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E-Cig POD USA LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, specifically electronic nicotine delivery systems, which have been subject to FDA jurisdiction since August 8, 2016. The FDA determined that the company's e-liquid products were marketed without the legally mandated premarket review and approval required for new tobacco products under section 910(a) of the FD&C Act.