FDA Authorizes Menthol Vapes, And Public Health Advocates Aren’t Happy

The Food and Drug Administration (FDA) has authorized four menthol-flavored e-cigarette products, marking the first time a non-tobacco flavored vape product has been allowed to be marketed in the US. However, the decision has quickly drawn criticism from public health groups over concerns about the appeal of flavored vape products to young people.

The newly authorized menthol-flavored products consist of two nonrefillable pods and two disposable e-cigarettes, all manufactured by American company NJOY.

In order to get the sign-off from the FDA, these products went through the agency’s specific tobacco product pathway , which evaluates how they’re made, the risks and benefits to the population, and how they might affect tobacco product use.

“We are a data driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” said Dr Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, in a statement .

So far, such reviews have been conducted on more than 26 million new tobacco product applications – only 27 vaping products or devices out of those have made the cut, with the four flavored ones from NJOY being the latest to make the cut.

“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,” stated Farrelly.

But that’s not been enough to hold off criticism of the authorization from healthcare providers and anti-tobacco groups, who are concerned about what the move might mean for youths.

Despite first being created as an alternative to regular cigarettes, vaping has taken off with young people, with e-cigarettes having been the most commonly used tobacco product among middle and high school student for 10 years running .

“Menthol is one of the most popular e-cigarette flavors among youth and has been shown to increase tobacco product initiation among children by masking the harshness of nicotine. These products have no place on the market,” said Dr Benjamin Hoffman, president of the American Academy of Pediatrics, in a statement .

“These products will inevitably end up in the backpacks of middle schoolers. Once that happens, the FDA will have an obligation to immediately reverse this deeply unwise decision.”

The FDA has said that it “remains concerned” about the risks of young people using e-cigarettes, particularly when it comes to the appeal of flavored products, and notes that the decision only authorizes the menthol products for marketing – it doesn’t mean they’re safe or FDA approved .

“Like previously authorized products, the FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure,” the agency stated. “The agency may suspend or withdraw authorization if the agency determines that continued marketing is no longer appropriate for the protection of the public health, including if there is a notable increase in use of the products among youth.”