Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 216

529US1

Unit: $U36

[09-26-01 08:36:38] PAGES PGT: OPIN

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

141

Opinion of the Court

“(B) with respect to the conditions of use prescribed,
recommended, or suggested in the labeling of the de-
vice, and

“(C) weighing any probable beneﬁt to health from the
use of the device against any probable risk of injury or
illness from such use.”

A straightforward reading of this provision dictates that the
FDA must weigh the probable therapeutic beneﬁts of the
device to the consumer against the probable risk of injury.
Applied to tobacco products, the inquiry is whether their
purported beneﬁts—satisfying addiction, stimulation and
sedation, and weight control—outweigh the risks to health
from their use. To accommodate the FDA’s conception of
safety, however, one must read “any probable beneﬁt to
health” to include the beneﬁt to public health stemming from
adult consumers’ continued use of tobacco products, even
though the reduction of tobacco use is the raison d’eˆtre of
the regulations.
In other words, the FDA is forced to con-
tend that the very evil it seeks to combat is a “beneﬁt to
health.” This is implausible.

The FDA’s conception of safety is also incompatible with
the FDCA’s misbranding provision. Again, § 352( j) pro-
vides that a product is “misbranded” if “it is dangerous to
health when used in the dosage or manner, or with the fre-
quency or duration prescribed, recommended, or suggested
in the labeling thereof.” According to the FDA’s under-
standing, a product would be “dangerous to health,” and
therefore misbranded under § 352( j), when, in comparison to
leaving the product on the market, a ban would not produce
“adverse health consequences” in aggregate. Quite simply,
these are different inquiries. Although banning a particular
product might be detrimental to public health in aggregate,
the product could still be “dangerous to health” when used
as directed. Section 352( j) focuses on dangers to the con-
sumer from use of the product, not those stemming from the
agency’s remedial measures.