Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 239.0

529US1

Unit: $U36

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164

FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Breyer, J., dissenting

that Congress, rather than an administrative agency, ought
to make this important regulatory decision.

I

Before 1938, the federal Pure Food and Drug Act con-

tained only two jurisdictional deﬁnitions of “drug”:

“[1] medicines and preparations recognized in the
United States Pharmacopoeia or National Formulary . . .
and [2] any substance or mixture of substances intended
to be used for the cure, mitigation, or prevention of dis-
ease.” Act of June 30, 1906, ch. 3915, § 6, 34 Stat. 769.

In 1938, Congress added a third deﬁnition, relevant here:

“(3) articles (other than food) intended to affect the
structure or any function of the body . . . .” Act of June
25, 1938, ch. 675, § 201(g), 52 Stat. 1041 (codiﬁed at 21
U. S. C. § 321(g)(1)(C)).

It also added a similar deﬁnition in respect to a “device.”
See § 201(h), 52 Stat. 1041 (codiﬁed at 21 U. S. C. § 321(h)).
As I have mentioned, the literal language of the third deﬁni-
tion and the FDCA’s general purpose both strongly support
a projurisdiction reading of the statute. See supra, at
161–162.

The statute’s history offers further support. The FDA
drafted the new language, and it testiﬁed before Congress
that the third deﬁnition would expand the FDCA’s jurisdic-
tional scope signiﬁcantly. See Hearings on S. 1944 before a
Subcommittee of the Senate Committee on Commerce, 73d
Cong., 2d Sess., 15–16 (1933), reprinted in 1 FDA, Legislative
History of the Federal Food, Drug, and Cosmetic Act and Its
Amendments 107–108 (1979) (hereinafter Leg. Hist.).
In-
deed, “[t]he purpose” of the new deﬁnition was to “make pos-
sible the regulation of a great many products that have been
found on the market that cannot be alleged to be treatments
for diseased conditions.”
Id., at 108. While the drafters fo-
cused speciﬁcally upon the need to give the FDA jurisdiction