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Sunset Wholesale Tobacco, Inc. was cited for selling and distributing electronic nicotine delivery system (ENDS) products without the required premarket authorization orders mandated by the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain premarket approval before being legally marketed in the United States, a requirement that applies to all ENDS products containing nicotine from any source under the expanded definition of tobacco products established in March 2022. The Center for Tobacco Products determined that the company's ENDS products were not in compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations.