Cite as: 529 U. S. 120 (2000)
Opinion of the Court
"(B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and
"(C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use."
A straightforward reading of this provision dictates that the FDA must weigh the probable therapeutic benefits of the device to the consumer against the probable risk of injury. Applied to tobacco products, the inquiry is whether their purported benefits—satisfying addiction, stimulation and sedation, and weight control—outweigh the risks to health from their use. To accommodate the FDA's conception of safety, however, one must read "any probable benefit to health" to include the benefit to public health stemming from adult consumers' continued use of tobacco products, even though the reduction of tobacco use is the raison d'être of the regulations. In other words, the FDA is forced to contend that the very evil it seeks to combat is a "benefit to health." This is implausible.
The FDA's conception of safety is also incompatible with the FDCA's misbranding provision. Again, § 352( j) provides that a product is "misbranded" if "it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof." According to the FDA's understanding, a product would be "dangerous to health," and therefore misbranded under § 352( j), when, in comparison to leaving the product on the market, a ban would not produce "adverse health consequences" in aggregate. Quite simply, these are different inquiries. Although banning a particular product might be detrimental to public health in aggregate, the product could still be "dangerous to health" when used as directed. Section 352( j) focuses on dangers to the consumer from use of the product, not those stemming from the agency's remedial measures.
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