Acting CTP Director Says FDA Cut Premarket Tobacco Application Backlog by About 70% Over the Past Year

Apr.23

FDA Center for Tobacco Products Acting Director Bret Koplow said at the American Tobacco and Nicotine Forum that the agency has reduced its premarket tobacco application backlog by about 70% over the past year and eliminated the acceptance queue. He said FDA has reviewed about 27 million applications, but only a small number have been authorized, mainly because most submissions lacked the scientific data needed to demonstrate public health benefits.

Key Takeaways

FDA Center for Tobacco Products Acting Director Bret Koplow spoke at the American Tobacco and Nicotine Forum.
Koplow said FDA cut its premarket tobacco application backlog by about 70% over the past year and eliminated the acceptance queue.
He said FDA has reviewed about 27 million applications, but only a small number have been authorized.
FDA plans to share lessons from the review process to help companies better meet regulatory standards.
Koplow said FDA is increasing enforcement against illicit products, including unauthorized e-cigarettes.

2Firsts, April 23，2026

According to Tobacco Reporter, Bret Koplow, acting director of the U.S. Food and Drug Administration’s Center for Tobacco Products, outlined recent agency progress on application review, transparency and enforcement during a fireside chat at the American Tobacco and Nicotine Forum in Leesburg, Virginia.

Koplow said the backlog fell by about 70% over the past year

The report said Koplow stated that FDA has made significant progress in reducing its premarket tobacco application backlog, cutting it by roughly 70% over the past year while also eliminating the acceptance queue.

FDA says it has reviewed about 27 million applications

Koplow said FDA has reviewed approximately 27 million applications, but only a small number of products have been authorized, largely because most submissions lacked the scientific data required to demonstrate public health benefits.

The agency says it will improve transparency and guidance

According to the report, Koplow said FDA is working to improve transparency and guidance for applicants, including plans to share lessons learned from the review process so companies can better meet regulatory standards.

Nicotine pouch pilot was described as helping speed authorizations

Koplow also pointed to efforts to streamline evaluations in certain product categories, such as nicotine pouches. The report said he described a pilot program that enabled faster authorizations and could help shape broader regulatory approaches.

FDA said it is continuing action against illicit products

On enforcement, Koplow highlighted increased action against illicit products, including major seizures of unauthorized e-cigarettes in coordination with federal agencies. He said most of those products originated from China.

Koplow said regulators still face a balance between harm reduction and youth protection

Koplow said FDA continues to face challenges in balancing harm reduction for adult smokers with youth protection. He noted that youth vaping has declined, but said there are still concerns about public understanding of nicotine risks and the need for stronger evidence on the comparative benefits of alternative products.

Image source: Tobacco Reporter

References:

[1] FDA Tobacco Chief Highlights Progress, Challenges in Product Reviews and Enforcement

Also Read:

[1] WSJ: White House Pushes for More Flavored Vape Approvals as FDA Commissioner Makary Blocks Move

[2] FDA and IKE Tech Hold Formal Listening Session on Youth Access and Illicit ENDS Products

[3] FDA Renews Exposure Modification Authorization for IQOS Devices and Three HeatSticks Products

[4] Glas Says FDA Scientific Review Backed Several Flavored Products Before Senior Leaders Blocked Them

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