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Hotspot Vapes manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, 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, specifically electronic nicotine delivery systems that have been subject to FDA jurisdiction since August 8, 2016. As a manufacturer of "new tobacco products" not commercially marketed prior to February 15, 2007, Hotspot Vapes was required to obtain a marketing authorization order under section 910 of the FD&C Act before distributing its e-liquid products in the United States.