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Smoxygen Inc was cited for offering electronic nicotine delivery system (ENDS) products for sale in the United States without required FDA premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company's products, which contain nicotine and fall under FDA's expanded tobacco product jurisdiction (effective as of the March 2022 legislative amendment), were deemed new tobacco products lacking the legally mandated premarket authorization order. The products were also found to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.