Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistTurning Point Brands operating as Directvapor.com was cited for offering electronic nicotine delivery systems (ENDS) for sale without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The FDA determined that these products, containing nicotine from any source, are subject to FDA jurisdiction as tobacco products and must comply with applicable regulations, including the requirement to obtain a premarket authorization order before marketing "new tobacco products" in the United States. The warning letter emphasized that as of March 15, 2022, FDA's jurisdiction was expanded to include all nicotine-containing products regardless of nicotine source, requiring full compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations.