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Cloud 9 Systems, LLC d/b/a Cloud 9 Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as electronic nicotine delivery systems under FDA jurisdiction since the August 8, 2016 deeming rule, were offered for sale in the United States without the mandatory marketing authorization orders required for new tobacco products. The FDA determined these products were not commercially marketed prior to February 15, 2007, making them subject to premarket review requirements that the company failed to complete.