(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(a) of the Federal
Food, Drug, and Cosmetic Act (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. 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:
‘‘Subchapter F—Special Provisions for
Tobacco Products
‘‘SEC. 565. SPECIAL STANDARD FOR TOBACCO PRODUCTS.
‘‘In the case of tobacco products, an action that is
appropriate for the protection of public health shall be
deemed to provide a reasonable assurance of safety and
effectiveness.
‘‘SEC. 
566. 
WARNINGS 
REGARDING 
CIGARETTES 
AND
SMOKELESS TOBACCO; REGULATIONS.
‘‘(a) IN GENERAL.—Not later than 18 months after
the date of the enactment of this subchapter, the Sec-
retary shall promulgate regulations to require warnings on
cigarette and smokeless tobacco labeling and advertise-
ments. The content, format, and rotation of warnings shall
conform to the specifications described in Title IB of the
Proposed Resolution entered into by the tobacco manufac-
turers and the State attorneys general on June 20, 1997.
‘‘(b) 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 public health.
‘‘(c) SAVINGS PROVISION.—Subsection (a) or (b) may
not be construed as limiting the authority provided under
other provisions of this Act with respect to tobacco prod-
ucts.
‘‘SEC. 567. RULE OF CONSTRUCTION REGARDING FARMERS
AND RELATED ENTITIES.
‘‘The provisions of this Act relating to tobacco prod-
ucts shall not apply to tobacco leaf that is not in the pos-
session of the manufacturer, or to the producers of tobacco
leaf, including tobacco growers, tobacco warehouses, and
tobacco grower cooperatives, nor shall any employee of the
Food and Drug Administration have any authority what-
soever to enter onto a farm owned by a producer of to-
bacco leaf without the written consent of such producer.
Notwithstanding any other provision of this subparagraph,
if a producer of tobacco leaf is also a tobacco product man-
ufacturer or controlled by a tobacco product manufac-
turer, the producer shall be subject to this chapter in the
producer’s capacity as a manufacturer. Nothing in this
chapter shall be construed to grant the Secretary author-
ity to promulgate regulations on any matter that involves
the production of tobacco leaf or a producer thereof, other
than activities by a manufacturer affecting production.
For purposes of the preceding sentence, the term ‘con-
trolled by’ means a member of the same controlled group
of corporations as that term is used in section 52(a) of
the Internal Revenue Code of 1986, or under common con-
trol within the meaning of the regulations promulgated
under section 52(b) of such Code.’’.
SEC. 6. VALIDATION OF FDA RULE.
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.
44615–44618), and codified in title 21, Code of Federal
Regulations, shall, upon the date of the enactment of this
Act, take effect under authority of the Federal Food,
Drug, and Cosmetic Act as amended by this Act. The Sec-
retary shall amend the designations of authorities in such
regulations accordingly.
SEC. 7. GENERAL PROVISIONS.
(a) ENFORCEMENT.—Section 301 (21 U.S.C. 331) is
amended by adding at the end the following:
‘‘(aa) 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:
‘‘(i) 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. REPEALS.
Effective on the date the regulations described in sec-
tion 566(a) of the Federal Food, Drug, and Cosmetic Act
take effect—
(1) the Federal Cigarette Labeling and Adver-
tising Act (15 U.S.C. 1331 et seq.), other than sec-
tions 6, 8, 10, and 11, is repealed; and