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American Legends Eliquid was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization, as these products fall under FDA jurisdiction as tobacco products containing nicotine. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to "new tobacco products," which must have FDA premarket approval before legal U.S. marketing. This violation was particularly significant given the March 2022 legislative expansion of FDA tobacco jurisdiction to include all products containing nicotine from any source, not just tobacco-derived nicotine.