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Vapors Inc d/b/a Vapors of Alabama Gardendale manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as electronic nicotine delivery systems under FDA jurisdiction as of August 8, 2016, were found to be unapproved "new tobacco products" that had not been commercially marketed in the United States as of February 15, 2007, and therefore required premarket authorization under section 901(b) of the Federal Food, Drug, and Cosmetic Act before being offered for sale or distribution.