Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistLDSD Vapor LLC d/b/a AtascaVapes manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company's products fell under FDA jurisdiction as tobacco products under the Federal Food, Drug, and Cosmetic Act, yet were offered for sale in the United States without compliance with applicable regulatory requirements. The warning was issued following FDA review of the company's submissions and inspection records on August 1, 2022, at a time when the FDA's tobacco jurisdiction had recently been expanded to cover products containing nicotine from any source, not just tobacco-derived nicotine.