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Carolina Vapor Mill was warned that its e-liquid products fall under FDA jurisdiction as tobacco products subject to the Family Smoking Prevention and Tobacco Control Act, but the company was manufacturing and selling them without required premarket authorization. The FDA determined that e-liquids, as electronic nicotine delivery systems (ENDS), have been deemed tobacco products since August 8, 2016, and must comply with FD&C Act requirements including obtaining a premarket authorization order before marketing "new tobacco products" in the United States. The company's website was found to be offering these non-compliant products for sale and distribution to U.S. customers without the legally required authorization.