Press Releases

Today, the U.S. Government Accountability Office (GAO) published a report that illustrates ongoing challenges with the tobacco product application process at the Food and Drug Administration (FDA). Since 2013, Congress has heard and seen the difficulties associated with reviewing tobacco product applications in a timely manner. The GAO report sheds light on this current system and the resulting backlog. 

Lengthy tobacco product application timelines can limit consumer choice away from more responsible tobacco products, as the status quo has promoted a wild west of options on U.S. shelves. Americans face a glaring public health crisis, as foreign countries like China have flooded the U.S. market with harmful products that lack regulation. The current regulatory review process can make it more difficult for adult smokers to access a range of less harmful smoking alternatives. This report provides insight into the current landscape to help policymakers better understand how improvements can be made to this process and strengthen enforcement against illicit products.

Key GAO Report Takeaways: 

-       FDA took an average of 507 days to review applications, even though federal law requires application reviews within 180 days.

-       FDA does not collect data to monitor whether it is meeting timeliness goals to review scientific information in all tobacco product applications.

-       The current Administration has taken steps to help improve the application process, but more work is needed.

As one of the chief lawmakers who requested this GAO report, U.S. Congressman Morgan Griffith (R-VA), Chairman of the House Committee on Energy and Commerce Subcommittee on Health, responded to the findings.

“I requested this GAO report to identity room for improvement at the FDA with respect to tobacco product applications. The agency’s findings show that the FDA is missing its goals,” said Chairman Griffith. “The current regulatory hurdles impacting tobacco product applications are unfair to American tobacco producers and consumers. These regulatory delays stall the progress of the tobacco harm reduction movement, which helps adult smokers transition away from combustible smoking such as cigarettes.”

Griffith continued, “Further, as legal producers try to follow U.S. laws and wait their turn, bad actors continue to jump the line and flood a ‘wild west’ marketplace with illicit and unsafe products. We should also recognize the broader public health opportunity before us. Youth tobacco and nicotine use remain at historic lows, and we must continue working to protect those gains.

“I support reforms to the current regulatory process that will allow the FDA to meet its objectives in a timely manner. This report is the first step in making this process work and I look forward to working with the Administration to make this happen.”

U.S. Congressman Brett Guthrie (R-KY), Chairman of the House Committee on Energy and Commerce, provided additional comments on the GAO report.

"Our Committee has focused intently on exploring polices that ensure adversarial nations like China can't exploit loopholes in our regulatory processes and harm American consumers," said Chairman Guthrie. "Our primary goal with this request was to make sure FDA can serve as an efficient regulator, and I thank Chairman Griffith on his commitment to enhancing the current regulatory review process for tobacco products. Even though we are currently experiencing record lows for American youth that are using illegal and illicit vape devices and tobacco products, this report is proof that further action is needed."

BACKGROUND

Chairman Griffith alongside Chairman Guthrie submitted a request to prompt this GAO report.

Chairman Griffith worked with Chairman Guthrie in prior Congresses to address systemic issues with the FDA regulatory process over tobacco products.

Chairman Griffith is a member of the Congressional Tobacco Harm Reduction Caucus.

###