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Big Chief Vapor Products LLC manufactured and distributed e-liquid products without obtaining required premarket authorization, as mandated by the Family Smoking Prevention and Tobacco Control Act for newly deemed tobacco products. The company's e-liquid products, classified as electronic nicotine delivery systems under FDA jurisdiction since August 8, 2016, were being offered for sale in the United States without compliance with FDA's new tobacco product authorization requirements under section 910(a) of the FD&C Act.