108th CONGRESS
2d Session
S. 2461
To protect the public health by providing the Food and Drug Administration with
certain authority to regulate tobacco products.
IN THE SENATE OF THE UNITED STATES
May 20, 2004
Mr. DEWINE (for himself and Mr. KENNEDY) introduced the following bill; which
was read twice and referred to the Committee on Health, Education, Labor, and
Pensions
A BILL
To protect the public health by providing the Food and Drug Administration with
certain authority to regulate tobacco products.
Be it enacted by the Senate and House of Representatives of the United States
of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE- This Act may be cited as the `Family Smoking Prevention and
Tobacco Control Act'.
(b) TABLE OF CONTENTS- The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
Sec. 5. Severability.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
Sec. 101. Amendment of Federal food, drug, and cosmetic act.
Sec. 102. Construction of current regulations.
Sec. 103. Conforming and other amendments to general provisions.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label Statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label
Statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the
public.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
Sec. 301. Labeling, record keeping, records inspection.
Sec. 302. Study and report.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) The use of tobacco products by the Nation's children is a pediatric
disease of considerable proportions that results in new generations of
tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical communities that
tobacco products are inherently dangerous and cause cancer, heart disease,
and other serious adverse health effects.
(3) Nicotine is an addictive drug.
(4) Virtually all new users of tobacco products are under the minimum legal
age to purchase such products.
(5) Tobacco advertising and marketing contribute significantly to the use of
nicotine-containing tobacco products by adolescents.
(6) Because past efforts to restrict advertising and marketing of tobacco
products have failed adequately to curb tobacco use by adolescents,
comprehensive restrictions on the sale, promotion, and distribution of such
products are needed.
(7) Federal and State governments have lacked the legal and regulatory
authority and resources they need to address comprehensively the public
health and societal problems caused by the use of tobacco products.
(8) Federal and State public health officials, the public health community,
and the public at large recognize that the tobacco industry should be
subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the Congress is vested
with the responsibility for regulating interstate commerce and commerce with
Indian tribes.
(10) The sale, distribution, marketing, advertising, and use of tobacco
products are activities in and substantially affecting interstate commerce
because they are sold, marketed, advertised, and distributed in interstate
commerce on a nationwide basis, and have a substantial effect on the
Nation's economy.
(11) The sale, distribution, marketing, advertising, and use of such
products substantially affect interstate commerce through the health care
and other costs attributable to the use of tobacco products.
(12) It is in the public interest for Congress to enact legislation that
provides the Food and Drug Administration with the authority to regulate
tobacco products and the advertising and promotion of such products. The
benefits to the American people from enacting such legislation would be
significant in human and economic terms.
(13) Tobacco use is the foremost preventable cause of premature death in
America. It causes over 400,000 deaths in the United States each year and
approximately 8,600,000 Americans have chronic illnesses related to smoking.
(14) Reducing the use of tobacco by minors by 50 percent would prevent well
over 6,500,000 of today's children from becoming regular, daily smokers,
saving over 2,000,000 of them from premature death due to tobacco induced
disease. Such a reduction in youth smoking would also result in
approximately $75,000,000,000 in savings attributable to reduced health care
costs.
(15) Advertising, marketing, and promotion of tobacco products have been
especially directed to attract young persons to use tobacco products and
these efforts have resulted in increased use of such products by youth. Past
efforts to oversee these activities have not been successful in adequately
preventing such increased use.
(16) In 2001, the tobacco industry spent more than $11,000,000,000 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 advertising than adults, they
smoke the most advertised brands.
(24) Tobacco company documents indicate that young people are an important
and often crucial segment of the tobacco market. Children, who tend to be
more price-sensitive than adults, are influenced by advertising and
promotion practices that result in drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will have a positive effect on
the smoking rates of young people.
(26) Restrictions on advertising are necessary to prevent unrestricted
tobacco advertising from undermining legislation prohibiting access to young
people and providing for education about tobacco use.
(27) International experience shows that advertising regulations that are
stringent and comprehensive have a greater impact on overall tobacco use and
young people's use than weaker or less comprehensive ones.
(28) Text only requirements, although not as stringent as a ban, will help
reduce underage use of tobacco products while preserving the informational
function of advertising.
(29) It is in the public interest for Congress to adopt legislation to
address the public health crisis created by actions of the tobacco industry.
(30) The final regulations promulgated by the Secretary of Health and Human
Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg.
44615-44618) for inclusion as part 897 of title 21, Code of Federal
Regulations, are consistent with the First Amendment to the United States
Constitution and with the standards set forth in the amendments made by this
Act for the regulation of tobacco products by the Food and Drug
Administration and the restriction on the sale and distribution, including
access to and the advertising and promotion of, tobacco products contained
in such regulations are substantially related to accomplishing the public
health goals of this Act.
(31) The regulations described in paragraph (30) will directly and
materially advance the Federal Government's substantial interest in reducing
the number of children and adolescents who use cigarettes and smokeless
tobacco and in preventing the life-threatening health consequences
associated with tobacco use. An overwhelming majority of Americans who use
tobacco products begin using such products while they are minors and become
addicted to the nicotine in those products before reaching the age of 18.
Tobacco advertising and promotion plays a crucial role in the decision of
these minors to begin using tobacco products. Less restrictive and less
comprehensive approaches have not and will not be effective in reducing the
problems addressed by such regulations. The reasonable restrictions on the
advertising and promotion of tobacco products contained in such regulations
will lead to a significant decrease in the number of minors using and
becoming addicted to those products.
(32) The regulations described in paragraph (30) impose no more extensive
restrictions on communication by tobacco manufacturers and sellers than are
necessary to reduce the number of children and adolescents who use
cigarettes and smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations are narrowly
tailored to restrict those advertising and promotional practices which are
most likely to be seen or heard by youth and most likely to entice them into
tobacco use, while affording tobacco manufacturers and sellers ample
opportunity to convey information about their products to adult consumers.
(33) Tobacco dependence is a chronic disease, one that typically requires
repeated interventions to achieve long-term or permanent abstinence.
(34) Because the only known safe alternative to smoking is cessation,
interventions should target all smokers to help them quit completely.
(35) Tobacco products have been used to facilitate and finance criminal
activities both domestically and internationally. Illicit trade of tobacco
products has been linked to organized crime and terrorist groups.
(36) It is essential that the Food and Drug Administration review products
sold or distributed for use to reduce risks or exposures associated with
tobacco products and that it be empowered to review any advertising and
labeling for such products. It is also essential that manufacturers, prior
to marketing such products, be required to demonstrate that such products
will meet a series of rigorous criteria, and will benefit the health of the
population as a whole, taking into account both users of tobacco products
and persons who do not currently use tobacco products.
(37) Unless tobacco products that purport to reduce the risks to the public
of tobacco use actually reduce such risks, those products can cause
substantial harm to the public health to the extent that the individuals,
who would otherwise not consume tobacco products or would consume such
products less, use tobacco products purporting to reduce risk. Those who use
products sold or distributed as modified risk products that do not in fact
reduce risk, rather than quitting or reducing their use of tobacco products,
have a substantially increased likelihood of suffering disability and
premature death. The costs to society of the widespread use of products sold
or distributed as modified risk products that do not in fact reduce risk or
that increase risk include thousands of unnecessary deaths and injuries and
huge costs to our health care system.
(38) As the National Cancer Institute has found, many smokers mistakenly
believe that `low tar' and `light' cigarettes cause fewer health problems
than other cigarettes. As the National Cancer Institute has also found,
mistaken beliefs about the health consequences of smoking `low tar' and
`light' cigarettes can reduce the motivation to quit smoking entirely and
thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been no reduction in
risk on a population-wide basis from `low tar' and `light' cigarettes and
such products may actually increase the risk of tobacco use.
(40) The dangers of products sold or distributed as modified risk tobacco
products that do not in fact reduce risk are so high that there is a
compelling governmental interest in insuring that statements about modified
risk tobacco products are complete, accurate, and relate to the overall
disease risk of the product.
(41) As the Federal Trade Commission has found, consumers have
misinterpreted advertisements in which one product is claimed to be less
harmful than a comparable product, even in the presence of disclosures and
advisories intended to provide clarification.
(42) Permitting manufacturers to make unsubstantiated statements concerning
modified risk tobacco products, whether express or implied, even if
accompanied by disclaimers would be detrimental to the public health.
(43) The only way to effectively protect the public health from the dangers
of unsubstantiated modified risk tobacco products is to empower the Food and
Drug Administration to require that products that tobacco manufacturers sold
or distributed for risk reduction be approved in advance of marketing, and
to require that the evidence relied on to support approval of these products
is rigorous.
SEC. 3. PURPOSE.
The purposes of this Act are--
(1) to provide authority to the Food and Drug Administration to regulate
tobacco products under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.), by recognizing it as the primary Federal regulatory authority
with respect to the manufacture, marketing, and distribution of tobacco
products;
(2) to ensure that the Food and Drug Administration has the authority to
address issues of particular concern to public health officials, especially
the use of tobacco by young people and dependence on tobacco;
(3) to authorize the Food and Drug Administration to set national standards
controlling the manufacture of tobacco products and the identity, public
disclosure, and amount of ingredients used in such products;
(4) to provide new and flexible enforcement authority to ensure that there
is effective oversight of the tobacco industry's efforts to develop,
introduce, and promote less harmful tobacco products;
(5) to vest the Food and Drug Administration with the authority to regulate
the levels of tar, nicotine, and other harmful components of tobacco
products;
(6) in order to ensure that consumers are better informed, to require
tobacco product manufacturers to disclose research which has not previously
been made available, as well as research generated in the future, relating
to the health and dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to adults in
conjunction with measures to ensure that they are not sold or accessible to
underage purchasers;
(8) to impose appropriate regulatory controls on the tobacco industry;
(9) to promote cessation to reduce disease risk and the social costs
associated with tobacco related diseases; and
(10) to strengthen legislation against illicit trade in tobacco products.
SEC. 4. SCOPE AND EFFECT.
(a) INTENDED EFFECT- Nothing in this Act (or an amendment made by this Act)
shall be construed to--
(1) establish a precedent with regard to any other industry, situation,
circumstance, or legal action; or
(2) affect any action pending in Federal, State, or Tribal court, or any
agreement, consent decree, or contract of any kind.
(b) AGRICULTURAL ACTIVITIES- The provisions of this Act (or an amendment made
by this Act) which authorize the Secretary to take certain actions with regard
to tobacco and tobacco products shall not be construed to affect any authority
of the Secretary of Agriculture under existing law regarding the growing,
cultivation, or curing of raw tobacco.
SEC. 5. SEVERABILITY.
If any provision of this Act, the amendments made by this Act, or the
application of any provision of this Act to any person or circumstance is held
to be invalid, the remainder of this Act, the amendments made by this Act, and
the application of the provisions of this Act to any other person or
circumstance shall not be affected and shall continue to be enforced to the
fullest extent possible.
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:
`(nn)(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--
`(A) a product in the form of conventional food (including water and chewing
gum), a product represented for use as or for use in a conventional food, or
a product that is intended for ingestion in capsule, tablet, softgel, or
liquid form; or
`(B) an article that is approved or is regulated as a drug by the Food and
Drug Administration.
`(3) The products described in paragraph (2)(A) shall be subject to chapter IV
or chapter V of this Act and the articles described in paragraph (2)(B) shall
be subject to chapter V of this Act.
`(4) A tobacco product may not be marketed in combination with any other
article or product regulated under this Act (including a drug, biologic, food,
cosmetics, medical device, or a dietary supplement).'.
(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 907 as sections 1001 through 1007;
and
(3) by inserting after section 803 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, 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, or packaging, logo, registered trademark or brand name,
identifiable pattern of colors, or any combination of such attributes.
`(3) CIGARETTE- The term `cigarette' has the meaning given that term by
section 3(1) of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1332(1)), but also includes tobacco, in any form, that is functional
in the product, which, because of its appearance, the type of tobacco used
in the filler, or its packaging and labeling, is likely to be offered to, or
purchased by, consumers as a cigarette or as roll-your-own tobacco.
`(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 for cigarettes 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 (15
U.S.C. 1332(2)).
`(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 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 TRIBE- The term `Indian tribe' has the meaning given such term
in section 4(e) of the Indian Self Determination and Education Assistance
Act (25 U.S.C. 450b(e)).
`(10) LITTLE CIGAR- The term `little cigar' has the meaning given that term
by section 3(7) of the Federal Cigarette Labeling and Advertising Act (15
U.S.C. 1332(7)).
`(11) 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.
`(12) 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.
`(13) RETAILER- The term `retailer' means any person who sells tobacco
products to individuals for personal consumption, or who operates a facility
where self-service displays of tobacco products are permitted.
`(14) ROLL-YOUR-OWN TOBACCO- The term `roll-your-own tobacco' means any
tobacco which, because of its appearance, type, packaging, or labeling, is
suitable for use and likely to be offered to, or purchased by, consumers as
tobacco for making cigarettes.
`(15) 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.
`(16) 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.
`(17) STATE- The term `State' means any State of the United States and, for
purposes of this chapter, includes the District of Columbia, the
Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake
Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana
Islands, and any other trust territory or possession of the United States.
`(18) TOBACCO PRODUCT MANUFACTURER- 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 cigarette or smokeless tobacco product for sale or
distribution in the United States.
`(19) 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 shall be regulated by the Secretary under
this chapter and shall not be subject to the provisions of chapter V, unless--
`(1) such products are intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease (within the meaning of section
201(g)(1)(B) or section 201(h)(2)); or
`(2) a claim is made for such products under section 201(g)(1)(C) or
201(h)(3);
other than modified risk tobacco products approved in accordance with
section 911.
`(b) APPLICABILITY- This chapter shall apply to all tobacco products subject
to the regulations referred to in section 102 of the Family Smoking Prevention
and Tobacco Control Act, and to any other tobacco products that
the Secretary by regulation deems to be subject to this chapter.
`(c) SCOPE-
`(1) IN GENERAL- Nothing in this chapter, or any policy issued or regulation
promulgated thereunder, or the Family Smoking Prevention and Tobacco Control
Act, shall be construed to affect the Secretary's authority over, 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 any other provision of this subparagraph,
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.
`(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.
`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 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) 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;
`(5)(A) it is required by section 910(a) to have premarket approval and does
not have an approved application in effect;
`(B) it is in violation of the order approving such an application; or
`(6) 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
`(7) 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 921(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;
`(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 any State in an establishment not duly registered under section 905(b),
905(c), 905(d), or 905(h), if it was not included in a list required by
section 905(i), if a notice or other information respecting it was not
provided as required by such section or section 905(j), or if it does not
bear such symbols from the uniform system for identification of tobacco
products prescribed under section 905(e) as the Secretary by regulation
requires;
`(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.
No regulation issued under this subsection may require prior approval by the
Secretary of the content of any advertisement, except for modified risk
tobacco products as provided in section 911. No advertisement of a tobacco
product published after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act shall, with respect to the language of label
statements as prescribed under section 4 of the Cigarette Labeling and
Advertising Act and section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 or the regulations issued under such sections, be
subject to the provisions of sections 12 through 15 of the Federal Trade
Commission Act (15 U.S.C. 52 through 55).
`SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.
`(a) REQUIREMENT- Not later than 6 months after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, each tobacco product
manufacturer or importer, or agents thereof, shall submit to the Secretary the
following information:
`(1) 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(a)(4)
of the Federal Cigarette Labeling and Advertising Act.
`(3) A listing of all constituents, including smoke constituents as
applicable, identified by the Secretary as harmful or potentially harmful to
health in each tobacco product, and as applicable in the smoke of each
tobacco product, by brand and by quantity in each brand and subbrand.
Effective beginning 2 years after the date of enactment of this chapter, the
manufacturer, importer, or agent shall comply with regulations promulgated
under section 915 in reporting information under this paragraph, where
applicable.
`(4) All documents developed after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act that relate to health,
toxicological, behavioral, or physiologic effects of current or future
tobacco products, their constituents (including smoke constituents),
ingredients, components, and additives.
`(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 (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 12 months after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act, the Secretary shall
establish a list of harmful and potentially harmful constituents, including
smoke constituents, to health in each tobacco product by brand and by quantity
in each brand and subbrand. The Secretary shall publish a public notice
requesting the submission by interested persons of scientific and other
information concerning the harmful and potentially harmful constituents in
tobacco products and tobacco smoke.
`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.
`(c) REGISTRATION OF 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 in
any State registered with the Secretary under this section shall be subject to
inspection under section 704, and every such establishment engaged in the
manufacture, compounding, or processing of a tobacco product or tobacco
products shall be so inspected by 1 or more officers or employees duly
designated by the Secretary at least once in the 2-year period beginning with
the date of registration of such establishment under this section and at least
once in every successive 2-year period thereafter.
`(h) FOREIGN ESTABLISHMENTS SHALL REGISTER- Any establishment within any
foreign country engaged in the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products, shall register under this
section under regulations promulgated by the Secretary. Such regulations shall
require such establishment to provide the information required by subsection
(i) of this section and shall include provisions for registration of any such
establishment upon condition that adequate and effective means are available,
by arrangement with the government of such foreign country or otherwise, to
enable the Secretary to determine from time to time whether tobacco products
manufactured, prepared, compounded, or processed in such establishment, if
imported or offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 801(a).
`(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 has not been included in any
list of tobacco products filed by that person with the Secretary under this
paragraph or paragraph (2) before such time of registration. Such list shall
be prepared in such form and manner as the Secretary may prescribe and shall
be accompanied by--
`(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 suchtobacco 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) 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 June 1, 2003, shall, at least 90
days prior to making such introduction or delivery, report to the Secretary
(in such form and manner as the Secretary shall prescribe)--
`(A) the basis for such person's determination that the tobacco product is
substantially equivalent, within the meaning of section 910, to a tobacco
product commercially marketed (other than for test marketing) in the
United States as of June 1, 2003, that is in compliance with the
requirements of this Act; and
`(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 JUNE 1, 2003 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 June 1, 2003, and prior to the date that is 15 months
after the date of enactment of the Family Smoking Prevention and Tobacco
Control Act shall be submitted to the Secretary not later than 15 months
after such date of enactment.
`(3) EXEMPTIONS-
`(A) IN GENERAL- The Secretary may by regulation, exempt from the
requirements of this subsection tobacco products that are modified by
adding or deleting a tobacco additive, or increasing or decreasing the
quantity of an existing tobacco additive, if the Secretary determines
that--
`(i) such modification would be a minor modification of a tobacco
product authorized for sale 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 9 months after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act, the Secretary shall
issue regulations to implement this paragraph.
`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 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
`(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
non-users 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 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.
`(e) Good Manufacturing Practice Requirements-
`(1) Methods, facilities, and controls to conform-
`(A) IN GENERAL- The Secretary may, in accordance with subparagraph (B),
prescribe regulations (which may differ based on the type of tobacco
product involved) requiring that the methods used in, and the facilities
and controls used for, the manufacture, pre-production design validation
(including a process to assess the performance of a tobacco product),
packing and storage of a tobacco product, conform to current good
manufacturing practice, as prescribed in such regulations, to assure that
the public health is protected and that the tobacco product is in
compliance with this chapter. Good manufacturing practices may include the
testing of raw tobacco for pesticide chemical residues regardless of
whether a tolerance for such chemical residues has been established.
`(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;
`(ii) before promulgating any regulation under subparagraph (A), afford
opportunity for an oral hearing;
`(iii) provide the advisory committee a reasonable time to make its
recommendation with respect to proposed regulations under subparagraph
(A); and
`(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.
`(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 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, controls, and
facilities 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 period ending 3 years after 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
without regard to section 3324(a) and (b) of title 31, United States Code, and
section 5 of title 41, United States Code.
`SEC. 907. TOBACCO PRODUCT STANDARDS.
`(a) IN GENERAL-
`(1) SPECIAL RULE FOR CIGARETTES- A cigarette or any of its component parts
(including the tobacco, filter, or paper) shall not contain, as a
constituent (including a smoke constituent) or additive, an artificial or
natural flavor (other than tobacco or menthol) or an herb or spice,
including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla,
coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a
characterizing flavor of the tobacco product or tobacco smoke. Nothing in
this subparagraph shall be construed to limit the Secretary's authority to
take action under this section or other sections of this Act applicable to
menthol or any artificial or natural flavor, herb, or spice not specified in
this paragraph.
`(2) REVISION OF TOBACCO PRODUCT STANDARDS- The Secretary may revise the
tobacco product standards in paragraph (1) in accordance with subsection
(b).
`(3) TOBACCO PRODUCT STANDARDS- The Secretary may adopt tobacco product
standards in addition to those in paragraph (1) if the Secretary finds that
a tobacco product standard is appropriate for the protection of the public
health. This finding shall be determined with respect to the risks and
benefits to the population as a whole, including users and non-users of the
tobacco product, and taking into account--
`(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.
`(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 the reduction of 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 (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;
`(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); and
`(C) shall, where appropriate, require the use and prescribe the form and
content of labeling for the proper use of the tobacco product.
`(5) PERIODIC RE-EVALUATION 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) Establishment of Standards-
`(1) Notice-
`(A) 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.
`(B) REQUIREMENTS OF NOTICE- A notice of proposed rulemaking for the
establishment or amendment of a tobacco product standard for a tobacco
product shall--
`(i) set forth a finding with supporting justification that the tobacco
product standard is appropriate for the protection of the public health;
`(ii) set forth proposed findings with respect to the risk of illness or
injury that the tobacco product standard is intended to reduce or
eliminate; and
`(iii) invite interested persons to submit an existing tobacco product
standard for the tobacco product, including a draft or proposed tobacco
product standard, for consideration by the Secretary.
`(C) STANDARD- Upon a determination by the Secretary that an additive,
constituent (including smoke constituent), or other component of the
product that is the subject of the proposed tobacco product standard is
harmful, it shall be the burden of any party challenging the proposed
standard to prove that the proposed standard will not reduce or eliminate
the risk of illness or injury.
`(D) 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.
`(E) CONSIDERATION BY SECRETARY- The Secretary shall consider all
information submitted in connection with a proposed standard, including
information concerning the countervailing effects of the tobacco product
standard on the health of adolescent tobacco users, adult tobacco users,
or non-tobacco users, such as the creation of a significant demand for
contraband or other tobacco products that do not meet the requirements of
this chapter and the significance of such demand, and shall issue the
standard if the Secretary determines that the standard would be
appropriate for the protection of the public health.
`(F) COMMENT- The Secretary shall provide for a comment period of not less
than 60 days.
`(2) PROMULGATION-
`(A) IN GENERAL- After the expiration of the period for comment on a
notice of proposed rulemaking published under paragraph (1) respecting a
tobacco product standard and after consideration of such comments and any
report from the Tobacco Products Scientific Advisory Committee, the
Secretary shall--
`(i) promulgate a regulation establishing a tobacco product standard and
publish in the Federal Register findings on the matters referred to in
paragraph (1); or
`(ii) publish a notice terminating the proceeding for the development of
the standard together with the reasons for such termination.
`(B) 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.
`(3) POWER RESERVED TO CONGRESS- Because of the importance of a decision of
the Secretary to issue a regulation establishing a tobacco product
standard--
`(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,
Congress expressly reserves to itself such power.
`(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 paragraphs (1) and (2)(B), 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) REFERENCE TO ADVISORY COMMITTEE- The Secretary may--
`(A) on the Secretary's own initiative, refer a proposed regulation for
the establishment, amendment, or revocation of a tobacco product standard;
or
`(B) upon the request of an interested person which demonstrates good
cause for referral and which is made before the expiration of the period
for submission of comments on such proposed regulation,
refer such proposed regulation 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.
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. The Tobacco Products Scientific Advisory Committee shall,
within 60 days after the referral of a proposed regulation 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.
A copy of such report and recommendation shall be made public by the
Secretary.
`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. 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) of this section.
`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 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 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 June 1, 2003; 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 June 1, 2003.
`(2) PREMARKET APPROVAL REQUIRED-
`(A) NEW PRODUCTS- Approval under this section of an application for
premarket approval for any new tobacco product is required unless--
`(i) the manufacturer has submitted a report under section 905(j); and
`(ii) 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
June 1, 2003; and
`(II)(aa) is in compliance with the requirements of this Act; or
`(bb) is exempt from the requirements of section 905(j) pursuant to a
regulation issued under section 905(j)(3).
`(B) APPLICATION TO CERTAIN POST JUNE 1, 2003 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 June 1, 2003, and prior to the date that is 15 months after the
date of enactment of the Family Smoking Prevention and Tobacco Control
Act; and
`(ii) for which a report was submitted under section 905(j) within such
15-month period, until 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 terms
`substantially equivalent' or `substantial equivalence' mean, with respect
to the tobacco product being compared to the predicate tobacco product,
that the Secretary by order has found that the tobacco product--
`(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 for premarket approval 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;
`(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) REFERENCE 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 approval of 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
paragraph (2) of such subsection, shall--
`(i) issue an order approving the application if the Secretary finds
that none of the grounds for denying approval specified in paragraph (2)
of this subsection applies; or
`(ii) deny approval of the application if the Secretary finds (and sets
forth the basis for such finding as part of or accompanying such denial)
that 1 or more grounds for denial specified in paragraph (2) of this
subsection apply.
`(B) RESTRICTIONS ON SALE AND DISTRIBUTION- An order approving an
application for a tobacco product may require as a condition to such
approval that the sale and distribution of the tobacco product be
restricted but only to the extent that the sale and distribution of a
tobacco product may be restricted under a regulation under section 906(d).
`(2) DENIAL OF APPROVAL- The Secretary shall deny approval of an application
for a tobacco product if, upon the basis of the information submitted to the
Secretary as part of the application and any other information before the
Secretary with respect to such tobacco product, the Secretary finds that--
`(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 section 907, compliance with
which is a condition to approval of the application, and there is a lack
of adequate information to justify the deviation from such standard.
`(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 place such application
in approvable form (which measures may include further research by the
applicant in accordance with 1 or more protocols prescribed by the
Secretary).
`(4) BASIS FOR FINDING- For purposes of this section, the finding as to
whether approval of a tobacco product is appropriate for the protection of
the public health shall be determined with respect to the risks and benefits
to the population as a whole, including users and nonusers of the tobacco
product, and taking into account--
`(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 an advisory committee, and after due
notice and opportunity for informal hearing to the holder of an approved
application for a tobacco product, issue an order withdrawing approval of
the application if the Secretary finds--
`(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;
`(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 approved, that the methods used in, or
the facilities and controls used for, the manufacture, processing,
packing, or installation of such tobacco product do not conform with the
requirements of section 906(e) and were not brought into conformity with
such requirements within a reasonable time after receipt of written notice
from the Secretary of nonconformity;
`(E) on the basis of new information before the Secretary, evaluated
together with the evidence before the Secretary when the application was
approved, that the labeling of such tobacco product, based on a fair
evaluation of all material facts, is false or misleading in any particular
and was not corrected within a reasonable time after receipt of written
notice from the Secretary of such fact; or
`(F) on the basis of new information before the Secretary, evaluated
together with the evidence before the Secretary when the application was
approved, that such tobacco product is not shown to conform in all
respects to a tobacco product standard which is in effect under section
907, compliance with which was a condition to approval of the application,
and that there is a lack of adequate information to justify the deviation
from such standard.
`(2) APPEAL- The holder of an application subject to an order issued under
paragraph (1) withdrawing approval of the application may, by petition filed
on or before the 30th day after the date upon which such holder receives
notice of such withdrawal, obtain review thereof in accordance with
subsection (e).
`(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 approved
application would cause serious, adverse health consequences or death, that
is greater than ordinarily caused by tobacco products on the market, the
Secretary shall by order temporarily suspend the approval of the application
approved under this section. If the Secretary issues such an order, the
Secretary shall proceed expeditiously under paragraph (1) to withdraw such
application.
`(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
approval of an application filed under subsection (b) is in effect, the
applicant shall establish and maintain such records, and make such reports
to the Secretary, as the Secretary may by regulation, or by order with
respect to such application, prescribe on the basis of a finding that such
records and reports are necessary in order to enable the Secretary to
determine, or facilitate a determination of, whether there is or may be
grounds for withdrawing or temporarily suspending such approval.
`(2) ACCESS TO RECORDS- Each person required under this section to maintain
records, and each person in charge or custody thereof, shall, upon request
of an officer or employee designated by the Secretary, permit such officer
or employee at all reasonable times to have access to and copy and verify
such records.
`(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 approval of an
application filed pursuant to subsection (d) 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 tobacco-related 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--
`(A) 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 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) 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 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 health-related conditions, including information both favorable
and unfavorable to the ability of the product to reduce risk or exposure and
relating to human health;
`(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 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 an advisory committee any
application submitted under this subsection.
`(2) RECOMMENDATIONS- Not later than 60 days after the date an application
is referred to an advisory committee under paragraph (1), the advisory
committee shall report its recommendations on the application to the
Secretary.
`(g) APPROVAL-
`(1) MODIFIED RISK PRODUCTS- Except as provided in paragraph (2), the
Secretary shall approve an application for a modified risk tobacco product
filed under this section only if the Secretary determines that the applicant
has demonstrated that such product, as it is actually used by consumers,
will--
`(A) significantly reduce harm and the risk of tobacco-related 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 approve an application for a tobacco
product that has not been approved as a modified risk tobacco product
pursuant to paragraph (1) if the Secretary makes the findings required
under this paragraph and determines that the applicant has demonstrated
that--
`(i) the approval of the application 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)(2) is limited to an explicit or
implicit representation that such tobacco product or its smoke contains
or is free of a substance or contains a reduced level of a substance, or
presents a reduced exposure to a substance in tobacco smoke.
`(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 anticipated in subsequent studies.
`(B) ADDITIONAL FINDINGS REQUIRED- In order to approve an application
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 anticipated 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) approval of the application is expected to benefit the health of
the population as a whole taking into account both users of tobacco
products and persons who do not currently use tobacco products.
`(C) CONDITIONS OF APPROVAL-
`(i) IN GENERAL- Applications approved under this paragraph shall be
limited to a term of not more than 5 years, but may be renewed upon a
finding by the Secretary that the requirements of this paragraph
continue to be satisfied based on the filing of a new application.
`(ii) AGREEMENTS BY APPLICANT- Applications approved under this
paragraph shall be conditioned on the applicant's agreement to conduct
post-market surveillance and studies and to submit to the Secretary the
results of such surveillance and studies to determine the impact of the
application approval on consumer perception, behavior, and health and to
enable the Secretary to review the accuracy of the determinations upon
which the approval was based in accordance with a protocol approved by
the Secretary.
`(iii) ANNUAL SUBMISSION- The results of such post-market 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
`(B) scientific evidence and other information that is 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 APPROVAL-
`(1) MODIFIED RISK PRODUCTS- The Secretary shall require for the approval of
an application under this section that any advertising or labeling
concerning modified risk products enable the public to comprehend the
information concerning modified risk and to understand the relative
significance of such information in the context of total health and in
relation to all of the diseases and health-related conditions associated
with the use of tobacco products.
`(2) COMPARATIVE CLAIMS-
`(A) IN GENERAL- The Secretary may require for the approval of an
application under this subsection that a claim comparing a tobacco product
to 1 or more other commercially marketed tobacco products shall compare
the tobacco product to a commercially marketed tobacco product that is
representative of that type of tobacco product on the market (for example
the average value of the top 3 brands of an established regular tobacco
product).
`(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.
`(4) TIME- The Secretary shall limit an approval under subsection (g)(1) for
a specified period of time.
`(5) ADVERTISING- The Secretary may require that an applicant, whose
application has been approved under this subsection, comply with
requirements relating to advertising and promotion of the tobacco product.
`(i) POSTMARKET SURVEILLANCE AND STUDIES-
`(1) IN GENERAL- The Secretary shall require that an applicant under
subsection (g)(1) conduct post market surveillance and studies for a tobacco
product for which an application has been approved to determine the impact
of the application approval on consumer perception, behavior, and health, to
enable the Secretary to review the accuracy of the determinations upon which
the approval was based,
and to provide information that the Secretary determines is otherwise necessary
regarding the use or health risks involving the tobacco product. The results of
post-market surveillance and studies shall be submitted to the Secretary on an
annual basis.
`(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 APPROVAL- The Secretary, after an opportunity for an
informal hearing, shall withdraw the approval of an application under this
section 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 approval of
the application 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 (i); or
`(5) the applicant failed to meet a condition imposed under subsection (h).
`(k) CHAPTER IV OR V- A product approved in accordance with this section 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) establish minimum standards for scientific studies needed prior to
approval to show that a substantial reduction in morbidity or mortality
among individual tobacco users is likely;
`(B) include validated biomarkers, intermediate clinical endpoints, and
other feasible outcome measures, as appropriate;
`(C) establish minimum standards for post market studies, that shall
include regular and long-term assessments of health outcomes and
mortality, intermediate clinical endpoints, consumer perception of harm
reduction, and the impact on quitting behavior and new use of tobacco
products, as appropriate;
`(D) establish minimum standards for required postmarket surveillance,
including ongoing assessments of consumer perception; and
`(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.
`(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 for which the applicant seeks approval as a modified
risk tobacco product under this section.
`(m) DISTRIBUTORS- No distributor may take any action, after the date of
enactment of the Family Smoking Prevention and Tobacco Control Act, with
respect to a tobacco product that would reasonably be expected to result in
consumers believing that the tobacco product or its smoke may present a lower
risk of disease or is less harmful than one or more commercially marketed
tobacco products, or presents a reduced exposure to, or does not contain or is
free of, a substance or substances.
`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 for approval 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.
`(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 (15 U.S.C.
45(a)) and shall be considered a violation of a rule promulgated under
section 18 of that Act (15 U.S.C. 57a).
`(b) COORDINATION- With respect to the requirements of section 4 of the
Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) and section 3
of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C.
4402)--
`(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. CONGRESSIONAL REVIEW PROVISIONS.
`In accordance with section 801 of title 5, United States Code, Congress shall
review, and may disapprove, any rule under this chapter that is subject to
section 801. This section and section 801 do not apply to the regulations
referred to in section 102 of the Family Smoking Prevention and Tobacco
Control Act.
`SEC. 916. REGULATION REQUIREMENT.
`(a) TESTING, REPORTING, AND DISCLOSURE- Not later than 24 months after the
date of enactment of the Family Smoking Prevention and Tobacco Control Act,
the Secretary, acting through the Commissioner of the Food and Drug
Administration, shall promulgate regulations under this Act that meet the
requirements of subsection (b).
`(b) CONTENTS OF RULES- The regulations promulgated under subsection (a) shall
require testing and reporting of tobacco product constituents, ingredients,
and additives, including smoke constituents, by brand and sub-brand that the
Secretary determines should be tested to protect the public health. The
regulations may require that tobacco product manufacturers, packagers, or
importers make disclosures relating to the results of the testing of tar and
nicotine through labels or advertising or other appropriate means, and make
disclosures regarding the results of the testing of other constituents,
including smoke constituents, ingredients, or additives, that the Secretary
determines should be disclosed to the public to protect the public health and
will not mislead consumers about the risk of tobacco related disease.
`(c) AUTHORITY- The Food and Drug Administration shall have the authority
under this chapter to conduct or to require the testing, reporting, or
disclosure of tobacco product constituents, including smoke constituents.
`SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHORITY.
`(a) IN GENERAL-
`(1) PRESERVATION- 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- Except as provided in paragraph (1) and subparagraph (B),
no State or political subdivision of a State may establish or continue in
effect with respect to a tobacco product any requirement which is
different from, or in addition to, any requirement under the provisions of
this chapter relating to tobacco product standards, premarket approval,
adulteration, misbranding, labeling, registration, good manufacturing
standards, or reduced risk 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 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 554(b)(4) of
title 5, United States Code, shall be treated as 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. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
`(a) ESTABLISHMENT- Not later than 1 year after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, the Secretary shall
establish a 11-member advisory committee, to be known as the `Tobacco Products
Scientific 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 the medicine, medical ethics,
science, or technology involving the manufacture, evaluation, or use of
tobacco products, who are of appropriately diversified professional
backgrounds. The committee shall be composed of--
`(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 in the tobacco
manufacturing industry; and
`(v) 1 individual as a representative of the interests of the tobacco
growers.
`(B) NONVOTING MEMBERS- The members of the committee appointed under
clauses (iv) and (v) of subparagraph (A) shall serve as consultants to
those described in clauses (i) through (iii) of subparagraph (A) and shall
be nonvoting representatives.
`(2) LIMITATION- The Secretary may not appoint to the Advisory Committee any
individual who is in the regular full-time employ of the Food and Drug
Administration or any agency responsible for the enforcement of this Act.
The Secretary may appoint Federal officials as ex officio members.
`(3) CHAIRPERSON- The Secretary shall designate 1 of the members of the
Advisory Committee 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 for level 4
of 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 (5 U.S.C. App.) 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. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
The Secretary shall consider--
`(1) at the request of the applicant, designating nicotine replacement
products as fast track research and approval products within the meaning of
section 506;
`(2) direct the Commissioner to consider approving the extended use of
nicotine replacement products (such as nicotine patches, nicotine gum, and
nicotine lozenges) for the treatment of tobacco dependence;
`(3) review and consider the evidence for additional indications for
nicotine replacement products, such as for craving relief or relapse
prevention; and
`(4) consider--
`(A) relieving companies of premarket burdens under section 505 if the
requirement is redundant considering other nicotine replacement therapies
already on the market; and
`(B) time and extent applications for nicotine replacement therapies that
have been approved by a regulatory body in a foreign country and have
marketing experience in such country.
`SEC. 920. USER FEE.
`(a) ESTABLISHMENT OF QUARTERLY USER FEE- The Secretary shall assess a
quarterly user fee with respect to every quarter of each fiscal year
commencing fiscal year 2004, calculated in accordance with this section, upon
each manufacturer and importer of tobacco products subject to this chapter.
`(b) FUNDING OF FDA REGULATION OF TOBACCO PRODUCTS- The Secretary shall make
user fees collected pursuant to this section available to pay, in each fiscal
year, for the costs of the activities of the Food and Drug Administration
related to the regulation of tobacco products under this chapter.
`(c) ASSESSMENT OF USER FEE-
`(1) AMOUNT OF ASSESSMENT- Except as provided in paragraph (4), the total
user fees assessed each year pursuant to this section shall be sufficient,
and shall not exceed what is necessary, to pay for the costs of the
activities described in subsection (b) for each fiscal year.
`(2) ALLOCATION OF ASSESSMENT BY CLASS OF TOBACCO PRODUCTS-
`(A) IN GENERAL- Subject to paragraph (3), the total user fees assessed
each fiscal year with respect to each class of importers and manufacturers
shall be equal to an amount that is the applicable percentage of the total
costs of activities of the Food and Drug Administration described in
subsection (b).
`(B) APPLICABLE PERCENTAGE- For purposes of subparagraph (A) the
applicable percentage for a fiscal year shall be the following:
`(i) 92.07 percent shall be assessed on manufacturers and importers of
cigarettes;
`(ii) 0.05 percent shall be assessed on manufacturers and importers of
little cigars;
`(iii) 7.15 percent shall be assessed on manufacturers and importers of
cigars other than little cigars;
`(iv) 0.43 percent shall be assessed on manufacturers and importers of
snuff;
`(v) 0.10 percent shall be assessed on manufacturers and importers of
chewing tobacco;
`(vi) 0.06 percent shall be assessed on manufacturers and importers of
pipe tobacco; and
`(vii) 0.14 percent shall be assessed on manufacturers and importers of
roll-your-own tobacco.
`(3) DISTRIBUTION OF FEE SHARES OF MANUFACTURERS AND IMPORTERS EXEMPT FROM
USER FEE- Where a class of tobacco products is not subject to a user fee
under this section, the portion of the user fee assigned to such class under
subsection (d)(2) shall be allocated by the Secretary on a pro rata basis
among the classes of tobacco products that are subject to a user fee under
this section. Such pro rata allocation for each class of tobacco products
that are subject to a user fee under this section shall be the quotient of--
`(A) the sum of the percentages assigned to all classes of tobacco
products subject to this section; divided by
`(B) the percentage assigned to such class under paragraph (2).
`(4) ANNUAL LIMIT ON ASSESSMENT- The total assessment under this section--
`(A) for fiscal year 2004 shall be $85,000,000;
`(B) for fiscal year 2005 shall be $175,000,000;
`(C) for fiscal year 2006 shall be $300,000,000; and
`(D) for each subsequent fiscal year, shall not exceed the limit on the
assessment imposed during the previous fiscal year, as adjusted by the
Secretary (after notice, published in the Federal Register) to reflect the
greater of--
`(i) the total percentage change that occurred in the Consumer Price
Index for all urban consumers (all items; United States city average)
for the 12-month period ending on June 30 of the preceding fiscal year
for which fees are being established; or
`(ii) the total percentage change for the previous fiscal year in basic
pay under the General Schedule in accordance with section 5332 of title
5, United States Code, as adjusted by any locality-based comparability
payment pursuant to section 5304 of such title for Federal employees
stationed in the District of Columbia.
`(5) TIMING OF USER FEE 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 subsection (f) during each quarter of each fiscal year. Such
notifications shall occur not earlier than 3 months prior to the end of the
quarter for which such assessment is made, and payments of all assessments
shall be made not later than 60 days after each such notification.
`(d) DETERMINATION OF USER FEE BY COMPANY MARKET SHARE-
`(1) IN GENERAL- The user fee to be paid by each manufacturer or importer of
a given class of tobacco products shall be determined in each quarter by
multiplying--
`(A) such manufacturer's or importer's market share of such class of
tobacco products; by
`(B) the portion of the user fee amount for the current quarter to be
assessed on manufacturers and importers of such class of tobacco products
as determined under subsection (e).
`(2) NO FEE IN EXCESS OF MARKET SHARE- No manufacturer or importer of
tobacco products shall be required to pay a user fee in excess of the market
share of such manufacturer or importer.
`(e) DETERMINATION OF VOLUME OF DOMESTIC SALES-
`(1) IN GENERAL- The calculation of gross domestic volume of a class of
tobacco product by a manufacturer or importer, and by all manufacturers and
importers as a group, shall be made by the Secretary using information
provided by manufacturers and importers pursuant to subsection (f), as well
as any other relevant information provided to or obtained by the Secretary.
`(2) MEASUREMENT- For purposes of the calculations under this subsection and
the information provided under subsection (f) by the Secretary, gross
domestic volume shall be measured by--
`(A) in the case of cigarettes, the number of cigarettes sold;
`(B) in the case of little cigars, the number of little cigars sold;
`(C) in the case of large cigars, the number of cigars weighing more than
3 pounds per thousand sold; and
`(D) in the case of other classes of tobacco products, in terms of number
of pounds, or fraction thereof, of these products sold.
`(f) MEASUREMENT OF GROSS DOMESTIC VOLUME-
`(1) IN GENERAL- Each manufacturer and importer of tobacco products shall
submit to the Secretary a certified copy of each of the returns or forms
described by this paragraph that are required to be filed with a Government
agency on the same date that those returns or forms are filed, or required
to be filed, with such agency. The returns and forms described by this
paragraph are those returns and forms related to the release of tobacco
products into domestic commerce, as defined by section 5702(k) of the
Internal Revenue Code of 1986, and the repayment of the taxes imposed under
chapter 52 of such Code (ATF Form 500.24 and United States Customs Form 7501
under currently applicable regulations).
`(2) PENALTIES- Any person that knowingly fails to provide information
required under this subsection or that provides false information under this
subsection shall be subject to the penalties described in section 1003 of
title 18, United States Code. In addition, such person may be subject to a
civil penalty in an amount not to exceed 2 percent of the value of the kind
of tobacco products manufactured or imported by such person during the
applicable quarter, as determined by the Secretary.
`(h) EFFECTIVE DATE- The user fees prescribed by this section shall be
assessed in fiscal year 2004, based on domestic sales of tobacco products
during fiscal year 2003 and shall be assessed in each fiscal year
thereafter.'.
SEC. 102. INTERIM FINAL RULE.
(a) CIGARETTES AND SMOKELESS TOBACCO-
(1) IN GENERAL- Not later than 30 days after the date of enactment of this
Act, the Secretary of Health and Human Services shall publish in the Federal
Register an interim final rule regarding cigarettes and smokeless tobacco,
which is hereby deemed to be in compliance with the Administrative
Procedures Act and other applicable law.
(2) CONTENTS OF RULE- Except as provided in this subsection, the interim
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;
(B) strike Subpart C--Labeling and section 897.32(c); and
(C) become effective not later than 1 year after the date of enactment of
this Act.
(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 the Administrative Procedures Act.
(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 the Administrative Procedures Act, the regulation
promulgated pursuant to this section.
(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 entitled `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 entitled `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 entitled `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 entitled `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), by striking `515(f), or 519' and inserting `515(f),
519, or 909';
(5) in subsection (g), by inserting `tobacco product,' after `device,';
(6) in subsection (h), by inserting `tobacco product,' after `device,';
(7) in subsection (j), by striking `708, or 721' and inserting `708, 721,
904, 905, 906, 907, 908, 909, or section 921(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)(2).';
(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)(8), or 908, or condition prescribed under section
903(b)(6)(B)(ii)(II);
`(B) to furnish any notification or other material or information required
by or under section 519, 520(g), 904, 909, or section 921; 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 `device'
each time that it appears; and
(13) by adding at the end the following:
`(aa) The sale of tobacco products in violation of a no-tobacco-sale order
issued under section 303(f).
`(bb) The introduction or delivery for introduction into interstate commerce
of a tobacco product in violation of section 911.
`(cc)(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.
`(dd) The charitable distribution of tobacco products.
`(ee) The failure of a manufacturer or distributor to notify the Attorney
General of their knowledge of tobacco products used in illicit trade.'.
(c) SECTION 303- Section 303 (21 U.S.C. 333(f)) is amended in subsection (f)--
(1) by striking the subsection heading and inserting the following:
`(f) CIVIL PENALTIES; NO-TOBACCO-SALE ORDERS- ';
(2) in paragraph (1)(A), by inserting `or tobacco products' after `devices';
(3) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5),
and (6), and inserting after paragraph (2) the following:
`(3) If the Secretary finds that a person has committed repeated violations
of restrictions promulgated under section 906(d) at a particular retail
outlet then the Secretary may impose a no-tobacco-sale order on that person
prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph (1).';
(4) in paragraph (4) as so redesignated--
(A) 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' and inserting `penalty, or upon whom a
no-tobacco-order is to be imposed,';
(B) 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 no-tobacco-sale order
permanently prohibiting an individual retail outlet from selling tobacco
products shall include provisions that allow the outlet, after a
specified period of time, to request that the Secretary compromise,
modify, or terminate the order.'; and
(C) by adding at the end, the following:
`(D) The Secretary may compromise, modify, or terminate, with or without
conditions, any no-tobacco-sale order.';
(5) in paragraph (5) as so redesignated--
(A) by striking `(3)(A)' as redesignated, and inserting `(4)(A)';
(B) by inserting `or the imposition of a no-tobacco-sale order' after
`penalty' the first 2 places it appears; and
(C) by striking `issued.' and inserting `issued, or on which the
no-tobacco-sale order was imposed, as the case may be.'; and
(6) in paragraph (6), as so redesignated, by striking `paragraph (4)' each
place it appears and inserting `paragraph (5)'.
(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: `, (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 `device'
each place it appears; and
(4) in subsection (g)(2)(A), by inserting `or tobacco product' after
`device' each place it appears.
(e) SECTION 702- Section 702(a) (21 U.S.C. 372(a)) is amended--
(1) by inserting `(1)' after `(a)'; and
(2) by adding at the end thereof the following:
`(2) For a tobacco product, to the extent feasible, the Secretary shall
contract with the States in accordance with paragraph (1) to carry out
inspections of retailers in connection with the enforcement of this Act.'.
(f) SECTION 703- Section 703 (21 U.S.C. 373) is amended--
(1) by inserting `tobacco product,' after `device,' each place it appears;
and
(2) by inserting `tobacco products,' after `devices,' each place it appears.
(g) SECTION 704- Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)(A), by inserting `tobacco products,' after
`devices,' each place it appears;
(2) in subsection (a)(1)(B), by inserting `or tobacco product' after
`restricted devices' each place it appears; and
(3) in subsection (b), by inserting `tobacco product,' after `device,'.
(h) SECTION 705- Section 705(b) (21 U.S.C. 375(b)) is amended by inserting
`tobacco products,' after `devices,'.
(i) SECTION 709- Section 709 (21 U.S.C. 379) is amended by inserting `or
tobacco product' after `device'.
(j) SECTION 801- Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting `tobacco products,' after `devices,' the first time it
appears;
(B) by inserting `or section 905(j)' after `section 510'; and
(C) by striking `drugs or devices' each time it appears and inserting
`drugs, devices, or tobacco products';
(2) in subsection (e)(1), by inserting `tobacco product,' after `device,';
and
(3) by adding at the end the following:
`(p)(1) Not later than 2 years after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, and annually thereafter, the
Secretary shall submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the House
of Representatives, a report regarding--
`(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.'.
(k) SECTION 1003- Section 1003(d)(2)(C) (as redesignated by section 101(a)) is
amended--
(1) by striking `and' after `cosmetics,'; and
(2) inserting a comma and `and tobacco products' after `devices'.
(l) EFFECTIVE DATE FOR NO-TOBACCO-SALE ORDER AMENDMENTS- The amendments made
by subsection (c), other than the amendment made by paragraph (2) of such
subsection, shall take effect upon the issuance of guidance by the Secretary
of Health and Human Services--
(1) defining the term `repeated violation', as used in section 303(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) as amended by
subsection (c), by identifying the number of violations of particular
requirements over a specified period of time at a particular retail outlet
that constitute a repeated violation;
(2) providing for timely and effective notice to the retailer of each
alleged violation at a particular retail outlet and an expedited procedure
for the administrative appeal of an alleged violation;
(3) 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;
(4) establishing a period of time during which, if there are no violations
by a particular retail outlet, that outlet will not be considered to have
been the site of repeated violations when the next violation occurs; and
(5) providing that good faith reliance on the presentation of a false
government issued photographic identification that contains the bearer's
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--
(A) adopting and enforcing a written policy against sales to minors;
(B) informing its employees of all applicable laws;
(C) establishing disciplinary sanctions for employee noncompliance; and
(D) requiring its employees to verify age by way of photographic
identification or electronic scanning device.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
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 non-smokers'.
`WARNING: Quitting smoking now greatly reduces serious risks to your
health'.
`(2) PLACEMENT; TYPOGRAPHY; ETC-
`(A) IN GENERAL- Each label statement required by paragraph (1) shall be
located in the upper portion of the front and rear panels of the package,
directly on the package underneath the cellophane or other clear wrapping.
Except as provided in subparagraph (B), each label statement shall
comprise at least the top 30 percent of the front and rear panels of the
package. The word `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 (b)(4).
`(B) FLIP-TOP BOXES- For any cigarette brand package manufactured or
distributed before January 1, 2000, which employs a flip-top style (if
such packaging was used for that brand in commerce prior to June 21,
1997), the label statement required by paragraph (1) shall be located on
the flip-top area of the package, even if such area is less than 25
percent of the area of the front panel. Except as provided in this
paragraph, the provisions of this subsection shall apply to such packages.
`(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 is supplied to the retailer
by a tobacco product manufacturer, importer, or distributor and is not
altered by the retailer in a way that is material to the requirements of
this subsection except that this paragraph shall not relieve a retailer of
liability if the retailer sells or distributes tobacco products that are not
labeled in accordance with this subsection.
`(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) of this section.
`(2) TYPOGRAPHY, ETC- Each label statement required by subsection (a) of
this section in cigarette advertising shall comply with the standards set
forth in this paragraph. For press and poster advertisements, each such
statement and (where applicable) any required statement relating to tar,
nicotine, or other constituent (including a smoke constituent) yield shall
comprise at least 20 percent of the area of the advertisement and shall
appear in a conspicuous and prominent format and location at the top of each
advertisement within the trim area. The Secretary may revise the required
type sizes in such area in such manner as the Secretary determines
appropriate. The word `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 paragraph (4) of
this subsection. The label statements shall be enclosed by a rectangular
border that is the same color as the letters of the statements and that is
the width of the first downstroke of the capital `W' of the word `WARNING'
in the label statements. The text of such label statements shall be in a
typeface pro rata to the following requirements: 45-point type for a
whole-page broadsheet newspaper advertisement; 39-point type for a half-page
broadsheet newspaper advertisement; 39-point type for a whole-page tabloid
newspaper advertisement; 27-point type for a half-page tabloid newspaper
advertisement; 31.5-point type for a double page spread magazine or
whole-page magazine advertisement; 22.5-point type for a 28 centimeter by 3
column advertisement; and 15-point type for a 20 centimeter by 2 column
advertisement. The label statements shall be in English, except that in the
case of--
`(A) 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 or the text, format, and
type sizes of any required tar, nicotine yield, or other constituent
(including smoke constituent) disclosures, or to establish the text, format,
and type sizes for any other disclosures required under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et. seq.). The text of any such label
statements or disclosures shall be required to appear only within the 20
percent area of cigarette advertisements provided by paragraph (2) of this
subsection. The Secretary shall promulgate regulations which provide for
adjustments in the format and type sizes of any text required to appear in
such area to ensure that the total text required to appear by law will fit
within such area.
`(5) MARKETING REQUIREMENTS-
`(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 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
cigarettes 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 subparagraph (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.
`(6) APPLICABILITY TO RETAILERS- This subsection applies to a retailer only
if that retailer is responsible for or directs the label statements required
under this section except that this paragraph shall not relieve a retailer
of liability if the retailer displays, in a location open to the public, an
advertisement that is not labeled in accordance with the requirements of
this subsection.'.
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL 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:
`(c) CHANGE IN REQUIRED STATEMENTS- The Secretary may, by a rulemaking
conducted under section 553 of title 5, United States Code, adjust the format,
type size, and text of any of the label requirements, require color graphics
to accompany the text, increase the required label area from 30 percent up to
50 percent of the front and rear panels of the package, or establish the
format, type size, and text of any other disclosures required under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary
finds that 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.
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.
`(5) A retailer of smokeless tobacco products shall not be in violation of
this subsection for packaging that is supplied to the retailer by a tobacco
products manufacturer, importer, or distributor and that is not altered by
the retailer unless the retailer offers for sale, sells, or distributes a
smokeless tobacco product that is not labeled in accordance with this
subsection.
`(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) Each label statement required by subsection (a) in smokeless tobacco
advertising shall comply with the standards set forth in this paragraph. For
press and poster advertisements, each such statement and (where applicable)
any required
statement relating to tar, nicotine, or other constituent yield shall--
`(A) comprise at least 20 percent of the area of the advertisement, and
the warning area shall be delineated by a dividing line of contrasting
color from the advertisement; and
`(B) 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 on a white background, or white on a black
background, in an alternating fashion under the plan submitted under
paragraph (3).
`(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 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 subparagraph (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 is not labeled in accordance with the requirements of this subsection.
`(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.'.
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL
STATEMENTS.
Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986
(15 U.S.C. 4402), as amended by section 203, 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 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 (21 U.S.C. 301 et seq.), if the
Secretary finds that such a change would promote greater public understanding
of the risks associated with the use of smokeless tobacco products.'.
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE PUBLIC.
Section 4(a) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C.
1333 (a)), as amended by section 201, is further amended by adding at the end
the following:
`(4)(A) 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.
`(B) Any differences between the requirements established by the Secretary
under subparagraph (A) 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.
`(C) In addition to the disclosures required by subparagraph (A) of this
paragraph, 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 (21 U.S.C. 301 et seq.).
`(D) This paragraph applies 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 sells or distributes tobacco products that are not labeled in
accordance with the requirements of this subsection.'.
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. 921. LABELING, RECORDKEEPING, RECORDS INSPECTION.
`(a) ORIGIN LABELING- The label, packaging, and shipping containers of tobacco
products for introduction or delivery for introduction into interstate
commerce shall bear the statement `sale only allowed in the United States.'
`(b) REGULATIONS CONCERNING RECORDKEEPING FOR TRACKING AND TRACING-
`(1) IN GENERAL- Not later than 9 months after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, the Secretary shall
promulgate regulations regarding the establishment and maintenance of
records by any person who manufactures, processes, transports, distributes,
receives, packages, holds, exports, or imports tobacco products.
`(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.
`(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.
`(d) KNOWLEDGE OF ILLEGAL TRANSACTION- 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 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.
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.
(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).
END
Action on Smoking and Health
(ASH)
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