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JP Ventures LLC dba iVape manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company's e-liquid products fell under FDA jurisdiction as tobacco products under the Family Smoking Prevention and Tobacco Control Act, requiring compliance with premarket review requirements for new tobacco products. The warning was issued following an FDA inspection that determined the company was offering these products for commercial sale in the United States without the legally mandated premarket authorization in effect.