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Thursday, July 11, 2024 | Back issues
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Senators press FDA, Justice Department on illegal vape sales

Lawmakers have long accused federal regulators of slow-walking enforcement action against companies selling unapproved e-cigarettes in the U.S., arguing the proliferation of such vaping products harms children in particular.

WASHINGTON (CN) — A pair of federal officials charged with regulating and enforcing vape sales got a bipartisan grilling on Wednesday from the Senate Judiciary Committee, as lawmakers accused them of being asleep at the wheel while companies illegally market tobacco devices to kids.

“You’ve completely fallen down on the job,” Senate Minority Whip Dick Durbin told Brian King, director of the Food and Drug Administration’s Center for Tobacco Products, during a contentious hearing.

Senators for months have lambasted the FDA over its enforcement of illegal tobacco products, arguing that the agency has been too slow to complete a court-ordered review of premarket tobacco product applications from manufacturers seeking federal approval to sell their devices in the U.S.

The issue is particularly urgent, lawmakers say, because many of these unauthorized vapes are aimed at children — and while the FDA stalls on enforcing its regulations companies are still selling billions of dollars in illegal product each year.

On Wednesday, Durbin sought to drive this point home, displaying images of a wall of vapes for sale in a convenience store in Silver Spring, Maryland, not far from FDA headquarters. The Illinois Democrat held up a disposable e-cigarette his staff purchased from the same store.

“Not a single one of these products has been authorized by the FDA,” he told King. “These illegal products, clearly designed for kids … are being sold in the shadow of FDA’s headquarters. How is that allowed to happen?”

King was adamant that, while there was work to be done, his agency was making progress to curb the proliferation of illegal vape devices. Vape use among middle and high school students, he added, has declined more than 60%.

But cracking down on the huge numbers of illicit e-cigarettes on the market is no easy undertaking, Kind told Durbin.

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

The FDA has conducted thousands of inspections of e-cigarette manufacturers and distributors and has issued hundreds of warning letters, King testified. The agency is also building its enforcement capability alongside other government agencies: The FDA and Justice Department on Monday announced the formation of a multi-agency task force aimed at coming down harder on illegal vape sales.

That task force will “use every available tool to bolster our efforts to halt the illegal sale of unauthorized e-cigarettes,” said Arun Rao, deputy assistant attorney general at the Justice Department’s consumer protection branch.

The FDA, which can’t by itself bring enforcement actions against vape manufacturers, works alongside the Justice Department to get unauthorized products off store shelves. Federal attorneys also defend the FDA from suits filed by e-cigarette producers.

Rao pointed to what he called significant enforcement actions by the Justice Department and FDA, saying the agencies seized roughly $700,000 in unauthorized vapes in April.

But lawmakers were far from satisfied with the rate of progress.

Durbin pointed out that it had been 33 months since the U.S. Court for the District of Maryland ordered the FDA to complete its review of premarket tobacco applications. The court ruled in September 2021 that the agency violated federal law by allowing vape sales from unauthorized manufacturers.

“Nothing has happened,” Durbin said. “You call this an urgent need. What is urgent about waiting almost three years and doing nothing?”

The new interagency vaping task force came too little, too late, the Illinois Democrat argued.

"What in the hell have you been waiting for?” he said.

Rao countered that regulators and federal law enforcement were working to fight unauthorized vape sales even before the task force was unveiled, seizing illegal products and levying civil penalties against manufacturers.

Durbin remained unmoved. “You’re failing,” the senator said.

Republicans on the Judiciary Committee, meanwhile, were particularly concerned about vape manufacturers from foreign countries such as China skirting federal tobacco regulations while American companies remain bogged down in procedure.

Texas Senator John Cornyn cited a recent order from the Center for Tobacco Products which rescinded the FDA’s marketing denial to Juul, a vape device owned by U.S. company Altria. Although the marketing ban was lifted, Juul can’t sell its products in stores while federal regulators weigh whether to approve the device.

Cornyn held up Juul in contrast to Chinese-owned vape manufacturers who are allowed to sell their products in violation of federal regulations.

“This strikes me as a Kafkaesque situation for an American company filing for approval and then finding themselves in this maze of regulation and litigation,” he said. “Meanwhile, illegal Chinese vapes make $3 billion a year advertising directly to American citizens.”

Cornyn argued that legislation was necessary to address “what is an outrageous and unacceptable status quo.”

Durbin challenged federal regulators to demonstrate their commitment to cracking down on unauthorized vape sales by starting close to home. He said he would provide regulators with the address of the convenience store near FDA headquarters selling illegal products.

“I hate to pick on one store, but I want you to prove to me that it is urgent,” Durbin said. “We know they are selling illegal products to children — it’s happening across the country. Now, we’re going to find out if this agency task force … is on the case.”

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Categories / Government, National, Politics

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