Megan Udinski, FISM News
On Wednesday the U.S. Food and Drug Administration authorized the marketing of the first electronic cigarette. The FDA approved three of R.J. Reynolds Vapor Company’s Vuse tobacco-flavored vapes.
The RJR Vapor Company went through the Premarket Tobacco Product Application (PTPA) process, where manufacturers must show evidence that the marketing of a new tobacco product would provide some sort of protection for the public health. One such factor in the FDA’s decision was a study that found that users of the approved e-cigarettes were exposed to less toxic aerosols and fewer harmful and potentially harmful constituents than those who used combusted cigarettes.
The agency also took into account the effects for smokers and non-smokers, in particular youths. They felt that the benefit to the adult smoker would outweigh the risks to youth. About 10% of high schoolers who use vapes are using the R.J. Reynolds brand, according to the 2021 National Youth Tobacco Survey. Considering the risk to young people, evidence seems to indicate that those who use electronic nicotine delivery systems are less likely to turn to tobacco products such as combusted cigarettes.
Mitch Zeller, J.D., the director of the FDA’s Center for Tobacco Products, stated in a press 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. 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.”
There is widespread controversy over the FDA decision. Michelle Eakin, a professor at Johns Hopkins University and chair of the American Thoracic Society Tobacco Action Committee, feels the FDA did not have strict enough standards in the e-cigarette approval.
Good news is FDA denied all fruit/candy flavored products-still no decision on menthol. Bad news Vuse has really high levels of nicotine. Big message is these are not approved for smoking cessation or deemed healthy. They have met a low bar and allowed to remain on the market.
— Michelle Eakin, Ph.D. (@mneakin) October 13, 2021
Get Healthy PHL also released a statement critical of the decision made. On the other hand, vaping advocate and President of the American Vaping Assn Greg Conley, among others, was disappointed that more was not approved.
While these e-cigarettes may now be legally sold in the U.S. ,the FDA is clear that products containing tobacco are not safe or FDA approved and should not be taken up by people who do not use tobacco products.