FDA's Move to OK First Menthol Vapes Is Big Mistake, Health Advocates Say

2024-06-24

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MONDAY, June 24, 2024 -- The U.S. Food and Drug Administration's decision to authorize the first menthol-flavored e-cigarettes has drawn the the ire of health advocates who say the decision undermines efforts to end the youth vaping epidemic in America.

In its approval of four flavored vaping products made by Njoy, the agency defended its decision.

“Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth," Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, said in an agency news release announcing the authorization.

But that argument did not convince anti-tobacco groups and health advocates.

"The FDA’s decision today to authorize the sale of four menthol-flavored e-cigarettes made by Njoy -- the first time the agency has authorized the sale of any flavored e-cigarettes -- is deeply troubling given the extensive scientific evidence that menthol is a flavor that appeals to kids and the FDA’s repeated conclusions that flavored e-cigarettes, including menthol-flavored products, have driven youth e-cigarette use," Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement.

"The scientific evidence demonstrates that menthol is a flavor that appeals to kids, and the tobacco industry has a long history of using menthol flavoring to attract and addict kids. According to the CDC, tobacco companies add menthol to tobacco products to make them seem less harsh and more appealing to young people," Richardson added.

Other anti-smoking experts agreed.

“On the heels of the administration refusing to finalize rules to prohibit menthol in cigarettes and all flavors in cigars, this decision is a missed opportunity for the FDA to do the right thing," Lisa Lecasse, president of the American Cancer Society Cancer Action Network, said in a statement. "By authorizing the sale of menthol flavored e-cigarettes, including two disposable menthol e-cigarettes, the agency is continuing to allow Big Tobacco to addict yet another generation of youth to their products."

Dr. Benjamin Hoffman, president of the American Academy of Pediatrics, also expressed deep dismay with the decision.

“Given everything we know about how appealing flavored tobacco products are to children, the American Academy of Pediatrics is profoundly disappointed that the Food and Drug Administration has chosen to authorize several menthol-flavored e-cigarettes," Hoffman said in a statement.

“Menthol is one of the most popular e-cigarette flavors among youth and has been shown to increase tobacco product initiation among children by masking the harshness of nicotine. These products have no place on the market,“ he added. "These products will inevitably end up in the backpacks of middle schoolers. Once that happens, FDA will have an obligation to immediately reverse this deeply unwise decision.”

Despite the outcry over Friday's FDA decision, youth vaping has actually declined from all-time highs in recent years, with about 10% of high schoolers reporting e-cigarette use last year, the Associated Press reported. But of those who did vape, 90% used flavors, including menthol.

Njoy’s products accounted for less than 3% of e-cigarette sales in the United States in the past year, according to the AP. Vuse, owned by Reynolds American, and Juul together control about 60% of the market.

In its application for authorization, Njoy data showed its menthol e-cigarettes helped smokers lower their use of traditional cigarettes, the FDA noted. Still, the agency stressed the products are not safe or “FDA-approved."

Meanwhile, the FDA faces a self-imposed court deadline at the end of this month to wrap up its long-running review of major vaping brands, including Juul and Vuse, the AP reported.

Those brands have been sold in the United States for years, awaiting FDA action on their authorization applications. To stay on the market, companies must show their e-cigarettes provide a health benefit for smokers without significantly appealing to kids.

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