10-12-2023 3:23pm

FDA Denies Marketing of Six Flavored Vuse Alto E-Cigarette Products Following Determination They Do Not Meet Public Health Standard

Anita Johnson-Brown Editor

On October 12th, the U.S. Food and Drug Administration (FDA) denied the marketing of six flavored e-cigarette products under the Vuse Alto brand by R.J. Reynolds Vapor Company. The denied products include three menthol-flavored and three mixed berry-flavored products, each with three different nicotine strengths. The company cannot distribute or market these products in the United States, or they risk facing FDA enforcement action. However, they may resubmit new applications for the products that have been denied.

The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product for the whole population. After reviewing the company's PMTAs, the FDA discovered that the applications lacked sufficient evidence to show that marketing these products would be appropriate for public health protection, which is legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, the evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes regarding complete switching or significant smoking reduction in comparison to tobacco-flavored products that are sufficient to outweigh the known risks to youth.

Matthew Farrelly, Ph.D., the director of the FDA's Center for Tobacco Products Office of Science, said, "We review each application on its own merits, and it's the responsibility of the applicant to provide sufficient science to support the product they're seeking to market. If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we'd authorize the product. But such evidence was lacking in this case."

Vuse is the most commonly sold e-cigarette brand in the U.S., and its most popular sub-brand is Vuse Alto. Additionally, the National Youth Tobacco Survey (NYTS) found that Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly used e-cigarette brand by youth in the U.S. since 2021.

The FDA has taken several measures to ensure that any tobacco products marketed in the U.S. undergo science-based review and receive marketing authorizations from the agency. The FDA has received applications for over 26 million deemed products and has made determinations on 99% of these applications.

"The Center for Tobacco Products continues to make meaningful progress in reviewing the unprecedented amount of premarket tobacco product applications that have been received," said Brian King, Ph.D., M.P.H., the director of the FDA's Center for Tobacco Products. "We're committed to completing the review of these applications as soon as possible, while ensuring that they undergo a rigorous scientific review in accordance with the law."

The products mentioned in these denial orders cannot be legally introduced into interstate commerce in the U.S. If the product is already being sold, it must be removed from the market or risk facing FDA enforcement. Currently, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that may be lawfully sold or distributed in the U.S. These authorizations include other products under the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and accompanying cartridges. The FDA is still reviewing applications for six tobacco-flavored Vuse Alto products.

By Anita Johnson-Brown