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

187

Breyer, J., dissenting

Letter to Directors of Bureaus, Divisions and Directors of
Districts from FDA Bureau of Enforcement (May 24, 1963),
in Public Health Cigarette Amendments of 1971: Hearings
on S. 1454 before the Consumer Subcommittee of the Senate
Committee on Commerce, 92d Cong., 2d Sess., 240 (1972)
(hereinafter FDA Enforcement Letter). And subsequent
FDA Commissioners made roughly the same assertion.
One pointed to the fact that the manufacturers only “recom-
mended” cigarettes “for smoking pleasure.” Two others re-
iterated the evidentiary need for “health claims.” Yet an-
other stressed the importance of proving “intent,” adding
that “[w]e have not had sufﬁcient evidence” of “intent with
regard to nicotine.” See, respectively, id., at 239 (Comm’r
Edwards); Letter of Dec. 5, 1977, App. 47 (Comm’r Kennedy);
1965 Hearings 193 (Comm’r Rankin); 1994 Hearings 28
(Comm’r Kessler). Tobacco company counsel also testiﬁed
that the FDA lacked jurisdiction because jurisdiction “de-
pends on .
. intended use,” which in turn “depends, in
general, on the claims and representations made by the
manufacturer.” Health Consequences of Smoking: Nicotine
Addiction, Hearing before the Subcommittee on Health and
the Environment of the House Committee on Energy and
Commerce, 100th Cong., 2d Sess., 288 (1988) (testimony of
Richard Cooper) (emphasis added).

.

Other agency statements occasionally referred to addi-
tional problems. Commissioner Kessler, for example, said
that the “enormous social consequences” ﬂowing from a deci-
sion to regulate tobacco counseled in favor of obtaining spe-
ciﬁc congressional “guidance.” 1994 Hearings 69; see also
ante, at 153 (quoting statement of Health and Human Services
Secretary Brandt to the effect that Congress wanted to make
the relevant jurisdictional decision). But a fair reading of
the FDA’s denials suggests that the overwhelming problem
was one of proving the requisite manufacturer intent. See
Action on Smoking and Health v. Harris, 655 F. 2d 236, 238–
239 (CADC 1980) (FDA “comments” reveal its “understand-