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Juice Mafia, Inc. dba 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 Family Smoking Prevention and Tobacco Control Act and regulations under the Federal Food, Drug, and Cosmetic Act, which mandate that new tobacco products, including e-liquids, obtain FDA approval before commercial distribution in the United States. This violation was particularly significant given the March 2022 legislative expansion of FDA jurisdiction to include all products containing nicotine from any source, not just tobacco-derived nicotine.