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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

ther stated that the FDA believed that the Public Health
Cigarette Smoking Act “demonstrates that the regulation of
cigarettes is to be the domain of Congress,” and that “label-
ing or banning cigarettes is a step that can be take[n] only
by the Congress. Any such move by FDA would be incon-
sistent with the clear congressional intent.”

Ibid.

Ibid.

In 1977, ASH ﬁled a citizen petition requesting that the
FDA regulate cigarettes, citing many of the same grounds
that motivated the FDA’s rulemaking here. See Citizen Pe-
tition, No. 77P–0185 (May 26, 1977), 10 Rec. in No. 97–1604
(CA4), Tab No. 22, pp. 1–10. ASH asserted that nicotine
was highly addictive and had strong physiological effects on
the body; that those effects were “intended” because con-
sumers use tobacco products precisely to obtain those ef-
fects; and that tobacco causes thousands of premature deaths
annually.
In denying ASH’s petition, FDA Commis-
sioner Kennedy stated that “[t]he interpretation of the Act
by FDA consistently has been that cigarettes are not a drug
unless health claims are made by the vendors.” Letter to
ASH Executive Director Banzhaf (Dec. 5, 1977), App. 47.
After the matter proceeded to litigation, the FDA argued in
its brief to the Court of Appeals that “cigarettes are not
comprehended within the statutory deﬁnition of the term
‘drug’ absent objective evidence that vendors represent or
intend that their products be used as a drug.” Brief for Ap-
pellee in Action on Smoking and Health v. Harris, 655 F. 2d
236 (CADC 1980), 9 Rec. in No. 97–1604 (CA4), Tab No. 4,
at 27–28. The FDA also contended that Congress had “long
been aware that the FDA does not consider cigarettes to be
within its regulatory authority in the absence of health
claims made on behalf of the manufacturer or vendor,” and
that, because “Congress has never acted to disturb the
agency’s interpretation,” it had “acquiesced in the FDA’s in-
terpretation of the statutory limits on its authority to regu-
late cigarettes.”
Id., at 23, 27, n. 23. The Court of Appeals
upheld the FDA’s position, concluding that “[i]f the statute