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Vaping Xtreme, LLC manufactured and sold e-liquid tobacco products without obtaining required premarket authorization orders, violating the Family Smoking Prevention and Tobacco Control Act and FDA regulations for newly deemed tobacco products. The company's e-liquids, listed on their website (vapingxtreme.com), met the definition of tobacco products subject to FDA jurisdiction but lacked the legally mandated marketing authorization needed to remain in commercial distribution. The violation centered on the company's failure to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires premarket approval for new tobacco products not commercially marketed before February 15, 2007.