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Mini Cup Vape was warned for offering electronic nicotine delivery system (ENDS) products for sale in the United States without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The FDA determined that the company's products constituted tobacco products under FDA jurisdiction because they contained nicotine and were intended for human consumption, including nicotine derived from non-tobacco sources under the expanded definition established by the Consolidated Appropriations Act of 2022. The company failed to obtain a marketing authorization order required for "new tobacco products" not commercially marketed in the United States as of February 15, 2007, making the products adulterated and misbranded.