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FDA, DOJ hammered on response to illegal vapes

About 7.7 percent of middle and high school students in 2023 used e-cigarettes, according to the National Youth Tobacco Survey

Sen. Richard J. Durbin, D-Ill., attends a news conference outside the Capitol. Durbin blasted the Food and Drug Administration Wednesday for not doing more to eliminate illegal vaping products that can be found in gas stations, vape shops and other retail locations.
Sen. Richard J. Durbin, D-Ill., attends a news conference outside the Capitol. Durbin blasted the Food and Drug Administration Wednesday for not doing more to eliminate illegal vaping products that can be found in gas stations, vape shops and other retail locations. (Tom Williams/CQ Roll Call)

Senators from both sides of the aisle took the Food and Drug Administration and Department of Justice to task Wednesday over what they described as a failure by both agencies to stop the sale of illegal e-cigarettes through online retailers, gas stations and vape shops across the country. 

During a Senate Judiciary Committee hearing focused on enforcement of e-cigarette laws, Chair Richard J. Durbin, D-Ill., held up a large, colorful photo print of illegal vapes that he said were being sold at a shop near the FDA’s headquarters in Silver Spring, Md., and asked why they are allowed to remain on store shelves.

“You have completely fallen down on the job,” Durbin said to Brian King, director of the FDA’s Center for Tobacco Products.

Much of the concern around illegal products revolves around its appeal to children. About 7.7 percent of middle and high school students in 2023 used e-cigarettes, according to the National Youth Tobacco Survey.

The survey found that among those who used e-cigarettes, the vast majority used flavored products, which are on the market illegally.

“During both the Trump and Biden administrations, e-cigarette companies addicted a new generation of children to nicotine, erasing the hard work so many of us undertook to convince kids not to smoke tobacco cigarettes,” Durbin said.

Only 23 products have received approval from the FDA for sale in the U.S., but products are still widely available and easily obtained. While the FDA has issued penalties and warnings to retailers and manufacturers, new products quickly appear in their place, most imported from China

“I simply do not understand how the Food and Drug Administration and our Department of Justice have permitted thousands and thousands of products to remain on store shelves when their manufacturers have not received authorization or in some cases even filed an application,” Durbin said. 

The FDA is in the process of reviewing millions of premarket applications for e-cigarettes that companies are supposed to file and receive approval for before selling their products in the United States.

But some companies are selling their products anyway.

King defended the FDA’s response, pointing to warning letters and civil monetary penalties it has issued to manufacturers and retailers as well as its work with other agencies like Customers and Border Protection to seize illegal products.

But he also said the agency is being overwhelmed with premarket applications for e-cigarettes that it needs more resources to respond to.

“We do have a premarket paradigm for reviewing applications, and the sheer volume of those applications and the volume of the market requires us to prioritize our enforcement efforts,” King said.

He noted that e-cigarette companies do not have to pay the user fees that tobacco companies and other regulated industries must pay.   

Both the Trump and Biden administration have proposed e-cigarette user fees, but those requests have not gotten through Congress. 

On Monday, the DOJ and FDA announced a new task force that will aim to crack down on the distribution and sale of illegal e-cigarettes.

“What the hell have you been waiting for?” Durbin asked.

Sen. Thom Tillis, R-N.C., called the task force announcement a “thinly veiled political stunt,” noting that the Reagan-Udall Foundation — which was created by Congress to support the FDA’s mission — recommended the creation of the task force in December of 2022. 

King said there is no “safe harbor” allowing manufacturers to sell their products after submitting an application. But tobacco control advocates told the committee that appears to be the case.

Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said companies that have pending applications often sell their products without any consequences from the FDA.

“There appears to be an unstated policy of not taking enforcement action against products with pending applications,” she said. “These products are no more legal than products for which no application was ever filed.”

Richardson said the FDA should issue larger penalties, the DOJ should prioritize seeking injunctions against manufacturers breaking the law and CBP should prioritize stopping importation of illegal products.

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