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Talk to a SpecialistTalk to a SpecialistVapor-Saloon, 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. The company's e-liquid products, classified as newly deemed tobacco products subject to FDA regulation since August 2016, lacked the necessary marketing approval required for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act. The Center for Tobacco Products determined the products were adulterated and misbranded due to the absence of proper premarket authorization and compliance with applicable tobacco product regulations.