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Talk to a SpecialistTalk to a SpecialistVapor Outlet Inc d/b/a Union Hills Vape Shop was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, deemed subject to FDA regulation as electronic nicotine delivery systems under the Family Smoking Prevention and Tobacco Control Act since August 8, 2016, were found to be unapproved "new tobacco products" lacking the marketing authorization order required under Section 910 of the Federal Food, Drug, and Cosmetic Act. The products were distributed for commercial sale in the United States without compliance with applicable FDA regulations governing tobacco products.