Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistParallel Direct LLC d/b/a The Magic Mist was warned for manufacturing and selling e-liquid tobacco products containing nicotine without required premarket authorization from the FDA. The company's website offered these products for sale in the United States, violating the Federal Food, Drug, and Cosmetic Act and FDA regulations that require all tobacco products—including those containing nicotine from any source—to obtain premarket approval before legal distribution. The warning addressed the company's failure to comply with FDA's jurisdiction over nicotine-containing products, which was expanded by legislation signed in March 2022 to include nicotine from non-tobacco sources.