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Ecig Charleston LLC was cited for manufacturing and distributing e-liquid products without required premarket authorization, as these nicotine-containing products fall under FDA's tobacco product jurisdiction. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to "new tobacco products," which mandate marketing authorization before legal distribution in the United States. The FDA's enforcement action reflects the agency's 2022 expansion of tobacco product jurisdiction to include all products containing nicotine from any source, not just tobacco-derived nicotine.