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Great American Vapes Bossier City 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 for newly deemed tobacco products, which have been subject to FDA jurisdiction since August 8, 2016, and require premarket approval before commercial distribution. The warning cited the company's e-liquid products as tobacco products under federal definition, making them subject to compliance requirements that the company had not met.