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Cool Vapes Allison Park manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations applicable to newly deemed tobacco products, specifically electronic nicotine delivery systems that require marketing authorization orders before commercial distribution. As e-liquid products made from or derived from tobacco and intended for human consumption, they were subject to FDA jurisdiction under the FD&C Act but were being sold without the necessary premarket approval required for new tobacco products.