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Juicemafia Inc. d/b/a ECIG-Works manufactured and distributed e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements for "new tobacco products," which mandate premarket approval before commercial distribution in the United States. This violation occurred after the March 2022 legislative expansion of FDA jurisdiction to include all nicotine-containing products, regardless of nicotine source.