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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Breyer, J., dissenting

In its own interpretation, the majority nowhere denies the
following two salient points. First, tobacco products (in-
cluding cigarettes) fall within the scope of this statutory
deﬁnition, read literally. Cigarettes achieve their mood-
stabilizing effects through the interaction of the chemical
nicotine and the cells of the central nervous system. Both
cigarette manufacturers and smokers alike know of, and de-
sire, that chemically induced result. Hence, cigarettes are
“intended to affect” the body’s “structure” and “function,” in
the literal sense of these words.

Second, the statute’s basic purpose—the protection of
public health—supports the inclusion of cigarettes within
its scope. See United States v. Article of Drug . . . Bacto-
Unidisk, 394 U. S. 784, 798 (1969) (FDCA “is to be given a
liberal construction consistent with [its] overriding pur-
pose to protect the public health” (emphasis added)). Un-
regulated tobacco use causes “[m]ore than 400,000 people [to]
die each year from tobacco-related illnesses, such as cancer,
respiratory illnesses, and heart disease.” 61 Fed. Reg.
44398 (1996).
Indeed, tobacco products kill more people in
this country every year “than . . . AIDS . . . , car accidents,
alcohol, homicides,
illegal drugs, suicides, and ﬁres, com-
bined.”

Ibid. (emphasis added).

Despite the FDCA’s literal language and general purpose
(both of which support the FDA’s ﬁnding that cigarettes
come within its statutory authority), the majority nonethe-
less reads the statute as excluding tobacco products for two
basic reasons:

(1) the FDCA does not “ﬁt” the case of tobacco because
the statute requires the FDA to prohibit dangerous
drugs or devices (like cigarettes) outright, and the
agency concedes that simply banning the sale of ciga-
rettes is not a proper remedy, ante, at 139–141; and

(2) Congress has enacted other statutes, which, when
viewed in light of the FDA’s long history of denying