FDA Permits Sale of E-Cigarette Products in First-of-its-Kind Authorization

A press release issued on Tuesday by the U.S. Food and Drug Administration (FDA) said that the agency authorized three new tobacco products made by R.J. Reynolds Vapor Company (RJR). According to the FDA, this is the very first marketing authorization of an electronic nicotine delivery system (ENDS) product made through the Premarket Tobacco Product Application (PMTA) pathway.

The press release explains that to obtain PMTA approval, manufacturers must show that new tobacco products meet certain public health requirements. RJR reportedly demonstrated that its products expose users to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to combusted cigarettes. 

“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,” Mitch Zeller, director of the FDA’s Center for Tobacco Products said in a statement. 

In approving the three products, the Vuse Solo vaping device and two accompanying tobacco-flavored e-liquid pods, the FDA also considered the risks and benefits to the population at large, including youth. In this case, the FDA determined that the potential benefit to smokers who switch completely or substantially reduce their cigarette use would outweigh the risk to youth if RJR adheres to FDA marketing strictures. 

Additionally, the FDA cited the products’ tobacco flavor, as opposed to mint, candy, or other flavors that appeal more to youth, as part of the reason for its authorization. By contrast, the press release notes that the FDA issued ten marketing denial orders for flavored ENDS products submitted under the Vuse Solo brand by RJR. 

The FDA makes clear that RJR must comply with strict marketing rules, including digital, radio, and television advertising limitations to reduce youth exposure. Compliance also requires that the company report consumer research studies, advertising and marketing plans, sales data, information on current and new users, manufacturing changes, and adverse experiences to the FDA on a regular basis.