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Talk to a SpecialistTalk to a SpecialistRogue Vapers, LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as electronic nicotine delivery systems, were subject to FDA jurisdiction as deemed tobacco products but lacked the necessary "new tobacco product" marketing authorization orders required by section 910 of the Federal Food, Drug, and Cosmetic Act. The FDA inspection and submission review determined the products were being offered for sale and distribution in the United States in violation of applicable tobacco product regulations.