically the ISO tar and nicotine
yields for that brand style, and shall post on an Internet-accessible website,
or other location electronically accessible to the public, the ISO tar and
nicotine yields for every brand style of cigarettes it manufactures for
commercial distribution domestically.</text>
</section><section id="ID33d59b53f7b74946ba0054fdd5c03dd8"><enum>505.</enum><header>Evaluation of
tobacco smoke toxicants</header><text display-inline="no-display-inline">Not
later than 24 months after the effective date of this Act, the Administrator
shall, after consultation with the Centers for Disease Control and Prevention
and the Food and Drug Administration, publish a plan to identify and review
constituents known to comprise tobacco smoke with regard to the toxicant
potential of each such constituent. Such plan shall consider and prioritize the
relative risk of serious or chronic tobacco-related diseases and adverse health
conditions that the various smoke constituents might present, taking into
account—</text>
<paragraph id="ID8b48f9088ce24971b8e2f7df86481546"><enum>(1)</enum><text>all relevant
chemical, toxicological, human exposure and epidemiologic studies, and other
relevant competent and reliable scientific evidence;</text>
</paragraph><paragraph id="ID8f389b6f3fee4535a10ae2f0cb94e998"><enum>(2)</enum><text>the likelihood
that the magnitude of a specific reduction in a smoke constituent may
reasonably be expected to reduce the risk of harm to users of the tobacco
product;</text>
</paragraph><paragraph id="ID47d7a02ebd6d4bfca3653655282ed8b2"><enum>(3)</enum><text>verification that
the magnitude of the specific reduction in a smoke constituent can be achieved
by existing agronomic practices, product technology, or manufacturing
capability; and</text>
</paragraph><paragraph id="IDb2ff557917ce4de9b2671d852d1ece73"><enum>(4)</enum><text>that the
magnitude of the specific reduction in a smoke constituent does not
significantly reduce consumer acceptance of the tobacco product.</text>
</paragraph></section><enum>VI</enum><header>Pubic
disclosures by tobacco product manufacturers</header>
<section id="IDac0193d1bf9441e9840e5bab9e60c48f"><enum>601.</enum><header>Disclosures on
packages of smoking articles</header>
<subsection id="IDd30c723f1a8f4f9886c3b61eaaac5e2b"><enum>(a)</enum><header>Back face for
required disclosures</header><text>For purposes of this section—</text>
<paragraph id="id9C8AED70E6654A72895EE9A641B3F8F6"><enum>(1)</enum><text>the principal
face of a package of a smoking article 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, except that a package shall not be characterized as
having more than 2 principal faces;</text>
</paragraph><paragraph id="idE2414417227D4B7782D1CAC7EFDACDCA"><enum>(2)</enum><text>the front face of
the package shall be the principal face of the package;</text>
</paragraph><paragraph id="id23A91E7CED0A4E0A879D671EC0CF40D0"><enum>(3)</enum><text>if the front and
back faces of the package are of different sizes in terms of area, then the
larger face shall be the front face;</text>
</paragraph><paragraph id="id7E35297908EC457885FDF094F3A5921B"><enum>(4)</enum><text>the back face of
the package shall be the principal face of a package that is opposite the front
face of the package;</text>
</paragraph><paragraph id="idD7A6BC355A604E518E17EC0E9F3FF331"><enum>(5)</enum><text>the entire back
face of the package shall be allocated for required package disclosures in
accordance with this section; and</text>
</paragraph><paragraph id="id626F2B0883494A45A8DBC6B8B42660A0"><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="ID2579e2cb53a145b6a60c2ec9ebbeff91"><enum>(b)</enum><header>Front face and
panels available to manufacturer</header><text>The front face and the side,
top, and bottom panels of a package of a smoking article shall be available
solely to a manufacturer (including a repackager) for identification of a
tobacco product, in accordance with this Act, and for other matter as
determined by the manufacturer, and shall not be available for any disclosure
that the Administrator requires a manufacturer to make.</text>
</subsection><subsection id="ID14b21e2155c64f98b1f78c6f8fb788b8"><enum>(c)</enum><header>Required
information on back face</header><text>Not later than 24 months after the
effective date of this Act, the back face of a package of a smoking article
shall be available solely for disclosures required by or under this Act, the
Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1331 et seq.), and
any other Federal law. Such disclosures shall include—</text>
<paragraph id="id18CAE1F92FD84CB5961F48D54939D121"><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="id5179F17B59C04F5A81575FDD331C9245"><enum>(2)</enum><text>1 statutorily
mandated warning label as required by section 4 of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1333);</text>
</paragraph><paragraph id="id1F051D7CB7054144B09D885E4A4AC868"><enum>(3)</enum><text>a list of
ingredients as required by subsection (e); and</text>
</paragraph><paragraph id="id6091F6D043B84BC8BBCB135A839CBA86"><enum>(4)</enum><text>the appropriate
tax registration number.</text>
</paragraph></subsection><subsection id="IDbe86a62c80394a079931a8c965274a20"><enum>(d)</enum><header>Amendment of
Federal Cigarette Labeling and Advertising Act</header><text>Section 4(b)(1) of
the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333(b)(1)) is
amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id7844D68DEC5E4AE88BE2A04DE98078E9" style="OLC">
<subsection id="idF77EAB4F1E854AA89994D22CE39510D1"><enum>(b)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id74065346812C4599B31A0EC74533E0B0"><enum>(1)</enum><text>Each label statement
required under paragraph (1) of subsection (a) shall be located on the back
face of a package of cigarettes in accordance with section 601 of the Federal
Tobacco Act of 2009. The phrase <quote>Surgeon General’s Warning</quote> shall
appear in capital letters, and the size of all other letters in the label shall
be the same size as the size of such letters on the date of introduction of the
Federal Tobacco Act of 2009. All letters in the label shall appear in
conspicuous and legible type in contrast by typography, layout, or color with
all other printed matter on the
package.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="IDfa616047fcd04f848b598e4ad2b63e1f"><enum>(e)</enum><header>Package
disclosure of ingredients</header><text>Not later than 24 months after the
effective date of this Act, the package of a smoking article shall bear a list
of the common or usual names of the ingredients present in the smoking article
in an amount greater than 0.1 percent of the total dry weight of the tobacco
product (including all ingredients), that shall comply with the
following:</text>
<paragraph id="IDc4e2d3cd89e8445ab9d99c3f1ffc0730"><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="ID47f0b2b3b27048dc8bcebd13a526ff81"><enum>(2)</enum><text>Tobacco may be
listed as <quote>tobacco,</quote> and shall be the first listed
ingredient.</text>
</paragraph><paragraph id="ID2451c3c120744e099869c8931c55dfee"><enum>(3)</enum><text>After tobacco,
the ingredients shall be listed in descending order of predominance, by
weight.</text>
</paragraph><paragraph id="ID0af1acf0c1b14d97bbdfed8cd7168677"><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="ID428366c208b1430fa1a4e9e1e2671ecc"><enum>(5)</enum><text>Preservatives may
be listed as <quote>preservatives</quote> without naming each.</text>
</paragraph><paragraph id="ID4c6d5563f0f14d438f6b35f8d586574d"><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></subsection></section><section id="IDe2ab8c8ddbd746b8a1f24337bc9d1aa2"><enum>602.</enum><header>Disclosures on
packages of chewing tobacco and dry snuff</header>
<subsection id="ID26a4c42882b4483daa9532b25534a927"><enum>(a)</enum><header>Back face for
required disclosures</header><text>For purposes of this section—</text>
<paragraph id="idD372DCEDA872485DA72CDFFA9F3D6077"><enum>(1)</enum><text>the principal
face of a package of chewing tobacco or dry snuff 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, except that a package shall not be
characterized as having more than 2 principal faces;</text>
</paragraph><paragraph id="idB15E9A49E05740298063888156668304"><enum>(2)</enum><text>the front or top
face shall be the principal face of the package;</text>
</paragraph><paragraph id="id8011BC62BD744D5CBD26246AD4AC3BDB"><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="idC45765F2F7A14F9EADFE8BAF6EC878FA"><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="id13FD605D348A42589865788FFBD39628"><enum>(5)</enum><text>beginning 24
months after the effective date of this Act, the entire back or bottom face of
the package shall be allocated for required package disclosures in accordance
with this section; and</text>
</paragraph><paragraph id="idADD7E7DBDCFD4534BE2955523DC12232"><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="IDa70df426589242599ebac93ab5e1ea1b"><enum>(b)</enum><header>Front or top
face and panels available to manufacturer</header><text>The front or top face
and the side, top, and bottom panels of a package of chewing tobacco or dry
snuff shall be available solely to a manufacturer (including a repackager) for
identification of a tobacco product, in accordance with this Act, and for other
matter as determined by the manufacturer, and shall not be available for any
disclosure that the Administrator requires a manufacturer to make.</text>
</subsection><subsection id="IDbe2caa8013de424eb12a368b258521e1"><enum>(c)</enum><header>Required
information on back or bottom face</header><text>The back or bottom face of a
package of chewing tobacco or dry snuff shall be available solely for
disclosures required by or under this Act, the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4401 et seq.), and any other Federal
law. Such disclosures shall include—</text>
<paragraph id="id40221C01BD2944319E499FB1FBE20C18"><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="id58E22C0155194E21865031EC51F00014"><enum>(2)</enum><text>1 warning label,
as required by section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (15 U.S.C. 4402);</text>
</paragraph><paragraph id="id71F8C87C88D64FCA8B722BCBD611AAC5"><enum>(3)</enum><text>a list of
ingredients as required by subsection (e); and</text>
</paragraph><paragraph id="id37AC3EABC6E84D30871B0DA5C5551583"><enum>(4)</enum><text>the appropriate
tax registration number.</text>
</paragraph></subsection><subsection id="ID94eb6bbf73dd4c56ae309992c9c05eb0"><enum>(d)</enum><header>Amendment of
Comprehensive Smokeless Tobacco Health Education Act of
1986</header><text>Section 3(b)(1) of the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4402(b)(1)) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idC8DCA07C4B654349B8F9709E0CC8B9B8" style="OLC">
<paragraph id="ID3f32f183baeb472198f09805ba466711"><enum>(1)</enum><text>in the case of
the smokeless tobacco product package—</text>
<subparagraph id="ID0c2bf79d96b842b198d09c8e43ea9d49"><enum>(A)</enum><text>in a conspicuous
and prominent place on the back face or bottom of the package; and</text>
</subparagraph><subparagraph id="IDc91e6420fdba4281ac078c444e7287e5"><enum>(B)</enum><text>in a conspicuous
format and in conspicuous and legible type in contrast with all other printed
material on the package;
and</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID8231400a14ef48e7a6714cac706fb16f"><enum>(e)</enum><header>Package
disclosure of ingredients</header><text>Beginning 24 months after the effective
date of this Act, a package of chewing tobacco or dry snuff shall bear a list
of the common or usual names of the ingredients present in the chewing tobacco
or dry snuff 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="IDa2a8a043109347f583b5466c4b3b6d06"><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="ID9fdf681bf4c04324918c9cdbbf97fc3f"><enum>(2)</enum><text>Tobacco may be
listed as <quote>tobacco,</quote> and shall be the first listed
ingredient.</text>
</paragraph><paragraph id="IDc22d68f1e85641a4b7fc0c424b3430f2"><enum>(3)</enum><text>After tobacco,
the ingredients shall be listed in descending order of predominance, by
weight.</text>
</paragraph><paragraph id="ID308f8dc84f814543a917663be3e10d47"><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="ID92087fa7843543e09ced0767c1852b6d"><enum>(5)</enum><text>Preservatives may
be listed as <quote>preservatives</quote> without naming each.</text>
</paragraph><paragraph id="ID128a18eef56642ba887ac86ecec429b0"><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></subsection></section><section id="ID392d3abadf444c5aa548fa2e060c038c"><enum>603.</enum><header>Public
disclosure of ingredients</header>
<subsection id="ID27fead9ab5b44b7d86f8a088d2189ea5"><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="ID9633fd20fde64c08a6623f45cd6b2f65"><enum>(1)</enum><text>a list of the
ingredients it uses in each brand style it manufactures for commercial
distribution domestically, as provided for in subsection (b); and</text>
</paragraph><paragraph id="IDa6569338971f4038b2f41bc31fbdce3a"><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 for in subsection (c).</text>
</paragraph></subsection><subsection id="ID75e100e38da3494aa9b5158575390c62"><enum>(b)</enum><header>Ingredients To
be disclosed as to each brand style</header>
<paragraph id="ID6e862c4566554f54ac6d382518fec7d3"><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="ID7f95e2745a4b4a5daee5f12fe9cefb2a"><enum>(2)</enum><header>Requirements</header><text>Disclosure
under paragraph (1) shall comply with the following:</text>
<subparagraph id="idAF6A36497900452D980C28153AFFD626"><enum>(A)</enum><text>Tobacco may be
listed as <quote>tobacco,</quote> and shall be the first listed
ingredient.</text>
</subparagraph><subparagraph id="idDEAD2C49FEED4AFCB15B78F433CC0424"><enum>(B)</enum><text>After tobacco,
the ingredients shall be listed in descending order of predominance, by
weight.</text>
</subparagraph><subparagraph id="id7E38C5B421F645488A5D0530C68BBE43"><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="id5F704997E973431CBE8E668C4E7583C3"><enum>(D)</enum><text>Preservatives may
be listed as <quote>preservatives</quote> without naming each.</text>
</subparagraph><subparagraph id="idCC498FCE6D384F27A1028D550330D90C"><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="ID8e5dabe182af40a0bf7e5a20afb4a0ee"><enum>(c)</enum><header>Aggregate
disclosure of ingredients</header>
<paragraph id="ID71117ce534464a59a4edb6e1f1d185de"><enum>(1)</enum><header>In
general</header><text>The public disclosure required of a tobacco product
manufacturer under subsection (a)(2) shall consist of a single list of all
ingredients used in any brand style that 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="IDb83b70c75edc41f590ac85d4617523d0"><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="ID7fba290f6efb4a4992581548a62016ad"><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="IDdbe024765b3149fca34e4e890f1cb5a1"><enum>(e)</enum><header>Disclosure on
website</header><text>The public disclosures required by subsection (a) may be
made 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="IDb524cad067eb4710996521937dcc8cba"><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><section id="ID520174a5f88043abbe51985d8bd9516e"><enum>604.</enum><header>Cigarette
label and advertising warnings</header><text display-inline="no-display-inline">Section 4(a)(1) of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1333(a)(1)) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idB9E56F5E76224ECF870F239EEA569D3A" style="OLC">
<paragraph id="ID4edb9d26e4c14ecb97f336ad83a652e8" indent="up1"><enum>(1)</enum><text>Beginning 18 months after the date of
enactment of the Federal Tobacco Act of 2009, 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, 1 of
the following labels:</text>
</paragraph><paragraph id="IDcfd5ba405de84b3891e19ff09b79de23"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Cigarettes are addictive</quote>.</text>
</paragraph><paragraph id="ID8d1b9bdd8db74c919eb09f0a92169470"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Tobacco smoke can harm your children</quote>.</text>
</paragraph><paragraph id="ID3d5cd267c85c44a9b6c95b501f728f5b"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Cigarettes cause fatal lung disease</quote>.</text>
</paragraph><paragraph id="ID4bf50952e83f465aba0398cce47376b7"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Cigarettes cause cancer</quote>.</text>
</paragraph><paragraph id="ID644197d72c1243c4ae5b2d0a84964644"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Cigarettes cause strokes and heart disease</quote>.</text>
</paragraph><paragraph id="IDf02b686db71f45c1aad0fa98d35adeef"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Smoking during pregnancy can harm your baby</quote>.</text>
</paragraph><paragraph id="IDe3fb814509b24b74a547e999f2d5edce"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Smoking can kill you</quote>.</text>
</paragraph><paragraph id="ID31754fbe376f4e31939d750efc88dd3b"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Tobacco smoke causes fatal lung disease in
non-smokers</quote>.</text>
</paragraph><paragraph id="ID95be3a52bd2a48de8402df99253f707f"><enum></enum><text><quote>SURGEON
GENERAL’S WARNING: Quitting smoking now greatly reduces serious risks to your
health</quote>.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>VII</enum><header>Enforcement
provisions</header>
<section id="ID4896208943fb4b66a48629be01184a67"><enum>701.</enum><header>Prohibited
acts</header><text display-inline="no-display-inline">The following acts and
the causing thereof are hereby prohibited:</text>
<paragraph id="ID5772ef25e9044b139f30a53ae4bd305d"><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="IDbcc6bd566eec4e849fe7a568191f2d6a"><enum>(2)</enum><text>The adulteration
or misbranding of any tobacco product in interstate commerce.</text>
</paragraph><paragraph id="IDce7d7e872a034da7811cf44369c5cc16"><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="ID17a972a6e9d04f678587c26df0e34570"><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="IDd9b9130be951402f98e4767955c1ffda"><enum>(5)</enum><text>The refusal to
permit entry or inspection as authorized by this Act.</text>
</paragraph><paragraph id="IDd2f4872230334ceb9a12465cefd36761"><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="ID8413a1921a7d4514b56c6ea6c8999cce"><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="IDbd714ac8da754c9d9c2ad32d32fa00f3"><enum>(8)</enum><text>The forging,
simulating without proper permission, falsely representing, or without proper
authority using any brand name.</text>
</paragraph><paragraph id="ID3275273f01b049ee97bc54a93f696fd0"><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 this paragraph shall not authorize the
withholding of information from the House of Representatives or the Senate 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="IDefc92e56283c4e22b9dc8493642d6f02"><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="ID8941b451c0f24d06b1d0ab0ddac786af"><enum>(11)</enum><text>The importation
of any tobacco product that is adulterated, misbranded, or otherwise not in
compliance with this Act.</text>
</paragraph><paragraph id="IDa6f5277a77fc4122a9934cc2dec669e4"><enum>(12)</enum><text>The commission
of any act prohibited by section 201.</text>
</paragraph></section><section id="IDcd5fbb4da70d49109de850b85f70457c"><enum>702.</enum><header>Injunction
proceedings</header>
<subsection id="IDf65c5cea45104b9ab208aba9ba097d85"><enum>(a)</enum><header>Jurisdiction</header><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(11).</text>
</subsection><subsection id="ID77f65db7db614044b037d82abf419149"><enum>(b)</enum><header>Type of
trial</header><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="ID95ac84f2a0f045ccb0861a2c6c1644c1"><enum>703.</enum><header>Penalties</header>
<subsection id="ID21700cae65814523ab4f7ca59c3b1551"><enum>(a)</enum><header>Violations of
section 701</header><text>Any person who willfully violates a provision of
section 701 shall be imprisoned for not more than 1 year, or fined not more
than $25,000, or both.</text>
</subsection><subsection id="IDfb1ca3999bcb426ebeba66e82087601d"><enum>(b)</enum><header>Civil penalties
for violation of section 803</header>
<paragraph id="IDc337e40cb4914f2c90b96086f59f4f31"><enum>(1)</enum><header>In
general</header><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="IDf058b83d83ac47938f449e0b39adba62"><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="IDcb0545983b624057b0e65b3648422c6e"><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 under this paragraph against any person with respect to
violations during any 30-day period shall not exceed $100,000.</continuation-text></paragraph><paragraph id="ID9dc4b9453dd24795bb76773893c743f9"><enum>(2)</enum><header>Retailers</header><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="IDb373496da64f44c382bd961df4a54b2e"><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="ID95a1fe078e6d44d0829d9afb83fba6f9"><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="IDb8bc2702f9fe4e6b962e8adbde9f3d05"><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="IDe12b74619b0d40bc9197e597b5ee69b5"><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="IDcbcb141598e74799a56e34aa11605784"><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="ID6cb87856d1e64f1d928d2ad948bdbfd1"><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 under this paragraph against any person during any
30-day period shall not exceed $25,000.</continuation-text></subparagraph></paragraph></subsection></section><section id="ID6cebaffe397e431fb8e38ab4cf518485"><enum>704.</enum><header>Seizure</header>
<subsection id="IDc153ed4a6035451583829c0b7f0e32e7"><enum>(a)</enum><header>Articles
subject to seizure</header>
<paragraph id="id620540CBCA324BB7A61C13038151E246"><enum>(1)</enum><header>In
general</header><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.</text>
</paragraph><paragraph id="idA5C0DF1D00874C13A9DE0B8EEB0DB36C"><enum>(2)</enum><header>Limitation</header><text>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 1 such proceeding shall be instituted if no such proceeding is so pending,
except that such limitations shall not apply—</text>
<subparagraph id="id681093BA1E0F4D32B456DCF7BDDD2E45"><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="id745D030E19164E53890DAB9F17939CA8"><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.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">In any case
in which the number of libel for condemnation proceedings is limited as
provided for in this paragraph, 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.</continuation-text></paragraph><paragraph id="id1978A0A5099C4AF6A3FA30D2F90C9390"><enum>(3)</enum><header>List</header><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="id193783CFD57A4CCAB5D8BCA5D52BD622"><enum>(A)</enum><text>Any tobacco
product that is an illicit tobacco product.</text>
</subparagraph><subparagraph id="idBE3E378D1FF345328E24CBA89805DE40"><enum>(B)</enum><text>Any container of
an illicit tobacco product.</text>
</subparagraph><subparagraph id="id4E762C9C07724CF2B63394F195E4644B"><enum>(C)</enum><text>Any equipment or
thing used in making an illicit tobacco product.</text>
</subparagraph><subparagraph id="id3ABD1C8587464F1689F5F6381503ACB7"><enum>(D)</enum><text>Any adulterated
or misbranded tobacco product.</text>
</subparagraph></paragraph><paragraph id="id693794BEC4D04DB48B4E0493A8F634B6"><enum>(4)</enum><header>Limitation</header>
<subparagraph id="id7E8D0A174D3E469B8736F0BB44E1957E"><enum>(A)</enum><header>In
general</header><text>Except as provided in subparagraph (B), no libel for
condemnation may be instituted under this subsection against any tobacco
product that—</text>
<clause id="idC6AC43B32224463DB4A74AFA0F286E04"><enum>(i)</enum><text>is
misbranded under this Act because of its advertising; and</text>
</clause><clause id="id9455EFF39E3D49A699DAD48F1D03D0EA"><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="idE25836CE0BF04B5D8DF6E85165D5A827"><enum>(B)</enum><header>Exception</header><text>A
libel for condemnation may be instituted under this subsection 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="idB12920BB6A2642388E141522D4D74A8F"><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="id323EB73D130E45DBA2BD588CC6D35F1E"><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="IDe8dd9931bfbb43b0bae334877c0abc5c"><enum>(b)</enum><header>Procedures</header>
<paragraph id="id6851420186C34C71A78F84CBCF7EEAEA"><enum>(1)</enum><header>In
general</header><text>The tobacco product, equipment, or other thing proceeded
against under this section shall be liable to seizure by process pursuant to
the libel, and the procedure in cases under this section shall conform, to the
maximum extent practicable, 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.</text>
</paragraph><paragraph id="idCBA86698CCBA49638F8757AB950D5C3C"><enum>(2)</enum><header>Consolidation</header>
<subparagraph id="idC6B81904408B46AC9E474AB3C4BED6EE"><enum>(A)</enum><header>In
general</header><text>When libel for condemnation proceedings under this
section, involving the same claimant and the same issues of adulteration or
misbranding, are pending in 2 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—</text>
<clause id="id17EAABDA965C43AABCC7C4068F61A789"><enum>(i)</enum><text>any
district selected by the claimant where one of such proceedings is pending;
or</text>
</clause><clause id="id20C4F61C9F614ABC82AD332B455D2CE5"><enum>(ii)</enum><text>a
district agreed upon by stipulation between the parties.</text>
</clause></subparagraph><subparagraph id="id1BA6EE7D745043F7BB15522918FEA894"><enum>(B)</enum><header>Application for
consolidation</header><text>If no order for consolidation is made under
subparagraph (A) 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>
</subparagraph></paragraph></subsection><subsection id="ID51dbf68323fb40bf8438668031d3d70e"><enum>(c)</enum><header>Samples and
analyses</header><text>The court at any time after seizure under this section
up to a reasonable time before trial shall by order allow any party to a
condemnation proceeding, or 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="ID7a60f7193ab3411eb056da92a0a2f6dc"><enum>(d)</enum><header>Disposition of
condemned tobacco products</header>
<paragraph id="idAEE9A85C375F4682A26769022F3DB86A"><enum>(1)</enum><header>Destruction or
sale</header>
<subparagraph id="id0B6874DBCF4F475893BA83031C9F2C1F"><enum>(A)</enum><header>In
general</header><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. 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.</text>
</subparagraph><subparagraph id="idC75C2783B7EE4A538E58EBE9FD15AF71"><enum>(B)</enum><header>Supervision</header><text>After
entry of the decree under subparagraph (A) and upon the payment of the costs of
the proceedings and the execution of a good and sufficient bond conditioned on
such article not being 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. The expenses of
such supervision shall be paid by the person obtaining release of the tobacco
product under bond.</text>
</subparagraph><subparagraph id="id7ADFC55298864E75919C36ABEF2A2EEB"><enum>(C)</enum><header>Imported
products</header><text>If the tobacco product involved in a condemnation under
this paragraph was imported into the United States and the person seeking its
release establishes—</text>
<clause id="id092F852B15DF47D9A665C462723AF3CB"><enum>(i)</enum><text>that the
adulteration, misbranding, or violation did not occur after the tobacco product
was imported; and</text>
</clause><clause id="idA1FFEA6BFFB442F28CC94720147473CC"><enum>(ii)</enum><text>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;</text>
</clause><continuation-text continuation-text-level="subparagraph">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 reimported into
the United States.</continuation-text></subparagraph></paragraph><paragraph id="id604C20DA6CD14ACEB3FCE8276980FD89"><enum>(2)</enum><header>Application to
equipment</header><text>The provisions of paragraph (1) shall, to the extent
deemed appropriate by the court, apply to any equipment or other thing that is
not otherwise within the scope of such paragraph and which is referred to in
paragraph (3) of subsection (a).</text>
</paragraph><paragraph id="id24F703BF41E445E9B68C36A29AED602A"><enum>(3)</enum><header>Remission or
mitigation</header><text>Whenever in any proceeding under this section,
involving paragraph (3) 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—</text>
<subparagraph id="idB5FB7AD02DAD47FF93F5B71B484BC182"><enum>(A)</enum><text>that such
claimant has not caused the equipment or thing to be within 1 of the categories
referred to in such paragraph (3) and has no interest in any tobacco product
referred to in such paragraph;</text>
</subparagraph><subparagraph id="id3203DCC103FE48EDB1638D277F2D1995"><enum>(B)</enum><text>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</text>
</subparagraph><subparagraph id="id36E13DF841044AF6B9585CF0FCC79753"><enum>(C)</enum><text>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>
</subparagraph></paragraph></subsection><subsection id="ID05d64a34adbe4c46b652ea32efc7e577"><enum>(e)</enum><header>Costs and
fees</header><text>When a decree of condemnation is entered against the tobacco
product or other article under this section, 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="IDb557fd0e9ecd49a69f138d75ff3a5baf"><enum>(f)</enum><header>Removal for
trial</header><text>In the case of removal for trial of any case as provided
for by subsection (a) or (b)—</text>
<paragraph id="ID48d6f3702ae146c3979547f23801da89"><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; and</text>
</paragraph><paragraph id="ID91a0e5e2b8284c5589b04b561a83beb8"><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="ID654a648e1a65489cbfcafbed80363a45"><enum>(g)</enum><header>Administrative
detention of tobacco products</header>
<paragraph id="id2D1CEF5A40044619BFCCB78278B6E316"><enum>(1)</enum><header>Detention
authority</header>
<subparagraph id="ID7c116c5d324a4ad5949f6b895f9d7cbf"><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="IDba904b72a81b48b1a153fb717971d880"><enum>(B)</enum><header>Administrator’s
approval</header><text>A tobacco product or component thereof may be ordered
detained under subparagraph (A) 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="ID142374bf77e44e0091e1e904898fa22c"><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="ID6df6419cc84847ed8aa0387e48503a32"><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 paragraph shall 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 shall not be construed to 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="ID06ad548946c94c64bb360fa71a00519e"><enum>(4)</enum><header>Appeal of
detention order</header>
<subparagraph id="ID6f968c180d8a40c0bddcbce024f8cd64"><enum>(A)</enum><header>In
general</header><text>With respect to a tobacco product ordered detained under
paragraph (1), any person that would be entitled to be a claimant of such
tobacco product if the tobacco product were seized under subsection (a) may
appeal the detention order to the Administrator. Within 5 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 5-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="ID66a1a2172ae84b6884b450745565c09c"><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) shall terminate if the Administrator
institutes an action under subsection (a) or section 702 regarding the tobacco
product involved.</text>
</subparagraph></paragraph></subsection></section><section id="ID3c0c5f1f4727443fb5453ded13a28d82"><enum>705.</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 the 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="IDafc3753608d847b59bd594c4747fda82"><enum>706.</enum><header>Inspection</header>
<subsection id="ID2f03b0d4ffb046779a045673ed3d09f0"><enum>(a)</enum><header>Authority To
inspect</header>
<paragraph id="idFED7A5CAA48D4D499DE2326FFC685463"><enum>(1)</enum><header>In
general</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 this Act.</text>
</paragraph><paragraph id="id26FF5C981D2448A5B3E94DC3C1AD132C"><enum>(2)</enum><header>Entry of
premises</header><text>Officers of the Agency designated by the Administrator,
upon presenting appropriate credentials and a written notice to the person in
charge of the premises involved, 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.</text>
</paragraph><paragraph id="idEAEDFDDB0C37492596094A2C0E80FB93"><enum>(3)</enum><header>Reasonable
limits and manner</header><text>An inspection under this subsection shall be
conducted within reasonable limits and in a reasonable manner, and shall be
limited to examining only those things, including records, relevant to
determining whether violations of this Act, or regulations under this Act, have
occurred.</text>
</paragraph><paragraph id="id1FCDB3C35B4244DFB7578A04E37800CD"><enum>(4)</enum><header>Limitation</header><text>No
inspection under 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>
</paragraph></subsection><subsection id="ID089195e54dbe458c84814cad6c1f93cc"><enum>(b)</enum><header>Report of
observations</header><text>Prior to 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 this Act.</text>
</subsection><subsection id="ID54f51a17db7346d1b09afe7dcbca6af7"><enum>(c)</enum><header>Samples</header><text>If
an officer has obtained any sample in the course of an inspection under this
section, prior to leaving the premises such officer shall give to the person in
charge of the premises a receipt describing the samples obtained. As to each
such 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="ID02b4069255cf4dbdaf38b9009cc01699"><enum>707.</enum><header>Effect of
compliance</header><text display-inline="no-display-inline">Compliance with the
provisions of this Act, and the regulations promulgated under this Act, shall
constitute a complete defense to any civil action, including relating to any
product 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="IDad8bb25150ba4f7b84485f7e493902d9"><enum>708.</enum><header>Imports</header>
<subsection id="ID7d92b702e5574464a3bc564ba401344a"><enum>(a)</enum><header>Imports; list
of registered foreign establishments; samples from unregistered foreign
establishments; examination and refusal of admission</header>
<paragraph id="id3B4663B369F74D5DB798B99676A3B6E6"><enum>(1)</enum><header>In
general</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.</text>
</paragraph><paragraph id="id29C8E6EB373C4C4A8C65AD8434683313"><enum>(2)</enum><header>List of
establishments and samples</header><text>The Administrator shall furnish to the
Secretary of Homeland Security a list of establishments registered pursuant to
subsection (d) of section 109, 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.</text>
</paragraph><paragraph id="idC3B0020805454DA29EF74B1694D45D42"><enum>(3)</enum><header>Examinations
and refusal</header><text>If it appears from the examination of samples
delivered under this subsection or otherwise that—</text>
<subparagraph id="idF306A6CE28304F1B9B3289C784A28C84"><enum>(A)</enum><text>such tobacco
product is forbidden or restricted in sale in the country in which it was
produced or from which it was exported; or</text>
</subparagraph><subparagraph id="id4410C45892804F99984CE1FC522AE6C4"><enum>(B)</enum><text>such tobacco
product is adulterated, misbranded, or otherwise in violation of this
Act;</text>
</subparagraph><continuation-text continuation-text-level="paragraph">then such
tobacco product shall be refused admission, except as provided in subsection
(b).</continuation-text></paragraph><paragraph id="id1857C83F9D374957947EB5842EC00E54"><enum>(4)</enum><header>Destruction</header><text>The
Secretary of Homeland Security shall cause the destruction of any such tobacco
product refused admission under this subsection unless such tobacco product is
exported, under regulations prescribed by the Secretary of Homeland Security,
within 90 days of the date of notice of such refusal or within such additional
time as may be permitted pursuant to such regulations.</text>
</paragraph></subsection><subsection id="ID72bc63ba02f849e19a9dbd2c5d48d944"><enum>(b)</enum><header>Disposition of
refused tobacco products</header>
<paragraph id="id5025C49C8B4446ABBE07CEEAA17D6725"><enum>(1)</enum><header>In
general</header><text>Pending a decision as to the admission of a tobacco
product being imported or offered for import, the Secretary of Homeland
Security may authorize the delivery of such tobacco product to the owner or
consignee upon the execution by such owner or 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.</text>
</paragraph><paragraph id="id50EB9FC01ECA4E20B5F370169B95EA10"><enum>(2)</enum><header>Actions for
compliance</header><text>If it appears to the Administrator that a tobacco
product that is refused admission under subsection (a)(3) may, by relabeling or
other action, be brought into compliance with this Act or rendered other than a
tobacco product, a 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 owner or consignee of a bond as provided in
paragraph (1), 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>
</paragraph></subsection><subsection id="IDf0f403e980e141f184b7ac8f5b3b548b"><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) and the supervision of the relabeling or other action authorized under the
provisions of subsection (b), 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), 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="IDedb96c0f13604ef28dfcd01aadc15b2a"><enum>709.</enum><header>Tobacco
products for export</header>
<subsection id="IDc0be56698efb46ad9fce2593a52a2002"><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="ID8cc6f883e54640399b6c51e81c130d27"><enum>(1)</enum><text>it is not in
conflict with the laws of the country to which it is intended for export, as
demonstrated by—</text>
<subparagraph id="id1AAAA588A63D47919AA36F182DA39838"><enum>(A)</enum><text>a document issued
by the government of that country; or</text>
</subparagraph><subparagraph id="idD94225F9385A47B88AAB27C3B0AB0CFC"><enum>(B)</enum><text>a document
provided by a person knowledgeable with respect to the relevant laws of that
country and qualified by training and experience to make determinations as to
whether the tobacco product is or is not in conflict with such laws;</text>
</subparagraph></paragraph><paragraph id="IDc65eb38bcb5b43b1a4e891ce2a9869ce"><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="ID9a4a5858a8754f3b99c2450911a949c5"><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="IDdd2889f102fa4f55b216737a5df56036"><enum>(b)</enum><header>Products for
United States 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="ID599a569cd2784254a7fcc0a4679161b7"><enum>(c)</enum><header>Limitation</header><text>This
Act shall not apply to a person that manufactures 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>VIII</enum><header>Miscellaneous
provisions</header>
<section id="ID94bb4f5bc11c46d882d01f08bf5cd7d0"><enum>801.</enum><header>Use of
payments under the master settlement agreement and individual State settlement
agreements</header>
<subsection id="IDc1da1dc708234078ab85d698123050fc"><enum>(a)</enum><header>Reduction of
grant amounts</header>
<paragraph id="id9ACB2CD804F541E08B57325B9AD82516"><enum>(1)</enum><header>In
general</header><text>For fiscal year 2010 and each subsequent fiscal year, the
Secretary shall reduce, as provided for in subsection (b), the amount of any
grant to a State under section 1921 of the Public Health Service Act (42 U.S.C.
300x–21) if the Secretary determines that the State is expending 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,
on tobacco control programs in amounts that are less than the amounts
recommended for that State by the Centers for Disease Control and
Prevention.</text>
</paragraph><paragraph id="ID935bd674f4e244b3b7708dbd41b7f273"><enum>(2)</enum><header>Certain
States</header><text>In the case of a State whose legislature does not convene
a regular session in fiscal year 2009, the requirement described in paragraph
(1) shall apply only for fiscal year 2010 and subsequent fiscal years.</text>
</paragraph></subsection><subsection id="IDa058c734a92b42c4b4cf7b0a4bbd7184"><enum>(b)</enum><header>Determination
of State spending</header>
<paragraph id="id3446A9B4A6BE4770806F70C937CA1F1A"><enum>(1)</enum><header>In
general</header><text>Prior to making a grant to a State under section 1921 of
the Public Health Service Act (42 U.S.C. 300x–21) 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 expended 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 recommended for that State by the Centers for Disease Control and
Prevention.</text>
</paragraph><paragraph id="idB8708BDCB5AA4234AFF512C9D1FD4FCD"><enum>(2)</enum><header>Reduction in
allotment</header><text>If, after notice to the State and an opportunity for a
hearing, the Secretary determines under paragraph (1) that the State has
expended less than the recommended amount, the Secretary shall reduce the
amount of the allotment to the State under section 1921 of the Public Health
Service Act (42 U.S.C. 300x–21) for the fiscal year involved by an amount equal
to—</text>
<subparagraph id="IDd7cbc8e5dfdb447daff8a27859952e40"><enum>(A)</enum><text>in the case of
the first applicable fiscal year, 10 percent of the amount determined under
section 1933 of such Act (42 U.S.C. 300x–33) for the State for the fiscal
year;</text>
</subparagraph><subparagraph id="ID19f03b4db181440799e65ce14279874b"><enum>(B)</enum><text>in the case of
the first fiscal year following such applicable fiscal year, 20 percent of the
amount determined under such section 1933, for the State for the fiscal
year;</text>
</subparagraph><subparagraph id="IDb1210c640e694f82a0c8f8ec4c95aa1d"><enum>(C)</enum><text>in the case of
the second such fiscal year, 30 percent of the amount determined under such
section 1933, for the State for the fiscal year; and</text>
</subparagraph><subparagraph id="ID9fc7f6d06601406f88396394f9fe279c"><enum>(D)</enum><text>in the case of
the third such fiscal year or any subsequent fiscal year, 40 percent of the
amount determined under such section 1933, for the State for the fiscal
year.</text>
</subparagraph></paragraph><continuation-text continuation-text-level="subsection">The
Secretary shall not grant to any State a waiver of the terms and requirements
of this subsection or subsection (a).</continuation-text></subsection><subsection id="ID0bdcba9e148547afb51979f7de0dc31b"><enum>(c)</enum><header>Definitions</header><text>For
the purposes of this section:</text>
<paragraph id="ID4cf4503b977e47908f31811519423e75"><enum>(1)</enum><header>First
applicable fiscal year</header><text>The term <term>first applicable fiscal
year</term> means—</text>
<subparagraph id="IDab94a7ca76e84172b6de24adff028410"><enum>(A)</enum><text>fiscal year 2011,
in the case of any State described in subsection (a)(2); and</text>
</subparagraph><subparagraph id="IDb51b3b8751494277b65ca27c50c65fb1"><enum>(B)</enum><text>fiscal year 2010,
in the case of any other State.</text>
</subparagraph></paragraph><paragraph id="ID1b1063cd0c3e4e1faac6bdb10dbdeefe"><enum>(2)</enum><header>Florida
Settlement Agreement</header><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="IDcc2b790378d14de4a623959058635285"><enum>(3)</enum><header>Master
Settlement Agreement</header><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="ID731b708836f845db88b89ebea37948e9"><enum>(4)</enum><header>Minnesota
Settlement Agreement</header><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="ID3dae5d8ac3c942b290ec29de0cfb1dd0"><enum>(5)</enum><header>Mississippi
Memorandum of Understanding</header><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="IDf4c0c72ea5454c7bbc2f6a823b0461b4"><enum>(6)</enum><header>Secretary</header><text>The
term <term>Secretary</term> means the Secretary of Health and Human
Services.</text>
</paragraph><paragraph id="ID97f5fe5456ee4440a60f7e8bf3b208db"><enum>(7)</enum><header>Texas
Settlement Agreement</header><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="ID9ba390d00d59485f9805833082a8a295"><enum>802.</enum><header>User
fees</header>
<subsection id="ID07ddaee1cb90436aa2d6854a3b5026d3"><enum>(a)</enum><header>Assessment of
user fees</header><text>The Administrator shall assess an annual user fee for
each fiscal year, beginning with fiscal year 2010, determined in accordance
with this section, upon each tobacco product manufacturer (including each
importer) that is subject to this Act.</text>
</subsection><subsection id="ID16d451176745463cbb89f237c08d020b"><enum>(b)</enum><header>Use of user
fees</header><text>The Administrator shall make user fees collected pursuant to
this section available to pay, in each fiscal year, for the costs of the
activities of the Agency related to the regulation of tobacco products under
this Act.</text>
</subsection><subsection id="IDd2df39278f574facad8a183dba1c5607"><enum>(c)</enum><header>Amounts of user
fees</header>
<paragraph id="id10F1BCD319654749879893E729C25F36"><enum>(1)</enum><header>Limitation</header><text>Except
as provided in paragraph (2), the total amount of the user fees assessed for
each fiscal year pursuant to this section shall be sufficient, and shall not
exceed the amount necessary, to pay for the costs of the activities described
in subsection (b) for the fiscal year involved.</text>
</paragraph><paragraph id="ID9febd228c6434cf596e9d5702dd8365f"><enum>(2)</enum><header>Amounts</header><text>The
total amount of the assessments under this section—</text>
<subparagraph id="ID6c986bb9e5144434b8ce7d2f056e6021"><enum>(A)</enum><text>for fiscal year
2010 shall not exceed $100,000,000; and</text>
</subparagraph><subparagraph id="ID25e25848431d4ec384984e17eae9a922"><enum>(B)</enum><text>for each
subsequent fiscal year, shall not exceed the limitation on the assessment
imposed during the preceding fiscal year, as adjusted by the Administrator
(after notice, published in the Federal Register) to reflect the greater
of—</text>
<clause id="ID4f2ea3b17c594dc7b1347c16a8da148d"><enum>(i)</enum><text>the
total percentage change that occurred in the Consumer Price Index for all urban
consumers (all items; United States city average) for the 12-month period
ending on June 30 preceding the fiscal year for which the fee amounts are being
established; or</text>
</clause><clause id="IDdd8accac4c644b4db0d2746f557d8130"><enum>(ii)</enum><text>the total
percentage change for the previous fiscal year in basic pay under the General
Schedule in accordance with section 5332 of title 5, United States Code, as
adjusted by any locality-based comparability payment pursuant to section 5304
of such title for Federal employees stationed in the District of
Columbia.</text>
</clause></subparagraph></paragraph><paragraph id="ID4df5e2e7d45e461592ca6402407c6bd2"><enum>(3)</enum><header>Notification</header><text>The
Administrator shall notify each tobacco product manufacturer subject to this
section of the amount of the annual assessment imposed on such tobacco product
manufacturer under subsection (d). Such notifications shall occur not later
than the July 31 prior to the beginning of the fiscal year for which such
assessment is being made, and payments of all assessments shall be made not
later than 60 days after the date of each such notification. Such notification
shall contain a complete list of the assessments imposed on tobacco product
manufacturers for that fiscal year.</text>
</paragraph></subsection><subsection id="ID10ffc9835afc43249afffa51e8bbd45b"><enum>(d)</enum><header>Liability of
tobacco product manufacturers for user fees</header>
<paragraph id="idA9FC039449C94EA3945EE16B45254C13"><enum>(1)</enum><header>Determination</header><text>The
user fee to be paid by each tobacco product manufacturer for a fiscal year
shall be determined by multiplying—</text>
<subparagraph id="id98F975ED60AF420C90357EC8270345AF"><enum>(A)</enum><text>such tobacco
product manufacturer’s market share of tobacco products, as determined under
regulations issued pursuant to subsection (e); by</text>
</subparagraph><subparagraph id="id3DA440112894480A86D4CC711772E686"><enum>(B)</enum><text>the total user
fee assessment for such fiscal year, as determined under subsection (c).</text>
</subparagraph></paragraph><paragraph id="idE5FF5A2238224691B74FBB8035CDF145"><enum>(2)</enum><header>Limitation</header><text>Except
as provided in paragraph (3), no tobacco product manufacturer shall be required
to pay a percentage of a total annual user fee for all tobacco product
manufacturers that exceeds the market share of such manufacturer.</text>
</paragraph><paragraph id="id70453EE12E7B45F1BD2B5F720836C332"><enum>(3)</enum><header>Failure to
pay</header><text>If—</text>
<subparagraph id="id486475EE31A649B29A60D817537ADB1B"><enum>(A)</enum><text>a tobacco product
manufacturer fails to pay the user fee in full by the due date;</text>
</subparagraph><subparagraph id="id37704E52A9C145FFBDD32B8F75D4BE97"><enum>(B)</enum><text>the
Administrator, after diligent inquiry, concludes that such manufacturer is
unlikely to make such payment in full by the time such payment will be needed
by the Administrator; and</text>
</subparagraph><subparagraph id="id2DFC695F17AD488B9883CFA00FA9E185"><enum>(C)</enum><text>the Administrator
and the Department of Justice make diligent efforts to obtain payment in full
from such tobacco product manufacturer;</text>
</subparagraph><continuation-text continuation-text-level="paragraph">the
Administrator may re-allocate the unpaid amount owed by that tobacco product
manufacturer to the other tobacco product manufacturers on the basis of their
respective market shares. If the Administrator makes such re-allocation, the
Administrator shall set a reasonable time, not less than 60 days from the date
of notice of the amount due, for payment of that amount by such manufacturers.
If and to the extent that the Administrator ultimately receives from that
tobacco product manufacturer or any successor to such tobacco product
manufacturer any payment of the previously unpaid user fee amount, the
Administrator shall credit such payment to the tobacco product manufacturers
that made payments of any such re-allocated amount, in proportion to their
respective payments of such amount.</continuation-text></paragraph></subsection><subsection id="IDf40c2d7f2dbd44b6834fc862e82e9769"><enum>(e)</enum><header>Regulations</header><text>Not
later than 12 months after the date of enactment of this Act, the Administrator
shall, by regulation, establish a system for determining the market shares of
tobacco products for each tobacco product manufacturer subject to this section.
In promulgating regulations under this subsection, the Administrator
shall—</text>
<paragraph id="IDc3e8a2e901d94f8889da5053f117be1a"><enum>(1)</enum><text>take into account
the differences between categories and subcategories of tobacco products in
terms of sales, manner of unit packaging, and any other factors relevant to the
calculation of market share for a tobacco product manufacturer;</text>
</paragraph><paragraph id="ID77739d9347bc45a5b0a25187b129bd50"><enum>(2)</enum><text>take into account
that different tobacco product manufacturers rely to varying degrees on the
sales of different categories and subcategories of tobacco products; and</text>
</paragraph><paragraph id="ID4fbc4cefb08f46629184a04365bcd774"><enum>(3)</enum><text>provide that the
market share of tobacco products for each tobacco product manufacturer shall be
recalculated on an annual basis.</text>
</paragraph></subsection></section><section id="ID1b541e618a3b4e81a04e805959e98c1e"><enum>803.</enum><header>Fire safety
standards for cigarettes</header>
<subsection id="ID9ddc8364c32e497ebb2ccdfa525d5746"><enum>(a)</enum><header>Prohibition</header><text>Beginning
on January 1, 2012, no person shall distribute, sell, or offer for sale
domestically any brand style of cigarettes unless—</text>
<paragraph id="ID50989edeacab4b69beeb068e80139d16"><enum>(1)</enum><text>cigarettes of
that brand style randomly sampled from a manufacturing facility of the tobacco
product manufacturer have been tested in accordance with subsection (b);</text>
</paragraph><paragraph id="IDd94c9a351ec3486e914531a5d1e9653e"><enum>(2)</enum><text>not more than 25
percent of the cigarettes of that brand style tested in a complete test in
accordance with subsection (b) exhibit full-length burns; and</text>
</paragraph><paragraph id="IDcca7a0edbf1c4b43b8f013258c8cb8c0"><enum>(3)</enum><text>a written
certification has been filed by the tobacco product manufacturer with the
Administrator in accordance with subsection (c), and that written certification
is current in accordance with subsection (d), except that—</text>
<subparagraph id="ID1a6417c85f844153937b77420e6b5593"><enum>(A)</enum><text>nothing in this
section shall be construed to prohibit a distributor or retailer that is in
possession of any cigarette brand style inventory prior to January 1, 2012,
from distributing or selling the cigarettes of that inventory after January 1,
2012, but prior to July 1, 2012; and</text>
</subparagraph><subparagraph id="ID4135ef4baa6e4164994a5fdc0c567c90"><enum>(B)</enum><text>nothing in this
section shall be construed to prohibit any person from distributing or selling,
or offering to distribute or sell, cigarettes of a brand style that has not
been tested and certified as meeting the performance standard set forth in
paragraph (2) if the cigarettes are manufactured and packaged for distribution
or sale outside the United States and are not intended for sale or distribution
to members or units of the Armed Forces of the United States located outside of
the United States; and</text>
</subparagraph></paragraph><paragraph id="ID8ff1f2e47249434aaa3030867bb3c7c8"><enum>(4)</enum><text>the cigarette
packages, cartons, and cases containing that brand style are marked—</text>
<subparagraph id="ID948ada9690d94b69bf7d6c1b248514d3"><enum>(A)</enum><text>to indicate that
cigarettes of that brand style have been certified in accordance with this
section; and</text>
</subparagraph><subparagraph id="ID52c33169d47048b1a49bb6e15ceb3976"><enum>(B)</enum><text>in a manner
designated by order by the Administrator.</text>
</subparagraph></paragraph></subsection><subsection id="ID1d5f5a2f8acf4076825abf42ddd6978f"><enum>(b)</enum><header>Testing of
cigarettes</header><text>Testing of each brand style of cigarettes shall be
conducted—</text>
<paragraph id="ID9de9e90d8d5a474199e3ba1e8bdd0a46"><enum>(1)</enum><text>in accordance
with the American Society of Testing and Materials standard E2187–4, entitled
<quote>Standard Test Method for Measuring the Ignition Strength of
Cigarettes</quote>;</text>
</paragraph><paragraph id="IDf4a7c6638ba14fea8cb7105ed71ceed9"><enum>(2)</enum><text>for each
cigarette on 10 layers of filter paper;</text>
</paragraph><paragraph id="ID62da1484da3248c7b0f1ea9bbe519cf5"><enum>(3)</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>
</paragraph><paragraph id="ID37e3c4ff61774a47b48b96315037d782"><enum>(4)</enum><text>in a laboratory
that has been accredited in accordance with ISO/IEC 17205 of the International
Organization for Standardization 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 not
greater than 0.19.</text>
</paragraph></subsection><subsection id="ID98858ba040a04306bb6822cdd3f59511"><enum>(c)</enum><header>Certifications
by manufacturers</header><text>Each tobacco product manufacturer shall submit,
with respect to each brand style of cigarettes that such manufacturer
manufactures for commercial distribution domestically, a written
certification—</text>
<paragraph id="ID976c043900e34c4d8d4049981fed762b"><enum>(1)</enum><text>that
contains—</text>
<subparagraph id="IDa2cf51a0c8b04c1d96ce9db601975a6d"><enum>(A)</enum><text>the brand name
and brand style name;</text>
</subparagraph><subparagraph id="ID33608e1132204d9f829fd9adf552aa5c"><enum>(B)</enum><text>the cigarette
length in millimeters;</text>
</subparagraph><subparagraph id="ID0b249920566242c385a839804367b396"><enum>(C)</enum><text>the cigarette
circumference in millimeters;</text>
</subparagraph><subparagraph id="ID5a7c2ec1ce6942a78e72380ce041278c"><enum>(D)</enum><text>the
classification of the cigarette as menthol or non-menthol;</text>
</subparagraph><subparagraph id="ID28d93fad011440d297ed545246542bf3"><enum>(E)</enum><text>the
classification of the cigarette as filter or non-filter;</text>
</subparagraph><subparagraph id="IDc338881f451c4e1f803b391869a2ac5f"><enum>(F)</enum><text>a description of
the type of package used for the brand style;</text>
</subparagraph><subparagraph id="IDf2e052455ebe47a6a01b4eb8dbc350db"><enum>(G)</enum><text>the name,
address, and telephone number of the laboratory that conducted the testing, if
different from those of the tobacco product manufacturer; and</text>
</subparagraph><subparagraph id="ID611b113abd6c4df784efeecab6a48856"><enum>(H)</enum><text>the date that the
testing occurred;</text>
</subparagraph></paragraph><paragraph id="ID62efdeb11fc3412d8858a9f461adf9ea"><enum>(2)</enum><text>attesting that
the brand style listed in the certification has been tested in accordance with
all requirements of subsection (b); and</text>
</paragraph><paragraph id="IDddfa604626d24eef985307b2bcbd9da4"><enum>(3)</enum><text>attesting that
the brand style meets the performance standard set forth in subsection
(a)(2).</text>
</paragraph></subsection><subsection id="ID02e8b490e1034813b8958a38a001cfa7"><enum>(d)</enum><header>Duration of
effectiveness of certification</header><text>A certification for each brand
style of cigarettes under subsection (c) shall be deemed current for the 3-year
period beginning on the date of on which the certification is received by the
Administrator. Such date shall be stated in a written acknowledgment of receipt
sent by the Administrator to the submitter. Cigarettes of each brand style
shall be tested in accordance with subsection (a)(1), and a new certification
shall be submitted in accordance with subsection (c), prior to the end of each
such 3-year certification period.</text>
</subsection><subsection id="IDb872c8d09c1e45edaff1369e518cbc38"><enum>(e)</enum><header>Changes in
cigarettes</header><text>If a tobacco product manufacturer makes a change to
the cigarettes of a brand style that is likely to alter the ability of the
cigarettes of that brand style to meet the performance standard set forth in
subsection (a)(2), the tobacco product manufacturer shall conduct subsequent
tests with respect to that brand style in accordance with the requirements of
subsection (b) and submit to the Administrator a new certification in
accordance with subsection (c) prior to introducing or delivering for
introduction, or causing the introduction or delivery for introduction, into
interstate commerce of any cigarettes of such changed brand style for
commercial distribution domestically or to members or units of the armed forces
of the United States located outside of the United States. If a tobacco product
manufacturer makes a change to the cigarettes of a brand style that is not
likely to alter the ability of the cigarettes of that brand style to meet the
performance standard set forth in subsection (a)(2), such re-testing shall not
be required.</text>
</subsection><subsection id="IDd3cb0f4b8ee9461fade9a0525bee4d4e"><enum>(f)</enum><header>Records</header><text>Each
tobacco product manufacturer shall keep a record of all testing conducted in
support of a certification under this section for a period of not less than
3-years from the date on which the certification is received by the
Administrator, and shall send to the Administrator, upon request by the
Administrator during that period, any and all records of such testing and the
results obtained.</text>
</subsection><subsection id="ID6d18d830906144ac94dad4a83b5da2cb"><enum>(g)</enum><header>Preemption</header><text>With
respect to fire safety or ignition-propensity, the Administrator and any State
or political subdivision thereof shall not—</text>
<paragraph id="ID39c848748b91465495502e8363708eef"><enum>(1)</enum><text>require testing
of cigarettes that would be in addition to, or different from, the testing
prescribed in subsections (a)(1) and (b);</text>
</paragraph><paragraph id="ID5110533fda2b4717945b35f632d03c03"><enum>(2)</enum><text>require a
performance standard that is in addition to, or different from, the performance
standard set forth in subsection (a)(2); or</text>
</paragraph><paragraph id="ID5e8da055af674a3c900e094c1d023dff"><enum>(3)</enum><text>require any other
or additional package marking.</text>
</paragraph><continuation-text continuation-text-level="subsection">No
requirement or prohibition based on fire safety or ignition propensity shall be
imposed under State or local law with respect to any cigarette.</continuation-text></subsection></section><section id="IDb30dc57cb7e84893b8e3dd02ac1297f1"><enum>804.</enum><header>Inspection by
the Alcohol and Tobacco Tax Trade Bureau of Records of certain cigarette and
smokeless tobacco sellers</header>
<subsection id="idFEEB3CFCDB16498993793865DDD5FD5D"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Any officer 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="IDd48e54af77fe42c6a7b09e113175971c"><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="ID78e027b84d5640fab699df40462e3872"><enum>(2)</enum><text>any cigarettes or
smokeless tobacco kept or stored by such person at such premises.</text>
</paragraph></subsection><subsection id="IDdfa1c031e9bc4f878848f57364721e3e"><enum>(b)</enum><header>Covered
persons</header><text>Subsection (a) shall apply 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="IDdaa1e61b95cf4ee5a0ee1fe17982c598"><enum>(c)</enum><header>Relief</header>
<paragraph id="IDc137bdf940cc4957883b054ed60aa899"><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="ID7c8c30a1c3914492aa11e8967c46d6fb"><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 that shall not exceed $10,000 for each
such violation.</text>
</paragraph></subsection><subsection id="ID9c233a1fa8a0420794c02cd9b8aa8445"><enum>(d)</enum><header>Covered
provisions of law</header><text>The provisions of law referred to in this
subsection are—</text>
<paragraph id="ID18d58628c03b44639f47dfee621a262f"><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="ID860fcd434bb34f1cafb4f312fdc710ce"><enum>(2)</enum><text>chapter 114 of
title 18, United States Code; and</text>
</paragraph><paragraph id="ID3bdfffd2b2844996ab15455fc00eabff"><enum>(3)</enum><text>this
title.</text>
</paragraph></subsection><subsection id="ID4177c78eca7c4a0db0186f0e9e9b5f4f"><enum>(e)</enum><header>Delivery sale
defined</header><text>In this section, the term <quote>delivery sale</quote>
has the meaning given that term in 2343(e) of title 18, United States
Code.</text>
</subsection></section><section id="id8B51C7087A9545509BF3C6B0DE8CC322"><enum>805.</enum><header>Tobacco grower
protection</header><text display-inline="no-display-inline">No provision of
this Act shall be construed to permit the Secretary of Health and Human
Services, or any other Federal official, 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><section id="IDeb015a82526b4604b53cd4e6339f9c8c"><enum>806.</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 or amendments
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 or amendments to any other person or circumstance shall not be affected,
and shall continue to be enforced to the fullest extent possible.</text>
</section>