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Chrimar Enterprises LLC d/b/a VapeGeek 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 as of August 8, 2016, were not in compliance with FD&C Act requirements for new tobacco products, which mandate premarket approval before commercial distribution. The FDA determined that the products were subject to regulation but lacked the necessary premarket authorization in effect at the time of distribution.