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Ecig Charleston LLC was warned that it manufactures and distributes e-liquid products containing nicotine, which are classified as tobacco products under FDA jurisdiction and require premarket authorization to be legally marketed in the United States. The company failed to obtain required marketing authorization orders for these "new tobacco products" as mandated by the Federal Food, Drug, and Cosmetic Act, particularly following the 2022 legislation that expanded FDA tobacco product jurisdiction to include all nicotine-containing products regardless of source. The FDA determined the company's e-liquid products were not in compliance with applicable tobacco product regulations and marketing requirements.