USA – FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency

Agency Also Denies Applications for Flavored Products for Failing to Demonstrate that Marketing of These Products Would Be Appropriate for the Protection of Public Health

Today, the U.S. Food and Drug Administration announced it has authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. As the RJR Vapor Company submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today’s authorization allows these products to be legally sold in the U.S…