FDA allows first ever menthol e-cigarettes to be sold in US

The Food and Drug Administration (FDA) on Friday authorized the first ever nontobacco flavored electronic cigarettes for adult smokers, a sign the agency believes some flavors of vaping products can be used to mitigate the effects of smoking traditional cigarettes.

The agency said it authorized four menthol products from NJOY, which was purchased in 2023 by tobacco giant Altria, manufacturer of Marlboro cigarettes.

Including the four authorized Friday, the FDA has authorized the sale of only 27 e-cigarette products. All other products have been tobacco flavored, which isn’t widely used by young people.

The FDA stressed that the decision was specific only to the four devices authorized and not for any other menthol-flavored e-cigarette products.

“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, director of the office of science in the FDA’s Center for Tobacco Products.

Additionally, the agency said the authorization does not mean the products are safe and advised nontobacco users against using them.

The FDA cited evidence submitted by the company that showed the menthol products provided a benefit for adults who smoke traditional cigarettes and want to switch, because it reduces their exposure to harmful chemicals.

The agency is overdue in its task of reviewing premarket tobacco product applications, which are required for new tobacco products to be legally marketed in the U.S. The FDA previously said it would finish reviewing applications by the end of 2023 but missed that deadline.

The agency’s action Friday was met with disappointment by leading vaping critics, including anti-tobacco groups and lawmakers, who have been pressing the FDA to ban flavors completely.

“Today’s decision is hard to understand in light of the FDA’s own repeated conclusions that flavored e-cigarettes, including menthol-flavored products, appeal to kids and have fueled the youth e-cigarette epidemic. What has changed?” said Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids. “The evidence is clear that menthol is a flavor that appeals to and is widely used by kids.”

The FDA’s authorization comes at a time when the U.S. government delayed a ban on menthol cigarettes, potentially indefinitely.

Sen. Dick Durbin (D-Ill.), who held a hearing last week blasting the FDA for its inaction on vaping regulation, echoed Richardson’s concerns.

“Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products,” Durbin said. “Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health.”

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