FDA Grants its First E-Cigarette Authorization

RJ Reynolds Vapor | Vuse Solo

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.”

In a press release, Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Product, issued the following statement: “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals. We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”

In addition to the authorization, the FDA issued 10 marketing denial orders (MDOs) for flavored ENDS products that were submitted under the Vuse Solo brand by RJR. While the has opted not to disclose the specific flavored products impacted by these MDOs due to potential confidential commercial information issues, the FDA is urging retailers contact RJR with any questions about products that may be in their inventory and impacted by these MDOs.