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The FDA shakeup could stall e-cigarette regulations

The FDA shakeup could stall e-cigarette regulations


It has public health experts worried

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Photo by Amelia Holowaty Krales / The Verge

Food and Drug Administration Commissioner Scott Gottlieb’s sudden resignation yesterday has public health experts worried that progress on e-cigarette regulations could stall, or even stop.

The news comes just a few days after Gottlieb reportedly brought a proposal for e-cigarette flavoring restrictions to the White House, according to Axios. His resignation — just as his agency was stepping up regulations — is worrying for people closely tracking the future of tobacco control. “I don’t think that anyone knows for sure what this means,” says Desmond Jenson, an attorney with the Public Health Law Center at the Mitchell Hamline School of Law, says in an email to The Verge. “It doesn’t feel like it will be good news.”

“It doesn’t feel like it will be good news.”

Gottlieb leaves behind a mixed legacy when it comes to tobacco regulations. Earlier in his time at the FDA, he delayed the deadline for when e-cigarette manufacturers had to apply for the agency’s permission to stay on the market. That extended the time products could stay on shelves largely unregulated. But after Juul hit headlines because of the device’s growing popularity with underage vapers, the FDA began increasing pressure on the e-cigarette industry to keep kids from vaping. In November 2018, for example, Gottlieb announced plans to limit sales of nicotine juice in kid-friendly flavors by banning them in stores without strict age restrictions.

Under Gottlieb, the FDA has also taken early steps to ban menthol in traditional tobacco products. (Menthol is a flavoring known to lure in kids that’s been especially marketed to communities of color.) And in July 2017, Gottlieb announced plans to cut the nicotine in cigarettes and started the long road to regulation in March 2018, but there hasn’t been significant progress since . “A lot of what Commissioner Gottlieb has done is start the wheels moving on proposals, rather than actually putting any rules and regulations in place,” says Micah Berman, a professor of public health and law at the Ohio State University.

“I don’t expect anything to happen at this point — if ever.”

Now, Kathleen Hoke, a law professor at the University of Maryland, suspects any progress on tobacco control and e-cigarette regulations could stall for months. “I don’t expect anything to happen at this point — if ever,” she says. “It’s a little concerning that somebody who was expressing this kind of support for the public health aspects of this issue is rapidly gone.”

The public health community is disappointed by the news. But the tobacco industry might stand to profit, according to an emailed report by Bonnie Herzog, a financial analyst for Wells Fargo Securities, LLC that was first reported by Vox. “We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives,” Herzog says. On Tuesday night, tobacco stocks were already climbing.  

“He was the champion behind these initiatives.”

The news could mean a reprieve for vaping giant Juul, the target of an FDA crackdown that included a surprise inspection of the company’s headquarters. Right before the FDA announced its plans to limit the sale of sweet-flavored vape juice, Juul announced it would stop supplying its flavored pods to brick-and-mortar stores. But after big tobacco company Altria spent $12.8 billion to buy a 35 percent stake in Juul, Gottlieb sent letters asking the companies to explain how their new alliance would affect their efforts to curb youth vaping. Juul declined to comment about Gottlieb’s resignation.

E-cigarette company Blu didn’t have substantial comment, but at least acknowledged Gottlieb’s departure. “We look forward to continuing our constructive engagement with the FDA,” says spokesperson James Campbell in an email to The Verge. “We have great respect for both Commissioner Gottlieb and his team, and recognize the ongoing challenge of balancing the public health potential of vapour products with the need to prevent youth access.”

Corey Henry, a spokesperson for tobacco company Philip Morris International, or PMI, applauded Gottlieb for raising awareness for “new, innovative non-combustible products,” he says in an email to The Verge. PMI is waiting for FDA authorization to market a device called IQOS, which heats a stubby tube of tobacco instead of burning it. FDA is also evaluating whether the company can claim that the product is less risky than traditional cigarettes. Henry says PMI can’t comment on the status of its applications with the FDA. But Wells Fargo analyst Herzog wrote that Gottlieb’s resignation could “have implications (positive, we hope)” for IQOS’s approval.

“I feel like there was some progress towards the middle.”

Gregory Conley, head of the advocacy group the American Vaping Association, had a mixed reaction to Gottlieb’s imminent departure. In a phone call with The Verge, he praised Gottlieb for giving e-cigarette manufacturers extra time to apply for FDA authorization to stay on the market. But, he says, “We are no closer today to a coherent, attainable structure for those applications than we were two years ago.” He worries about how companies will meet looming regulatory deadlines without clear FDA guidance.

Hoke thinks Gottlieb’s legacy may be some incremental progress towards bringing together both extremes of the polarized conversation around vaping: “Folks who think you should be issued a vape pen on Earth, and folks who think you should burned at the stake if you sell vapes,” she says. “I feel like there was some progress towards the middle where rational policy making can occur.” Gottlieb’s departure means slowing that momentum. That, she says, is the biggest loss.