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Talk to a SpecialistTalk to a SpecialistK&D Vapors Inc manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, classified as newly deemed tobacco products under FDA jurisdiction since August 8, 2016, were not in compliance with applicable regulations requiring "new tobacco products" to have marketing authorization orders in effect before commercial distribution. The FDA inspection and review of the company's submissions determined that K&D Vapors was distributing these products without the mandatory premarket approval required under section 910 of the FD&C Act.