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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

commerce. Contrary to the dissent’s contention, the Act ad-
mits no remedial discretion once it is evident that the device
is misbranded.

Second, the FDCA requires the FDA to place all devices
that it regulates into one of three classiﬁcations. See
§ 360c(b)(1). The agency relies on a device’s classiﬁcation in
determining the degree of control and regulation necessary
to ensure that there is “a reasonable assurance of safety and
61 Fed. Reg. 44412 (1996). The FDA has
effectiveness.”
yet to classify tobacco products.
Instead, the regulations at
issue here represent so-called “general controls,” which the
Act entitles the agency to impose in advance of classiﬁcation.
See id., at 44404–44405. Although the FDCA prescribes no
deadline for device classiﬁcation, the FDA has stated that it
will classify tobacco products “in a future rulemaking” as
required by the Act.
Id., at 44412. Given the FDA’s ﬁnd-
ings regarding the health consequences of tobacco use, the
agency would have to place cigarettes and smokeless tobacco
in Class III because, even after the application of the Act’s
available controls, they would “presen[t] a potential unrea-
sonable risk of illness or injury.”
21 U. S. C. § 360c(a)(1)(C).
As Class III devices, tobacco products would be subject to
the FDCA’s premarket approval process. See 21 U. S. C.
§ 360c(a)(1)(C) (1994 ed., Supp. III); 21 U. S. C. § 360e; 61
Fed. Reg. 44412 (1996). Under these provisions, the FDA
would be prohibited from approving an application for pre-
market approval without “a showing of reasonable assurance
that such device is safe under the conditions of use pre-
scribed, recommended, or suggested in the proposed labeling
thereof.”
In view of the FDA’s
conclusions regarding the health effects of tobacco use, the
agency would have no basis for ﬁnding any such reasonable
assurance of safety. Thus, once the FDA fulﬁlled its statu-
tory obligation to classify tobacco products, it could not allow
them to be marketed.

21 U. S. C. § 360e(d)(2)(A).