FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 21 (2000)

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Opinion of the Court

It may well be, as the FDA asserts, that "these factors must be considered when developing a regulatory scheme that achieves the best public health result for these products." Id., at 44413. But the FDA's judgment that leaving tobacco products on the market "is more effective in achieving public health goals than a ban," ibid., is no substitute for the specific safety determinations required by the FDCA's various operative provisions. Several provisions in the Act require the FDA to determine that the product itself is safe as used by consumers. That is, the product's probable therapeutic benefits must outweigh its risk of harm. See United States v. Rutherford, 442 U. S., at 555 ("[T]he Commissioner generally considers a drug safe when the expected therapeutic gain justifies the risk entailed by its use"). In contrast, the FDA's conception of safety would allow the agency, with respect to each provision of the FDCA that requires the agency to determine a product's "safety" or "dangerousness," to compare the aggregate health effects of alternative administrative actions. This is a qualitatively different inquiry. Thus, although the FDA has concluded that a ban would be "dangerous," it has not concluded that tobacco products are "safe" as that term is used throughout the Act.

Consider 21 U. S. C. 360c(a)(2), which specifies those factors that the FDA may consider in determining the safety and effectiveness of a device for purposes of classification, performance standards, and premarket approval. For all devices regulated by the FDA, there must at least be a "reasonable assurance of the safety and effectiveness of the device." See 21 U. S. C. 360c(a)(1)(A)(i), (B), (C) (1994 ed. and Supp. III); 61 Fed. Reg. 44412 (1996). Title 21 U. S. C. 360c(a)(2) provides that

"the safety and effectiveness of a device are to be determined—

"(A) with respect to the persons for whose use the device is represented or intended,

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