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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

the FCLAA, Representative Udall again introduced a bill to
amend the FDCA “to make that Act applicable to smoking
products.” H. R. 2248, 89th Cong., 1st Sess., 1. None of
these proposals became law.

Congress ultimately decided in 1965 to subject tobacco
products to the less extensive regulatory scheme of the
FCLAA, which created a “comprehensive Federal program
to deal with cigarette labeling and advertising with respect
to any relationship between smoking and health.” Pub. L.
89–92, § 2, 79 Stat. 282. The FCLAA rejected any regula-
tion of advertising, but it required the warning, “Caution:
Cigarette Smoking May Be Hazardous to Your Health,” to
In
appear on all cigarette packages.
the FCLAA’s “Declaration of Policy,” Congress stated that
its objective was to balance the goals of ensuring that “the
public may be adequately informed that cigarette smoking
may be hazardous to health” and protecting “commerce and
the national economy . . . to the maximum extent.”
Id., § 2,
79 Stat. 282 (codiﬁed at 15 U. S. C. § 1331).

Id., § 4, 79 Stat. 283.

Not only did Congress reject the proposals to grant the
FDA jurisdiction, but it explicitly pre-empted any other reg-
ulation of cigarette labeling: “No statement relating to smok-
ing and health, other than the statement required by . . . this
Act, shall be required on any cigarette package.” Pub. L.
89–92, § 5(a), 79 Stat. 283. The regulation of product label-
ing, however, is an integral aspect of the FDCA, both as it
existed in 1965 and today. The labeling requirements cur-
rently imposed by the FDCA, which are essentially identical
to those in force in 1965, require the FDA to regulate the
labeling of drugs and devices to protect the safety of consum-
ers. See 21 U. S. C. § 352; 21 U. S. C. § 352 (1964 ed. and
Supp. IV). As discussed earlier, the Act requires that all
products bear “adequate directions for use . . . as are neces-
sary for the protection of users,” 21 U. S. C. § 352(f)(1); 21
U. S. C. § 352(f)(1) (1964 ed.); requires that all products pro-
vide “adequate warnings against use in those pathological