FDA Issues Ban on Sale of Six Flavored E-cigarettes

On October 12, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) for six flavored e-cigarette products from RJ Reynolds Vapor's Vuse Alto brand. RJ Reynolds Vapor is a subsidiary of British American Tobacco.

The e-cigarette products receiving the FDA's marketing denial orders cannot legally enter interstate commerce in the U.S., cannot be marketed or sold in the U.S. market, and if these products are already on the market, they must be removed; otherwise, they will face enforcement actions from the FDA.

The banned products include three menthol flavors and three mixed berry flavors of Vuse Alto. RJ Reynolds Vapor can subsequently submit new PMTA applications for the banned products to have them re-evaluated by the FDA.

The FDA stated that after reviewing the company's PMTA applications, it determined that these applications lacked sufficient evidence to demonstrate that allowing these products to be marketed is appropriate for the protection of public health, which is the standard required by the Family Smoking Prevention and Tobacco Control Act of 2009.

In other words, the FDA believes that the evidence submitted by PMTA applicants did not prove that menthol and mixed berry flavored products provide additional benefits compared to tobacco-flavored products for adult smokers looking to quit or reduce smoking, and that these flavors may pose greater risks to minors compared to tobacco-flavored e-cigarettes, thus denying the applications for these six flavored e-cigarette products.

Dr. Matthew Farrelly, director of the FDA's Center for Tobacco Products Science Office, said: "We review each PMTA application based on its merits, and applicants must provide sufficient scientific evidence to support their products seeking marketing authorization. If the application materials contain enough evidence to meet necessary public health standards, we will approve even flavored e-cigarette products. However, this case lacked such evidence."

The FDA noted that Vuse is currently the best-selling e-cigarette brand in the U.S., and Vuse Alto is its most popular sub-brand. National youth tobacco survey results show that since 2021, the pod-based e-cigarette brand Vuse has become the second most used brand among U.S. youth.

The FDA has received over 26 million PMTA applications and has made decisions on 99% of them.

So far, the agency has only authorized 23 tobacco-flavored e-cigarette products and devices for legal sale or distribution in the U.S. Authorized e-cigarettes include tobacco-flavored Vuse Vibe and Vuse Ciro devices and their accessories. Six applications for tobacco-flavored Vuse Alto products are still under FDA review.