Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 221.0

529US1

Unit: $U36

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

146

FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

“smoking products” because, in light of the ﬁndings in the
Surgeon General’s report, such a “provision might well com-
pletely outlaw at least cigarettes. This would be contrary
to what, we understand, is intended or what, in the light of
our experience with the 18th amendment, would be accept-
able to the American people.” 1964 Hearings 18.

The FDA’s disavowal of jurisdiction was consistent with
the position that it had taken since the agency’s inception.
As the FDA concedes, it never asserted authority to regulate
tobacco products as customarily marketed until it promul-
gated the regulations at issue here. See Brief for Petition-
ers 37; see also Brief for Appellee (FDA) in Action on Smok-
ing and Health v. Harris, 655 F. 2d 236 (CADC 1980), in 9
Rec. in No. 97–1604 (CA4), Tab No. 4, pp. 14–15 (“In the 73
years since the enactment of the original Food and Drug Act,
and in the 41 years since the promulgation of the modern
Food, Drug, and Cosmetic Act, the FDA has repeatedly in-
formed Congress that cigarettes are beyond the scope of the
statute absent health claims establishing a therapeutic intent
on behalf of the manufacturer or vendor”).

The FDA’s position was also consistent with Congress’
speciﬁc intent when it enacted the FDCA. Before the Act’s
adoption in 1938, the FDA’s predecessor agency, the Bureau
of Chemistry, announced that it lacked authority to regulate
tobacco products under the Pure Food and Drug Act of 1906,
ch. 3915, 34 Stat. 768, unless they were marketed with thera-
peutic claims. See U. S. Dept. of Agriculture, Bureau of
Chemistry, 13 Service and Regulatory Announcements 24
(Apr. 1914) (Feb. 1914 Announcements ¶ 13, Opinion of Chief
of Bureau C. L. Alsberg).
In 1929, Congress considered and
rejected a bill “[t]o amend the Food and Drugs Act of June
30, 1906, by extending its provisions to tobacco and tobacco
products.” S. 1468, 71st Cong., 1st Sess., 1. See also 71
Cong. Rec. 2589 (1929) (remarks of Sen. Smoot). And, as the
FDA admits, there is no evidence in the text of the FDCA or
its legislative history that Congress in 1938 even considered