I
107TH CONGRESS
1ST SESSION
H. R. 1097
To amend the Federal Food, Drug, and Cosmetic Act with respect to tobacco
products, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 20, 2001
Mr. GANSKE (for himself, Mr. DINGELL, Mr. BALDACCI, Mr. BARTLETT of
Maryland, Mr. BEREUTER, Mr. BLUMENAUER, Mrs. BONO, Mrs. CAPPS,
Mr. DEFAZIO, Ms. DEGETTE, Mr. DOGGETT, Ms. ESHOO, Mr. EVANS,
Mr. FRANK, Mr. GALLEGLY, Mr. GILMAN, Mr. GREEN of Texas, Mr.
HANSEN, Mr. HINCHEY, Mr. HORN, Ms. KAPTUR, Mr. KIND, Mr.
KUCINICH, Mr. LAFALCE, Mr. LEACH, Mr. LIPINSKI, Mr. LUTHER, Mrs.
MALONEY of New York, Mr. MCDERMOTT, Mr. MCGOVERN, Mr. MEE-
HAN, Mr. MORAN of Virginia, Mrs. MORELLA, Mr. NADLER, Mr.
NETHERCUTT, Mr. OLVER, Mr. PALLONE, Mr. PAYNE, Ms. ROYBAL-AL-
LARD, Ms. SCHAKOWSKY, Mr. SNYDER, Mr. STARK, Mr. STUPAK, Mrs.
TAUSCHER, Mr. THOMPSON of California, Mr. UDALL of New Mexico,
Mr. UNDERWOOD, Mr. WAXMAN, Mr. WEINER, and Mr. WELLER) intro-
duced the following bill; which was referred to the Committee on Energy
and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with
respect to tobacco products, and for other purposes.
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 Author-
ity Amendments Act’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) Tobacco products are addictive.
(2) Such products cause over 400,000 deaths
each year in the United States.
(3) The Supreme Court has held that there is
no congressional intent to provide the Food and
Drug Administration with the authority to regulate
tobacco products.
(4) The Congress should amend the Federal
Food, Drug, and Cosmetic Act to provide the Food
and Drug Administration with the authority to regu-
late tobacco products.
SEC. 3. DEFINITIONS.
(a) DRUG.—Section 201(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)) is amend-
ed by inserting after the first sentence the following:
‘‘Such term includes nicotine in a tobacco product.’’.
(b) DEVICES.—Section 201(h) of the Federal Food,
Drug, and Cosmetic Act (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 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 321) is
amended by adding at the end the following:
‘‘(kk) The term ‘tobacco product’ means any product
made or derived from tobacco that is intended for human
consumption.’’.
SEC. 4. AMENDMENTS TO CHAPTER V.
(a) MISBRANDING.—Section 502 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amend-
ed 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 REGARDING AD-
VERTISING AND PROMOTION; EQUAL TREATMENT OF RE-
TAIL OUTLETS.—Section 520(e) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360j(e)) is amended
by adding at the end the following:
‘‘(3) In the case of tobacco products:
‘‘(A) The restrictions on sale and distribution
authorized by paragraph (1) shall include restric-
tions on advertising and promotion of tobacco prod-
ucts.
‘‘(B) The Secretary shall ensure that such re-
strictions are applied uniformly to all entities that
make retail sales of tobacco products. For purposes
of the preceding sentence, such restrictions may not
exempt or apply differently to retail establishments
that predominantly or exclusively sell tobacco prod-
ucts.’’.
(c) PREEMPTION.—Section 521 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360k) is amended—
(1) in subsection (a), by striking ‘‘Except as
provided in subsection (b)’’ and inserting ‘‘Except in
the case of tobacco products and as provided in sub-
section (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. SPECIAL PROVISIONS FOR TOBACCO PRODUCTS.
Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by adding at the
end the following: