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StrikesUSA was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without obtaining required FDA premarket authorization orders, in violation of the Federal Food, Drug, and Cosmetic Act. The company's products, which contain nicotine from any source, fall under FDA's expanded tobacco product jurisdiction following the March 2022 legislative amendment that extended regulatory authority beyond tobacco-derived nicotine. The FDA determined that these ENDS products were not in compliance with applicable regulations and lacked the necessary marketing authorization required for new tobacco products under section 910 of the FD&C Act.