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

127

Opinion of the Court

missions, more than “at any other time in its history on any
61 Fed. Reg. 44418 (1996).
other subject.”

On August 28, 1996, the FDA issued a ﬁnal rule entitled
“Regulations Restricting the Sale and Distribution of Ciga-
rettes and Smokeless Tobacco to Protect Children and Ado-
Id., at 44396. The FDA determined that nico-
lescents.”
tine is a “drug” and that cigarettes and smokeless tobacco
are “drug delivery devices,” and therefore it had jurisdiction
under the FDCA to regulate tobacco products as customarily
marketed—that is, without manufacturer claims of therapeu-
tic beneﬁt.
Id., at 44397, 44402. First, the FDA found that
tobacco products “ ‘affect the structure or any function of
the body’ ” because nicotine “has signiﬁcant pharmacological
effects.”
Id., at 44631. Speciﬁcally, nicotine “exerts psy-
choactive, or mood-altering, effects on the brain” that cause
and sustain addiction, have both tranquilizing and stimulat-
Id., at 44631–44632. Sec-
ing effects, and control weight.
ond, the FDA determined that these effects were “intended”
under the FDCA because they “are so widely known and
foreseeable that [they] may be deemed to have been intended
by the manufacturers,” id., at 44687; consumers use tobacco
products “predominantly or nearly exclusively” to obtain
these effects, id., at 44807; and the statements, research, and
actions of manufacturers revealed that they “have ‘designed’
cigarettes to provide pharmacologically active doses of nico-
tine to consumers,” id., at 44849. Finally, the agency con-
cluded that cigarettes and smokeless tobacco are “combina-
tion products” because, in addition to containing nicotine,
they include device components that deliver a controlled
amount of nicotine to the body, id., at 45208–45216.

Having resolved the jurisdictional question, the FDA next
explained the policy justiﬁcations for its regulations, detail-
ing the deleterious health effects associated with tobacco
use.
It found that tobacco consumption was “the single
leading cause of preventable death in the United States.”
Id., at 44398. According to the FDA, “[m]ore than 400,000