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Vapor Sense League City manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products, which contained nicotine from tobacco or other sources, fell under FDA jurisdiction as tobacco products but lacked the legally mandated premarket review and approval before being offered for sale in the United States. The warning was issued following FDA review of the company's submissions and inspection records, which confirmed commercial manufacturing and distribution of non-compliant e-liquid products.