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Vape Mania was cited for offering electronic nicotine delivery systems (ENDS) for sale on its website without required premarket authorization from the FDA. The products violated the Federal Food, Drug, and Cosmetic Act because they were not in compliance with FDA requirements for "new tobacco products," which require marketing authorization orders before legal sale in the United States. The violation encompasses both products made from tobacco-derived nicotine and those containing nicotine from any source, as covered under the expanded FDA jurisdiction that took effect in 2022.