Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
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529US1

Unit: $U36

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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Breyer, J., dissenting

U. S. C. § 321(h). Taken literally, this deﬁnition might in-
clude everything from room air conditioners to thermal paja-
mas. The companies argue that, to avoid such a result, the
meaning of “drug” or “device” should be conﬁned to medical
or therapeutic products, narrowly deﬁned. See Brief for
Respondent United States Tobacco Co. 8–9.

The companies may well be right that the statute should
not be read to cover room air conditioners and winter under-
wear. But I do not agree that we must accept their pro-
posed limitation. For one thing, such a cramped reading
contravenes the established purpose of the statutory lan-
guage. See Bacto-Unidisk, 394 U. S., at 798 (third deﬁni-
tion is “clearly, broader than any strict medical deﬁnition”);
1 Leg. Hist. 108 (deﬁnition covers products “that can-
not be alleged to be treatments for diseased conditions”).
For another, the companies’ restriction would render the
other two “drug” deﬁnitions superﬂuous. See 21 U. S. C.
§§ 321(g)(1)(A), (g)(1)(B) (covering articles in the leading
pharmacology compendia and those “intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of
disease”).

Most importantly, the statute’s language itself supplies a
different, more suitable, limitation: that a “drug” must be a
chemical agent. The FDCA’s “device” deﬁnition states that
an article which affects the structure or function of the body
is a “device” only if it “does not achieve its primary intended
purposes through chemical action within . . . the body,” and
“is not dependent upon being metabolized for the achieve-
ment of its primary intended purposes.”
§ 321(h) (emphasis
added). One can readily infer from this language that at
least an article that does achieve its primary purpose
through chemical action within the body and that is depend-
ent upon being metabolized is a “drug,” provided that it oth-
erwise falls within the scope of the “drug” deﬁnition. And
one need not hypothesize about air conditioners or thermal