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Team MC Inc. d/b/a Community Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, which are electronic nicotine delivery systems subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act as of August 8, 2016, failed to comply with the FD&C Act requirement that "new tobacco products" obtain premarket authorization before commercial distribution. The FDA determined these products were not commercially marketed in the United States prior to February 15, 2007, and therefore required regulatory approval before being offered for sale.