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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

42 U. S. C. § 290aa et seq.), which require the Secretary of
HHS to report to Congress every three years on the “addic-
tive property of tobacco” and to include recommendations for
action that the Secretary may deem appropriate. A year
later, Congress enacted the Comprehensive Smoking Educa-
tion Act, Pub. L. 98–474, 98 Stat. 2200, which amended the
FCLAA by again modifying the prescribed warning. Nota-
bly, during debate on the Senate ﬂoor, Senator Hawkins
argued that the FCLAA was necessary in part because
“[u]nder the Food, Drug and Cosmetic Act, the Congress
exempted tobacco products.” 130 Cong. Rec. 26953 (1984).
And in 1986, Congress enacted the Comprehensive Smoke-
less Tobacco Health Education Act of 1986 (CSTHEA), Pub.
L. 99–252, 100 Stat. 30 (codiﬁed at 15 U. S. C. § 4401 et seq.),
which essentially extended the regulatory provisions of the
FCLAA to smokeless tobacco products. Like the FCLAA,
the CSTHEA provided that “[n]o statement relating to the
use of smokeless tobacco products and health, other than the
statements required by [the Act], shall be required by any
Federal agency to appear on any package . . . of a smokeless
tobacco product.” § 7(a), 100 Stat. 34 (codiﬁed at 15 U. S. C.
§ 4406(a)). Thus, as with cigarettes, Congress reserved for
itself an aspect of smokeless tobacco regulation that is partic-
ularly important to the FDCA’s regulatory scheme.

In 1988, the Surgeon General released a report summa-
rizing the abundant scientiﬁc literature demonstrating that
“[c]igarettes and other forms of tobacco are addicting,” and
that “nicotine is psychoactive” and “causes physical depend-
ence characterized by a withdrawal syndrome that usually
accompanies nicotine abstinence.”
1988 Surgeon General’s
Report 14. The report further concluded that the “pharma-
cologic and behavioral processes that determine tobacco ad-
diction are similar to those that determine addiction to drugs
such as heroin and cocaine.”
In the same year,
FDA Commissioner Young stated before Congress that “it
doesn’t look like it is possible to regulate [tobacco] under the

Id., at 15.