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FDA plans oversight changes after critical tobacco report

Agency also dealing with ongoing legal fallout over its rejection of menthol and other flavored e-cigarettes

FDA Commissioner Robert Califf has reiterated a call for Congress to pass a user fee agreement with the e-cigarette industry to help fund the massive vaping workload the agency has struggled to handle.
FDA Commissioner Robert Califf has reiterated a call for Congress to pass a user fee agreement with the e-cigarette industry to help fund the massive vaping workload the agency has struggled to handle. (Tom Williams/CQ Roll Call file photo)

The Food and Drug Administration on Friday announced a series of actions meant to improve its oversight of tobacco and nicotine products, most notably e-cigarettes.

FDA Commissioner Robert Califf outlined plans for better communication and transparency on product reviews, increased use of the tobacco advisory committee and intra-agency meetings on enforcement. 

He also reiterated a call for Congress to pass a user fee agreement with the e-cigarette industry to help fund the massive vaping workload the agency has struggled to handle.

“To achieve these goals, we need to have the appropriate resources to hire and retain staff with the skills needed to effectively meet our public health mandate around tobacco,” Califf said.

The moves come in response to a report released by the Reagan-Udall Foundation in December that recommended the FDA clarify rules regarding oversight and e-cigarette reviews, including its shifting scientific standards that vaping manufacturers say have undercut their applications. 

The report also recommended the FDA utilize its tobacco advisory committee, improve staff recruitment and work with Congress on securing user fees from vaping manufacturers. 

The FDA solicited twin evaluations of its tobacco and food programs in July, after months of backlash against the agency’s response to e-cigarette reviews and the infant formula shortage.

Lawmakers have been critical of both industry tactics and the FDA response. Sens. Jeanne Shaheen, D-N.H., and Richard Blumenthal, D-Conn., earlier this month introduced a bill aiming to eliminate tax deductions for e-cigarette and tobacco ads.

Sen. Richard J. Durbin, D-Ill., has been an outspoken critic of the FDA’s failure to meet its deadlines on e-cigarette reviews. Most recently, the FDA signaled it could wrap up applications by June, nearly two years after a court-ordered deadline of September 2021.

Vaping companies were initially instructed to apply for FDA marketing authorizations by September 2020. But store shelves are currently awash in illegal products after the FDA was bogged down by the review workload.

The agency is also dealing with ongoing legal fallout over its rejection of menthol and other flavored e-cigarettes as the manufacturers continue to sue. So far, the FDA has not authorized any menthol-flavored products, citing a lack of evidence that the benefits of getting traditional smokers to switch outweigh the benefits that tobacco-flavored vapes have in their reduced appeal to kids. 

Vaping companies say the standard is unfair, because the FDA did not make it clear that it would draw direct comparisons between menthol and tobacco flavors until after the application deadline.

It’s unclear how the legal battle will ultimately be resolved. The FDA is revisiting its most high-profile rejection of Juul’s tobacco- and menthol-flavored products over potentially leaking chemicals after the company sued. 

“It’s imperative that we are able to meaningfully implement transformational regulations and make decisions based on the public health standard in the law, with the American public — not the interests of the tobacco industry — at the forefront,” Califf said. “We’ve made progress, but there’s a lot more work to come.”

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