RJR Vapor Company’s Vuse Solo – the first new ENDS tobacco products authorized to be marketed and sold in the US by FDA.
In the first of what many vape, ENDS, and HNB manufacturers hope to be many, the US Food & Drug Administration (FDA) authorized the marketing of three new tobacco products. This landmark move marks the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by FDA through the Premarket Tobacco Product Application (PMTA) pathway.
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. RJR submitted data that FDA says demonstrates that the marketing of these products is appropriate for the protection of public health. This authorization allows these products to be sold legally in the US.
"Today's authorizations are an important step toward ensuring all new tobacco products undergo FDA's robust, scientific premarket evaluation,” said Mitch Zeller, director of the FDA's Center for Tobacco Products. “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.”
These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes. The toxicological assessment also found the authorized products' aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies.
Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. For these products, FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.
However, FDA also issued 10 marketing denial orders (MDOs) for other Vuse Solo brands. FDA did not publicly disclose the specific flavored products. That means that these 10 Vuse products may not be introduced or delivered within the US. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory.
The agency is still evaluating the company's application for menthol-flavored products under the Vuse Solo brand.