Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the agency itself have sought reasonable limits on the definitions.

This Article critiques one limit that is sometimes offered: that the FDA cannot regulate certain non-therapeutic technologies because those technologies cannot be shown to be safe and effective. A careful review of the FDA’s past decisions on non-therapeutic uses reveals that this reasoning is descriptively incorrect. Further, examining the purposes of FDA oversight demonstrates that the agency is not necessarily normatively required to set an insurmountable bar for showing the safety and effectiveness of non-therapeutic uses. Reconsidering this reasoning as a limit on FDA jurisdiction is warranted at a time when evolutions in both policy and science are opening the door to a potentially diverse market of new, or newly legal, non-therapeutic technologies.



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