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MJ Asset Holdings, LLC d/b/a Marco's Vapor manufactured and distributed e-liquid tobacco products without required premarket authorization as mandated under 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 products were deemed adulterated and/or misbranded for lacking the required premarket authorization that all new tobacco products must obtain prior to commercial distribution in the United States.