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Buku Vapor LLC was cited for manufacturing and distributing e-liquid products without obtaining required premarket authorization, as these products are deemed tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires new tobacco products to have marketing authorization orders in effect before commercial distribution. As e-liquid products were not commercially marketed in the United States prior to February 15, 2007, they qualified as "new tobacco products" requiring premarket FDA approval before being offered for sale.