Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistLingkey Co. Ltd. d/b/a Vape Hammer was cited for offering electronic nicotine delivery system (ENDS) products for sale in the United States without required premarket authorization. The company's products, which contain nicotine and fall under FDA tobacco product jurisdiction, were found to be in violation of the Federal Food, Drug, and Cosmetic Act's requirement that "new tobacco products" obtain a marketing authorization order before being legally marketed. The FDA determined that these ENDS products were not commercially marketed in the United States prior to February 15, 2007, making them subject to premarket review requirements regardless of nicotine source.