(b) REFERENCE.—Whenever in this Act (other than
sections 5(b)(1) and 5(b)(2)) an amendment or repeal is
expressed in terms of an amendment to, or repeal of, a
section or other provision, the reference shall be consid-
ered to be made to a section or other provision of the
Federal Food, Drug, and Cosmetic Act.
SEC. 2. FINDINGS.
The Congress finds that—
(1) Cigarette smoking and tobacco use account
for approximately 450,000 deaths each year in the
United States.
(2) Cigarette smoking accounts for approxi-
mately $65 billion in lost productivity and health
care costs.
(3) Environmental tobacco smoke is a cause of
disease in nonsmokers.
(4) In spite of well established dangers of ciga-
rette smoking and tobacco use, no Federal regu-
latory agency has the authority to regulate the man-
ufacture, sale, distribution, labeling, and advertising
of such products.
(5) Tobacco is as addictive as cocaine and
heroin.
(6) The tobacco industry spends approximately
$4 billion each year to promote its products.
(7) The tobacco industry’s voluntary advertising
code which was enacted to prohibit the use of images
of sexual attraction, sophistication, and athletic
abilities and the making of implied health claims has
for the last 30 years not been followed or enforced.
(8) Each day 3,000 children try cigarettes for
the first time and many become life-long addicted
smokers.
(9) There is no Federal minimum age of sale of
cigarettes and tobacco products.
(10) The labeling of tobacco products is inad-
equate as to provide smokers and nonsmokers alike
with full and complete information about tobacco
products.
(11) The tobacco industry adds chemical addi-
tives to their products that are neither disclosed to
the public or tested for health and safety in a com-
parable manner to food.
(12) There is no listing of chemical constituents
found in mainstream and sidestream smoke (includ-
ing benzene, arsenic, cyanide, etc.).
(13) The Food and Drug Administration is the
most qualified Federal agency to comprehensively
regulate tobacco products.
(14) It is inconsistent for the Food and Drug
Administration to regulate the manufacture, sale,
distribution, labeling, advertising, and promotion of
other nicotine containing products used as sub-
stitutes for cigarette smoking and tobacco use and
not be able to regulate tobacco products in a com-
parable manner.
SEC. 3. DEFINITIONS.
Section 201 (21 U.S.C. 321) is amended by adding
at the end thereof the following new paragraphs:
‘‘(gg) The term ‘tobacco product’ means cigarettes,
cigars, little cigars, pipe tobacco, smokeless tobacco, snuff,
and chewing tobacco.
‘‘(hh) The term ‘tobacco additive’ means any sub-
stance 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 characteristics of
any tobacco product.
‘‘(ii) The term ‘constituent’ means any element of
cigarette mainstream or sidestream smoke which is
present in quantities which represent a potential health
hazard or where the health effect is unknown.
‘‘(jj) The term ‘tar’ means mainstream total articu-
late matter minus nicotine and water.
SEC. 4. ENFORCEMENT.
Section 301 (21 U.S.C. 331) is amended by adding
at the end thereof the following new subsection:
‘‘(u) The manufacture, labeling, sale, distribution,
advertising, and promotion of tobacco products in violation
of regulations of the Secretary pursuant to section 701.’’
SEC. 5. REGULATION OF TOBACCO PRODUCTS.
(a) REGULATION.—The Federal Food, Drug, and
Cosmetic Act is amended by redesignating chapters VII,
VIII, and IX as chapters VIII, IX, and X, respectively,
and by adding after chapter VI the following:
‘‘CHAPTER VII—TOBACCO PRODUCTS
‘‘REGULATIONS
‘‘SEC. 701. (a) PROMULGATION.—The Secretary
shall promulgate regulations governing the manufacture,
distribution, sale, labeling, and advertising and promotion
of tobacco products which are consistent with the manner
in which other products which are ingested into the body
are regulated, except that the Secretary may not promul-
gate a regulation which prohibits the sale and distribution
of a tobacco product solely on the basis of the fact that
tobacco causes disease. Such regulations shall be promul-
gated not later than 12 months after the date the Sec-
retary receives the recommendations of the Tobacco and
Nicotine Products Advisory Committee under section
702(e).
‘‘(b) MINIMUM REQUIREMENTS.—
‘‘(1) SALE
OR
DISTRIBUTION.—Regulations
under subsection (a) shall with respect to the sale or
distribution of tobacco products make unlawful—
‘‘(A) the sale of a tobacco product intended
for use by man to any person under the age of
18 years or under such other age greater than
18 years as the State in which the sale occurs
may establish by law,
‘‘(B) the distribution of a tobacco product
as a free sample or the distribution of a tobacco
product as a result of coupons or other mate-
rials which allow for the obtaining of free or
discounted tobacco products, or
‘‘(C) the sale or distribution of a tobacco
product if the label fails to carry the following
statement: ‘‘Federal Law Prohibits Sale To
Minors’’.
The Secretary shall enforce this paragraph in a
manner that can reasonably be expected to ensure
that tobacco products are not made available to indi-
viduals under the age of 18 years.
‘‘(2) LABELING.—
‘‘(A) IN
GENERAL.—Regulations under
subsection (a) with respect to the labeling of to-
bacco products shall require that a tobacco
product shall be deemed misbranded if—
‘‘(i) it is not in compliance with the
labeling requirements of the Federal Ciga-
rette Labeling and Advertising Act and the
Comprehensive Smokeless Tobacco Health
Education Act of 1986,
‘‘(ii) it does not include a warning and
information about the dangers associated
with environmental tobacco smoke,
‘‘(iii) it does not provide a list of
chemical additives and constituents found
in tobacco products and tobacco smoke, or
‘‘(iv) it contains any implied or direct
health claim, including the use of such
terms as light, lower tar, medium, lowest,
or nicotine free, unless such terms have
been approved by the Secretary on the
basis of sound scientific data and the Sec-
retary determines that such terms will
have a significant impact on the health
consequences associated with cigarette
smoking and other tobacco use.
‘‘(B) SPECIFIC
INFORMATION.—The Sec-
retary may include in regulations under sub-
section (a) relating to labeling of tobacco prod-
ucts labeling requirements requiring manufac-
turers of tobacco products to provide to con-
sumers by way of labeling of packages, package
inserts, or other means—
‘‘(i) information about the adverse ef-
fects of tobacco products,
‘‘(ii) adequate warnings and directions
for use,
‘‘(iii) contraindications,
‘‘(iv) adequate warnings against use
in pathological conditions, and
‘‘(v) any other information deemed
necessary by the Secretary.’’.
‘‘(3) ADVERTISING AND PROMOTION.—
‘‘(A) CONSISTENCY.—Regulations under
subsection (a) with respect to the advertising
and promotion of tobacco products shall be con-
sistent with regulations governing the advertis-
ing and promotion of prescription drugs, espe-
cially such drugs which contain nicotine.
‘‘(B) SPONSORSHIP.—In such regulations,
the Secretary shall make it unlawful for any
sporting event, cultural event, or any other
event or function open to the public to be spon-
sored by a tobacco manufacturer who at such
event or function displays the name or logo of
any brand of cigarettes or tobacco product of
such manufacturer.
‘‘(C) CONSTRUCTION.—Such regulations
and the authority provided the Secretary does
not repeal or modify the authority of the Fed-
eral Trade Commission in carrying out its
responsibilities.
‘‘(4) 
MANUFACTURING.—Regulations 
under
subsection (a) governing the manufacture of tobacco
products shall—
‘‘(A) require that all additives used in the
manufacture of tobacco products are safe,
‘‘(B) classify as a drug any nicotine con-
taining product which does not meet the defini-
tion of a tobacco product, and
‘‘(C) have the authority to subpoena any
document which relates to the manner in which
tobacco products are manufactured.
‘‘ADVISORY COMMITTEE
‘‘SEC. 702. (a) ESTABLISHMENT.—To assist in the
development of regulations required by section 701, there
is established in the Food and Drug Administration a To-
bacco and Nicotine Products Advisory Committee (herein-
after in this section referred to as the ‘‘advisory commit-
tee’’).
‘‘(b) MEMBERSHIP.—
‘‘(1) SECRETARIAL APPOINTMENTS.—The Sec-
retary shall appoint to the advisory committee 10 in-
dividuals who are qualified by training and experi-
ence to evaluate and make recommendations for the
issuance of regulations governing the manufacture,
distribution, sale, labeling, and advertising and pro-
motion of tobacco products which, to the greatest ex-
tent practical, promote and protect the public’s
health without banning the product. The 10 mem-
bers shall consist of—
‘‘(A) one expert in the field of nicotine
addiction,
‘‘(B) one expert in the field of pharmacol-
ogy,
‘‘(C) one expert in the field of food and
drug law,
‘‘(D) one expert in the field of marketing
and promotion of products,
‘‘(E) one expert in the field of public
education,
‘‘(F) one expert in the field of toxicology,
‘‘(G) two representing the interests of fam-
ily medicine, internal medicine, or pediatrics,
and
‘‘(H) two consumer representatives from
the public health community.
‘‘(2) EX OFFICIO.—The Directors of the Na-
tional Cancer Institute, the National Heart, Lung,
and Blood Institute, the National Institute of Drug
Abuse, the Centers for Disease Control and Preven-
tion, and the Surgeon General of the United States
shall serve as ex officio members of the advisory
committee.
‘‘(3) CHAIRMAN.—The chairman of the advisory
committee shall be appointed by the Secretary with
the advice and consent of the Commissioner of Food
and Drugs.
‘‘(4) APPOINTMENT DATE.—The Secretary shall
make appointments to the advisory committee within
60 days of the date of the enactment of this section.
‘‘(c) FUNCTION.—The advisory committee shall give
specific consideration to—
‘‘(1) reviewing the available scientific evidence
on the effects of tobacco products on human health,
including the effects of environmental tobacco smoke
on nonsmokers,
‘‘(2) reviewing the manufacturing process of to-
bacco products, including the use of additives,
sprayed on chemicals, product development, and
product manipulation,
‘‘(3) reviewing the role of nicotine as part of
the smoking habit, including its addictive properties
and health effects,
‘‘(4) reviewing the marketing and promotional
techniques used by tobacco manufacturers in selling
their products, and
‘‘(5) reviewing current Federal, State, and local
laws governing the manufacture, distribution, sale,
labeling, and advertising and promotion of tobacco
products.
‘‘(d) AUTHORITY.—The advisory committee may for
the purpose of carrying out its functions hold such hear-
ings, sit and act at such times and places, take such testi-
mony, and receive such evidence as the advisory committee
deems appropriate.
‘‘(e) RECOMMENDATIONS.—The advisory committee
shall make recommendations respecting the issuance of
regulations under section 701 within 12 months of the ap-
pointment of the 10 members of the advisory committee.
‘‘REGISTRATION
‘‘SEC. 703. Each tobacco product manufacturer shall
register with the Secretary. Any such manufacturer who
is in business on the date of the enactment of this Act
shall register with the Secretary not later than 120 days
after the date of the enactment of this section.
‘‘TOBACCO PRODUCT MANUFACTURER FEE
‘‘SEC. 704.(a) FEE PURPOSE.—For the purpose of
paying the costs of implementing this chapter, each to-
bacco product manufacturer shall pay an annual fee estab-
lished pursuant to paragraph (2). Such fee shall be pay-
able on or before January 31 of each year.
‘‘(b) ESTABLISHMENT BY THE SECRETARY.—Subject
to the amount established in appropriation Acts, the an-
nual tobacco product manufacturer fee shall be deter-
mined by the Secretary based upon the total market share
for each brand of tobacco product.
‘‘(c) CREDITING AND AVAILABILITY OF FEES.—
‘‘(1) IN GENERAL.—Fees collected for a fiscal
year pursuant to subsection (a) shall be credited to
the appropriation account for salaries and expenses
of the Food and Drug Administration and shall be
available in accordance with appropriation Acts until
expended without fiscal year limitation.
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION
ACTS.—The fees authorized by subsection (a)—
‘‘(A) shall be collected in each fiscal year
in an amount equal to the amount specified in
appropriation Acts for such fiscal year, and
‘‘(B) shall only be collected and available
to defray the costs of implementing this chap-
ter.’’.
(b) CONFORMING AMENDMENTS.—
(1) TOBACCO LABELING AND ADVERTISING.—
The Federal Cigarette Labeling and Advertising Act
(15 U.S.C. 1331 et seq.) is amended—
(A) in section 4 (15 U.S.C. 1333) by strik-
ing out ‘‘SURGEON GENERAL’S WARN-
ING: Cigarette Smoke Contains Carbon Mon-
oxide’’ each place it appears and inserting in
lieu thereof ‘‘SURGEON GENERAL’S WARN-
ING: Smoking is Addictive. Once You Start
You May Not Be Able to Stop’’, and
(B) by repealing sections 5(b) and 7 (15
U.S.C. 1334(b), 1335a).
(2) SMOKELESS TOBACCO.—The Comprehensive
Smokeless Tobacco Health Education Act of 1986 is
amended—
(A) 
in 
section 
3(a)(1) 
(15 
U.S.C.
4402(a)(1)), by striking out the close quotation
marks and the period following at the end and
inserting the following: