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Vegas Vapor Emporium manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The company's products fell under FDA jurisdiction as tobacco products under the expanded definition that includes any products containing nicotine from any source, effective after March 15, 2022. The inspection determined the e-liquids were being offered for sale or distribution in the United States without compliance with applicable FDA regulations for new tobacco products.