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Talk to a SpecialistTalk to a SpecialistShenzhen Greensound High-Tech Co. Ltd. (ENVA) manufactured and offered electronic nicotine delivery systems (ENDS) for sale in the United States without premarket authorization, as required for new tobacco products under the Federal Food, Drug, and Cosmetic Act. The company's website listed ENDS products containing nicotine from any source, which fall under FDA jurisdiction following the March 2022 legislation expanding the definition of tobacco products to include non-tobacco-derived nicotine. The products were found to be in violation of premarket authorization requirements that apply to any tobacco product not commercially marketed in the United States as of February 15, 2007.