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Go Vapor LLC manufactured and distributed e-liquid products for electronic nicotine delivery systems (ENDS) without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's e-liquids are regulated as tobacco products under FDA jurisdiction and qualified as "new tobacco products" requiring marketing authorization under section 910 of the Federal Food, Drug, and Cosmetic Act, which Go Vapor LLC had failed to obtain prior to commercial distribution in the United States.