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Highbrow Vapor 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 FDA regulations under the Federal Food, Drug, and Cosmetic Act. The FDA determined that the company's e-liquid products, identified through review of their website, qualified as newly deemed tobacco products subject to FDA jurisdiction as of August 8, 2016, and therefore required marketing authorization before legal sale in the United States. The company failed to obtain the necessary section 910 premarket approval orders required for new tobacco products not commercially marketed prior to February 15, 2007, or for modified tobacco products marketed after that date.