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Little Town Vaping d/b/a Swamp Vapor Lafayette manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization as mandated by the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as newly deemed tobacco products under FDA jurisdiction effective August 8, 2016, were being sold commercially in the United States without the necessary marketing authorization order required for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act. The FDA determined the products were unapproved and therefore adulterated and misbranded under federal tobacco product regulations.