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E-Cig Central, LLC manufactured and distributed e-liquid products that are regulated as tobacco products under the Family Smoking Prevention and Tobacco Control Act, but failed to obtain required premarket authorization for new tobacco products as mandated by the Federal Food, Drug, and Cosmetic Act. The company's e-liquids, classified as electronic nicotine delivery systems, were subject to FDA jurisdiction following the August 8, 2016 deeming rule but lacked the necessary marketing authorization orders required for products not commercially marketed in the United States prior to February 15, 2007.