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BC VAPIN'APE manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products fell under FDA jurisdiction as tobacco products under the expanded definition that includes all products containing nicotine from any source, effective April 14, 2022. The FDA determined the products were being offered for commercial sale in the United States without compliance with applicable tobacco product regulations and premarket review requirements.