Michele Mital, the current deputy director of the Food and Drug Administration’s Center for Tobacco Products (CTP), will become its new acting director in mid-April. On March 30, the FDA told Filter that she will assume the role once Mitch Zeller, CTP’s current director, retires in a few weeks. The agency has not yet made a public announcement.
Mital, who has been at the agency for 25 years in a variety of roles, inherits the politically loaded job of overseeing the regulation of cigarettes and vaping products. She will be under intense pressure from, on the one hand, industry and harm reduction advocates who argue that vapes should be widely available as a safer alternative for smokers; and on the other, the Michael Bloomberg-funded anti-vaping lobby, which wants tight restrictions including a total ban on the flavors they claim only appeal to youth.
In the past month, speculation has swirled that Zeller, only the second CTP director since the agency formed in 2009, would make more substantial decisions to bolster a legacy dominated by controversies—from an outcry over youth vaping rates to the FDA’s widely condemned failure to make timely or fair regulatory decisions. Would he, at least, sign off by authorizing a bevy of tobacco-flavored products from manufacturers with the biggest market share? With his retirement looming, that becomes increasingly unlikely.
Though the FDA has rejected or denied a majority of vaping products through its premarket tobacco product application (PMTA) process, it has yet to weigh in on most of the largest players—and has provided little hope that it’ll ever authorize flavored vaping products, including menthol. The agency has authorized just a handful of tobacco-flavored brands, both made by tobacco companies and used by few vapers.
“It’ll be status quo for a while, given her long career.” However, “she’s probably the best option for permanent head of CTP, given possible alternatives”
Mital has said little, if anything, publicly about e-cigarettes or tobacco harm reduction. But the fact she is being promoted from within means few imagine she’ll do anything drastically different from Zeller.
“It’ll be status quo for a while, given her long career,” one industry insider, who requested anonymity so as not to affect the PMTA process, told Filter. However, “she’s probably the best option for permanent head of CTP, given possible alternatives”—by which they meant more prohibition-minded candidates.
“To the extent that there are decisions that are ready to go out while she is there, I would expect they would go out,” echoed another industry insider, requesting anonymity for the same reason. “I would not expect her to take any new initiatives.”
The CTP’s agenda, which Mital will now lead for the time being, includes planned moves on cigarettes that are also highly contentious. A ban on the sale of menthol cigarettes, for example, is expected to move forward soon, and the agency intends one day to limit the nicotine levels in combustible cigarettes to effectively zero.
On top of all that, Mital will face legal ramifications from the sweeping denials of vaping products issued under Zeller. Dozens of vapor companies have filed lawsuits against the FDA, mainly arguing the agency acted “arbitrarily” and “capriciously” in reviewing—and subsequently denying—their PMTAs.