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As with drugs, the FFDCAs definition of medical devices includes articles that are intended by the manufacturer to affect the structure and function of the body.6 Unlike a drug, however, a device is defined, in part, as an article which does not achieve its primary intended purpose through chemical action.7 In the absence of direct claims by the manufacturers about the intended use of tobacco products, the FDA relied on other lines of evidence in order to meet this key definitional criterion for drugs and devices