FDA Authorizes 4 Menthol-Flavored E-Cigarettes from NJOY

FDA Authorizes Menthol E-Cigarettes

In a landmark decision, the U.S. Food and Drug Administration (FDA) has authorized the marketing of four menthol-flavored e-cigarette products in the United States. This authorization comes after an extensive scientific review process through the premarket tobacco product application (PMTA) pathway.

NJOY LLC, the company behind the products, received marketing granted orders for their 4 menthol flavored vape devices:

  • NJOY ACE Pod Menthol 2.4%
  • NJOY ACE Pod Menthol 5%
  • NJOY DAILY Menthol 4.5%
  • NJOY DAILY EXTRA Menthol 6%

The ACE products are sealed, pre-filled, non-refillable pods designed for use with the previously authorized ACE device, while the DAILY products are disposable vapes with a prefilled, non-refillable e-liquid reservoir.

FDA approved NJO vape

First Non-Tobacco Flavored E-Cigarette Products Authorized by FDA

The authorization of these four menthol-flavored e-cigarette products marks a significant milestone, as they are the first non-tobacco flavored e-cigarettes to receive FDA approval. However, it is crucial to note that each application is reviewed on a case-by-case basis, and today’s actions are specific to these four products only. The authorizations do not apply to any other menthol-flavored e-cigarette products.

Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products, emphasized the importance of providing the necessary evidence to obtain marketing authorization:

“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,” he stated. “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.”

Evaluating PMTAs Based on Public Health Standards

The FDA evaluates PMTAs based on a public health standard that considers, among other factors, the risks and benefits of the product to the population as a whole. In this case, the FDA determined that there was sufficient evidence to demonstrate that permitting the marketing of these menthol-flavored products would be appropriate for the protection of public health.

The evidence submitted by NJOY showed that these menthol-flavored products provided a benefit for adult smokers relative to the company’s previously authorized tobacco-flavored products, in terms of complete switching. This benefit was deemed sufficient to outweigh the risks of the product, including youth appeal.

Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products, emphasized the agency’s commitment to following the science in their review of premarket tobacco applications:

“We are a data driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” he said. “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.”

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Addressing Concerns Over Youth Use and Marketing Restrictions

Despite the authorization, the FDA remains concerned about the risk of youth use of all e-cigarettes, particularly flavored products that are more appealing to young people. To address this concern, the FDA has placed stringent marketing restrictions on the newly authorized products to prevent youth access and exposure.

The agency has made it clear that it will closely monitor how these products are marketed and will take appropriate action if the company fails to comply with any applicable statutory or regulatory requirements. The FDA may suspend or withdraw authorization if it determines that continued marketing is no longer appropriate for the protection of public health, including instances where there is a notable increase in use of the products among youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.

Ongoing Efforts to Regulate Tobacco Products

The authorization of these four menthol-flavored e-cigarette products is just one of the many actions the FDA has taken to ensure that all new tobacco products marketed in the U.S. undergo a science-based review and receive marketing authorizations from the agency.

To date, the agency has:

  • Authorized a total of 27 tobacco- and menthol-flavored e-cigarette products and devices, including the four mentioned above
  • Received applications for nearly 27 million deemed products
  • Made determinations on more than 26 million of these applications

The FDA maintains a printable one-page flyer of all authorized vape products, which are the only vape products that may currently be lawfully marketed and sold in the U.S. Those manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement action.

Individuals seeking a list of tobacco products, including e-cigarettes, that may be legally marketed in the United States can visit the FDA’s new Searchable Tobacco Products Database.

News source: FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review

Matthew Ma