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Madvapes Vape Shop was warned for manufacturing, selling, and distributing e-liquid tobacco products without required premarket authorization orders, in violation of the Federal Food, Drug, and Cosmetic Act. The company's nicotine-containing products fall under FDA jurisdiction as tobacco products—including those made with nicotine from non-tobacco sources following 2022 legislation—and must comply with new tobacco product approval requirements under section 910 of the FD&C Act. The FDA determined that the company's e-liquids were being marketed without the legally mandated premarket authorization necessary for new tobacco products to be sold in the United States.