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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

15 U. S. C. §§ 1331, 1333, 4402; prohibit the advertisement of
tobacco products through “any medium of electronic commu-
nication” subject to regulation by the Federal Communica-
tions Commission (FCC), see §§ 1335, 4402(f); require the
Secretary of HHS to report every three years to Congress
on research ﬁndings concerning “the addictive property of
tobacco,” 42 U. S. C. § 290aa–2(b)(2); and make States’ receipt
of certain federal block grants contingent on their making
it unlawful “for any manufacturer, retailer, or distributor of
tobacco products to sell or distribute any such product to any
individual under the age of 18,” § 300x–26(a)(1).

In adopting each statute, Congress has acted against the
backdrop of the FDA’s consistent and repeated statements
that it lacked authority under the FDCA to regulate tobacco
absent claims of therapeutic beneﬁt by the manufacturer.
In fact, on several occasions over this period, and after the
health consequences of tobacco use and nicotine’s pharmaco-
logical effects had become well known, Congress considered
and rejected bills that would have granted the FDA such
jurisdiction. Under these circumstances, it is evident that
Congress’ tobacco-speciﬁc statutes have effectively ratiﬁed
the FDA’s long-held position that it lacks jurisdiction under
the FDCA to regulate tobacco products. Congress has
created a distinct regulatory scheme to address the problem
of tobacco and health, and that scheme, as presently con-
structed, precludes any role for the FDA.

On January 11, 1964, the Surgeon General released the
report of the Advisory Committee on Smoking and Health.
That report documented the deleterious health effects of
smoking in great detail, concluding, in relevant part, “that
cigarette smoking contributes substantially to mortality
from certain speciﬁc diseases and to the overall death rate.”
1964 Surgeon General’s Report 31.
It also identiﬁed the
pharmacological effects of nicotine, including “stimulation,”
“tranquilization,” and “suppression of appetite.”
Id., at 74–
75. Seven days after the report’s release, the Federal Trade