Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistFreeMax Technology was cited for manufacturing and distributing electronic nicotine delivery systems (ENDS/vape products) on its websites without obtaining required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing "new tobacco products" containing nicotine from any source, which require premarket approval before legal U.S. marketing. The FDA identified the violation through review of the company's websites (freemaxvape.com and friobarvape.com) showing ENDS products offered for sale to U.S. customers without demonstrated compliance with section 901(b) of the Federal Food, Drug, and Cosmetic Act and its implementing regulations.