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T.S.V.L. LLC d/b/a Times Square Vape Lab manufactured and distributed e-liquid tobacco products without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as electronic nicotine delivery systems under FDA jurisdiction, were deemed tobacco products subject to FDA regulation as of August 8, 2016, yet the firm failed to obtain marketing authorization orders required for new tobacco products not commercially marketed prior to February 15, 2007. The FDA's inspection and review of the company's submissions determined that the products were being manufactured and offered for sale in the United States in violation of the Federal Food, Drug, and Cosmetic Act.