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Wise Vice LLC dba Wise Vice Vapors manufactured and distributed e-liquid tobacco products containing nicotine without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA tobacco product regulations under section 901(b) of the FD&C Act and 21 C.F.R. § 1100.1, which require new tobacco products to obtain premarket authorization before commercial distribution in the United States. The violations were particularly significant given the March 2022 legislative expansion of FDA's tobacco jurisdiction to include all nicotine-containing products, regardless of nicotine source.