Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
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Cite as: 529 U. S. 120 (2000)

135

Opinion of the Court

heart disease, often suffering long and painful deaths,” and
that “[t]obacco alone kills more people each year in the
United States than acquired immunodeﬁciency syndrome
(AIDS), car accidents, alcohol, homicides, illegal drugs, sui-
cides, and ﬁres, combined.”
Indeed, the FDA charac-
Ibid.
terized smoking as “a pediatric disease,” id., at 44421, be-
cause “one out of every three young people who become
regular smokers . . . will die prematurely as a result,” id.,
at 44399.

These ﬁndings logically imply that, if tobacco products
were “devices” under the FDCA, the FDA would be required
to remove them from the market. Consider, ﬁrst, the
FDCA’s provisions concerning the misbranding of drugs or
devices. The Act prohibits “[t]he introduction or delivery
for introduction into interstate commerce of any food, drug,
device, or cosmetic that is adulterated or misbranded.” 21
In light of the FDA’s ﬁndings, two distinct
U. S. C. § 331(a).
FDCA provisions would render cigarettes and smokeless to-
bacco misbranded devices. First, § 352( j) deems a drug or
device misbranded “[i]f it is dangerous to health when used
in the dosage or manner, or with the frequency or duration
prescribed, recommended, or suggested in the labeling
thereof.” The FDA’s ﬁndings make clear that tobacco prod-
ucts are “dangerous to health” when used in the manner pre-
scribed. Second, a drug or device is misbranded under the
Act “[u]nless its labeling bears . . . adequate directions for
use .
in such manner and form, as are necessary for
the protection of users,” except where such directions are
“not necessary for the protection of the public health.”
§ 352(f)(1). Given the FDA’s conclusions concerning the
health consequences of tobacco use, there are no directions
that could adequately protect consumers. That is, there are
no directions that could make tobacco products safe for ob-
taining their intended effects. Thus, were tobacco products
within the FDA’s jurisdiction, the Act would deem them mis-
branded devices that could not be introduced into interstate

.

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