FDA Grants Historic Authorization to Vuse E-Cigarette for Adults

The indication came via the Premarket Tobacco Product Application, which requires evidence of public health benefit and company agreement to post-marketing strategies that avoid young users.

The US Food and Drug Administration (FDA) has authorized marketing for 3 electronic nicotine delivery system products from RJ Reynolds Vapor Company, in a historic decision that introduces the concept of regulated electronic cigarette products for the benefit of reduced combustible cigarette consumption in adults.

The authorization for the company’s Vuse Solo closed delivery system device and accompanying tobacco flavored liquid pods (Vuse Solo Power Unit; Vuse Replacement Cartridge Original 4.8% G1; Vuse Replacement Cartridge Original 4.8% G2) was supported by accompanying data demonstrating public health protective benefits of the e-cigarette when marketed in the US.

The first-of-its-kind indication was authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway, under which manufacturers must demonstrate the new tobacco products would be “appropriate for the protection of the public health.” Among the factors supporting authorization of the Vuse product were data showing trial participants who only used the e-cigarette were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols than those who smoked combustible cigarettes.

The FDA additionally determined under regulatory review that the potential benefit of smokers switching to this product outweighed the risk of youths acquiring and using the product. This decision comes with the caveat that the company must follow post-marketing requirements that aim to reduce youth exposure and access to the products.

The authorizations are a critical step toward ensuring all new tobacco products going forward undergo the FDA’s “robust, scientific premarket evaluation,” Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said in a statement.

“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 said.

Zeller added that the FDA will remain vigilant in post-marketing authorization stages, and is willing to go as far as to withdraw the indication should the company fail to comply with requirements or if “credible evidence emergences” of significant use of the e-cigarette by tobacco-naïve individuals, including youth.

The FDA also called attention to the 2021 National Youth Tobacco Survey, which reported that about 1 in 10 high school students who were using e-cigarettes at the time of assessment named Vuse as their usual brand. The data also showed an association between adolescent and young adults beginning e-cigarette use with flavors including fruit, candy, or mint—reinforcing their rationale for only authorizing 3 tobacco-flavored products which would likely be less appealing to younger users.

In an episode of the HCPLive® and American Lung Association (ALA) respiratory health podcast series Lungcast this June, Kevin Walton, PhD, Chief of the Clinical Research Grants Branch at the NIH’s National Institute on Drug Abuse, spoke with ALA Chief Medical Office Al Rizzo, MD, on the longtime pursuit of regulated e-cigarette products to combat the increased health risks of combustible cigarettes.

“With FDA being able to regulate tobacco…it really gave them a lot of power to move the field in a new direction,” Walton said. “What we really want is for people to quit using tobacco products. But a lot of people can’t quit. We don’t want to forget those people, so what we want is for people to use products with modified risk. Creating that authorization for reduced exposure or risk allows for the legal sale of products that meet those less risky characteristics.”