GAO Report Finds FDA Lagging Behind Approving THR Products

Tobacco harm reduction (THR) products have been proven to be an effective and accessible way for smokers to quit smoking cigarettes.  However, it takes years for the Food and Drug Administration (FDA) to approve these products so that they can reach or remain on the market.  A September 30, 2026, Government Accountability Office (GAO) report found that the FDA is facing a large backlog of authorization applications for THR products, and the agency is failing to conduct timely reviews or collect sufficient data to monitor its progress towards approving more products.

The FDA took control of reviewing and approving e-cigarettes and other tobacco products that were already on the market in 2020.  This led to the agency receiving 25 million applications for authorization in 2020 and 2021, leading to a backlog of products awaiting review.  GAO found that while most applications have been reviewed, 132,000 had not been reviewed as of December 31, 2025.  GAO also found that from 2018 to 2025, the average time for a tobacco or THR product application review to be completed was 507 days, and the FDA failed to meet its goals for the screening phase and did not collect the data needed to monitor progress towards its goal of a speedy review process.

The GAO report noted that if the FDA reviewed applications more efficiently, it will lead to more legally approved products being made available on the market and help clarify which products are legal and not sold from the black market.  This clarity will help smokers make better informed decisions when looking to quit smoking and help the agency crack down on the black market sale of illicit products.

Citizens Against Government Waste has been following and promoting the benefits of THR products in reducing smoking since 2016.  The GAO report recommendations should serve as a first step to FDA approve THR products more efficiently, and lawmakers should continue to pursue policies that will allow for greater access to THR products.

E-cigarettes and other THR products are an effective, less harmful alternative for tobacco users looking to quit smoking.  The GAO recommendations would improve how FDA reviews and approves applications.  By speeding up this process and allowing more products to reach the market, smokers will be given more options to choose from and more likely to quit smoking.