The Food and Drug Administration (FDA) on Friday, June 21, approved the first menthol-flavored e-cigarette products, drawing swift criticism from some public health advocates, while noting that agency believes vaporizers can help adult smokers quit tobacco.
The decision comes as the FDA faces growing criticism for failing to police vaping products with illegal but widely available flavors that appeal to young people and amid growing legal challenges over its handling of e-cigarette regulations.
Friday’s approval included two disposable e-cigarettes and two pre-filled e-cigarette pods manufactured by NJOYa subsidiary of tobacco giant Altria Group, which makes Marlboro and some menthol-flavored cigarettes.
FDA decision supports 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 each year in the United States.
Matthew Farrellya senior scientific official at FDA Center for Tobacco Productssaid in a statement that after a “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 emphasized 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 only 23 flavored tobacco products. Anti-smoking groups say most teens prefer flavored or menthol vaping products.
“Today’s decision is difficult to understand in light of the FDA’s repeated findings that flavored e-cigarettes, including menthol-flavored products, appeal to children and have fueled the e-cigarette epidemic among youth. . “What has changed?” he said. Yolonda C. Richardsonpresident and CEO of the Campaign for Tobacco-Free Childrenit’s a statement.
Sen. Dick Durbin (D-Ill.) said in a statement that “The authorization of menthol-flavored vaporizers will create an opportunity for more children to become addicted to harmful products”. The decision could boost the multibillion-dollar U.S. e-cigarette industry. In a statement Friday night, executives at Altria they said that 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 be successful, adult smokers must have access to a robust market for FDA-cleared smoke-free alternatives,” said Paige Magness, senior vice president of regulatory affairs at Altria Client Services. “FDA clearance of NJOY’s menthol e-vapor products provides adult smokers and vapers with regulated alternatives to illicitly flavored disposable e-vapor products on the market today.”
Big tobacco companies have increasingly turned to Black and LGBTQ+ groups to influence 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 harm the president bidengiven that black voters are key to his re-election. African American smokers make up a significant portion of menthol users.
The Supreme Court is also weighing the possibility of reviewing conflicting decisions by lower courts regarding the regulation of the FDA about electronic cigarette products. In January, a Divided U.S. Court of Appeals for the Fifth Circuit Ordered FDA reconsider its decision prohibiting two companies from marketing its electronic cigarette products. In a stinging ruling, the majority said the agency’s application process sent manufacturers to a “useless search” for 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 criticized the FDA for delays in reviewing companies’ applications and for the proliferation of illegal flavored e-cigarette products, many of them made in China. . Durbin highlighted the fruit and bubblegum flavored vapes found in a store about a mile from the headquarters. the FDA in Maryland.
Days before the hearing in the Senate, FDA and federal authorities announced the creation of a task force to combat the flood of illegal e-cigarettes in vape shops and online markets. The FDA also reversed a decision to ban products made by Juul Labs, the company widely cited for boosting youth vaping nearly a decade ago. Its products remained on shelves while the company appealed the decision.
Tony Abboud, executive director of the Vapor Technology Association, a trade group, called the decision FDA on Friday as a result of political pressure. He said that The FDA continues to authorize smokable tobacco products, but has refused to acknowledge the science showing that e-cigarettes are less harmful. In an interview, he also criticized the agency for authorizing products only from one big tobacco company while denying or delaying those from independent companies that belong to his association. “It’s another big day for Big Tobacco”he claimed.
