PRESS RELEASE: New GAO Report Confirms Systemic Challenges with FDA’s Premarket Tobacco Review Framework
WASHINGTON, D.C. – A new U.S. Government Accountability Office (GAO) Report highlighted the challenges at the U.S. Food and Drug Administration (FDA) regarding the premarket tobacco and nicotine product application review framework. The report underscored significant performance issues at the agency and the need for greater accountability, while also acknowledging FDA’s more recent strides to improve its regulatory performance.
FDA’s failure to authorize smoke-free products to meet the demand of millions of adult consumers moving away from smoking has resulted in a massive illicit market. This GAO report highlights the need for greater accountability to ensure FDA is capable of delivering a well-regulated marketplace. Here are the top five challenges FDA needs to address:
Excessive Timelines for Application Reviews. On average, FDA took 507 days to review applications from 2018-2025, exceeding the 180-day timeline required by Congress in the bipartisan 2009 Tobacco Control Act.
Major Backlog of Applications Remains: Almost 132,000 applications remain pending as of the end of 2025, most of which have been awaiting an FDA review and decision for at least two years.
Review Standards Remain Unclear. All five manufacturers GAO interviewed said FDA needs to provide clearer guidance. FDA officials told GAO there is no set definition of its authorization standard and that decisions are made case by case.
FDA Doesn't Track Scientific Review Timelines. FDA's data system does not capture how long the scientific review phase takes, making it impossible to hold reviewers accountable and understand whether it is meeting its established performance goals.
FDA Failed to Meet Its Own Performance Targets. Between 2018 and 2025, FDA set internal target review times for each of its premarket pathways but rarely met them. Agency timelines for premarket tobacco product applications were particularly long, averaging 596 days for refuse to accept and 236 days for accepted applications.
“The new report from an independent and credible third-party confirms what we have been saying about application decision delays and unclear review standards,” said Richard Burr, chairman of the Regulate Smarter coalition and former U.S. Senator. “Huge backlogs missed deadlines and an authorization rate of nearly zero percent – these are the ingredients fueling an illicit market that is putting kids and adults at risk. The Administration’s recent steps to increase enforcement have helped, but the time to reform FDA’s review framework is now. It’s time for smarter regulation – the recent announcement by FDA regarding its intention to evaluate changes to its regulatory framework is a sign of positive change.”
Last week, FDA announced its intent to evaluate changes to the PMTA regulatory framework.
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