Tuesday, August 30, 2022

FDA isn't using its power to stop the sale of hundreds of vaping products that it's ordered off the shelves, Stat reports

Food and Drug Administration photo
Even though the U.S. Food and Drug Administration has ordered hundreds of flavored, nicotine-heavy vaping products off of the market, "Vape companies are regularly flouting the FDA’s orders. They’re making, stocking, and selling the illicit goods. And the agency is just letting it happen," Nicholas Florko and Elissa Welle report for Stat, the medicine-and-science publication of The Boston Globe 

The authors write that while the FDA has ordered more than 100 vape manufacturers to stop making more than 250 specific flavors and vapes, "We found scores of companies across the country that are defying the FDA's demands." And despite having "sweeping legal authorities" to crack down on vape companies that ignore its bans, "ranging from levying seven-figure fines to physically pulling products off shelves," the Stat investigation found that the FDA has never used those powers, according to its own data. And in several cases, "It’s even dropped cases against companies that it knows are still selling illegal products." 

The FDA declined Stat’s request for an interview with Commissioner Robert Califf or the head of the FDA’s Center for Tobacco Products, Brian King, but a spokesperson implied that the agency may soon get tougher against companies that ignore its orders, Stat reports.

Vape shops argue that the FDA’s orders aren’t clear enough, and that until they are more so, they'll keep selling the products. The shops “are doing their best, despite a complete lack of clarity or transparency from the agency, to piece together what products are still legally able to be sold,” Amanda Wheeler, president of American Vapor Manufacturers, told Stat.

The writers say their investigation is likely an underestimation of the issue, since they only analyzed warning letters sent to companies that formally asked the agency for permission to sell their products, and then had that request denied and did not focus on the hundreds more companies that received warning letters for never asking the FDA for permission at all.

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