Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistCVM 3, LLC d/b/a Carolina Vapor Mill, a manufacturer and distributor of e-liquid products, was warned that its tobacco products containing nicotine were subject to FDA jurisdiction and required premarket authorization as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA requirements applicable to tobacco products, including obtaining the required premarket authorization orders before marketing e-liquid products in the United States. This enforcement action was issued following the March 2022 legislative expansion of FDA's tobacco jurisdiction to include all products containing nicotine from any source, not just tobacco-derived nicotine.