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U.S. Vapes manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, which have been subject to FDA jurisdiction since August 8, 2016, and require marketing authorization orders before commercial distribution. The e-liquid products were found to be adulterated and/or misbranded under the Federal Food, Drug, and Cosmetic Act because they lacked the necessary premarket approval as "new tobacco products."