FDA denies marketing of two menthol e-cigarettes that are popular among youth

The FDA has issued marketing denial orders to R.J. Reynolds Vapor Company for two popular menthol e-cigarette products today, stating that the company cannot distribute or market them in the United States.

The products are the Vuse Vibe Tank Menthol 3% and the Vuse Ciro Cartridge Menthol 1.5%. The 2022 National Youth Tobacco Survey indicated that Vuse was the second-most common brand that youth e-cigarette users said they typically used, according to a press release from the agency.

This is “just one of many actions” the FDA has taken recently to ensure that marketed tobacco products are authorized and undergo a science-based review, according to the release. The agency has already made determinations on more than 99% of the roughly 6.7 million products that submitted applications before a court-ordered deadline in September 2020.

“Today’s decision pertains to the specific application submitted for review by FDA,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in the release. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”

In recent months, reports have indicated that 2.5 million middle and high schoolers use e-cigarettes, and the U.S. Department of Justice filed for permanent injunctions against six e-cigarette manufacturers on behalf of the FDA. However, researchers have said that the organization’s enforcement actions will likely have a minimal impact on the vaping industry, since it targets smaller retailers rather than larger e-cigarette brands or products.

The FDA said it evaluates factors like additives, the product’s components, constituents, design, harmful and potentially harmful constituents and health risks, ingredients and more when reviewing premarket tobacco product applications (PMTAs). The FDA determined after reviewing Vuse’s PMTAs that “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health” — a legally required standard.

“Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” King said in the release. “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.”

Non-tobacco-flavored e-cigarettes — including those that are menthol flavored — “have a known and substantial risk with regard to youth appeal, uptake and use,” according to the release. However, tobacco-flavored e-cigarettes do not pose the same degree of risk since they do not have the same youth appeal.

Because of the differing risks for youth, applicants must “provide robust evidence to demonstrate that using their menthol flavored e-cigarette products are likely to promote a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes products,” according to the release.