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Kaleidoscope Custom Vapor Lounge manufactured and distributed e-liquid tobacco products without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act and the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as tobacco products under FDA jurisdiction since the August 2016 deeming rule, were found to be unapproved "new tobacco products" lacking the mandated premarket authorization needed for commercial distribution in the United States. The FDA determined the products were adulterated and/or misbranded under applicable tobacco product regulations.