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Vape House Inc. 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. As e-liquids fall under FDA jurisdiction as deemed tobacco products since August 8, 2016, the company was required to secure marketing authorization orders under section 910 of the Federal Food, Drug, and Cosmetic Act before commercial distribution. The inspection and submission review revealed that Vape House offered these products for sale in the United States without compliance with applicable premarket requirements for new tobacco products.