Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 251

529US1

Unit: $U36

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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Breyer, J., dissenting

a device in light of its regulatory alternatives, and where the
FDA has chosen the least dangerous path, i. e., the safest
path, then it can—and does—provide a “reasonable assur-
ance” of “safety” within the meaning of the statute. A good
football helmet provides a reasonable assurance of safety for
the player even if the sport itself is still dangerous. And the
safest regulatory choice by deﬁnition offers a “reasonable”
assurance of safety in a world where the other alternatives
are yet more dangerous.

In any event, it is not entirely clear from the statute’s text
that a Class III categorization would require the FDA af-
ﬁrmatively to withdraw from the market dangerous devices,
such as cigarettes, which are already widely distributed.
See, e. g., § 360f(a) (when a device presents an “unreasonable
and substantial risk of illness or injury,” the Secretary “may”
make it “a banned device”); § 360h(a) (when a device “pre-
sents an unreasonable risk of substantial harm to the
public health,” the Secretary “may” require “notiﬁcation”);
§ 360h(b) (when a defective device creates an “unreasonable
risk” of harm, the Secretary “may” order “[r]epair, replace-
ment, or refund”); cf. 2 O’Reilly § 18.08, at 18–29 (point of
Class III “premarket approval” is to allow “careful scientiﬁc
review” of each “truly new” device “before it is exposed” to
users (emphasis added)).

Noting that the FDCA requires banning a “misbranded”
drug, the majority also points to 21 U. S. C. § 352( j), which
deems a drug or device “misbranded” if “it is dangerous to
health when used” as “prescribed, recommended, or sug-
gested in the labeling.” See ante, at 135.
In addition, the
majority mentions § 352(f)(1), which calls a drug or device
“misbranded” unless “its labeling bears . . . adequate direc-
tions for use” as “are necessary for the protection of users.”
Ibid. But this “misbranding” language is not determina-
tive, for it permits the FDA to conclude that a drug or device
is not “dangerous to health” and that it does have “adequate”