FDA permits marketing of new e-cigarette products, marking first authorization of its kind
The FDA announced it has authorized marketing of three new tobacco products — the first set of electronic nicotine delivery system products ever to be authorized by the FDA via the Premarket Tobacco Product Application pathway.
The FDA issued marketing granted orders to R.J. Reynolds Vapor Company for its Vuse Solo closed electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods (Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1 and Vuse Replacement Cartridge Original 4.8% G2), according to an agency press release.
The new authorization allows these products to be legally sold in the U.S. Under the Premarket Tobacco Product Application (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, according to the release.
The FDA determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents from aerosols compared with users of combusted cigarettes, and a toxicological assessment found that the aerosols in the authorized products are significantly less toxic compared with combusted cigarettes. Further, the FDA said it considered risks and benefits to the population as a whole, including those who use and do not use tobacco products as well as youths, according to the release.
“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,” Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said in the release. “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, the new authorization imposes strict marketing restrictions on the company, including for digital, radio and television advertising, to reduce the potential for youth exposure to advertising of these products, according to the release. RJR Vapor Company must report regularly to the FDA regarding consumer research studies, advertising, marketing plans, sales data, current and new users, manufacturing changes and adverse experiences, according to the release.
According to the release, the FDA is aware that the 2021 National Youth Tobacco Survey found that about 10% of high school students currently using e-cigarettes named Vuse as their usual brand. The data also indicated that young people are less likely to begin using tobacco-flavored ENDS products and then switch to higher-risk products compared with users of non-tobacco flavored ENDS products, and most youth and young adults who use ENDS begin with non-tobacco flavors. The FDA said these data reinforce its decision to authorize the tobacco-flavored products as they are less appealing to youth and the authorization may be beneficial for adult combusted cigarette users who switch to ENDS only or significantly reduce their use, according to the release.
The new action does not mean that these products are safe or “FDA approved,” according to the release.
The FDA said it will continue to issue decisions on applications and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that the product marketing is appropriate for the protection of the public health, according to the release.