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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

It may well be, as the FDA asserts, that “these factors
must be considered when developing a regulatory scheme
that achieves the best public health result for these prod-
ucts.”
Id., at 44413. But the FDA’s judgment that leaving
tobacco products on the market “is more effective in achiev-
ing public health goals than a ban,” ibid., is no substitute for
the speciﬁc safety determinations required by the FDCA’s
various operative provisions. Several provisions in the Act
require the FDA to determine that the product itself is safe
as used by consumers. That is, the product’s probable ther-
apeutic beneﬁts must outweigh its risk of harm. See United
States v. Rutherford, 442 U. S., at 555 (“[T]he Commissioner
generally considers a drug safe when the expected therapeu-
tic gain justiﬁes the risk entailed by its use”).
In contrast,
the FDA’s conception of safety would allow the agency, with
respect to each provision of the FDCA that requires the
agency to determine a product’s “safety” or “dangerousness,”
to compare the aggregate health effects of alternative admin-
istrative actions. This is a qualitatively different inquiry.
Thus, although the FDA has concluded that a ban would be
“dangerous,” it has not concluded that tobacco products are
“safe” as that term is used throughout the Act.

Consider 21 U. S. C. § 360c(a)(2), which speciﬁes those fac-
tors that the FDA may consider in determining the safety
and effectiveness of a device for purposes of classiﬁcation,
performance standards, and premarket approval. For all
devices regulated by the FDA, there must at least be a “rea-
sonable assurance of the safety and effectiveness of the de-
vice.” See 21 U. S. C. §§ 360c(a)(1)(A)(i), (B), (C) (1994 ed.
and Supp. III); 61 Fed. Reg. 44412 (1996). Title 21 U. S. C.
§ 360c(a)(2) provides that

“the safety and effectiveness of a device are to be
determined—

“(A) with respect to the persons for whose use the

device is represented or intended,