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FF Vapors, LLC manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction requirements established under section 901(b) of the FD&C Act and regulations at 21 C.F.R. § 1100.1, which mandate that tobacco products—including those containing nicotine from any source following the 2022 legislative expansion of FDA authority—must have premarket approval before legal U.S. marketing. The inspection determined the products were being manufactured and offered for sale in the United States without the legally required authorization for new tobacco products.