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Advanced Vapor manufactured and distributed e-liquid products containing nicotine without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control 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, which took effect in March 2022. The Center for Tobacco Products determined that Advanced Vapor's e-liquid products were being offered for sale or distribution in the United States without compliance with applicable FDA regulations requiring premarket review for new tobacco products.