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TNT Vapors manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which are electronic nicotine delivery systems subject to FDA jurisdiction since the August 8, 2016 deeming rule, were being sold commercially in the United States as "new tobacco products" without the mandatory marketing authorization orders required by section 910 of the Federal Food, Drug, and Cosmetic Act. The FDA determined that TNT Vapors' failure to obtain premarket approval for these products constituted violations of the Act's requirements for newly deemed tobacco products.