U.S. Food and Drug Administration Commissioner Robert Califf last week testified before the U.S. House Oversight & Accountability Committee over concerns about FDA operations, including tobacco regulation.
The bipartisan concerns raised by Congress included the sale of illegal vape productsin the U.S. marketplace and the lack of enforcement to remove these products from store shelves.
Rep. Krishnamoorthi (D-Illinois) voiced his frustration of what wasn’t being done to prevent youth from buying illicit vapor products.
“It’s illegal, but you can buy it today because you folks have not cleared the shelves of these illicit products,” Krishnamoorthi said.
Looking to find further answers, Rep. Virginia Foxx (R-North Carolina) pressed Califf by asking what the FDA is doing to rectify this problem of illicit products in the market.
The commissioner testified that the FDA has stepped up enforcement activity of illicit tobacco products including issuing more than 600 warning letters, approximately 100 civil monetary penalties and recent seizures at ports of entry.
“It is a very large number of products,” he said. “It is a big job, and we have a lot more work to do.”
Over in the Senate Chamber, Sen. Dick Durbin (D-Illinois) last week said the FDA has turned a blind eye to dangerous vapes that are illegally being sold following a meeting with leaders from the agency as well as the U.S. Department of Justice (DOJ).
“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,” said Durbin. “I reminded them that they have a job to do and that they have the legal authority to stop unlawful e-cigarette manufacturers from flooding the market.”
In the meeting, Durbin questioned the FDA’s Center for Tobacco Products (CTP) Director Brian King and DOJ Principal Deputy Assistant Attorney General Brian Boynton on the lack of enforcement against unauthorized e-cigarettes.
“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. “For two-and-a-half years, FDA has dragged its feet on completing its review of e-cigarette products, while at the same time has turned a blind eye to dangerous vapes that are illegally being sold. My patience has worn thin.”
At the recent Midwest Fuel and Convenience Trade Show (M-PACT) in Indianapolis, David Spross, executive director of the National Association of Tobacco Outlets, told attendees that since receiving Reagan-Udall Foundation recommendations, the FDA has stepped up its plan of actions towards enforcement.
"We've seen an uptick in enforcement of illegal vapor products and a huge uptick with the civil monetary penalties,” he said.
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