I
107TH CONGRESS
1ST SESSION
H. R. 1043
To amend the Federal Food, Drug, and Cosmetic Act to provide the Food
and Drug Administration jurisdiction over tobacco.
IN THE HOUSE OF REPRESENTATIVES
MARCH 15, 2001
Mr. WAXMAN (for himself, Mr. HANSEN, Mr. MEEHAN, Mr. GANSKE, Mr.
DINGELL, Mrs. MORELLA, Mr. BROWN of Ohio, Mr. DOGGETT, Mr.
BONIOR, Ms. DEGETTE, Mrs. CAPPS, Ms. DELAURO, Mr. LANTOS, Mr.
MARKEY, Ms. ESHOO, Mr. STARK, Mr. ALLEN, Mr. MCDERMOTT, Mrs.
MINK of Hawaii, Ms. SCHAKOWSKY, Mr. OLVER, Mr. HINCHEY, Ms.
NORTON, Mrs. TAUSCHER, Mr. OBERSTAR, Mr. GEORGE MILLER of Cali-
fornia, Ms. RIVERS, Mr. BALDACCI, Mr. PAYNE, Mr. BORSKI, Ms. ROY-
BAL-ALLARD, Mr. LAFALCE, Mr. DEFAZIO, Ms. SLAUGHTER, Ms.
PELOSI, Mr. COYNE, Mr. BLUMENAUER, Mrs. MALONEY of New York,
and Mr. WEXLER) introduced the following bill; which was referred to the
Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
provide the Food and Drug Administration jurisdiction
over tobacco.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘FDA Tobacco Juris-
diction Act of 2001’’.
SEC. 2. REFERENCE.
Whenever in this Act an amendment or repeal is ex-
pressed in terms of an amendment to, or repeal of, a sec-
tion or other provision, the reference shall be considered
to be made to a section or other provision of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 3. DEFINITIONS.
(a) DRUG.—Section 201(g)(1) (21 U.S.C. 321(g)(1))
is amended by striking ‘‘; and (D)’’ and inserting ‘‘; (D)
nicotine in tobacco products; and (E)’’.
(b) DEVICES.—Section 201(h) (21 U.S.C. 321(h)) is
amended by adding at the end the following: ‘‘Such term
includes a tobacco product.’’.
(c) OTHER DEFINITIONS.—Section 201 (21 U.S.C.
321) is amended by adding at the end the following:
‘‘(kk) The term ‘tobacco product’ means any product
made or derived from tobacco that is intended for human
consumption.’’.
SEC. 4. AMENDMENTS TO CHAPTER V.
(a) MISBRANDING.—Section 502 (21 U.S.C. 360) is
amended by adding at the end the following:
‘‘(u) In the case of a tobacco product, if it does not
comply with a requirement under subchapter F.’’.
(b) CLARIFICATION OF AUTHORITY.—Section 520(e)
(21 U.S.C. 360j(e)) is amended by adding at the end the
following:
‘‘(3) In the case of tobacco products, the restrictions
on sale and distribution authorized by paragraph (1) shall
include restrictions on advertising and promotion of to-
bacco products.’’.
(c) 
PREEMPTION.—Section 
521(a) 
(21 
U.S.C.
360k(a)) is amended—
(1) by striking ‘‘Except as provided in sub-
section (b)’’ and inserting ‘‘Except in the case of to-
bacco products and as provided in subsection (b)’’;
and
(2) by adding at the end the following:
‘‘TOBACCO PRODUCTS
‘‘(c) If the package or advertisement of a tobacco
product is required to bear a warning under this Act, no
statement relating to the use of the tobacco product and
health, other than a statement required under this Act,
may be required by any State or local statute or regulation
to be included on any package or in any advertisement
of such tobacco product.’’.
SEC. 5. VALIDATION OF THE FDA RULE.
(a) IN GENERAL.—All provisions of the regulations
related to tobacco products promulgated by the Secretary
of Health and Human Services on August 28, 1996 (61
Fed. Reg. 44396) shall be considered to be lawful, and
to have been lawfully promulgated, under the Federal
Food, Drug, and Cosmetic Act.
(b) EFFECTIVE DATE.—All provisions of such regula-
tions shall take effect upon the expiration of 1 year after
the date of the enactment of this Act.
SEC. 6. SPECIAL PROVISIONS FOR TOBACCO PRODUCTS.
Chapter V is amended by adding at the end the fol-
lowing:
‘‘Subchapter F—Special Provisions for
Tobacco Products
‘‘SEC. 565. SPECIAL STANDARD FOR TOBACCO PRODUCTS.
‘‘In the case of tobacco products, an action that pro-
vides appropriate protection of public health shall be
deemed to provide a reasonable assurance of safety and
effectiveness.
‘‘SEC. 566. IMPLEMENTATION OF THE PROPOSED RESOLU-
TION.
‘‘(a) ADDITIONAL RESTRICTIONS
ON MARKETING,
ADVERTISING, AND ACCESS.—Not later than 18 months
after the date of the enactment of this subchapter, the
Secretary shall revise the regulations related to tobacco
products promulgated by the Secretary on August 28,
1996 (61 Fed. Reg. 44396) to include the additional re-
strictions on marketing, advertising, and access described
in Title IA and Title IC of the Proposed Resolution en-
tered into by the tobacco manufacturers and the State at-
torneys general on June 20, 1997, except that the Sec-
posed Resolution entered into by the tobacco manu-
facturers and the State attorneys general on June
20, 1997.
‘‘(2) FAILURE TO ACT.—If the Secretary fails
to approve or disapprove an ingredient’s safety with-
in the review period prescribed under the regulations
under paragraph (1), such failure shall not be con-
sidered an approval of such ingredient.
‘‘(d) REDUCED-RISK PRODUCTS.—No manufacturer
of a tobacco product may state or imply in the labeling
or advertisements of the tobacco product that the tobacco
product presents a reduced risk to health unless the Sec-
retary has determined that the tobacco product does
present a significantly reduced risk to health.
‘‘(e) OTHER AUTHORITY.—This section does not
limit the authority the Secretary has under other provi-
sions of this Act with respect to tobacco products.
‘‘SEC. 567. STATE TOBACCO CONTROL PROGRAMS.
‘‘(a) IN GENERAL.—Effective 2 years after the date
of the enactment of this subchapter, a State may not re-
ceive funds under this Act for tobacco control activities
unless the State has put into law a State tobacco control
program that conforms to the model State program estab-
lished by the Secretary under subsection (b).
‘‘(b) MODEL STATE PROGRAM.—
‘‘(1) GENERAL RULE.—Within one year of the
date of the enactment of this subchapter, the Sec-
retary shall establish a model State tobacco control
program.
‘‘(2) PROGRAM CONTENT.—The model State to-
bacco control program established under paragraph
(1) shall—
‘‘(A) require persons who sell tobacco
products to individuals for personal consump-
tion to obtain a license from the State;
‘‘(B) require licensed retailers to comply
with the requirements under this Act that are
applicable to tobacco product retailers;
‘‘(C) prohibit any individual from pur-
chasing tobacco products for resale or distribu-
tion to individuals under the age of 18;
‘‘(D) include minimum requirements for
the conduct and frequency of compliance in-
spections of licensed retailers;
‘‘(E) include State performance objectives,
including objectives for reducing the level of vio-
lations observed during compliance inspections;
‘‘(F) include provisions for appropriate
penalties for violations of the program require-
ments, including provisions for license suspen-
sion and revocation; and
‘‘(G) include such other provisions as the
Secretary determines are appropriate to protect
public health.
‘‘(c) FAILURE TO IMPLEMENT.—If a State fails to
effectively implement a State tobacco control program
which conforms to the Model State program established
under subsection (b) or if a State fails to achieve the per-
formance objectives applicable to the State under the
Model State program, the Secretary shall withhold up to
20 percent of the funds made available under this Act to
the State for tobacco control activities.
‘‘(d) FEDERAL LICENSING PROGRAM.—Within one
year of the date of the enactment of this subchapter, the
Secretary shall establish Federal licensing requirements
for—
‘‘(1) tobacco product retailers operating on
Federal property;
‘‘(2) tobacco product retailers operating in a
State which does not put into law or effectively im-
plement a State tobacco control program which con-
forms to the Model State Program; and
‘‘(3) such other tobacco product retailers as the
Secretary may specify.
The Federal tobacco control requirements shall conform
to the licensing requirements of the Model State Program.
‘‘(e) FEDERAL AUTHORITY.—The Secretary may
order a retailer licensed by a State to suspend or cease
selling tobacco products if the tobacco product retailer is
in violation of a requirement under this Act related to to-
bacco products.
‘‘(f) INDIAN TRIBES.—In the case of tobacco product
retailers operating on Indian reservations, the governing
Indian tribe or tribal organization shall be treated as a
State.’’.
SEC. 7. GENERAL PROVISIONS.
(a) ENFORCEMENT.—Section 301 (21 U.S.C. 331) is
amended by adding at the end the following:
‘‘(bb) The violation of any requirement under this Act
relating to tobacco products.’’.
(b) ACCESS
TO INFORMATION.—Section 701 (21
U.S.C 371) is amended by adding at the end the following:
‘‘(h) To acquire information related to tobacco prod-
ucts, the Secretary may administer oaths and require the
testimony of witnesses and the production of documents
and other materials. The Secretary may disclose to the
public information acquired under this subsection if the
Secretary determines that disclosure is appropriate to pro-
tect public health.’’.
SEC. 8. REPEAL.
The Federal Cigarette Labeling and Advertising Act
(15 U.S.C. 1331 et seq.) and the Comprehensive Smoke-
less Tobacco Health Education Act of 1986 (15 U.S.C.
4401 et seq.) are repealed on the date the regulations de-
scribed in section 566(b) of the Federal Food, Drug, and
Cosmetic Act take effect.
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