The U.S. Food and Drug Administration (FDA) this week 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 Co. for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.
As the RJR Vapor Co. submitted data to the FDA that demonstrated that 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.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the 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.”
Zeller added that the agency will remain vigilant with the authorization and 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.
Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. The approved products were found to meet the 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.
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. That included review of available data on the likelihood of use of the product by young people. For these products, the 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.
Denial of 10 Flavored Products
The FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products. The products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Any of them already be on the market 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.
The FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found approximately 10 percent of high school students who currently used e-cigarettes named Vuse as their usual brand. The agency takes the data very seriously and considered risks to youth when reviewing the products. The evidence also indicated that, compared to users of non-tobacco flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products and then switch to higher-risk products, such as combusted cigarettes.
The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a significant increase in youth initiation.
The agency will continue to issue decisions on applications, as appropriate, and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public health.”