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Vapors Inc d/b/a Vapors of Alabama of Jasper manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. As an electronic nicotine delivery system, the company's e-liquid products were subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act's deeming rule (effective August 8, 2016), which classified them as regulated tobacco products requiring compliance with Federal Food, Drug, and Cosmetic Act requirements. The company failed to obtain premarket authorization for these "new tobacco products" as mandated by law.