Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistMountain Oak Vapors LLC manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's products, derived from or containing nicotine from any source, were determined to be tobacco products subject to FDA jurisdiction but lacked compliance with FD&C Act requirements for legal marketing in the United States. The warning was issued following FDA inspection records review on December 7, 2023, addressing the company's failure to secure premarket approval for these newly marketed tobacco products.