The US Food and Drug Administration has issued marketing denial orders for two mentholated e-cigarette products marketed by the RJ Reynolds Vapor Company. The agency said Tuesday that Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5% should not be marketed or distributed.
“Applications for these products did not present sufficient scientific evidence to demonstrate that the potential benefit to adult smokers outweighs the risks of initiation and use by youth,” Dr. Brian said in an agency news release. King, director of the FDA’s Center for Tobacco Products. .
RJ Reynolds said he was disappointed with the decision. The company intends to seek a suspension of the app immediately and told CNN on Tuesday that it will pursue other appropriate avenues to allow Vuse to continue to offer its products to adults without interruption.
“We believe that menthol vapor products are critical in helping adult smokers to quit combustible cigarettes. The FDA’s decision, if allowed to take effect, will harm, not benefit, public health. Reynolds will challenge the denials,” the company said in an email to CNN.
The FDA said that when it reviews applications for tobacco products, it assesses the health risks and how the product is manufactured, labeled and packaged.
The agency decided that the applications for these two flavored products did not have sufficient evidence to show that they would be “appropriate for the protection of public health.” That is the standard required by the Family Smoking Prevention and Tobacco Control Act of 2009.
The FDA said the company can resubmit applications that address any issues that don’t meet government standards.
Other Vuse products, including menthol products, are not affected by the denial.
E-cigarette products have been allowed to be sold in the US for years without regulation, but in 2020, the FDA asked companies to submit applications to keep their products on the market and has been reviewing these applications ever since. The agency has been criticized for years for moving too slowly in regulating e-cigarettes.
Companies filed applications for more than 6.7 million products. The FDA said it has reviewed 99% of them. As of last year, the agency said it had denied authorization to more than 1 million products.
The FDA has given the green light to some of the companies that submitted product applications. To date, the FDA has cleared 23 tobacco-flavored e-cigarette products and devices, including several tobacco-flavored products made by RJ Reynolds.
Vuse offers several different electronic cigarette products. Tuesday’s denial applies to two of its products.
Tobacco companies have used menthol to mask the off-flavors and harsh qualities of some tobacco products. Studies show that it makes it easier for people to start using, and that menthol products can become more addictive and harder to quit.
Flavored products, including those made with menthol, are more appealing to children than tobacco-flavored products, the FDA said.
In 2022, nearly 17% of high school students, or more than 2.14 million high school students, reported that they currently used e-cigarettes, according to the US Centers for Disease Control and Prevention and one About 3.3% of every 30 high school students said they used an e-cigarette in the past 30 days. For high school students, it was one in seven students, the CDC said.
In 2021, 28.8% of middle and high school students who used e-cigarettes reported using menthol-flavored products.
Public health experts are concerned about the use of tobacco products among young people because it can become a lifelong habit. Nearly 9 out of 10 adults who smoke cigarettes daily try for the first time at age 18.
In April, the FDA announced a proposed rule that would ban menthol in cigarettes. The FDA has not yet agreed to a final rule.
“The FDA’s continued acknowledgment that flavored e-cigarettes or any flavored tobacco products do not protect the public health is very welcome,” said Erika Sward, assistant vice president of national advocacy for the American Lung Association. “It’s clear that menthol products, including menthol-flavored e-cigarettes, attract and engage kids, and the American Lung Association expects to see similar pushbacks on the road to the eventual removal of menthol cigarettes from the market as well.”