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Kaleidoscope Custom Vapor Lounge, LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act and the FD&C Act. The company's e-liquid products, deemed tobacco products under FDA jurisdiction as of August 8, 2016, failed to comply with federal requirements mandating premarket approval for "new tobacco products" not commercially marketed in the United States prior to February 15, 2007. The FDA's inspection and review of the company's submissions identified these unauthorized products being offered for sale and distribution in the United States market.