Authorizing Legislation
PUBLIC LAW 111–31—JUNE 22, 2009
FAMILY SMOKING PREVENTION AND
TOBACCO CONTROL AND FEDERAL
RETIREMENT REFORM
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123 STAT. 1776 PUBLIC LAW 111–31—JUNE 22, 2009
Public Law 111–31
111th Congress
An Act
To protect the public health by providing the Food and Drug Administration with
certain authority to regulate tobacco products, to amend title 5, United States
Code, to make certain modifications in the Thrift Savings Plan, the Civil Service
Retirement System, and the Federal Employees’ Retirement System, and for
other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
DIVISION A—FAMILY SMOKING PREVENTION
AND TOBACCO CONTROL
ACT
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This division may be cited as the ‘‘Family
Smoking Prevention and Tobacco Control Act’’.
(b) TABLE OF CONTENTS.—The table of contents of this division
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
Sec. 6. Modification of deadlines for Secretarial action.
TITLE I—AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 102. Final rule.
Sec. 103. Conforming and other amendments to general provisions.
Sec. 104. Study on raising the minimum age to purchase tobacco products.
Sec. 105. Enforcement action plan for advertising and promotion restrictions.
Sec. 106. Studies of progress and effectiveness.
TITLE II—TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE
CONSTITUENT DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the public.
TITLE III—PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.
SEC. 2. FINDINGS.
The Congress finds the following:
21 USC 387 note.
21 USC 301 note.
Family Smoking
Prevention and
Tobacco Control
Act.
June 22, 2009
[H.R. 1256]
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1777
(1) The use of tobacco products by the Nation’s children
is a pediatric disease of considerable proportions that results
in new generations of tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous
and cause cancer, heart disease, and other serious adverse
health effects.
(3) Nicotine is an addictive drug.
(4) Virtually all new users of tobacco products are under
the minimum legal age to purchase such products.
(5) Tobacco advertising and marketing contribute significantly
to the use of nicotine-containing tobacco products by
adolescents.
(6) Because past efforts to restrict advertising and marketing
of tobacco products have failed adequately to curb
tobacco use by adolescents, comprehensive restrictions on the
sale, promotion, and distribution of such products are needed.
(7) Federal and State governments have lacked the legal
and regulatory authority and resources they need to address
comprehensively the public health and societal problems caused
by the use of tobacco products.
(8) Federal and State public health officials, the public
health community, and the public at large recognize that the
tobacco industry should be subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the Congress
is vested with the responsibility for regulating interstate
commerce and commerce with Indian tribes.
(10) The sale, distribution, marketing, advertising, and use
of tobacco products are activities in and substantially affecting
interstate commerce because they are sold, marketed, advertised,
and distributed in interstate commerce on a nationwide
basis, and have a substantial effect on the Nation’s economy.
(11) The sale, distribution, marketing, advertising, and use
of such products substantially affect interstate commerce
through the health care and other costs attributable to the
use of tobacco products.
(12) It is in the public interest for Congress to enact legislation
that provides the Food and Drug Administration with
the authority to regulate tobacco products and the advertising
and promotion of such products. The benefits to the American
people from enacting such legislation would be significant in
human and economic terms.
(13) Tobacco use is the foremost preventable cause of premature
death in America. It causes over 400,000 deaths in
the United States each year, and approximately 8,600,000
Americans have chronic illnesses related to smoking.
(14) Reducing the use of tobacco by minors by 50 percent
would prevent well over 10,000,000 of today’s children from
becoming regular, daily smokers, saving over 3,000,000 of them
from premature death due to tobacco-induced disease. Such
a reduction in youth smoking would also result in approximately
$75,000,000,000 in savings attributable to reduced
health care costs.
(15) Advertising, marketing, and promotion of tobacco products
have been especially directed to attract young persons
to use tobacco products, and these efforts have resulted in
increased use of such products by youth. Past efforts to oversee
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123 STAT. 1778 PUBLIC LAW 111–31—JUNE 22, 2009
these activities have not been successful in adequately preventing
such increased use.
(16) In 2005, the cigarette manufacturers spent more than
$13,000,000,000 to attract new users, retain current users,
increase current consumption, and generate favorable long-term
attitudes toward smoking and tobacco use.
(17) Tobacco product advertising often misleadingly portrays
the use of tobacco as socially acceptable and healthful
to minors.
(18) Tobacco product advertising is regularly seen by persons
under the age of 18, and persons under the age of 18
are regularly exposed to tobacco product promotional efforts.
(19) Through advertisements during and sponsorship of
sporting events, tobacco has become strongly associated with
sports and has become portrayed as an integral part of sports
and the healthy lifestyle associated with rigorous sporting
activity.
(20) Children are exposed to substantial and unavoidable
tobacco advertising that leads to favorable beliefs about tobacco
use, plays a role in leading young people to overestimate the
prevalence of tobacco use, and increases the number of young
people who begin to use tobacco.
(21) The use of tobacco products in motion pictures and
other mass media glamorizes its use for young people and
encourages them to use tobacco products.
(22) Tobacco advertising expands the size of the tobacco
market by increasing consumption of tobacco products including
tobacco use by young people.
(23) Children are more influenced by tobacco marketing
than adults: more than 80 percent of youth smoke three heavily
marketed brands, while only 54 percent of adults, 26 and older,
smoke these same brands.
(24) Tobacco company documents indicate that young
people are an important and often crucial segment of the
tobacco market. Children, who tend to be more price sensitive
than adults, are influenced by advertising and promotion practices
that result in drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will have a
positive effect on the smoking rates of young people.
(26) Restrictions on advertising are necessary to prevent
unrestricted tobacco advertising from undermining legislation
prohibiting access to young people and providing for education
about tobacco use.
(27) International experience shows that advertising regulations
that are stringent and comprehensive have a greater
impact on overall tobacco use and young people’s use than
weaker or less comprehensive ones.
(28) Text only requirements, although not as stringent
as a ban, will help reduce underage use of tobacco products
while preserving the informational function of advertising.
(29) It is in the public interest for Congress to adopt legislation
to address the public health crisis created by actions of
the tobacco industry.
(30) The final regulations promulgated by the Secretary
of Health and Human Services in the August 28, 1996, issue
of the Federal Register (61 Fed. Reg. 44615–44618) for inclusion
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1779
as part 897 of title 21, Code of Federal Regulations, are consistent
with the first amendment to the United States Constitution
and with the standards set forth in the amendments made
by this subtitle for the regulation of tobacco products by the
Food and Drug Administration, and the restriction on the sale
and distribution of, including access to and the advertising
and promotion of, tobacco products contained in such regulations
are substantially related to accomplishing the public
health goals of this division.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government’s
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences associated
with tobacco use. An overwhelming majority of Americans who
use tobacco products begin using such products while they
are minors and become addicted to the nicotine in those products
before reaching the age of 18. Tobacco advertising and
promotion play a crucial role in the decision of these minors
to begin using tobacco products. Less restrictive and less comprehensive
approaches have not and will not be effective in
reducing the problems addressed by such regulations. The
reasonable restrictions on the advertising and promotion of
tobacco products contained in such regulations will lead to
a significant decrease in the number of minors using and
becoming addicted to those products.
(32) The regulations described in paragraph (30) impose
no more extensive restrictions on communication by tobacco
manufacturers and sellers than are necessary to reduce the
number of children and adolescents who use cigarettes and
smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations are
narrowly tailored to restrict those advertising and promotional
practices which are most likely to be seen or heard by youth
and most likely to entice them into tobacco use, while affording
tobacco manufacturers and sellers ample opportunity to convey
information about their products to adult consumers.
(33) Tobacco dependence is a chronic disease, one that
typically requires repeated interventions to achieve long-term
or permanent abstinence.
(34) Because the only known safe alternative to smoking
is cessation, interventions should target all smokers to help
them quit completely.
(35) Tobacco products have been used to facilitate and
finance criminal activities both domestically and internationally.
Illicit trade of tobacco products has been linked to organized
crime and terrorist groups.
(36) It is essential that the Food and Drug Administration
review products sold or distributed for use to reduce risks
or exposures associated with tobacco products and that it be
empowered to review any advertising and labeling for such
products. It is also essential that manufacturers, prior to marketing
such products, be required to demonstrate that such
products will meet a series of rigorous criteria, and will benefit
the health of the population as a whole, taking into account
both users of tobacco products and persons who do not currently
use tobacco products.
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123 STAT. 1780 PUBLIC LAW 111–31—JUNE 22, 2009
(37) Unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such risks,
those products can cause substantial harm to the public health
to the extent that the individuals, who would otherwise not
consume tobacco products or would consume such products
less, use tobacco products purporting to reduce risk. Those
who use products sold or distributed as modified risk products
that do not in fact reduce risk, rather than quitting or reducing
their use of tobacco products, have a substantially increased
likelihood of suffering disability and premature death. The
costs to society of the widespread use of products sold or distributed
as modified risk products that do not in fact reduce risk
or that increase risk include thousands of unnecessary deaths
and injuries and huge costs to our health care system.
(38) As the National Cancer Institute has found, many
smokers mistakenly believe that ‘‘low tar’’ and ‘‘light’’ cigarettes
cause fewer health problems than other cigarettes. As the
National Cancer Institute has also found, mistaken beliefs
about the health consequences of smoking ‘‘low tar’’ and ‘‘light’’
cigarettes can reduce the motivation to quit smoking entirely
and thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been
no reduction in risk on a population-wide basis from ‘‘low
tar’’ and ‘‘light’’ cigarettes, and such products may actually
increase the risk of tobacco use.
(40) The dangers of products sold or distributed as modified
risk tobacco products that do not in fact reduce risk are so
high that there is a compelling governmental interest in
ensuring that statements about modified risk tobacco products
are complete, accurate, and relate to the overall disease risk
of the product.
(41) As the Federal Trade Commission has found, consumers
have misinterpreted advertisements in which one
product is claimed to be less harmful than a comparable
product, even in the presence of disclosures and advisories
intended to provide clarification.
(42) Permitting manufacturers to make unsubstantiated
statements concerning modified risk tobacco products, whether
express or implied, even if accompanied by disclaimers would
be detrimental to the public health.
(43) The only way to effectively protect the public health
from the dangers of unsubstantiated modified risk tobacco products
is to empower the Food and Drug Administration to require
that products that tobacco manufacturers sold or distributed
for risk reduction be reviewed in advance of marketing, and
to require that the evidence relied on to support claims be
fully verified.
(44) The Food and Drug Administration is a regulatory
agency with the scientific expertise to identify harmful substances
in products to which consumers are exposed, to design
standards to limit exposure to those substances, to evaluate
scientific studies supporting claims about the safety of products,
and to evaluate the impact of labels, labeling, and advertising
on consumer behavior in order to reduce the risk of harm
and promote understanding of the impact of the product on
health. In connection with its mandate to promote health and
reduce the risk of harm, the Food and Drug Administration
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1781
routinely makes decisions about whether and how products
may be marketed in the United States.
(45) The Federal Trade Commission was created to protect
consumers from unfair or deceptive acts or practices, and to
regulate unfair methods of competition. Its focus is on those
marketplace practices that deceive or mislead consumers, and
those that give some competitors an unfair advantage. Its mission
is to regulate activities in the marketplace. Neither the
Federal Trade Commission nor any other Federal agency except
the Food and Drug Administration possesses the scientific
expertise needed to implement effectively all provisions of the
Family Smoking Prevention and Tobacco Control Act.
(46) If manufacturers state or imply in communications
directed to consumers through the media or through a label,
labeling, or advertising, that a tobacco product is approved
or inspected by the Food and Drug Administration or complies
with Food and Drug Administration standards, consumers are
likely to be confused and misled. Depending upon the particular
language used and its context, such a statement could result
in consumers being misled into believing that the product is
endorsed by the Food and Drug Administration for use or
in consumers being misled about the harmfulness of the product
because of such regulation, inspection, approval, or compliance.
(47) In August 2006 a United States district court judge
found that the major United States cigarette companies continue
to target and market to youth. USA v. Philip Morris,
USA, Inc., et al. (Civil Action No. 99–2496 (GK), August 17,
2006).
(48) In August 2006 a United States district court judge
found that the major United States cigarette companies
dramatically increased their advertising and promotional
spending in ways that encourage youth to start smoking subsequent
to the signing of the Master Settlement Agreement in
1998. USA v. Philip Morris, USA, Inc., et al. (Civil Action
No. 99–2496 (GK), August 17, 2006).
(49) In August 2006 a United States district court judge
found that the major United States cigarette companies have
designed their cigarettes to precisely control nicotine delivery
levels and provide doses of nicotine sufficient to create and
sustain addiction while also concealing much of their nicotinerelated
research. USA v. Philip Morris, USA, Inc., et al. (Civil
Action No. 99–2496 (GK), August 17, 2006).
SEC. 3. PURPOSE.
The purposes of this division are—
(1) to provide authority to the Food and Drug Administration
to regulate tobacco products under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it
as the primary Federal regulatory authority with respect to
the manufacture, marketing, and distribution of tobacco products
as provided for in this division;
(2) to ensure that the Food and Drug Administration has
the authority to address issues of particular concern to public
health officials, especially the use of tobacco by young people
and dependence on tobacco;
21 USC 387 note.
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123 STAT. 1782 PUBLIC LAW 111–31—JUNE 22, 2009
(3) to authorize the Food and Drug Administration to set
national standards controlling the manufacture of tobacco products
and the identity, public disclosure, and amount of ingredients
used in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco industry’s
efforts to develop, introduce, and promote less harmful tobacco
products;
(5) to vest the Food and Drug Administration with the
authority to regulate the levels of tar, nicotine, and other
harmful components of tobacco products;
(6) in order to ensure that consumers are better informed,
to require tobacco product manufacturers to disclose research
which has not previously been made available, as well as
research generated in the future, relating to the health and
dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to
adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the tobacco
industry;
(9) to promote cessation to reduce disease risk and the
social costs associated with tobacco-related diseases; and
(10) to strengthen legislation against illicit trade in tobacco
products.
SEC. 4. SCOPE AND EFFECT.
(a) INTENDED EFFECT.—Nothing in this division (or an amendment
made by this division) shall be construed to—
(1) establish a precedent with regard to any other industry,
situation, circumstance, or legal action; or
(2) affect any action pending in Federal, State, or tribal
court, or any agreement, consent decree, or contract of any
kind.
(b) AGRICULTURAL ACTIVITIES.—The provisions of this division
(or an amendment made by this division) which authorize the
Secretary to take certain actions with regard to tobacco and tobacco
products shall not be construed to affect any authority of the Secretary
of Agriculture under existing law regarding the growing,
cultivation, or curing of raw tobacco.
(c) REVENUE ACTIVITIES.—The provisions of this division (or
an amendment made by this division) which authorize the Secretary
to take certain actions with regard to tobacco products shall not
be construed to affect any authority of the Secretary of the Treasury
under chapter 52 of the Internal Revenue Code of 1986.
SEC. 5. SEVERABILITY.
If any provision of this division, of the amendments made
by this division, or of the regulations promulgated under this division
(or under such amendments), or the application of any such
provision to any person or circumstance is held to be invalid,
the remainder of this division, such amendments and such regulations,
and the application of such provisions to any other person
or circumstance shall not be affected and shall continue to be
enforced to the fullest extent possible.
21 USC 387 note.
21 USC 387 note.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1783
SEC. 6. MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION.
(a) DELAYED COMMENCEMENT OF DATES FOR SECRETARIAL
ACTION.—
(1) IN GENERAL.—Except as provided in subsection (c), with
respect to any time periods specified in this division (or in
an amendment made by this division) that begin on the date
of enactment of this Act, within which the Secretary of Health
and Human Services is required to carry out and complete
specified activities, the calculation of such time periods shall
commence on the date described in subsection (b).
(2) LIMITATION.—Subsection (a) shall only apply with
respect to obligations of the Secretary of Health and Human
Services that must be completed within a specified time period
and shall not apply to the obligations of any other person
or to any other provision of this division (including the amendments
made by this division) that do not create such obligations
of the Secretary and are not contingent on actions by the
Secretary.
(b) DATE DESCRIBED.—The date described in this subsection
is the first day of the first fiscal quarter following the initial
2 consecutive fiscal quarters of fiscal year 2010 for which the
Secretary of Health and Human Services has collected fees under
section 919 of the Federal Food, Drug, and Cosmetic Act (as added
by section 101).
(c) EXCEPTION.—Subsection (a) shall not apply to any time
period (or date) contained—
(1) in section 102, except that the reference to ‘‘180 days’’
in subsection (a)(1) of such section shall be deemed to be
‘‘270 days’’; and
(2) in sections 201 through 204 (or the amendments made
by any such sections).
(d) ADJUSTMENT.—The Secretary of Health and Human Services
may extend or reduce the duration of one or more time periods
to which subsection (a) applies if the Secretary determines appropriate,
except that no such period shall be extended for more than
90 days.
TITLE I—AUTHORITY OF THE FOOD
AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) DEFINITION OF TOBACCO PRODUCTS.—Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended
by adding at the end the following:
‘‘(rr)(1) The term ‘tobacco product’ means any product made
or derived from tobacco that is intended for human consumption,
including any component, part, or accessory of a tobacco product
(except for raw materials other than tobacco used in manufacturing
a component, part, or accessory of a tobacco product).
‘‘(2) The term ‘tobacco product’ does not mean an article that
is a drug under subsection (g)(1), a device under subsection (h),
or a combination product described in section 503(g).
‘‘(3) The products described in paragraph (2) shall be subject
to chapter V of this Act.
Applicability.
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123 STAT. 1784 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(4) A tobacco product shall not be marketed in combination
with any other article or product regulated under this Act (including
a drug, biologic, food, cosmetic, medical device, or a dietary supplement).’’.
(b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—The Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended—
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 910 as sections
1001 through 1010; and
(3) by inserting after chapter VIII the following:
‘‘CHAPTER IX—TOBACCO PRODUCTS
‘‘SEC. 900. DEFINITIONS.
‘‘In this chapter:
‘‘(1) ADDITIVE.—The term ‘additive’ means any substance
the intended use of which results or may reasonably be expected
to result, directly or indirectly, in its becoming a component
or otherwise affecting the characteristic of any tobacco product
(including any substances intended for use as a flavoring or
coloring or in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding), except
that such term does not include tobacco or a pesticide chemical
residue in or on raw tobacco or a pesticide chemical.
‘‘(2) BRAND.—The term ‘brand’ means a variety of tobacco
product distinguished by the tobacco used, tar content, nicotine
content, flavoring used, size, filtration, packaging, logo, registered
trademark, brand name, identifiable pattern of colors,
or any combination of such attributes.
‘‘(3) CIGARETTE.—The term ‘cigarette’—
‘‘(A) means a product that—
‘‘(i) is a tobacco product; and
‘‘(ii) meets the definition of the term ‘cigarette’
in section 3(1) of the Federal Cigarette Labeling and
Advertising Act; and
‘‘(B) includes tobacco, in any form, that is functional
in the product, which, because of its appearance, the type
of tobacco used in the filler, or its packaging and labeling,
is likely to be offered to, or purchased by, consumers as
a cigarette or as roll-your-own tobacco.
‘‘(4) CIGARETTE TOBACCO.—The term ‘cigarette tobacco’
means any product that consists of loose tobacco that is
intended for use by consumers in a cigarette. Unless otherwise
stated, the requirements applicable to cigarettes under this
chapter shall also apply to cigarette tobacco.
‘‘(5) COMMERCE.—The term ‘commerce’ has the meaning
given that term by section 3(2) of the Federal Cigarette Labeling
and Advertising Act.
‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The term ‘counterfeit
tobacco product’ means a tobacco product (or the container
or labeling of such a product) that, without authorization, bears
the trademark, trade name, or other identifying mark, imprint,
or device, or any likeness thereof, of a tobacco product listed
in a registration under section 905(i)(1).
‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as regards a
tobacco product means any person who furthers the distribution
of a tobacco product, whether domestic or imported, at any
21 USC 387.
21 USC 391
et seq.
21 USC 391,
301 note,
392 and note,
393–399a.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1785
point from the original place of manufacture to the person
who sells or distributes the product to individuals for personal
consumption. Common carriers are not considered distributors
for purposes of this chapter.
‘‘(8) ILLICIT TRADE.—The term ‘illicit trade’ means any practice
or conduct prohibited by law which relates to production,
shipment, receipt, possession, distribution, sale, or purchase
of tobacco products including any practice or conduct intended
to facilitate such activity.
‘‘(9) INDIAN COUNTRY.—The term ‘Indian country’ has the
meaning given such term in section 1151 of title 18, United
States Code.
‘‘(10) INDIAN TRIBE.—The term ‘Indian tribe’ has the
meaning given such term in section 4(e) of the Indian Self-
Determination and Education Assistance Act.
‘‘(11) LITTLE CIGAR.—The term ‘little cigar’ means a product
that—
‘‘(A) is a tobacco product; and
‘‘(B) meets the definition of the term ‘little cigar’ in
section 3(7) of the Federal Cigarette Labeling and Advertising
Act.
‘‘(12) NICOTINE.—The term ‘nicotine’ means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or
C[10]H[14]N[2], including any salt or complex of nicotine.
‘‘(13) PACKAGE.—The term ‘package’ means a pack, box,
carton, or container of any kind or, if no other container,
any wrapping (including cellophane), in which a tobacco product
is offered for sale, sold, or otherwise distributed to consumers.
‘‘(14) RETAILER.—The term ‘retailer’ means any person,
government, or entity who sells tobacco products to individuals
for personal consumption, or who operates a facility where
self-service displays of tobacco products are permitted.
‘‘(15) ROLL-YOUR-OWN TOBACCO.—The term ‘roll-your-own
tobacco’ means any tobacco product which, because of its
appearance, type, packaging, or labeling, is suitable for use
and likely to be offered to, or purchased by, consumers as
tobacco for making cigarettes.
‘‘(16) SMALL TOBACCO PRODUCT MANUFACTURER.—The term
‘small tobacco product manufacturer’ means a tobacco product
manufacturer that employs fewer than 350 employees. For purposes
of determining the number of employees of a manufacturer
under the preceding sentence, the employees of a manufacturer
are deemed to include the employees of each entity
that controls, is controlled by, or is under common control
with such manufacturer.
‘‘(17) SMOKE CONSTITUENT.—The term ‘smoke constituent’
means any chemical or chemical compound in mainstream or
sidestream tobacco smoke that either transfers from any component
of the cigarette to the smoke or that is formed by the
combustion or heating of tobacco, additives, or other component
of the tobacco product.
‘‘(18) SMOKELESS TOBACCO.—The term ‘smokeless tobacco’
means any tobacco product that consists of cut, ground, powdered,
or leaf tobacco and that is intended to be placed in
the oral or nasal cavity.
‘‘(19) STATE; TERRITORY.—The terms ‘State’ and ‘Territory’
shall have the meanings given to such terms in section 201.
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123 STAT. 1786 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(20) TOBACCO PRODUCT MANUFACTURER.—The term
‘tobacco product manufacturer’ means any person, including
any repacker or relabeler, who—
‘‘(A) manufactures, fabricates, assembles, processes, or
labels a tobacco product; or
‘‘(B) imports a finished tobacco product for sale or
distribution in the United States.
‘‘(21) TOBACCO WAREHOUSE.—
‘‘(A) Subject to subparagraphs (B) and (C), the term
‘tobacco warehouse’ includes any person—
‘‘(i) who—
‘‘(I) removes foreign material from tobacco leaf
through nothing other than a mechanical process;
‘‘(II) humidifies tobacco leaf with nothing other
than potable water in the form of steam or mist;
or
‘‘(III) de-stems, dries, and packs tobacco leaf
for storage and shipment;
‘‘(ii) who performs no other actions with respect
to tobacco leaf; and
‘‘(iii) who provides to any manufacturer to whom
the person sells tobacco all information related to the
person’s actions described in clause (i) that is necessary
for compliance with this Act.
‘‘(B) The term ‘tobacco warehouse’ excludes any person
who—
‘‘(i) reconstitutes tobacco leaf;
‘‘(ii) is a manufacturer, distributor, or retailer of
a tobacco product; or
‘‘(iii) applies any chemical, additive, or substance
to the tobacco leaf other than potable water in the
form of steam or mist.
‘‘(C) The definition of the term ‘tobacco warehouse’
in subparagraph (A) shall not apply to the extent to which
the Secretary determines, through rulemaking, that regulation
under this chapter of the actions described in such
subparagraph is appropriate for the protection of the public
health.
‘‘(22) UNITED STATES.—The term ‘United States’ means the
50 States of the United States of America and the District
of Columbia, the Commonwealth of Puerto Rico, Guam, the
Virgin Islands, American Samoa, Wake Island, Midway Islands,
Kingman Reef, Johnston Atoll, the Northern Mariana Islands,
and any other trust territory or possession of the United States.
‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—Tobacco products, including modified risk
tobacco products for which an order has been issued in accordance
with section 911, shall be regulated by the Secretary under this
chapter and shall not be subject to the provisions of chapter V.
‘‘(b) APPLICABILITY.—This chapter shall apply to all cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and
to any other tobacco products that the Secretary by regulation
deems to be subject to this chapter.
‘‘(c) SCOPE.—
‘‘(1) IN GENERAL.—Nothing in this chapter, or any policy
issued or regulation promulgated thereunder, or in sections
Regulations.
21 USC 387a.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1787
101(a), 102, or 103 of title I, title II, or title III of the Family
Smoking Prevention and Tobacco Control Act, shall be construed
to affect, expand, or limit the Secretary’s authority over
(including the authority to determine whether products may
be regulated), or the regulation of, products under this Act
that are not tobacco products under chapter V or any other
chapter.
‘‘(2) LIMITATION OF AUTHORITY.—
‘‘(A) IN GENERAL.—The provisions of this chapter shall
not apply to tobacco leaf that is not in the possession
of a manufacturer of tobacco products, or to the producers
of tobacco leaf, including tobacco growers, tobacco warehouses,
and tobacco grower cooperatives, nor shall any
employee of the Food and Drug Administration have any
authority to enter onto a farm owned by a producer of
tobacco leaf without the written consent of such producer.
‘‘(B) EXCEPTION.—Notwithstanding subparagraph (A),
if a producer of tobacco leaf is also a tobacco product
manufacturer or controlled by a tobacco product manufacturer,
the producer shall be subject to this chapter in
the producer’s capacity as a manufacturer. The exception
in this subparagraph shall not apply to a producer of
tobacco leaf who grows tobacco under a contract with a
tobacco product manufacturer and who is not otherwise
engaged in the manufacturing process.
‘‘(C) RULE OF CONSTRUCTION.—Nothing in this chapter
shall be construed to grant the Secretary authority to
promulgate regulations on any matter that involves the
production of tobacco leaf or a producer thereof, other than
activities by a manufacturer affecting production.
‘‘(d) RULEMAKING PROCEDURES.—Each rulemaking under this
chapter shall be in accordance with chapter 5 of title 5, United
States Code. This subsection shall not be construed to affect the
rulemaking provisions of section 102(a) of the Family Smoking
Prevention and Tobacco Control Act.
‘‘(e) CENTER FOR TOBACCO PRODUCTS.—Not later than 90 days
after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, the Secretary shall establish within the
Food and Drug Administration the Center for Tobacco Products,
which shall report to the Commissioner of Food and Drugs in
the same manner as the other agency centers within the Food
and Drug Administration. The Center shall be responsible for the
implementation of this chapter and related matters assigned by
the Commissioner.
‘‘(f) OFFICE TO ASSIST SMALL TOBACCO PRODUCT MANUFACTURERS.—
The Secretary shall establish within the Food and Drug
Administration an identifiable office to provide technical and other
nonfinancial assistance to small tobacco product manufacturers to
assist them in complying with the requirements of this Act.
‘‘(g) CONSULTATION PRIOR TO RULEMAKING.—Prior to promulgating
rules under this chapter, the Secretary shall endeavor to
consult with other Federal agencies as appropriate.
‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS.
‘‘A tobacco product shall be deemed to be adulterated if—
‘‘(1) it consists in whole or in part of any filthy, putrid,
or decomposed substance, or is otherwise contaminated by any
21 USC 387b.
Establishment.
Deadline.
Establishment.
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123 STAT. 1788 PUBLIC LAW 111–31—JUNE 22, 2009
added poisonous or added deleterious substance that may
render the product injurious to health;
‘‘(2) it has been prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth,
or whereby it may have been rendered injurious to health;
‘‘(3) its package is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health;
‘‘(4) the manufacturer or importer of the tobacco product
fails to pay a user fee assessed to such manufacturer or
importer pursuant to section 919 by the date specified in section
919 or by the 30th day after final agency action on a resolution
of any dispute as to the amount of such fee;
‘‘(5) it is, or purports to be or is represented as, a tobacco
product which is subject to a tobacco product standard established
under section 907 unless such tobacco product is in
all respects in conformity with such standard;
‘‘(6)(A) it is required by section 910(a) to have premarket
review and does not have an order in effect under section
910(c)(1)(A)(i); or
‘‘(B) it is in violation of an order under section 910(c)(1)(A);
‘‘(7) the methods used in, or the facilities or controls used
for, its manufacture, packing, or storage are not in conformity
with applicable requirements under section 906(e)(1) or an
applicable condition prescribed by an order under section
906(e)(2); or
‘‘(8) it is in violation of section 911.
‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—A tobacco product shall be deemed to be
misbranded—
‘‘(1) if its labeling is false or misleading in any particular;
‘‘(2) if in package form unless it bears a label containing—
‘‘(A) the name and place of business of the tobacco
product manufacturer, packer, or distributor;
‘‘(B) an accurate statement of the quantity of the contents
in terms of weight, measure, or numerical count;
‘‘(C) an accurate statement of the percentage of the
tobacco used in the product that is domestically grown
tobacco and the percentage that is foreign grown tobacco;
and
‘‘(D) the statement required under section 920(a),
except that under subparagraph (B) reasonable variations shall
be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary;
‘‘(3) if any word, statement, or other information required
by or under authority of this chapter to appear on the label
or labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
or designs in the labeling) and in such terms as to render
it likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
‘‘(4) if it has an established name, unless its label bears,
to the exclusion of any other nonproprietary name, its established
name prominently printed in type as required by the
Secretary by regulation;
Regulations.
Labeling.
21 USC 387c.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1789
‘‘(5) if the Secretary has issued regulations requiring that
its labeling bear adequate directions for use, or adequate
warnings against use by children, that are necessary for the
protection of users unless its labeling conforms in all respects
to such regulations;
‘‘(6) if it was manufactured, prepared, propagated, compounded,
or processed in an establishment not duly registered
under section 905(b), 905(c), 905(d), or 905(h), if it was not
included in a list required by section 905(i), if a notice or
other information respecting it was not provided as required
by such section or section 905(j), or if it does not bear such
symbols from the uniform system for identification of tobacco
products prescribed under section 905(e) as the Secretary by
regulation requires;
‘‘(7) if, in the case of any tobacco product distributed or
offered for sale in any State—
‘‘(A) its advertising is false or misleading in any particular;
or
‘‘(B) it is sold or distributed in violation of regulations
prescribed under section 906(d);
‘‘(8) unless, in the case of any tobacco product distributed
or offered for sale in any State, the manufacturer, packer,
or distributor thereof includes in all advertisements and other
descriptive printed matter issued or caused to be issued by
the manufacturer, packer, or distributor with respect to that
tobacco product—
‘‘(A) a true statement of the tobacco product’s established
name as described in paragraph (4), printed prominently;
and
‘‘(B) a brief statement of—
‘‘(i) the uses of the tobacco product and relevant
warnings, precautions, side effects, and contraindications;
and
‘‘(ii) in the case of specific tobacco products made
subject to a finding by the Secretary after notice and
opportunity for comment that such action is appropriate
to protect the public health, a full description
of the components of such tobacco product or the formula
showing quantitatively each ingredient of such
tobacco product to the extent required in regulations
which shall be issued by the Secretary after an opportunity
for a hearing;
‘‘(9) if it is a tobacco product subject to a tobacco product
standard established under section 907, unless it bears such
labeling as may be prescribed in such tobacco product standard;
or
‘‘(10) if there was a failure or refusal—
‘‘(A) to comply with any requirement prescribed under
section 904 or 908; or
‘‘(B) to furnish any material or information required
under section 909.
‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.—The Secretary
may, by regulation, require prior approval of statements made
on the label of a tobacco product to ensure that such statements
do not violate the misbranding provisions of subsection (a) and
that such statements comply with other provisions of the Family
Regulations.
Hearings.
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123 STAT. 1790 PUBLIC LAW 111–31—JUNE 22, 2009
Smoking Prevention and Tobacco Control Act (including the amendments
made by such Act). No regulation issued under this subsection
may require prior approval by the Secretary of the content
of any advertisement, except for modified risk tobacco products
as provided in section 911. No advertisement of a tobacco product
published after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act shall, with respect to the language
of label statements as prescribed under section 4 of the
Federal Cigarette Labeling and Advertising Act and section 3 of
the Comprehensive Smokeless Tobacco Health Education Act of
1986 or the regulations issued under such sections, be subject
to the provisions of sections 12 through 15 of the Federal Trade
Commission Act.
‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.
‘‘(a) REQUIREMENT.—Each tobacco product manufacturer or
importer, or agents thereof, shall submit to the Secretary the following
information:
‘‘(1) Not later than 6 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act,
a listing of all ingredients, including tobacco, substances, compounds,
and additives that are, as of such date, added by
the manufacturer to the tobacco, paper, filter, or other part
of each tobacco product by brand and by quantity in each
brand and subbrand.
‘‘(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Secretary in accordance with section 4(e) of the Federal Cigarette
Labeling and Advertising Act.
‘‘(3) Beginning 3 years after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, a listing
of all constituents, including smoke constituents as applicable,
identified by the Secretary as harmful or potentially harmful
to health in each tobacco product, and as applicable in the
smoke of each tobacco product, by brand and by quantity in
each brand and subbrand. Effective beginning 3 years after
such date of enactment, the manufacturer, importer, or agent
shall comply with regulations promulgated under section 915
in reporting information under this paragraph, where
applicable.
‘‘(4) Beginning 6 months after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act, all
documents developed after such date of enactment that relate
to health, toxicological, behavioral, or physiologic effects of current
or future tobacco products, their constituents (including
smoke constituents), ingredients, components, and additives.
‘‘(b) DATA SUBMISSION.—At the request of the Secretary, each
tobacco product manufacturer or importer of tobacco products, or
agents thereof, shall submit the following:
‘‘(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the manufacturer
(or agents thereof) on the health, toxicological, behavioral,
or physiologic effects of tobacco products and their constituents
Effective date.
Effective date.
Deadline.
21 USC 387d.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1791
(including smoke constituents), ingredients, components, and
additives.
‘‘(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the manufacturer
(or agents thereof) that relate to the issue of whether
a reduction in risk to health from tobacco products can occur
upon the employment of technology available or known to the
manufacturer.
‘‘(3) Any or all documents (including underlying scientific
or financial information) relating to marketing research
involving the use of tobacco products or marketing practices
and the effectiveness of such practices used by tobacco manufacturers
and distributors.
An importer of a tobacco product not manufactured in the United
States shall supply the information required of a tobacco product
manufacturer under this subsection.
‘‘(c) TIME FOR SUBMISSION.—
‘‘(1) IN GENERAL.—At least 90 days prior to the delivery
for introduction into interstate commerce of a tobacco product
not on the market on the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the manufacturer
of such product shall provide the information required under
subsection (a).
‘‘(2) DISCLOSURE OF ADDITIVE.—If at any time a tobacco
product manufacturer adds to its tobacco products a new
tobacco additive or increases the quantity of an existing tobacco
additive, the manufacturer shall, except as provided in paragraph
(3), at least 90 days prior to such action so advise
the Secretary in writing.
‘‘(3) DISCLOSURE OF OTHER ACTIONS.—If at any time a
tobacco product manufacturer eliminates or decreases an
existing additive, or adds or increases an additive that has
by regulation been designated by the Secretary as an additive
that is not a human or animal carcinogen, or otherwise harmful
to health under intended conditions of use, the manufacturer
shall within 60 days of such action so advise the Secretary
in writing.
‘‘(d) DATA LIST.—
‘‘(1) IN GENERAL.—Not later than 3 years after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, and annually thereafter, the Secretary shall publish
in a format that is understandable and not misleading
to a lay person, and place on public display (in a manner
determined by the Secretary) the list established under subsection
(e).
‘‘(2) CONSUMER RESEARCH.—The Secretary shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay persons. Not
later than 5 years after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the Secretary
shall submit to the appropriate committees of Congress a report
on the results of such research, together with recommendations
on whether such publication should be continued or modified.
‘‘(e) DATA COLLECTION.—Not later than 24 months after the
date of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall establish, and periodically revise
Deadline.
Deadline.
Reports.
Recommendations.
Deadlines.
Publication.
Public
information.
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123 STAT. 1792 PUBLIC LAW 111–31—JUNE 22, 2009
as appropriate, a list of harmful and potentially harmful constituents,
including smoke constituents, to health in each tobacco product
by brand and by quantity in each brand and subbrand. The Secretary
shall publish a public notice requesting the submission by
interested persons of scientific and other information concerning
the harmful and potentially harmful constituents in tobacco products
and tobacco smoke.
‘‘SEC. 905. ANNUAL REGISTRATION.
‘‘(a) DEFINITIONS.—In this section:
‘‘(1) MANUFACTURE, PREPARATION, COMPOUNDING, OR PROCESSING.—
The term ‘manufacture, preparation, compounding, or
processing’ shall include repackaging or otherwise changing
the container, wrapper, or labeling of any tobacco product package
in furtherance of the distribution of the tobacco product
from the original place of manufacture to the person who makes
final delivery or sale to the ultimate consumer or user.
‘‘(2) NAME.—The term ‘name’ shall include in the case
of a partnership the name of each partner and, in the case
of a corporation, the name of each corporate officer and director,
and the State of incorporation.
‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.—On or before
December 31 of each year, every person who owns or operates
any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product or
tobacco products shall register with the Secretary the name, places
of business, and all such establishments of that person. If enactment
of the Family Smoking Prevention and Tobacco Control Act occurs
in the second half of the calendar year, the Secretary shall designate
a date no later than 6 months into the subsequent calendar year
by which registration pursuant to this subsection shall occur.
‘‘(c) REGISTRATION BY NEW OWNERS AND OPERATORS.—Every
person upon first engaging in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products
in any establishment owned or operated in any State by that
person shall immediately register with the Secretary that person’s
name, place of business, and such establishment.
‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—Every person
required to register under subsection (b) or (c) shall immediately
register with the Secretary any additional establishment which
that person owns or operates in any State and in which that
person begins the manufacture, preparation, compounding, or processing
of a tobacco product or tobacco products.
‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYSTEM.—The Secretary
may by regulation prescribe a uniform system for the identification
of tobacco products and may require that persons who
are required to list such tobacco products under subsection (i)
shall list such tobacco products in accordance with such system.
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMATION.—The Secretary
shall make available for inspection, to any person so
requesting, any registration filed under this section.
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTABLISHMENTS.—
Every establishment registered with the Secretary under this section
shall be subject to inspection under section 704 or subsection
(h), and every such establishment engaged in the manufacture,
compounding, or processing of a tobacco product or tobacco products
shall be so inspected by 1 or more officers or employees duly
Deadline.
21 USC 387e.
Publication.
Notice.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1793
designated by the Secretary at least once in the 2-year period
beginning with the date of registration of such establishment under
this section and at least once in every successive 2-year period
thereafter.
‘‘(h) REGISTRATION BY FOREIGN ESTABLISHMENTS.—Any
establishment within any foreign country engaged in the manufacture,
preparation, compounding, or processing of a tobacco product
or tobacco products, shall register under this section under regulations
promulgated by the Secretary. Such regulations shall require
such establishment to provide the information required by subsection
(i) and shall include provisions for registration of any such
establishment upon condition that adequate and effective means
are available, by arrangement with the government of such foreign
country or otherwise, to enable the Secretary to determine from
time to time whether tobacco products manufactured, prepared,
compounded, or processed in such establishment, if imported or
offered for import into the United States, shall be refused admission
on any of the grounds set forth in section 801(a).
‘‘(i) REGISTRATION INFORMATION.—
‘‘(1) PRODUCT LIST.—Every person who registers with the
Secretary under subsection (b), (c), (d), or (h) shall, at the
time of registration under any such subsection, file with the
Secretary a list of all tobacco products which are being manufactured,
prepared, compounded, or processed by that person for
commercial distribution and which have not been included in
any list of tobacco products filed by that person with the Secretary
under this paragraph or paragraph (2) before such time
of registration. Such list shall be prepared in such form and
manner as the Secretary may prescribe and shall be accompanied
by—
‘‘(A) in the case of a tobacco product contained in
the applicable list with respect to which a tobacco product
standard has been established under section 907 or which
is subject to section 910, a reference to the authority for
the marketing of such tobacco product and a copy of all
labeling for such tobacco product;
‘‘(B) in the case of any other tobacco product contained
in an applicable list, a copy of all consumer information
and other labeling for such tobacco product, a representative
sampling of advertisements for such tobacco product,
and, upon request made by the Secretary for good cause,
a copy of all advertisements for a particular tobacco
product; and
‘‘(C) if the registrant filing a list has determined that
a tobacco product contained in such list is not subject
to a tobacco product standard established under section
907, a brief statement of the basis upon which the registrant
made such determination if the Secretary requests
such a statement with respect to that particular tobacco
product.
‘‘(2) CONSULTATION WITH RESPECT TO FORMS.—The Secretary
shall consult with the Secretary of the Treasury in
developing the forms to be used for registration under this
section to minimize the burden on those persons required to
register with both the Secretary and the Tax and Trade Bureau
of the Department of the Treasury.
Regulations.
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123 STAT. 1794 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(3) BIANNUAL REPORT OF ANY CHANGE IN PRODUCT LIST.—
Each person who registers with the Secretary under this section
shall report to the Secretary once during the month of June
of each year and once during the month of December of each
year the following:
‘‘(A) A list of each tobacco product introduced by the
registrant for commercial distribution which has not been
included in any list previously filed by that person with
the Secretary under this subparagraph or paragraph (1).
A list under this subparagraph shall list a tobacco product
by its established name and shall be accompanied by the
other information required by paragraph (1).
‘‘(B) If since the date the registrant last made a report
under this paragraph that person has discontinued the
manufacture, preparation, compounding, or processing for
commercial distribution of a tobacco product included in
a list filed under subparagraph (A) or paragraph (1), notice
of such discontinuance, the date of such discontinuance,
and the identity of its established name.
‘‘(C) If since the date the registrant reported under
subparagraph (B) a notice of discontinuance that person
has resumed the manufacture, preparation, compounding,
or processing for commercial distribution of the tobacco
product with respect to which such notice of discontinuance
was reported, notice of such resumption, the date of such
resumption, the identity of such tobacco product by established
name, and other information required by paragraph
(1), unless the registrant has previously reported such
resumption to the Secretary under this subparagraph.
‘‘(D) Any material change in any information previously
submitted under this paragraph or paragraph (1).
‘‘(j) REPORT PRECEDING INTRODUCTION OF CERTAIN SUBSTANTIALLY
EQUIVALENT PRODUCTS INTO INTERSTATE COMMERCE.—
‘‘(1) IN GENERAL.—Each person who is required to register
under this section and who proposes to begin the introduction
or delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for
human use that was not commercially marketed (other than
for test marketing) in the United States as of February 15,
2007, shall, at least 90 days prior to making such introduction
or delivery, report to the Secretary (in such form and manner
as the Secretary shall prescribe)—
‘‘(A) the basis for such person’s determination that—
‘‘(i) the tobacco product is substantially equivalent,
within the meaning of section 910, to a tobacco product
commercially marketed (other than for test marketing)
in the United States as of February 15, 2007, or to
a tobacco product that the Secretary has previously
determined, pursuant to subsection (a)(3) of section
910, is substantially equivalent and that is in compliance
with the requirements of this Act; or
‘‘(ii) the tobacco product is modified within the
meaning of paragraph (3), the modifications are to
a product that is commercially marketed and in compliance
with the requirements of this Act, and all of
the modifications are covered by exemptions granted
by the Secretary pursuant to paragraph (3); and
Notice.
Notice.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1795
‘‘(B) action taken by such person to comply with the
requirements under section 907 that are applicable to the
tobacco product.
‘‘(2) APPLICATION TO CERTAIN POST-FEBRUARY 15, 2007, PRODUCTS.—
A report under this subsection for a tobacco product
that was first introduced or delivered for introduction into
interstate commerce for commercial distribution in the United
States after February 15, 2007, and prior to the date that
is 21 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act shall be submitted to the
Secretary not later than 21 months after such date of enactment.
‘‘(3) EXEMPTIONS.—
‘‘(A) IN GENERAL.—The Secretary may exempt from
the requirements of this subsection relating to the demonstration
that a tobacco product is substantially equivalent
within the meaning of section 910, tobacco products
that are modified by adding or deleting a tobacco additive,
or increasing or decreasing the quantity of an existing
tobacco additive, if the Secretary determines that—
‘‘(i) such modification would be a minor modification
of a tobacco product that can be sold under this
Act;
‘‘(ii) a report under this subsection is not necessary
to ensure that permitting the tobacco product to be
marketed would be appropriate for protection of the
public health; and
‘‘(iii) an exemption is otherwise appropriate.
‘‘(B) REGULATIONS.—Not later than 15 months after
the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, the Secretary shall issue regulations
to implement this paragraph.
‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO
PRODUCTS.
‘‘(a) IN GENERAL.—Any requirement established by or under
section 902, 903, 905, or 909 applicable to a tobacco product shall
apply to such tobacco product until the applicability of the requirement
to the tobacco product has been changed by action taken
under section 907, section 910, section 911, or subsection (d) of
this section, and any requirement established by or under section
902, 903, 905, or 909 which is inconsistent with a requirement
imposed on such tobacco product under section 907, section 910,
section 911, or subsection (d) of this section shall not apply to
such tobacco product.
‘‘(b) INFORMATION ON PUBLIC ACCESS AND COMMENT.—Each
notice of proposed rulemaking or other notification under section
907, 908, 909, 910, or 911 or under this section, any other notice
which is published in the Federal Register with respect to any
other action taken under any such section and which states the
reasons for such action, and each publication of findings required
to be made in connection with rulemaking under any such section
shall set forth—
‘‘(1) the manner in which interested persons may examine
data and other information on which the notice or findings
is based; and
Notice.
Federal Register,
publication.
Applicability.
21 USC 387f.
Deadline.
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123 STAT. 1796 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(2) the period within which interested persons may present
their comments on the notice or findings (including the need
therefore) orally or in writing, which period shall be at least
60 days but may not exceed 90 days unless the time is extended
by the Secretary by a notice published in the Federal Register
stating good cause therefore.
‘‘(c) LIMITED CONFIDENTIALITY OF INFORMATION.—Any information
reported to or otherwise obtained by the Secretary or the
Secretary’s representative under section 903, 904, 907, 908, 909,
910, 911, or 704, or under subsection (e) or (f) of this section,
which is exempt from disclosure under subsection (a) of section
552 of title 5, United States Code, by reason of subsection (b)(4)
of that section shall be considered confidential and shall not be
disclosed, except that the information may be disclosed to other
officers or employees concerned with carrying out this chapter,
or when relevant in any proceeding under this chapter.
‘‘(d) RESTRICTIONS.—
‘‘(1) IN GENERAL.—The Secretary may by regulation require
restrictions on the sale and distribution of a tobacco product,
including restrictions on the access to, and the advertising
and promotion of, the tobacco product, if the Secretary determines
that such regulation would be appropriate for the protection
of the public health. The Secretary may by regulation
impose restrictions on the advertising and promotion of a
tobacco product consistent with and to full extent permitted
by the first amendment to the Constitution. The finding as
to whether such regulation would be appropriate for the protection
of the public health shall be determined with respect
to the risks and benefits to the population as a whole, including
users and nonusers of the tobacco product, and taking into
account—
‘‘(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products;
and
‘‘(B) the increased or decreased likelihood that those
who do not use tobacco products will start using such
products.
No such regulation may require that the sale or distribution
of a tobacco product be limited to the written or oral authorization
of a practitioner licensed by law to prescribe medical
products.
‘‘(2) LABEL STATEMENTS.—The label of a tobacco product
shall bear such appropriate statements of the restrictions
required by a regulation under subsection (a) as the Secretary
may in such regulation prescribe.
‘‘(3) LIMITATIONS.—
‘‘(A) IN GENERAL.—No restrictions under paragraph (1)
may—
‘‘(i) prohibit the sale of any tobacco product in
face-to-face transactions by a specific category of retail
outlets; or
‘‘(ii) establish a minimum age of sale of tobacco
products to any person older than 18 years of age.
‘‘(B) MATCHBOOKS.—For purposes of any regulations
issued by the Secretary, matchbooks of conventional size
containing not more than 20 paper matches, and which
are customarily given away for free with the purchase
Time period.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1797
of tobacco products, shall be considered as adult-written
publications which shall be permitted to contain advertising.
Notwithstanding the preceding sentence, if the Secretary
finds that such treatment of matchbooks is not
appropriate for the protection of the public health, the
Secretary may determine by regulation that matchbooks
shall not be considered adult-written publications.
‘‘(4) REMOTE SALES.—
‘‘(A) IN GENERAL.—The Secretary shall—
‘‘(i) within 18 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control
Act, promulgate regulations regarding the sale and
distribution of tobacco products that occur through
means other than a direct, face-to-face exchange
between a retailer and a consumer in order to prevent
the sale and distribution of tobacco products to individuals
who have not attained the minimum age established
by applicable law for the purchase of such products,
including requirements for age verification; and
‘‘(ii) within 2 years after such date of enactment,
issue regulations to address the promotion and marketing
of tobacco products that are sold or distributed
through means other than a direct, face-to-face
exchange between a retailer and a consumer in order
to protect individuals who have not attained the minimum
age established by applicable law for the purchase
of such products.
‘‘(B) RELATION TO OTHER AUTHORITY.—Nothing in this
paragraph limits the authority of the Secretary to take
additional actions under the other paragraphs of this subsection.
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIREMENTS.—
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO CONFORM.—
‘‘(A) IN GENERAL.—In applying manufacturing restrictions
to tobacco, the Secretary shall, in accordance with
subparagraph (B), prescribe regulations (which may differ
based on the type of tobacco product involved) requiring
that the methods used in, and the facilities and controls
used for, the manufacture, preproduction design validation
(including a process to assess the performance of a tobacco
product), packing, and storage of a tobacco product conform
to current good manufacturing practice, or hazard analysis
and critical control point methodology, as prescribed in
such regulations to assure that the public health is protected
and that the tobacco product is in compliance with
this chapter. Such regulations may provide for the testing
of raw tobacco for pesticide chemical residues regardless
of whether a tolerance for such chemical residues has been
established.
‘‘(B) REQUIREMENTS.—The Secretary shall—
‘‘(i) before promulgating any regulation under
subparagraph (A), afford the Tobacco Products Scientific
Advisory Committee an opportunity to submit
recommendations with respect to the regulation proposed
to be promulgated;
Recommendations.
Regulations.
Deadlines.
Regulations.
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123 STAT. 1798 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(ii) before promulgating any regulation under
subparagraph (A), afford opportunity for an oral
hearing;
‘‘(iii) provide the Tobacco Products Scientific
Advisory Committee a reasonable time to make its
recommendation with respect to proposed regulations
under subparagraph (A);
‘‘(iv) in establishing the effective date of a regulation
promulgated under this subsection, take into
account the differences in the manner in which the
different types of tobacco products have historically
been produced, the financial resources of the different
tobacco product manufacturers, and the state of their
existing manufacturing facilities, and shall provide for
a reasonable period of time for such manufacturers
to conform to good manufacturing practices; and
‘‘(v) not require any small tobacco product manufacturer
to comply with a regulation under subparagraph
(A) for at least 4 years following the effective
date established by the Secretary for such regulation.
‘‘(2) EXEMPTIONS; VARIANCES.—
‘‘(A) PETITION.—Any person subject to any requirement
prescribed under paragraph (1) may petition the Secretary
for a permanent or temporary exemption or variance from
such requirement. Such a petition shall be submitted to
the Secretary in such form and manner as the Secretary
shall prescribe and shall—
‘‘(i) in the case of a petition for an exemption
from a requirement, set forth the basis for the petitioner’s
determination that compliance with the
requirement is not required to assure that the tobacco
product will be in compliance with this chapter;
‘‘(ii) in the case of a petition for a variance from
a requirement, set forth the methods proposed to be
used in, and the facilities and controls proposed to
be used for, the manufacture, packing, and storage
of the tobacco product in lieu of the methods, facilities,
and controls prescribed by the requirement; and
‘‘(iii) contain such other information as the Secretary
shall prescribe.
‘‘(B) REFERRAL TO THE TOBACCO PRODUCTS SCIENTIFIC
ADVISORY COMMITTEE.—The Secretary may refer to the
Tobacco Products Scientific Advisory Committee any petition
submitted under subparagraph (A). The Tobacco Products
Scientific Advisory Committee shall report its recommendations
to the Secretary with respect to a petition
referred to it within 60 days after the date of the petition’s
referral. Within 60 days after—
‘‘(i) the date the petition was submitted to the
Secretary under subparagraph (A); or
‘‘(ii) the day after the petition was referred to
the Tobacco Products Scientific Advisory Committee,
whichever occurs later, the Secretary shall by order either
deny the petition or approve it.
‘‘(C) APPROVAL.—The Secretary may approve—
‘‘(i) a petition for an exemption for a tobacco
product from a requirement if the Secretary determines
Reports.
Deadline.
Compliance date.
Hearings.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1799
that compliance with such requirement is not required
to assure that the tobacco product will be in compliance
with this chapter; and
‘‘(ii) a petition for a variance for a tobacco product
from a requirement if the Secretary determines that
the methods to be used in, and the facilities and controls
to be used for, the manufacture, packing, and
storage of the tobacco product in lieu of the methods,
facilities, and controls prescribed by the requirement
are sufficient to assure that the tobacco product will
be in compliance with this chapter.
‘‘(D) CONDITIONS.—An order of the Secretary approving
a petition for a variance shall prescribe such conditions
respecting the methods used in, and the facilities and controls
used for, the manufacture, packing, and storage of
the tobacco product to be granted the variance under the
petition as may be necessary to assure that the tobacco
product will be in compliance with this chapter.
‘‘(E) HEARING.—After the issuance of an order under
subparagraph (B) respecting a petition, the petitioner shall
have an opportunity for an informal hearing on such order.
‘‘(3) COMPLIANCE.—Compliance with requirements under
this subsection shall not be required before the end of the
3-year period following the date of enactment of the Family
Smoking Prevention and Tobacco Control Act.
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary may enter
into contracts for research, testing, and demonstrations respecting
tobacco products and may obtain tobacco products for research,
testing, and demonstration purposes.
‘‘SEC. 907. TOBACCO PRODUCT STANDARDS.
‘‘(a) IN GENERAL.—
‘‘(1) SPECIAL RULES.—
‘‘(A) SPECIAL RULE FOR CIGARETTES.—Beginning 3
months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, a cigarette or any
of its component parts (including the tobacco, filter, or
paper) shall not contain, as a constituent (including a
smoke constituent) or additive, an artificial or natural
flavor (other than tobacco or menthol) or an herb or spice,
including strawberry, grape, orange, clove, cinnamon, pineapple,
vanilla, coconut, licorice, cocoa, chocolate, cherry,
or coffee, that is a characterizing flavor of the tobacco
product or tobacco smoke. Nothing in this subparagraph
shall be construed to limit the Secretary’s authority to
take action under this section or other sections of this
Act applicable to menthol or any artificial or natural flavor,
herb, or spice not specified in this subparagraph.
‘‘(B) ADDITIONAL SPECIAL RULE.—Beginning 2 years
after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, a tobacco product manufacturer
shall not use tobacco, including foreign grown tobacco,
that contains a pesticide chemical residue that is at a
level greater than is specified by any tolerance applicable
under Federal law to domestically grown tobacco.
Effective dates.
21 USC 387g.
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123 STAT. 1800 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(2) REVISION OF TOBACCO PRODUCT STANDARDS.—The Secretary
may revise the tobacco product standards in paragraph
(1) in accordance with subsection (c).
‘‘(3) TOBACCO PRODUCT STANDARDS.—
‘‘(A) IN GENERAL.—The Secretary may adopt tobacco
product standards in addition to those in paragraph (1)
if the Secretary finds that a tobacco product standard is
appropriate for the protection of the public health.
‘‘(B) DETERMINATIONS.—
‘‘(i) CONSIDERATIONS.—In making a finding
described in subparagraph (A), the Secretary shall consider
scientific evidence concerning—
‘‘(I) the risks and benefits to the population
as a whole, including users and nonusers of tobacco
products, of the proposed standard;
‘‘(II) the increased or decreased likelihood that
existing users of tobacco products will stop using
such products; and
‘‘(III) the increased or decreased likelihood
that those who do not use tobacco products will
start using such products.
‘‘(ii) ADDITIONAL CONSIDERATIONS.—In the event
that the Secretary makes a determination, set forth
in a proposed tobacco product standard in a proposed
rule, that it is appropriate for the protection of public
health to require the reduction or elimination of an
additive, constituent (including a smoke constituent),
or other component of a tobacco product because the
Secretary has found that the additive, constituent, or
other component is or may be harmful, any party
objecting to the proposed standard on the ground that
the proposed standard will not reduce or eliminate
the risk of illness or injury may provide for the Secretary’s
consideration scientific evidence that demonstrates
that the proposed standard will not reduce
or eliminate the risk of illness or injury.
‘‘(4) CONTENT OF TOBACCO PRODUCT STANDARDS.—A tobacco
product standard established under this section for a tobacco
product—
‘‘(A) shall include provisions that are appropriate for
the protection of the public health, including provisions,
where appropriate—
‘‘(i) for nicotine yields of the product;
‘‘(ii) for the reduction or elimination of other
constituents, including smoke constituents, or harmful
components of the product; or
‘‘(iii) relating to any other requirement under
subparagraph (B);
‘‘(B) shall, where appropriate for the protection of the
public health, include—
‘‘(i) provisions respecting the construction, components,
ingredients, additives, constituents, including
smoke constituents, and properties of the tobacco
product;
‘‘(ii) provisions for the testing (on a sample basis
or, if necessary, on an individual basis) of the tobacco
product;
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1801
‘‘(iii) provisions for the measurement of the tobacco
product characteristics of the tobacco product;
‘‘(iv) provisions requiring that the results of each
or of certain of the tests of the tobacco product required
to be made under clause (ii) show that the tobacco
product is in conformity with the portions of the
standard for which the test or tests were required;
and
‘‘(v) a provision requiring that the sale and distribution
of the tobacco product be restricted but only
to the extent that the sale and distribution of a tobacco
product may be restricted under a regulation under
section 906(d);
‘‘(C) shall, where appropriate, require the use and prescribe
the form and content of labeling for the proper
use of the tobacco product; and
‘‘(D) shall require tobacco products containing foreigngrown
tobacco to meet the same standards applicable to
tobacco products containing domestically grown tobacco.
‘‘(5) PERIODIC REEVALUATION OF TOBACCO PRODUCT STANDARDS.—
The Secretary shall provide for periodic evaluation of
tobacco product standards established under this section to
determine whether such standards should be changed to reflect
new medical, scientific, or other technological data. The Secretary
may provide for testing under paragraph (4)(B) by any
person.
‘‘(6) INVOLVEMENT OF OTHER AGENCIES; INFORMED PERSONS.—
In carrying out duties under this section, the Secretary
shall endeavor to—
‘‘(A) use personnel, facilities, and other technical support
available in other Federal agencies;
‘‘(B) consult with other Federal agencies concerned with
standard setting and other nationally or internationally
recognized standard-setting entities; and
‘‘(C) invite appropriate participation, through joint or
other conferences, workshops, or other means, by informed
persons representative of scientific, professional, industry,
agricultural, or consumer organizations who in the Secretary’s
judgment can make a significant contribution.
‘‘(b) CONSIDERATIONS BY SECRETARY.—
‘‘(1) TECHNICAL ACHIEVABILITY.—The Secretary shall consider
information submitted in connection with a proposed
standard regarding the technical achievability of compliance
with such standard.
‘‘(2) OTHER CONSIDERATIONS.—The Secretary shall consider
all other information submitted in connection with a proposed
standard, including information concerning the countervailing
effects of the tobacco product standard on the health of adolescent
tobacco users, adult tobacco users, or nontobacco users,
such as the creation of a significant demand for contraband
or other tobacco products that do not meet the requirements
of this chapter and the significance of such demand.
‘‘(c) PROPOSED STANDARDS.—
‘‘(1) IN GENERAL.—The Secretary shall publish in the Federal
Register a notice of proposed rulemaking for the establishment,
amendment, or revocation of any tobacco product
standard.
Federal Register,
publication.
Notice.
Consultation.
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123 STAT. 1802 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(2) REQUIREMENTS OF NOTICE.—A notice of proposed rulemaking
for the establishment or amendment of a tobacco
product standard for a tobacco product shall—
‘‘(A) set forth a finding with supporting justification
that the tobacco product standard is appropriate for the
protection of the public health;
‘‘(B) invite interested persons to submit a draft or
proposed tobacco product standard for consideration by the
Secretary;
‘‘(C) invite interested persons to submit comments on
structuring the standard so that it does not advantage
foreign-grown tobacco over domestically grown tobacco; and
‘‘(D) invite the Secretary of Agriculture to provide any
information or analysis which the Secretary of Agriculture
believes is relevant to the proposed tobacco product
standard.
‘‘(3) FINDING.—A notice of proposed rulemaking for the
revocation of a tobacco product standard shall set forth a finding
with supporting justification that the tobacco product standard
is no longer appropriate for the protection of the public health.
‘‘(4) COMMENT.—The Secretary shall provide for a comment
period of not less than 60 days.
‘‘(d) PROMULGATION.—
‘‘(1) IN GENERAL.—After the expiration of the period for
comment on a notice of proposed rulemaking published under
subsection (c) respecting a tobacco product standard and after
consideration of comments submitted under subsections (b) and
(c) and any report from the Tobacco Products Scientific Advisory
Committee, the Secretary shall—
‘‘(A) if the Secretary determines that the standard
would be appropriate for the protection of the public health,
promulgate a regulation establishing a tobacco product
standard and publish in the Federal Register findings on
the matters referred to in subsection (c); or
‘‘(B) publish a notice terminating the proceeding for
the development of the standard together with the reasons
for such termination.
‘‘(2) EFFECTIVE DATE.—A regulation establishing a tobacco
product standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation may
take effect before 1 year after the date of its publication unless
the Secretary determines that an earlier effective date is necessary
for the protection of the public health. Such date or
dates shall be established so as to minimize, consistent with
the public health, economic loss to, and disruption or dislocation
of, domestic and international trade. In establishing such effective
date or dates, the Secretary shall consider information
submitted in connection with a proposed product standard by
interested parties, including manufacturers and tobacco
growers, regarding the technical achievability of compliance
with the standard, and including information concerning the
existence of patents that make it impossible to comply in the
timeframe envisioned in the proposed standard. If the Secretary
determines, based on the Secretary’s evaluation of submitted
comments, that a product standard can be met only by manufacturers
requiring substantial changes to the methods of farming
the domestically grown tobacco used by the manufacturer, the
Publication.
Notice.
Regulations.
Federal Register,
publication.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1803
effective date of that product standard shall be not less than
2 years after the date of publication of the final regulation
establishing the standard.
‘‘(3) LIMITATION ON POWER GRANTED TO THE FOOD AND
DRUG ADMINISTRATION.—Because of the importance of a decision
of the Secretary to issue a regulation—
‘‘(A) banning all cigarettes, all smokeless tobacco products,
all little cigars, all cigars other than little cigars,
all pipe tobacco, or all roll-your-own tobacco products; or
‘‘(B) requiring the reduction of nicotine yields of a
tobacco product to zero,
the Secretary is prohibited from taking such actions under
this Act.
‘‘(4) AMENDMENT; REVOCATION.—
‘‘(A) AUTHORITY.—The Secretary, upon the Secretary’s
own initiative or upon petition of an interested person,
may by a regulation, promulgated in accordance with the
requirements of subsection (c) and paragraph (2), amend
or revoke a tobacco product standard.
‘‘(B) EFFECTIVE DATE.—The Secretary may declare a
proposed amendment of a tobacco product standard to be
effective on and after its publication in the Federal Register
and until the effective date of any final action taken on
such amendment if the Secretary determines that making
it so effective is in the public interest.
‘‘(5) REFERRAL TO ADVISORY COMMITTEE.—
‘‘(A) IN GENERAL.—The Secretary may refer a proposed
regulation for the establishment, amendment, or revocation
of a tobacco product standard to the Tobacco Products
Scientific Advisory Committee for a report and recommendation
with respect to any matter involved in the
proposed regulation which requires the exercise of scientific
judgment.
‘‘(B) INITIATION OF REFERRAL.—The Secretary may
make a referral under this paragraph—
‘‘(i) on the Secretary’s own initiative; or
‘‘(ii) upon the request of an interested person
that—
‘‘(I) demonstrates good cause for the referral;
and
‘‘(II) is made before the expiration of the period
for submission of comments on the proposed regulation.
‘‘(C) PROVISION OF DATA.—If a proposed regulation is
referred under this paragraph to the Tobacco Products
Scientific Advisory Committee, the Secretary shall provide
the Advisory Committee with the data and information
on which such proposed regulation is based.
‘‘(D) REPORT AND RECOMMENDATION.—The Tobacco
Products Scientific Advisory Committee shall, within 60
days after the referral of a proposed regulation under this
paragraph and after independent study of the data and
information furnished to it by the Secretary and other
data and information before it, submit to the Secretary
a report and recommendation respecting such regulation,
together with all underlying data and information and
a statement of the reason or basis for the recommendation.
Statement.
Deadline.
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123 STAT. 1804 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(E) PUBLIC AVAILABILITY.—The Secretary shall make
a copy of each report and recommendation under subparagraph
(D) publicly available.
‘‘(e) MENTHOL CIGARETTES.—
‘‘(1) REFERRAL; CONSIDERATIONS.—Immediately upon the
establishment of the Tobacco Products Scientific Advisory Committee
under section 917(a), the Secretary shall refer to the
Committee for report and recommendation, under section
917(c)(4), the issue of the impact of the use of menthol in
cigarettes on the public health, including such use among children,
African-Americans, Hispanics, and other racial and ethnic
minorities. In its review, the Tobacco Products Scientific
Advisory Committee shall address the considerations listed in
subsections (a)(3)(B)(i) and (b).
‘‘(2) REPORT AND RECOMMENDATION.—Not later than 1 year
after its establishment, the Tobacco Product Scientific Advisory
Committee shall submit to the Secretary the report and recommendations
required pursuant to paragraph (1).
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection
shall be construed to limit the Secretary’s authority to take
action under this section or other sections of this Act applicable
to menthol.
‘‘(f) DISSOLVABLE TOBACCO PRODUCTS.—
‘‘(1) REFERRAL; CONSIDERATIONS.—The Secretary shall refer
to the Tobacco Products Scientific Advisory Committee for
report and recommendation, under section 917(c)(4), the issue
of the nature and impact of the use of dissolvable tobacco
products on the public health, including such use among children.
In its review, the Tobacco Products Scientific Advisory
Committee shall address the considerations listed in subsection
(a)(3)(B)(i).
‘‘(2) REPORT AND RECOMMENDATION.—Not later than 2
years after its establishment, the Tobacco Product Scientific
Advisory Committee shall submit to the Secretary the report
and recommendations required pursuant to paragraph (1).
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection
shall be construed to limit the Secretary’s authority to take
action under this section or other sections of this Act at any
time applicable to any dissolvable tobacco product.
‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES.
‘‘(a) NOTIFICATION.—If the Secretary determines that—
‘‘(1) a tobacco product which is introduced or delivered
for introduction into interstate commerce for commercial distribution
presents an unreasonable risk of substantial harm
to the public health; and
‘‘(2) notification under this subsection is necessary to eliminate
the unreasonable risk of such harm and no more practicable
means is available under the provisions of this chapter
(other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure
that adequate notification is provided in an appropriate form, by
the persons and means best suited under the circumstances
involved, to all persons who should properly receive such notification
in order to eliminate such risk. The Secretary may order notification
by any appropriate means, including public service announcements.
21 USC 387h.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1805
Before issuing an order under this subsection, the Secretary shall
consult with the persons who are to give notice under the order.
‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.—Compliance with
an order issued under this section shall not relieve any person
from liability under Federal or State law. In awarding damages
for economic loss in an action brought for the enforcement of any
such liability, the value to the plaintiff in such action of any
remedy provided under such order shall be taken into account.
‘‘(c) RECALL AUTHORITY.—
‘‘(1) IN GENERAL.—If the Secretary finds that there is a
reasonable probability that a tobacco product contains a manufacturing
or other defect not ordinarily contained in tobacco
products on the market that would cause serious, adverse
health consequences or death, the Secretary shall issue an
order requiring the appropriate person (including the manufacturers,
importers, distributors, or retailers of the tobacco
product) to immediately cease distribution of such tobacco
product. The order shall provide the person subject to the
order with an opportunity for an informal hearing, to be held
not later than 10 days after the date of the issuance of the
order, on the actions required by the order and on whether
the order should be amended to require a recall of such tobacco
product. If, after providing an opportunity for such a hearing,
the Secretary determines that inadequate grounds exist to support
the actions required by the order, the Secretary shall
vacate the order.
‘‘(2) AMENDMENT OF ORDER TO REQUIRE RECALL.—
‘‘(A) IN GENERAL.—If, after providing an opportunity
for an informal hearing under paragraph (1), the Secretary
determines that the order should be amended to include
a recall of the tobacco product with respect to which the
order was issued, the Secretary shall, except as provided
in subparagraph (B), amend the order to require a recall.
The Secretary shall specify a timetable in which the tobacco
product recall will occur and shall require periodic reports
to the Secretary describing the progress of the recall.
‘‘(B) NOTICE.—An amended order under subparagraph
(A)—
‘‘(i) shall not include recall of a tobacco product
from individuals; and
‘‘(ii) shall provide for notice to persons subject to
the risks associated with the use of such tobacco
product.
In providing the notice required by clause (ii), the Secretary
may use the assistance of retailers and other persons who
distributed such tobacco product. If a significant number
of such persons cannot be identified, the Secretary shall
notify such persons under section 705(b).
‘‘(3) REMEDY NOT EXCLUSIVE.—The remedy provided by this
subsection shall be in addition to remedies provided by subsection
(a).
‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—Every person who is a tobacco product manufacturer
or importer of a tobacco product shall establish and maintain
such records, make such reports, and provide such information,
as the Secretary may by regulation reasonably require to assure
Regulations.
21 USC 387i.
Notification.
Timetable.
Reports.
Deadline.
Order.
Consultation.
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123 STAT. 1806 PUBLIC LAW 111–31—JUNE 22, 2009
that such tobacco product is not adulterated or misbranded and
to otherwise protect public health. Regulations prescribed under
the preceding sentence—
‘‘(1) may require a tobacco product manufacturer or
importer to report to the Secretary whenever the manufacturer
or importer receives or otherwise becomes aware of information
that reasonably suggests that one of its marketed tobacco products
may have caused or contributed to a serious unexpected
adverse experience associated with the use of the product or
any significant increase in the frequency of a serious, expected
adverse product experience;
‘‘(2) shall require reporting of other significant adverse
tobacco product experiences as determined by the Secretary
to be necessary to be reported;
‘‘(3) shall not impose requirements unduly burdensome to
a tobacco product manufacturer or importer, taking into account
the cost of complying with such requirements and the need
for the protection of the public health and the implementation
of this chapter;
‘‘(4) when prescribing the procedure for making requests
for reports or information, shall require that each request made
under such regulations for submission of a report or information
to the Secretary state the reason or purpose for such request
and identify to the fullest extent practicable such report or
information;
‘‘(5) when requiring submission of a report or information
to the Secretary, shall state the reason or purpose for the
submission of such report or information and identify to the
fullest extent practicable such report or information; and
‘‘(6) may not require that the identity of any patient or
user be disclosed in records, reports, or information required
under this subsection unless required for the medical welfare
of an individual, to determine risks to public health of a tobacco
product, or to verify a record, report, or information submitted
under this chapter.
In prescribing regulations under this subsection, the Secretary shall
have due regard for the professional ethics of the medical profession
and the interests of patients. The prohibitions of paragraph (6)
continue to apply to records, reports, and information concerning
any individual who has been a patient, irrespective of whether
or when he ceases to be a patient.
‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.—
‘‘(1) IN GENERAL.—Except as provided in paragraph (2),
the Secretary shall by regulation require a tobacco product
manufacturer or importer of a tobacco product to report
promptly to the Secretary any corrective action taken or
removal from the market of a tobacco product undertaken by
such manufacturer or importer if the removal or correction
was undertaken—
‘‘(A) to reduce a risk to health posed by the tobacco
product; or
‘‘(B) to remedy a violation of this chapter caused by
the tobacco product which may present a risk to health.
A tobacco product manufacturer or importer of a tobacco
product who undertakes a corrective action or removal from
the market of a tobacco product which is not required to be
Applicability.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1807
reported under this subsection shall keep a record of such
correction or removal.
‘‘(2) EXCEPTION.—No report of the corrective action or
removal of a tobacco product may be required under paragraph
(1) if a report of the corrective action or removal is required
and has been submitted under subsection (a).
‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—
‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For purposes of this
section the term ‘new tobacco product’ means—
‘‘(A) any tobacco product (including those products in
test markets) that was not commercially marketed in the
United States as of February 15, 2007; or
‘‘(B) any modification (including a change in design,
any component, any part, or any constituent, including
a smoke constituent, or in the content, delivery or form
of nicotine, or any other additive or ingredient) of a tobacco
product where the modified product was commercially marketed
in the United States after February 15, 2007.
‘‘(2) PREMARKET REVIEW REQUIRED.—
‘‘(A) NEW PRODUCTS.—An order under subsection
(c)(1)(A)(i) for a new tobacco product is required unless—
‘‘(i) the manufacturer has submitted a report under
section 905(j); and the Secretary has issued an order
that the tobacco product—
‘‘(I) is substantially equivalent to a tobacco
product commercially marketed (other than for test
marketing) in the United States as of February
15, 2007; and
‘‘(II) is in compliance with the requirements
of this Act; or
‘‘(ii) the tobacco product is exempt from the
requirements of section 905(j) pursuant to a regulation
issued under section 905(j)(3).
‘‘(B) APPLICATION TO CERTAIN POST-FEBRUARY 15, 2007,
PRODUCTS.—Subparagraph (A) shall not apply to a tobacco
product—
‘‘(i) that was first introduced or delivered for
introduction into interstate commerce for commercial
distribution in the United States after February 15,
2007, and prior to the date that is 21 months after
the date of enactment of the Family Smoking Prevention
and Tobacco Control Act; and
‘‘(ii) for which a report was submitted under section
905(j) within such 21-month period,
except that subparagraph (A) shall apply to the tobacco
product if the Secretary issues an order that the tobacco
product is not substantially equivalent.
‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.—
‘‘(A) IN GENERAL.—In this section and section 905(j),
the term ‘substantially equivalent’ or ‘substantial equivalence’
means, with respect to the tobacco product being
compared to the predicate tobacco product, that the Secretary
by order has found that the tobacco product—
21 USC 387j.
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123 STAT. 1808 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(i) has the same characteristics as the predicate
tobacco product; or
‘‘(ii) has different characteristics and the information
submitted contains information, including clinical
data if deemed necessary by the Secretary, that demonstrates
that it is not appropriate to regulate the
product under this section because the product does
not raise different questions of public health.
‘‘(B) CHARACTERISTICS.—In subparagraph (A), the term
‘characteristics’ means the materials, ingredients, design,
composition, heating source, or other features of a tobacco
product.
‘‘(C) LIMITATION.—A tobacco product may not be found
to be substantially equivalent to a predicate tobacco product
that has been removed from the market at the initiative
of the Secretary or that has been determined by a judicial
order to be misbranded or adulterated.
‘‘(4) HEALTH INFORMATION.—
‘‘(A) SUMMARY.—As part of a submission under section
905(j) respecting a tobacco product, the person required
to file a premarket notification under such section shall
provide an adequate summary of any health information
related to the tobacco product or state that such information
will be made available upon request by any person.
‘‘(B) REQUIRED INFORMATION.—Any summary under
subparagraph (A) respecting a tobacco product shall contain
detailed information regarding data concerning adverse
health effects and shall be made available to the public
by the Secretary within 30 days of the issuance of a determination
that such tobacco product is substantially equivalent
to another tobacco product.
‘‘(b) APPLICATION.—
‘‘(1) CONTENTS.—An application under this section shall
contain—
‘‘(A) full reports of all information, published or known
to, or which should reasonably be known to, the applicant,
concerning investigations which have been made to show
the health risks of such tobacco product and whether such
tobacco product presents less risk than other tobacco products;
‘‘(B) a full statement of the components, ingredients,
additives, and properties, and of the principle or principles
of operation, of such tobacco product;
‘‘(C) a full description of the methods used in, and
the facilities and controls used for, the manufacture, processing,
and, when relevant, packing and installation of,
such tobacco product;
‘‘(D) an identifying reference to any tobacco product
standard under section 907 which would be applicable to
any aspect of such tobacco product, and either adequate
information to show that such aspect of such tobacco
product fully meets such tobacco product standard or adequate
information to justify any deviation from such
standard;
‘‘(E) such samples of such tobacco product and of
components thereof as the Secretary may reasonably
require;
Public
information.
Deadline.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1809
‘‘(F) specimens of the labeling proposed to be used
for such tobacco product; and
‘‘(G) such other information relevant to the subject
matter of the application as the Secretary may require.
‘‘(2) REFERRAL TO TOBACCO PRODUCTS SCIENTIFIC ADVISORY
COMMITTEE.—Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Secretary—
‘‘(A) may, on the Secretary’s own initiative; or
‘‘(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission (within
such period as the Secretary may establish) of a report and
recommendation respecting the application, together with all
underlying data and the reasons or basis for the recommendation.
‘‘(c) ACTION ON APPLICATION.—
‘‘(1) DEADLINE.—
‘‘(A) IN GENERAL.—As promptly as possible, but in no
event later than 180 days after the receipt of an application
under subsection (b), the Secretary, after considering the
report and recommendation submitted under subsection
(b)(2), shall—
‘‘(i) issue an order that the new product may be
introduced or delivered for introduction into interstate
commerce if the Secretary finds that none of the
grounds specified in paragraph (2) of this subsection
applies; or
‘‘(ii) issue an order that the new product may
not be introduced or delivered for introduction into
interstate commerce if the Secretary finds (and sets
forth the basis for such finding as part of or accompanying
such denial) that 1 or more grounds for denial
specified in paragraph (2) of this subsection apply.
‘‘(B) RESTRICTIONS ON SALE AND DISTRIBUTION.—An
order under subparagraph (A)(i) may require that the sale
and distribution of the tobacco product be restricted but
only to the extent that the sale and distribution of a tobacco
product may be restricted under a regulation under section
906(d).
‘‘(2) DENIAL OF APPLICATION.—The Secretary shall deny
an application submitted under subsection (b) if, upon the
basis of the information submitted to the Secretary as part
of the application and any other information before the Secretary
with respect to such tobacco product, the Secretary finds
that—
‘‘(A) there is a lack of a showing that permitting such
tobacco product to be marketed would be appropriate for
the protection of the public health;
‘‘(B) the methods used in, or the facilities or controls
used for, the manufacture, processing, or packing of such
tobacco product do not conform to the requirements of
section 906(e);
‘‘(C) based on a fair evaluation of all material facts,
the proposed labeling is false or misleading in any particular;
or
‘‘(D) such tobacco product is not shown to conform
in all respects to a tobacco product standard in effect under
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123 STAT. 1810 PUBLIC LAW 111–31—JUNE 22, 2009
section 907, and there is a lack of adequate information
to justify the deviation from such standard.
‘‘(3) DENIAL INFORMATION.—Any denial of an application
shall, insofar as the Secretary determines to be practicable,
be accompanied by a statement informing the applicant of
the measures required to remove such application from deniable
form (which measures may include further research by the
applicant in accordance with 1 or more protocols prescribed
by the Secretary).
‘‘(4) BASIS FOR FINDING.—For purposes of this section, the
finding as to whether the marketing of a tobacco product for
which an application has been submitted is appropriate for
the protection of the public health shall be determined with
respect to the risks and benefits to the population as a whole,
including users and nonusers of the tobacco product, and taking
into account—
‘‘(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products;
and
‘‘(B) the increased or decreased likelihood that those
who do not use tobacco products will start using such
products.
‘‘(5) BASIS FOR ACTION.—
‘‘(A) INVESTIGATIONS.—For purposes of paragraph
(2)(A), whether permitting a tobacco product to be marketed
would be appropriate for the protection of the public health
shall, when appropriate, be determined on the basis of
well-controlled investigations, which may include 1 or more
clinical investigations by experts qualified by training and
experience to evaluate the tobacco product.
‘‘(B) OTHER EVIDENCE.—If the Secretary determines
that there exists valid scientific evidence (other than evidence
derived from investigations described in subparagraph
(A)) which is sufficient to evaluate the tobacco
product, the Secretary may authorize that the determination
for purposes of paragraph (2)(A) be made on the basis
of such evidence.
‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.—
‘‘(1) IN GENERAL.—The Secretary shall, upon obtaining,
where appropriate, advice on scientific matters from the
Tobacco Products Scientific Advisory Committee, and after due
notice and opportunity for informal hearing for a tobacco
product for which an order was issued under subsection
(c)(1)(A)(i), issue an order withdrawing the order if the Secretary
finds—
‘‘(A) that the continued marketing of such tobacco
product no longer is appropriate for the protection of the
public health;
‘‘(B) that the application contained or was accompanied
by an untrue statement of a material fact;
‘‘(C) that the applicant—
‘‘(i) has failed to establish a system for maintaining
records, or has repeatedly or deliberately failed to
maintain records or to make reports, required by an
applicable regulation under section 909;
Notice.
Hearings.
Statement.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1811
‘‘(ii) has refused to permit access to, or copying
or verification of, such records as required by section
704; or
‘‘(iii) has not complied with the requirements of
section 905;
‘‘(D) on the basis of new information before the Secretary
with respect to such tobacco product, evaluated
together with the evidence before the Secretary when the
application was reviewed, that the methods used in, or
the facilities and controls used for, the manufacture, processing,
packing, or installation of such tobacco product
do not conform with the requirements of section 906(e)
and were not brought into conformity with such requirements
within a reasonable time after receipt of written
notice from the Secretary of nonconformity;
‘‘(E) on the basis of new information before the Secretary,
evaluated together with the evidence before the
Secretary when the application was reviewed, that the
labeling of such tobacco product, based on a fair evaluation
of all material facts, is false or misleading in any particular
and was not corrected within a reasonable time after receipt
of written notice from the Secretary of such fact; or
‘‘(F) on the basis of new information before the Secretary,
evaluated together with the evidence before the
Secretary when such order was issued, that such tobacco
product is not shown to conform in all respects to a tobacco
product standard which is in effect under section 907,
compliance with which was a condition to the issuance
of an order relating to the application, and that there
is a lack of adequate information to justify the deviation
from such standard.
‘‘(2) APPEAL.—The holder of an application subject to an
order issued under paragraph (1) withdrawing an order issued
pursuant to subsection (c)(1)(A)(i) may, by petition filed on
or before the 30th day after the date upon which such holder
receives notice of such withdrawal, obtain review thereof in
accordance with section 912.
‘‘(3) TEMPORARY SUSPENSION.—If, after providing an opportunity
for an informal hearing, the Secretary determines there
is reasonable probability that the continuation of distribution
of a tobacco product under an order would cause serious,
adverse health consequences or death, that is greater than
ordinarily caused by tobacco products on the market, the Secretary
shall by order temporarily suspend the authority of
the manufacturer to market the product. If the Secretary issues
such an order, the Secretary shall proceed expeditiously under
paragraph (1) to withdraw such application.
‘‘(e) SERVICE OF ORDER.—An order issued by the Secretary
under this section shall be served—
‘‘(1) in person by any officer or employee of the department
designated by the Secretary; or
‘‘(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant’s last known
address in the records of the Secretary.
‘‘(f) RECORDS.—
‘‘(1) ADDITIONAL INFORMATION.—In the case of any tobacco
product for which an order issued pursuant to subsection
Reports.
Order.
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123 STAT. 1812 PUBLIC LAW 111–31—JUNE 22, 2009
(c)(1)(A)(i) for an application filed under subsection (b) is in
effect, the applicant shall establish and maintain such records,
and make such reports to the Secretary, as the Secretary may
by regulation, or by order with respect to such application,
prescribe on the basis of a finding that such records and reports
are necessary in order to enable the Secretary to determine,
or facilitate a determination of, whether there is or may be
grounds for withdrawing or temporarily suspending such order.
‘‘(2) ACCESS TO RECORDS.—Each person required under this
section to maintain records, and each person in charge of custody
thereof, shall, upon request of an officer or employee
designated by the Secretary, permit such officer or employee
at all reasonable times to have access to and copy and verify
such records.
‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMPTION FOR
INVESTIGATIONAL USE.—The Secretary may exempt tobacco products
intended for investigational use from the provisions of this
chapter under such conditions as the Secretary may by regulation
prescribe.
‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—No person may introduce or deliver for
introduction into interstate commerce any modified risk tobacco
product unless an order issued pursuant to subsection (g) is effective
with respect to such product.
‘‘(b) DEFINITIONS.—In this section:
‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The term ‘modified
risk tobacco product’ means any tobacco product that is sold
or distributed for use to reduce harm or the risk of tobaccorelated
disease associated with commercially marketed tobacco
products.
‘‘(2) SOLD OR DISTRIBUTED.—
‘‘(A) IN GENERAL.—With respect to a tobacco product,
the term ‘sold or distributed for use to reduce harm or
the risk of tobacco-related disease associated with commercially
marketed tobacco products’ means a tobacco
product—
‘‘(i) the label, labeling, or advertising of which represents
explicitly or implicitly that—
‘‘(I) the tobacco product presents a lower risk
of tobacco-related disease or is less harmful than
one or more other commercially marketed tobacco
products;
‘‘(II) the tobacco product or its smoke contains
a reduced level of a substance or presents a
reduced exposure to a substance; or
‘‘(III) the tobacco product or its smoke does
not contain or is free of a substance;
‘‘(ii) the label, labeling, or advertising of which
uses the descriptors ‘light’, ‘mild’, or ‘low’ or similar
descriptors; or
‘‘(iii) the tobacco product manufacturer of which
has taken any action directed to consumers through
the media or otherwise, other than by means of the
tobacco product’s label, labeling, or advertising, after
the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, respecting the product
21 USC 387k.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1813
that would be reasonably expected to result in consumers
believing that the tobacco product or its smoke
may present a lower risk of disease or is less harmful
than one or more commercially marketed tobacco products,
or presents a reduced exposure to, or does not
contain or is free of, a substance or substances.
‘‘(B) LIMITATION.—No tobacco product shall be considered
to be ‘sold or distributed for use to reduce harm
or the risk of tobacco-related disease associated with
commercially marketed tobacco products’, except as
described in subparagraph (A).
‘‘(C) SMOKELESS TOBACCO PRODUCT.—No smokeless
tobacco product shall be considered to be ‘sold or distributed
for use to reduce harm or the risk of tobacco-related disease
associated with commercially marketed tobacco products’
solely because its label, labeling, or advertising uses the
following phrases to describe such product and its use:
‘smokeless tobacco’, ‘smokeless tobacco product’, ‘not consumed
by smoking’, ‘does not produce smoke’, ‘smokefree’,
‘smoke-free’, ‘without smoke’, ‘no smoke’, or ‘not smoke’.
‘‘(3) EFFECTIVE DATE.—The provisions of paragraph
(2)(A)(ii) shall take effect 12 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act
for those products whose label, labeling, or advertising contains
the terms described in such paragraph on such date of enactment.
The effective date shall be with respect to the date
of manufacture, provided that, in any case, beginning 30 days
after such effective date, a manufacturer shall not introduce
into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in conformance
with paragraph (2)(A)(ii).
‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product that is
intended to be used for the treatment of tobacco dependence,
including smoking cessation, is not a modified risk tobacco product
under this section if it has been approved as a drug or device
by the Food and Drug Administration and is subject to the requirements
of chapter V.
‘‘(d) FILING.—Any person may file with the Secretary an application
for a modified risk tobacco product. Such application shall
include—
‘‘(1) a description of the proposed product and any proposed
advertising and labeling;
‘‘(2) the conditions for using the product;
‘‘(3) the formulation of the product;
‘‘(4) sample product labels and labeling;
‘‘(5) all documents (including underlying scientific information)
relating to research findings conducted, supported, or
possessed by the tobacco product manufacturer relating to the
effect of the product on tobacco-related diseases and healthrelated
conditions, including information both favorable and
unfavorable to the ability of the product to reduce risk or
exposure and relating to human health;
‘‘(6) data and information on how consumers actually use
the tobacco product; and
‘‘(7) such other information as the Secretary may require.
‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall make the
application described in subsection (d) publicly available (except
Comment period.
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123 STAT. 1814 PUBLIC LAW 111–31—JUNE 22, 2009
matters in the application which are trade secrets or otherwise
confidential, commercial information) and shall request comments
by interested persons on the information contained in the application
and on the label, labeling, and advertising accompanying such
application.
‘‘(f) ADVISORY COMMITTEE.—
‘‘(1) IN GENERAL.—The Secretary shall refer to the Tobacco
Products Scientific Advisory Committee any application submitted
under this section.
‘‘(2) RECOMMENDATIONS.—Not later than 60 days after the
date an application is referred to the Tobacco Products Scientific
Advisory Committee under paragraph (1), the Advisory Committee
shall report its recommendations on the application
to the Secretary.
‘‘(g) MARKETING.—
‘‘(1) MODIFIED RISK PRODUCTS.—Except as provided in paragraph
(2), the Secretary shall, with respect to an application
submitted under this section, issue an order that a modified
risk product may be commercially marketed only if the Secretary
determines that the applicant has demonstrated that
such product, as it is actually used by consumers, will—
‘‘(A) significantly reduce harm and the risk of tobaccorelated
disease to individual tobacco users; and
‘‘(B) benefit the health of the population as a whole
taking into account both users of tobacco products and
persons who do not currently use tobacco products.
‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.—
‘‘(A) IN GENERAL.—The Secretary may issue an order
that a tobacco product may be introduced or delivered
for introduction into interstate commerce, pursuant to an
application under this section, with respect to a tobacco
product that may not be commercially marketed under
paragraph (1) if the Secretary makes the findings required
under this paragraph and determines that the applicant
has demonstrated that—
‘‘(i) such order would be appropriate to promote
the public health;
‘‘(ii) any aspect of the label, labeling, and advertising
for such product that would cause the tobacco
product to be a modified risk tobacco product under
subsection (b) is limited to an explicit or implicit representation
that such tobacco product or its smoke
does not contain or is free of a substance or contains
a reduced level of a substance, or presents a reduced
exposure to a substance in tobacco smoke;
‘‘(iii) scientific evidence is not available and, using
the best available scientific methods, cannot be made
available without conducting long-term epidemiological
studies for an application to meet the standards set
forth in paragraph (1); and
‘‘(iv) the scientific evidence that is available without
conducting long-term epidemiological studies demonstrates
that a measurable and substantial reduction
in morbidity or mortality among individual tobacco
users is reasonably likely in subsequent studies.
Order.
Deadline.
Reports.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1815
‘‘(B) ADDITIONAL FINDINGS REQUIRED.—To issue an
order under subparagraph (A) the Secretary must also
find that the applicant has demonstrated that—
‘‘(i) the magnitude of the overall reductions in exposure
to the substance or substances which are the
subject of the application is substantial, such substance
or substances are harmful, and the product as actually
used exposes consumers to the specified reduced level
of the substance or substances;
‘‘(ii) the product as actually used by consumers
will not expose them to higher levels of other harmful
substances compared to the similar types of tobacco
products then on the market unless such increases
are minimal and the reasonably likely overall impact
of use of the product remains a substantial and measurable
reduction in overall morbidity and mortality
among individual tobacco users;
‘‘(iii) testing of actual consumer perception shows
that, as the applicant proposes to label and market
the product, consumers will not be misled into believing
that the product—
‘‘(I) is or has been demonstrated to be less
harmful; or
‘‘(II) presents or has been demonstrated to
present less of a risk of disease than 1 or more
other commercially marketed tobacco products;
and
‘‘(iv) issuance of an order with respect to the
application is expected to benefit the health of the
population as a whole taking into account both users
of tobacco products and persons who do not currently
use tobacco products.
‘‘(C) CONDITIONS OF MARKETING.—
‘‘(i) IN GENERAL.—Applications subject to an order
under this paragraph shall be limited to a term of
not more than 5 years, but may be renewed upon
a finding by the Secretary that the requirements of
this paragraph continue to be satisfied based on the
filing of a new application.
‘‘(ii) AGREEMENTS BY APPLICANT.—An order under
this paragraph shall be conditioned on the applicant’s
agreement to conduct postmarket surveillance and
studies and to submit to the Secretary the results
of such surveillance and studies to determine the
impact of the order on consumer perception, behavior,
and health and to enable the Secretary to review the
accuracy of the determinations upon which the order
was based in accordance with a protocol approved by
the Secretary.
‘‘(iii) ANNUAL SUBMISSION.—The results of such
postmarket surveillance and studies described in clause
(ii) shall be submitted annually.
‘‘(3) BASIS.—The determinations under paragraphs (1) and
(2) shall be based on—
‘‘(A) the scientific evidence submitted by the applicant;
and
Study.
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123 STAT. 1816 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(B) scientific evidence and other information that is
made available to the Secretary.
‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS AND OF POPULATION
AS A WHOLE.—In making the determinations under
paragraphs (1) and (2), the Secretary shall take into account—
‘‘(A) the relative health risks to individuals of the
tobacco product that is the subject of the application;
‘‘(B) the increased or decreased likelihood that existing
users of tobacco products who would otherwise stop using
such products will switch to the tobacco product that is
the subject of the application;
‘‘(C) the increased or decreased likelihood that persons
who do not use tobacco products will start using the tobacco
product that is the subject of the application;
‘‘(D) the risks and benefits to persons from the use
of the tobacco product that is the subject of the application
as compared to the use of products for smoking cessation
approved under chapter V to treat nicotine dependence;
and
‘‘(E) comments, data, and information submitted by
interested persons.
‘‘(h) ADDITIONAL CONDITIONS FOR MARKETING.—
‘‘(1) MODIFIED RISK PRODUCTS.—The Secretary shall require
for the marketing of a product under this section that any
advertising or labeling concerning modified risk products enable
the public to comprehend the information concerning modified
risk and to understand the relative significance of such information
in the context of total health and in relation to all of
the diseases and health-related conditions associated with the
use of tobacco products.
‘‘(2) COMPARATIVE CLAIMS.—
‘‘(A) IN GENERAL.—The Secretary may require for the
marketing of a product under this subsection that a claim
comparing a tobacco product to 1 or more other commercially
marketed tobacco products shall compare the tobacco
product to a commercially marketed tobacco product that
is representative of that type of tobacco product on the
market (for example the average value of the top 3 brands
of an established regular tobacco product).
‘‘(B) QUANTITATIVE COMPARISONS.—The Secretary may
also require, for purposes of subparagraph (A), that the
percent (or fraction) of change and identity of the reference
tobacco product and a quantitative comparison of the
amount of the substance claimed to be reduced shall be
stated in immediate proximity to the most prominent claim.
‘‘(3) LABEL DISCLOSURE.—
‘‘(A) IN GENERAL.—The Secretary may require the
disclosure on the label of other substances in the tobacco
product, or substances that may be produced by the
consumption of that tobacco product, that may affect a
disease or health-related condition or may increase the
risk of other diseases or health-related conditions associated
with the use of tobacco products.
‘‘(B) CONDITIONS OF USE.—If the conditions of use of
the tobacco product may affect the risk of the product
to human health, the Secretary may require the labeling
of conditions of use.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1817
‘‘(4) TIME.—An order issued under subsection (g)(1) shall
be effective for a specified period of time.
‘‘(5) ADVERTISING.—The Secretary may require, with
respect to a product for which an applicant obtained an order
under subsection (g)(1), that the product comply with requirements
relating to advertising and promotion of the tobacco
product.
‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.—
‘‘(1) IN GENERAL.—The Secretary shall require, with respect
to a product for which an applicant obtained an order under
subsection (g)(1), that the applicant conduct postmarket surveillance
and studies for such a tobacco product to determine
the impact of the order issuance on consumer perception,
behavior, and health, to enable the Secretary to review the
accuracy of the determinations upon which the order was based,
and to provide information that the Secretary determines is
otherwise necessary regarding the use or health risks involving
the tobacco product. The results of postmarket surveillance
and studies shall be submitted to the Secretary on an annual
basis.
‘‘(2) SURVEILLANCE PROTOCOL.—Each applicant required to
conduct a surveillance of a tobacco product under paragraph
(1) shall, within 30 days after receiving notice that the applicant
is required to conduct such surveillance, submit, for the
approval of the Secretary, a protocol for the required surveillance.
The Secretary, within 60 days of the receipt of such
protocol, shall determine if the principal investigator proposed
to be used in the surveillance has sufficient qualifications and
experience to conduct such surveillance and if such protocol
will result in collection of the data or other information designated
by the Secretary as necessary to protect the public
health.
‘‘(j) WITHDRAWAL OF AUTHORIZATION.—The Secretary, after an
opportunity for an informal hearing, shall withdraw an order under
subsection (g) if the Secretary determines that—
‘‘(1) the applicant, based on new information, can no longer
make the demonstrations required under subsection (g), or
the Secretary can no longer make the determinations required
under subsection (g);
‘‘(2) the application failed to include material information
or included any untrue statement of material fact;
‘‘(3) any explicit or implicit representation that the product
reduces risk or exposure is no longer valid, including if—
‘‘(A) a tobacco product standard is established pursuant
to section 907;
‘‘(B) an action is taken that affects the risks presented
by other commercially marketed tobacco products that were
compared to the product that is the subject of the application;
or
‘‘(C) any postmarket surveillance or studies reveal that
the order is no longer consistent with the protection of
the public health;
‘‘(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or subsection (i); or
‘‘(5) the applicant failed to meet a condition imposed under
subsection (h).
Hearings.
Deadlines.
Notice.
Deadline.
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123 STAT. 1818 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(k) CHAPTER IV OR V.—A product for which the Secretary
has issued an order pursuant to subsection (g) shall not be subject
to chapter IV or V.
‘‘(l) IMPLEMENTING REGULATIONS OR GUIDANCE.—
‘‘(1) SCIENTIFIC EVIDENCE.—Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue regulations or
guidance (or any combination thereof) on the scientific evidence
required for assessment and ongoing review of modified risk
tobacco products. Such regulations or guidance shall—
‘‘(A) to the extent that adequate scientific evidence
exists, establish minimum standards for scientific studies
needed prior to issuing an order under subsection (g) to
show that a substantial reduction in morbidity or mortality
among individual tobacco users occurs for products
described in subsection (g)(1) or is reasonably likely for
products described in subsection (g)(2);
‘‘(B) include validated biomarkers, intermediate clinical
endpoints, and other feasible outcome measures, as appropriate;
‘‘(C) establish minimum standards for postmarket
studies, that shall include regular and long-term assessments
of health outcomes and mortality, intermediate clinical
endpoints, consumer perception of harm reduction, and
the impact on quitting behavior and new use of tobacco
products, as appropriate;
‘‘(D) establish minimum standards for required
postmarket surveillance, including ongoing assessments of
consumer perception;
‘‘(E) require that data from the required studies and
surveillance be made available to the Secretary prior to
the decision on renewal of a modified risk tobacco product;
and
‘‘(F) establish a reasonable timetable for the Secretary
to review an application under this section.
‘‘(2) CONSULTATION.—The regulations or guidance issued
under paragraph (1) shall be developed in consultation with
the Institute of Medicine, and with the input of other appropriate
scientific and medical experts, on the design and conduct
of such studies and surveillance.
‘‘(3) REVISION.—The regulations or guidance under paragraph
(1) shall be revised on a regular basis as new scientific
information becomes available.
‘‘(4) NEW TOBACCO PRODUCTS.—Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue a regulation
or guidance that permits the filing of a single application for
any tobacco product that is a new tobacco product under section
910 and which the applicant seeks to commercially market
under this section.
‘‘(m) DISTRIBUTORS.—Except as provided in this section, no
distributor may take any action, after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act, with
respect to a tobacco product that would reasonably be expected
to result in consumers believing that the tobacco product or its
smoke may present a lower risk of disease or is less harmful
Deadline.
Deadline.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1819
than one or more commercially marketed tobacco products, or presents
a reduced exposure to, or does not contain or is free of,
a substance or substances.
‘‘SEC. 912. JUDICIAL REVIEW.
‘‘(a) RIGHT TO REVIEW.—
‘‘(1) IN GENERAL.—Not later than 30 days after—
‘‘(A) the promulgation of a regulation under section
907 establishing, amending, or revoking a tobacco product
standard; or
‘‘(B) a denial of an application under section 910(c),
any person adversely affected by such regulation or denial
may file a petition for judicial review of such regulation or
denial with the United States Court of Appeals for the District
of Columbia or for the circuit in which such person resides
or has their principal place of business.
‘‘(2) REQUIREMENTS.—
‘‘(A) COPY OF PETITION.—A copy of the petition filed
under paragraph (1) shall be transmitted by the clerk
of the court involved to the Secretary.
‘‘(B) RECORD OF PROCEEDINGS.—On receipt of a petition
under subparagraph (A), the Secretary shall file in the
court in which such petition was filed—
‘‘(i) the record of the proceedings on which the
regulation or order was based; and
‘‘(ii) a statement of the reasons for the issuance
of such a regulation or order.
‘‘(C) DEFINITION OF RECORD.—In this section, the term
‘record’ means—
‘‘(i) all notices and other matter published in the
Federal Register with respect to the regulation or order
reviewed;
‘‘(ii) all information submitted to the Secretary
with respect to such regulation or order;
‘‘(iii) proceedings of any panel or advisory committee
with respect to such regulation or order;
‘‘(iv) any hearing held with respect to such regulation
or order; and
‘‘(v) any other information identified by the Secretary,
in the administrative proceeding held with
respect to such regulation or order, as being relevant
to such regulation or order.
‘‘(b) STANDARD OF REVIEW.—Upon the filing of the petition
under subsection (a) for judicial review of a regulation or order,
the court shall have jurisdiction to review the regulation or order
in accordance with chapter 7 of title 5, United States Code, and
to grant appropriate relief, including interim relief, as provided
for in such chapter. A regulation or denial described in subsection
(a) shall be reviewed in accordance with section 706(2)(A) of title
5, United States Code.
‘‘(c) FINALITY OF JUDGMENT.—The judgment of the court
affirming or setting aside, in whole or in part, any regulation
or order shall be final, subject to review by the Supreme Court
of the United States upon certiorari or certification, as provided
in section 1254 of title 28, United States Code.
Statement.
Deadline.
21 USC 387l.
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123 STAT. 1820 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(d) OTHER REMEDIES.—The remedies provided for in this section
shall be in addition to, and not in lieu of, any other remedies
provided by law.
‘‘(e) REGULATIONS AND ORDERS MUST RECITE BASIS IN
RECORD.—To facilitate judicial review, a regulation or order issued
under section 906, 907, 908, 909, 910, or 916 shall contain a
statement of the reasons for the issuance of such regulation or
order in the record of the proceedings held in connection with
its issuance.
‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.
‘‘The Secretary shall issue regulations to require that retail
establishments for which the predominant business is the sale
of tobacco products comply with any advertising restrictions
applicable to retail establishments accessible to individuals under
the age of 18.
‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL
TRADE COMMISSION.
‘‘(a) JURISDICTION.—
‘‘(1) IN GENERAL.—Except where expressly provided in this
chapter, nothing in this chapter shall be construed as limiting
or diminishing the authority of the Federal Trade Commission
to enforce the laws under its jurisdiction with respect to the
advertising, sale, or distribution of tobacco products.
‘‘(2) ENFORCEMENT.—Any advertising that violates this
chapter or a provision of the regulations referred to in section
102 of the Family Smoking Prevention and Tobacco Control
Act, is an unfair or deceptive act or practice under section
5(a) of the Federal Trade Commission Act and shall be considered
a violation of a rule promulgated under section 18 of
that Act.
‘‘(b) COORDINATION.—With respect to the requirements of section
4 of the Federal Cigarette Labeling and Advertising Act and
section 3 of the Comprehensive Smokeless Tobacco Health Education
Act of 1986—
‘‘(1) the Chairman of the Federal Trade Commission shall
coordinate with the Secretary concerning the enforcement of
such Act as such enforcement relates to unfair or deceptive
acts or practices in the advertising of cigarettes or smokeless
tobacco; and
‘‘(2) the Secretary shall consult with the Chairman of such
Commission in revising the label statements and requirements
under such sections.
‘‘SEC. 915. REGULATION REQUIREMENT.
‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not later than
36 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary shall promulgate
regulations under this Act that meet the requirements of subsection
(b).
‘‘(b) CONTENTS OF RULES.—The regulations promulgated under
subsection (a)—
‘‘(1) shall require testing and reporting of tobacco product
constituents, ingredients, and additives, including smoke
constituents, by brand and subbrand that the Secretary determines
should be tested to protect the public health, provided
that, for purposes of the testing requirements of this paragraph,
21 USC 387o.
Consultation.
21 USC 387n.
Regulations.
21 USC 387m.
Statement.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1821
tobacco products manufactured and sold by a single tobacco
product manufacturer that are identical in all respects except
the labels, packaging design, logo, trade dress, trademark,
brand name, or any combination thereof, shall be considered
as a single brand; and
‘‘(2) may require that tobacco product manufacturers, packagers,
or importers make disclosures relating to the results
of the testing of tar and nicotine through labels or advertising
or other appropriate means, and make disclosures regarding
the results of the testing of other constituents, including smoke
constituents, ingredients, or additives, that the Secretary determines
should be disclosed to the public to protect the public
health and will not mislead consumers about the risk of tobaccorelated
disease.
‘‘(c) AUTHORITY.—The Secretary shall have the authority under
this chapter to conduct or to require the testing, reporting, or
disclosure of tobacco product constituents, including smoke constituents.
‘‘(d) SMALL TOBACCO PRODUCT MANUFACTURERS.—
‘‘(1) FIRST COMPLIANCE DATE.—The initial regulations
promulgated under subsection (a) shall not impose requirements
on small tobacco product manufacturers before the later
of—
‘‘(A) the end of the 2-year period following the final
promulgation of such regulations; and
‘‘(B) the initial date set by the Secretary for compliance
with such regulations by manufacturers that are not small
tobacco product manufacturers.
‘‘(2) TESTING AND REPORTING INITIAL COMPLIANCE PERIOD.—
‘‘(A) 4-YEAR PERIOD.—The initial regulations promulgated
under subsection (a) shall give each small tobacco
product manufacturer a 4-year period over which to conduct
testing and reporting for all of its tobacco products. Subject
to paragraph (1), the end of the first year of such 4-
year period shall coincide with the initial date of compliance
under this section set by the Secretary with respect to
manufacturers that are not small tobacco product manufacturers
or the end of the 2-year period following the final
promulgation of such regulations, as described in paragraph
(1)(A). A small tobacco product manufacturer shall
be required—
‘‘(i) to conduct such testing and reporting for 25
percent of its tobacco products during each year of
such 4-year period; and
‘‘(ii) to conduct such testing and reporting for its
largest-selling tobacco products (as determined by the
Secretary) before its other tobacco products, or in such
other order of priority as determined by the Secretary.
‘‘(B) CASE-BY-CASE DELAY.—Notwithstanding subparagraph
(A), the Secretary may, on a case-by-case basis,
delay the date by which an individual small tobacco product
manufacturer must conduct testing and reporting for its
tobacco products under this section based upon a showing
of undue hardship to such manufacturer. Notwithstanding
the preceding sentence, the Secretary shall not extend the
deadline for a small tobacco product manufacturer to conduct
testing and reporting for all of its tobacco products
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123 STAT. 1822 PUBLIC LAW 111–31—JUNE 22, 2009
beyond a total of 5 years after the initial date of compliance
under this section set by the Secretary with respect to
manufacturers that are not small tobacco product manufacturers.
‘‘(3) SUBSEQUENT AND ADDITIONAL TESTING AND
REPORTING.—The regulations promulgated under subsection (a)
shall provide that, with respect to any subsequent or additional
testing and reporting of tobacco products required under this
section, such testing and reporting by a small tobacco product
manufacturer shall be conducted in accordance with the timeframes
described in paragraph (2)(A), except that, in the case
of a new product, or if there has been a modification described
in section 910(a)(1)(B) of any product of a small tobacco product
manufacturer since the last testing and reporting required
under this section, the Secretary shall require that any subsequent
or additional testing and reporting be conducted in
accordance with the same timeframe applicable to manufacturers
that are not small tobacco product manufacturers.
‘‘(4) JOINT LABORATORY TESTING SERVICES.—The Secretary
shall allow any 2 or more small tobacco product manufacturers
to join together to purchase laboratory testing services required
by this section on a group basis in order to ensure that such
manufacturers receive access to, and fair pricing of, such testing
services.
‘‘(e) EXTENSIONS FOR LIMITED LABORATORY CAPACITY.—
‘‘(1) IN GENERAL.—The regulations promulgated under subsection
(a) shall provide that a small tobacco product manufacturer
shall not be considered to be in violation of this section
before the deadline applicable under paragraphs (3) and (4),
if—
‘‘(A) the tobacco products of such manufacturer are
in compliance with all other requirements of this chapter;
and
‘‘(B) the conditions described in paragraph (2) are met.
‘‘(2) CONDITIONS.—Notwithstanding the requirements of
this section, the Secretary may delay the date by which a
small tobacco product manufacturer must be in compliance
with the testing and reporting required by this section until
such time as the testing is reported if, not later than 90
days before the deadline for reporting in accordance with this
section, a small tobacco product manufacturer provides evidence
to the Secretary demonstrating that—
‘‘(A) the manufacturer has submitted the required products
for testing to a laboratory and has done so sufficiently
in advance of the deadline to create a reasonable expectation
of completion by the deadline;
‘‘(B) the products currently are awaiting testing by
the laboratory; and
‘‘(C) neither that laboratory nor any other laboratory
is able to complete testing by the deadline at customary,
nonexpedited testing fees.
‘‘(3) EXTENSION.—The Secretary, taking into account the
laboratory testing capacity that is available to tobacco product
manufacturers, shall review and verify the evidence submitted
by a small tobacco product manufacturer in accordance with
paragraph (2). If the Secretary finds that the conditions
described in such paragraph are met, the Secretary shall notify
Notification.
Deadline.
Evidence.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1823
the small tobacco product manufacturer that the manufacturer
shall not be considered to be in violation of the testing and
reporting requirements of this section until the testing is
reported or until 1 year after the reporting deadline has passed,
whichever occurs sooner. If, however, the Secretary has not
made a finding before the reporting deadline, the manufacturer
shall not be considered to be in violation of such requirements
until the Secretary finds that the conditions described in paragraph
(2) have not been met, or until 1 year after the reporting
deadline, whichever occurs sooner.
‘‘(4) ADDITIONAL EXTENSION.—In addition to the time that
may be provided under paragraph (3), the Secretary may provide
further extensions of time, in increments of no more than
1 year, for required testing and reporting to occur if the Secretary
determines, based on evidence properly and timely submitted
by a small tobacco product manufacturer in accordance
with paragraph (2), that a lack of available laboratory capacity
prevents the manufacturer from completing the required testing
during the period described in paragraph (3).
‘‘(f) RULE OF CONSTRUCTION.—Nothing in subsection (d) or (e)
shall be construed to authorize the extension of any deadline, or
to otherwise affect any timeframe, under any provision of this
Act or the Family Smoking Prevention and Tobacco Control Act
other than this section.
‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHORITY.
‘‘(a) IN GENERAL.—
‘‘(1) PRESERVATION.—Except as provided in paragraph
(2)(A), nothing in this chapter, or rules promulgated under
this chapter, shall be construed to limit the authority of a
Federal agency (including the Armed Forces), a State or political
subdivision of a State, or the government of an Indian
tribe to enact, adopt, promulgate, and enforce any law, rule,
regulation, or other measure with respect to tobacco products
that is in addition to, or more stringent than, requirements
established under this chapter, including a law, rule, regulation,
or other measure relating to or prohibiting the sale, distribution,
possession, exposure to, access to, advertising and promotion
of, or use of tobacco products by individuals of any
age, information reporting to the State, or measures relating
to fire safety standards for tobacco products. No provision of
this chapter shall limit or otherwise affect any State, tribal,
or local taxation of tobacco products.
‘‘(2) PREEMPTION OF CERTAIN STATE AND LOCAL REQUIREMENTS.—
‘‘(A) IN GENERAL.—No State or political subdivision
of a State may establish or continue in effect with respect
to a tobacco product any requirement which is different
from, or in addition to, any requirement under the provisions
of this chapter relating to tobacco product standards,
premarket review, adulteration, misbranding, labeling, registration,
good manufacturing standards, or modified risk
tobacco products.
‘‘(B) EXCEPTION.—Subparagraph (A) does not apply to
requirements relating to the sale, distribution, possession,
information reporting to the State, exposure to, access to,
the advertising and promotion of, or use of, tobacco products
21 USC 387p.
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123 STAT. 1824 PUBLIC LAW 111–31—JUNE 22, 2009
by individuals of any age, or relating to fire safety standards
for tobacco products. Information disclosed to a State
under subparagraph (A) that is exempt from disclosure
under section 552(b)(4) of title 5, United States Code, shall
be treated as a trade secret and confidential information
by the State.
‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT LIABILITY.—
No provision of this chapter relating to a tobacco product shall
be construed to modify or otherwise affect any action or the liability
of any person under the product liability law of any State.
‘‘SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
‘‘(a) ESTABLISHMENT.—Not later than 6 months after the date
of enactment of the Family Smoking Prevention and Tobacco Control
Act, the Secretary shall establish a 12-member advisory committee,
to be known as the Tobacco Products Scientific Advisory
Committee (in this section referred to as the ‘Advisory Committee’).
‘‘(b) MEMBERSHIP.—
‘‘(1) IN GENERAL.—
‘‘(A) MEMBERS.—The Secretary shall appoint as members
of the Tobacco Products Scientific Advisory Committee
individuals who are technically qualified by training and
experience in medicine, medical ethics, science, or technology
involving the manufacture, evaluation, or use of
tobacco products, who are of appropriately diversified
professional backgrounds. The committee shall be composed
of—
‘‘(i) 7 individuals who are physicians, dentists, scientists,
or health care professionals practicing in the
area of oncology, pulmonology, cardiology, toxicology,
pharmacology, addiction, or any other relevant specialty;
‘‘(ii) 1 individual who is an officer or employee
of a State or local government or of the Federal Government;
‘‘(iii) 1 individual as a representative of the general
public;
‘‘(iv) 1 individual as a representative of the
interests of the tobacco manufacturing industry;
‘‘(v) 1 individual as a representative of the interests
of the small business tobacco manufacturing industry,
which position may be filled on a rotating, sequential
basis by representatives of different small business
tobacco manufacturers based on areas of expertise relevant
to the topics being considered by the Advisory
Committee; and
‘‘(vi) 1 individual as a representative of the
interests of the tobacco growers.
‘‘(B) NONVOTING MEMBERS.—The members of the committee
appointed under clauses (iv), (v), and (vi) of subparagraph
(A) shall serve as consultants to those described
in clauses (i) through (iii) of subparagraph (A) and shall
be nonvoting representatives.
‘‘(C) CONFLICTS OF INTEREST.—No members of the committee,
other than members appointed pursuant to clauses
(iv), (v), and (vi) of subparagraph (A) shall, during the
member’s tenure on the committee or for the 18-month
Deadline.
21 USC 387q.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1825
period prior to becoming such a member, receive any salary,
grants, or other payments or support from any business
that manufactures, distributes, markets, or sells cigarettes
or other tobacco products.
‘‘(2) LIMITATION.—The Secretary may not appoint to the
Advisory Committee any individual who is in the regular fulltime
employ of the Food and Drug Administration or any agency
responsible for the enforcement of this Act. The Secretary may
appoint Federal officials as ex officio members.
‘‘(3) CHAIRPERSON.—The Secretary shall designate 1 of the
members appointed under clauses (i), (ii), and (iii) of paragraph
(1)(A) to serve as chairperson.
‘‘(c) DUTIES.—The Tobacco Products Scientific Advisory Committee
shall provide advice, information, and recommendations to
the Secretary—
‘‘(1) as provided in this chapter;
‘‘(2) on the effects of the alteration of the nicotine yields
from tobacco products;
‘‘(3) on whether there is a threshold level below which
nicotine yields do not produce dependence on the tobacco
product involved; and
‘‘(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the Secretary.
‘‘(d) COMPENSATION; SUPPORT; FACA.—
‘‘(1) COMPENSATION AND TRAVEL.—Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the committee
or otherwise engaged in its business, shall be entitled
to receive compensation at rates to be fixed by the Secretary,
which may not exceed the daily equivalent of the rate in effect
under the Senior Executive Schedule under section 5382 of
title 5, United States Code, for each day (including travel
time) they are so engaged; and while so serving away from
their homes or regular places of business each member may
be allowed travel expenses, including per diem in lieu of subsistence,
as authorized by section 5703 of title 5, United States
Code, for persons in the Government service employed intermittently.
‘‘(2) ADMINISTRATIVE SUPPORT.—The Secretary shall furnish
the Advisory Committee clerical and other assistance.
‘‘(3) NONAPPLICATION OF FACA.—Section 14 of the Federal
Advisory Committee Act does not apply to the Advisory Committee.
‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COMMITTEES.—
The Advisory Committee shall make and maintain a transcript
of any proceeding of the panel or committee. Each such panel
and committee shall delete from any transcript made under this
subsection information which is exempt from disclosure under section
552(b) of title 5, United States Code.
‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
‘‘(a) IN GENERAL.—The Secretary shall—
‘‘(1) at the request of the applicant, consider designating
products for smoking cessation, including nicotine replacement
products as fast track research and approval products within
the meaning of section 506;
21 USC 387r.
Records.
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123 STAT. 1826 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(2) consider approving the extended use of nicotine replacement
products (such as nicotine patches, nicotine gum, and
nicotine lozenges) for the treatment of tobacco dependence;
and
‘‘(3) review and consider the evidence for additional indications
for nicotine replacement products, such as for craving
relief or relapse prevention.
‘‘(b) REPORT ON INNOVATIVE PRODUCTS.—
‘‘(1) IN GENERAL.—Not later than 3 years after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary, after consultation with recognized
scientific, medical, and public health experts (including both
Federal agencies and nongovernmental entities, the Institute
of Medicine of the National Academy of Sciences, and the
Society for Research on Nicotine and Tobacco), shall submit
to the Congress a report that examines how best to regulate,
promote, and encourage the development of innovative products
and treatments (including nicotine-based and non-nicotinebased
products and treatments) to better achieve, in a manner
that best protects and promotes the public health—
‘‘(A) total abstinence from tobacco use;
‘‘(B) reductions in consumption of tobacco; and
‘‘(C) reductions in the harm associated with continued
tobacco use.
‘‘(2) RECOMMENDATIONS.—The report under paragraph (1)
shall include the recommendations of the Secretary on how
the Food and Drug Administration should coordinate and facilitate
the exchange of information on such innovative products
and treatments among relevant offices and centers within the
Administration and within the National Institutes of Health,
the Centers for Disease Control and Prevention, and other
relevant agencies.
‘‘SEC. 919. USER FEES.
‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Beginning on the
date of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall in accordance with this section
assess user fees on, and collect such fees from, each manufacturer
and importer of tobacco products subject to this chapter. The fees
shall be assessed and collected with respect to each quarter of
each fiscal year, and the total amount assessed and collected for
a fiscal year shall be the amount specified in subsection (b)(1)
for such year, subject to subsection (c).
‘‘(b) ASSESSMENT OF USER FEE.—
‘‘(1) AMOUNT OF ASSESSMENT.—The total amount of user
fees authorized to be assessed and collected under subsection
(a) for a fiscal year is the following, as applicable to the fiscal
year involved:
‘‘(A) For fiscal year 2009, $85,000,000 (subject to subsection
(e)).
‘‘(B) For fiscal year 2010, $235,000,000.
‘‘(C) For fiscal year 2011, $450,000,000.
‘‘(D) For fiscal year 2012, $477,000,000.
‘‘(E) For fiscal year 2013, $505,000,000.
‘‘(F) For fiscal year 2014, $534,000,000.
‘‘(G) For fiscal year 2015, $566,000,000.
‘‘(H) For fiscal year 2016, $599,000,000.
Effective date.
21 USC 387s.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1827
‘‘(I) For fiscal year 2017, $635,000,000.
‘‘(J) For fiscal year 2018, $672,000,000.
‘‘(K) For fiscal year 2019 and each subsequent fiscal
year, $712,000,000.
‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF TOBACCO
PRODUCTS.—
‘‘(A) IN GENERAL.—The total user fees assessed and
collected under subsection (a) each fiscal year with respect
to each class of tobacco products shall be an amount that
is equal to the applicable percentage of each class for
the fiscal year multiplied by the amount specified in paragraph
(1) for the fiscal year.
‘‘(B) APPLICABLE PERCENTAGE.—
‘‘(i) IN GENERAL.—For purposes of subparagraph
(A), the applicable percentage for a fiscal year for each
of the following classes of tobacco products shall be
determined in accordance with clause (ii):
‘‘(I) Cigarettes.
‘‘(II) Cigars, including small cigars and cigars
other than small cigars.
‘‘(III) Snuff.
‘‘(IV) Chewing tobacco.
‘‘(V) Pipe tobacco.
‘‘(VI) Roll-your-own tobacco.
‘‘(ii) ALLOCATIONS.—The applicable percentage of
each class of tobacco product described in clause (i)
for a fiscal year shall be the percentage determined
under section 625(c) of Public Law 108–357 for each
such class of product for such fiscal year.
‘‘(iii) REQUIREMENT OF REGULATIONS.—Notwithstanding
clause (ii), no user fees shall be assessed
on a class of tobacco products unless such class of
tobacco products is listed in section 901(b) or is deemed
by the Secretary in a regulation under section 901(b)
to be subject to this chapter.
‘‘(iv) REALLOCATIONS.—In the case of a class of
tobacco products that is not listed in section 901(b)
or deemed by the Secretary in a regulation under section
901(b) to be subject to this chapter, the amount
of user fees that would otherwise be assessed to such
class of tobacco products shall be reallocated to the
classes of tobacco products that are subject to this
chapter in the same manner and based on the same
relative percentages otherwise determined under
clause (ii).
‘‘(3) DETERMINATION OF USER FEE BY COMPANY.—
‘‘(A) IN GENERAL.—The total user fee to be paid by
each manufacturer or importer of a particular class of
tobacco products shall be determined for each quarter by
multiplying—
‘‘(i) such manufacturer’s or importer’s percentage
share as determined under paragraph (4); by
‘‘(ii) the portion of the user fee amount for the
current quarter to be assessed on all manufacturers
and importers of such class of tobacco products as
determined under paragraph (2).
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123 STAT. 1828 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(B) NO FEE IN EXCESS OF PERCENTAGE SHARE.—No
manufacturer or importer of tobacco products shall be
required to pay a user fee in excess of the percentage
share of such manufacturer or importer.
‘‘(4) ALLOCATION OF ASSESSMENT WITHIN EACH CLASS OF
TOBACCO PRODUCT.—The percentage share of each manufacturer
or importer of a particular class of tobacco products
of the total user fee to be paid by all manufacturers or importers
of that class of tobacco products shall be the percentage determined
for purposes of allocations under subsections (e) through
(h) of section 625 of Public Law 108–357.
‘‘(5) ALLOCATION FOR CIGARS.—Notwithstanding paragraph
(4), if a user fee assessment is imposed on cigars, the percentage
share of each manufacturer or importer of cigars shall be based
on the excise taxes paid by such manufacturer or importer
during the prior fiscal year.
‘‘(6) TIMING OF ASSESSMENT.—The Secretary shall notify
each manufacturer and importer of tobacco products subject
to this section of the amount of the quarterly assessment
imposed on such manufacturer or importer under this subsection
for each quarter of each fiscal year. Such notifications
shall occur not later than 30 days prior to the end of the
quarter for which such assessment is made, and payments
of all assessments shall be made by the last day of the quarter
involved.
‘‘(7) MEMORANDUM OF UNDERSTANDING.—
‘‘(A) IN GENERAL.—The Secretary shall request the
appropriate Federal agency to enter into a memorandum
of understanding that provides for the regular and timely
transfer from the head of such agency to the Secretary
of the information described in paragraphs (2)(B)(ii) and
(4) and all necessary information regarding all tobacco
product manufacturers and importers required to pay user
fees. The Secretary shall maintain all disclosure restrictions
established by the head of such agency regarding
the information provided under the memorandum of understanding.
‘‘(B) ASSURANCES.—Beginning not later than fiscal year
2015, and for each subsequent fiscal year, the Secretary
shall ensure that the Food and Drug Administration is
able to determine the applicable percentages described in
paragraph (2) and the percentage shares described in paragraph
(4). The Secretary may carry out this subparagraph
by entering into a contract with the head of the Federal
agency referred to in subparagraph (A) to continue to provide
the necessary information.
‘‘(c) CREDITING AND AVAILABILITY OF FEES.—
‘‘(1) IN GENERAL.—Fees authorized under subsection (a)
shall be collected and available for obligation only to the extent
and in the amount provided in advance in appropriations Acts,
subject to paragraph (2)(D). Such fees are authorized to remain
available until expended. Such sums as may be necessary may
be transferred from the Food and Drug Administration salaries
and expenses appropriation account without fiscal year limitation
to such appropriation account for salaries and expenses
with such fiscal year limitation.
‘‘(2) AVAILABILITY.—
Effective dates.
Disclosure.
Deadlines.
Notification.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1829
‘‘(A) IN GENERAL.—Fees appropriated under paragraph
(3) are available only for the purpose of paying the costs
of the activities of the Food and Drug Administration
related to the regulation of tobacco products under this
chapter and the Family Smoking Prevention and Tobacco
Control Act (referred to in this subsection as ‘tobacco regulation
activities’), except that such fees may be used for
the reimbursement specified in subparagraph (C).
‘‘(B) PROHIBITION AGAINST USE OF OTHER FUNDS.—
‘‘(i) IN GENERAL.—Except as provided in clause
(ii), fees collected under subsection (a) are the only
funds authorized to be made available for tobacco regulation
activities.
‘‘(ii) STARTUP COSTS.—Clause (i) does not apply
until October 1, 2009. Until such date, any amounts
available to the Food and Drug Administration
(excluding user fees) shall be available and allocated
as needed to pay the costs of tobacco regulation activities.
‘‘(C) REIMBURSEMENT OF START-UP AMOUNTS.—
‘‘(i) IN GENERAL.—Any amounts allocated for the
start-up period pursuant to subparagraph (B)(ii) shall
be reimbursed through any appropriated fees collected
under subsection (a), in such manner as the Secretary
determines appropriate to ensure that such allocation
results in no net change in the total amount of funds
otherwise available, for the period from October 1,
2008, through September 30, 2010, for Food and Drug
Administration programs and activities (other than
tobacco regulation activities) for such period.
‘‘(ii) TREATMENT OF REIMBURSED AMOUNTS.—
Amounts reimbursed under clause (i) shall be available
for the programs and activities for which funds allocated
for the start-up period were available, prior to
such allocation, until September 30, 2010, notwithstanding
any otherwise applicable limits on amounts
for such programs or activities for a fiscal year.
‘‘(D) FEE COLLECTED DURING START-UP PERIOD.—Notwithstanding
the first sentence of paragraph (1), fees under
subsection (a) may be collected through September 30, 2009
under subparagraph (B)(ii) and shall be available for obligation
and remain available until expended. Such offsetting
collections shall be credited to the salaries and expenses
account of the Food and Drug Administration.
‘‘(E) OBLIGATION OF START-UP COSTS IN ANTICIPATION
OF AVAILABLE FEE COLLECTIONS.—Notwithstanding any
other provision of law, following the enactment of an appropriation
for fees under this section for fiscal year 2010,
or any portion thereof, obligations for costs of tobacco regulation
activities during the start-up period may be incurred
in anticipation of the receipt of offsetting fee collections
through procedures specified in section 1534 of title 31,
United States Code.
‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For fiscal year
2009 and each subsequent fiscal year, there is authorized to
be appropriated for fees under this section an amount equal
to the amount specified in subsection (b)(1) for the fiscal year.
Deadline.
Deadline.
Effective date.
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123 STAT. 1830 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(d) COLLECTION OF UNPAID FEES.—In any case where the
Secretary does not receive payment of a fee assessed under subsection
(a) within 30 days after it is due, such fee shall be treated
as a claim of the United States Government subject to subchapter
II of chapter 37 of title 31, United States Code.
‘‘(e) APPLICABILITY TO FISCAL YEAR 2009.—If the date of enactment
of the Family Smoking Prevention and Tobacco Control Act
occurs during fiscal year 2009, the following applies, subject to
subsection (c):
‘‘(1) The Secretary shall determine the fees that would
apply for a single quarter of such fiscal year according to
the application of subsection (b) to the amount specified in
paragraph (1)(A) of such subsection (referred to in this subsection
as the ‘quarterly fee amounts’).
‘‘(2) For the quarter in which such date of enactment occurs,
the amount of fees assessed shall be a pro rata amount, determined
according to the number of days remaining in the quarter
(including such date of enactment) and according to the daily
equivalent of the quarterly fee amounts. Fees assessed under
the preceding sentence shall not be collected until the next
quarter.
‘‘(3) For the quarter following the quarter to which paragraph
(2) applies, the full quarterly fee amounts shall be
assessed and collected, in addition to collection of the pro rata
fees assessed under paragraph (2).’’.
(c) CONFORMING AMENDMENT.—Section 9(1) of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C.
4408(i)) is amended to read as follows:
‘‘(1) The term ‘smokeless tobacco’ has the meaning given
such term by section 900(18) of the Federal Food, Drug, and
Cosmetic Act.’’.
SEC. 102. FINAL RULE.
(a) CIGARETTES AND SMOKELESS TOBACCO.—
(1) IN GENERAL.—On the first day of publication of the
Federal Register that is 180 days or more after the date of
enactment of this Act, the Secretary of Health and Human
Services shall publish in the Federal Register a final rule
regarding cigarettes and smokeless tobacco, which—
(A) is deemed to be issued under chapter 9 of the
Federal Food, Drug, and Cosmetic Act, as added by section
101 of this division; and
(B) shall be deemed to be in compliance with all
applicable provisions of chapter 5 of title 5, United States
Code, and all other provisions of law relating to rulemaking
procedures.
(2) CONTENTS OF RULE.—Except as provided in this subsection,
the final rule published under paragraph (1), shall
be identical in its provisions to part 897 of the regulations
promulgated by the Secretary of Health and Human Services
in the August 28, 1996, issue of the Federal Register (61
Fed. Reg. 44615–44618). Such rule shall—
(A) provide for the designation of jurisdictional
authority that is in accordance with this subsection in
accordance with this division and the amendments made
by this division;
(B) strike Subpart C—Labels and section 897.32(c);
Deadline.
Federal Register,
publication.
21 USC 387a–1.
Fees.
Deadline.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1831
(C) strike paragraphs (a), (b), and (i) of section 897.3
and insert definitions of the terms ‘‘cigarette’’, ‘‘cigarette
tobacco’’, and ‘‘smokeless tobacco’’ as defined in section
900 of the Federal Food, Drug, and Cosmetic Act;
(D) insert ‘‘or roll-your-own paper’’ in section 897.34(a)
after ‘‘other than cigarettes or smokeless tobacco’’;
(E) include such modifications to section 897.30(b), if
any, that the Secretary determines are appropriate in light
of governing First Amendment case law, including the decision
of the Supreme Court of the United States in Lorillard
Tobacco Co. v. Reilly (533 U.S. 525 (2001));
(F) become effective on the date that is 1 year after
the date of enactment of this Act; and
(G) amend paragraph (d) of section 897.16 to read
as follows:
‘‘(d)(1) Except as provided in subparagraph (2), no manufacturer,
distributor, or retailer may distribute or cause to be distributed
any free samples of cigarettes, smokeless tobacco, or other
tobacco products (as such term is defined in section 201 of the
Federal Food, Drug, and Cosmetic Act).
‘‘(2)(A) Subparagraph (1) does not prohibit a manufacturer,
distributor, or retailer from distributing or causing to be distributed
free samples of smokeless tobacco in a qualified adult-only facility.
‘‘(B) This subparagraph does not affect the authority of a State
or local government to prohibit or otherwise restrict the distribution
of free samples of smokeless tobacco.
‘‘(C) For purposes of this paragraph, the term ‘qualified adultonly
facility’ means a facility or restricted area that—
‘‘(i) requires each person present to provide to a law enforcement
officer (whether on or off duty) or to a security guard
licensed by a governmental entity government-issued identification
showing a photograph and at least the minimum age
established by applicable law for the purchase of smokeless
tobacco;
‘‘(ii) does not sell, serve, or distribute alcohol;
‘‘(iii) is not located adjacent to or immediately across from
(in any direction) a space that is used primarily for youthoriented
marketing, promotional, or other activities;
‘‘(iv) is a temporary structure constructed, designated, and
operated as a distinct enclosed area for the purpose of distributing
free samples of smokeless tobacco in accordance with
this subparagraph;
‘‘(v) is enclosed by a barrier that—
‘‘(I) is constructed of, or covered with, an opaque material
(except for entrances and exits);
‘‘(II) extends from no more than 12 inches above the
ground or floor (which area at the bottom of the barrier
must be covered with material that restricts visibility but
may allow airflow) to at least 8 feet above the ground
or floor (or to the ceiling); and
‘‘(III) prevents persons outside the qualified adult-only
facility from seeing into the qualified adult-only facility,
unless they make unreasonable efforts to do so; and
‘‘(vi) does not display on its exterior—
‘‘(I) any tobacco product advertising;
Effective date.
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123 STAT. 1832 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(II) a brand name other than in conjunction with
words for an area or enclosure to identify an adult-only
facility; or
‘‘(III) any combination of words that would imply to
a reasonable observer that the manufacturer, distributor,
or retailer has a sponsorship that would violate section
897.34(c).
‘‘(D) Distribution of samples of smokeless tobacco under this
subparagraph permitted to be taken out of the qualified adultonly
facility shall be limited to 1 package per adult consumer
containing no more than 0.53 ounces (15 grams) of smokeless
tobacco. If such package of smokeless tobacco contains individual
portions of smokeless tobacco, the individual portions of smokeless
tobacco shall not exceed 8 individual portions and the collective
weight of such individual portions shall not exceed 0.53 ounces
(15 grams). Any manufacturer, distributor, or retailer who distributes
or causes to be distributed free samples also shall take reasonable
steps to ensure that the above amounts are limited to one
such package per adult consumer per day.
‘‘(3) Notwithstanding subparagraph (2), no manufacturer, distributor,
or retailer may distribute or cause to be distributed any
free samples of smokeless tobacco—
‘‘(A) to a sports team or entertainment group; or
‘‘(B) at any football, basketball, baseball, soccer, or hockey
event or any other sporting or entertainment event determined
by the Secretary to be covered by this subparagraph.
‘‘(4) The Secretary shall implement a program to ensure compliance
with this paragraph and submit a report to the Congress
on such compliance not later than 18 months after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act.
‘‘(5) Nothing in this paragraph shall be construed to authorize
any person to distribute or cause to be distributed any sample
of a tobacco product to any individual who has not attained the
minimum age established by applicable law for the purchase of
such product.’’.
(3) AMENDMENTS TO RULE.—Prior to making amendments
to the rule published under paragraph (1), the Secretary shall
promulgate a proposed rule in accordance with chapter 5 of
title 5, United States Code.
(4) RULE OF CONSTRUCTION.—Except as provided in paragraph
(3), nothing in this section shall be construed to limit
the authority of the Secretary to amend, in accordance with
chapter 5 of title 5, United States Code, the regulation promulgated
pursuant to this section, including the provisions of such
regulation relating to distribution of free samples.
(5) ENFORCEMENT OF RETAIL SALE PROVISIONS.—The Secretary
of Health and Human Services shall ensure that the
provisions of this division, the amendments made by this division,
and the implementing regulations (including such provisions,
amendments, and regulations relating to the retail sale
of tobacco products) are enforced with respect to the United
States and Indian tribes.
(6) QUALIFIED ADULT-ONLY FACILITY.—A qualified adultonly
facility (as such term is defined in section 897.16(d) of
the final rule published under paragraph (1)) that is also a
retailer and that commits a violation as a retailer shall not
Penalties.
Reports.
Deadline.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1833
be subject to the limitations in section 103(q) and shall be
subject to penalties applicable to a qualified adult-only facility.
(7) CONGRESSIONAL REVIEW PROVISIONS.—Section 801 of
title 5, United States Code, shall not apply to the final rule
published under paragraph (1).
(b) LIMITATION ON ADVISORY OPINIONS.—As of the date of enactment
of this Act, the following documents issued by the Food
and Drug Administration shall not constitute advisory opinions
under section 10.85(d)(1) of title 21, Code of Federal Regulations,
except as they apply to tobacco products, and shall not be cited
by the Secretary of Health and Human Services or the Food and
Drug Administration as binding precedent:
(1) The preamble to the proposed rule in the document
titled ‘‘Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco Products to Protect Children
and Adolescents’’ (60 Fed. Reg. 41314–41372 (August 11, 1995)).
(2) The document titled ‘‘Nicotine in Cigarettes and Smokeless
Tobacco Products is a Drug and These Products Are Nicotine
Delivery Devices Under the Federal Food, Drug, and Cosmetic
Act’’ (60 Fed. Reg. 41453–41787 (August 11, 1995)).
(3) The preamble to the final rule in the document titled
‘‘Regulations Restricting the Sale and Distribution of Cigarettes
and Smokeless Tobacco to Protect Children and Adolescents’’
(61 Fed. Reg. 44396–44615 (August 28, 1996)).
(4) The document titled ‘‘Nicotine in Cigarettes and Smokeless
Tobacco is a Drug and These Products are Nicotine Delivery
Devices Under the Federal Food, Drug, and Cosmetic Act; Jurisdictional
Determination’’ (61 Fed. Reg. 44619–45318 (August
28, 1996)).
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL
PROVISIONS.
(a) AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC
ACT.—Except as otherwise expressly provided, whenever in this
section an amendment is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference is to
a section or other provision of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.).
(b) SECTION 301.—Section 301 (21 U.S.C. 331) is amended—
(1) in subsection (a), by inserting ‘‘tobacco product,’’ after
‘‘device,’’;
(2) in subsection (b), by inserting ‘‘tobacco product,’’ after
‘‘device,’’;
(3) in subsection (c), by inserting ‘‘tobacco product,’’ after
‘‘device,’’;
(4) in subsection (e)—
(A) by striking the period after ‘‘572(i)’’; and
(B) by striking ‘‘or 761 or the refusal to permit access
to’’ and inserting ‘‘761, 909, or 920 or the refusal to permit
access to’’;
(5) in subsection (g), by inserting ‘‘tobacco product,’’ after
‘‘device,’’;
(6) in subsection (h), by inserting ‘‘tobacco product,’’ after
‘‘device,’’;
(7) in subsection (j)—
(A) by striking the period after ‘‘573’’; and
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123 STAT. 1834 PUBLIC LAW 111–31—JUNE 22, 2009
(B) by striking ‘‘708, or 721’’ and inserting ‘‘708, 721,
904, 905, 906, 907, 908, 909, or 920(b)’’;
(8) in subsection (k), by inserting ‘‘tobacco product,’’ after
‘‘device,’’;
(9) by striking subsection (p) and inserting the following:
‘‘(p) The failure to register in accordance with section 510
or 905, the failure to provide any information required by section
510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice
required by section 510(j)(2) or 905(i)(3).’’;
(10) by striking subsection (q)(1) and inserting the following:
‘‘(q)(1) The failure or refusal—
‘‘(A) to comply with any requirement prescribed under section
518, 520(g), 903(b), 907, 908, or 915;
‘‘(B) to furnish any notification or other material or information
required by or under section 519, 520(g), 904, 909, or
920; or
‘‘(C) to comply with a requirement under section 522 or
913.’’;
(11) in subsection (q)(2), by striking ‘‘device,’’ and inserting
‘‘device or tobacco product,’’;
(12) in subsection (r), by inserting ‘‘or tobacco product’’
after the term ‘‘device’’ each time that such term appears;
and
(13) by adding at the end the following:
‘‘(oo) The sale of tobacco products in violation of a no-tobaccosale
order issued under section 303(f).
‘‘(pp) The introduction or delivery for introduction into interstate
commerce of a tobacco product in violation of section 911.
‘‘(qq)(1) Forging, counterfeiting, simulating, or falsely representing,
or without proper authority using any mark, stamp
(including tax stamp), tag, label, or other identification device upon
any tobacco product or container or labeling thereof so as to render
such tobacco product a counterfeit tobacco product.
‘‘(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate, stone, or
other item that is designed to print, imprint, or reproduce the
trademark, trade name, or other identifying mark, imprint, or device
of another or any likeness of any of the foregoing upon any tobacco
product or container or labeling thereof so as to render such tobacco
product a counterfeit tobacco product.
‘‘(3) The doing of any act that causes a tobacco product to
be a counterfeit tobacco product, or the sale or dispensing, or
the holding for sale or dispensing, of a counterfeit tobacco product.
‘‘(rr) The charitable distribution of tobacco products.
‘‘(ss) The failure of a manufacturer or distributor to notify
the Attorney General and the Secretary of the Treasury of their
knowledge of tobacco products used in illicit trade.
‘‘(tt) Making any express or implied statement or representation
directed to consumers with respect to a tobacco product, in a label
or labeling or through the media or advertising, that either conveys,
or misleads or would mislead consumers into believing, that—
‘‘(1) the product is approved by the Food and Drug Administration;
‘‘(2) the Food and Drug Administration deems the product
to be safe for use by consumers;
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1835
‘‘(3) the product is endorsed by the Food and Drug Administration
for use by consumers; or
‘‘(4) the product is safe or less harmful by virtue of—
‘‘(A) its regulation or inspection by the Food and Drug
Administration; or
‘‘(B) its compliance with regulatory requirements set
by the Food and Drug Administration;
including any such statement or representation rendering the
product misbranded under section 903.’’.
(c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f)) is amended—
(1) in paragraph (5)—
(A) by striking ‘‘paragraph (1), (2), (3), or (4)’’ each
place such appears and inserting ‘‘paragraph (1), (2), (3),
(4), or (9)’’;
(B) in subparagraph (A)—
(i) by striking ‘‘assessed’’ the first time it appears
and inserting ‘‘assessed, or a no-tobacco-sale order may
be imposed,’’; and
(ii) by striking ‘‘penalty’’ the second time it appears
and inserting ‘‘penalty, or upon whom a no-tobaccosale
order is to be imposed,’’;
(C) in subparagraph (B)—
(i) by inserting after ‘‘penalty,’’ the following: ‘‘or
the period to be covered by a no-tobacco-sale order,’’;
and
(ii) by adding at the end the following: ‘‘A notobacco-
sale order permanently prohibiting an individual
retail outlet from selling tobacco products shall
include provisions that allow the outlet, after a specified
period of time, to request that the Secretary compromise,
modify, or terminate the order.’’; and
(D) by adding at the end the following:
‘‘(D) The Secretary may compromise, modify, or terminate, with
or without conditions, any no-tobacco-sale order.’’;
(2) in paragraph (6)—
(A) by inserting ‘‘or the imposition of a no-tobaccosale
order’’ after the term ‘‘penalty’’ each place such term
appears; and
(B) by striking ‘‘issued.’’ and inserting ‘‘issued, or on
which the no-tobacco-sale order was imposed, as the case
may be.’’; and
(3) by adding at the end the following:
‘‘(8) If the Secretary finds that a person has committed repeated
violations of restrictions promulgated under section 906(d) at a
particular retail outlet then the Secretary may impose a no-tobaccosale
order on that person prohibiting the sale of tobacco products
in that outlet. A no-tobacco-sale order may be imposed with a
civil penalty under paragraph (1). Prior to the entry of a nosale
order under this paragraph, a person shall be entitled to
a hearing pursuant to the procedures established through regulations
of the Food and Drug Administration for assessing civil money
penalties, including at a retailer’s request a hearing by telephone,
or at the nearest regional or field office of the Food and Drug
Administration, or at a Federal, State, or county facility within
100 miles from the location of the retail outlet, if such a facility
is available.
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123 STAT. 1836 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(9) CIVIL MONETARY PENALTIES FOR VIOLATION OF TOBACCO
PRODUCT REQUIREMENTS.—
‘‘(A) IN GENERAL.—Subject to subparagraph (B), any person
who violates a requirement of this Act which relates to tobacco
products shall be liable to the United States for a civil penalty
in an amount not to exceed $15,000 for each such violation,
and not to exceed $1,000,000 for all such violations adjudicated
in a single proceeding.
‘‘(B) ENHANCED PENALTIES.—
‘‘(i) Any person who intentionally violates a requirement
of section 902(5), 902(6), 904, 908(c), or 911(a), shall
be subject to a civil monetary penalty of—
‘‘(I) not to exceed $250,000 per violation, and not
to exceed $1,000,000 for all such violations adjudicated
in a single proceeding; or
‘‘(II) in the case of a violation that continues after
the Secretary provides written notice to such person,
$250,000 for the first 30-day period (or any portion
thereof) that the person continues to be in violation,
and such amount shall double for every 30-day period
thereafter that the violation continues, not to exceed
$1,000,000 for any 30-day period, and not to exceed
$10,000,000 for all such violations adjudicated in a
single proceeding.
‘‘(ii) Any person who violates a requirement of section
911(g)(2)(C)(ii) or 911(i)(1), shall be subject to a civil monetary
penalty of—
‘‘(I) not to exceed $250,000 per violation, and not
to exceed $1,000,000 for all such violations adjudicated
in a single proceeding; or
‘‘(II) in the case of a violation that continues after
the Secretary provides written notice to such person,
$250,000 for the first 30-day period (or any portion
thereof) that the person continues to be in violation,
and such amount shall double for every 30-day period
thereafter that the violation continues, not to exceed
$1,000,000 for any 30-day period, and not to exceed
$10,000,000 for all such violations adjudicated in a
single proceeding.
‘‘(iii) In determining the amount of a civil penalty
under clause (i)(II) or (ii)(II), the Secretary shall take into
consideration whether the person is making efforts toward
correcting the violation of the requirements of the section
for which such person is subject to such civil penalty.’’.
(d) SECTION 304.—Section 304 (21 U.S.C. 334) is amended—
(1) in subsection (a)(2)—
(A) by striking ‘‘and’’ before ‘‘(D)’’; and
(B) by striking ‘‘device.’’ and inserting the following:
‘‘device, and (E) Any adulterated or misbranded tobacco
product.’’;
(2) in subsection (d)(1), by inserting ‘‘tobacco product,’’ after
‘‘device,’’;
(3) in subsection (g)(1), by inserting ‘‘or tobacco product’’
after the term ‘‘device’’ each place such term appears; and
(4) in subsection (g)(2)(A), by inserting ‘‘or tobacco product’’
after ‘‘device’’.
Notice.
Notice.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1837
(e) SECTION 505.—Section 505(n)(2) (21 U.S.C. 355(n)(2)) is
amended by striking ‘‘section 904’’ and inserting ‘‘section 1004’’.
(f) SECTION 523.—Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D))
is amended by striking ‘‘section 903(g)’’ and inserting ‘‘section
1003(g)’’.
(g) SECTION 702.—Section 702(a)(1) (U.S.C. 372(a)(1)) is
amended—
(1) by striking ‘‘(a)(1)’’ and inserting ‘‘(a)(1)(A)’’; and
(2) by adding at the end the following:
‘‘(B)(i) For a tobacco product, to the extent feasible, the Secretary
shall contract with the States in accordance with this paragraph
to carry out inspections of retailers within that State in
connection with the enforcement of this Act.
‘‘(ii) The Secretary shall not enter into any contract under
clause (i) with the government of any of the several States to
exercise enforcement authority under this Act on Indian country
without the express written consent of the Indian tribe involved.’’.
(h) SECTION 703.—Section 703 (21 U.S.C. 373) is amended—
(1) by inserting ‘‘tobacco product,’’ after the term ‘‘device,’’
each place such term appears; and
(2) by inserting ‘‘tobacco products,’’ after the term ‘‘devices,’’
each place such term appears.
(i) SECTION 704.—Section 704 (21 U.S.C. 374) is amended—
(1) in subsection (a)(1)—
(A) by striking ‘‘devices, or cosmetics’’ each place it
appears and inserting ‘‘devices, tobacco products, or cosmetics’’;
(B) by striking ‘‘or restricted devices’’ each place it
appears and inserting ‘‘restricted devices, or tobacco products’’;
and
(C) by striking ‘‘and devices and subject to’’ and all
that follows through ‘‘other drugs or devices’’ and inserting
‘‘devices, and tobacco products and subject to reporting
and inspection under regulations lawfully issued pursuant
to section 505 (i) or (k), section 519, section 520(g), or
chapter IX and data relating to other drugs, devices, or
tobacco products’’;
(2) in subsection (b), by inserting ‘‘tobacco product,’’ after
‘‘device,’’; and
(3) in subsection (g)(13), by striking ‘‘section 903(g)’’ and
inserting ‘‘section 1003(g)’’.
(j) SECTION 705.—Section 705(b) (21 U.S.C. 375(b)) is amended
by inserting ‘‘tobacco products,’’ after ‘‘devices,’’.
(k) SECTION 709.—Section 709 (21 U.S.C. 379a) is amended
by inserting ‘‘tobacco product,’’ after ‘‘device,’’.
(l) SECTION 801.—Section 801 (21 U.S.C. 381) is amended—
(1) in subsection (a)—
(A) by inserting ‘‘tobacco products,’’ after the term
‘‘devices,’’;
(B) by inserting ‘‘or section 905(h)’’ after ‘‘section 510’’;
and
(C) by striking the term ‘‘drugs or devices’’ each time
such term appears and inserting ‘‘drugs, devices, or tobacco
products’’;
(2) in subsection (e)(1)—
(A) by inserting ‘‘tobacco product’’ after ‘‘drug, device,’’;
and
Contracts.
Intergovernmental
relations.
21 USC 372.
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123 STAT. 1838 PUBLIC LAW 111–31—JUNE 22, 2009
(B) by inserting ‘‘, and a tobacco product intended
for export shall not be deemed to be in violation of section
906(e), 907, 911, or 920(a),’’ before ‘‘if it—’’; and
(3) by adding at the end the following:
‘‘(p)(1) Not later than 36 months after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act, and
annually thereafter, the Secretary shall submit to the Committee
on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives,
a report regarding—
‘‘(A) the nature, extent, and destination of United States
tobacco product exports that do not conform to tobacco product
standards established pursuant to this Act;
‘‘(B) the public health implications of such exports,
including any evidence of a negative public health impact;
and
‘‘(C) recommendations or assessments of policy alternatives
available to Congress and the executive branch to reduce any
negative public health impact caused by such exports.
‘‘(2) The Secretary is authorized to establish appropriate
information disclosure requirements to carry out this subsection.’’.
(m) SECTION 1003.—Section 1003(d)(2)(C) (as redesignated by
section 101(b)) is amended—
(1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and
(2) inserting ‘‘, and tobacco products’’ after ‘‘devices’’.
(n) SECTION 1009.—Section 1009(b) (as redesignated by section
101(b)) is amended by striking ‘‘section 908’’ and inserting ‘‘section
1008’’.
(o) SECTION 409 OF THE FEDERAL MEAT INSPECTION ACT.—
Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a))
is amended by striking ‘‘section 902(b)’’ and inserting ‘‘section
1002(b)’’.
(p) RULE OF CONSTRUCTION.—Nothing in this section is
intended or shall be construed to expand, contract, or otherwise
modify or amend the existing limitations on State government
authority over tribal restricted fee or trust lands.
(q) GUIDANCE AND EFFECTIVE DATES.—
(1) IN GENERAL.—The Secretary of Health and Human
Services shall issue guidance—
(A) defining the term ‘‘repeated violation’’, as used
in section 303(f)(8) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 333(f)(8)) as amended by subsection (c),
as including at least 5 violations of particular requirements
over a 36-month period at a particular retail outlet that
constitute a repeated violation and providing for civil penalties
in accordance with paragraph (2);
(B) providing for timely and effective notice by certified
or registered mail or personal delivery to the retailer of
each alleged violation at a particular retail outlet prior
to conducting a followup compliance check, such notice
to be sent to the location specified on the retailer’s registration
or to the retailer’s registered agent if the retailer
has provider such agent information to the Food and Drug
Administration prior to the violation;
(C) providing for a hearing pursuant to the procedures
established through regulations of the Food and Drug
Administration for assessing civil money penalties,
21 USC 333 note.
21 USC 331 note.
21 USC 399.
21 USC 393.
Requirements.
Deadline.
Reports.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1839
including at a retailer’s request a hearing by telephone
or at the nearest regional or field office of the Food and
Drug Administration, and providing for an expedited procedure
for the administrative appeal of an alleged violation;
(D) providing that a person may not be charged with
a violation at a particular retail outlet unless the Secretary
has provided notice to the retailer of all previous violations
at that outlet;
(E) establishing that civil money penalties for multiple
violations shall increase from one violation to the next
violation pursuant to paragraph (2) within the time periods
provided for in such paragraph;
(F) providing that good faith reliance on the presentation
of a false government-issued photographic identification
that contains a date of birth does not constitute a
violation of any minimum age requirement for the sale
of tobacco products if the retailer has taken effective steps
to prevent such violations, including—
(i) adopting and enforcing a written policy against
sales to minors;
(ii) informing its employees of all applicable laws;
(iii) establishing disciplinary sanctions for
employee noncompliance; and
(iv) requiring its employees to verify age by way
of photographic identification or electronic scanning
device; and
(G) providing for the Secretary, in determining whether
to impose a no-tobacco-sale order and in determining
whether to compromise, modify, or terminate such an order,
to consider whether the retailer has taken effective steps
to prevent violations of the minimum age requirements
for the sale of tobacco products, including the steps listed
in subparagraph (F).
(2) PENALTIES FOR VIOLATIONS.—
(A) IN GENERAL.—The amount of the civil penalty to
be applied for violations of restrictions promulgated under
section 906(d), as described in paragraph (1), shall be as
follows:
(i) With respect to a retailer with an approved
training program, the amount of the civil penalty shall
not exceed—
(I) in the case of the first violation, $0.00
together with the issuance of a warning letter
to the retailer;
(II) in the case of a second violation within
a 12-month period, $250;
(III) in the case of a third violation within
a 24-month period, $500;
(IV) in the case of a fourth violation within
a 24-month period, $2,000;
(V) in the case of a fifth violation within a
36-month period, $5,000; and
(VI) in the case of a sixth or subsequent violation
within a 48-month period, $10,000 as determined
by the Secretary on a case-by-case basis.
21 USC 333 note.
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123 STAT. 1840 PUBLIC LAW 111–31—JUNE 22, 2009
(ii) With respect to a retailer that does not have
an approved training program, the amount of the civil
penalty shall not exceed—
(I) in the case of the first violation, $250;
(II) in the case of a second violation within
a 12-month period, $500;
(III) in the case of a third violation within
a 24-month period, $1,000;
(IV) in the case of a fourth violation within
a 24-month period, $2,000;
(V) in the case of a fifth violation within a
36-month period, $5,000; and
(VI) in the case of a sixth or subsequent violation
within a 48-month period, $10,000 as determined
by the Secretary on a case-by-case basis.
(B) TRAINING PROGRAM.—For purposes of subparagraph
(A), the term ‘‘approved training program’’ means a training
program that complies with standards developed by the
Food and Drug Administration for such programs.
(C) CONSIDERATION OF STATE PENALTIES.—The Secretary
shall coordinate with the States in enforcing the
provisions of this Act and, for purposes of mitigating a
civil penalty to be applied for a violation by a retailer
of any restriction promulgated under section 906(d), shall
consider the amount of any penalties paid by the retailer
to a State for the same violation.
(3) GENERAL EFFECTIVE DATE.—The amendments made by
paragraphs (2), (3), and (4) of subsection (c) shall take effect
upon the issuance of guidance described in paragraph (1) of
this subsection.
(4) SPECIAL EFFECTIVE DATE.—The amendment made by
subsection (c)(1) shall take effect on the date of enactment
of this Act.
(5) PACKAGE LABEL REQUIREMENTS.—The package label
requirements of paragraphs (3) and (4) of section 903(a) of
the Federal Food, Drug, and Cosmetic Act (as amended by
this division) shall take effect on the date that is 12 months
after the date of enactment of this Act. The package label
requirements of paragraph (2) of such section 903(a) for cigarettes
shall take effect on the date that is 15 months after
the issuance of the regulations required by section 4(d) of
the Federal Cigarette Labeling and Advertising Act (15 U.S.C.
1333), as amended by section 201 of this division. The package
label requirements of paragraph (2) of such section 903(a) for
tobacco products other than cigarettes shall take effect on the
date that is 12 months after the date of enactment of this
Act. The effective date shall be with respect to the date of
manufacture, provided that, in any case, beginning 30 days
after such effective date, a manufacturer shall not introduce
into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in conformance
with section 903(a) (2), (3), and (4) and section 920(a)
of the Federal Food, Drug, and Cosmetic Act.
(6) ADVERTISING REQUIREMENTS.—The advertising requirements
of section 903(a)(8) of the Federal Food, Drug, and Cosmetic
Act (as amended by this division) shall take effect on
21 USC 387c
note.
21 USC 333 note.
21 USC 333 note.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1841
the date that is 12 months after the date of enactment of
this Act.
SEC. 104. STUDY ON RAISING THE MINIMUM AGE TO PURCHASE
TOBACCO PRODUCTS.
The Secretary of Health and Human Services shall—
(1) convene an expert panel to conduct a study on the
public health implications of raising the minimum age to purchase
tobacco products; and
(2) not later than 5 years after the date of enactment
of this Act, submit a report to the Congress on the results
of such study.
SEC. 105. ENFORCEMENT ACTION PLAN FOR ADVERTISING AND PROMOTION
RESTRICTIONS.
(a) ACTION PLAN.—
(1) DEVELOPMENT.—Not later than 6 months after the date
of enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ‘‘Secretary’’) shall
develop and publish an action plan to enforce restrictions
adopted pursuant to section 906 of the Federal Food, Drug,
and Cosmetic Act, as added by section 101(b) of this division,
or pursuant to section 102(a) of this division, on promotion
and advertising of menthol and other cigarettes to youth.
(2) CONSULTATION.—The action plan required by paragraph
(1) shall be developed in consultation with public health
organizations and other stakeholders with demonstrated expertise
and experience in serving minority communities.
(3) PRIORITY.—The action plan required by paragraph (1)
shall include provisions designed to ensure enforcement of the
restrictions described in paragraph (1) in minority communities.
(b) STATE AND LOCAL ACTIVITIES.—
(1) INFORMATION ON AUTHORITY.—Not later than 3 months
after the date of enactment of this Act, the Secretary shall
inform State, local, and tribal governments of the authority
provided to such entities under section 5(c) of the Federal
Cigarette Labeling and Advertising Act, as added by section
203 of this division, or preserved by such entities under section
916 of the Federal Food, Drug, and Cosmetic Act, as added
by section 101(b) of this division.
(2) COMMUNITY ASSISTANCE.—At the request of communities
seeking assistance to prevent underage tobacco use, the
Secretary shall provide such assistance, including assistance
with strategies to address the prevention of underage tobacco
use in communities with a disproportionate use of menthol
cigarettes by minors.
SEC. 106. STUDIES OF PROGRESS AND EFFECTIVENESS.
(a) FDA REPORT.—Not later than 3 years after the date of
enactment of this Act, and not less than every 2 years thereafter,
the Secretary of Health and Human Services shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of
Representatives, a report concerning—
(1) the progress of the Food and Drug Administration in
implementing this division, including major accomplishments,
objective measurements of progress, and the identification of
any areas that have not been fully implemented;
21 USC 387u.
Deadline.
Deadline.
Publication.
21 USC 387f–1.
Deadline.
Reports.
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123 STAT. 1842 PUBLIC LAW 111–31—JUNE 22, 2009
(2) impediments identified by the Food and Drug Administration
to progress in implementing this division and to meeting
statutory timeframes;
(3) data on the number of new product applications received
under section 910 of the Federal Food, Drug, and Cosmetic
Act and modified risk product applications received under section
911 of such Act, and the number of applications acted
on under each category; and
(4) data on the number of full time equivalents engaged
in implementing this division.
(b) GAO REPORT.—Not later than 5 years after the date of
enactment of this Act, the Comptroller General of the United States
shall conduct a study of, and submit to the Committees described
in subsection (a) a report concerning—
(1) the adequacy of the authority and resources provided
to the Secretary of Health and Human Services for this division
to carry out its goals and purposes; and
(2) any recommendations for strengthening that authority
to more effectively protect the public health with respect to
the manufacture, marketing, and distribution of tobacco products.
(c) PUBLIC AVAILABILITY.—The Secretary of Health and Human
Services and the Comptroller General of the United States, respectively,
shall make the reports required under subsection (a) and
(b) available to the public, including by posting such reports on
the respective Internet websites of the Food and Drug Administration
and the Government Accountability Office.
TITLE II—TOBACCO PRODUCT WARNINGS;
CONSTITUENT AND SMOKE
CONSTITUENT DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
(a) AMENDMENT.—Section 4 of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333) is amended to read as follows:
‘‘SEC. 4. LABELING.
‘‘(a) LABEL REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or import
for sale or distribution within the United States any cigarettes
the package of which fails to bear, in accordance with the
requirements of this section, one of the following labels:
‘‘WARNING: Cigarettes are addictive.
‘‘WARNING: Tobacco smoke can harm your children.
‘‘WARNING: Cigarettes cause fatal lung disease.
‘‘WARNING: Cigarettes cause cancer.
‘‘WARNING: Cigarettes cause strokes and heart disease.
‘‘WARNING: Smoking during pregnancy can harm your
baby.
‘‘WARNING: Smoking can kill you.
‘‘WARNING: Tobacco smoke causes fatal lung disease
in nonsmokers.
Web posting.
Study.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1843
‘‘WARNING: Quitting smoking now greatly reduces
serious risks to your health.
‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—Each label statement
required by paragraph (1) shall be located in the upper portion
of the front and rear panels of the package, directly on the
package underneath the cellophane or other clear wrapping.
Each label statement shall comprise the top 50 percent of
the front and rear panels of the package. The word ‘WARNING’
shall appear in capital letters and all text shall be in conspicuous
and legible 17-point type, unless the text of the label
statement would occupy more than 70 percent of such area,
in which case the text may be in a smaller conspicuous and
legible type size, provided that at least 60 percent of such
area is occupied by required text. The text shall be black
on a white background, or white on a black background, in
a manner that contrasts, by typography, layout, or color, with
all other printed material on the package, in an alternating
fashion under the plan submitted under subsection (c).
‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBUTION.—The provisions
of this subsection do not apply to a tobacco product
manufacturer or distributor of cigarettes which does not manufacture,
package, or import cigarettes for sale or distribution
within the United States.
‘‘(4) APPLICABILITY TO RETAILERS.—A retailer of cigarettes
shall not be in violation of this subsection for packaging that—
‘‘(A) contains a warning label;
‘‘(B) is supplied to the retailer by a license- or permitholding
tobacco product manufacturer, importer, or distributor;
and
‘‘(C) is not altered by the retailer in a way that is
material to the requirements of this subsection.
‘‘(b) ADVERTISING REQUIREMENTS.—
‘‘(1) IN GENERAL.—It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of cigarettes
to advertise or cause to be advertised within the United
States any cigarette unless its advertising bears, in accordance
with the requirements of this section, one of the labels specified
in subsection (a).
‘‘(2) TYPOGRAPHY, ETC.—Each label statement required by
subsection (a) in cigarette advertising shall comply with the
standards set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable)
any required statement relating to tar, nicotine, or other constituent
(including a smoke constituent) yield shall comprise
at least 20 percent of the area of the advertisement and shall
appear in a conspicuous and prominent format and location
at the top of each advertisement within the trim area. The
Secretary may revise the required type sizes in such area
in such manner as the Secretary determines appropriate. The
word ‘WARNING’ shall appear in capital letters, and each
label statement shall appear in conspicuous and legible type.
The text of the label statement shall be black if the background
is white and white if the background is black, under the plan
submitted under subsection (c). The label statements shall be
enclosed by a rectangular border that is the same color as
the letters of the statements and that is the width of the
first downstroke of the capital ‘W’ of the word ‘WARNING’
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123 STAT. 1844 PUBLIC LAW 111–31—JUNE 22, 2009
in the label statements. The text of such label statements
shall be in a typeface pro rata to the following requirements:
45-point type for a whole-page broadsheet newspaper advertisement;
39-point type for a half-page broadsheet newspaper
advertisement; 39-point type for a whole-page tabloid newspaper
advertisement; 27-point type for a half-page tabloid newspaper
advertisement; 31.5-point type for a double page spread
magazine or whole-page magazine advertisement; 22.5-point
type for a 28 centimeter by 3 column advertisement; and 15-
point type for a 20 centimeter by 2 column advertisement.
The label statements shall be in English, except that—
‘‘(A) in the case of an advertisement that appears in
a newspaper, magazine, periodical, or other publication
that is not in English, the statements shall appear in
the predominant language of the publication; and
‘‘(B) in the case of any other advertisement that is
not in English, the statements shall appear in the same
language as that principally used in the advertisement.
‘‘(3) MATCHBOOKS.—Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of tobacco products,
each label statement required by subsection (a) may be printed
on the inside cover of the matchbook.
‘‘(4) ADJUSTMENT BY SECRETARY.—The Secretary may,
through a rulemaking under section 553 of title 5, United
States Code, adjust the format and type sizes for the label
statements required by this section; the text, format, and type
sizes of any required tar, nicotine yield, or other constituent
(including smoke constituent) disclosures; or the text, format,
and type sizes for any other disclosures required under the
Federal Food, Drug, and Cosmetic Act. The text of any such
label statements or disclosures shall be required to appear
only within the 20 percent area of cigarette advertisements
provided by paragraph (2). The Secretary shall promulgate
regulations which provide for adjustments in the format and
type sizes of any text required to appear in such area to
ensure that the total text required to appear by law will fit
within such area.
‘‘(c) MARKETING REQUIREMENTS.—
‘‘(1) RANDOM DISPLAY.—The label statements specified in
subsection (a)(1) shall be randomly displayed in each 12-month
period, in as equal a number of times as is possible on each
brand of the product and be randomly distributed in all areas
of the United States in which the product is marketed in
accordance with a plan submitted by the tobacco product manufacturer,
importer, distributor, or retailer and approved by the
Secretary.
‘‘(2) ROTATION.—The label statements specified in subsection
(a)(1) shall be rotated quarterly in alternating sequence
in advertisements for each brand of cigarettes in accordance
with a plan submitted by the tobacco product manufacturer,
importer, distributor, or retailer to, and approved by, the Secretary.
‘‘(3) REVIEW.—The Secretary shall review each plan submitted
under paragraph (2) and approve it if the plan—
Deadline.
Time period.
Regulations.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1845
‘‘(A) will provide for the equal distribution and display
on packaging and the rotation required in advertising
under this subsection; and
‘‘(B) assures that all of the labels required under this
section will be displayed by the tobacco product manufacturer,
importer, distributor, or retailer at the same time.
‘‘(4) APPLICABILITY TO RETAILERS.—This subsection and subsection
(b) apply to a retailer only if that retailer is responsible
for or directs the label statements required under this section
except that this paragraph shall not relieve a retailer of liability
if the retailer displays, in a location open to the public, an
advertisement that does not contain a warning label or has
been altered by the retailer in a way that is material to the
requirements of this subsection and subsection (b).
‘‘(d) GRAPHIC LABEL STATEMENTS.—Not later than 24 months
after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, the Secretary shall issue regulations that
require color graphics depicting the negative health consequences
of smoking to accompany the label statements specified in subsection
(a)(1). The Secretary may adjust the type size, text and
format of the label statements specified in subsections (a)(2) and
(b)(2) as the Secretary determines appropriate so that both the
graphics and the accompanying label statements are clear, conspicuous,
legible and appear within the specified area.’’.
(b) EFFECTIVE DATE.—The amendment made by subsection (a)
shall take effect 15 months after the issuance of the regulations
required by subsection (a). Such effective date shall be with respect
to the date of manufacture, provided that, in any case, beginning
30 days after such effective date, a manufacturer shall not introduce
into the domestic commerce of the United States any product,
irrespective of the date of manufacture, that is not in conformance
with section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333), as amended by subsection (a).
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.
(a) PREEMPTION.—Section 5(a) of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1334(a)) is amended by striking
‘‘No’’ and inserting ‘‘Except to the extent the Secretary requires
additional or different statements on any cigarette package by
a regulation, by an order, by a standard, by an authorization
to market a product, or by a condition of marketing a product,
pursuant to the Family Smoking Prevention and Tobacco Control
Act (and the amendments made by that Act), or as required under
section 903(a)(2) or section 920(a) of the Federal Food, Drug, and
Cosmetic Act, no’’.
(b) CHANGE IN REQUIRED STATEMENTS.—Section 4 of the Federal
Cigarette Labeling and Advertising Act (15 U.S.C. 1333), as
amended by section 201, is further amended by adding at the
end the following:
‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The Secretary
through a rulemaking conducted under section 553 of title 5, United
States Code, may adjust the format, type size, color graphics, and
text of any of the label requirements, or establish the format,
type size, and text of any other disclosures required under the
Federal Food, Drug, and Cosmetic Act, if the Secretary finds that
15 USC 1333
note.
Deadline.
Regulations.
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123 STAT. 1846 PUBLIC LAW 111–31—JUNE 22, 2009
such a change would promote greater public understanding of the
risks associated with the use of tobacco products.’’.
SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND PROMOTION.
Section 5 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1334) is amended by adding at the end the following:
‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a State or
locality may enact statutes and promulgate regulations, based on
smoking and health, that take effect after the effective date of
the Family Smoking Prevention and Tobacco Control Act, imposing
specific bans or restrictions on the time, place, and manner, but
not content, of the advertising or promotion of any cigarettes.’’.
SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING
WARNINGS.
(a) AMENDMENT.—Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402) is amended
to read as follows:
‘‘SEC. 3. SMOKELESS TOBACCO WARNING.
‘‘(a) GENERAL RULE.—
‘‘(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale or
distribution within the United States any smokeless tobacco
product unless the product package bears, in accordance with
the requirements of this Act, one of the following labels:
‘‘WARNING: This product can cause mouth cancer.
‘‘WARNING: This product can cause gum disease and
tooth loss.
‘‘WARNING: This product is not a safe alternative
to cigarettes.
‘‘WARNING: Smokeless tobacco is addictive.
‘‘(2) Each label statement required by paragraph (1) shall
be—
‘‘(A) located on the 2 principal display panels of the
package, and each label statement shall comprise at least
30 percent of each such display panel; and
‘‘(B) in 17-point conspicuous and legible type and in
black text on a white background, or white text on a
black background, in a manner that contrasts by typography,
layout, or color, with all other printed material
on the package, in an alternating fashion under the plan
submitted under subsection (b)(3), except that if the text
of a label statement would occupy more than 70 percent
of the area specified by subparagraph (A), such text may
appear in a smaller type size, so long as at least 60 percent
of such warning area is occupied by the label statement.
‘‘(3) The label statements required by paragraph (1) shall
be introduced by each tobacco product manufacturer, packager,
importer, distributor, or retailer of smokeless tobacco products
concurrently into the distribution chain of such products.
‘‘(4) The provisions of this subsection do not apply to a
tobacco product manufacturer or distributor of any smokeless
tobacco product that does not manufacture, package, or import
smokeless tobacco products for sale or distribution within the
United States.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1847
‘‘(5) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that—
‘‘(A) contains a warning label;
‘‘(B) is supplied to the retailer by a license- or permitholding
tobacco product manufacturer, importer, or distributor;
and
‘‘(C) is not altered by the retailer in a way that is
material to the requirements of this subsection.
‘‘(b) REQUIRED LABELS.—
‘‘(1) It shall be unlawful for any tobacco product manufacturer,
packager, importer, distributor, or retailer of smokeless
tobacco products to advertise or cause to be advertised within
the United States any smokeless tobacco product unless its
advertising bears, in accordance with the requirements of this
section, one of the labels specified in subsection (a).
‘‘(2)(A) Each label statement required by subsection (a)
in smokeless tobacco advertising shall comply with the standards
set forth in this paragraph.
‘‘(B) For press and poster advertisements, each such statement
and (where applicable) any required statement relating
to tar, nicotine, or other constituent yield shall comprise at
least 20 percent of the area of the advertisement.
‘‘(C) The word ‘WARNING’ shall appear in capital letters,
and each label statement shall appear in conspicuous and legible
type.
‘‘(D) The text of the label statement shall be black on
a white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph
(3).
‘‘(E) The label statements shall be enclosed by a rectangular
border that is the same color as the letters of the statements
and that is the width of the first downstroke of the capital
‘W’ of the word ‘WARNING’ in the label statements.
‘‘(F) The text of such label statements shall be in a typeface
pro rata to the following requirements: 45-point type for a
whole-page broadsheet newspaper advertisement; 39-point type
for a half-page broadsheet newspaper advertisement; 39-point
type for a whole-page tabloid newspaper advertisement; 27-
point type for a half-page tabloid newspaper advertisement;
31.5-point type for a double page spread magazine or wholepage
magazine advertisement; 22.5-point type for a 28 centimeter
by 3 column advertisement; and 15-point type for a
20 centimeter by 2 column advertisement.
‘‘(G) The label statements shall be in English, except that—
‘‘(i) in the case of an advertisement that appears in
a newspaper, magazine, periodical, or other publication
that is not in English, the statements shall appear in
the predominant language of the publication; and
‘‘(ii) in the case of any other advertisement that is
not in English, the statements shall appear in the same
language as that principally used in the advertisement.
‘‘(3)(A) The label statements specified in subsection (a)(1)
shall be randomly displayed in each 12-month period, in as
equal a number of times as is possible on each brand of the
product and be randomly distributed in all areas of the United
States in which the product is marketed in accordance with
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123 STAT. 1848 PUBLIC LAW 111–31—JUNE 22, 2009
a plan submitted by the tobacco product manufacturer,
importer, distributor, or retailer and approved by the Secretary.
‘‘(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product
in accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and approved
by, the Secretary.
‘‘(C) The Secretary shall review each plan submitted under
subparagraphs (A) and (B) and approve it if the plan—
‘‘(i) will provide for the equal distribution and display
on packaging and the rotation required in advertising
under this subsection; and
‘‘(ii) assures that all of the labels required under this
section will be displayed by the tobacco product manufacturer,
importer, distributor, or retailer at the same time.
‘‘(D) This paragraph applies to a retailer only if that retailer
is responsible for or directs the label statements under this
section, unless the retailer displays, in a location open to the
public, an advertisement that does not contain a warning label
or has been altered by the retailer in a way that is material
to the requirements of this subsection.
‘‘(4) The Secretary may, through a rulemaking under section
553 of title 5, United States Code, adjust the format
and type sizes for the label statements required by this section;
the text, format, and type sizes of any required tar, nicotine
yield, or other constituent disclosures; or the text, format, and
type sizes for any other disclosures required under the Federal
Food, Drug, and Cosmetic Act. The text of any such label
statements or disclosures shall be required to appear only
within the 20 percent area of advertisements provided by paragraph
(2). The Secretary shall promulgate regulations which
provide for adjustments in the format and type sizes of any
text required to appear in such area to ensure that the total
text required to appear by law will fit within such area.
‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is unlawful to
advertise smokeless tobacco on any medium of electronic communications
subject to the jurisdiction of the Federal Communications
Commission.’’.
(b) EFFECTIVE DATE.—The amendment made by subsection (a)
shall take effect 12 months after the date of enactment of this
Act. Such effective date shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such
effective date, a manufacturer shall not introduce into the domestic
commerce of the United States any product, irrespective of the
date of manufacture, that is not in conformance with section 3
of the Comprehensive Smokeless Tobacco Health Education Act
of 1986 (15 U.S.C. 4402), as amended by subsection (a).
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT
WARNING LABEL STATEMENTS.
(a) IN GENERAL.—Section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4402), as amended
by section 204, is further amended by adding at the end the following:
‘‘(d) AUTHORITY TO REVISE WARNING LABEL STATEMENTS.—
The Secretary may, by a rulemaking conducted under section 553
15 USC 4402
note.
Regulations.
Applicability.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1849
of title 5, United States Code, adjust the format, type size, and
text of any of the label requirements, require color graphics to
accompany the text, increase the required label area from 30 percent
up to 50 percent of the front and rear panels of the package,
or establish the format, type size, and text of any other disclosures
required under the Federal Food, Drug, and Cosmetic Act, if the
Secretary finds that such a change would promote greater public
understanding of the risks associated with the use of smokeless
tobacco products.’’.
(b) PREEMPTION.—Section 7(a) of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 (15 U.S.C. 4406(a)) is
amended by striking ‘‘No’’ and inserting ‘‘Except as provided in
the Family Smoking Prevention and Tobacco Control Act (and the
amendments made by that Act), no’’.
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE
TO THE PUBLIC.
Section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333), as amended by sections 201 and 202, is
further amended by adding at the end the following:
‘‘(e) TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE.—
‘‘(1) IN GENERAL.—The Secretary shall, by a rulemaking
conducted under section 553 of title 5, United States Code,
determine (in the Secretary’s sole discretion) whether cigarette
and other tobacco product manufacturers shall be required
to include in the area of each cigarette advertisement specified
by subsection (b) of this section, or on the package label, or
both, the tar and nicotine yields of the advertised or packaged
brand. Any such disclosure shall be in accordance with the
methodology established under such regulations, shall conform
to the type size requirements of subsection (b) of this section,
and shall appear within the area specified in subsection (b)
of this section.
‘‘(2) RESOLUTION OF DIFFERENCES.—Any differences
between the requirements established by the Secretary under
paragraph (1) and tar and nicotine yield reporting requirements
established by the Federal Trade Commission shall be resolved
by a memorandum of understanding between the Secretary
and the Federal Trade Commission.
‘‘(3) CIGARETTE AND OTHER TOBACCO PRODUCT CONSTITUENTS.—
In addition to the disclosures required by paragraph
(1), the Secretary may, under a rulemaking conducted under
section 553 of title 5, United States Code, prescribe disclosure
requirements regarding the level of any cigarette or other
tobacco product constituent including any smoke constituent.
Any such disclosure may be required if the Secretary determines
that disclosure would be of benefit to the public health,
or otherwise would increase consumer awareness of the health
consequences of the use of tobacco products, except that no
such prescribed disclosure shall be required on the face of
any cigarette package or advertisement. Nothing in this section
shall prohibit the Secretary from requiring such prescribed
disclosure through a cigarette or other tobacco product package
or advertisement insert, or by any other means under the
Federal Food, Drug, and Cosmetic Act.
Memorandum.
Regulations.
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123 STAT. 1850 PUBLIC LAW 111–31—JUNE 22, 2009
‘‘(4) RETAILERS.—This subsection applies to a retailer only
if that retailer is responsible for or directs the label statements
required under this section.’’.
TITLE III—PREVENTION OF ILLICIT
TRADE IN TOBACCO PRODUCTS
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as
added by section 101, is further amended by adding at the end
the following:
‘‘SEC. 920. LABELING, RECORDKEEPING, RECORDS INSPECTION.
‘‘(a) ORIGIN LABELING.—
‘‘(1) REQUIREMENT.—Beginning 1 year after the date of
enactment of the Family Smoking Prevention and Tobacco Control
Act, the label, packaging, and shipping containers of tobacco
products other than cigarettes for introduction or delivery for
introduction into interstate commerce in the United States
shall bear the statement ‘sale only allowed in the United
States’. Beginning 15 months after the issuance of the regulations
required by section 4(d) of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1333), as amended by section
201 of Family Smoking Prevention and Tobacco Control Act,
the label, packaging, and shipping containers of cigarettes for
introduction or delivery for introduction into interstate commerce
in the United States shall bear the statement ‘Sale
only allowed in the United States’.
‘‘(2) EFFECTIVE DATE.—The effective date specified in paragraph
(1) shall be with respect to the date of manufacture,
provided that, in any case, beginning 30 days after such effective
date, a manufacturer shall not introduce into the domestic
commerce of the United States any product, irrespective of
the date of manufacture, that is not in conformance with such
paragraph.
‘‘(b) REGULATIONS CONCERNING RECORDKEEPING FOR TRACKING
AND TRACING.—
‘‘(1) IN GENERAL.—The Secretary shall promulgate regulations
regarding the establishment and maintenance of records
by any person who manufactures, processes, transports, distributes,
receives, packages, holds, exports, or imports tobacco products.
‘‘(2) INSPECTION.—In promulgating the regulations
described in paragraph (1), the Secretary shall consider which
records are needed for inspection to monitor the movement
of tobacco products from the point of manufacture through
distribution to retail outlets to assist in investigating potential
illicit trade, smuggling, or counterfeiting of tobacco products.
‘‘(3) CODES.—The Secretary may require codes on the labels
of tobacco products or other designs or devices for the purpose
of tracking or tracing the tobacco product through the distribution
system.
‘‘(4) SIZE OF BUSINESS.—The Secretary shall take into
account the size of a business in promulgating regulations
under this section.
Effective dates.
21 USC 387t.
Applicability.
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PUBLIC LAW 111–31—JUNE 22, 2009 123 STAT. 1851
‘‘(5) RECORDKEEPING BY RETAILERS.—The Secretary shall
not require any retailer to maintain records relating to individual
purchasers of tobacco products for personal consumption.
‘‘(c) RECORDS INSPECTION.—If the Secretary has a reasonable
belief that a tobacco product is part of an illicit trade or smuggling
or is a counterfeit product, each person who manufactures, processes,
transports, distributes, receives, holds, packages, exports,
or imports tobacco products shall, at the request of an officer
or employee duly designated by the Secretary, permit such officer
or employee, at reasonable times and within reasonable limits and
in a reasonable manner, upon the presentation of appropriate
credentials and a written notice to such person, to have access
to and copy all records (including financial records) relating to
such article that are needed to assist the Secretary in investigating
potential illicit trade, smuggling, or counterfeiting of tobacco products.
The Secretary shall not authorize an officer or employee
of the government of any of the several States to exercise authority
under the preceding sentence on Indian country without the express
written consent of the Indian tribe involved.
‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.—
‘‘(1) NOTIFICATION.—If the manufacturer or distributor of
a tobacco product has knowledge which reasonably supports
the conclusion that a tobacco product manufactured or distributed
by such manufacturer or distributor that has left the
control of such person may be or has been—
‘‘(A) imported, exported, distributed, or offered for sale
in interstate commerce by a person without paying duties
or taxes required by law; or
‘‘(B) imported, exported, distributed, or diverted for
possible illicit marketing,
the manufacturer or distributor shall promptly notify the
Attorney General and the Secretary of the Treasury of such
knowledge.
‘‘(2) KNOWLEDGE DEFINED.—For purposes of this subsection,
the term ‘knowledge’ as applied to a manufacturer or distributor
means—
‘‘(A) the actual knowledge that the manufacturer or
distributor had; or
‘‘(B) the knowledge which a reasonable person would
have had under like circumstances or which would have
been obtained upon the exercise of due care.
‘‘(e) CONSULTATION.—In carrying out this section, the Secretary
shall consult with the Attorney General of the United States and
the Secretary of the Treasury, as appropriate.’’.
SEC. 302. STUDY AND REPORT.
(a) STUDY.—The Comptroller General of the United States shall
conduct a study of cross-border trade in tobacco products to—
(1) collect data on cross-border trade in tobacco products,
including illicit trade and trade of counterfeit tobacco products
and make recommendations on the monitoring of such trade;
(2) collect data on cross-border advertising (any advertising
intended to be broadcast, transmitted, or distributed from the
United States to another country) of tobacco products and make
recommendations on how to prevent or eliminate, and what
technologies could help facilitate the elimination of, cross-border
advertising; and
Notice.
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123 STAT. 1852 PUBLIC LAW 111–31—JUNE 22, 2009
(3) collect data on the health effects (particularly with
respect to individuals under 18 years of age) resulting from
cross-border trade in tobacco products, including the health
effects resulting from—
(A) the illicit trade of tobacco products and the trade
of counterfeit tobacco products; and
(B) the differing tax rates applicable to tobacco products.
(b) REPORT.—Not later than 18 months after the date of enactment
of this Act, the Comptroller General of the United States
shall submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives a report on the study
described in subsection (a).
(c) DEFINITION.—In this section:
(1) The term ‘‘cross-border trade’’ means trade across a
border of the United States, a State or Territory, or Indian
country.
(2) The term ‘‘Indian country’’ has the meaning given to
such term in section 1151 of title 18, United States Code.
(3) The terms ‘‘State’’ and ‘‘Territory’’ have the meanings
given to those terms in section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321).
From the U.S. House of Representatives Downloadable U.S. Code [uscode. house.gov]
[Laws in effect as of January 5, 1999]
[Document affected by Public Law 104-134 Section 101(d)]
[Document affected by Public Law 104-140 Section 1(a)]
[CITE: 42USC241]
TITLE 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 6A - PUBLIC HEALTH SERVICE
SUBCHAPTER II - GENERAL POWERS AND DUTIES Part A - Research and Investigations
HEAD-Sec. 241. Research and investigations generally STATUTE
(a) Authority of Secretary
The Secretary shall conduct in the Service, and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man, including water purification, sewage treatment, and pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to - (1) collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities; (2) make available research facilities of the Service to appropriate public authorities, and to health officials and scientists engaged in special study; (3) make grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects as are recommended by the advisory council to the entity of the Department supporting such projects and make, upon recommendation of the advisory council to the appropriate entity of the Department, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research; (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of experts, scholars, and consultants from the United States or abroad; (5) for purposes of study, admit and treat at institutions, hospitals, and stations of the Service, persons not otherwise eligible for such treatment; (6) make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application of statistical methods to experiments, studies, and surveys in health and medical fields; (7) enter into contracts, including contracts for research in accordance with and subject to the provisions of law applicable to contracts entered into by the military departments under sections 2353 and 2354 of title 10, except that determination, approval, and certification required thereby shall be by the Secretary of Health and Human Services; and (8) adopt, upon recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers necessary or appropriate to carry out the purposes of this section. The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Jim |
| File Modified | 0000-00-00 |
| File Created | 2021-01-30 |