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Velvet Vapor, an e-liquid manufacturer based in Arkansas, was cited for manufacturing and distributing tobacco products containing nicotine without obtaining required premarket authorization from the FDA. Under the Federal Food, Drug, and Cosmetic Act and amendments that expanded FDA jurisdiction to include products containing nicotine from any source (effective March 15, 2022), the company's e-liquid products were determined to be unapproved "new tobacco products" lacking the legally mandated premarket authorization needed for commercial U.S. distribution. The FDA's inspection records and review of the company's submissions confirmed the products were manufactured and offered for sale in violation of applicable tobacco product regulations.