Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a Specialistesmokeronline.com was cited for offering electronic nicotine delivery system (ENDS) products for sale without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's ENDS products—which contain nicotine from any source—are tobacco products subject to FDA jurisdiction and must comply with premarket review requirements under section 910 of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain the legally required premarket authorization order before marketing these products in the United States.