The U.S. Food and Drug Administration on Friday approved the first menthol-flavored e-cigarette product, drawing swift criticism from public health advocates but signaling that the agency believes e-cigarettes can help adult smokers quit.
The decision comes as the FDA faces increasing criticism for failing to regulate illegal but widely available flavored e-cigarette products popular with young people and a mounting legal challenge over its handling of e-cigarette regulations.
Friday's approval included two disposable e-cigarettes and two prefilled e-cigarette pods made by NJOY, a subsidiary of tobacco giant Altria Group, which makes Marlboro and menthol-flavored cigarettes.
The FDA's decision supports claims by the e-cigarette industry that e-cigarettes can reduce the harms of smoking, which health experts say kills more than 480,000 people each year in the United States from cancer, heart disease and lung disease caused by smoking.
Matthew Farrelly, a senior scientist in the FDA's Center for Tobacco Products, said in a statement that after a “rigorous scientific review,” the FDA concluded that the benefits of adult smokers switching to e-cigarettes “are sufficient to outweigh the risks to youth.”
E-cigarettes are regulated as tobacco products because they often contain addictive nicotine. The agency stressed on Friday that the approval “does not mean that these tobacco products are safe,” saying all tobacco products can be harmful and addictive.
In recent years, the agency has refused to approve thousands of e-cigarette products for sale, citing public health risks, and as of Friday had approved just 23 tobacco-flavored products. Anti-tobacco groups say most teenagers prefer flavored or menthol e-cigarette products.
“Today's decision is difficult to understand given that the FDA has repeatedly concluded that flavored e-cigarettes, including menthol-flavored products, are popular with kids and are contributing to the youth vaping epidemic. What has changed?” Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement.
“Allowing menthol-flavored e-cigarettes will allow even more kids to become addicted to these harmful products,” Sen. Dick Durbin (D-Ill.) said in a statement.
The decision could revitalize the multi-billion dollar U.S. e-cigarette industry.
Altria executives said in a statement Friday night that the FDA's action provides an important option for adults who want to reduce the health harms of tobacco use.
“We believe that to be successful in reducing tobacco harms, adult smokers must have access to a robust market of FDA-approved smoke-free alternatives,” said Paige Magness, senior vice president of regulatory affairs for Altria Client Services. “FDA approval of NJOY menthol e-vapor products provides adult smokers and vapers with a regulated alternative to the illegal flavored disposable e-vapor products currently on the market.”
The Biden administration, under political pressure from Big Tobacco, is again postponing the ban on menthol cigarettes. Here's how we got here and why it matters. (Video: Drea Cornejo and Brian Monroe/The Washington Post)
Big tobacco companies are increasingly turning to Black and LGBTQ+ groups to spur public support for e-cigarettes and menthol cigarettes. The Biden administration has held off on a proposed menthol cigarette ban over concerns it could hurt Black voters, who are key to his reelection. African-American smokers make up a large portion of menthol consumers.
The Supreme Court is also considering whether to review conflicting lower court decisions regarding the FDA's regulation of e-cigarette products. In January, a divided Fifth Circuit Court of Appeals ordered the FDA to reconsider its decisions that banned two companies from selling e-cigarette products. In a scathing decision, the majority said the FDA's application process forces manufacturers to “fruitlessly chase” requirements.
The FDA is under increasing pressure to end its review of applications from companies wanting to sell e-cigarette products. At a Senate Judiciary Committee hearing this month, Durbin and other senators blasted the FDA for delays in reviewing company applications and the proliferation of illegal flavored e-cigarette products, many made in China. Durbin cited fruity and bubblegum flavored e-cigarettes found in a store about a mile from FDA headquarters in Maryland.
The Senate hearing comes just days after the FDA and federal law enforcement agencies announced the creation of a task force to crack down on illegal e-cigarettes that have flooded e-cigarette stores and online marketplaces. The FDA also overturned a decision nearly a decade ago to ban Juul Labs products, which have been widely blamed for encouraging youth use of e-cigarettes. The company has appealed the decision, and the products remain on store shelves.
Tony Aboud, executive director of the Vapor Technology Association, an industry group, said Friday's FDA decision was the result of political pressure. He said the FDA continues to approve smokable tobacco products but has not acknowledged the scientific evidence that e-cigarettes are less harmful. In an interview, he also accused the FDA of only approving products from major tobacco companies while refusing or delaying approval of products from independent companies that are members of the association.
“It's another great day for big tobacco,” he said.
