Sets forth criteria by which tobacco products will be deemed adulterated and/or misbranded.
Sets forth health information submission and annual registration requirements.
Authorizes the Secretary to adopt performance standards.
Provides for notification and other remedial measures, including recalls.
Requires manufacturers and importers of such products to keep records as specified.
Requires premarket review of new tobacco products, as specified.
Provides a right of judicial review concerning the promulgation of regulations and the denial of premarket approval.
Authorizes postmarket surveillance as necessary.
Authorizes the Secretary to designate reduced risk tobacco products, as specified.
Requires all retail outlets for tobacco products to be treated equally with regard to advertising restrictions.
Requires coordination with the Federal Trade Commission, specifically retaining to the Commission the authority to enforce certain laws concerning the advertising, sale, or distribution of tobacco products.
Sets forth provisions concerning: (1) congressional review; (2) regulations; (3) preservation of State and local authority; (4) construction of current regulations; and (5) conforming amendments.
Establishes a Tobacco Products Scientific Advisory Committee.
Amends the Federal Cigarette Labeling and Advertising Act to revise tobacco and smokeless tobacco label and advertising warning requirements.
Amends the Comprehensive Smokeless Tobacco Health Education Act of 1986 to revise smokeless tobacco warning label and advertising requirements.
[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2626 Introduced in Senate (IS)]
107th CONGRESS
2d Session
S. 2626
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
June 14, 2002
Mr. Kennedy (for himself, Mr. DeWine, Mr. Harkin, Mr. McCain, Mr.
Durbin, Mr. Graham, Mr. Wellstone, Ms. Collins, Mrs. Feinstein,
and Mr. Reed) introduced the following bill; which was read
twice and referred to the Committee on Health, Education,
Labor, and PensionsYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYY
_______________________________________________________________________
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 ``Youth Smoking
Prevention and Public Health Protection Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.
``CHAPTER IX--TOBACCO PRODUCTS
``Sec. 900. Definitions.
``Sec. 901. FDA authority over tobacco products.
``Sec. 902. Adulterated tobacco products.
``Sec. 903. Misbranded tobacco products.
``Sec. 904. Submission of health information to the Secretary.
``Sec. 905. Annual registration.
``Sec. 906. General provisions respecting control of tobacco
products.
``Sec. 907. Performance standards.
``Sec. 908. Notification and other remedies.
``Sec. 909. Records and reports on tobacco products.
``Sec. 910. Premarket review of certain tobacco products.
``Sec. 911. Judicial review.
``Sec. 912. Postmarket surveillance.
``Sec. 913. Reduced risk tobacco products.
``Sec. 914. Equal treatment of retail outlets.
``Sec. 915. Jurisdiction of and coordination with the Federal
Trade Commission.
``Sec. 916. Congressional review provisions.
``Sec. 917. Regulation requirement.
``Sec. 918. Preservation of State and local authority.
``Sec. 919. Tobacco Products Scientific Advisory Committee.
Sec. 102. Construction of current regulations.
Sec. 103. Conforming and other amendments to general provisions.
TITLE II--TOBACCO PRODUCT WARNINGS AND SMOKE CONSTITUENT DISCLOSURE
Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label Statements.
Sec. 203. Smokeless tobacco labels and advertising warnings.
Sec. 204. Authority to revise smokeless tobacco product warning label
Statements.
Sec. 205. Tar, nicotine, and other smoke constituent disclosure to the
public.
Sec. 206. Unlawful advertisements.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) The use of tobacco products by the Nation's children is
a pediatric disease of epic and worsening 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. 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.
(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
$110,000,000,000 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 1999, the tobacco industry spent close to
$8,240,000,000 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, and
children as young as 3 to 6 years old can recognize a character
associated with smoking at the same rate as they recognize
cartoons and fast food characters.
(24) Tobacco company documents indicate that young people
are an important and often crucial segment of the tobacco
market.
(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, while 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 (62 Fed. Reg. 44615-44618) for inclusion as
part 897 of title 21, Code of Federal Regulations, are
consistent with the standards set forth in the amendments made
by this Act for the regulation of tobacco products by the Food
and Drug Administration and the restriction on the sale and
distribution, including access to and the advertising and
promotion of, tobacco products contained in such regulations
are substantially related to accomplishing the public health
goals of this Act.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government's
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences associated
with tobacco use. An overwhelming majority of Americans who use
tobacco products begin using such products while they are
minors and become addicted to the nicotine in those product
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.
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 and introduce 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 adults 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; and
(8) to impose appropriate regulatory controls on the
tobacco industry
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 State, Tribal, or Federal
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.
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:
``(kk) 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).''.
(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) 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.
``(2) 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.
``(3) 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.
``(4) 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)).
``(5) Distributor.--The term `distributor' as regards a
tobacco product means any person who furthers the distribution
of cigarette or smokeless tobacco, 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.
``(6) 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)).
``(7) 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)).
``(8) 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.
``(9) 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 cigarettes or
smokeless tobacco are offered for sale, sold, or otherwise
distributed to consumers.
``(10) Retailer.--The term `retailer' means any person who
sells cigarettes or smokeless tobacco to individuals for
personal consumption, or who operates a facility where self-
service displays of tobacco products are permitted.
``(11) 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.
``(12) Smokeless tobacco.--The term `smokeless tobacco'
means any product that consists of cut, ground, powdered, or
leaf tobacco and that is intended to be placed in the oral or
nasal cavity.
``(13) 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.
``(14) Tobacco product manufacturer.--Term `tobacco product
manufacturer' means any person, including any repacker or
relabeler, who--
``(A) manufactures, fabricates, assembles,
processes, or labels a finished cigarette or smokeless
tobacco product; or
``(B) imports a finished cigarette or smokeless
tobacco product for sale or distribution in the United
States.
``(15) 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 health claim is made for such products under
section 201(g)(1)(C) or 201(h)(3).
``(b) Applicability.--This chapter shall apply to all tobacco
products subject to the regulations referred to in section 102 of the
Youth Smoking Prevention and Public Health Protection 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 Youth
Smoking Prevention and Public Health Protection 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) Tobacco leaf.--
``(A) In general.--The provisions of this chapter
shall not apply to tobacco leaf that is not in the
possession of the manufacturer, 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. For purposes of the preceding
sentence, the term `controlled by' means a member of
the same controlled group of corporations as that term
is used in section 52(a) of the Internal Revenue Code
of 1986, or under common control within the meaning of
the regulations promulgated under section 52(b) of such
Code.
``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 poisonous or 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 container 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 performance standard
established under section 907 unless such tobacco product is in
all respects in conformity with such standard;
``(5) it is required by section 910(a) to have premarket
approval, is not exempt under section 906(f), and does not have
an approved application in effect;
``(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 a tobacco product for which an exemption has
been granted under section 906(f) for investigational use and
the person who was granted such exemption or any investigator
who uses such tobacco product under such exemption fails to comply with
a requirement prescribed by or under such section.
``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; and
``(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,
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), 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 defined 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 necessary 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 performance
standard established under section 907, unless it bears such
labeling as may be prescribed in such performance standard; or
``(10) if there was a failure or refusal--
``(A) to comply with any requirement prescribed
under section 904 or 908;
``(B) to furnish any material or information
required by or under section 909; or
``(C) to comply with a requirement under section
912.
``(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. No
advertisement of a tobacco product, published after the date of
enactment of the Youth Smoking Prevention and Public Health Protection
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 Youth Smoking Prevention and Public Health Protection
Act, each tobacco product manufacturer or importer of tobacco products,
or agents thereof, shall submit to the Secretary the following
information:
``(1) A listing of all tobacco ingredients, substances and
compounds that are, on such date, added by the manufacturer to
the tobacco, paper, filter, or other component 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.
``(3) 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, behavioral, or
physiologic effects of tobacco products, their constituents,
ingredients, and components, and tobacco additives, described
in paragraph (1).
``(4) 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.
``(5) All documents (including underlying scientific
information) relating to marketing research involving the use
of tobacco products.
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.
``(b) Annual Submission.--A tobacco product manufacturer or
importer that is required to submit information under subsection (a)
shall update such information on an annual basis under a schedule
determined by the Secretary.
``(c) Time for Submission.--
``(1) New products.--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 Youth Smoking
Prevention and Public Health Protection Act, the manufacturer
of such product shall provide the information required under
subsection (a) and such product shall be subject to the annual
submission under subsection (b).
``(2) Modification of existing products.--If at any time a
tobacco product manufacturer adds to its tobacco products a new
tobacco additive, increases or decreases the quantity of an
existing tobacco additive or the nicotine content, delivery, or
form, or eliminates a tobacco additive from any tobacco
product, the manufacturer shall within 60 days of such action
so advise the Secretary in writing and reference such
modification in submissions made under subsection (b).
``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 one 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 May Register.--Any establishment
within any foreign country engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products,
may 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), or (d) 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 performance
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 performance 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, 2002, as defined
by the Secretary by regulation shall, at least 90 days before
making such introduction or delivery, report to the Secretary
(in such form and manner as the Secretary shall by regulation
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, 2002, 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, 2002 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, 2002, and before the date of enactment of the Youth
Smoking Prevention and Public Health Protection Act shall be
submitted to the Secretary within 6 months after the date of
enactment of that Act.
``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, 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, 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, or 910, 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 904, 907, 908, 909, or 910 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 tobacco products 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) Limitation.--No restriction under paragraph (1) may
prohibit the sale of any tobacco product in face-to face
transactions by a specific category of retail outlets.
``(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 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.
``(B) Requirements.--The Secretary shall--
``(i) before promulgating any regulation
under subparagraph (A), afford an 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 advisory committee.--The
Secretary may refer to an advisory committee any
petition submitted under subparagraph (A). The 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 an 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 Youth Smoking
Prevention and Public Health Protection Act.
``(f) Exemption for Investigational Use.--The Secretary may exempt
tobacco products intended for investigational use from this chapter
under such conditions as the Secretary may prescribe by regulation.
``(g) 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. PERFORMANCE STANDARDS.
``(a) In General.--
``(1) Finding required.--The Secretary may adopt
performance standards for a tobacco product if the Secretary
finds that a performance 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.
``(2) Content of performance standards.--A performance
standard established under this section for a tobacco product--
``(A) shall include provisions to provide
performance that is appropriate for the protection of
the public health, including provisions, where
appropriate--
``(i) for the reduction or elimination of
nicotine yields of the product;
``(ii) for the reduction or elimination of
other constituents or harmful components of the
product; or
``(iii) relating to any other requirement
under (B);
``(B) shall, where necessary to be appropriate for
the protection of the public health, include--
``(i) provisions respecting the
construction, components, ingredients, 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 performance 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.
``(3) Periodic re-evaluation of performance standards.--The
Secretary shall provide for periodic evaluation of performance
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 (2) by any person.
``(4) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Secretary shall, to
the maximum extent practicable--
``(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, 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
performance standard for a tobacco product.
``(B) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a
performance standard for a tobacco product shall--
``(i) set forth a finding with supporting
justification that the performance 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 performance standard is intended to reduce
or eliminate; and
``(iii) invite interested persons to submit
an existing performance standard for the
tobacco product, including a draft or proposed
performance standard, for consideration by the
Secretary.
``(C) Finding.--A notice of proposed rulemaking for
the revocation of a performance standard shall set
forth a finding with supporting justification that the
performance standard is no longer necessary to be
appropriate for the protection of the public health.
``(D) Consideration by secretary.--The Secretary
shall consider all information submitted in connection
with a proposed standard, including information
concerning the countervailing effects of the
performance 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.
``(E) 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 performance
standard and after consideration of such comments and
any report from an advisory committee, the Secretary
shall--
``(i) promulgate a regulation establishing
a performance 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
performance standard shall set forth the date or dates
upon which the standard shall take effect, but no such
regulation may take effect before one 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) Special rule for standard banning class of product or
eliminating nicotine content.--Because of the importance of a
decision of the Secretary to issue a regulation establishing a
performance standard--
``(A) eliminating all cigarettes, all smokeless
tobacco products, or any similar class of tobacco
products, or
``(B) requiring the reduction of nicotine yields of
a tobacco product to zero,
it is appropriate for the Congress to have the opportunity to
review such a decision. Therefore, any such standard may not
take effect before a date that is 2 years after the President
notifies the Congress that a final regulation imposing the
restriction has been issued.
``(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 performance standard.
``(B) Effective date.--The Secretary may declare a
proposed amendment of a performance 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--
``(A) may, on the Secretary's own initiative, refer
a proposed regulation for the establishment, amendment,
or revocation of a performance standard; or
``(B) shall, 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 an 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 advisory
committee, the Secretary shall provide the advisory committee with the
data and information on which such proposed regulation is based. The
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. PREMARKET REVIEW OF CERTAIN TOBACCO PRODUCTS.
``(a) In General.--
``(1) Premarket approval required.--
``(A) New products.--Approval under this section of
an application for premarket approval for any tobacco
product that is not commercially marketed (other than
for test marketing) in the United States as of June 1,
2002, is required unless the manufacturer has submitted
a report under section 905(j), and the Secretary has
issued an order that the tobacco product is
substantially equivalent to a tobacco product
commercially marketed (other than for test marketing)
in the United States as of June 1, 2002, that is in
compliance with the requirements of this Act.
``(B) Products introduced between June 1, 2002, and
enactment of this chapter.--Subparagraph (A) does not
apply to a tobacco product that--
``(i) was first introduced or delivered for
introduction into interstate commerce for
commercial distribution in the United States
after June 1, 2002, and before the date of
enactment of the Youth Smoking Prevention and
Public Health Protection Act; and
``(ii) for which a report was submitted
under section 905(j) within 6 months after such
date,
until the Secretary issues an order that the tobacco
product is substantially equivalent for purposes of
this section or requires premarket approval.
``(2) Substantially equivalent defined.--
``(A) In general.--For purposes of 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.--For purposes of
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.
``(3) 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, 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 performance
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 performance 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 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) shall, upon the request of an applicant,
refer such application to an advisory committee 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 one 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 performance 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 one 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 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.
``(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 one 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 performance 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.
``SEC. 911. 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
performance standard for a tobacco product; or
``(B) a denial of an application for approval under
section 910(c),
any person adversely affected by such regulation or order may
file a petition with the United States Court of Appeals for the
District of Columbia or for the circuit wherein such person
resides or has his or her principal place of business for
judicial review of such regulation or order.
``(2) Requirements.--
``(A) Copy of petition.--A copy of the petition
filed under paragraph (1) shall be transmitted by the
clerk of the court to the Secretary or other officer
designated by the Secretary for that purpose.
``(B) Record of proceedings.--With respect to an
action under paragraph (1), the Secretary shall file in
the court the record of the proceedings on which the
Secretary based the Secretary's regulation or order and
each record or order shall contain a statement of the
reasons for its issuance and the basis, on the record,
for its issuance.
``(C) Definition.--For purposes of this section,
the term `record' means all notices and other matter
published in the Federal Register with respect to the
regulation or order reviewed, all information submitted
to the Secretary with respect to such regulation or
order, proceedings of any panel or advisory committee
with respect to such regulation or order, any hearing
held with respect to such regulation or order, and 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) Court May Order Secretary To Make Additional Findings.--
``(1) In general.--If the petitioner in an action under
subsection (a)(1) applies to the court for leave to adduce
additional data, views, or arguments respecting the regulation
or order being reviewed and shows to the satisfaction of the
court that such additional data, views, or arguments are
material and that there were reasonable grounds for the
petitioner's failure to adduce such data, views, or arguments
in the proceedings before the Secretary, the court may order
the Secretary to provide additional opportunity for the oral
presentation of data, views, or arguments and for written
submissions.
``(2) Modification of or additional findings.--The
Secretary may modify the Secretary's findings, or make new
findings by reason of the additional data, views, or arguments
under paragraph (1) and shall file with the court such modified
or new findings, and the Secretary's recommendation, if any,
for the modification or setting aside of the regulation or
order being reviewed, with the return of such additional data,
views, or arguments.
``(c) 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 in such chapter. A
regulation or order described in paragraph (1) or (2) of subsection (a)
shall not be affirmed if it is found to be unsupported by substantial
evidence on the record taken as a whole.
``(d) 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.
``(e) 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.
``(f) Regulations and Orders Must Recite Basis in Record.--To
facilitate judicial review under this section or under any other
provision of law or a regulation or order issued under section 906,
907, 908, 909, 910, or 914, each such regulation or order shall contain
a statement of the reasons for its issuance and the basis, in the
record of the proceedings held in connection with its issuance, for its
issuance.
``SEC. 912. POSTMARKET SURVEILLANCE.
``(a) Discretionary Surveillance.--The Secretary may require a
tobacco product manufacturer to conduct postmarket surveillance for a
tobacco product of the manufacturer if the Secretary determines that
postmarket surveillance of the tobacco product is necessary to protect
the public health or is necessary to provide information regarding the
health risks and other safety issues involving the tobacco product.
``(b) Surveillance Approval.--Each tobacco product manufacturer
required to conduct a surveillance of a tobacco product under
subsection (a) shall, within 30 days after receiving notice that the
manufacturer 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
useful data or other information necessary to protect the public
health. The Secretary may not approve such a protocol until it has been
reviewed by an appropriately qualified scientific and technical review
committee established by the Secretary.
``SEC. 913. REDUCED RISK TOBACCO PRODUCTS.
``(a) Requirements.--
``(1) In general.--For purposes of this section, the term
`reduced risk tobacco product' means a tobacco product
designated by the Secretary under paragraph (2).
``(2) Designation.--
``(A) In general.--A product may be designated by
the Secretary as a reduced risk tobacco product if the
Secretary finds that the product will significantly
reduce harm to individuals caused by a tobacco product
and is otherwise appropriate to protect public health,
based on an application submitted by the manufacturer
of the product (or other responsible person) that--
``(i) demonstrates through testing on
animals and short-term human testing that use
of such product results in ingestion or
inhalation of a substantially lower yield of
toxic substances than use of conventional
tobacco products; and
``(ii) if required by the Secretary,
includes studies of the long-term health
effects of the product.
If such studies are required, the manufacturer may
consult with the Secretary regarding protocols for
conducting the studies.
``(B) Basis for finding.--In making the finding
under subparagraph (A), the Secretary shall take into
account--
``(i) the risks and benefits to the
population as a whole, including both users of
tobacco products and non-users of tobacco
products;
``(ii) the increased or decreased
likelihood that existing users of tobacco
products will stop using such products
including reduced risk tobacco products;
``(iii) the increased or decreased
likelihood that those who do not use tobacco
products will start to use such products,
including reduced risk tobacco products; and
``(iv) the risks and benefits to consumers
from the use of a reduced risk tobacco product
as compared to the use of products approved
under chapter V to reduce exposure to tobacco.
``(3) Marketing requirements.--A tobacco product may be
marketed and labeled as a reduced risk tobacco product if it--
``(A) has been designated as a reduced risk tobacco
product by the Secretary under paragraph (2);
``(B) bears a label prescribed by the Secretary
concerning the product's contribution to reducing harm
to health; and
``(C) complies with requirements prescribed by the
Secretary relating to marketing and advertising of the
product, and other provisions of this chapter as
prescribed by the Secretary.
``(b) Revocation of Designation.--At any time after the date on
which a tobacco product is designated as a reduced risk tobacco product
under this section the Secretary may, after providing an opportunity
for an informal hearing, revoke such designation if the Secretary
determines, based on information not available at the time of the
designation, that--
``(1) the finding made under subsection (a)(2) is no longer
valid; or
``(2) the product is being marketed in violation of
subsection (a)(3).
``(c) Limitation.--A tobacco product that is designated as a
reduced risk tobacco product that is in compliance with subsection (a)
shall not be regulated as a drug or device.
``(d) Development of Reduced Risk Tobacco Product Technology.--A
tobacco product manufacturer shall provide written notice to the
Secretary upon the development or acquisition by the manufacturer of
any technology that would reduce the risk of a tobacco product to the
health of the user for which the manufacturer is not seeking
designation as a `reduced risk tobacco product' under subsection (a).
``SEC. 914. 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. 915. 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 Youth Smoking Prevention and Public Health
Protection 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. 916. CONGRESSIONAL REVIEW PROVISIONS.
``In accordance with section 801 of title 5, United States Code,
the Congress shall review, and may disapprove, any rule under this
chapter that is subject to section 801. This section does not apply to
the regulations referred to in section 102 of the Youth Smoking
Prevention and Public Health Protection Act.
``SEC. 917. REGULATION REQUIREMENT.
``(a) Testing, Reporting, and Disclosure.--Not later than 24 months
after the date of enactment of the Youth Smoking Prevention and Public
Health Protection 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 the testing, reporting, and disclosure of
tobacco product smoke constituents and ingredients that the Secretary
determines should be disclosed to the public in order to protect the
public health. Such constituents shall include tar, nicotine, carbon
monoxide, and such other smoke constituents or ingredients as the
Secretary may determine to be appropriate. The regulations may require
that tobacco product manufacturers, packagers, or importers make such
disclosures relating to tar and nicotine through labels or advertising,
and make such disclosures regarding other smoke constituents or
ingredients as the Secretary determines are necessary to protect the
public health.
``(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 smoke constituents.
``SEC. 918. PRESERVATION OF STATE AND LOCAL AUTHORITY.
``(a) Additional Requirements.--
``(1) In general.--Except as provided in paragraph (2),
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,
including laws, rules, regulations, or other measures relating
to or prohibiting the sale, distribution, possession, exposure
to, or use of tobacco products by individuals of any age that
are in addition to, or more stringent than, requirements
established under this chapter. 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
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
applicable under the provisions of this chapter
relating to performance standards, premarket approval,
adulteration, misbranding, registration, reporting,
good manufacturing standards, or reduced risk products.
``(B) Exception.--Subparagraph (A) does not apply
to requirements relating to the sale, use, or
distribution of a tobacco product including
requirements related to the access to, and the
advertising and promotion of, a tobacco product.
``(b) Additional Restrictions on Underage Usage.--Nothing in this
chapter shall be construed to prevent a Federal agency (including the
Armed Forces), a State or a political subdivision of a State, or the
government of an Indian tribe from adopting and enforcing additional
measures that further restrict or prohibit tobacco product sale to, use
by, and accessibility to individuals under the legal age of purchase
established by such agency, State, subdivision, or government of an
Indian tribe.
``(c) No Less Stringent.--Nothing in this chapter is intended to
supersede any State, local, or Tribal law that is not less stringent
than this chapter.
``(d) 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.
``(e) Waivers.--Upon the application of a State or political
subdivision thereof, the Secretary may, by regulation promulgated after
notice and an opportunity for an oral hearing, exempt from subsection
(a), under such conditions as may be prescribed in such regulation, a
requirement of such State or political subdivision applicable to a
tobacco product if--
``(1) the requirement is more stringent than a requirement
applicable under the provisions described in subsection (a)(1)
which would be applicable to the tobacco product if an
exemption were not in effect under this subsection; or
``(2) the requirement--
``(A) is required by compelling local conditions;
and
``(B) compliance with the requirement would not
cause the tobacco product to be in violation of any
applicable requirement of this chapter.
``SEC. 919. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
``(a) Establishment.--Not later than 1 year after the date of
enactment of the Youth Smoking Prevention and Public Health Protection
Act, the Secretary shall establish a 9-member advisory committee, to be
known as the `Tobacco Products Scientific Advisory Committee'.
``(b) Membership.--
``(1) In general.--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--
``(A) 3 individuals who are officers or employees
of a State or local government, or of the Federal
government;
``(B) 2 individuals as representatives of interests
of the tobacco manufacturing industry;
``(C) 2 individuals as representatives of interests
of physicians and other health care professionals; and
``(D) 2 individuals as representatives of the
general public.
``(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. 102. CONSTRUCTION OF CURRENT REGULATIONS.
(a) In General.--The final regulations promulgated by the Secretary
of Health and Human Services in the August 28, 1996, issue of the
Federal Register (62 Fed. Reg. 44615-44618 beginning at ``part 897'')
are hereby deemed to be lawful and shall have the same legal force and
effect as if such regulations had been lawfully promulgated by the
Secretary under chapter IX and section 701 of the Federal Food, Drug,
and Cosmetic Act (as amended by this Act). Not later than 30 days after
the date of enactment of this Act, the Secretary shall republish such
regulations in the Federal Register. Such regulations shall take effect
on the date that is 12 months after such date of enactment, except that
the Secretary may designate an earlier effective date. The Secretary
shall amend the designation of authority in such regulations in
accordance with this subsection.
(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, or 909'';
(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(j)(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), 906(f), or 908;
``(B) to furnish any notification or other material or
information required by or under section 519, 520(g), 904,
906(f), or 909; or
``(C) to comply with a requirement under section 522 or
912.'';
(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).''.
(c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
(1) by striking the subsection heading and inserting the
following:
``(f) Civil Penalties; No-Tobacco-Sale Orders.--'';
(2) in paragraph (1)(A), by inserting ``or tobacco
products'' after ``devices'';
(3) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), and inserting after paragraph (2)
the following:
``(3) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph
(1).'';
(4) in paragraph (4) as so redesignated--
(A) in subparagraph (A)--
(i) by striking ``assessed'' the first time
it appears and inserting ``assessed, or a no-
tobacco-sale order may be imposed,''; and
(ii) by striking ``penalty'' and inserting
``penalty, or upon whom a no-tobacco-order is
to be imposed,'';
(B) in subparagraph (B)--
(i) by inserting after ``penalty,'' the
following: ``or the period to be covered by a
no-tobacco-sale order,''; and
(ii) by adding at the end the following:
``A no-tobacco-sale order permanently
prohibiting an individual retail outlet from
selling tobacco products shall include
provisions that allow the outlet, after a
specified period of time, to request that the
Secretary compromise, modify, or terminate the
order.''; and
(C) by adding at the end, the following:
``(D) The Secretary may compromise, modify, or
terminate, with or without conditions, any no-tobacco-
sale order.'';
(5) in paragraph (5) as so redesignated--
(A) by striking ``(3)(A)'' as redesignated, and
inserting ``(4)(A)'';
(B) by inserting ``or the imposition of a no-
tobacco-sale order'' after ``penalty'' the first 2
places it appears; and
(C) by striking ``issued.'' and inserting ``issued,
or on which the no-tobacco-sale order was imposed, as
the case may be.''; and
(6) in paragraph (6), as so redesignated, by striking
``paragraph (4)'' each place it appears and inserting
``paragraph (5)''.
(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and'' before ``(D)''; and
(B) by striking ``device.'' and inserting the
following: ``, (E) Any adulterated or misbranded
tobacco product.'';
(2) in subsection (d)(1), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (g)(1), by inserting ``or tobacco
product'' after ``device'' each place it appears; and
(4) in subsection (g)(2)(A), by inserting ``or tobacco
product'' after ``device'' each place it appears.
(e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is amended--
(1) by inserting ``(1)'' after ``(a)''; and
(2) by adding at the end thereof the following:
``(2) For a tobacco product, to the extent feasible, the Secretary
shall contract with the States in accordance with paragraph (1) to
carry out inspections of retailers in connection with the enforcement
of this Act.''.
(f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
(1) by inserting ``tobacco product,'' after ``device,''
each place it appears; and
(2) by inserting ``tobacco products,'' after ``devices,''
each place it appears.
(g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)(A), by inserting ``tobacco
products,'' after ``devices,'' each place it appears;
(2) in subsection (a)(1)(B), by inserting ``or tobacco
product'' after ``restricted devices'' each place it appears;
and
(3) in subsection (b), by inserting ``tobacco product,''
after ``device,''.
(h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by
inserting ``tobacco products,'' after ``devices,''.
(i) Section 709.--Section 709 (21 U.S.C. 379) is amended by
inserting ``or tobacco product'' after ``device''.
(j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``tobacco products,'' after
``devices,'' the first time it appears;
(B) by inserting ``or subsection (j) of section
905'' 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)--
(A) in paragraph (1), by inserting ``tobacco
product,'' after ``device,''; and
(B) by redesignating paragraph (4) as paragraph (5)
and inserting after paragraph (3), the following:
``(4) Paragraph (1) does not apply to any tobacco product--
``(A) which does not comply with an applicable
requirement of section 907 or 910; or
``(B) which under section 906(f) is exempt from
either such section.
This paragraph does not apply if the Secretary has determined
that the exportation of the tobacco product is not contrary to
the public health and safety and has the approval of the
country to which it is intended for export or the tobacco
product is eligible for export under section 802.''.
(k) Section 802.--Section 802 (21 U.S.C. 382) is amended--
(1) in subsection (a), by striking ``device--'' and
inserting ``device or tobacco product--'';
(2) in subsection (a)(1)(C), by striking ``and'' after the
semicolon;
(3) in subsection (a)(2), by striking subparagraph (C) and
all that follows in that subsection and inserting the
following:
``(C) is a banned device under section 516; or
``(3) which, in the case of a tobacco product--
``(A) does not comply with an applicable
requirement of section 907 or 910; or
``(B) under section 906(f) is exempt from either
such section,
is adulterated, misbranded, and in violation of such sections
or Act unless the export of the drug, device, or tobacco
product is, except as provided in subsection (f), authorized
under subsection (b), (c), (d), or (e) of this section or
section 801(e)(2) or 801(e)(4). If a drug, device, or tobacco
product described in paragraph (1), (2), or (3) may be exported
under subsection (b) and if an application for such drug or
device under section 505, 515, or 910 of this Act or section
351 of the Public Health Service Act (42 U.S.C. 262) was
disapproved, the Secretary shall notify the appropriate public
health official of the country to which such drug, device, or
tobacco product will be exported of such disapproval.'';
(4) in subsection (b)(1)(A), by inserting ``or tobacco
product'' after ``device'' each time it appears;
(5) in subsection (c), by inserting ``or tobacco product''
after ``device'' and inserting ``or section 906(f)'' after
``520(g).'';
(6) in subsection (f), by inserting ``or tobacco product''
after ``device'' each time it appears; and
(7) in subsection (g), by inserting ``or tobacco product''
after ``device'' each time it appears.
(l) 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''.
(m) Effective Date for No-Tobacco-Sale Order Amendments.--The
amendments made by subsection (c), other than the amendment made by
paragraph (2) of such subsection, shall take effect only upon the
promulgation of final regulations by the Secretary of Health and Human
Services--
(1) defining the term ``repeated violation'', as used in
section 303(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 333(f)) as amended by subsection (c), by identifying the
number of violations of particular requirements over a
specified period of time that constitute a repeated violation;
(2) providing for notice to the retailer of each violation
at a particular retail outlet;
(3) providing that a person may not be charged with a
violation at a particular retail outlet unless the Secretary
has provided notice to the retailer of all previous violations
at that outlet;
(4) establishing a period of time during which, if there
are no violations by a particular retail outlet, that outlet
will not considered to have been the site of repeated
violations when the next violation occurs; and
(5) providing that good faith reliance on false
identification does not constitute a violation of any minimum
age requirement for the sale of tobacco products.
TITLE II--TOBACCO PRODUCT WARNINGS AND SMOKE CONSTITUENT DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
(a) In General.--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, 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 25
percent of the front and rear panels of the package.
The word ``WARNING'' shall appear in capital letters
and all text shall be in conspicuous and legible 17-
point type, unless the text of the label statement
would occupy more than 70 percent of such area, in
which case the text may be in a smaller conspicuous and
legible type size, provided that at least 60 percent of
such area is occupied by required text. The text shall
be black on a white background, or white on a black
background, in a manner that contrasts, by typography,
layout, or color, with all other printed material on
the package, in an alternating fashion under the plan
submitted under subsection (b)(4).
``(B) Flip-top boxes.--For any cigarette brand
package manufactured or distributed before January 1,
2000, which employs a flip-top style (if such packaging
was used for that brand in commerce prior to June 21,
1997), the label statement required by paragraph (1)
shall be located on the flip-top area of the package,
even if such area is less than 25 percent of the area
of the front panel. Except as provided in this
paragraph, the provisions of this subsection shall
apply to such packages.
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco product
manufacturer or distributor of cigarettes which does not
manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(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 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) 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 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.
``(4) Marketing requirements.--
``(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month
period, in as equal a number of times as is possible on
each brand of the product and be randomly distributed
in all areas of the United States in which the product
is marketed in accordance with a plan submitted by the
tobacco product manufacturer, importer, distributor, or
retailer and approved by the Secretary.
``(B) The label statements specified in subsection
(a)(1) shall be rotated quarterly in alternating
sequence in advertisements for each brand of cigarettes
in accordance with a plan submitted by the tobacco
product manufacturer, importer, distributor, or
retailer to, and approved by, the Secretary.
``(C) The Secretary shall review each plan
submitted under subparagraph (B) and approve it if the
plan--
``(i) will provide for the equal
distribution and display on packaging and the
rotation required in advertising under this
subsection; and
``(ii) assures that all of the labels
required under this section will be displayed
by the tobacco product manufacturer, importer,
distributor, or retailer at the same time.''.
(b) Repeal of Prohibition on State Restriction.--Section 5 of the
Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1334) is
amended--
(1) by striking ``(a) Additional Statements.--'' in
subsection (a); and
(2) by striking 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 301 of this title, is further
amended by adding at the end the following:
``(c) Change in Required Statements.--The Secretary may, by a
rulemaking conducted under section 553 of title 5, United States Code,
adjust the format, type size, and text of any of the warning label
statements required by subsection (a) of this section, 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. 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, 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 25 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.
``(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.
``(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. 204. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL
STATEMENTS.
Section 3 of, as amended by section 303 of this title, 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
warning label statements required by subsection (a) of this section, 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. 205. 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 301 of this title, 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 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.).''.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S5599-5601)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S5601-5613)
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