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Absolute Vapor Lounge, LLC manufactured and distributed e-liquid tobacco products without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, including electronic nicotine delivery systems, which have been subject to FDA jurisdiction since August 8, 2016. As a tobacco product manufacturer, the company was required to obtain premarket authorization for these "new tobacco products" not commercially marketed in the United States before February 15, 2007, but had not obtained such approval prior to manufacturing and distributing the products.