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Vape King, Inc manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization as mandated 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. As a manufacturer of electronic nicotine delivery system products, Vape King was required to demonstrate compliance with Federal Food, Drug, and Cosmetic Act requirements applicable to new tobacco products.