Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistSelon Company Limited d/b/a Elf Bar Flavors was cited for manufacturing and distributing electronic nicotine delivery system (ENDS) products through their website without obtaining required premarket authorization from the FDA. The company's tobacco products, which contain nicotine from any source, are subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act and must comply with all requirements of the Federal Food, Drug, and Cosmetic Act, including obtaining a marketing authorization order for new tobacco products not commercially marketed in the United States prior to February 15, 2007.