The U.S. Food and Drug Administration (FDA) has, for the first time, authorized the marketing of three nicotine vaping products.
The products, technically known as “electronic nicotine delivery system (ENDS) products,” were developed by the R.J. Reynolds (RJR) Vaping Company. They are specifically designed to help people using traditional tobacco products to stop smoking.
Under the order, RJR is granted permission to market its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. The FDA said the tobacco company subsidiary submitted data that showed the products would be useful in reducing the number of cigarette smokers.
“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,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
Targeting young people
Critics of vaping products, including former FDA Commissioner Dr. Scott Gottlieb, have warned that their use by teenagers and young adults who don’t smoke cigarettes can lead to a new generation of people who are addicted to nicotine. Zeller makes clear that the approved products are to only be used to wean smokers off tobacco.
“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 said. “We will take action as appropriate, including withdrawing the authorization.”
In the past, the FDA has cracked down on vaping products that it determined were being marketed to young people by using fruit flavors. The agency said vaping products designed as a smoking cessation aid must be tobacco flavored.
The FDA said it granted approval to the RJR products because it 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.”
Research also showed the products getting the FDA seal of approval are “significantly less toxic than combusted cigarettes” based on available data comparisons and results of nonclinical studies.
In the end, the FDA concluded that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, as long as steps are taken to limit sales to adult smokers.