Tobacco Products: FDA Should Monitor Timeliness of Application Reviews

What GAO Found In 2016, the Food and Drug Administration (FDA) expanded its authority to oversee all tobacco products, including millions of e-cigarettes that were already on the market. In response, it received a surge of applications from manufacturers in 2020 for products seeking authorization to remain on the market legally. Specifically, it received over 25 million applications in 2020 and 2021, compared to just over 1 thousand applications in 2018 and 2019. This led to a backlog of applications. While FDA has since reviewed most of the applications submitted during this period, almost 132 thousand remained without a completed review as of December 31, 2025. (See figure.) Figure: FDA Tobacco Product Application Reviews, Calendar Year (CY) 2018-2025 From CY2018 to CY2025, FDA took an average of 507 days to complete its review of tobacco product applications. FDA has goals for each phase of the review process, ranging from 7 to 180 days. For the screening phase, FDA did not meet its goals, although it has made progress toward them. FDA also has goals for the last phase of review, when it must review an application’s scientific information. However, FDA’s data system was not designed to track steps in this part of the review process. Thus, it does not collect the data necessary to monitor whether it is meeting these goals. According to practices identified in prior GAO work, collecting performance information and using it to monitor performance are needed to assess if progr