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Unlit Vapor Shoppe LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as tobacco products under FDA jurisdiction since the August 8, 2016 deeming rule, were deemed "new tobacco products" requiring marketing approval before commercial distribution in the United States. The FDA determined the products were adulterated and misbranded due to the absence of premarket authorization and compliance with applicable tobacco product regulations.