First E-Cigarette Authorization Granted by FDA

The U.S. Food and Drug Administration (FDA) has authorized the marketing of three new electronic nicotine delivery system (ENDS) products. These products are the first to receive such an authorization through the FDA’s Premarket Tobacco Product Application (PMTA) pathway.

These authorizations were extended to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods. These include Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. According to the FDA, RJR Vapor Company submitted data that demonstrated that the 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.”

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