[Congressional Record Volume 150, Number 129 (Sunday, October 10, 2004)]
[Senate]
[Pages S11068-S11087]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT AMENDING FAIR LABOR
STANDARDS ACT OF 1938
Mr. FRIST. Mr. President, I understand there are two bills at the
desk to be passed under a previous order.
The PRESIDING OFFICER. Under the previous order, S. 2974 and S. 2975
are read the third time and passed en bloc, and the motion to
reconsider is laid on the table.
The bills (S. 2974 and S. 2975) were read the third time and passed,
en bloc, as follows:
S. 2974
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Family Smoking Prevention
and Tobacco Control Act''.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) The use of tobacco products by the Nation's children is
a pediatric disease of considerable proportions that results
in new generations of tobacco-dependent children and adults.
(2) A consensus exists within the scientific and medical
communities that tobacco products are inherently dangerous
and cause cancer, heart disease, and other serious adverse
health effects.
(3) Nicotine is an addictive drug.
(4) Virtually all new users of tobacco products are under
the minimum legal age to purchase such products.
(5) Tobacco advertising and marketing contribute
significantly to the use of nicotine-containing tobacco
products by adolescents.
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(6) Because past efforts to restrict advertising and
marketing of tobacco products have failed adequately to curb
tobacco use by adolescents, comprehensive restrictions on the
sale, promotion, and distribution of such products are
needed.
(7) Federal and State governments have lacked the legal and
regulatory authority and resources they need to address
comprehensively the public health and societal problems
caused by the use of tobacco products.
(8) Federal and State public health officials, the public
health community, and the public at large recognize that the
tobacco industry should be subject to ongoing oversight.
(9) Under article I, section 8 of the Constitution, the
Congress is vested with the responsibility for regulating
interstate commerce and commerce with Indian tribes.
(10) The sale, distribution, marketing, advertising, and
use of tobacco products are activities in and substantially
affecting interstate commerce because they are sold,
marketed, advertised, and distributed in interstate commerce
on a nationwide basis, and have a substantial effect on the
Nation's economy.
(11) The sale, distribution, marketing, advertising, and
use of such products substantially affect interstate commerce
through the health care and other costs attributable to the
use of tobacco products.
(12) It is in the public interest for Congress to enact
legislation that provides the Food and Drug Administration
with the authority to regulate tobacco products and the
advertising and promotion of such products. The benefits to
the American people from enacting such legislation would be
significant in human and economic terms.
(13) Tobacco use is the foremost preventable cause of
premature death in America. It causes over 400,000 deaths in
the United States each year and approximately 8,600,000
Americans have chronic illnesses related to smoking.
(14) Reducing the use of tobacco by minors by 50 percent
would prevent well over 6,500,000 of today's children from
becoming regular, daily smokers, saving over 2,000,000 of
them from premature death due to tobacco induced disease.
Such a reduction in youth smoking would also result in
approximately $75,000,000,000 in savings attributable to
reduced health care costs.
(15) Advertising, marketing, and promotion of tobacco
products have been especially directed to attract young
persons to use tobacco products and these efforts have
resulted in increased use of such products by youth. Past
efforts to oversee these activities have not been successful
in adequately preventing such increased use.
(16) In 2001, the tobacco industry spent more than
$11,000,000,000 to attract new users, retain current users,
increase current consumption, and generate favorable long-
term attitudes toward smoking and tobacco use.
(17) Tobacco product advertising often misleadingly
portrays the use of tobacco as socially acceptable and
healthful to minors.
(18) Tobacco product advertising is regularly seen by
persons under the age of 18, and persons under the age of 18
are regularly exposed to tobacco product promotional efforts.
(19) Through advertisements during and sponsorship of
sporting events, tobacco has become strongly associated with
sports and has become portrayed as an integral part of sports
and the healthy lifestyle associated with rigorous sporting
activity.
(20) Children are exposed to substantial and unavoidable
tobacco advertising that leads to favorable beliefs about
tobacco use, plays a role in leading young people to
overestimate the prevalence of tobacco use, and increases the
number of young people who begin to use tobacco.
(21) The use of tobacco products in motion pictures and
other mass media glamorizes its use for young people and
encourages them to use tobacco products.
(22) Tobacco advertising expands the size of the tobacco
market by increasing consumption of tobacco products
including tobacco use by young people.
(23) Children are more influenced by tobacco advertising
than adults, they smoke the most advertised brands.
(24) Tobacco company documents indicate that young people
are an important and often crucial segment of the tobacco
market. Children, who tend to be more price-sensitive than
adults, are influenced by advertising and promotion practices
that result in drastically reduced cigarette prices.
(25) Comprehensive advertising restrictions will have a
positive effect on the smoking rates of young people.
(26) Restrictions on advertising are necessary to prevent
unrestricted tobacco advertising from undermining legislation
prohibiting access to young people and providing for
education about tobacco use.
(27) International experience shows that advertising
regulations that are stringent and comprehensive have a
greater impact on overall tobacco use and young people's use
than weaker or less comprehensive ones.
(28) Text only requirements, although not as stringent as a
ban, will help reduce underage use of tobacco products while
preserving the informational function of advertising.
(29) It is in the public interest for Congress to adopt
legislation to address the public health crisis created by
actions of the tobacco industry.
(30) The final regulations promulgated by the Secretary of
Health and Human Services in the August 28, 1996, issue of
the Federal Register (61 Fed. Reg. 44615-44618) for inclusion
as part 897 of title 21, Code of Federal Regulations, are
consistent with the First Amendment to the United States
Constitution and with the standards set forth in the
amendments made by this subtitle for the regulation of
tobacco products by the Food and Drug Administration and the
restriction on the sale and distribution, including access to
and the advertising and promotion of, tobacco products
contained in such regulations are substantially related to
accomplishing the public health goals of this Act.
(31) The regulations described in paragraph (30) will
directly and materially advance the Federal Government's
substantial interest in reducing the number of children and
adolescents who use cigarettes and smokeless tobacco and in
preventing the life-threatening health consequences
associated with tobacco use. An overwhelming majority of
Americans who use tobacco products begin using such products
while they are minors and become addicted to the nicotine in
those products before reaching the age of 18. Tobacco
advertising and promotion plays a crucial role in the
decision of these minors to begin using tobacco products.
Less restrictive and less comprehensive approaches have not
and will not be effective in reducing the problems addressed
by such regulations. The reasonable restrictions on the
advertising and promotion of tobacco products contained in
such regulations will lead to a significant decrease in the
number of minors using and becoming addicted to those
products.
(32) The regulations described in paragraph (30) impose no
more extensive restrictions on communication by tobacco
manufacturers and sellers than are necessary to reduce the
number of children and adolescents who use cigarettes and
smokeless tobacco and to prevent the life-threatening health
consequences associated with tobacco use. Such regulations
are narrowly tailored to restrict those advertising and
promotional practices which are most likely to be seen or
heard by youth and most likely to entice them into tobacco
use, while affording tobacco manufacturers and sellers ample
opportunity to convey information about their products to
adult consumers.
(33) Tobacco dependence is a chronic disease, one that
typically requires repeated interventions to achieve long-
term or permanent abstinence.
(34) Because the only known safe alternative to smoking is
cessation, interventions should target all smokers to help
them quit completely.
(35) Tobacco products have been used to facilitate and
finance criminal activities both domestically and
internationally. Illicit trade of tobacco products has been
linked to organized crime and terrorist groups.
(36) It is essential that the Food and Drug Administration
review products sold or distributed for use to reduce risks
or exposures associated with tobacco products and that it be
empowered to review any advertising and labeling for such
products. It is also essential that manufacturers, prior to
marketing such products, be required to demonstrate that such
products will meet a series of rigorous criteria, and will
benefit the health of the population as a whole, taking into
account both users of tobacco products and persons who do not
currently use tobacco products.
(37) Unless tobacco products that purport to reduce the
risks to the public of tobacco use actually reduce such
risks, those products can cause substantial harm to the
public health to the extent that the individuals, who would
otherwise not consume tobacco products or would consume such
products less, use tobacco products purporting to reduce
risk. Those who use products sold or distributed as modified
risk products that do not in fact reduce risk, rather than
quitting or reducing their use of tobacco products, have a
substantially increased likelihood of suffering disability
and premature death. The costs to society of the widespread
use of products sold or distributed as modified risk products
that do not in fact reduce risk or that increase risk include
thousands of unnecessary deaths and injuries and huge costs
to our health care system.
(38) As the National Cancer Institute has found, many
smokers mistakenly believe that ``low tar'' and ``light''
cigarettes cause fewer health problems than other cigarettes.
As the National Cancer Institute has also found, mistaken
beliefs about the health consequences of smoking ``low tar''
and ``light'' cigarettes can reduce the motivation to quit
smoking entirely and thereby lead to disease and death.
(39) Recent studies have demonstrated that there has been
no reduction in risk on a population-wide basis from ``low
tar'' and ``light'' cigarettes and such products may actually
increase the risk of tobacco use.
(40) The dangers of products sold or distributed as
modified risk tobacco products that do not in fact reduce
risk are so high that there is a compelling governmental
interest in insuring that statements about modified risk
tobacco products are complete, accurate, and relate to the
overall disease risk of the product.
(41) As the Federal Trade Commission has found, consumers
have misinterpreted advertisements in which one product is
claimed to be less harmful than a comparable product, even in
the presence of disclosures and advisories intended to
provide clarification.
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(42) Permitting manufacturers to make unsubstantiated
statements concerning modified risk tobacco products, whether
express or implied, even if accompanied by disclaimers would
be detrimental to the public health.
(43) The only way to effectively protect the public health
from the dangers of unsubstantiated modified risk tobacco
products is to empower the Food and Drug Administration to
require that products that tobacco manufacturers sold or
distributed for risk reduction be approved in advance of
marketing, and to require that the evidence relied on to
support approval of these products is rigorous.
SEC. 3. PURPOSE.
The purposes of this Act are--
(1) to provide authority to the Food and Drug
Administration to regulate tobacco products under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by
recognizing it as the primary Federal regulatory authority
with respect to the manufacture, marketing, and distribution
of tobacco products;
(2) to ensure that the Food and Drug Administration has the
authority to address issues of particular concern to public
health officials, especially the use of tobacco by young
people and dependence on tobacco;
(3) to authorize the Food and Drug Administration to set
national standards controlling the manufacture of tobacco
products and the identity, public disclosure, and amount of
ingredients used in such products;
(4) to provide new and flexible enforcement authority to
ensure that there is effective oversight of the tobacco
industry's efforts to develop, introduce, and promote less
harmful tobacco products;
(5) to vest the Food and Drug Administration with the
authority to regulate the levels of tar, nicotine, and other
harmful components of tobacco products;
(6) in order to ensure that consumers are better informed,
to require tobacco product manufacturers to disclose research
which has not previously been made available, as well as
research generated in the future, relating to the health and
dependency effects or safety of tobacco products;
(7) to continue to permit the sale of tobacco products to
adults in conjunction with measures to ensure that they are
not sold or accessible to underage purchasers;
(8) to impose appropriate regulatory controls on the
tobacco industry;
(9) to promote cessation to reduce disease risk and the
social costs associated with tobacco related diseases; and
(10) to strengthen legislation against illicit trade in
tobacco products.
SEC. 4. SCOPE AND EFFECT.
(a) Intended Effect.--Nothing in this Act (or an amendment
made by this Act) shall be construed to--
(1) establish a precedent with regard to any other
industry, situation, circumstance, or legal action; or
(2) affect any action pending in Federal, State, or Tribal
court, or any agreement, consent decree, or contract of any
kind.
(b) Agricultural Activities.--The provisions of this Act
(or an amendment made by this Act) which authorize the
Secretary to take certain actions with regard to tobacco and
tobacco products shall not be construed to affect any
authority of the Secretary of Agriculture under existing law
regarding the growing, cultivation, or curing of raw tobacco.
SEC. 5. SEVERABILITY.
If any provision of this Act, the amendments made by this
Act, or the application of any provision of this Act to any
person or circumstance is held to be invalid, the remainder
of this Act, the amendments made by this Act, and the
application of the provisions of this Act to any other person
or circumstance shall not be affected and shall continue to
be enforced to the fullest extent possible.
TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION
SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Definition of Tobacco Products.--Section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is
amended by adding at the end the following:
``(nn)(1) The term `tobacco product' means any product made
or derived from tobacco that is intended for human
consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco
used in manufacturing a component, part, or accessory of a
tobacco product).
``(2) The term `tobacco product' does not mean--
``(A) a product in the form of conventional food (including
water and chewing gum), a product represented for use as or
for use in a conventional food, or a product that is intended
for ingestion in capsule, tablet, softgel, or liquid form; or
``(B) an article that is approved or is regulated as a drug
by the Food and Drug Administration.
``(3) The products described in paragraph (2)(A) shall be
subject to chapter IV or chapter V of this Act and the
articles described in paragraph (2)(B) shall be subject to
chapter V of this Act.
``(4) A tobacco product may not be marketed in combination
with any other article or product regulated under this Act
(including a drug, biologic, food, cosmetics, medical device,
or a dietary supplement).''.
(b) FDA Authority Over Tobacco Products.--The Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) by redesignating chapter IX as chapter X;
(2) by redesignating sections 901 through 907 as sections
1001 through 1007; and
(3) by inserting after section 803 the following:
``CHAPTER IX--TOBACCO PRODUCTS
``SEC. 900. DEFINITIONS.
``In this chapter:
``(1) Additive.--The term `additive' means any substance
the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a
component or otherwise affecting the characteristic of any
tobacco product (including any substances intended for use as
a flavoring, coloring or in producing, manufacturing,
packing, processing, preparing, treating, packaging,
transporting, or holding), except that such term does not
include tobacco or a pesticide chemical residue in or on raw
tobacco or a pesticide chemical.
``(2) Brand.--The term `brand' means a variety of tobacco
product distinguished by the tobacco used, tar content,
nicotine content, flavoring used, size, filtration, or
packaging, logo, registered trademark or brand name,
identifiable pattern of colors, or any combination of such
attributes.
``(3) Cigarette.--The term `cigarette' has the meaning
given that term by section 3(1) of the Federal Cigarette
Labeling and Advertising Act (15 U.S.C. 1332(1)), but also
includes tobacco, in any form, that is functional in the
product, which, because of its appearance, the type of
tobacco used in the filler, or its packaging and labeling, is
likely to be offered to, or purchased by, consumers as a
cigarette or as roll-your-own tobacco.
``(4) Cigarette tobacco.--The term `cigarette tobacco'
means any product that consists of loose tobacco that is
intended for use by consumers in a cigarette. Unless
otherwise stated, the requirements for cigarettes shall also
apply to cigarette tobacco.
``(5) Commerce.--The term `commerce' has the meaning given
that term by section 3(2) of the Federal Cigarette Labeling
and Advertising Act (15 U.S.C. 1332(2)).
``(6) Counterfeit tobacco product.--The term `counterfeit
tobacco product' means a tobacco product (or the container or
labeling of such a product) that, without authorization,
bears the trademark, trade name, or other identifying mark,
imprint or device, or any likeness thereof, of a tobacco
product listed in a registration under section 905(i)(1).
``(7) Distributor.--The term `distributor' as regards a
tobacco product means any person who furthers the
distribution of a tobacco product, whether domestic or
imported, at any point from the original place of manufacture
to the person who sells or distributes the product to
individuals for personal consumption. Common carriers are not
considered distributors for purposes of this chapter.
``(8) Illicit trade.--The term `illicit trade' means any
practice or conduct prohibited by law which relates to
production, shipment, receipt, possession, distribution,
sale, or purchase of tobacco products including any practice
or conduct intended to facilitate such activity.
``(9) Indian tribe.--The term `Indian tribe' has the
meaning given such term in section 4(e) of the Indian Self
Determination and Education Assistance Act (25 U.S.C.
450b(e)).
``(10) Little cigar.--The term `little cigar' has the
meaning given that term by section 3(7) of the Federal
Cigarette Labeling and Advertising Act (15 U.S.C. 1332(7)).
``(11) Nicotine.--The term `nicotine' means the chemical
substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or
C[10]H[14]N[2], including any salt or complex of nicotine.
``(12) Package.--The term `package' means a pack, box,
carton, or container of any kind or, if no other container,
any wrapping (including cellophane), in which a tobacco
product is offered for sale, sold, or otherwise distributed
to consumers.
``(13) Retailer.--The term `retailer' means any person who
sells tobacco products to individuals for personal
consumption, or who operates a facility where self-service
displays of tobacco products are permitted.
``(14) Roll-your-own tobacco.--The term `roll-your-own
tobacco' means any tobacco which, because of its appearance,
type, packaging, or labeling, is suitable for use and likely
to be offered to, or purchased by, consumers as tobacco for
making cigarettes.
``(15) Smoke constituent.--The term `smoke constituent'
means any chemical or chemical compound in mainstream or
sidestream tobacco smoke that either transfers from any
component of the cigarette to the smoke or that is formed by
the combustion or heating of tobacco, additives, or other
component of the tobacco product.
``(16) Smokeless tobacco.--The term `smokeless tobacco'
means any tobacco product that consists of cut, ground,
powdered, or leaf tobacco and that is intended to be placed
in the oral or nasal cavity.
``(17) State.--The term `State' means any State of the
United States and, for purposes of this chapter, includes the
District of Columbia, the Commonwealth of Puerto Rico, Guam,
the Virgin Islands, American Samoa, Wake Island, Midway
Islands, Kingman Reef, Johnston Atoll, the Northern Mariana
Islands, and any other trust territory or possession of the
United States.
``(18) Tobacco product manufacturer.--Term `tobacco product
manufacturer' means
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any person, including any repacker or relabeler, who--
``(A) manufactures, fabricates, assembles, processes, or
labels a tobacco product; or
``(B) imports a finished cigarette or smokeless tobacco
product for sale or distribution in the United States.
``(19) United states.--The term `United States' means the
50 States of the United States of America and the District of
Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin
Islands, American Samoa, Wake Island, Midway Islands, Kingman
Reef, Johnston Atoll, the Northern Mariana Islands, and any
other trust territory or possession of the United States.
``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
``(a) In General.--Tobacco products shall be regulated by
the Secretary under this chapter and shall not be subject to
the provisions of chapter V, unless--
``(1) such products are intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease (within
the meaning of section 201(g)(1)(B) or section 201(h)(2)); or
``(2) a claim is made for such products under section
201(g)(1)(C) or 201(h)(3);
other than modified risk tobacco products approved in
accordance with section 911.
``(b) Applicability.--This chapter shall apply to all
tobacco products subject to the regulations referred to in
section 102 of the Family Smoking Prevention and Tobacco
Control Act, and to any other tobacco products that the
Secretary by regulation deems to be subject to this chapter.
``(c) Scope.--
``(1) In general.--Nothing in this chapter, or any policy
issued or regulation promulgated thereunder, or the Family
Smoking Prevention and Tobacco Control Act, shall be
construed to affect the Secretary's authority over, or the
regulation of, products under this Act that are not tobacco
products under chapter V or any other chapter.
``(2) Limitation of authority.--
``(A) In general.--The provisions of this chapter shall not
apply to tobacco leaf that is not in the possession of a
manufacturer of tobacco products, or to the producers of
tobacco leaf, including tobacco growers, tobacco warehouses,
and tobacco grower cooperatives, nor shall any employee of
the Food and Drug Administration have any authority to enter
onto a farm owned by a producer of tobacco leaf without the
written consent of such producer.
``(B) Exception.--Notwithstanding any other provision of
this subparagraph, if a producer of tobacco leaf is also a
tobacco product manufacturer or controlled by a tobacco
product manufacturer, the producer shall be subject to this
chapter in the producer's capacity as a manufacturer.
``(C) Rule of construction.--Nothing in this chapter shall
be construed to grant the Secretary authority to promulgate
regulations on any matter that involves the production of
tobacco leaf or a producer thereof, other than activities by
a manufacturer affecting production.
``SEC. 902. ADULTERATED TOBACCO PRODUCTS.
``A tobacco product shall be deemed to be adulterated if--
``(1) it consists in whole or in part of any filthy,
putrid, or decomposed substance, or is otherwise contaminated
by any added poisonous or added deleterious substance that
may render the product injurious to health;
``(2) it has been prepared, packed, or held under
insanitary conditions whereby it may have been contaminated
with filth, or whereby it may have been rendered injurious to
health;
``(3) its package is composed, in whole or in part, of any
poisonous or deleterious substance which may render the
contents injurious to health;
``(4) it is, or purports to be or is represented as, a
tobacco product which is subject to a tobacco product
standard established under section 907 unless such tobacco
product is in all respects in conformity with such standard;
``(5)(A) it is required by section 910(a) to have premarket
approval and does not have an approved application in effect;
``(B) it is in violation of the order approving such an
application; or
``(6) the methods used in, or the facilities or controls
used for, its manufacture, packing or storage are not in
conformity with applicable requirements under section
906(e)(1) or an applicable condition prescribed by an order
under section 906(e)(2); or
``(7) it is in violation of section 911.
``SEC. 903. MISBRANDED TOBACCO PRODUCTS.
``(a) In General.--A tobacco product shall be deemed to be
misbranded--
``(1) if its labeling is false or misleading in any
particular;
``(2) if in package form unless it bears a label
containing--
``(A) the name and place of business of the tobacco product
manufacturer, packer, or distributor;
``(B) an accurate statement of the quantity of the contents
in terms of weight, measure, or numerical count;
``(C) an accurate statement of the percentage of the
tobacco used in the product that is domestically grown
tobacco and the percentage that is foreign grown tobacco; and
``(D) the statement required under section 921(a),
except that under subparagraph (B) reasonable variations
shall be permitted, and exemptions as to small packages shall
be established, by regulations prescribed by the Secretary;
``(3) if any word, statement, or other information required
by or under authority of this chapter to appear on the label
or labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements or
designs in the labeling) and in such terms as to render it
likely to be read and understood by the ordinary individual
under customary conditions of purchase and use;
``(4) if it has an established name, unless its label
bears, to the exclusion of any other nonproprietary name, its
established name prominently printed in type as required by
the Secretary by regulation;
``(5) if the Secretary has issued regulations requiring
that its labeling bear adequate directions for use, or
adequate warnings against use by children, that are necessary
for the protection of users unless its labeling conforms in
all respects to such regulations;
``(6) if it was manufactured, prepared, propagated,
compounded, or processed in any State in an establishment not
duly registered under section 905(b), 905(c), 905(d), or
905(h), if it was not included in a list required by section
905(i), if a notice or other information respecting it was
not provided as required by such section or section 905(j),
or if it does not bear such symbols from the uniform system
for identification of tobacco products prescribed under
section 905(e) as the Secretary by regulation requires;
``(7) if, in the case of any tobacco product distributed or
offered for sale in any State--
``(A) its advertising is false or misleading in any
particular; or
``(B) it is sold or distributed in violation of regulations
prescribed under section 906(d);
``(8) unless, in the case of any tobacco product
distributed or offered for sale in any State, the
manufacturer, packer, or distributor thereof includes in all
advertisements and other descriptive printed matter issued or
caused to be issued by the manufacturer, packer, or
distributor with respect to that tobacco product--
``(A) a true statement of the tobacco product's established
name as described in paragraph (4), printed prominently; and
``(B) a brief statement of--
``(i) the uses of the tobacco product and relevant
warnings, precautions, side effects, and contraindications;
and
``(ii) in the case of specific tobacco products made
subject to a finding by the Secretary after notice and
opportunity for comment that such action is appropriate to
protect the public health, a full description of the
components of such tobacco product or the formula showing
quantitatively each ingredient of such tobacco product to the
extent required in regulations which shall be issued by the
Secretary after an opportunity for a hearing;
``(9) if it is a tobacco product subject to a tobacco
product standard established under section 907, unless it
bears such labeling as may be prescribed in such tobacco
product standard; or
``(10) if there was a failure or refusal--
``(A) to comply with any requirement prescribed under
section 904 or 908; or
``(B) to furnish any material or information required under
section 909.
``(b) Prior Approval of Label Statements.--The Secretary
may, by regulation, require prior approval of statements made
on the label of a tobacco product. No regulation issued under
this subsection may require prior approval by the Secretary
of the content of any advertisement, except for modified risk
tobacco products as provided in section 911. No advertisement
of a tobacco product published after the date of enactment of
the Family Smoking Prevention and Tobacco Control Act shall,
with respect to the language of label statements as
prescribed under section 4 of the Cigarette Labeling and
Advertising Act and section 3 of the Comprehensive Smokeless
Tobacco Health Education Act of 1986 or the regulations
issued under such sections, be subject to the provisions of
sections 12 through 15 of the Federal Trade Commission Act
(15 U.S.C. 52 through 55).
``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE
SECRETARY.
``(a) Requirement.--Not later than 6 months after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, each tobacco product manufacturer or importer,
or agents thereof, shall submit to the Secretary the
following information:
``(1) A listing of all ingredients, including tobacco,
substances, compounds, and additives that are, as of such
date, added by the manufacturer to the tobacco, paper,
filter, or other part of each tobacco product by brand and by
quantity in each brand and subbrand.
``(2) A description of the content, delivery, and form of
nicotine in each tobacco product measured in milligrams of
nicotine in accordance with regulations promulgated by the
Secretary in accordance with section 4(a)(4) of the Federal
Cigarette Labeling and Advertising Act.
``(3) A listing of all constituents, including smoke
constituents as applicable, identified by the Secretary as
harmful or potentially harmful to health in each tobacco
product, and as applicable in the smoke of each tobacco
product, by brand and by quantity in each brand and subbrand.
Effective beginning 2 years after the date of enactment of
this chapter, the manufacturer, importer, or agent shall
comply with regulations promulgated under section 915 in
reporting information under this paragraph, where applicable.
[[Page S11072]]
``(4) All documents developed after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act that
relate to health, toxicological, behavioral, or physiologic
effects of current or future tobacco products, their
constituents (including smoke constituents), ingredients,
components, and additives.
``(b) Data Submission.--At the request of the Secretary,
each tobacco product manufacturer or importer of tobacco
products, or agents thereof, shall submit the following:
``(1) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) on the health,
toxicological, behavioral, or physiologic effects of tobacco
products and their constituents (including smoke
constituents), ingredients, components, and additives.
``(2) Any or all documents (including underlying scientific
information) relating to research activities, and research
findings, conducted, supported, or possessed by the
manufacturer (or agents thereof) that relate to the issue of
whether a reduction in risk to health from tobacco products
can occur upon the employment of technology available or
known to the manufacturer.
``(3) Any or all documents (including underlying scientific
or financial information) relating to marketing research
involving the use of tobacco products or marketing practices
and the effectiveness of such practices used by tobacco
manufacturers and distributors.
An importer of a tobacco product not manufactured in the
United States shall supply the information required of a
tobacco product manufacturer under this subsection.
``(c) Time for Submission.--
``(1) In general.--At least 90 days prior to the delivery
for introduction into interstate commerce of a tobacco
product not on the market on the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, the
manufacturer of such product shall provide the information
required under subsection (a).
``(2) Disclosure of additive.--If at any time a tobacco
product manufacturer adds to its tobacco products a new
tobacco additive or increases the quantity of an existing
tobacco additive, the manufacturer shall, except as provided
in paragraph (3), at least 90 days prior to such action so
advise the Secretary in writing.
``(3) Disclosure of other actions.--If at any time a
tobacco product manufacturer eliminates or decreases an
existing additive, or adds or increases an additive that has
by regulation been designated by the Secretary as an additive
that is not a human or animal carcinogen, or otherwise
harmful to health under intended conditions of use, the
manufacturer shall within 60 days of such action so advise
the Secretary in writing.
``(d) Data List.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act, and annually thereafter, the Secretary shall
publish in a format that is understandable and not misleading
to a lay person, and place on public display (in a manner
determined by the Secretary) the list established under
subsection (e).
``(2) Consumer research.--The Secretary shall conduct
periodic consumer research to ensure that the list published
under paragraph (1) is not misleading to lay persons. Not
later than 5 years after the date of enactment of the Family
Smoking Prevention and Tobacco Control Act, the Secretary
shall submit to the appropriate committees of Congress a
report on the results of such research, together with
recommendations on whether such publication should be
continued or modified.
``(e) Data Collection.--Not later than 12 months after the
date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall establish a list of
harmful and potentially harmful constituents, including smoke
constituents, to health in each tobacco product by brand and
by quantity in each brand and subbrand. The Secretary shall
publish a public notice requesting the submission by
interested persons of scientific and other information
concerning the harmful and potentially harmful constituents
in tobacco products and tobacco smoke.
``SEC. 905. ANNUAL REGISTRATION.
``(a) Definitions.--In this section:
``(1) Manufacture, preparation, compounding, or
processing.--The term `manufacture, preparation, compounding,
or processing' shall include repackaging or otherwise
changing the container, wrapper, or labeling of any tobacco
product package in furtherance of the distribution of the
tobacco product from the original place of manufacture to the
person who makes final delivery or sale to the ultimate
consumer or user.
``(2) Name.--The term `name' shall include in the case of a
partnership the name of each partner and, in the case of a
corporation, the name of each corporate officer and director,
and the State of incorporation.
``(b) Registration by Owners and Operators.--On or before
December 31 of each year every person who owns or operates
any establishment in any State engaged in the manufacture,
preparation, compounding, or processing of a tobacco product
or tobacco products shall register with the Secretary the
name, places of business, and all such establishments of that
person.
``(c) Registration of New Owners and Operators.--Every
person upon first engaging in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco
products in any establishment owned or operated in any State
by that person shall immediately register with the Secretary
that person's name, place of business, and such
establishment.
``(d) Registration of Added Establishments.--Every person
required to register under subsection (b) or (c) shall
immediately register with the Secretary any additional
establishment which that person owns or operates in any State
and in which that person begins the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco
products.
``(e) Uniform Product Identification System.--The Secretary
may by regulation prescribe a uniform system for the
identification of tobacco products and may require that
persons who are required to list such tobacco products under
subsection (i) shall list such tobacco products in accordance
with such system.
``(f) Public Access to Registration Information.--The
Secretary shall make available for inspection, to any person
so requesting, any registration filed under this section.
``(g) Biennial Inspection of Registered Establishments.--
Every establishment in any State registered with the
Secretary under this section shall be subject to inspection
under section 704, and every such establishment engaged in
the manufacture, compounding, or processing of a tobacco
product or tobacco products shall be so inspected by 1 or
more officers or employees duly designated by the Secretary
at least once in the 2-year period beginning with the date of
registration of such establishment under this section and at
least once in every successive 2-year period thereafter.
``(h) Foreign Establishments Shall Register.--Any
establishment within any foreign country engaged in the
manufacture, preparation, compounding, or processing of a
tobacco product or tobacco products, shall register under
this section under regulations promulgated by the Secretary.
Such regulations shall require such establishment to provide
the information required by subsection (i) of this section
and shall include provisions for registration of any such
establishment upon condition that adequate and effective
means are available, by arrangement with the government of
such foreign country or otherwise, to enable the Secretary to
determine from time to time whether tobacco products
manufactured, prepared, compounded, or processed in such
establishment, if imported or offered for import into the
United States, shall be refused admission on any of the
grounds set forth in section 801(a).
``(i) Registration Information.--
``(1) Product list.--Every person who registers with the
Secretary under subsection (b), (c), (d), or (h) shall, at
the time of registration under any such subsection, file with
the Secretary a list of all tobacco products which are being
manufactured, prepared, compounded, or processed by that
person for commercial distribution and which has not been
included in any list of tobacco products filed by that person
with the Secretary under this paragraph or paragraph (2)
before such time of registration. Such list shall be prepared
in such form and manner as the Secretary may prescribe and
shall be accompanied by--
``(A) in the case of a tobacco product contained in the
applicable list with respect to which a tobacco product
standard has been established under section 907 or which is
subject to section 910, a reference to the authority for the
marketing of such tobacco product and a copy of all labeling
for such tobacco product;
``(B) in the case of any other tobacco product contained in
an applicable list, a copy of all consumer information and
other labeling for such tobacco product, a representative
sampling of advertisements for such tobacco product, and,
upon request made by the Secretary for good cause, a copy of
all advertisements for a particular tobacco product; and
``(C) if the registrant filing a list has determined that a
tobacco product contained in such list is not subject to a
tobacco product standard established under section 907, a
brief statement of the basis upon which the registrant made
such determination if the Secretary requests such a statement
with respect to that particular tobacco product.
``(2) Biannual report of any change in product list.--Each
person who registers with the Secretary under this section
shall report to the Secretary once during the month of June
of each year and once during the month of December of each
year the following:
``(A) A list of each tobacco product introduced by the
registrant for commercial distribution which has not been
included in any list previously filed by that person with the
Secretary under this subparagraph or paragraph (1). A list
under this subparagraph shall list a tobacco product by its
established name and shall be accompanied by the other
information required by paragraph (1).
``(B) If since the date the registrant last made a report
under this paragraph that person has discontinued the
manufacture, preparation, compounding, or processing for
commercial distribution of a tobacco product included in a
list filed under subparagraph (A) or paragraph (1), notice of
such discontinuance, the date of such discontinuance, and the
identity of its established name.
[[Page S11073]]
``(C) If since the date the registrant reported under
subparagraph (B) a notice of discontinuance that person has
resumed the manufacture, preparation, compounding, or
processing for commercial distribution of the tobacco product
with respect to which such notice of discontinuance was
reported, notice of such resumption, the date of such
resumption, the identity of such tobacco product by
established name, and other information required by paragraph
(1), unless the registrant has previously reported such
resumption to the Secretary under this subparagraph.
``(D) Any material change in any information previously
submitted under this paragraph or paragraph (1).
``(j) Report Preceding Introduction of Certain
Substantially-Equivalent Products Into Interstate Commerce.--
``(1) In general.--Each person who is required to register
under this section and who proposes to begin the introduction
or delivery for introduction into interstate commerce for
commercial distribution of a tobacco product intended for
human use that was not commercially marketed (other than for
test marketing) in the United States as of June 1, 2003,
shall, at least 90 days prior to making such introduction or
delivery, report to the Secretary (in such form and manner as
the Secretary shall prescribe)--
``(A) the basis for such person's determination that the
tobacco product is substantially equivalent, within the
meaning of section 910, to a tobacco product commercially
marketed (other than for test marketing) in the United States
as of June 1, 2003, that is in compliance with the
requirements of this Act; and
``(B) action taken by such person to comply with the
requirements under section 907 that are applicable to the
tobacco product.
``(2) Application to certain post june 1, 2003 products.--A
report under this subsection for a tobacco product that was
first introduced or delivered for introduction into
interstate commerce for commercial distribution in the United
States after June 1, 2003, and prior to the date that is 15
months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act shall be submitted to the
Secretary not later than 15 months after such date of
enactment.
``(3) Exemptions.--
``(A) In general.--The Secretary may by regulation, exempt
from the requirements of this subsection tobacco products
that are modified by adding or deleting a tobacco additive,
or increasing or decreasing the quantity of an existing
tobacco additive, if the Secretary determines that--
``(i) such modification would be a minor modification of a
tobacco product authorized for sale under this Act;
``(ii) a report under this subsection is not necessary to
ensure that permitting the tobacco product to be marketed
would be appropriate for protection of the public health; and
``(iii) an exemption is otherwise appropriate.
``(B) Regulations.--Not later than 9 months after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall issue regulations to
implement this paragraph.
``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO
PRODUCTS.
``(a) In General.--Any requirement established by or under
section 902, 903, 905, or 909 applicable to a tobacco product
shall apply to such tobacco product until the applicability
of the requirement to the tobacco product has been changed by
action taken under section 907, section 910, section 911, or
subsection (d) of this section, and any requirement
established by or under section 902, 903, 905, or 909 which
is inconsistent with a requirement imposed on such tobacco
product under section 907, section 910, section 911, or
subsection (d) of this section shall not apply to such
tobacco product.
``(b) Information on Public Access and Comment.--Each
notice of proposed rulemaking under section 907, 908, 909,
910, or 911 or under this section, any other notice which is
published in the Federal Register with respect to any other
action taken under any such section and which states the
reasons for such action, and each publication of findings
required to be made in connection with rulemaking under any
such section shall set forth--
``(1) the manner in which interested persons may examine
data and other information on which the notice or findings is
based; and
``(2) the period within which interested persons may
present their comments on the notice or findings (including
the need therefore) orally or in writing, which period shall
be at least 60 days but may not exceed 90 days unless the
time is extended by the Secretary by a notice published in
the Federal Register stating good cause therefore.
``(c) Limited Confidentiality of Information.--Any
information reported to or otherwise obtained by the
Secretary or the Secretary's representative under section
903, 904, 907, 908, 909, 910, 911, or 704, or under
subsection (e) or (f) of this section, which is exempt from
disclosure under subsection (a) of section 552 of title 5,
United States Code, by reason of subsection (b)(4) of that
section shall be considered confidential and shall not be
disclosed, except that the information may be disclosed to
other officers or employees concerned with carrying out this
chapter, or when relevant in any proceeding under this
chapter.
``(d) Restrictions.--
``(1) In general.--The Secretary may by regulation require
restrictions on the sale and distribution of a tobacco
product, including restrictions on the access to, and the
advertising and promotion of, the tobacco product, if the
Secretary determines that such regulation would be
appropriate for the protection of the public health. The
Secretary may by regulation impose restrictions on the
advertising and promotion of a tobacco product consistent
with and to full extent permitted by the first amendment to
the Constitution. The finding as to whether such regulation
would be appropriate for the protection of the public health
shall be determined with respect to the risks and benefits to
the population as a whole, including users and non-users of
the tobacco product, and taking into account--
``(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(B) the increased or decreased likelihood that those who
do not use tobacco products will start using such products.
No such regulation may require that the sale or distribution
of a tobacco product be limited to the written or oral
authorization of a practitioner licensed by law to prescribe
medical products.
``(2) Label statements.--The label of a tobacco product
shall bear such appropriate statements of the restrictions
required by a regulation under subsection (a) as the
Secretary may in such regulation prescribe.
``(3) Limitations.--
``(A) In general.--No restrictions under paragraph (1)
may--
``(i) prohibit the sale of any tobacco product in face-to-
face transactions by a specific category of retail outlets;
or
``(ii) establish a minimum age of sale of tobacco products
to any person older than 18 years of age.
``(B) Matchbooks.--For purposes of any regulations issued
by the Secretary, matchbooks of conventional size containing
not more than 20 paper matches, and which are customarily
given away for free with the purchase of tobacco products
shall be considered as adult written publications which shall
be permitted to contain advertising. Notwithstanding the
preceding sentence, if the Secretary finds that such
treatment of matchbooks is not appropriate for the protection
of the public health, the Secretary may determine by
regulation that matchbooks shall not be considered adult
written publications.
``(e) Good Manufacturing Practice Requirements.--
``(1) Methods, facilities, and controls to conform.--
``(A) In general.--The Secretary may, in accordance with
subparagraph (B), prescribe regulations (which may differ
based on the type of tobacco product involved) requiring that
the methods used in, and the facilities and controls used
for, the manufacture, pre-production design validation
(including a process to assess the performance of a tobacco
product), packing and storage of a tobacco product, conform
to current good manufacturing practice, as prescribed in such
regulations, to assure that the public health is protected
and that the tobacco product is in compliance with this
chapter. Good manufacturing practices may include the testing
of raw tobacco for pesticide chemical residues regardless of
whether a tolerance for such chemical residues has been
established.
``(B) Requirements.--The Secretary shall--
``(i) before promulgating any regulation under subparagraph
(A), afford the Tobacco Products Scientific Advisory
Committee an opportunity to submit recommendations with
respect to the regulation proposed to be promulgated;
``(ii) before promulgating any regulation under
subparagraph (A), afford opportunity for an oral hearing;
``(iii) provide the advisory committee a reasonable time to
make its recommendation with respect to proposed regulations
under subparagraph (A); and
``(iv) in establishing the effective date of a regulation
promulgated under this subsection, take into account the
differences in the manner in which the different types of
tobacco products have historically been produced, the
financial resources of the different tobacco product
manufacturers, and the state of their existing manufacturing
facilities, and shall provide for a reasonable period of time
for such manufacturers to conform to good manufacturing
practices.
``(2) Exemptions; variances.--
``(A) Petition.--Any person subject to any requirement
prescribed under paragraph (1) may petition the Secretary for
a permanent or temporary exemption or variance from such
requirement. Such a petition shall be submitted to the
Secretary in such form and manner as the Secretary shall
prescribe and shall--
``(i) in the case of a petition for an exemption from a
requirement, set forth the basis for the petitioner's
determination that compliance with the requirement is not
required to assure that the tobacco product will be in
compliance with this chapter;
``(ii) in the case of a petition for a variance from a
requirement, set forth the methods proposed to be used in,
and the facilities and controls proposed to be used for, the
manufacture, packing, and storage of the tobacco product in
lieu of the methods, facilities, and controls prescribed by
the requirement; and
[[Page S11074]]
``(iii) contain such other information as the Secretary
shall prescribe.
``(B) Referral to the tobacco products scientific advisory
committee.--The Secretary may refer to the Tobacco Products
Scientific Advisory Committee any petition submitted under
subparagraph (A). The Tobacco Products Scientific Advisory
Committee shall report its recommendations to the Secretary
with respect to a petition referred to it within 60 days
after the date of the petition's referral. Within 60 days
after--
``(i) the date the petition was submitted to the Secretary
under subparagraph (A); or
``(ii) the day after the petition was referred to the
Tobacco Products Scientific Advisory Committee,
whichever occurs later, the Secretary shall by order either
deny the petition or approve it.
``(C) Approval.--The Secretary may approve--
``(i) a petition for an exemption for a tobacco product
from a requirement if the Secretary determines that
compliance with such requirement is not required to assure
that the tobacco product will be in compliance with this
chapter; and
``(ii) a petition for a variance for a tobacco product from
a requirement if the Secretary determines that the methods to
be used in, and the facilities and controls to be used for,
the manufacture, packing, and storage of the tobacco product
in lieu of the methods, controls, and facilities prescribed
by the requirement are sufficient to assure that the tobacco
product will be in compliance with this chapter.
``(D) Conditions.--An order of the Secretary approving a
petition for a variance shall prescribe such conditions
respecting the methods used in, and the facilities and
controls used for, the manufacture, packing, and storage of
the tobacco product to be granted the variance under the
petition as may be necessary to assure that the tobacco
product will be in compliance with this chapter.
``(E) Hearing.--After the issuance of an order under
subparagraph (B) respecting a petition, the petitioner shall
have an opportunity for an informal hearing on such order.
``(3) Compliance.--Compliance with requirements under this
subsection shall not be required before the period ending 3
years after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act.
``(f) Research and Development.--The Secretary may enter
into contracts for research, testing, and demonstrations
respecting tobacco products and may obtain tobacco
products for research, testing, and demonstration purposes
without regard to section 3324(a) and (b) of title 31,
United States Code, and section 5 of title 41, United
States Code.
``SEC. 907. TOBACCO PRODUCT STANDARDS.
``(a) In General.--
``(1) Special rule for cigarettes.--A cigarette or any of
its component parts (including the tobacco, filter, or paper)
shall not contain, as a constituent (including a smoke
constituent) or additive, an artificial or natural flavor
(other than tobacco or menthol) or an herb or spice,
including strawberry, grape, orange, clove, cinnamon,
pineapple, vanilla, coconut, licorice, cocoa, chocolate,
cherry, or coffee, that is a characterizing flavor of the
tobacco product or tobacco smoke. Nothing in this
subparagraph shall be construed to limit the Secretary's
authority to take action under this section or other sections
of this Act applicable to menthol or any artificial or
natural flavor, herb, or spice not specified in this
paragraph.
``(2) Revision of tobacco product standards.--The Secretary
may revise the tobacco product standards in paragraph (1) in
accordance with subsection (b).
``(3) Tobacco product standards.--The Secretary may adopt
tobacco product standards in addition to those in paragraph
(1) if the Secretary finds that a tobacco product standard is
appropriate for the protection of the public health. This
finding shall be determined with respect to the risks and
benefits to the population as a whole, including users and
non-users of the tobacco product, and taking into account--
``(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(B) the increased or decreased likelihood that those who
do not use tobacco products will start using such products.
``(4) Content of tobacco product standards.--A tobacco
product standard established under this section for a tobacco
product--
``(A) shall include provisions that are appropriate for the
protection of the public health, including provisions, where
appropriate--
``(i) for the reduction of nicotine yields of the product;
``(ii) for the reduction or elimination of other
constituents, including smoke constituents, or harmful
components of the product; or
``(iii) relating to any other requirement under (B);
``(B) shall, where appropriate for the protection of the
public health, include--
``(i) provisions respecting the construction, components,
ingredients, additives, constituents, including smoke
constituents, and properties of the tobacco product;
``(ii) provisions for the testing (on a sample basis or, if
necessary, on an individual basis) of the tobacco product;
``(iii) provisions for the measurement of the tobacco
product characteristics of the tobacco product;
``(iv) provisions requiring that the results of each or of
certain of the tests of the tobacco product required to be
made under clause (ii) show that the tobacco product is in
conformity with the portions of the standard for which the
test or tests were required; and
``(v) a provision requiring that the sale and distribution
of the tobacco product be restricted but only to the extent
that the sale and distribution of a tobacco product may be
restricted under a regulation under section 906(d); and
``(C) shall, where appropriate, require the use and
prescribe the form and content of labeling for the proper use
of the tobacco product.
``(5) Periodic re-evaluation of tobacco product
standards.--The Secretary shall provide for periodic
evaluation of tobacco product standards established under
this section to determine whether such standards should be
changed to reflect new medical, scientific, or other
technological data. The Secretary may provide for testing
under paragraph (4)(B) by any person.
``(6) Involvement of other agencies; informed persons.--In
carrying out duties under this section, the Secretary shall
endeavor to--
``(A) use personnel, facilities, and other technical
support available in other Federal agencies;
``(B) consult with other Federal agencies concerned with
standard-setting and other nationally or internationally
recognized standard-setting entities; and
``(C) invite appropriate participation, through joint or
other conferences, workshops, or other means, by informed
persons representative of scientific, professional, industry,
agricultural, or consumer organizations who in the
Secretary's judgment can make a significant contribution.
``(b) Establishment of Standards.--
``(1) Notice.--
``(A) In general.--The Secretary shall publish in the
Federal Register a notice of proposed rulemaking for the
establishment, amendment, or revocation of any tobacco
product standard.
``(B) Requirements of notice.--A notice of proposed
rulemaking for the establishment or amendment of a tobacco
product standard for a tobacco product shall--
``(i) set forth a finding with supporting justification
that the tobacco product standard is appropriate for the
protection of the public health;
``(ii) set forth proposed findings with respect to the risk
of illness or injury that the tobacco product standard is
intended to reduce or eliminate; and
``(iii) invite interested persons to submit an existing
tobacco product standard for the tobacco product, including a
draft or proposed tobacco product standard, for consideration
by the Secretary.
``(C) Standard.--Upon a determination by the Secretary that
an additive, constituent (including smoke constituent), or
other component of the product that is the subject of the
proposed tobacco product standard is harmful, it shall be the
burden of any party challenging the proposed standard to
prove that the proposed standard will not reduce or eliminate
the risk of illness or injury.
``(D) Finding.--A notice of proposed rulemaking for the
revocation of a tobacco product standard shall set forth a
finding with supporting justification that the tobacco
product standard is no longer appropriate for the protection
of the public health.
``(E) Consideration by secretary.--The Secretary shall
consider all information submitted in connection with a
proposed standard, including information concerning the
countervailing effects of the tobacco product standard on the
health of adolescent tobacco users, adult tobacco users, or
non-tobacco users, such as the creation of a significant
demand for contraband or other tobacco products that do not
meet the requirements of this chapter and the significance of
such demand, and shall issue the standard if the Secretary
determines that the standard would be appropriate for the
protection of the public health.
``(F) Comment.--The Secretary shall provide for a comment
period of not less than 60 days.
``(2) Promulgation.--
``(A) In general.--After the expiration of the period for
comment on a notice of proposed rulemaking published under
paragraph (1) respecting a tobacco product standard and after
consideration of such comments and any report from the
Tobacco Products Scientific Advisory Committee, the Secretary
shall--
``(i) promulgate a regulation establishing a tobacco
product standard and publish in the Federal Register findings
on the matters referred to in paragraph (1); or
``(ii) publish a notice terminating the proceeding for the
development of the standard together with the reasons for
such termination.
``(B) Effective date.--A regulation establishing a tobacco
product standard shall set forth the date or dates upon which
the standard shall take effect, but no such regulation may
take effect before 1 year after the date of its publication
unless the Secretary determines that an earlier effective
date is necessary for the protection of the public health.
Such date or dates shall be established so as to minimize,
consistent with the
[[Page S11075]]
public health, economic loss to, and disruption or
dislocation of, domestic and international trade.
``(3) Power reserved to congress.--Because of the
importance of a decision of the Secretary to issue a
regulation establishing a tobacco product standard--
``(A) banning all cigarettes, all smokeless tobacco
products, all little cigars, all cigars other than little
cigars, all pipe tobacco, or all roll your own tobacco
products; or
``(B) requiring the reduction of nicotine yields of a
tobacco product to zero,
Congress expressly reserves to itself such power.
``(4) Amendment; revocation.--
``(A) Authority.--The Secretary, upon the Secretary's own
initiative or upon petition of an interested person may by a
regulation, promulgated in accordance with the requirements
of paragraphs (1) and (2)(B), amend or revoke a tobacco
product standard.
``(B) Effective date.--The Secretary may declare a proposed
amendment of a tobacco product standard to be effective on
and after its publication in the Federal Register and until
the effective date of any final action taken on such
amendment if the Secretary determines that making it so
effective is in the public interest.
``(5) Reference to advisory committee.--The Secretary may--
``(A) on the Secretary's own initiative, refer a proposed
regulation for the establishment, amendment, or revocation of
a tobacco product standard; or
``(B) upon the request of an interested person which
demonstrates good cause for referral and which is made before
the expiration of the period for submission of comments on
such proposed regulation,
refer such proposed regulation to the Tobacco Products
Scientific Advisory Committee, for a report and
recommendation with respect to any matter involved in the
proposed regulation which requires the exercise of scientific
judgment. If a proposed regulation is referred under this
paragraph to the Tobacco Products Scientific Advisory
Committee, the Secretary shall provide the advisory committee
with the data and information on which such proposed
regulation is based. The Tobacco Products Scientific Advisory
Committee shall, within 60 days after the referral of a
proposed regulation and after independent study of the data
and information furnished to it by the Secretary and other
data and information before it, submit to the Secretary a
report and recommendation respecting such regulation,
together with all underlying data and information and a
statement of the reason or basis for the recommendation. A
copy of such report and recommendation shall be made public
by the Secretary.
``SEC. 908. NOTIFICATION AND OTHER REMEDIES.
``(a) Notification.--If the Secretary determines that--
``(1) a tobacco product which is introduced or delivered
for introduction into interstate commerce for commercial
distribution presents an unreasonable risk of substantial
harm to the public health; and
``(2) notification under this subsection is necessary to
eliminate the unreasonable risk of such harm and no more
practicable means is available under the provisions of this
chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to
assure that adequate notification is provided in an
appropriate form, by the persons and means best suited under
the circumstances involved, to all persons who should
properly receive such notification in order to eliminate such
risk. The Secretary may order notification by any appropriate
means, including public service announcements. Before issuing
an order under this subsection, the Secretary shall consult
with the persons who are to give notice under the order.
``(b) No Exemption From Other Liability.--Compliance with
an order issued under this section shall not relieve any
person from liability under Federal or State law. In awarding
damages for economic loss in an action brought for the
enforcement of any such liability, the value to the plaintiff
in such action of any remedy provided under such order shall
be taken into account.
``(c) Recall Authority.--
``(1) In general.--If the Secretary finds that there is a
reasonable probability that a tobacco product contains a
manufacturing or other defect not ordinarily contained in
tobacco products on the market that would cause serious,
adverse health consequences or death, the Secretary shall
issue an order requiring the appropriate person (including
the manufacturers, importers, distributors, or retailers of
the tobacco product) to immediately cease distribution of
such tobacco product. The order shall provide the person
subject to the order with an opportunity for an informal
hearing, to be held not later than 10 days after the date of
the issuance of the order, on the actions required by the
order and on whether the order should be amended to require a
recall of such tobacco product. If, after providing an
opportunity for such a hearing, the Secretary determines that
inadequate grounds exist to support the actions required by
the order, the Secretary shall vacate the order.
``(2) Amendment of order to require recall.--
``(A) In general.--If, after providing an opportunity for
an informal hearing under paragraph (1), the Secretary
determines that the order should be amended to include a
recall of the tobacco product with respect to which the order
was issued, the Secretary shall, except as provided in
subparagraph (B), amend the order to require a recall. The
Secretary shall specify a timetable in which the tobacco
product recall will occur and shall require periodic reports
to the Secretary describing the progress of the recall.
``(B) Notice.--An amended order under subparagraph (A)--
``(i) shall not include recall of a tobacco product from
individuals; and
``(ii) shall provide for notice to persons subject to the
risks associated with the use of such tobacco product.
In providing the notice required by clause (ii), the
Secretary may use the assistance of retailers and other
persons who distributed such tobacco product. If a
significant number of such persons cannot be identified, the
Secretary shall notify such persons under section 705(b).
``(3) Remedy not exclusive.--The remedy provided by this
subsection shall be in addition to remedies provided by
subsection (a) of this section.
``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.
``(a) In General.--Every person who is a tobacco product
manufacturer or importer of a tobacco product shall establish
and maintain such records, make such reports, and provide
such information, as the Secretary may by regulation
reasonably require to assure that such tobacco product is not
adulterated or misbranded and to otherwise protect public
health. Regulations prescribed under the preceding sentence--
``(1) may require a tobacco product manufacturer or
importer to report to the Secretary whenever the manufacturer
or importer receives or otherwise becomes aware of
information that reasonably suggests that one of its marketed
tobacco products may have caused or contributed to a serious
unexpected adverse experience associated with the use of the
product or any significant increase in the frequency of a
serious, expected adverse product experience;
``(2) shall require reporting of other significant adverse
tobacco product experiences as determined by the Secretary to
be necessary to be reported;
``(3) shall not impose requirements unduly burdensome to a
tobacco product manufacturer or importer, taking into account
the cost of complying with such requirements and the need for
the protection of the public health and the implementation of
this chapter;
``(4) when prescribing the procedure for making requests
for reports or information, shall require that each request
made under such regulations for submission of a report or
information to the Secretary state the reason or purpose for
such request and identify to the fullest extent practicable
such report or information;
``(5) when requiring submission of a report or information
to the Secretary, shall state the reason or purpose for the
submission of such report or information and identify to the
fullest extent practicable such report or information; and
``(6) may not require that the identity of any patient or
user be disclosed in records, reports, or information
required under this subsection unless required for the
medical welfare of an individual, to determine risks to
public health of a tobacco product, or to verify a record,
report, or information submitted under this chapter.
In prescribing regulations under this subsection, the
Secretary shall have due regard for the professional ethics
of the medical profession and the interests of patients. The
prohibitions of paragraph (6) continue to apply to records,
reports, and information concerning any individual who has
been a patient, irrespective of whether or when he ceases to
be a patient.
``(b) Reports of Removals and Corrections.--
``(1) In general.--Except as provided in paragraph (2), the
Secretary shall by regulation require a tobacco product
manufacturer or importer of a tobacco product to report
promptly to the Secretary any corrective action taken or
removal from the market of a tobacco product undertaken by
such manufacturer or importer if the removal or correction
was undertaken--
``(A) to reduce a risk to health posed by the tobacco
product; or
``(B) to remedy a violation of this chapter caused by the
tobacco product which may present a risk to health.
A tobacco product manufacturer or importer of a tobacco
product who undertakes a corrective action or removal from
the market of a tobacco product which is not required to be
reported under this subsection shall keep a record of such
correction or removal.
``(2) Exception.--No report of the corrective action or
removal of a tobacco product may be required under paragraph
(1) if a report of the corrective action or removal is
required and has been submitted under subsection (a).
``SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TOBACCO
PRODUCTS.
``(a) In General.--
``(1) New tobacco product defined.--For purposes of this
section the term `new tobacco product' means--
``(A) any tobacco product (including those products in test
markets) that was not commercially marketed in the United
States as of June 1, 2003; or
``(B) any modification (including a change in design, any
component, any part, or any
[[Page S11076]]
constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or any other additive
or ingredient) of a tobacco product where the modified
product was commercially marketed in the United States after
June 1, 2003.
``(2) Premarket approval required.--
``(A) New products.--Approval under this section of an
application for premarket approval for any new tobacco
product is required unless--
``(i) the manufacturer has submitted a report under section
905(j); and
``(ii) the Secretary has issued an order that the tobacco
product--
``(I) is substantially equivalent to a tobacco product
commercially marketed (other than for test marketing) in the
United States as of June 1, 2003; and
``(II)(aa) is in compliance with the requirements of this
Act; or
``(bb) is exempt from the requirements of section 905(j)
pursuant to a regulation issued under section 905(j)(3).
``(B) Application to certain post june 1, 2003 products.--
Subparagraph (A) shall not apply to a tobacco product--
``(i) that was first introduced or delivered for
introduction into interstate commerce for commercial
distribution in the United States after June 1, 2003, and
prior to the date that is 15 months after the date of
enactment of the Family Smoking Prevention and Tobacco
Control Act; and
``(ii) for which a report was submitted under section
905(j) within such 15-month period, until the Secretary
issues an order that the tobacco product is not substantially
equivalent.
``(3) Substantially equivalent defined.--
``(A) In general.--In this section and section 905(j), the
terms `substantially equivalent' or `substantial equivalence'
mean, with respect to the tobacco product being compared to
the predicate tobacco product, that the Secretary by order
has found that the tobacco product--
``(i) has the same characteristics as the predicate tobacco
product; or
``(ii) has different characteristics and the information
submitted contains information, including clinical data if
deemed necessary by the Secretary, that demonstrates that it
is not appropriate to regulate the product under this section
because the product does not raise different questions of
public health.
``(B) Characteristics.--In subparagraph (A), the term
`characteristics' means the materials, ingredients, design,
composition, heating source, or other features of a tobacco
product.
``(C) Limitation.--A tobacco product may not be found to be
substantially equivalent to a predicate tobacco product that
has been removed from the market at the initiative of the
Secretary or that has been determined by a judicial order to
be misbranded or adulterated.
``(4) Health information.--
``(A) Summary.--As part of a submission under section
905(j) respecting a tobacco product, the person required to
file a premarket notification under such section shall
provide an adequate summary of any health information related
to the tobacco product or state that such information will be
made available upon request by any person.
``(B) Required information.--Any summary under subparagraph
(A) respecting a tobacco product shall contain detailed
information regarding data concerning adverse health effects
and shall be made available to the public by the Secretary
within 30 days of the issuance of a determination that such
tobacco product is substantially equivalent to another
tobacco product.
``(b) Application.--
``(1) Contents.--An application for premarket approval
shall contain--
``(A) full reports of all information, published or known
to, or which should reasonably be known to, the applicant,
concerning investigations which have been made to show the
health risks of such tobacco product and whether such tobacco
product presents less risk than other tobacco products;
``(B) a full statement of the components, ingredients,
additives, and properties, and of the principle or principles
of operation, of such tobacco product;
``(C) a full description of the methods used in, and the
facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of,
such tobacco product;
``(D) an identifying reference to any tobacco product
standard under section 907 which would be applicable to any
aspect of such tobacco product, and either adequate
information to show that such aspect of such tobacco product
fully meets such tobacco product standard or adequate
information to justify any deviation from such standard;
``(E) such samples of such tobacco product and of
components thereof as the Secretary may reasonably require;
``(F) specimens of the labeling proposed to be used for
such tobacco product; and
``(G) such other information relevant to the subject matter
of the application as the Secretary may require.
``(2) Reference to tobacco products scientific advisory
committee.--Upon receipt of an application meeting the
requirements set forth in paragraph (1), the Secretary--
``(A) may, on the Secretary's own initiative; or
``(B) may, upon the request of an applicant,
refer such application to the Tobacco Products Scientific
Advisory Committee for reference and for submission (within
such period as the Secretary may establish) of a report and
recommendation respecting approval of the application,
together with all underlying data and the reasons or basis
for the recommendation.
``(c) Action on Application.--
``(1) Deadline.--
``(A) In general.--As promptly as possible, but in no event
later than 180 days after the receipt of an application under
subsection (b), the Secretary, after considering the report
and recommendation submitted under paragraph (2) of such
subsection, shall--
``(i) issue an order approving the application if the
Secretary finds that none of the grounds for denying approval
specified in paragraph (2) of this subsection applies; or
``(ii) deny approval of the application if the Secretary
finds (and sets forth the basis for such finding as part of
or accompanying such denial) that 1 or more grounds for
denial specified in paragraph (2) of this subsection apply.
``(B) Restrictions on sale and distribution.--An order
approving an application for a tobacco product may require as
a condition to such approval that the sale and distribution
of the tobacco product be restricted but only to the extent
that the sale and distribution of a tobacco product may be
restricted under a regulation under section 906(d).
``(2) Denial of approval.--The Secretary shall deny
approval of an application for a tobacco product if, upon the
basis of the information submitted to the Secretary as part
of the application and any other information before the
Secretary with respect to such tobacco product, the Secretary
finds that--
``(A) there is a lack of a showing that permitting such
tobacco product to be marketed would be appropriate for the
protection of the public health;
``(B) the methods used in, or the facilities or controls
used for, the manufacture, processing, or packing of such
tobacco product do not conform to the requirements of section
906(e);
``(C) based on a fair evaluation of all material facts, the
proposed labeling is false or misleading in any particular;
or
``(D) such tobacco product is not shown to conform in all
respects to a tobacco product standard in effect under
section 907, compliance with which is a condition to approval
of the application, and there is a lack of adequate
information to justify the deviation from such standard.
``(3) Denial information.--Any denial of an application
shall, insofar as the Secretary determines to be practicable,
be accompanied by a statement informing the applicant of the
measures required to place such application in approvable
form (which measures may include further research by the
applicant in accordance with 1 or more protocols prescribed
by the Secretary).
``(4) Basis for finding.--For purposes of this section, the
finding as to whether approval of a tobacco product is
appropriate for the protection of the public health shall be
determined with respect to the risks and benefits to the
population as a whole, including users and nonusers of the
tobacco product, and taking into account--
``(A) the increased or decreased likelihood that existing
users of tobacco products will stop using such products; and
``(B) the increased or decreased likelihood that those who
do not use tobacco products will start using such products.
``(5) Basis for action.--
``(A) Investigations.--For purposes of paragraph (2)(A),
whether permitting a tobacco product to be marketed would be
appropriate for the protection of the public health shall,
when appropriate, be determined on the basis of well-
controlled investigations, which may include 1 or more
clinical investigations by experts qualified by training and
experience to evaluate the tobacco product.
``(B) Other evidence.--If the Secretary determines that
there exists valid scientific evidence (other than evidence
derived from investigations described in subparagraph (A))
which is sufficient to evaluate the tobacco product the
Secretary may authorize that the determination for purposes
of paragraph (2)(A) be made on the basis of such evidence.
``(d) Withdrawal and Temporary Suspension.--
``(1) In general.--The Secretary shall, upon obtaining,
where appropriate, advice on scientific matters from an
advisory committee, and after due notice and opportunity for
informal hearing to the holder of an approved application for
a tobacco product, issue an order withdrawing approval of the
application if the Secretary finds--
``(A) that the continued marketing of such tobacco product
no longer is appropriate for the protection of the public
health;
``(B) that the application contained or was accompanied by
an untrue statement of a material fact;
``(C) that the applicant--
``(i) has failed to establish a system for maintaining
records, or has repeatedly or deliberately failed to maintain
records or to make reports, required by an applicable
regulation under section 909;
``(ii) has refused to permit access to, or copying or
verification of, such records as required by section 704; or
``(iii) has not complied with the requirements of section
905;
``(D) on the basis of new information before the Secretary
with respect to such tobacco
[[Page S11077]]
product, evaluated together with the evidence before the
Secretary when the application was approved, that the methods
used in, or the facilities and controls used for, the
manufacture, processing, packing, or installation of such
tobacco product do not conform with the requirements of
section 906(e) and were not brought into conformity with such
requirements within a reasonable time after receipt of
written notice from the Secretary of nonconformity;
``(E) on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary
when the application was approved, that the labeling of such
tobacco product, based on a fair evaluation of all material
facts, is false or misleading in any particular and was not
corrected within a reasonable time after receipt of written
notice from the Secretary of such fact; or
``(F) on the basis of new information before the Secretary,
evaluated together with the evidence before the Secretary
when the application was approved, that such tobacco product
is not shown to conform in all respects to a tobacco product
standard which is in effect under section 907, compliance
with which was a condition to approval of the application,
and that there is a lack of adequate information to justify
the deviation from such standard.
``(2) Appeal.--The holder of an application subject to an
order issued under paragraph (1) withdrawing approval of the
application may, by petition filed on or before the 30th day
after the date upon which such holder receives notice of such
withdrawal, obtain review thereof in accordance with
subsection (e).
``(3) Temporary suspension.--If, after providing an
opportunity for an informal hearing, the Secretary determines
there is reasonable probability that the continuation of
distribution of a tobacco product under an approved
application would cause serious, adverse health consequences
or death, that is greater than ordinarily caused by tobacco
products on the market, the Secretary shall by order
temporarily suspend the approval of the application approved
under this section. If the Secretary issues such an order,
the Secretary shall proceed expeditiously under paragraph (1)
to withdraw such application.
``(e) Service of Order.--An order issued by the Secretary
under this section shall be served--
``(1) in person by any officer or employee of the
department designated by the Secretary; or
``(2) by mailing the order by registered mail or certified
mail addressed to the applicant at the applicant's last known
address in the records of the Secretary.
``(f) Records.--
``(1) Additional information.--In the case of any tobacco
product for which an approval of an application filed under
subsection (b) is in effect, the applicant shall establish
and maintain such records, and make such reports to the
Secretary, as the Secretary may by regulation, or by order
with respect to such application, prescribe on the basis of a
finding that such records and reports are necessary in order
to enable the Secretary to determine, or facilitate a
determination of, whether there is or may be grounds for
withdrawing or temporarily suspending such approval.
``(2) Access to records.--Each person required under this
section to maintain records, and each person in charge or
custody thereof, shall, upon request of an officer or
employee designated by the Secretary, permit such officer or
employee at all reasonable times to have access to and copy
and verify such records.
``(g) Investigational Tobacco Product Exemption for
Investigational Use.--The Secretary may exempt tobacco
products intended for investigational use from the provisions
of this chapter under such conditions as the Secretary may by
regulation prescribe.
``SEC. 911. MODIFIED RISK TOBACCO PRODUCTS.
``(a) In General.--No person may introduce or deliver for
introduction into interstate commerce any modified risk
tobacco product unless approval of an application filed
pursuant to subsection (d) is effective with respect to such
product.
``(b) Definitions.--In this section:
``(1) Modified risk tobacco product.--The term `modified
risk tobacco product' means any tobacco product that is sold
or distributed for use to reduce harm or the risk of tobacco-
related disease associated with commercially marketed tobacco
products.
``(2) Sold or distributed.--
``(A) In general.--With respect to a tobacco product, the
term `sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products' means a tobacco product--
``(A) the label, labeling, or advertising of which
represents explicitly or implicitly that--
``(I) the tobacco product presents a lower risk of tobacco-
related disease or is less harmful than one or more other
commercially marketed tobacco products;
``(II) the tobacco product or its smoke contains a reduced
level of a substance or presents a reduced exposure to a
substance; or
``(III) the tobacco product or its smoke does not contain
or is free of a substance;
``(ii) the label, labeling, or advertising of which uses
the descriptors `light', `mild', or `low' or similar
descriptors; or
``(iii) the tobacco product manufacturer of which has taken
any action directed to consumers through the media or
otherwise, other than by means of the tobacco product's
label, labeling or advertising, after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act,
respecting the product that would be reasonably expected to
result in consumers believing that the tobacco product or its
smoke may present a lower risk of disease or is less harmful
than one or more commercially marketed tobacco products, or
presents a reduced exposure to, or does not contain or is
free of, a substance or substances.
``(B) Limitation.--No tobacco product shall be considered
to be `sold or distributed for use to reduce harm or the risk
of tobacco-related disease associated with commercially
marketed tobacco products', except as described in
subparagraph (A).
``(c) Tobacco Dependence Products.--A product that is
intended to be used for the treatment of tobacco dependence,
including smoking cessation, is not a modified risk tobacco
product under this section and is subject to the requirements
of chapter V.
``(d) Filing.--Any person may file with the Secretary an
application for a modified risk tobacco product. Such
application shall include--
``(1) a description of the proposed product and any
proposed advertising and labeling;
``(2) the conditions for using the product;
``(3) the formulation of the product;
``(4) sample product labels and labeling;
``(5) all documents (including underlying scientific
information) relating to research findings conducted,
supported, or possessed by the tobacco product manufacturer
relating to the effect of the product on tobacco related
diseases and health-related conditions, including information
both favorable and unfavorable to the ability of the product
to reduce risk or exposure and relating to human health;
``(6) data and information on how consumers actually use
the tobacco product; and
``(7) such other information as the Secretary may require.
``(e) Public Availability.--The Secretary shall make the
application described in subsection (d) publicly available
(except matters in the application which are trade secrets or
otherwise confidential, commercial information) and shall
request comments by interested persons on the information
contained in the application and on the label, labeling, and
advertising accompanying such application.
``(f) Advisory Committee.--
``(1) In general.--The Secretary shall refer to an advisory
committee any application submitted under this subsection.
``(2) Recommendations.--Not later than 60 days after the
date an application is referred to an advisory committee
under paragraph (1), the advisory committee shall report its
recommendations on the application to the Secretary.
``(g) Approval.--
``(1) Modified risk products.--Except as provided in
paragraph (2), the Secretary shall approve an application for
a modified risk tobacco product filed under this section only
if the Secretary determines that the applicant has
demonstrated that such product, as it is actually used by
consumers, will--
``(A) significantly reduce harm and the risk of tobacco-
related disease to individual tobacco users; and
``(B) benefit the health of the population as a whole
taking into account both users of tobacco products and
persons who do not currently use tobacco products.
``(2) Special rule for certain products.--
``(A) In general.--The Secretary may approve an application
for a tobacco product that has not been approved as a
modified risk tobacco product pursuant to paragraph (1) if
the Secretary makes the findings required under this
paragraph and determines that the applicant has demonstrated
that--
``(i) the approval of the application would be appropriate
to promote the public health;
``(ii) any aspect of the label, labeling, and advertising
for such product that would cause the tobacco product to be a
modified risk tobacco product under subsection (b)(2) is
limited to an explicit or implicit representation that such
tobacco product or its smoke contains or is free of a
substance or contains a reduced level of a substance, or
presents a reduced exposure to a substance in tobacco smoke.
``(iii) scientific evidence is not available and, using the
best available scientific methods, cannot be made available
without conducting long-term epidemiological studies for an
application to meet the standards set forth in paragraph (1);
and
``(iv) the scientific evidence that is available without
conducting long-term epidemiological studies demonstrates
that a measurable and substantial reduction in morbidity or
mortality among individual tobacco users is anticipated in
subsequent studies.
``(B) Additional findings required.--In order to approve an
application under subparagraph (A) the Secretary must also
find that the applicant has demonstrated that--
``(i) the magnitude of the overall reductions in exposure
to the substance or substances which are the subject of the
application is substantial, such substance or substances are
harmful, and the product as actually used exposes consumers
to the specified reduced level of the substance or
substances;
``(ii) the product as actually used by consumers will not
expose them to higher levels of other harmful substances
compared to the
[[Page S11078]]
similar types of tobacco products then on the market unless
such increases are minimal and the anticipated overall impact
of use of the product remains a substantial and measurable
reduction in overall morbidity and mortality among individual
tobacco users;
``(iii) testing of actual consumer perception shows that,
as the applicant proposes to label and market the product,
consumers will not be misled into believing that the
product--
``(I) is or has been demonstrated to be less harmful; or
``(II) presents or has been demonstrated to present less of
a risk of disease than 1 or more other commercially marketed
tobacco products; and
``(iv) approval of the application is expected to benefit
the health of the population as a whole taking into account
both users of tobacco products and persons who do not
currently use tobacco products.
``(C) Conditions of approval.--
``(i) In general.--Applications approved under this
paragraph shall be limited to a term of not more than 5
years, but may be renewed upon a finding by the Secretary
that the requirements of this paragraph continue to be
satisfied based on the filing of a new application.
``(ii) Agreements by applicant.--Applications approved
under this paragraph shall be conditioned on the applicant's
agreement to conduct post-market surveillance and studies and
to submit to the Secretary the results of such surveillance
and studies to determine the impact of the application
approval on consumer perception, behavior, and health and to
enable the Secretary to review the accuracy of the
determinations upon which the approval was based in
accordance with a protocol approved by the Secretary.
``(iii) Annual submission.--The results of such post-market
surveillance and studies described in clause (ii) shall be
submitted annually.
``(3) Basis.--The determinations under paragraphs (1) and
(2) shall be based on--
``(A) the scientific evidence submitted by the applicant;
and
``(B) scientific evidence and other information that is
available to the Secretary.
``(4) Benefit to health of individuals and of population as
a whole.--In making the determinations under paragraphs (1)
and (2), the Secretary shall take into account--
``(A) the relative health risks to individuals of the
tobacco product that is the subject of the application;
``(B) the increased or decreased likelihood that existing
users of tobacco products who would otherwise stop using such
products will switch to the tobacco product that is the
subject of the application;
``(C) the increased or decreased likelihood that persons
who do not use tobacco products will start using the tobacco
product that is the subject of the application;
``(D) the risks and benefits to persons from the use of the
tobacco product that is the subject of the application as
compared to the use of products for smoking cessation
approved under chapter V to treat nicotine dependence; and
``(E) comments, data, and information submitted by
interested persons.
``(h) Additional Conditions for Approval.--
``(1) Modified risk products.--The Secretary shall require
for the approval of an application under this section that
any advertising or labeling concerning modified risk products
enable the public to comprehend the information concerning
modified risk and to understand the relative significance of
such information in the context of total health and in
relation to all of the diseases and health-related conditions
associated with the use of tobacco products.
``(2) Comparative claims.--
``(A) In general.--The Secretary may require for the
approval of an application under this subsection that a claim
comparing a tobacco product to 1 or more other commercially
marketed tobacco products shall compare the tobacco product
to a commercially marketed tobacco product that is
representative of that type of tobacco product on the market
(for example the average value of the top 3 brands of an
established regular tobacco product).
``(B) Quantitative comparisons.--The Secretary may also
require, for purposes of subparagraph (A), that the percent
(or fraction) of change and identity of the reference tobacco
product and a quantitative comparison of the amount of the
substance claimed to be reduced shall be stated in immediate
proximity to the most prominent claim.
``(3) Label disclosure.--
``(A) In general.--The Secretary may require the disclosure
on the label of other substances in the tobacco product, or
substances that may be produced by the consumption of that
tobacco product, that may affect a disease or health-related
condition or may increase the risk of other diseases or
health-related conditions associated with the use of tobacco
products.
``(B) Conditions of use.--If the conditions of use of the
tobacco product may affect the risk of the product to human
health, the Secretary may require the labeling of conditions
of use.
``(4) Time.--The Secretary shall limit an approval under
subsection (g)(1) for a specified period of time.
``(5) Advertising.--The Secretary may require that an
applicant, whose application has been approved under this
subsection, comply with requirements relating to advertising
and promotion of the tobacco product.
``(i) Postmarket Surveillance and Studies.--
``(1) In general.--The Secretary shall require that an
applicant under subsection (g)(1) conduct post market
surveillance and studies for a tobacco product for which an
application has been approved to determine the impact of the
application approval on consumer perception, behavior, and
health, to enable the Secretary to review the accuracy of the
determinations upon which the approval was based, and to
provide information that the Secretary determines is
otherwise necessary regarding the use or health risks
involving the tobacco product. The results of post-market
surveillance and studies shall be submitted to the Secretary
on an annual basis.
``(2) Surveillance protocol.--Each applicant required to
conduct a surveillance of a tobacco product under paragraph
(1) shall, within 30 days after receiving notice that the
applicant is required to conduct such surveillance, submit,
for the approval of the Secretary, a protocol for the
required surveillance. The Secretary, within 60 days of the
receipt of such protocol, shall determine if the principal
investigator proposed to be used in the surveillance has
sufficient qualifications and experience to conduct such
surveillance and if such protocol will result in collection
of the data or other information designated by the Secretary
as necessary to protect the public health.
``(j) Withdrawal of Approval.--The Secretary, after an
opportunity for an informal hearing, shall withdraw the
approval of an application under this section if the
Secretary determines that--
``(1) the applicant, based on new information, can no
longer make the demonstrations required under subsection (g),
or the Secretary can no longer make the determinations
required under subsection (g);
``(2) the application failed to include material
information or included any untrue statement of material
fact;
``(3) any explicit or implicit representation that the
product reduces risk or exposure is no longer valid,
including if--
``(A) a tobacco product standard is established pursuant to
section 907;
``(B) an action is taken that affects the risks presented
by other commercially marketed tobacco products that were
compared to the product that is the subject of the
application; or
``(C) any postmarket surveillance or studies reveal that
the approval of the application is no longer consistent with
the protection of the public health;
``(4) the applicant failed to conduct or submit the
postmarket surveillance and studies required under subsection
(g)(2)(C)(ii) or (i); or
``(5) the applicant failed to meet a condition imposed
under subsection (h).
``(k) Chapter IV or V.--A product approved in accordance
with this section shall not be subject to chapter IV or V.
``(l) Implementing Regulations or Guidance.--
``(1) Scientific evidence.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue regulations or
guidance (or any combination thereof) on the scientific
evidence required for assessment and ongoing review of
modified risk tobacco products. Such regulations or guidance
shall--
``(A) establish minimum standards for scientific studies
needed prior to approval to show that a substantial reduction
in morbidity or mortality among individual tobacco users is
likely;
``(B) include validated biomarkers, intermediate clinical
endpoints, and other feasible outcome measures, as
appropriate;
``(C) establish minimum standards for post market studies,
that shall include regular and long-term assessments of
health outcomes and mortality, intermediate clinical
endpoints, consumer perception of harm reduction, and the
impact on quitting behavior and new use of tobacco products,
as appropriate;
``(D) establish minimum standards for required postmarket
surveillance, including ongoing assessments of consumer
perception; and
``(E) require that data from the required studies and
surveillance be made available to the Secretary prior to the
decision on renewal of a modified risk tobacco product.
``(2) Consultation.--The regulations or guidance issued
under paragraph (1) shall be developed in consultation with
the Institute of Medicine, and with the input of other
appropriate scientific and medical experts, on the design and
conduct of such studies and surveillance.
``(3) Revision.--The regulations or guidance under
paragraph (1) shall be revised on a regular basis as new
scientific information becomes available.
``(4) New tobacco products.--Not later than 2 years after
the date of enactment of the Family Smoking Prevention and
Tobacco Control Act, the Secretary shall issue a regulation
or guidance that permits the filing of a single application
for any tobacco product that is a new tobacco product under
section 910 and for which the applicant seeks approval as a
modified risk tobacco product under this section.
``(m) Distributors.--No distributor may take any action,
after the date of enactment of the Family Smoking Prevention
and Tobacco Control Act, with respect to a tobacco
[[Page S11079]]
product that would reasonably be expected to result in
consumers believing that the tobacco product or its smoke may
present a lower risk of disease or is less harmful than one
or more commercially marketed tobacco products, or presents a
reduced exposure to, or does not contain or is free of, a
substance or substances.
``SEC. 912. JUDICIAL REVIEW.
``(a) Right To Review.--
``(1) In general.--Not later than 30 days after--
``(A) the promulgation of a regulation under section 907
establishing, amending, or revoking a tobacco product
standard; or
``(B) a denial of an application for approval under section
910(c),
any person adversely affected by such regulation or denial
may file a petition for judicial review of such regulation or
denial with the United States Court of Appeals for the
District of Columbia or for the circuit in which such person
resides or has their principal place of business.
``(2) Requirements.--
``(A) Copy of petition.--A copy of the petition filed under
paragraph (1) shall be transmitted by the clerk of the court
involved to the Secretary.
``(B) Record of proceedings.--On receipt of a petition
under subparagraph (A), the Secretary shall file in the court
in which such petition was filed--
``(i) the record of the proceedings on which the regulation
or order was based; and
``(ii) a statement of the reasons for the issuance of such
a regulation or order.
``(C) Definition of record.--In this section, the term
`record' means--
``(i) all notices and other matter published in the Federal
Register with respect to the regulation or order reviewed;
``(ii) all information submitted to the Secretary with
respect to such regulation or order;
``(iii) proceedings of any panel or advisory committee with
respect to such regulation or order;
``(iv) any hearing held with respect to such regulation or
order; and
``(v) any other information identified by the Secretary, in
the administrative proceeding held with respect to such
regulation or order, as being relevant to such regulation or
order.
``(b) Standard of Review.--Upon the filing of the petition
under subsection (a) for judicial review of a regulation or
order, the court shall have jurisdiction to review the
regulation or order in accordance with chapter 7 of title 5,
United States Code, and to grant appropriate relief,
including interim relief, as provided for in such chapter. A
regulation or denial described in subsection (a) shall be
reviewed in accordance with section 706(2)(A) of title 5,
United States Code.
``(c) Finality of Judgment.--The judgment of the court
affirming or setting aside, in whole or in part, any
regulation or order shall be final, subject to review by the
Supreme Court of the United States upon certiorari or
certification, as provided in section 1254 of title 28,
United States Code.
``(d) Other Remedies.--The remedies provided for in this
section shall be in addition to, and not in lieu of, any
other remedies provided by law.
``(e) Regulations and Orders Must Recite Basis in Record.--
To facilitate judicial review, a regulation or order issued
under section 906, 907, 908, 909, 910, or 916 shall contain a
statement of the reasons for the issuance of such regulation
or order in the record of the proceedings held in connection
with its issuance.
``SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS.
``The Secretary shall issue regulations to require that
retail establishments for which the predominant business is
the sale of tobacco products comply with any advertising
restrictions applicable to retail establishments accessible
to individuals under the age of 18.
``SEC. 914. JURISDICTION OF AND COORDINATION WITH THE FEDERAL
TRADE COMMISSION.
``(a) Jurisdiction.--
``(1) In general.--Except where expressly provided in this
chapter, nothing in this chapter shall be construed as
limiting or diminishing the authority of the Federal Trade
Commission to enforce the laws under its jurisdiction with
respect to the advertising, sale, or distribution of tobacco
products.
``(2) Enforcement.--Any advertising that violates this
chapter or a provision of the regulations referred to in
section 102 of the Family Smoking Prevention and Tobacco
Control Act, is an unfair or deceptive act or practice under
section 5(a) of the Federal Trade Commission Act (15 U.S.C.
45(a)) and shall be considered a violation of a rule
promulgated under section 18 of that Act (15 U.S.C. 57a).
``(b) Coordination.--With respect to the requirements of
section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333) and section 3 of the Comprehensive
Smokeless Tobacco Health Education Act of 1986 (15 U.S.C.
4402)--
``(1) the Chairman of the Federal Trade Commission shall
coordinate with the Secretary concerning the enforcement of
such Act as such enforcement relates to unfair or deceptive
acts or practices in the advertising of cigarettes or
smokeless tobacco; and
``(2) the Secretary shall consult with the Chairman of such
Commission in revising the label statements and requirements
under such sections.
``SEC. 915. CONGRESSIONAL REVIEW PROVISIONS.
``In accordance with section 801 of title 5, United States
Code, Congress shall review, and may disapprove, any rule
under this chapter that is subject to section 801. This
section and section 801 do not apply to the regulations
referred to in section 102 of the Family Smoking Prevention
and Tobacco Control Act.
``SEC. 916. REGULATION REQUIREMENT.
``(a) Testing, Reporting, and Disclosure.--Not later than
24 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, the Secretary, acting
through the Commissioner of the Food and Drug Administration,
shall promulgate regulations under this Act that meet the
requirements of subsection (b).
``(b) Contents of Rules.--The regulations promulgated under
subsection (a) shall require testing and reporting of tobacco
product constituents, ingredients, and additives, including
smoke constituents, by brand and sub-brand that the Secretary
determines should be tested to protect the public health. The
regulations may require that tobacco product manufacturers,
packagers, or importers make disclosures relating to the
results of the testing of tar and nicotine through labels or
advertising or other appropriate means, and make disclosures
regarding the results of the testing of other constituents,
including smoke constituents, ingredients, or additives, that
the Secretary determines should be disclosed to the public to
protect the public health and will not mislead consumers
about the risk of tobacco related disease.
``(c) Authority.--The Food and Drug Administration shall
have the authority under this chapter to conduct or to
require the testing, reporting, or disclosure of tobacco
product constituents, including smoke constituents.
``SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHORITY.
``(a) In General.--
``(1) Preservation.--Nothing in this chapter, or rules
promulgated under this chapter, shall be construed to limit
the authority of a Federal agency (including the Armed
Forces), a State or political subdivision of a State, or the
government of an Indian tribe to enact, adopt, promulgate,
and enforce any law, rule, regulation, or other measure with
respect to tobacco products that is in addition to, or more
stringent than, requirements established under this chapter,
including a law, rule, regulation, or other measure relating
to or prohibiting the sale, distribution, possession,
exposure to, access to, advertising and promotion of, or use
of tobacco products by individuals of any age, information
reporting to the State, or measures relating to fire safety
standards for tobacco products. No provision of this chapter
shall limit or otherwise affect any State, Tribal, or local
taxation of tobacco products.
``(2) Preemption of certain state and local requirements.--
``(A) In general.--Except as provided in paragraph (1) and
subparagraph (B), no State or political subdivision of a
State may establish or continue in effect with respect to a
tobacco product any requirement which is different from, or
in addition to, any requirement under the provisions of this
chapter relating to tobacco product standards, premarket
approval, adulteration, misbranding, labeling, registration,
good manufacturing standards, or reduced risk products.
``(B) Exception.--Subparagraph (A) does not apply to
requirements relating to the sale, distribution, possession,
information reporting to the State, exposure to, access to,
the advertising and promotion of, or use of, tobacco products
by individuals of any age, or relating to fire safety
standards for tobacco products. Information disclosed to a
State under subparagraph (A) that is exempt from disclosure
under section 554(b)(4) of title 5, United States Code, shall
be treated as trade secret and confidential information by
the State.
``(b) Rule of Construction Regarding Product Liability.--No
provision of this chapter relating to a tobacco product shall
be construed to modify or otherwise affect any action or the
liability of any person under the product liability law of
any State.
``SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.
``(a) Establishment.--Not later than 1 year after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall establish a 11-member
advisory committee, to be known as the `Tobacco Products
Scientific Advisory Committee'.
``(b) Membership.--
``(1) In general.--
``(A) Members.--The Secretary shall appoint as members of
the Tobacco Products Scientific Advisory Committee
individuals who are technically qualified by training and
experience in the medicine, medical ethics, science, or
technology involving the manufacture, evaluation, or use of
tobacco products, who are of appropriately diversified
professional backgrounds. The committee shall be composed
of--
``(i) 7 individuals who are physicians, dentists,
scientists, or health care professionals practicing in the
area of oncology, pulmonology, cardiology, toxicology,
pharmacology, addiction, or any other relevant specialty;
[[Page S11080]]
``(ii) 1 individual who is an officer or employee of a
State or local government or of the Federal Government;
``(iii) 1 individual as a representative of the general
public;
``(iv) 1 individual as a representative of the interests in
the tobacco manufacturing industry; and
``(v) 1 individual as a representative of the interests of
the tobacco growers.
``(B) Nonvoting members.--The members of the committee
appointed under clauses (iv) and (v) of subparagraph (A)
shall serve as consultants to those described in clauses (i)
through (iii) of subparagraph (A) and shall be nonvoting
representatives.
``(2) Limitation.--The Secretary may not appoint to the
Advisory Committee any individual who is in the regular full-
time employ of the Food and Drug Administration or any agency
responsible for the enforcement of this Act. The Secretary
may appoint Federal officials as ex officio members.
``(3) Chairperson.--The Secretary shall designate 1 of the
members of the Advisory Committee to serve as chairperson.
``(c) Duties.--The Tobacco Products Scientific Advisory
Committee shall provide advice, information, and
recommendations to the Secretary--
``(1) as provided in this chapter;
``(2) on the effects of the alteration of the nicotine
yields from tobacco products;
``(3) on whether there is a threshold level below which
nicotine yields do not produce dependence on the tobacco
product involved; and
``(4) on its review of other safety, dependence, or health
issues relating to tobacco products as requested by the
Secretary.
``(d) Compensation; Support; FACA.--
``(1) Compensation and travel.--Members of the Advisory
Committee who are not officers or employees of the United
States, while attending conferences or meetings of the
committee or otherwise engaged in its business, shall be
entitled to receive compensation at rates to be fixed by the
Secretary, which may not exceed the daily equivalent of the
rate in effect for level 4 of the Senior Executive Schedule
under section 5382 of title 5, United States Code, for each
day (including travel time) they are so engaged; and while so
serving away from their homes or regular places of business
each member may be allowed travel expenses, including per
diem in lieu of subsistence, as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
``(2) Administrative support.--The Secretary shall furnish
the Advisory Committee clerical and other assistance.
``(3) Nonapplication of faca.--Section 14 of the Federal
Advisory Committee Act (5 U.S.C.
App.) does not apply to the Advisory Committee.
``(e) Proceedings of Advisory Panels and Committees.--The
Advisory Committee shall make and maintain a transcript of
any proceeding of the panel or committee. Each such panel and
committee shall delete from any transcript made under this
subsection information which is exempt from disclosure under
section 552(b) of title 5, United States Code.
``SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.
``The Secretary shall consider--
``(1) at the request of the applicant, designating nicotine
replacement products as fast track research and approval
products within the meaning of section 506;
``(2) direct the Commissioner to consider approving the
extended use of nicotine replacement products (such as
nicotine patches, nicotine gum, and nicotine lozenges) for
the treatment of tobacco dependence;
``(3) review and consider the evidence for additional
indications for nicotine replacement products, such as for
craving relief or relapse prevention; and
``(4) consider--
``(A) relieving companies of premarket burdens under
section 505 if the requirement is redundant considering other
nicotine replacement therapies already on the market; and
``(B) time and extent applications for nicotine replacement
therapies that have been approved by a regulatory body in a
foreign country and have marketing experience in such
country.
``SEC. 920. USER FEE.
``(a) Establishment of Quarterly User Fee.--The Secretary
shall assess a quarterly user fee with respect to every
quarter of each fiscal year commencing fiscal year 2004,
calculated in accordance with this section, upon each
manufacturer and importer of tobacco products subject to this
chapter.
``(b) Funding of FDA Regulation of Tobacco Products.--The
Secretary shall make user fees collected pursuant to this
section available to pay, in each fiscal year, for the costs
of the activities of the Food and Drug Administration related
to the regulation of tobacco products under this chapter.
``(c) Assessment of User Fee.--
``(1) Amount of assessment.--Except as provided in
paragraph (4), the total user fees assessed each year
pursuant to this section shall be sufficient, and shall not
exceed what is necessary, to pay for the costs of the
activities described in subsection (b) for each fiscal year.
``(2) Allocation of assessment by class of tobacco
products.--
``(A) In general.--Subject to paragraph (3), the total user
fees assessed each fiscal year with respect to each class of
importers and manufacturers shall be equal to an amount that
is the applicable percentage of the total costs of activities
of the Food and Drug Administration described in subsection
(b).
``(B) Applicable percentage.--For purposes of subparagraph
(A) the applicable percentage for a fiscal year shall be the
following:
``(i) 92.07 percent shall be assessed on manufacturers and
importers of cigarettes;
``(ii) 0.05 percent shall be assessed on manufacturers and
importers of little cigars;
``(iii) 7.15 percent shall be assessed on manufacturers and
importers of cigars other than little cigars;
``(iv) 0.43 percent shall be assessed on manufacturers and
importers of snuff;
``(v) 0.10 percent shall be assessed on manufacturers and
importers of chewing tobacco;
``(vi) 0.06 percent shall be assessed on manufacturers and
importers of pipe tobacco; and
``(vii) 0.14 percent shall be assessed on manufacturers and
importers of roll-your-own tobacco.
``(3) Distribution of fee shares of manufacturers and
importers exempt from user fee.--Where a class of tobacco
products is not subject to a user fee under this section, the
portion of the user fee assigned to such class under
subsection (d)(2) shall be allocated by the Secretary on a
pro rata basis among the classes of tobacco products that are
subject to a user fee under this section. Such pro rata
allocation for each class of tobacco products that are
subject to a user fee under this section shall be the
quotient of--
``(A) the sum of the percentages assigned to all classes of
tobacco products subject to this section; divided by
``(B) the percentage assigned to such class under paragraph
(2).
``(4) Annual limit on assessment.--The total assessment
under this section--
``(A) for fiscal year 2004 shall be $85,000,000;
``(B) for fiscal year 2005 shall be $175,000,000;
``(C) for fiscal year 2006 shall be $300,000,000; and
``(D) for each subsequent fiscal year, shall not exceed the
limit on the assessment imposed during the previous fiscal
year, as adjusted by the Secretary (after notice, published
in the Federal Register) to reflect the greater of--
``(i) the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items;
United States city average) for the 12-month period ending on
June 30 of the preceding fiscal year for which fees are being
established; or
``(ii) the total percentage change for the previous fiscal
year in basic pay under the General Schedule in accordance
with section 5332 of title 5, United States Code, as adjusted
by any locality-based comparability payment pursuant to
section 5304 of such title for Federal employees stationed in
the District of Columbia.
``(5) Timing of user fee assessment.--The Secretary shall
notify each manufacturer and importer of tobacco products
subject to this section of the amount of the quarterly
assessment imposed on such manufacturer or importer under
subsection (f) during each quarter of each fiscal year. Such
notifications shall occur not earlier than 3 months prior to
the end of the quarter for which such assessment is made, and
payments of all assessments shall be made not later than 60
days after each such notification.
``(d) Determination of User Fee by Company Market Share.--
``(1) In general.--The user fee to be paid by each
manufacturer or importer of a given class of tobacco products
shall be determined in each quarter by multiplying--
``(A) such manufacturer's or importer's market share of
such class of tobacco products; by
``(B) the portion of the user fee amount for the current
quarter to be assessed on manufacturers and importers of such
class of tobacco products as determined under subsection (e).
``(2) No fee in excess of market share.--No manufacturer or
importer of tobacco products shall be required to pay a user
fee in excess of the market share of such manufacturer or
importer.
``(e) Determination of Volume of Domestic Sales.--
``(1) In general.--The calculation of gross domestic volume
of a class of tobacco product by a manufacturer or importer,
and by all manufacturers and importers as a group, shall be
made by the Secretary using information provided by
manufacturers and importers pursuant to subsection (f), as
well as any other relevant information provided to or
obtained by the Secretary.
``(2) Measurement.--For purposes of the calculations under
this subsection and the information provided under subsection
(f) by the Secretary, gross domestic volume shall be measured
by--
``(A) in the case of cigarettes, the number of cigarettes
sold;
``(B) in the case of little cigars, the number of little
cigars sold;
``(C) in the case of large cigars, the number of cigars
weighing more than 3 pounds per thousand sold; and
``(D) in the case of other classes of tobacco products, in
terms of number of pounds, or fraction thereof, of these
products sold.
``(f) Measurement of Gross Domestic Volume.--
``(1) In general.--Each manufacturer and importer of
tobacco products shall submit to the Secretary a certified
copy of each of the
[[Page S11081]]
returns or forms described by this paragraph that are
required to be filed with a Government agency on the same
date that those returns or forms are filed, or required to be
filed, with such agency. The returns and forms described by
this paragraph are those returns and forms related to the
release of tobacco products into domestic commerce, as
defined by section 5702(k) of the Internal Revenue Code of
1986, and the repayment of the taxes imposed under chapter 52
of such Code (ATF Form 500.24 and United States Customs Form
7501 under currently applicable regulations).
``(2) Penalties.--Any person that knowingly fails to
provide information required under this subsection or that
provides false information under this subsection shall be
subject to the penalties described in section 1003 of title
18, United States Code. In addition, such person may be
subject to a civil penalty in an amount not to exceed 2
percent of the value of the kind of tobacco products
manufactured or imported by such person during the applicable
quarter, as determined by the Secretary.
``(h) Effective Date.--The user fees prescribed by this
section shall be assessed in fiscal year 2004, based on
domestic sales of tobacco products during fiscal year 2003
and shall be assessed in each fiscal year thereafter.''.
SEC. 102. INTERIM FINAL RULE.
(a) Cigarettes and Smokeless Tobacco.--
(1) In general.--Not later than 30 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall publish in the Federal Register an interim
final rule regarding cigarettes and smokeless tobacco, which
is hereby deemed to be in compliance with the Administrative
Procedures Act and other applicable law.
(2) Contents of rule.--Except as provided in this
subsection, the interim final rule published under paragraph
(1), shall be identical in its provisions to part 897 of the
regulations promulgated by the Secretary of Health and Human
Services in the August 28, 1996, issue of the Federal
Register (61 Fed. Reg., 44615-44618). Such rule shall--
(A) provide for the designation of jurisdictional authority
that is in accordance with this subsection;
(B) strike Subpart C--Labeling and section 897.32(c); and
(C) become effective not later than 1 year after the date
of enactment of this Act.
(3) Amendments to rule.--Prior to making amendments to the
rule published under paragraph (1), the Secretary shall
promulgate a proposed rule in accordance with the
Administrative Procedures Act.
(4) Rule of construction.--Except as provided in paragraph
(3), nothing in this section shall be construed to limit the
authority of the Secretary to amend, in accordance with the
Administrative Procedures Act, the regulation promulgated
pursuant to this section.
(b) Limitation on Advisory Opinions.--As of the date of
enactment of this Act, the following documents issued by the
Food and Drug Administration shall not constitute advisory
opinions under section 10.85(d)(1) of title 21, Code of
Federal Regulations, except as they apply to tobacco
products, and shall not be cited by the Secretary of Health
and Human Services or the Food and Drug Administration as
binding precedent:
(1) The preamble to the proposed rule in the document
entitled ``Regulations Restricting the Sale and Distribution
of Cigarettes and Smokeless Tobacco Products to Protect
Children and Adolescents'' (60 Fed. Reg. 41314-41372 (August
11, 1995)).
(2) The document entitled ``Nicotine in Cigarettes and
Smokeless Tobacco Products is a Drug and These Products Are
Nicotine Delivery Devices Under the Federal Food, Drug, and
Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
(3) The preamble to the final rule in the document entitled
``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and
Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
(4) The document entitled ``Nicotine in Cigarettes and
Smokeless Tobacco is a Drug and These Products are Nicotine
Delivery Devices Under the Federal Food, Drug, and Cosmetic
Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318
(August 28, 1996)).
SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL
PROVISIONS.
(a) Amendment of Federal Food, Drug, and Cosmetic Act.--
Except as otherwise expressly provided, whenever in this
section an amendment is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference
is to a section or other provision of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
(1) in subsection (a), by inserting ``tobacco product,''
after ``device,'';
(2) in subsection (b), by inserting ``tobacco product,''
after ``device,'';
(3) in subsection (c), by inserting ``tobacco product,''
after ``device,'';
(4) in subsection (e), by striking ``515(f), or 519'' and
inserting ``515(f), 519, or 909'';
(5) in subsection (g), by inserting ``tobacco product,''
after ``device,'';
(6) in subsection (h), by inserting ``tobacco product,''
after ``device,'';
(7) in subsection (j), by striking ``708, or 721'' and
inserting ``708, 721, 904, 905, 906, 907, 908, 909, or
section 921(b)'';
(8) in subsection (k), by inserting ``tobacco product,''
after ``device,'';
(9) by striking subsection (p) and inserting the following:
``(p) The failure to register in accordance with section
510 or 905, the failure to provide any information required
by section 510(j), 510(k), 905(i), or 905(j), or the failure
to provide a notice required by section 510(j)(2) or
905(i)(2).'';
(10) by striking subsection (q)(1) and inserting the
following:
``(q)(1) The failure or refusal--
``(A) to comply with any requirement prescribed under
section 518, 520(g), 903(b)(8), or 908, or condition
prescribed under section 903(b)(6)(B)(ii)(II);
``(B) to furnish any notification or other material or
information required by or under section 519, 520(g), 904,
909, or section 921; or
``(C) to comply with a requirement under section 522 or
913.'';
(11) in subsection (q)(2), by striking ``device,'' and
inserting ``device or tobacco product,'';
(12) in subsection (r), by inserting ``or tobacco product''
after ``device'' each time that it appears; and
(13) by adding at the end the following:
``(aa) The sale of tobacco products in violation of a no-
tobacco-sale order issued under section 303(f).
``(bb) The introduction or delivery for introduction into
interstate commerce of a tobacco product in violation of
section 911.
``(cc)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark,
stamp (including tax stamp), tag, label, or other
identification device upon any tobacco product or container
or labeling thereof so as to render such tobacco product a
counterfeit tobacco product.
``(2) Making, selling, disposing of, or keeping in
possession, control, or custody, or concealing any punch,
die, plate, stone, or other item that is designed to print,
imprint, or reproduce the trademark, trade name, or other
identifying mark, imprint, or device of another or any
likeness of any of the foregoing upon any tobacco product or
container or labeling thereof so as to render such tobacco
product a counterfeit tobacco product.
``(3) The doing of any act that causes a tobacco product to
be a counterfeit tobacco product, or the sale or dispensing,
or the holding for sale or dispensing, of a counterfeit
tobacco product.
``(dd) The charitable distribution of tobacco products.
``(ee) The failure of a manufacturer or distributor to
notify the Attorney General of their knowledge of tobacco
products used in illicit trade.''.
(c) Section 303.--Section 303 (21 U.S.C. 333(f)) is amended
in subsection (f)--
(1) by striking the subsection heading and inserting the
following:
``(f) Civil Penalties; No-Tobacco-Sale Orders.--'';
(2) in paragraph (1)(A), by inserting ``or tobacco
products'' after ``devices'';
(3) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), and inserting after paragraph
(2) the following:
``(3) If the Secretary finds that a person has committed
repeated violations of restrictions promulgated under section
906(d) at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the
sale of tobacco products in that outlet. A no-tobacco-sale
order may be imposed with a civil penalty under paragraph
(1).'';
(4) in paragraph (4) as so redesignated--
(A) in subparagraph (A)--
(i) by striking ``assessed'' the first time it appears and
inserting ``assessed, or a no-tobacco-sale order may be
imposed,''; and
(ii) by striking ``penalty'' and inserting ``penalty, or
upon whom a no-tobacco-order is to be imposed,'';
(B) in subparagraph (B)--
(i) by inserting after ``penalty,'' the following: ``or the
period to be covered by a no-tobacco-sale order,''; and
(ii) by adding at the end the following: ``A no-tobacco-
sale order permanently prohibiting an individual retail
outlet from selling tobacco products shall include provisions
that allow the outlet, after a specified period of time, to
request that the Secretary compromise, modify, or terminate
the order.''; and
(C) by adding at the end, the following:
``(D) The Secretary may compromise, modify, or terminate,
with or without conditions, any no-tobacco-sale order.'';
(5) in paragraph (5) as so redesignated--
(A) by striking ``(3)(A)'' as redesignated, and inserting
``(4)(A)'';
(B) by inserting ``or the imposition of a no-tobacco-sale
order'' after ``penalty'' the first 2 places it appears; and
(C) by striking ``issued.'' and inserting ``issued, or on
which the no-tobacco-sale order was imposed, as the case may
be.''; and
(6) in paragraph (6), as so redesignated, by striking
``paragraph (4)'' each place it appears and inserting
``paragraph (5)''.
(d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
(1) in subsection (a)(2)--
(A) by striking ``and'' before ``(D)''; and
(B) by striking ``device.'' and inserting the following:
``, (E) Any adulterated or misbranded tobacco product.'';
(2) in subsection (d)(1), by inserting ``tobacco product,''
after ``device,'';
[[Page S11082]]
(3) in subsection (g)(1), by inserting ``or tobacco
product'' after ``device'' each place it appears; and
(4) in subsection (g)(2)(A), by inserting ``or tobacco
product'' after ``device'' each place it appears.
(e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is
amended--
(1) by inserting ``(1)'' after ``(a)''; and
(2) by adding at the end thereof the following:
``(2) For a tobacco product, to the extent feasible, the
Secretary shall contract with the States in accordance with
paragraph (1) to carry out inspections of retailers in
connection with the enforcement of this Act.''.
(f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
(1) by inserting ``tobacco product,'' after ``device,''
each place it appears; and
(2) by inserting ``tobacco products,'' after ``devices,''
each place it appears.
(g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
(1) in subsection (a)(1)(A), by inserting ``tobacco
products,'' after ``devices,'' each place it appears;
(2) in subsection (a)(1)(B), by inserting ``or tobacco
product'' after ``restricted devices'' each place it appears;
and
(3) in subsection (b), by inserting ``tobacco product,''
after ``device,''.
(h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is
amended by inserting ``tobacco products,'' after
``devices,''.
(i) Section 709.--Section 709 (21 U.S.C. 379) is amended by
inserting ``or tobacco product'' after ``device''.
(j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (a)--
(A) by inserting ``tobacco products,'' after ``devices,''
the first time it appears;
(B) by inserting ``or section 905(j)'' after ``section
510''; and
(C) by striking ``drugs or devices'' each time it appears
and inserting ``drugs, devices, or tobacco products'';
(2) in subsection (e)(1), by inserting ``tobacco product,''
after ``device,''; and
(3) by adding at the end the following:
``(p)(1) Not later than 2 years after the date of enactment
of the Family Smoking Prevention and Tobacco Control Act, and
annually thereafter, the Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives, a report regarding--
``(A) the nature, extent, and destination of United States
tobacco product exports that do not conform to tobacco
product standards established pursuant to this Act;
``(B) the public health implications of such exports,
including any evidence of a negative public health impact;
and
``(C) recommendations or assessments of policy alternatives
available to Congress and the Executive Branch to reduce any
negative public health impact caused by such exports.
``(2) The Secretary is authorized to establish appropriate
information disclosure requirements to carry out this
subsection.''.
(k) Section 1003.--Section 1003(d)(2)(C) (as redesignated
by section 101(a)) is amended--
(1) by striking ``and'' after ``cosmetics,''; and
(2) inserting a comma and ``and tobacco products'' after
``devices''.
(l) Effective Date for No-Tobacco-Sale Order Amendments.--
The amendments made by subsection (c), other than the
amendment made by paragraph (2) of such subsection, shall
take effect upon the issuance of guidance by the Secretary of
Health and Human Services--
(1) defining the term ``repeated violation'', as used in
section 303(f) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 333(f)) as amended by subsection (c), by
identifying the number of violations of particular
requirements over a specified period of time at a particular
retail outlet that constitute a repeated violation;
(2) providing for timely and effective notice to the
retailer of each alleged violation at a particular retail
outlet and an expedited procedure for the administrative
appeal of an alleged violation;
(3) providing that a person may not be charged with a
violation at a particular retail outlet unless the Secretary
has provided notice to the retailer of all previous
violations at that outlet;
(4) establishing a period of time during which, if there
are no violations by a particular retail outlet, that outlet
will not be considered to have been the site of repeated
violations when the next violation occurs; and
(5) providing that good faith reliance on the presentation
of a false government issued photographic identification that
contains the bearer's date of birth does not constitute a
violation of any minimum age requirement for the sale of
tobacco products if the retailer has taken effective steps to
prevent such violations, including--
(A) adopting and enforcing a written policy against sales
to minors;
(B) informing its employees of all applicable laws;
(C) establishing disciplinary sanctions for employee
noncompliance; and
(D) requiring its employees to verify age by way of
photographic identification or electronic scanning device.
TITLE II--TOBACCO PRODUCT WARNINGS; CONSTITUENT AND SMOKE CONSTITUENT
DISCLOSURE
SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.
Section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333) is amended to read as follows:
``SEC. 4. LABELING.
``(a) Label Requirements.--
``(1) In general.--It shall be unlawful for any person to
manufacture, package, sell, offer to sell, distribute, or
import for sale or distribution within the United States any
cigarettes the package of which fails to bear, in accordance
with the requirements of this section, one of the following
labels:
`WARNING: Cigarettes are addictive'.
`WARNING: Tobacco smoke can harm your children'.
`WARNING: Cigarettes cause fatal lung disease'.
`WARNING: Cigarettes cause cancer'.
`WARNING: Cigarettes cause strokes and heart disease'.
`WARNING: Smoking during pregnancy can harm your baby'.
`WARNING: Smoking can kill you'.
`WARNING: Tobacco smoke causes fatal lung disease in non-
smokers'.
`WARNING: Quitting smoking now greatly reduces serious risks
to your health'.
``(2) Placement; typography; etc.--
``(A) In general.--Each label statement required by
paragraph (1) shall be located in the upper portion of the
front and rear panels of the package, directly on the package
underneath the cellophane or other clear wrapping. Except as
provided in subparagraph (B), each label statement shall
comprise at least the top 30 percent of the front and rear
panels of the package. The word `WARNING' shall appear in
capital letters and all text shall be in conspicuous and
legible 17-point type, unless the text of the label statement
would occupy more than 70 percent of such area, in which case
the text may be in a smaller conspicuous and legible type
size, provided that at least 60 percent of such area is
occupied by required text. The text shall be black on a white
background, or white on a black background, in a manner that
contrasts, by typography, layout, or color, with all other
printed material on the package, in an alternating fashion
under the plan submitted under subsection (b)(4).
``(B) Flip-top boxes.--For any cigarette brand package
manufactured or distributed before January 1, 2000, which
employs a flip-top style (if such packaging was used for that
brand in commerce prior to June 21, 1997), the label
statement required by paragraph (1) shall be located on the
flip-top area of the package, even if such area is less than
25 percent of the area of the front panel. Except as provided
in this paragraph, the provisions of this subsection shall
apply to such packages.
``(3) Does not apply to foreign distribution.--The
provisions of this subsection do not apply to a tobacco
product manufacturer or distributor of cigarettes which does
not manufacture, package, or import cigarettes for sale or
distribution within the United States.
``(4) Applicability to retailers.--A retailer of cigarettes
shall not be in violation of this subsection for packaging
that is supplied to the retailer by a tobacco product
manufacturer, importer, or distributor and is not altered by
the retailer in a way that is material to the requirements of
this subsection except that this paragraph shall not relieve
a retailer of liability if the retailer sells or distributes
tobacco products that are not labeled in accordance with this
subsection.
``(b) Advertising Requirements.--
``(1) In general.--It shall be unlawful for any tobacco
product manufacturer, importer, distributor, or retailer of
cigarettes to advertise or cause to be advertised within the
United States any cigarette unless its advertising bears, in
accordance with the requirements of this section, one of the
labels specified in subsection (a) of this section.
``(2) Typography, etc.--Each label statement required by
subsection (a) of this section in cigarette advertising shall
comply with the standards set forth in this paragraph. For
press and poster advertisements, each such statement and
(where applicable) any required statement relating to tar,
nicotine, or other constituent (including a smoke
constituent) yield shall comprise at least 20 percent of the
area of the advertisement and shall appear in a conspicuous
and prominent format and location at the top of each
advertisement within the trim area. The Secretary may revise
the required type sizes in such area in such manner as the
Secretary determines appropriate. The word `WARNING' shall
appear in capital letters, and each label statement shall
appear in conspicuous and legible type. The text of the label
statement shall be black if the background is white and white
if the background is black, under the plan submitted under
paragraph (4) of this subsection. The label statements shall
be enclosed by a rectangular border that is the same color as
the letters of the statements and that is the width of the
first downstroke of the capital `W' of the word `WARNING' in
the label statements. The text of such label statements shall
be in a typeface pro rata to the following requirements: 45-
point type for a whole-page broadsheet newspaper
advertisement; 39-point type for a half-page broadsheet
newspaper advertisement; 39-point type for a whole-page
tabloid newspaper advertisement; 27-point type for a half-
page tabloid newspaper advertisement; 31.5-point type for a
double page spread magazine or whole-page magazine
advertisement; 22.5-point type for
[[Page S11083]]
a 28 centimeter by 3 column advertisement; and 15-point type
for a 20 centimeter by 2 column advertisement. The label
statements shall be in English, except that in the case of--
``(A) an advertisement that appears in a newspaper,
magazine, periodical, or other publication that is not in
English, the statements shall appear in the predominant
language of the publication; and
``(B) in the case of any other advertisement that is not in
English, the statements shall appear in the same language as
that principally used in the advertisement.
``(3) Matchbooks.--Notwithstanding paragraph (2), for
matchbooks (defined as containing not more than 20 matches)
customarily given away with the purchase of tobacco products,
each label statement required by subsection (a) may be
printed on the inside cover of the matchbook.
``(4) Adjustment by secretary.--The Secretary may, through
a rulemaking under section 553 of title 5, United States
Code, adjust the format and type sizes for the label
statements required by this section or the text, format, and
type sizes of any required tar, nicotine yield, or other
constituent (including smoke constituent) disclosures, or to
establish the text, format, and type sizes for any other
disclosures required under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et. seq.). The text of any such
label statements or disclosures shall be required to appear
only within the 20 percent area of cigarette advertisements
provided by paragraph (2) of this subsection. The Secretary
shall promulgate regulations which provide for adjustments in
the format and type sizes of any text required to appear in
such area to ensure that the total text required to appear by
law will fit within such area.
``(5) Marketing requirements.--
``(A) The label statements specified in subsection (a)(1)
shall be randomly displayed in each 12-month period, in as
equal a number of times as is possible on each brand of the
product and be randomly distributed in all areas of the
United States in which the product is marketed in accordance
with a plan submitted by the tobacco product manufacturer,
importer, distributor, or retailer and approved by the
Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of cigarettes in accordance
with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraph (B) and approve it if the plan--
``(i) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(ii) assures that all of the labels required under this
section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(6) Applicability to retailers.--This subsection applies
to a retailer only if that retailer is responsible for or
directs the label statements required under this section
except that this paragraph shall not relieve a retailer of
liability if the retailer displays, in a location open to the
public, an advertisement that is not labeled in accordance
with the requirements of this subsection.''.
SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL
STATEMENTS.
Section 4 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1333), as amended by section 201, is further
amended by adding at the end the following:
``(c) Change in Required Statements.--The Secretary may, by
a rulemaking conducted under section 553 of title 5, United
States Code, adjust the format, type size, and text of any of
the label requirements, require color graphics to accompany
the text, increase the required label area from 30 percent up
to 50 percent of the front and rear panels of the package, or
establish the format, type size, and text of any other
disclosures required under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary finds
that such a change would promote greater public understanding
of the risks associated with the use of tobacco products.''.
SEC. 203. STATE REGULATION OF CIGARETTE ADVERTISING AND
PROMOTION.
Section 5 of the Federal Cigarette Labeling and Advertising
Act (15 U.S.C. 1334) is amended by adding at the end the
following:
``(c) Exception.--Notwithstanding subsection (b), a State
or locality may enact statutes and promulgate regulations,
based on smoking and health, that take effect after the
effective date of the Family Smoking Prevention and Tobacco
Control Act, imposing specific bans or restrictions on the
time, place, and manner, but not content, of the advertising
or promotion of any cigarettes.''.
SEC. 204. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.
Section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (15 U.S.C. 4402) is amended to read as
follows:
``SEC. 3. SMOKELESS TOBACCO WARNING.
``(a) General Rule.--
``(1) It shall be unlawful for any person to manufacture,
package, sell, offer to sell, distribute, or import for sale
or distribution within the United States any smokeless
tobacco product unless the product package bears, in
accordance with the requirements of this Act, one of the
following labels:
`WARNING: This product can cause mouth cancer'.
`WARNING: This product can cause gum disease and tooth loss'.
`WARNING: This product is not a safe alternative to
cigarettes'.
`WARNING: Smokeless tobacco is addictive'.
``(2) Each label statement required by paragraph (1) shall
be--
``(A) located on the 2 principal display panels of the
package, and each label statement shall comprise at least 30
percent of each such display panel; and
``(B) in 17-point conspicuous and legible type and in black
text on a white background, or white text on a black
background, in a manner that contrasts by typography, layout,
or color, with all other printed material on the package, in
an alternating fashion under the plan submitted under
subsection (b)(3), except that if the text of a label
statement would occupy more than 70 percent of the area
specified by subparagraph (A), such text may appear in a
smaller type size, so long as at least 60 percent of such
warning area is occupied by the label statement.
``(3) The label statements required by paragraph (1) shall
be introduced by each tobacco product manufacturer, packager,
importer, distributor, or retailer of smokeless tobacco
products concurrently into the distribution chain of such
products.
``(4) The provisions of this subsection do not apply to a
tobacco product manufacturer or distributor of any smokeless
tobacco product that does not manufacture, package, or import
smokeless tobacco products for sale or distribution within
the United States.
``(5) A retailer of smokeless tobacco products shall not be
in violation of this subsection for packaging that is
supplied to the retailer by a tobacco products manufacturer,
importer, or distributor and that is not altered by the
retailer unless the retailer offers for sale, sells, or
distributes a smokeless tobacco product that is not labeled
in accordance with this subsection.
``(b) Required Labels.--
``(1) It shall be unlawful for any tobacco product
manufacturer, packager, importer, distributor, or retailer of
smokeless tobacco products to advertise or cause to be
advertised within the United States any smokeless tobacco
product unless its advertising bears, in accordance with the
requirements of this section, one of the labels specified in
subsection (a).
``(2) Each label statement required by subsection (a) in
smokeless tobacco advertising shall comply with the standards
set forth in this paragraph. For press and poster
advertisements, each such statement and (where applicable)
any required statement relating to tar, nicotine, or other
constituent yield shall--
``(A) comprise at least 20 percent of the area of the
advertisement, and the warning area shall be delineated by a
dividing line of contrasting color from the advertisement;
and
``(B) the word `WARNING' shall appear in capital letters
and each label statement shall appear in conspicuous and
legible type. The text of the label statement shall be black
on a white background, or white on a black background, in an
alternating fashion under the plan submitted under paragraph
(3).
``(3)(A) The label statements specified in subsection
(a)(1) shall be randomly displayed in each 12-month period,
in as equal a number of times as is possible on each brand of
the product and be randomly distributed in all areas of the
United States in which the product is marketed in accordance
with a plan submitted by the tobacco product manufacturer,
importer, distributor, or retailer and approved by the
Secretary.
``(B) The label statements specified in subsection (a)(1)
shall be rotated quarterly in alternating sequence in
advertisements for each brand of smokeless tobacco product in
accordance with a plan submitted by the tobacco product
manufacturer, importer, distributor, or retailer to, and
approved by, the Secretary.
``(C) The Secretary shall review each plan submitted under
subparagraph (B) and approve it if the plan--
``(i) will provide for the equal distribution and display
on packaging and the rotation required in advertising under
this subsection; and
``(ii) assures that all of the labels required under this
section will be displayed by the tobacco product
manufacturer, importer, distributor, or retailer at the same
time.
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
under this section, unless the retailer displays in a
location open to the public, an advertisement that is not
labeled in accordance with the requirements of this
subsection.
``(c) Television and Radio Advertising.--It is unlawful to
advertise smokeless tobacco on any medium of electronic
communications subject to the jurisdiction of the Federal
Communications Commission.''.
SEC. 205. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT
WARNING LABEL STATEMENTS.
Section 3 of the Comprehensive Smokeless Tobacco Health
Education Act of 1986 (15 U.S.C. 4402), as amended by section
203, is further amended by adding at the end the following:
``(d) Authority To Revise Warning Label Statements.--The
Secretary may, by a rulemaking conducted under section 553 of
title 5, United States Code, adjust the format,
[[Page S11084]]
type size, and text of any of the label requirements, require
color graphics to accompany the text, increase the required
label area from 30 percent up to 50 percent of the front and
rear panels of the package, or establish the format, type
size, and text of any other disclosures required under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
if the Secretary finds that such a change would promote
greater public understanding of the risks associated with the
use of smokeless tobacco products.''.
SEC. 206. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT
DISCLOSURE TO THE PUBLIC.
Section 4(a) of the Federal Cigarette Labeling and
Advertising Act (15 U.S.C. 1333 (a)), as amended by section
201, is further amended by adding at the end the following:
``(4)(A) The Secretary shall, by a rulemaking conducted
under section 553 of title 5, United States Code, determine
(in the Secretary's sole discretion) whether cigarette and
other tobacco product manufacturers shall be required to
include in the area of each cigarette advertisement specified
by subsection (b) of this section, or on the package label,
or both, the tar and nicotine yields of the advertised or
packaged brand. Any such disclosure shall be in accordance
with the methodology established under such regulations,
shall conform to the type size requirements of subsection (b)
of this section, and shall appear within the area specified
in subsection (b) of this section.
``(B) Any differences between the requirements established
by the Secretary under subparagraph (A) and tar and nicotine
yield reporting requirements established by the Federal Trade
Commission shall be resolved by a memorandum of understanding
between the Secretary and the Federal Trade Commission.
``(C) In addition to the disclosures required by
subparagraph (A) of this paragraph, the Secretary may, under
a rulemaking conducted under section 553 of title 5, United
States Code, prescribe disclosure requirements regarding the
level of any cigarette or other tobacco product constituent
including any smoke constituent. Any such disclosure may be
required if the Secretary determines that disclosure would be
of benefit to the public health, or otherwise would increase
consumer awareness of the health consequences of the use of
tobacco products, except that no such prescribed disclosure
shall be required on the face of any cigarette package or
advertisement. Nothing in this section shall prohibit the
Secretary from requiring such prescribed disclosure through a
cigarette or other tobacco product package or advertisement
insert, or by any other means under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
``(D) This paragraph applies to a retailer only if that
retailer is responsible for or directs the label statements
required under this section, except that this paragraph shall
not relieve a retailer of liability if the retailer sells or
distributes tobacco products that are not labeled in
accordance with the requirements of this subsection.''.
TITLE III--PREVENTION OF ILLICIT TRADE IN TOBACCO PRODUCTS
SEC. 301. LABELING, RECORDKEEPING, RECORDS INSPECTION.
Chapter IX of the Federal Food, Drug, and Cosmetic Act, as
added by section 101, is further amended by adding at the end
the following:
``SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPECTION.
``(a) Origin Labeling.--The label, packaging, and shipping
containers of tobacco products for introduction or delivery
for introduction into interstate commerce shall bear the
statement `sale only allowed in the United States.'
``(b) Regulations Concerning Recordkeeping for Tracking and
Tracing.--
``(1) In general.--Not later than 9 months after the date
of enactment of the Family Smoking Prevention and Tobacco
Control Act, the Secretary shall promulgate regulations
regarding the establishment and maintenance of records by any
person who manufactures, processes, transports, distributes,
receives, packages, holds, exports, or imports tobacco
products.
``(2) Inspection.--In promulgating the regulations
described in paragraph (1), the Secretary shall consider
which records are needed for inspection to monitor the
movement of tobacco products from the point of manufacture
through distribution to retail outlets to assist in
investigating potential illicit trade, smuggling or
counterfeiting of tobacco products.
``(3) Codes.--The Secretary may require codes on the labels
of tobacco products or other designs or devices for the
purpose of tracking or tracing the tobacco product through
the distribution system.
``(4) Size of business.--The Secretary shall take into
account the size of a business in promulgating regulations
under this section.
``(5) Recordkeeping by retailers.--The Secretary shall not
require any retailer to maintain records relating to
individual purchasers of tobacco products for personal
consumption.
``(c) Records Inspection.--If the Secretary has a
reasonable belief that a tobacco product is part of an
illicit trade or smuggling or is a counterfeit product, each
person who manufactures, processes, transports, distributes,
receives, holds, packages, exports, or imports tobacco
products shall, at the request of an officer or employee duly
designated by the Secretary, permit such officer or employee,
at reasonable times and within reasonable limits and in a
reasonable manner, upon the presentation of appropriate
credentials and a written notice to such person, to have
access to and copy all records (including financial records)
relating to such article that are needed to assist the
Secretary in investigating potential illicit trade, smuggling
or counterfeiting of tobacco products.
``(d) Knowledge of Illegal Transaction.--If the
manufacturer or distributor of a tobacco product has
knowledge which reasonably supports the conclusion that a
tobacco product manufactured or distributed by such
manufacturer or distributor that has left the control of such
person may be or has been--
``(A) imported, exported, distributed or offered for sale
in interstate commerce by a person without paying duties or
taxes required by law; or
``(B) imported, exported, distributed or diverted for
possible illicit marketing,
the manufacturer or distributor shall promptly notify the
Attorney General of such knowledge.
``(2) Knowledge defined.--For purposes of this subsection,
the term `knowledge' as applied to a manufacturer or
distributor means--
``(A) the actual knowledge that the manufacturer or
distributor had; or
``(B) the knowledge which a reasonable person would have
had under like circumstances or which would have been
obtained upon the exercise of due care.''.
SEC. 302. STUDY AND REPORT.
(a) Study.--The Comptroller General of the United States
shall conduct a study of cross-border trade in tobacco
products to--
(1) collect data on cross-border trade in tobacco products,
including illicit trade and trade of counterfeit tobacco
products and make recommendations on the monitoring of such
trade;
(2) collect data on cross-border advertising (any
advertising intended to be broadcast, transmitted, or
distributed from the United States to another country) of
tobacco products and make recommendations on how to prevent
or eliminate, and what technologies could help facilitate the
elimination of, cross-border advertising.
(b) Report.--Not later than 18 months after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on the
study described in subsection (a).
____
S. 2975
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. CLARIFICATION OF REGULATIONS RELATING TO OVERTIME
COMPENSATION.
Section 13 of the Fair Labor Standards Act of 1938 (29
U.S.C. 213) is amended by adding at the end the following:
``(k) Notwithstanding the provisions of subchapter II of
chapter 5 and chapter 7 of title 5, United States Code
(commonly referred to as the Administrative Procedures Act)
or any other provision of law, any portion of the final rule
promulgated on April 23, 2004, revising part 541 of title 29,
Code of Federal Regulations, that exempts from the overtime
pay provisions of section 7 any employee who would not
otherwise be exempt if the regulations in effect on March 31,
2003 remained in effect, shall have no force or effect and
that portion of such regulations (as in effect on March 31,
2003) that would prevent such employee from being exempt
shall remain in effect. Notwithstanding the preceding
sentence, the increased salary requirements provided for in
such final rule at section 541.600 of such title 29, shall
remain in effect.''.
Mr. FRIST. Madam President, I yield the floor.
The PRESIDING OFFICER. The Senator from Louisiana is recognized.
Ms. LANDRIEU. Madam President, I ask unanimous consent to speak for
about 10 minutes.
The PRESIDING OFFICER. Without objection, it is so ordered.
Ms. LANDRIEU. Madam President, I am so pleased to be on the floor and
to thank our leadership: First, Senator Frist, our majority leader,
from Tennessee; Senator Daschle, the minority leader; and Senator Reid,
who has worked so tirelessly today. Reasonable minds came together on
some of these issues. I particularly thank the Senator from Oklahoma,
Senator Nickles, for working throughout the day with us on this very
important amendment for the Guard and Reserve; and particularly,
Senator Kit Bond, who was one of the leaders on the Republican side;
Senator Jeff Sessions for his kind remarks today; Senator Jeffords, who
signed the letter to the President; Senator Nelson of Florida and
Senator Akaka, who came to the floor; Senator Murray for her strong
support of the amendment; Senator Boxer for being an original cosponsor
of the amendment, along with Senator Durbin and
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Senator Kerry. There may be others I can mention in the next few
minutes because this truly was a success for all of us and the Senate,
for the Republican leadership and the Democratic leadership of the
Senate, to be able to come to a reasonable agreement to pass a tax
credit for members of the Guard and Reserve, to pass a significant tax
credit for businesses in this country, particularly small businesses
that are really struggling to make ends meet and are doing the
patriotic thing.
Madam President, I had submitted this for the Record several days
ago, so I will not repeat it. I call attention to the hundreds of
businesses--potentially thousands--that will benefit directly from this
tax credit, but most important, it is the guardsmen and reservists
whose paychecks will continue, whose families will be supported, who
will be the direct and most important beneficiaries of the agreement
reached tonight. I thank my colleagues, and I will speak in more detail
tomorrow about the benefits.
Because we worked together and kept working in good faith and because
we kept them in our minds, the Senate tomorrow at some time will pass,
by unanimous consent, according to the agreement just reached, a tax
credit for businesses. It won't technically be in this huge bill I have
been holding up for 3 days. As I started this discussion, there was
nothing we could do to get it in this bill. The only thing that could
have happened to get it in the bill is if we pass it, the President
would veto it, send it back, and tell us to rewrite it. The chances of
that happening were not good. So we negotiated the next best thing,
which was passing a stand-alone tax credit for the Guard and Reserve
out of the Senate again, as we have already done with 100 Members of
the Senate--Republicans and Democrats--and sent to the House.
Now the focus will be on the House leadership. Now the focus will be
on the House. Is the Republican leadership in the House going to stand
up for the men and women in the Guard and Reserve? Are they going to
include them or leave them out of their tax bill? That is something the
House leadership will have to discuss.
I am so proud tonight of the Senators. Again, many Senators helped. I
will go into more detail in the morning about that.
Let me make sure that I have included in the Record the Military
Officers Association, representing 376,000 members. I will submit for
the Record the Reserve Officers Association. In the morning, I will
submit many other documents we have received from Active and Reserve
military organizations for members of the military coalition thanking
us for standing strong for them to get a tax credit for them. If
anybody deserves a tax credit--and if we can afford $137 billion for
many other interests in America--nobody deserves it more than the
employers, particularly the small employers of under 500 or a thousand.
That is not that small, but in the definition of small business,
something under 500 is technically called a small business. In my
State, we think of a 10- or 15-employee company as small. But
particularly for those small- and medium-sized businesses that are
doing the patriotic thing, keeping the paycheck whole for the Guard and
Reserve while they are on the front line and also hiring replacements
for them to run the factories, the businesses, the architectural firm,
or drive a truck, et cetera.
So I am just as proud as I can be tonight to thank my colleagues for
working so well together. It has been a pleasure particularly working
with Senator Daschle, who has the patience of a saint on many of these
issues and in the way he has negotiated with Senator Frist to bring
this to a good end.
I will yield back the remainder of my time tonight and, of course,
reserve the right to speak again in the morning on this important
subject.
I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. HARKIN. Mr. President, I ask unanimous consent that the order for
the quorum call be rescinded.
The PRESIDING OFFICER (Mr. Bennett). Without objection, it is so
ordered.
Ms. LANDRIEU. Will the Senator yield for 30 seconds?
Mr. HARKIN. I will yield.
Ms. LANDRIEU. I would particularly like to thank the Senator from
Iowa. There is a long list of Senators, but I need to particularly
thank the Senator from Iowa, for the two of us have been on the floor
together for the last 2 days. He has been very generous in terms of
helping with this issue, and he is a cosponsor of this amendment as
well. He has been a tremendous supporter.
The Senator from Iowa has also, our colleagues know, had other issues
which he will speak about in a moment, very important to farmers,
actually in my State as well as Iowa and States all over the Nation,
but I would be remiss if I did not thank the Senator from Iowa who has
been arguing, holding the floor, making our points so we could get our
colleagues to focus on this issue, which has been done, and now we have
a bill we can send to the House. So I thank the Senator.
Mr. HARKIN. I thank the Senator from Louisiana. Let me return the
bouquet. I thank the Senator from Louisiana on behalf of all the
friends I have who are reservists--I was a reservist once myself in my
younger years--all the National Guard people and the employers, the
small businesspeople who try to do their best. These people are called
up. They go to Iraq. Many times they try to give them some
compensation, but they are leaving their families behind, their kids,
their communities, and all the Senator has been asking for is to treat
them fairly and decently, to help these employers make up that
difference in income, many of whom are trying to do their best. But
let's face it, a lot of them are small businesses. They cannot do it.
I thank the Senator from Louisiana for standing up for small
businesses, for standing up for our Guard and Reserve people who have
given so much to this country, making sure they are treated equitably
and fairly. I thank the Senator for doing this. This is an issue that
has to be resolved, and again every guardsman and every Reserve person
in the United States owes the Senator from Louisiana a great debt of
thanks.
I have to say this: If I am ever in a foxhole someplace, I want the
Senator from Louisiana on my side because I know I will never have to
worry about my backside if the Senator from Louisiana is there. She has
what we call real grit. I am proud of her and thank her for being here
this weekend and for never backing down. I thank her for standing up
for our people in uniform in this country who are in the Guard and the
Reserves.
I also want to thank those on the Republican side, Leader Frist and
others, who have worked to try to get accommodations made and
reasonable agreements worked out. This is a place where there must be
compromise. It is not your way or my way all the time. It is trying to
work out compromises, trying to work out reasonable solutions to
things. I thank those on the other side of the aisle who have worked
this weekend with us.
I especially want to also thank our leaders, Senator Daschle and
Senator Reid, again for their willingness to work hard to try and work
out these agreements with the leadership on the other side.
These are contentious things, but we know that. Sometimes around here
we are not the masters of our own fate. I know the administration comes
in and they want things a certain way. Sometimes it is hard being a
member of the majority party whose President is in the White House. It
is tough. I know that because a lot of times we may want to do things
one way and the White House wants it the other way and they make it
very tough on Members of their party. I understand that. I have been
there before.
People of good reason can come together and work together to work
these issues out. I know people took me to task today on the other side
of the aisle. That is all right. I do not mind that. We have been
around this place a long time. I want people to know I am going to
stand here and fight for my farmers. They do not have many people
fighting for them. They are a minority in this country. We got through
a good farm bill in 2002 and the President signed it, touted
conservation, and now twice conservation has been invaded, taking the
money out of
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our farm program. It is not right to do it that way.
So I am glad that when we come back in November to finalize our
appropriations bills for next year--we have a continuing resolution
until November 20 so we have to come back to finish that. Under the
agreement we worked out, there will be an instruction to the conferees
to undo what we did on the omnibus, to right what we did here and to
make the conservation program whole again. That can be done. It can be
done in November and, quite frankly, not too much will be upset in 1
month. We can live with that. We will get it straightened out in
November.
I am glad we have reached this kind of a resolution and we will come
back in November and try to get things straightened out at that time.
I want to thank those who have worked so hard to reach this
agreement. I guess, as it goes now, we will be finished tomorrow and
people can get back to their homes and campaign.
I also want to publicly thank all of the people at the desk, the
clerks, the reading clerks, our Parliamentarians and others, the floor
people on both sides, Republican and Democrat. They have had to give up
their family this weekend. I know that. I want to thank them publicly
for being here and working long hours on Saturday, Saturday night, and
Sunday. It is now 8 at night. They provide a tremendous public service
on both sides of the aisle. I know a lot of times they could probably
get a lot more done if we Senators were not around. The staff can work
out things.
I also want to thank our reporters who are here. They have also
worked long hours this weekend and given up their family time. I have
to mention the pages, too. The pages probably had a nice weekend
planned. We thank them for being here and permitting us to do our job.
These are things sometimes that take a long time to work out. We try
our best and we have our debates. We go back and forth, but we could
not do our job without all of these wonderful people. They do make the
Senate a wonderful place in which to work. It is 20 years that I have
spent here. I never would have imagined in my younger life I would have
had such an opportunity or an honor to serve my constituents in Iowa,
indeed all of the people in this country, as a Senator. All of you who
work and labor here do not get much glory. Nobody ever writes about you
and you probably do not get on television, you do not get to speak on
the Senate floor like we do, but we could never do our job without you.
I want you to know I appreciate each and every one of you, Republican,
Democrat, and those of you who do not have a party who are here in a
nonpartisan capacity. You do make this place function well, and I thank
you for it. I thank you for letting us do our job on the weekend.
Mr. REID. Will the Senator yield?
Mr. HARKIN. I would be delighted to yield to my leader. I paid homage
to him earlier and I will pay it again most respectfully. I cannot say
enough good things about Senator Reid's strength and character, about
his own personal attributes of honesty and forthrightness. When Senator
Reid gives his word, go to the bank. One does not have to worry about
it.
He has a tough job. He has to deal with us and then he has to deal
with the other side and try to work out these agreements. These are
very tough negotiations. I could not ask for a better friend, a better
person, to negotiate and work things out and get these compromises
made. I could not ask for a better friend and a better person to do it
than Senator Reid of Nevada.
I yield to the Senator.
Mr. REID. Through the Chair to the distinguished Senator from Iowa, I
have a State that is rapidly growing. It has, as you know, the tourism
interests and the mining, and we have some ranching. There is limited
agriculture, but we have some. But the State of Iowa is agricultural
based. It is hard for a lot of us who come from big cities to
understand. Nevada is the most urban State in the Union, with Las Vegas
and Reno making up about 90 percent of the population. So it is hard
for a lot of us to understand the passion that someone like Tom Harkin
has for farming and farmers. It is hard for me to understand that. But
I have come to learn the passion and the depth of feeling that the
junior Senator from Iowa has about farmers and farming--agricultural
matters.
I hope the people of Iowa have some understanding, which I know they
do, about how you fight for farmers, family farmers. I have learned a
lot about family farmers because of listening to the Senator talk. It
is not only listening to him talk, it is how he talks. I think it is so
good that we have in this body people like Tom Harkin, who believe in
something, who have a knowledge of agriculture, but not only is it a
broad-brush knowing a lot about agriculture, you care about the people
who are involved in it.
What we have gone through in the last few days--and when I say gone
through, as I told Senator Harkin as I was going home last night, I had
a Harkin headache--I feel good being one of 100 here and knowing that I
serve with people like Tom Harkin who believes so deeply in a subject.
Not only does he express, personally, his feelings, he wants everyone
here to know.
When the history books are written about agriculture and what has
happened legislatively with agriculture, Tom Harkin's chapter in that
book will be in bold print.
I don't know much about this program that Senator Harkin feels so
strongly about, but I was there when he got it done. And I know how
good he felt about having accomplished this farming conservation. I
have some understanding of what it is but not the knowledge that
Senator Harkin has--how he felt about this. When this was accomplished,
it was like somebody hit a home run. I have had some legislative
victories and I know how good it feels. And I know how bad it feels
when someone tries to take that away from you. That is what has
happened here, a legislative victory that is significantly important to
the farmers of this country, in Tom Harkin's mind. He proved to me that
people were trying to take that away from him. And by taking it away
from him, they were taking it away from American farmers.
Mr. HARKIN. That's right.
Mr. REID. So I say to my friend, Senator Harkin, thank you very much
for being a believer, for being a believer in something that is
important to this country, family farms.
Mr. HARKIN. I thank my friend. I thank my friend for those very kind
and overly generous words. I again say to Senator Reid, you do me a
great honor. I don't think there is any higher honor than to have
someone that you respect and that you admire say those kinds of things.
I hope the Senator from Nevada understands the depth of my feeling
about him personally--personally and professionally. Personally, as
just a good, decent, wonderful human being, someone who cares deeply
about people and making our Government work for people, making sure
that people have the same kind of opportunities we had when we were
kids.
A young kid from Searchlight, NV, and a young kid from Cumming, IA,
knowing what our parents were like, poor--we see the two things we have
in common. We were both born in small houses in small towns to poor
parents. But we had a country that gave us an opportunity.
I know the Senator feels very deeply that he wants to pass on to his
kids, and his grandkids, a country that gives them the same kind of
opportunities the country gave us; for the Harry Reids of today who are
born in some little house in some unknown town someplace out in the
middle of nowhere, that they, too, have the same opportunity that this
Harry Reid had to succeed in America.
That is the kind of America I know the Senator wants to leave. That
is why I admire him so much. He is just a great human being.
I am glad you are our assistant minority leader, hopefully our
assistant majority leader in the next term.
I thank you for those kind words, and thanks for your words on behalf
of our farmers. We couldn't have gotten where we are without your great
help and your great leadership. Even though you may not have a lot of
farmers in Nevada, you have a lot of farmers who are your friends from
Iowa, the Midwest, Ohio, and everywhere else.
I thank you for that very much.
Mr. President, I understand I have some time tomorrow to speak
further on the issue. I will at this time yield the floor and suggest
the absence of a quorum.
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The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. FRIST. Mr. President, I ask unanimous consent that the order for
the quorum call be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
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