Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistMister Vapor was warned for offering electronic nicotine delivery system (ENDS) products for sale to U.S. customers without required FDA premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The products, which contained nicotine from any source, were determined to be tobacco products subject to FDA jurisdiction but lacked the legally required premarket authorization order for new tobacco products. The company failed to comply with Federal Food, Drug, and Cosmetic Act requirements applicable to tobacco products, including those containing non-tobacco-derived nicotine following the 2022 legislative expansion of FDA's jurisdiction.