Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 220.0

529US1

Unit: $U36

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

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

145

Opinion of the Court

Commission (FTC) issued a notice of proposed rulemaking,
see 29 Fed. Reg. 530–532 (1964), and in June 1964, the FTC
promulgated a ﬁnal rule requiring cigarette manufacturers
“to disclose, clearly and prominently, in all advertising and
on every pack, box, carton or other container . . . that ciga-
rette smoking is dangerous to health and may cause death
from cancer and other diseases,” id., at 8325. The rule was
to become effective January 1, 1965, but, on a request from
Congress, the FTC postponed enforcement for six months.
See Cipollone v. Liggett Group, Inc., 505 U. S. 504, 513–514
(1992).

In response to the Surgeon General’s report and the FTC’s
proposed rule, Congress convened hearings to consider legis-
lation addressing “the tobacco problem.” 1964 Hearings 1.
During those deliberations, FDA representatives testiﬁed
before Congress that the agency lacked jurisdiction under
the FDCA to regulate tobacco products. Surgeon General
Terry was asked during hearings in 1964 whether HEW had
the “authority to brand or label the packages of cigarettes or
to control the advertising there.”
Id., at 56. The Surgeon
General stated that “we do not have such authority in exist-
ing laws governing the . . . Food and Drug Administration.”
Ibid. Similarly, FDA Deputy Commissioner Rankin testi-
ﬁed in 1965 that “[t]he Food and Drug Administration has no
jurisdiction under the Food, Drug, and Cosmetic Act over
tobacco, unless it bears drug claims.” Cigarette Labeling
and Advertising—1965: Hearings on H. R. 2248 before the
House Committee on Interstate and Foreign Commerce, 89th
Cong., 1st Sess., 193 (hereinafter 1965 Hearings). See also
Letter to Directors of Bureaus, Divisions and Directors of
Districts from FDA Bureau of Enforcement (May 24, 1963),
in 1972 Hearings 240 (“[T]obacco marketed for chewing or
smoking without accompanying therapeutic claims, does not
meet the deﬁnitions in the Food, Drug, and Cosmetic Act for
food, drug, device or cosmetic”).
In fact, HEW Secretary
Celebrezze urged Congress not to amend the FDCA to cover