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Black Dog Reserve LLC was cited for manufacturing and distributing e-liquid tobacco products without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company's e-liquids, which are deemed tobacco products under FDA regulations effective August 8, 2016, were being sold through their website without obtaining the necessary marketing authorization required for new tobacco products. The FDA determined that these products lacked the required premarket approval to be legally marketed in the United States.