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Cool Vape LLC, a manufacturer and distributor of e-liquid tobacco products containing nicotine, was notified that its products are subject to FDA jurisdiction and must comply with the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket authorization orders for its "new tobacco products" as mandated by section 910 of the FD&C Act, which requires such products to have FDA approval before legal marketing in the United States. The warning was issued by the Center for Tobacco Products following a review of FDA inspection records and applied to all e-liquid products containing nicotine from any source, consistent with FDA's expanded regulatory authority over non-tobacco-derived nicotine products effective April 14, 2022.