WASHINGTON (CN) — The Food and Drug Administration faced renewed criticism Tuesday from a top Senate Democrat, who chided the agency’s director for giving a “free pass” to unauthorized vape manufacturers that he said pose a public health threat.
In his letter to FDA Commissioner Robert Califf, Illinois Senator Dick Durbin did not seem optimistic that his months of urging the agency to take a stronger stance on its e-cigarette guidelines would soon bear fruit.
“Another Durbin vaping letter for you to ignore,” the lawmaker told Califf.
Durbin, who chairs the Senate Judiciary Committee, has pressed the FDA to follow through on a review of premarket tobacco product applications from vape manufacturers seeking federal approval to market their devices. The survey, which was supposed to have been completed in September 2021, was mandated by the U.S. Court for the District of Maryland in a ruling which found that the agency had violated federal law by allowing vape sales from unauthorized companies.
As of January, the FDA is 28 months behind the court-ordered deadline, Durbin said Tuesday.
“Given these delays, and with no end in sight, there is absolutely no reason why FDA continues to permit unauthorized e-cigarettes to remain on store shelves,” the lawmaker wrote. “FDA has the tools and authority to clear the market of unauthorized products today, yet the agency is granting a free pass to scores of vaping products that are harming the health of children in our country.”
Durbin acknowledged that the agency had taken some “modest and long-overdue actions” to enforce compliance with federal regulations. The FDA over the summer placed an import ban on Elfbar, a Chinese-made disposable vape, and fined several manufacturers that had sidestepped marketing regulations.
Despite those developments, the Illinois Democrat argued that delays in the premarket review remained a threat to public health.
Durbin also dinged the FDA for what he called “timid enforcement” of synthetic nicotine products.
Congress in 2022 expanded the agency’s authority over e-cigarettes using synthetic nicotine, requiring manufacturers of such products to apply for marketing approval with federal regulators.
Yet the FDA has yet to issue any marketing denials to companies manufacturing synthetic tobacco vapes, the Illinois Democrat said, arguing it was “outrageous that FDA sounded the alarm on this emerging public health threat” but failed to act “at a time when the most popular e-cigarettes used by children contain synthetic nicotine.”
Congress has taken steps to help the FDA crack down on unauthorized vape products, Durbin told Califf.
“But the simple truth is that FDA does not appear to want to meet court orders or statutory requirements,” he wrote. “Your unwillingness to utilize FDA’s arsenal of enforcement tools and the repeated apparent deference to industry is at the expense of our children.”
An FDA spokesperson on Tuesday confirmed that the agency had received Durbin's letter and said that it would "respond directly to the senator."
Durbin last pressed Califf on his agency’s enforcement of unauthorized vape sales in September, telling the FDA director in a letter that his office had found that nearly two dozen e-cigarette products available for purchase online lacked federal approval. That figure, the lawmaker said at the time, did not account for vape manufacturers who had pending premarket review applications before the FDA — or companies that had failed to apply for such approvals at all.
Meanwhile, tobacco use among some minors dipped last year, the FDA said in a November report. Just around 10% of U.S. high school students reported using e-cigarettes in 2023, a decline from around 14% in the year prior. Overall tobacco use among high schoolers also decreased to roughly 13% from 16.5%.
Among middle school students, the FDA reported a slight increase in tobacco use, up to around 7% from 4.5%.
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