Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistECIGRUSA LLC, d/b/a Worldwide Vape Distribution was warned for selling and distributing electronic nicotine delivery system (ENDS) products without obtaining required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations applicable to "new tobacco products," which require premarket authorization before legal marketing in the United States. The warning specifically cited that ENDS products containing nicotine from any source—including non-tobacco-derived nicotine—fall under FDA's expanded tobacco product jurisdiction effective April 14, 2022, and must meet all applicable FD&C Act requirements.