FDA approves menthol vapes, drawing criticism from health advocates

Friday’s approval included two disposable e-cigarettes and two pre-filled e-cigarette pods manufactured by NJOY, a subsidiary of tobacco giant Altria Group, which makes Marlboro and some menthol-flavored cigarettes.

The FDA decision supports the vaping industry’s assertion that e-cigarettes can reduce the harms of smoking. Health experts say cancer and heart and lung disease caused by smoking kill more than 480,000 people in the United States annually.

Matthew Farrelly, a top science official with the FDA’s Center for Tobacco Products, said in a statement that after “rigorous scientific review,” the agency concluded that the benefit of adult smokers switching to e-cigarettes “was sufficient to outweigh the risks to youth.”

E-cigarette products are regulated as tobacco products because they often contain nicotine, which is addictive. The agency stressed Friday that the approval “does not mean these tobacco products are safe” and that all tobacco product can be harmful and potentially addictive.

In recent years, the agency has cited public health risks in denying marketing approvals for thousands of e-cigarettes — until Friday, it had approved just 23 tobacco-flavored products. Anti-tobacco groups say most teens prefer flavored or menthol vape products.

“Today’s decision is hard to understand in light of the FDA’s own repeated conclusions that flavored e-cigarettes, including menthol-flavored products, appeal to kids and have fueled the youth e-cigarette epidemic. What has changed?” Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement.

Sen. Dick Durbin (D-Ill.) said in a statement that the “authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”

The decision may boost the multibillion dollar U.S. e-cigarette industry.

In a statement Friday evening, Altria executives said the FDA’s action provides an important option for adults seeking to lessen the health consequences of tobacco use.

“We believe that, for tobacco harm reduction to succeed, adult smokers must have access to a robust marketplace of FDA-authorized smoke-free alternatives,” said Paige Magness, senior vice president of Regulatory Affairs for Altria Client Services. “FDA authorization of NJOY menthol e-vapor products provides adult smokers and vapers with regulated alternatives to the illicit flavored disposable e-vapor products on the market today.”

Big Tobacco companies have increasingly turned to Black and LGBTQ+ groups to sway public opinion in favor of vaping — as well as menthol cigarettes. The Biden administration delayed a decision on a proposed menthol cigarette ban amid concerns it might hurt President Biden with Black voters key to his reelection. African American smokers make up a significant portion of menthol consumers.

The Supreme Court is also weighing whether to review conflicting lower-court decisions regarding FDA regulation of e-cigarette products. In January, a divided U.S. Court of Appeals for the 5th Circuit ordered the FDA to reconsider its decision prohibiting two companies from marketing their e-cigarette products. In a stinging decision, the majority said the agency’s application process sent manufacturers on a “wild goose chase” of requirements.

The FDA has come under increasing pressure to finish reviewing applications from companies seeking to market e-cigarette products. During a Senate Judiciary Committee hearing this month, Durbin and other senators ripped into the FDA over delays in reviewing company applications and over the proliferation of illegal flavored e-cigarette products, many manufactured in China. Durbin highlighted fruity and bubblegum-flavored vapes found in a shop about a mile from the FDA’s Maryland headquarters.

Days before the Senate hearing, the FDA and federal law enforcement announced the creation of a task force to crack down on the flood of illegal e-cigarettes in vape shops and online marketplaces. The FDA also reversed a decision to ban products made by Juul Labs, the company widely cited for igniting youth vaping nearly a decade ago. Its products have remained on shelves as the company appealed the decision.

Tony Abboud, executive director of the Vapor Technology Association, a trade group, called the FDA’s decision Friday the result of political pressure. He said the FDA keeps authorizing smokable tobacco products but has refused to recognize science showing e-cigarettes are less harmful. In an interview, he also blasted the agency for authorizing products only from a Big Tobacco company while denying or delaying those from independent companies that belong to his association.

“It’s another great day to be Big Tobacco,” he said.