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Vapor Source Inc. manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, as mandated under the Family Smoking Prevention and Tobacco Control Act for newly deemed tobacco products. The company failed to comply with FDA regulations governing electronic nicotine delivery systems, which became subject to FDA jurisdiction effective August 8, 2016, and must obtain marketing authorization orders under section 910 of the Federal Food, Drug, and Cosmetic Act. The Center for Tobacco Products determined the products were adulterated and/or misbranded under applicable regulations.