FDA OKs menthol e-cigs made by company Altria recently bought, endorsing its smoking-cessation claims; health advocates object

By Matthew Parrone
Associated Press

The Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking.

Njoy menthol product

The FDA said it authorized four menthol e-cigarettes from Njoy, the vaping brand recently acquired by tobacco giant Altria, which also sells Marlboro cigarettes.

The decision lends new credibility to vaping companies’ longstanding claim that their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease. E-cigarettes have been sold in the U.S. since 2007 but in recent years their potential benefits for smokers have been overshadowed by their use by adolescents and teens.

Parents and anti-tobacco groups immediately criticized the decision, which follows years of advocacy efforts to keep menthol and other flavors that can appeal to teens off the market.

“This decision could mean we’ll never be able to close the Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “FDA has once again failed American families by allowing a predatory industry to source its next generation of lifetime customers — America’s children."

Youth vaping has declined from all-time highs in recent years, with about 10% of high schoolers reporting e-cigarette use last year. Of those who vaped, 90% used flavors, including menthol.

In Kentucky polling in 2021, 45% of high-school students said they had used an electronic vapor product, 22% were current users, 8% were frequent users, and 7% used the products daily. Among Kentucky middle-school students, 24% said they had used an electronic vapor product, 11% said they were current users, nearly 3% said they were frequent users, and 2% said they used the products daily.

All the e-cigarettes previously authorized by the FDA have been tobacco, which isn't widely used by young people who vape.

Njoy is one of only three companies that previously received FDA's OK for vaping products. Like those products, two of the Njoy menthol varieties come as cartridges that plug into a reusable device that heats liquid nicotine, turning it into an inhalable aerosol. The other two Njoy menthol products are disposable e-cigarettes.

Njoy’s products accounted for less than 3% of U.S. e-cigarette sales in the past year, according to Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while hundreds of disposable brands account for the rest.

Most teens who vape use disposable e-cigarettes, including brands like Elf Bar, which come in flavors such as watermelon and blueberry ice.

Altria's data showed Njoy e-cigarettes helped smokers reduce their exposure to the harmful chemicals in traditional cigarettes, the FDA said. The agency stressed the products are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

Friday’s action is part of a sweeping FDA review intended to bring scientific scrutiny to the multibillion-dollar vaping market after years of regulatory delays. The U.S. market includes thousands of fruit- and candy-flavored vapes that are technically illegal but are widely available in convenience stores, gas stations and vape shops.

The FDA faced a self-imposed court deadline at the end of this month to wrap up its yearslong review of major vaping brands, including Juul and Vuse.

Those brands have been sold in the U.S. for years, awaiting FDA action on their scientific applications. To stay on the market, companies must show that their e-cigarettes provide an overall health benefit for smokers, without significantly appealing to kids.

“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,” said Matthew Farrelly of FDA’s Center for Tobacco Products.

Richmond-based Altria previously took a $13 billion stake in Juul in 2018, when the brand controlled most of the U.S. vaping market. But Juul's value plummeted after it was hit with lawsuits and investigations over its role in sparking a national spike in underage vaping.

Two of the four FDA-approved products are "sealed, pre-filled, non-refillable pods that are used with a previously authorized Njoy device, and two are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir," Jessica Kairns reports for Inside Health Policy.

Several longtime health-advocacy groups criticized the decision.

American Lung Association CEO Harold Wimmer wrote, “The tobacco industry has been using menthol and other flavors to attract kids for decades - this opens up a legal pathway for Njoy to market their highly addictive products.”

Lisa Lacasse, president of the American Cancer Society Cancer Action Network, noted that the move comes less than two months after the Biden adminisration announced an indefinite delay in FDA’s proposed rule to ban menthol cigarettes and flavored cigars, which had bene pending for two years.

"FDA has been more closely scrutinized by Congress over its e-cigarette regulation approach in recent months," Kairns notes. "Lawmakers in both parties agree FDA isn’t doing enough to combat illegally imported e-cigarettes, but a partisan divide is emerging on whether the agency should respond by approving more domestic products. Some Republicans have suggested the agency should approve more applications for American companies’ products while Democrats largely want those products off the market as well."

In its announcement, "FDA appeared to respond to criticisms," Kairns writes. Center for Tobacco Products Director Brian King said, “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.” 

King said Njoy submitted evidence "showing a benefit to adult smokers relative to the company’s previous tobacco-flavored products that is sufficient to outweigh risks of the products, including potential appeal to youth."

Kairns notes, "FDA’s statement says authorization of the products does not mean they are safe, adding that people who do not use nicotine products shouldn’t start. It also says the agency remains concerned about youth vaping. It will monitor the marketing of the Njoy products levels of use of the products among youth and former smokers, and the number of smokers who are able to completely switch to the products."

Under the FDA rule, Njoy may not "use most advertising methods," and ads "cannot include cartoon images, images of food or fruit, or depictions of people who appear to be younger than 45," Kairns reports. "Retailers must place Njoy products only in non-self-service areas of stores."