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Prior Lake Smokes Inc, a manufacturer and distributor of electronic nicotine delivery system (ENDS) products, was cited for failing to comply with Federal Food, Drug, and Cosmetic Act requirements applicable to tobacco products containing nicotine from any source. The company's ENDS products were subject to FDA jurisdiction but lacked the required premarket authorization orders necessary for legal marketing in the United States. The FDA determined that these products, as "new tobacco products" not commercially marketed before February 15, 2007, must undergo premarket review and receive marketing authorization before being sold to consumers.