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Vapor Proz USA LLC 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's e-liquid products, which contain nicotine derived from tobacco and are intended for human consumption through electronic delivery systems, were deemed tobacco products subject to FDA regulation as of August 8, 2016, but were marketed without the mandatory premarket approval required for new tobacco products under section 910 of the FD&C Act. The FDA's inspection records and review of the company's submissions confirmed that Vapor Proz USA LLC was manufacturing and offering these unapproved products for commercial sale and distribution in the United States.