Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistWisemen Wholesale, Inc. was warned for selling and distributing electronic nicotine delivery system (ENDS) products without required premarket authorization under FDA tobacco product regulations. The company failed to comply with the Federal Food, Drug, and Cosmetic Act's requirement that "new tobacco products"—including ENDS products containing nicotine from any source—obtain a marketing authorization order before being legally sold in the United States. The warning was issued by the FDA's Center for Tobacco Products following a review of inspection records that identified the unlawful distribution of these tobacco products.