Menthol-Flavored Electronic Cigarette Receives Marketing Granted Order from the FDA
On June 21, 2024, the Food and Drug Administration’s Center for Tobacco Products (CTP) announced that four electronic nicotine delivery systems (ENDS) had successfully completed the regulatory pathway known as the premarket tobacco application (PMTA) process. Notably, these products are menthol-flavored, representing the first-of-their-kind approvals via the PMTA process. This is especially important in light of ongoing regulatory efforts to ban menthol combustible products and represents what we hope will be the first of many products that menthol smokers might be able to choose from on their smoking cessation journey.
NJOY (an ENDS manufacturer recently purchased by Altria), created these four products—two designed to work with the already approved reusable system, and two as disposable ENDS products. They are the first nicotine products since January 2023, and the first ENDS since June of 2022, to receive a marketing granted order (MGO). The announcement of an MGO for a non-tobacco flavored ENDS product can be hailed as a victory for both consumers and manufacturers of ENDS products, though significant concerns and challenges still lie ahead.
The CTP has long promised that products entering the PMTA process would receive timely reviews based on a fair, scientifically focused evaluation of the information in the application package. While the CTP initially estimated the time required to review an accepted PMTA would not exceed 180 days, the application for these products was submitted over four years ago, months before the court-mandated premarket application deadline of Sept. 9, 2020. The size and scope of PMTA authorization delays generates uncertainty and slows innovation in the marketplace. Ultimately, these delays hinder public health by gatekeeping the availability of reduced-risk products while their deadlier predecessors—cigarettes—continue to be approved for sale nationwide.
In the absence of an effective and timely review of ENDS products, new products have entered the U.S. ENDS marketplace without submitting (let alone completing) PMTA applications. The flood of these illicit products, the majority of which are produced in China, has created both legal and political turmoil, which continues to inject uncertainty into the debate that surrounds the potential benefits associated with transitioning consumers to reduced-risk nicotine products. A fully functional and effective regulatory process would stymie the illegal marketplace and ensure that the products consumers purchase function as designed.
The announcement of the most recent MGOs should be the beginning of a string of announcements from the CTP. A court decision mandated the agency to complete the review of all outstanding PMTAs by June 30, 2024. Though the total number of pending PMTAs is unknown, it is estimated that thousands in the PMTA review process have yet to be acted upon by the CTP.
The pathway forward for the CTP must be to streamline the PMTA process to provide clear guidance to ENDS product manufacturers regarding what specific evidence is required. The regulatory agency should provide clear guidance as to which scientific assays, constituent levels, and specific endpoints are required to have a successful and timely application review process. Providing this information to manufacturers would allow for clarity in the process and efficient access to the U.S. ENDS marketplace in a manner that best serves consumers.