Smoke-Free CHOICE: GAO Report Should Spark Constructive Oversight of FDA Tobacco Program

October 2, 2026

Washington, D.C. – A new report released by the Government Accountability Office (GAO) on the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) found that while the agency is making measurable progress in reviewing more than 25 million tobacco product applications submitted in 2020 and 2021, nearly 132,000 still lacked a completed review as of December 31, 2025. To improve, GAO recommends that the FDA monitor and collect the data needed to determine whether it is meeting its statutory obligations and scientific-review timeliness goals across all tobacco product application pathways. 

The GAO report assessed how CTP, the nation’s primary tobacco regulatory agency, is performing on its implementation of performance standards, resource allocation, transparency and review timeliness. 

Following the release of the GAO report, the Smoke-Free Coalition for Health, Opportunity, Innovation and Consumer Education (CHOICE) issued the following statement: 

“GAO’s report should be the start of a constructive oversight conversation about whether FDA’s tobacco regulatory program is delivering measurable results for public health. The report clearly concludes that CTP is not consistently meeting its statutory obligations for timely premarket tobacco product application reviews and identifies continuing gaps in the transparency, predictability and efficiency of the process,” said the organization. “We recognize that FDA has taken steps to improve its operations, and that progress matters. Congress now has an opportunity to evaluate what is working, what remains unresolved and what benchmarks should guide future progress.”

The GAO report identified notable progress in CTP’s efforts in the following areas, which should help guide future benchmarking:

  • Completed reviews for 26,526,862 of the 26,658,777 applications received since 2018.
    • FDA averaged 507 days to complete reviews from 2018 through 2025.
  • Improved screening times for certain applications, including the average time to refuse certain substantial-equivalence applications, which fell from 596 days in 2023 to 170 days in 2025. 
  • Enacted steps to streamline application reviews, including issuing application guidance, training additional reviewers, bundling similar applications, automating submission checks and piloting a streamlined nicotine-pouch review process. 

“For adults who smoke, clear and accurate information is essential. Adult consumers should understand that tobacco and nicotine products exist on a continuum of risk, and that combustion is the primary driver of smoking-related disease,” said the organization. “At the same time, underage prevention must remain a central focus of federal policy and enforcement.”

For both adult awareness and youth prevention, GAO’s findings also present an opportunity for CTP to reevaluate the following areas:

  • Efficient reviews can help make products meeting the public-health standard available to adult tobacco users.
    • Application reviews received the largest share of CTP’s time, while public-education obligations declined during FY2018–FY2025.
  • Public-education and communication obligations declined 52 percent from FY2018 to FY2025. 
  • Public-education campaigns reached 80 percent of youth with messages about tobacco’s harmful effects in FY2025, exceeding its goal.

“A transparent, predictable, science-based regulatory system can better support enforcement against illicit products and bad actors, while giving adults who smoke access to accurate information and authorized alternatives,” said the organization. “We encourage Congress to use the GAO report to ask practical questions about implementation, accountability, and public health outcomes.”

The report’s findings present actionable steps for Congress to address to ensure CTP is best positioned to execute on its core responsibilities, including the following areas of improvement:

  • CTP’s current system does not track the start and end of scientific review, so the agency cannot determine whether it meets its scientific-review timeliness goals.
  • CTP also does not track time when applications are returned to manufacturers for changes.

About CHOICE 

The Coalition for Health, Opportunity, Innovation and Consumer Education (CHOICE) believes that there is an urgent need to provide the 25 million adult smokers with access to and information about smoke-free alternatives to cigarettes. Smoke-Free CHOICE is committed to working with federal, state and local policymakers, the medical and scientific community, businesses, community groups and nonprofits to help American adults make the transition away from cigarettes. Together, the shared goal of ending smoking can be achieved by focusing on sound policies that favor science and scientifically substantiated smoke-free products for current adult smokers. Smoke-Free CHOICE is a nonpartisan, non-profit, tax-exempt 501(c)(4) organization funded by PMI US Corporate Services Inc., an affiliate of Philip Morris International Inc. As a 501(c)(4), Coalition for Health, Opportunity, Innovation and Consumer Education is empowered to engage in activities that promote the common good and general welfare of the community. 

For media inquiries, please contact [email protected]. To learn more about the CHOICE coalition, visit choicecoalition.com.

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