FDA rejects two menthol Vuse e-cigarette products

The US Food and Drug Administration issued marketing denial orders for two menthol e-cigarette products marketed by R.J. Reynolds Vapor Company. The agency said Tuesday that Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5% should not be marketed or distributed.

“The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use,” Dr. Brian King, director of the FDA’s Center for Tobacco Products said in an agency news release.

R.J. Reynolds said it was disappointed in the decision. The company intends to seek a stay of enforcement immediately and it told CNN Tuesday that it will pursue other appropriate avenues to allow Vuse to continue offering its products to adults without interruption.

“We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into 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 evaluates the health risks as well as how the product is manufactured, labeled and packaged.

The agency decided that the applications for these two flavored products did not have enough evidence to show that they would be “appropriate for the protection of the public health.” That’s the standard required by the 2009 Family Smoking Prevention and Tobacco Control Act.

The FDA said that the company may resubmit applications that would address any issues that did not 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 since. The agency has been criticized for years for moving too slowly to regulate e-cigarettes.

Companies submitted 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 go-ahead to some of the companies that submitted product applications. So far 23 tobacco flavored e-cigarette products and devices have been authorized by the FDA, including several tobacco-flavored products made by R.J. Reynolds.

Vuse offers several different e-cigarette products. Tuesday’s denial applies to two of its products.

Menthol has been used by tobacco companies to mask the unpleasant flavors and the harsh qualities of some tobacco products. Studies show that makes it easier for people to start using them and menthol products can become more addictive and harder to quit.

Flavored products, including ones made with menthol, have more appeal to kids than tobacco-flavored products, the FDA said.

In 2022, nearly 17% of high school students – or more than 2.14 million high schoolers – reported that they currently used e-cigarettes, according to the US Centers for Disease Control and Prevention. And one out of every 30 middle school students, about 3.3%, said that they used an e-cigarette in the past 30 days. For high schoolers, it was one and every 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 youth use of tobacco products because it can become a lifetime habit. Nearly 9 out of 10 adults who smoke cigarettes daily first try smoking by age 18.

In April the FDA announced a proposed rule that would ban menthol in cigarettes. The FDA has not agreed to a final rule yet.

“The FDA’s continued recognition that flavored e-cigarette or any flavored tobacco product does 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 hook kids and the American Lung Association hopes to see similar rejections on the way to them ultimately eliminating menthol cigarettes, as well, from the marketplace.”