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Synergy Mixing Labs, LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act and FDA regulations governing newly deemed tobacco products. The company's e-liquids were determined to be tobacco products subject to FDA jurisdiction under section 901(b) of the Federal Food, Drug, and Cosmetic Act, requiring compliance with applicable requirements including premarket review for products not commercially marketed before February 15, 2007. The Center for Tobacco Products identified that the company was manufacturing and offering these products for commercial distribution in the United States without the legally mandated premarket authorization in effect.