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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

Consequently, the analogy made by the FDA and the dis-
sent to highly toxic drugs used in the treatment of various
cancers is unpersuasive. See 61 Fed. Reg. 44413 (1996);
post, at 177 (opinion of Breyer, J.). Although “dangerous”
in some sense, these drugs are safe within the meaning of
the Act because, for certain patients, the therapeutic beneﬁts
outweigh the risk of harm. Accordingly, such drugs cannot
properly be described as “dangerous to health” under 21
U. S. C. § 352( j). The same is not true for tobacco products.
As the FDA has documented in great detail, cigarettes and
smokeless tobacco are an unsafe means to obtaining any
pharmacological effect.

The dissent contends that our conclusion means that “the
FDCA requires the FDA to ban outright ‘dangerous’ drugs
or devices,” post, at 174, and that this is a “perverse” reading
of the statute, post, at 174, 180. This misunderstands our
holding. The FDA, consistent with the FDCA, may clearly
regulate many “dangerous” products without banning them.
Indeed, virtually every drug or device poses dangers under
certain conditions. What the FDA may not do is conclude
that a drug or device cannot be used safely for any therapeu-
tic purpose and yet, at the same time, allow that product to
remain on the market. Such regulation is incompatible with
the FDCA’s core objective of ensuring that every drug or
device is safe and effective.

Considering the FDCA as a whole, it is clear that Con-
gress intended to exclude tobacco products from the FDA’s
jurisdiction. A fundamental precept of the FDCA is that
any product regulated by the FDA—but not banned—must
be safe for its intended use. Various provisions of the Act
make clear that this refers to the safety of using the product
to obtain its intended effects, not the public health ramiﬁca-
tions of alternative administrative actions by the FDA.
That is, the FDA must determine that there is a reasonable
assurance that the product’s therapeutic beneﬁts outweigh
the risk of harm to the consumer. According to this stand-