Cite as: 529 U. S. 120 (2000)
Breyer, J., dissenting
the more dangerous remedy? For the following reasons, I think not.
First, the statute's language does not restrict the FDA's remedial powers in this way. The FDCA permits the FDA to regulate a "combination product"—i. e., a "device" (such as a cigarette) that contains a "drug" (such as nicotine)— under its "device" provisions. 21 U. S. C. § 353(g)(1). And the FDCA's "device" provisions explicitly grant the FDA wide remedial discretion. For example, where the FDA cannot "otherwise" obtain "reasonable assurance" of a device's "safety and effectiveness," the agency may restrict by regulation a product's "sale, distribution, or use" upon "such . . . conditions as the Secretary may prescribe." § 360j(e)(1) (emphasis added). And the statutory section that most clearly addresses the FDA's power to ban (entitled "Banned devices") says that, where a device presents "an unreasonable and substantial risk of illness or injury," the Secretary "may"—not must—"initiate a proceeding . . . to make such device a banned device." § 360f(a) (emphasis added).
The Court points to other statutory subsections which it believes require the FDA to ban a drug or device entirely, even where an outright ban risks more harm than other regulatory responses. See ante, at 135-136. But the cited provisions do no such thing. It is true, as the majority contends, that "the FDCA requires the FDA to place all devices" in "one of three classifications" and that Class III devices require "premarket approval." Ante, at 136. But it is not the case that the FDA must place cigarettes in Class III because tobacco itself "presents a potential unreasonable risk of illness or injury." 21 U. S. C. § 360c(a)(1)(C). In fact, Class III applies only where regulation cannot otherwise "provide reasonable assurance of . . . safety." §§ 360c(a) (1)(A), (B) (placing a device in Class I or Class II when regulation can provide that assurance). Thus, the statute plainly allows the FDA to consider the relative, overall "safety" of
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