‘‘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.
Effective one year after the date of the enactment
of this Act, all provisions of the regulations related to to-
bacco products promulgated by the Secretary of Health
and Human Services on August 28, 1996 (61 Fed. Reg.
44615–44618) shall take effect under authority of the
Federal Food, Drug, and Cosmetic Act as amended by this
Act. The Secretary shall amend the designations of au-
thorities 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:
‘‘(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:
‘‘(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
(2) the Comprehensive Smokeless Tobacco
Health Education Act of 1986 (15 U.S.C. 4401 et
seq.), other than sections 3(f), 5, and 6, is repealed.
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