Sen. Durbin Questions FDA Over Youth Access to Unauthorized E-Cigarettes

The briefing raised concerns about the agency's delayed deadlines for reviewing premarket tobacco product applications.
cigarettes & gavel

WASHINGTON D.C. — Brian King, director of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products, and Brian Boynton, U.S. Department of Justice (DOJ) principal deputy assistant attorney general, briefed U.S. Senate Majority Whip Dick Durbin (D-Ill.) on enforcement efforts against unauthorized e-cigarettes used by minor smokers.

[Read more: FDA Warns Retailers Over Illegal Tobacco Sales]

Durbin, who chairs the Senate Judiciary Committee, convened the meeting after raising concerns over the FDA's missed and delayed deadlines for reviewing premarket tobacco product applications (PMTAs) from e-cigarette manufacturers as the law requires, allowing e-cigarette products that are popular among youth smokers to remain on store shelves.  

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After being sued by public health groups, the FDA was ordered by the U.S. District Court in Maryland to complete these reviews by Sept. 9, 2021. According to Durbin's office, more than two and a half years later, FDA has still not completed all of its PMTA reviews.

"The law is clear. E-cigarette manufacturers must prove that a product is 'appropriate for the protection of public health' to gain market entry. But thousands of vape products on store shelves today, full of harmful chemicals and nicotine, have not met that requirement, yet are being sold and addicting children nationwide," said Durbin. "I called in FDA and DOJ leaders to my office to understand why they are failing to enforce the law in the face of clear harms to children."

In the meeting, Durbin questioned King on the FDA's delay in reviewing PMTAs and pushed for answers on why the agency appears to be failing to use its full authority to take enforcement actions against manufacturers or retailers found to be selling unauthorized vaping products. 

[Read more: FDA Levels Penalties Against Retailers Over Elf Bar Sales]

Last year, Durbin's office examined the FDA's public data files to identify e-cigarette manufacturers who have received both marketing denial orders and warning letters yet continue to sell unauthorized products. The review found at least 22 vaping products that appeared to be sold online by the manufacturer in violation of the law and in defiance of repeated enforcement actions by the FDA.  

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