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Edora Solutions, Inc d/b/a JoJo Vapes Brookville manufactured and distributed e-liquid tobacco products without the required premarket authorization mandated by the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, specifically electronic nicotine delivery systems that became subject to FDA jurisdiction effective August 8, 2016. The e-liquid products were being offered for commercial sale and distribution in the United States without obtaining premarket authorization as required for any tobacco product not commercially marketed before February 15, 2007.