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Center Point Vapes manufactured and distributed e-liquid tobacco products without the required premarket authorization mandated by the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction requirements for tobacco products containing nicotine, regardless of whether the nicotine was derived from tobacco or other sources, as established under legislation effective April 14, 2022. The products were offered for sale or commercial distribution in the United States without demonstrating compliance with applicable FDA regulations for new tobacco products.