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Texas Tobacco Barn LLC, operating as TX VapeBarn, manufactured and distributed e-liquid products that are classified as tobacco products under FDA jurisdiction but lacked required premarket authorization for new tobacco products. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act requirements applicable to deemed tobacco products, which have been subject to FDA regulation since August 8, 2016. The FDA determined that the e-liquid products were adulterated and misbranded under applicable tobacco regulations due to the absence of proper premarket review and authorization.