Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 250

529US1

Unit: $U36

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

175

Breyer, J., dissenting

the more dangerous remedy? For the following reasons,
I think not.

First, the statute’s language does not restrict the FDA’s
remedial powers in this way. The FDCA permits the FDA
to regulate a “combination product”—i. e., a “device” (such
as a cigarette) that contains a “drug” (such as nicotine)—
under its “device” provisions.
21 U. S. C. § 353(g)(1). And
the FDCA’s “device” provisions explicitly grant the FDA
wide remedial discretion. For example, where the FDA
cannot “otherwise” obtain “reasonable assurance” of a de-
vice’s “safety and effectiveness,” the agency may restrict by
regulation a product’s “sale, distribution, or use” upon
. conditions as the Secretary may prescribe.”
“such .
§ 360j(e)(1) (emphasis added). And the statutory section
that most clearly addresses the FDA’s power to ban (entitled
“Banned devices”) says that, where a device presents “an
unreasonable and substantial risk of illness or injury,” the
Secretary “may”—not must—“initiate a proceeding . . . to
make such device a banned device.” § 360f(a) (emphasis
added).

.

The Court points to other statutory subsections which it
believes require the FDA to ban a drug or device entirely,
even where an outright ban risks more harm than other reg-
ulatory responses. See ante, at 135–136. But the cited
It is true, as the majority con-
provisions do no such thing.
tends, that “the FDCA requires the FDA to place all de-
vices” in “one of three classiﬁcations” and that Class III de-
vices require “premarket approval.” Ante, at 136. But it
is not the case that the FDA must place cigarettes in Class
III because tobacco itself “presents a potential unreasonable
risk of illness or injury.”
In fact,
Class III applies only where regulation cannot otherwise
“provide reasonable assurance of .
. safety.” §§ 360c(a)
(1)(A), (B) (placing a device in Class I or Class II when regu-
lation can provide that assurance). Thus, the statute plainly
allows the FDA to consider the relative, overall “safety” of

21 U. S. C. § 360c(a)(1)(C).

.