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ZOVOO Technology Co., Ltd. manufactured and offered electronic nicotine delivery system (ENDS) products for sale in the United States without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products, containing nicotine from any source, were subject to FDA jurisdiction as tobacco products but lacked the legally mandated premarket authorization order necessary for new tobacco products to be marketed in the United States. This violation fell under the FDA's expanded regulatory authority over nicotine-containing products, which was extended in March 2022 to include products with nicotine from any source, not just tobacco-derived nicotine.