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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

priate inference—that Congress intended to ratify the FDA’s
prior position that it lacks jurisdiction—is unmistakable.

The dissent alternatively argues that, even if Congress’
subsequent tobacco-speciﬁc legislation did, in fact, ratify the
FDA’s position, that position was merely a contingent dis-
avowal of jurisdiction. Speciﬁcally, the dissent contends
that “the FDA’s traditional view was largely premised on
a perceived inability to prove the necessary statutory ‘in-
tent’ requirement.” Post, at 189–190. A fair reading of the
FDA’s representations prior to 1995, however, demonstrates
that the agency’s position was essentially unconditional.
See, e. g., 1972 Hearings 239, 242 (statement of Comm’r Ed-
wards) (“[R]egulation of cigarettes is to be the domain of
Congress,” and “[a]ny such move by FDA would be inconsist-
ent with the clear congressional intent”); 1983 House Hear-
ings 74 (statement of Assistant Secretary Brandt) (“[T]he
issue of regulation of tobacco . . . is something that Congress
has reserved to itself ”); 1983 Senate Hearings 56 (statement
of Assistant Secretary Brandt) (“Congress has assumed the
responsibility of regulating . . . cigarettes”); Brief for Appel-
lee 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, n. 23 (because “Congress has never acted to disturb
the agency’s interpretation,” it “acquiesced in the FDA’s in-
terpretation”). To the extent the agency’s position could be
characterized as equivocal, it was only with respect to the
well-established exception of when the manufacturer makes
express claims of therapeutic beneﬁt. See, e. g., 1965 Hear-
ings 193 (statement of Deputy Comm’r Rankin) (“The Food
and Drug Administration has no jurisdiction under the Food,
Drug, and Cosmetic Act over tobacco, unless it bears drug
claims”); Letter to ASH Executive Director Banzhaf from
FDA Comm’r Kennedy (Dec. 5, 1977), App. 47 (“The inter-
pretation of the Act by FDA consistently has been that ciga-
rettes are not a drug unless health claims are made by the
vendors”); Letter to ASH Executive Director Banzhaf from