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Hence "a claim that e-cigarettes are intended to help someone quit smoking is not necessarily a claim that the product is intended to treat a disease." Rather, "The intention is to help alter a health-related behavior." The FDA pretends to address this argument but conspicuously fails to do so: Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence

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The New Cigarette Paternalism. Regulation 25

Thats quite a lot of people with a moderate increase in risk