The FDA denies the sale of two menthol-based e-cigarettes that are popular among young people

January 24, 2023

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The FDA today issued marketing denial orders to RJ Reynolds Vapor Company for two popular menthol e-cigarette products, saying the company cannot distribute or sell them in the United States.

The products are Vuse Vibe Tank Menthol 3% and Vuse Ciro Cartridge Menthol 1.5%. The 2022 National Youth Smoking Survey shows Vuse is the second most common brand that young e-cigarette users say they usually use, according to a news release from the agency.

The FDA today issued marketing denial orders to RJ Reynolds Vapor Company for two popular menthol e-cigarette products, saying the company cannot distribute or sell them in the U.S. Source: Adobe Stock

This is “just one of many actions” the FDA has taken recently to ensure that tobacco products on the market are authorized and subject to science-based review, according to the release. The agency has already made decisions on more than 99 percent of the approximately 6.7 million products that submitted applications before the court’s September 2020 deadline.

“Today’s decision concerns the specific application submitted for FDA review,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, the release said. β€œIt is the applicant’s responsibility to provide sufficient robust scientific evidence to demonstrate that the required public health standard is met. In this case, the evidence presented does not meet that standard.

In recent months, reports have indicated that 2.5 million middle and high school students use e-cigarettes, and the US Department of Justice has filed for permanent bans against six e-cigarette manufacturers on behalf of the FDA. However, the researchers said the enforcement action is likely to have minimal impact on the e-cigarette industry because it targets smaller retailers rather than larger e-cigarette brands or products.

The FDA said it evaluates factors such as additives, product components, ingredients, design, harmful and potentially harmful ingredients and health risks, ingredients and others when it reviews premarket tobacco product applications (PMTAs). After reviewing Vuse’s PMTA, the FDA determined that “the applications lack sufficient evidence to demonstrate that allowing the products to be placed on the market would be appropriate to protect public health” β€” a standard required by law.

“Consistent with authority granted by Congress, 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 general population,” King said in the release. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to older smokers outweighs the risks of initiation and use by young people.”

Tobacco-free e-cigarettes — including those that are menthol-flavored — “have a known and significant risk in terms of youth appeal, uptake, and use,” according to the release. However, tobacco-flavored e-cigarettes do not pose the same degree of risk because they do not have the same appeal to young people.

Because of the different risks to youth, applicants must “provide robust evidence to show that the use of their menthol-flavored e-cigarette products is likely to promote complete switching or is likely to significantly reduce combustible cigarette use among adult smokers outside of this , facilitated by tobacco. flavored e-cigarette products,” the release said.

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