Tobacco

FDA Authorizes First Menthol-Flavored E-Cigarettes

Agency issued marketing granted orders to 4 Njoy applications
FDA
Photograph: Shutterstock

The Food and Drug Administration issued marketing granted orders to Njoy LLC for four menthol-flavored e-cigarette products: Njoy Ace Pod Menthol 2.4%, Njoy Ace Pod Menthol 5%, Njoy Daily Menthol 4.5% and Njoy Daily Extra Menthol 6%. The announcement marks the first non-tobacco flavored e-cigarette products to be authorized by the FDA.

The move allows the products to be legally sold in the United States; however, it does not mean the products are safe or FDA approved, the agency said.

The two authorized Ace products are sealed, pre-filled, non-refillable pods that are used with the previously authorized Ace device. The two authorized Daily products are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir. 

“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “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.” 

After reviewing the company’s applications, the agency said it determined that there was sufficient evidence to demonstrate that permitting marketing of these products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Under the premarket tobacco product application (PMTA) pathway, evidence submitted by Njoy LLC showed that these menthol-flavored products offer a benefit for adults who smoke cigarettes relative to that of the applicant’s previously authorized tobacco-flavored products—in terms of complete switching—that is sufficient to outweigh the risks of the product, including youth appeal, the FDA said.

“We are a data-driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” said Matthew Farrelly, director of the CTP's Office of Science. “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.”

The FDA said it has placed “stringent” marketing restrictions on the new products in an effort to prevent youth access and exposure. The agency will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any requirements.

In May, Njoy submitted its PMTA to the FDA to commercialize and market the Njoy Ace 2.0 device. The new device features age-gated technology to prevent underage use via Bluetooth connectivity to authenticate the user before unlocking the device. The tobacco company has also re-submitted PMTAs for blueberry and watermelon pod products that work exclusively with the Njoy Ace 2.0 device.

The FDA said it has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of these applications. To date, the FDA has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices, including the four authorized Friday.

In June 2023, Richmond, Virginia-based Altria acquired the e-vapor company Njoy, whose products are now distributed by Altria Group Distribution Co.

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