Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistMilu 1 Inc. d/b/a Peace Novelty was cited for offering electronic nicotine delivery system (ENDS) products for sale through their website without required premarket authorization. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain premarket approval before legal marketing in the United States, and their products containing nicotine from any source fell under FDA jurisdiction as tobacco products under the amended Federal Food, Drug, and Cosmetic Act. The violations involved both adulteration and misbranding of tobacco products in violation of the Family Smoking Prevention and Tobacco Control Act.