Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 212

529US1

Unit: $U36

[09-26-01 08:36:38] PAGES PGT: OPIN

Cite as: 529 U. S. 120 (2000)

137

Opinion of the Court

The FDCA’s misbranding and device classiﬁcation provi-
sions therefore make evident that were the FDA to regulate
cigarettes and smokeless tobacco, the Act would require the
agency to ban them.
In fact, based on these provisions, the
FDA itself has previously taken the position that if tobacco
products were within its jurisdiction, “they would have to
be removed from the market because it would be impossi-
ble to prove they were safe for their intended us[e].” Pub-
lic Health Cigarette Amendments of 1971: Hearings before
the Commerce Subcommittee on S. 1454, 92d Cong., 2d Sess.,
239 (1972) (hereinafter 1972 Hearings) (statement of FDA
Comm’r Charles Edwards). See also Cigarette Labeling
and Advertising: Hearings before the House Committee on
Interstate and Foreign Commerce, 88th Cong., 2d Sess., 18
(1964) (hereinafter 1964 Hearings) (statement of Dept. of
Health, Education, and Welfare (HEW) Secretary Anthony
Celebrezze that proposed amendments to the FDCA that
would have given the FDA jurisdiction over “smoking prod-
uct[s]” “might well completely outlaw at least cigarettes”).
Congress, however, has foreclosed the removal of tobacco
products from the market. A provision of the United States
Code currently in force states that “[t]he marketing of to-
bacco constitutes one of the greatest basic industries of the
United States with ramifying activities which directly affect
interstate and foreign commerce at every point, and stable
conditions therein are necessary to the general welfare.” 7
U. S. C. § 1311(a). More importantly, Congress has directly
addressed the problem of tobacco and health through legisla-
tion on six occasions since 1965. See Federal Cigarette La-
beling and Advertising Act (FCLAA), Pub. L. 89–92, 79 Stat.
282; Public Health Cigarette Smoking Act of 1969, Pub. L.
91–222, 84 Stat. 87; Alcohol and Drug Abuse Amendments of
1983, Pub. L. 98–24, 97 Stat. 175; Comprehensive Smoking
Education Act, Pub. L. 98–474, 98 Stat. 2200; Comprehensive
Smokeless Tobacco Health Education Act of 1986, Pub. L.
99–252, 100 Stat. 30; Alcohol, Drug Abuse, and Mental