Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistShenzhen IJOY Technology Co., LTD. was warned for manufacturing and distributing electronic nicotine delivery system (ENDS) products through its website to U.S. customers without required premarket authorization. The company's products violated the Federal Food, Drug, and Cosmetic Act by failing to obtain marketing authorization orders, which are mandated for all "new tobacco products" not commercially marketed in the United States prior to February 15, 2007. The FDA's enforcement action was issued under its expanded jurisdiction over tobacco products containing nicotine from any source, as extended by legislation signed in March 2022.