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By Mitch Zeller, Director of the FDA’s Center for Tobacco Products (CTP) September 9, 2021 Following updates provided in May and February, as well as our initial perspective published in August 2020, this piece describes the current status of our review of applications for “deemed” new tobacco products submitted by Sept. 9, 2020. Previously, we also created a webpage with general information and resources related to the submission of tobacco product applications for these products. FDA’s...

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...