Family Smoking Prevention and Tobacco Control Act - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration, including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements.
Sets forth criteria by which tobacco products are deemed adulterated or misbranded.
Allows the Secretary to require prior approval of all label statements.
Allows the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Prohibits such regulations from: (1) limiting product sales or distribution to authorization of a practitioner licensed to prescribe medical products; (2) prohibiting product sales in face-to-face transactions by a specific category of retail outlets; or (3) establishing a minimum age greater than 18 years of age for product purchases.
Prohibits cigarettes from containing any artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, cinnamon, or coffee.
Requires the Secretary to establish tobacco product standards to protect the public health, but reserves to Congress the power to ban any tobacco products or reduce the nicotine level to zero.
Allows the Secretary to take specified actions, including public notification and recall, against unreasonably harmful products.
Requires premarket approval of all new tobacco products.
Sets forth standards for the sale of modified risk tobacco products.
Sets forth provisions regarding: (1) judicial review; (2) coordination with the Federal Trade Commission (FTC); (3) congressional review of regulations; and (4) state and local authority.
Requires the Secretary to establish a Tobacco Products Scientific Advisory Committee.
Amends the Federal Cigarette Labeling and Advertising Act to change cigarette warning label and advertising requirements.
Amends the Comprehensive Smokeless Tobacco Health Education Act of 1986 to change smokeless tobacco warning label and advertising requirements.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 666 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 666
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
March 17, 2005
Mr. DeWine (for himself, Mr. Kennedy, Mr. Lugar, Mr. Harkin, Ms.
Collins, Mr. Durbin, Mr. Smith, Mr. Dodd, Mr. Cornyn, Mr. Lautenberg,
Mr. McCain, Mr. Reed, Ms. Snowe, Ms. Murkowski, Mr. Chafee, and Mr.
Specter) 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. Interim final rule.
Sec. 103. Conforming and other amendments to general provisions.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label statements.
Sec. 203. State regulation of cigarette advertising and promotion.
Sec. 204. Smokeless tobacco labels and advertising warnings.
Sec. 205. Authority to revise smokeless tobacco product warning label
statements.
Sec. 206. Tar, nicotine, and other smoke constituent disclosure to the
public.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
Sec. 301. Labeling, recordkeeping, records inspection.
Sec. 302. Study and report.
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 10,000,000 of today's children from
becoming regular, daily smokers, saving over 3,000,000 of them
from premature death due to tobacco induced disease. Such a
reduction in youth smoking would also result in approximately
$75,000,000,000 in savings attributable to reduced health care
costs.
(15) Advertising, marketing, and promotion of tobacco
products have been especially directed to attract young persons
to use tobacco products and these efforts have resulted in
increased use of such products by youth. Past efforts to
oversee these activities have not been successful in adequately
preventing such increased use.
(16) In 2002, the tobacco industry spent more than
$12,466,000,000 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 subtitle for the regulation of tobacco products by
the Food and Drug Administration and the restriction on the
sale and distribution, including access to and the advertising
and promotion of, tobacco products contained in such
regulations are substantially related to accomplishing the
public health goals of this Act.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government's
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences associated
with tobacco use. An overwhelming majority of Americans who use
tobacco products begin using such products while they are
minors and become addicted to the nicotine in those products
before reaching the age of 18. Tobacco advertising and
promotion plays a crucial role in the decision of these minors
to begin using tobacco products. Less restrictive and less
comprehensive approaches have not and will not be effective in
reducing the problems addressed by such regulations. The
reasonable restrictions on the advertising and promotion of
tobacco products contained in such regulations will lead to a
significant decrease in the number of minors using and becoming
addicted to those products.
(32) The regulations described in paragraph (30) impose no
more extensive restrictions on communication by tobacco
manufacturers and sellers than are necessary to reduce the
number of children and adolescents who use cigarettes and
smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations are
narrowly tailored to restrict those advertising and promotional
practices which are most likely to be seen or heard by youth
and most likely to entice them into tobacco use, while
affording tobacco manufacturers and sellers ample opportunity
to convey information about their products to adult consumers.
(33) Tobacco dependence is a chronic disease, one that
typically requires repeated interventions to achieve long-term
or permanent abstinence.
(34) Because the only known safe alternative to smoking is
cessation, interventions should target all smokers to help them
quit completely.
(35) Tobacco products have been used to facilitate and
finance criminal activities both domestically and
internationally. Illicit trade of tobacco products has been
linked to organized crime and terrorist groups.
(36) It is essential that the Food and Drug Administration
review products sold or distributed for use to reduce risks or
exposures associated with tobacco products and that it be
empowered to review any advertising and labeling for such
products. It is also essential that manufacturers, prior to
marketing such products, be required to demonstrate that such
products will meet a series of rigorous criteria, and will
benefit the health of the population as a whole, taking into
account both users of tobacco products and persons who do not
currently use tobacco products.
(37) Unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such risks,
those products can cause substantial harm to the public health
to the extent that the individuals, who would otherwise not
consume tobacco products or would consume such products less,
use tobacco products purporting to reduce risk. Those who use
products sold or distributed as modified risk products that do
not in fact reduce risk, rather than quitting or reducing their
use of tobacco products, have a substantially increased
likelihood of suffering disability and premature death. The
costs to society of the widespread use of products sold or
distributed as modified risk products that do not in fact
reduce risk or that increase risk include thousands of
unnecessary deaths and injuries and huge costs to our health
care system.
(38) As the National Cancer Institute has found, many
smokers mistakenly believe that ``low tar'' and ``light''
cigarettes cause fewer health problems than other cigarettes.
As the National Cancer Institute has also found, mistaken
beliefs about the health consequences of smoking ``low tar''
and ``light'' cigarettes can reduce the motivation to quit
smoking entirely and thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been
no reduction in risk on a population-wide basis from ``low
tar'' and ``light'' cigarettes and such products may actually
increase the risk of tobacco use.
(40) The dangers of products sold or distributed as
modified risk tobacco products that do not in fact reduce risk
are so high that there is a compelling governmental interest in
insuring that statements about modified risk tobacco products
are complete, accurate, and relate to the overall disease risk
of the product.
(41) As the Federal Trade Commission has found, consumers
have misinterpreted advertisements in which one product is
claimed to be less harmful than a comparable product, even in
the presence of disclosures and advisories intended to provide
clarification.
(42) Permitting manufacturers to make unsubstantiated
statements concerning modified risk tobacco products, whether
express or implied, even if accompanied by disclaimers would be
detrimental to the public health.
(43) The only way to effectively protect the public health
from the dangers of unsubstantiated modified risk tobacco
products is to empower the Food and Drug Administration to
require that products that tobacco manufacturers sold or
distributed for risk reduction be approved in advance of
marketing, and to require that the evidence relied on to
support approval of these products is rigorous.
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;
or
``(B) it is in violation of the order approving such an
application;
``(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 916 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 such tobacco product, and, upon request made by the
Secretary for good cause, a copy of all advertisements
for a particular tobacco product; and
``(C) if the registrant filing a list has
determined that a tobacco product contained in such
list is not subject to a tobacco product standard
established under section 907, a brief statement of the
basis upon which the registrant made such determination
if the Secretary requests such a statement with respect
to that particular tobacco product.
``(2) 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--
``(i) the label, labeling, or advertising
of which represents explicitly or implicitly
that--
``(I) the tobacco product presents
a lower risk of tobacco-related disease
or is less harmful than one or more
other commercially marketed tobacco
products;
``(II) the tobacco product or its
smoke contains a reduced level of a
substance or presents a reduced
exposure to a substance; or
``(III) the tobacco product or its
smoke does not contain or is free of a
substance;
``(ii) the label, labeling, or advertising
of which uses the descriptors `light', `mild',
or `low' or similar descriptors; or
``(iii) the tobacco product manufacturer of
which has taken any action directed to
consumers through the media or otherwise, other
than by means of the tobacco product's label,
labeling or advertising, after the date of
enactment of the Family Smoking Prevention and
Tobacco Control Act, respecting the product
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 modified
risk tobacco products.
``(B) Exception.--Subparagraph (A) does not apply
to requirements relating to the sale, distribution,
possession, information reporting to the State,
exposure to, access to, the advertising and promotion
of, or use of, tobacco products 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--
``(1) at the request of the applicant, consider designating
nicotine replacement products as fast track research and
approval products within the meaning of section 506;
``(2) consider approving the extended use of nicotine
replacement products (such as nicotine patches, nicotine gum,
and nicotine lozenges) for the treatment of tobacco dependence;
and
``(3) review and consider the evidence for additional
indications for nicotine replacement products, such as for
craving relief or relapse prevention.
``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 2005, 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 2005 shall be $85,000,000;
``(B) for fiscal year 2006 shall be $175,000,000;
``(C) for fiscal year 2007 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 2005, based on domestic sales of
tobacco products during fiscal year 2004 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) in paragraph (2)(C), by striking ``paragraph (3)(A)''
and inserting ``paragraph (4)(A)'';
(4) 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).'';
(5) 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.'';
(6) 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
(7) 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 within that State 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) Guidance and Effective Dates.--
(1) In general.--The Secretary of Health and Human Services
shall issue guidance--
(A) defining the term ``repeated violation'', as
used in section 303(f) 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;
(B) providing for timely and effective notice to
the retailer of each alleged violation at a particular
retail outlet;
(C) providing for an expedited procedure for the
administrative appeal of an alleged violation;
(D) providing that a person may not be charged with
a violation at a particular retail outlet unless the
Secretary has provided notice to the retailer of all
previous violations at that outlet;
(E) establishing 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
(F) providing that good faith reliance on the
presentation of a false government issued photographic
identification that contains a date of birth does not
constitute a violation of any minimum age requirement
for the sale of tobacco products if the retailer has
taken effective steps to prevent such violations,
including--
(i) adopting and enforcing a written policy
against sales to minors;
(ii) informing its employees of all
applicable laws;
(iii) establishing disciplinary sanctions
for employee noncompliance; and
(iv) requiring its employees to verify age
by way of photographic identification or
electronic scanning device.
(2) General effective date.--The amendments made by
subsection (c), other than the amendment made by paragraph (2)
of such subsection, shall take effect upon the issuance of
guidance described in paragraph (1).
(3) Special effective date.--The amendments made by
paragraph (2) of subsection (c) shall take effect on the date
of enactment of this Act.
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) Hinged lid boxes.--For any cigarette brand
package manufactured or distributed before January 1,
2000, which employs a hinged lid style (if such
packaging was used for that brand in commerce prior to
June 21, 1997), the label statement required by
paragraph (1) shall be located on the hinged lid area
of the package, even if such area is less than 25
percent of the area of the front panel. Except as
provided in this paragraph, the provisions of this
subsection shall apply to such packages.
``(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.
``(c) Marketing Requirements.--
``(1) Random display.--The label statements specified in
subsection (a)(1) shall be randomly displayed in each 12-month
period, in as equal a number of times as is possible on each
brand of the product and be randomly distributed in all areas
of the United States in which the product is marketed in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer and approved
by the Secretary.
``(2) Rotation.--The label statements specified in
subsection (a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(3) Review.--The Secretary shall review each plan
submitted under paragraph (2) and approve it if the plan--
``(A) will provide for the equal distribution and
display on packaging and the rotation required in
advertising under this subsection; and
``(B) assures that all of the labels required under
this section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the
same time.
``(4) Applicability to retailers.--This subsection and
subsection (b) apply to a retailer only if that retailer is
responsible for or directs the label statements required under
this section except that this paragraph shall not relieve a
retailer of liability if the retailer displays, in a location
open to the public, an advertisement that is not labeled in
accordance with the requirements of this subsection and
subsection (b).''.
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:
``(d) 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 in the United States 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).
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S3037)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S3037-3053)
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