Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistRAD Glass Inc d/b/a Ohmies Vape Shop manufactured and distributed e-liquid tobacco products without the required premarket authorization mandated by the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, specifically electronic nicotine delivery systems, which have been subject to FDA jurisdiction since August 8, 2016. The violations involved offering these products for commercial sale and distribution in the United States without obtaining the necessary premarket approval that is required for any new tobacco product not commercially marketed prior to February 15, 2007.