WASHINGTON (CN) — A top Senate Democrat doubled down over the weekend on his push to keep e-cigarette products out of the hands of children, accusing the Food and Drug Administration’s top regulator of being asleep at the wheel as vape manufacturers skirt federal guidelines.
“For years, you and FDA leadership have sought to distract from or justify your failures to protect children from being preyed upon by Big Tobacco by touting something just around the corner,” Illinois Senator Dick Durbin told agency commissioner Robert Califf in a letter dated Friday.
Durbin, who chairs the upper chamber’s judiciary committee, has long criticized the food and drug regulator’s failure to complete a review of vape manufacturers seeking federal marketing approval by a court-ordered 2021 deadline. That date was set by the U.S. District Court for the District of Maryland, which ruled in 2019 that the FDA had violated parts of the 2009 Tobacco Control Act by allowing vape manufacturers to sell their products without prior approval from the federal government.
Friday, Durbin noted in his letter to Califf, marked two years since the review deadline.
“Happy anniversary,” the lawmaker wryly remarked.
Durbin argued that the FDA’s failure to finish analyzing its backlog of PMTAs, short for pre-market tobacco product applications, “jeopardizes public health” and raises questions about the agency’s compliance with federal tobacco law.
“It is unacceptable for a federal agency to be so delinquent in complying with a federal court order, given the inexcusable harm it has caused to America’s children,” Durbin wrote. He pointed to reports that as many as two million children may have started vaping since the 2021 review deadline elapsed.
Although Durbin acknowledged that the food and drug regulator has processed millions of PMTA forms from vape manufacturers, he said the agency has failed to enforce its own guidelines by allowing companies to sidestep a requirement to demonstrate that their products will protect public health.
“Despite the clear requirements under the law, thousands of unauthorized and addictive e-cigarettes currently are peddled to children every day because FDA refuses to enforce violations of the law,” the lawmaker said.
According to research conducted by Durbin’s office, at least 22 vaping products from manufacturers who are thus far unauthorized by the FDA, and have received warnings from the agency, are still available for purchase online. Those are “only the tip of the iceberg,” Durbin suggested, since his staff’s review did not include e-cigarette products that have pending marketing applications before the food and drug regulator, or ones that never submitted such a request in the first place.
“These appear to be flagrant examples of e-cigarette companies flouting FDA rules that are ripe for additional penalties, and yet FDA has not acted,” the Illinois Democrat wrote.
Further, Durbin’s office discovered that, of the more than 680 warning letters the agency has issued to tobacco companies since January 2021, the FDA has only verified that the firms corrected course in about 10% of cases.
Durbin noted that the feds have taken some steps to keep unauthorized e-cigs off store shelves: The FDA in June placed an import ban on the Chinese-made vape product Elfbar and has issued fines to some companies flouting marketing regulations.
However, “it simply is not credible to suggest that this makes a dent in the flagrantly illegal products being sold to children,” the lawmaker said.
Durbin urged the FDA to step up, arguing that what he sees as the agency’s years of inaction have contributed to the drastic increase of vaping products on the market. “If you are unwilling to meet this moment,” he told Commissioner Califf, “perhaps FDA requires new leadership.”
A spokesperson for the FDA said Monday that the agency has received Durbin's letter and "will respond directly to the Senator." The FDA has said that it aims to review nearly all of the 26 million PMTA forms it has received from tobacco companies thus far.
Lawmakers’ increased interest in federal vaping regulations comes after a December report rom independent FDA watchdog, the Reagan-Udall Foundation, which found a lack of transparency in the agency’s review of tobacco products. Procedures at the Justice Department, which litigates on behalf of the FDA have also made it more difficult to prosecute manufacturers who run afoul of marketing regulations, according to the study.
Sales of flavored disposable vapes, such as those manufactured by Elfbar and JUUL, have skyrocketed in recent years. According to a June report from the Centers for Disease Control and Prevention, sales of flavored e-cigs jumped to 41% by the end of 2022, compared with just around 30% at the beginning of 2020. Conversely, sales of tobacco and mint-flavored vapes declined during that period.
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