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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 regulation of advertising, but it required the warning, "Caution: Cigarette Smoking May Be Hazardous to Your Health," to appear on all cigarette packages. Id., § 4, 79 Stat. 283. In 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).
Not only did Congress reject the proposals to grant the FDA jurisdiction, but it explicitly pre-empted any other regulation of cigarette labeling: "No statement relating to smoking 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 labeling, however, is an integral aspect of the FDCA, both as it existed in 1965 and today. The labeling requirements currently 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 consumers. 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 necessary 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 provide "adequate warnings against use in those pathological
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