WASHINGTON - The U.S. Food and Drug Administration announced Tuesday it has authorized the marketing of e-cigarettes for one manufacturer, making it a first for the agency.
The FDA granted permission to R.J. Reynolds Vapor Company to market its Vuse Solo closed electronic nicotine delivery system (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.
"Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation," FDA’s Center for Tobacco Products Director Mitch Zeller said. "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."
"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," Zeller added.
R.J. Reynolds Vapor Company was able to get permission through the FDA’s Premarket Tobacco Product Application, or PMTA. In the application process, manufacturers must demonstrate their products protect public health.
The FDA found that people who participated in a study using the Vuse products "were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes." Study results also showed that the Vuse products’ aerosols were significantly less toxic than combusted cigarettes.
One stipulation is that R.J. Reynolds Vapor Company must aim to reduce youth exposure and access to its e-cigarettes. FDA officials said they acknowledge a 2021 National Youth Tobacco Survey that found approximately 10% of high school students use Vuse e-cigarettes. But officials said the greater benefit is the number of adults who will eventually stop or reduce smoking combusted cigarettes because of e-cigarettes. They also said it’s less likely that minors who smoke e-cigarettes will switch over to combusted cigarettes or other high-risk products.
FDA officials reiterated that all tobacco products are harmful.
"While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or ‘FDA approved,‘" the agency said. "All tobacco products are harmful and addictive and those who do not use tobacco products should not start."
This story was reported from Los Angeles.