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Chevaline Investments, LLC d/b/a VaporCore 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 for deemed tobacco products, specifically electronic nicotine delivery systems that have been subject to FDA jurisdiction since August 8, 2016. As "new tobacco products" not commercially marketed prior to February 15, 2007, the e-liquids required premarket approval before being offered for sale or distribution in the United States.