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Southeast Distro Inc. was cited for selling and distributing electronic nicotine delivery system (ENDS) products without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction over tobacco products containing nicotine from any source, which expanded under 2022 legislation to include synthetic nicotine products. As a distributor of ENDS products, the company was required to ensure these "new tobacco products" obtained marketing authorization before being legally sold in the United States.