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doi:10.1155/2017/4517971 Pichette, Andr et al

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And under the Family Smoking Prevention and Tobacco Control Act, the 2009 law that charged the FDA with regulating tobacco products, manufacturers have to persuade the agency that a modified-risk claim is not only accurate but will "benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products." That "population as a whole" standard means it's not enough to demonstrate that a product is significantly less dangerous than cigarettes