FDA approves menthol vapes, drawing criticism from health advocates

The Food and Drug Administration on Friday approved the first menthol-flavored e-cigarette products, drawing swift criticism from some public health advocates as it signaled that the agency believes the vapors can help adult smokers quit.

The decision comes as the FDA faces growing criticism for failing to curb illegal but widely available flavored vaping products that appeal to young people and comes between the increase in legal challenges related to the handling of electronic cigarette regulations.

Including Friday approval two disposable e-cigarettes and two pre-filled e-cigarette cups made by NJOY, a subsidiary of tobacco giant Altria Group, which makes Marlboro and some menthol-flavored cigarettes.

FDA The ruling supports the vaping industry’s claim 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 each year.

Matthew Farrelly, a senior science officer with the FDA’s Center for Tobacco Products, said in a statement that after “rigorous scientific review,” the agency concluded that the benefit to adult smokers switching to e-cigarettes “was substantial to overcome the dangers for young people.

E-cigarette products are regulated like 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 products 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 — as of Friday, it had approved just 23 tobacco-flavored products. Anti-smoking groups say most teenagers prefer flavored or menthol products.

“Today’s decision is difficult to understand in light of FDA’s own repeated findings that flavored e-cigarettes, including menthol-flavored products, appeal to children 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 “authorizing peppermint flavored vapes will create an opening for more children to become addicted to harmful products.”

The decision could boost the multibillion-dollar e-cigarette industry.

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

“We believe that, for tobacco harm reduction to succeed, adult smokers must have access to a robust FDA-authorized tobacco-free alternative market,” said Paige Magness, senior vice president of regulatory affairs for Health Services. Altria customer. “The FDA’s clearance of NJOY menthol e-vape products provides smokers and adult vapers with regulated alternatives to the illicit flavored e-vape products available on the market today.”

The Biden administration is again delaying a ban on menthol cigarettes amid political pressure from Big Tobacco. Here’s how we got here—and why it matters. (Video: Drea Cornejo, Brian Monroe/The Washington Post)

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 ban on menthol cigarettes amid concerns it could hurt President Biden with black voters key to his re-election. African-American smokers make up a significant portion of menthol consumers.

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

The FDA has been under increasing pressure to end its review of applications from companies seeking to market e-cigarette products. During a Senate Judiciary Committee hearing this month, Durbin and other senators blasted the FDA over delays in reviewing company applications and over the proliferation of illegal flavored e-cigarette products, many made in China. Durbin highlighted the fruity, bubblegum-flavored vapors found at a store about a mile from FDA headquarters in Maryland.

Days before the Senate at the 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 remained on the shelves after 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 continues to authorize tobacco products to be smoked, but has refused to recognize the science that shows e-cigarettes are less harmful. In an interview, he also criticized the agency for only authorizing products from one Big Tobacco company while denying or delaying those from independent companies belonging to his association.

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

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