Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistGreen Rush, LLC d/b/a XHALE CITY was warned for offering electronic nicotine delivery system (ENDS) products for sale through their website without required premarket authorization. The FDA determined the company's products fall under tobacco product jurisdiction because they contain nicotine from any source and are intended for human consumption, bringing them under Federal Food, Drug, and Cosmetic Act requirements that took effect in March 2022. The company failed to obtain a premarket authorization order, which is legally required for any "new tobacco products" not commercially marketed in the United States before February 15, 2007.