Tobacco

FDA Highlights Progress on Tobacco Product Regulation in 2023

Review includes updates regarding agency's 5-year strategic plan and latest compliance and enforcement actions
FDA building
Photograph: Shutterstock

The Food and Drug Administration’s Center for Tobacco Products on Thursday released its 2023 review of the FDA’s progress on tobacco product regulation.

CTP Director Brian King said the CTP had reached “several important milestones in 2023,” including its new five-year strategic plan. The plan follows the recommendation from the Reagan-Udall Foundation report that criticized the agency’s priorities, premarket tobacco application (PMTA) review process, transparency and more.

The plan advances “four central themes—science, health equity, stakeholder engagement and transparency,” King said.

This week’s review also singled out the agency’s enforcement and compliance actions against unauthorized products, including e-cigarettes.

In December, the FDA, in collaboration with the U.S. Customers and Border Protection, seized about 1.4 million units, estimated to have a retail value of more than $18 million, of unauthorized e-cigarette products.

“We remain committed to using the full scope of tools in our regulatory toolbox—in coordination with federal partners—to ensure entities that make, distribute, or sell illegal tobacco products, especially products that appeal to youth, are held accountable,” King said.

He also pointed out that since 2020, the FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.

“We remain committed to making determinations on all remaining applications as expeditiously as possible, while ensuring the decisions are scientifically accurate, legally defensible, and aligned with the authorities granted to us by Congress,” King said.

He highlighted the progress made in 2023 on two separate rules establishing product standards prohibiting menthol as a characterizing flavor in cigarettes and characterizing flavors in cigars.

“Staff across CTP worked tirelessly and relentlessly throughout 2023 to continue to advance these important rules, resulting in their successful submission to the White House Office of Management and Budget in October 2023,” said King.

Looking ahead, “we can undoubtedly expect challenges,” King said, adding “our future is bright.”

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