On April 8, Mitch Zeller punched the clock for the last time at the Food and Drug Administration (FDA), retiring after nearly a decade as director of the Center for Tobacco Products (CTP).
Just weeks later, he spoke to his former agency about his long career. In an interview published on the FDA’s website, Zeller lauded his former colleagues. “In the face of some disappointments that we’ve experienced over the years, no one’s given up,” he said. “We lick our wounds, take a deep breath, and get on with our jobs.” He boasted that “it’s a short list” when it came to what more could have been done under his stewardship. He was pleased that it saw the processing of some 6.7 million vaping products through the agency’s premarket tobacco product application (PMTA) pathway: The agency rejected almost all of them, and has 50,000 or so left to sort through. He wished he’d been there long enough to see the prohibition of menthol and nicotine reduction in cigarettes.
Conspicuously absent from his comments, though, was any mention of tobacco harm reduction and the so-called “continuum of risk” he once championed—the idea that some nicotine products are less harmful than others and that public health would benefit by shifting smokers to safer alternatives. It’s an omission that reflects severe consequences for millions of Americans who vape and millions more who smoke but might not if they could vape instead.
“He seemed perfectly suited to the task of leading all of the above. And look at where we are.”
The story of how the FDA and CTP, which had in the past said that they’d streamline PMTAs for small- and medium-sized vapor manufacturers, managed to backtrack on this promise has not yet been told—and is primarily still grounded in conjecture. Experts remain unsure how much of the FDA’s perceived botching of the PMTA process and misinformation around nicotine was Zeller’s fault and how much of it was the structural failing of an agency that increasingly faces political pressures from all sides. His former deputy, Michelle Mital, now serves as acting director of CTP until a permanent person is installed.
“I tend to think that if Mitch Zeller couldn’t get graphic cigarette warnings done, couldn’t move the ball appreciably on the concept of nicotine reduction in combustibles, couldn’t sort out the PMTA process for e-cigarettes effectively before departing, couldn’t complete the menthol cigarette (and cigar flavor) rule before departing, and couldn’t ensure a greater national education effort regarding nicotine and the continuum of risk, then maybe nobody can,” one prominent tobacco control figure told Filter, requesting anonymity so as not to damage their career. “He seemed perfectly suited to the task of leading all of the above. And look at where we are.”
Described by former FDA Commissioner David Kessler as a “lawyer who hated law school,” Zeller had never planned for a career at the FDA. Longtime acquaintances interviewed for this piece praised his pragmatic approach to public health but also noted he was something of a crusader, attracted to big—often unattainable—goals and unwilling to change course even in the face of overwhelming evidence. This seemingly contradictory mix of traits may have propelled Zeller into the upper ranks of one of the most powerful agencies in Washington, where the changes he envisaged were within his reach—but it may also be why he then let those opportunities slip away.
Zeller got his start in the 1980s as an attorney for the Center for Science in the Public Interest (CSPI), a nonprofit known for its hyperbolic and often misguided food activism. He then served as counsel to Rep. Ted Weiss’s (D-NY) investigation of the George H.W. Bush administration’s allegedly improper interference with federal health agencies, during which he publicly butted heads with the agency for which he’d end up working.
Zeller’s confrontational nature and tenacity engendered hostility at the FDA—but it was exactly what Kessler wanted for the anti-tobacco project he established at the agency in the 1990s. For years prior, pressure had been building for the FDA to do something about smoking. But the agency had declined to act, largely because it was unclear if it had the authority to regulate tobacco. As Kessler’s predecessors had argued, Congress would first have to enact legislation giving the FDA that power. Everything changed in 1993, just as Zeller joined the FDA’s policy team.
That year, Cliff Douglas, who then served as a lobbyist for the American Cancer Society and is now an adjunct professor and director of the University of Michigan Tobacco Research Network, called the FDA and introduced the agency to a tobacco industry whistleblower codenamed “Deep Cough,” who revealed evidence that tobacco manufacturers had intentionally manipulated nicotine levels in cigarettes to make it harder for people to quit. This gave Kessler and his tobacco team something that had previously eluded the agency: a justification to regulate tobacco without the need for congressional action.
“Mitch always had a very strong and opinionated personality … but tobacco control is full of big egos.”
They tested the theory in their 1994 response to a citizens’ petition from the Coalition for Smoking or Health (COSH), in which the FDA announced its belief that it could regulate cigarettes as “drug delivery devices.” If the agency could make a convincing case that nicotine met the statutory definition of a “drug,” it could bypass Congress and unilaterally assert authority over tobacco. Kessler put Mitch Zeller, by then the associate commissioner of CTP, in charge of making this argument.
Although the FDA never succeeded in gaining the authority to regulate cigarettes as drug delivery devices, the tobacco team’s research on nicotine and Zeller’s 18-month investigation of the industry spurred public and congressional interest. That led, ultimately, to the eventual passage of the Family Smoking Prevention and Tobacco Control Act. Signed into law by President Barack Obama in 2009, it finally gave the FDA the authority to regulate tobacco it had long sought.
The Battle for the Soul of Tobacco Control
“Mitch always had a very strong and opinionated personality … but tobacco control is full of big egos,” Scott Ballin, the vice president of the American Heart Association and chairman of COSH (an alliance of the American Cancer Society, American Heart Association, and American Lung Association) during the 1980s and 1990s, told Filter. Ballin, now an independent health policy consultant, was responsible for most of the citizens’ petition requesting FDA action on tobacco and played a central role in the formation of tobacco control. In short, a group of health charities, academics and activists would soon become the dominant voice in the debate over tobacco, smoking and nicotine.
The initial fight was largely a competition between Zeller and Myers.
By the early 1990s, COSH led tobacco control. But “due to the politicking of one group and at one person’s egoistical urging,” Ballin said, COSH reconfigured into the Campaign for Tobacco-Free Kids (CTFK), which has been headed by Matthew Myers since 2000. As several people involved recounted, the years saw the battle of tobacco control ramp up: over who should lead, what the objectives should be and what role—if any—industry ought to play. The initial fight was largely a competition between Zeller and Myers. (Over email, Zeller declined to comment for this story; Myers did not respond to Filter’s request for comment.)
“We saw Mitch as a possible alternative to Matt’s leadership,” David Sweanor told Filter. “Zeller had enough personality to do that.” Sweanor, now a law professor at the University of Ottawa, has known Zeller for decades, and the two met regularly throughout the 1990s—both during and after Zeller’s initial spell at the FDA—to discuss the evolving nicotine market. When Zeller was beginning his investigation into tobacco industry practices for the FDA, Sweanor and his colleague Dr. John Slade, a celebrated addiction expert, had already been long at work on a similar project: They were scouring every resource—including from the industry—to gain an understanding of where the market for nicotine was headed. Their hope was that, by sharing this information with the FDA and mainstream tobacco control, they could make the market safer for consumers. But not everyone in tobacco control shared this goal.
“It took us a while to realize that people like Matt [Myers] didn’t see the opportunity and were only interested in using the information to smite the industry,” Sweanor said.
While Zeller had his own moralistic streak and anti-industry instincts, Sweanor noted that Zeller also advocated for tobacco control to think about how to replace cigarettes with safer products and believed the industry had a role to play in this transformation.
Myers also wasn’t always opposed to working with the tobacco industry. In the 1990s, representing CTFK, he led negotiations with Altria on the terms of the Master Settlement Agreement, the controversial deal struck by the largest cigarette makers to settle the many lawsuits filed against them by a group of state attorneys general. That deal, among other things, required cigarette makers to pay the states billions in fines, in exchange for immunity from future state or federal lawsuits.
The consequences of giving major tobacco companies control over how the government regulated their industry only became clear years later.
In the mid-2000s, Myers brokered another backroom deal with Altria and the pharmaceutical companies manufacturing nicotine replacement therapies, to get them on board with the legislation that would ultimately give the FDA regulatory power over the tobacco industry.
At the time of that deal, Zeller had left the FDA to work for Pinney Associates, a consulting firm representing, among others, pharmaceutical companies—including GlaxoSmithKline (GSK), which makes nicotine replacement products like gums and lozenges. By then, according to Sweanor, Zeller believed that the FDA needed to regulate tobacco, but “he didn’t really seem to adequately consider how the FDA should regulate the industry for the benefit of public health.”
“When Matt Myers came in saying the way to finally get [FDA authority over tobacco] was to partner with Altria, Mitch didn’t really question the ramifications, including that Altria then got to dictate the terms of FDA regulation on tobacco,” Sweanor told Filter. The consequences of giving major tobacco companies control over how the government regulated their industry only became clear years later.
Mistakes and Missed Opportunities
The Tobacco Control Act of 2009 was, Ballin wrote, “outdated before the President’s signature was dry”—a fact that had become glaringly apparent by the time Zeller rejoined the FDA as CTP director in 2013. By then, e-cigarettes had emerged. The safer nicotine safer nicotine products he and others had dreamed about decades earlier, which could compete with and displace combustible cigarettes, were taking off. But it was functionally impossible for any sort of legal market for these innovative products to really thrive under a regulatory framework that had been designed to protect cigarettes.
Zeller seemed to doubt that “agencies like the FDA [would] be up to the task.” Ironically, after taking the helm at CTP, he fulfilled his own prophecy.
Cigarettes and other combustible tobacco products available prior to FDA regulation were grandfathered in—they didn’t need the agency’s authorization to remain on the market. Even new cigarettes, if they were functionally similar to those on the market prior to 2007, could bypass the pre-authorization process. In contrast, new reduced-risk noncombustible products, like vapes, would have to undergo the PMTA process and receive FDA authorization in order to be legally marketed in the US (albeit they could remain on the market while their PMTA applications were pending).
The onerous pathway favors larger companies with robust resources and usually with ties to Big Tobacco. These high regulatory hurdles make it less likely that companies will bother investing in the development of safer nicotine products, blocking many of the truly innovative and potentially life-saving alternatives that already exist from becoming legally available to smokers.
In fact, in the 13 years since the FDA has regulated the industry, the agency has only authorized—very recently—a handful of vaping products for sale, all of which are outdated products manufactured by two large tobacco companies, R.J. Reynolds and Japan Tobacco International (JTI).
This scenario wasn’t what anyone in public health, including Mitch Zeller, wanted. Just prior to taking the job as CTP director, he urged the tobacco control community to “acknowledge that the continuum of risk exists” and to pursue strategies aimed at incentivizing people away “from the most deadly and dangerous to the least harmful forms of nicotine delivery.” Dorothy Hatsukami, a longtime collaborator of Zeller’s and a professor of psychiatry and behavioral sciences at the University of Minnesota, told Filter that she and Zeller had been interested in the idea of tobacco harm reduction since at least the mid-2000s.
Zeller did little to combat the steady stream of junk science, the sensationalist media coverage or the demagoguery of the tobacco control movement.
But for the transition to safer alternatives to ultimately work, the regulation of that market would have to support the development of, and access to, lower-risk products that consumers actually want to use. Zeller seemed to doubt that “agencies like the FDA [would] be up to the task.” Ironically, after taking the helm at CTP, he fulfilled his own prophecy.
While serving as CTP director, Zeller did little to combat the steady stream of junk science, the sensationalist media coverage or the demagoguery of the tobacco control movement—by then fully under Matt Myers’s ironclad command—which triggered a moral panic about vaping. He didn’t speak out against legislation proliferating throughout the states and around the world aimed at eradicating safer alternatives to cigarettes.
It would have been relatively easy for CTP under Zeller to combat growing misunderstanding about the role that nicotine plays—and doesn’t play—in disease by initiating a public education campaign. Apart from a single video to improve public understanding about nicotine released by CTP in 2019, this never happened.
Watch @FDATobacco’s Tobacco Centers of Regulatory Science (TCORS) researcher, Dr. Andrea Villanti, discuss her research on how to improve the public’s understanding of nicotine. https://t.co/EIr7aO5OTH pic.twitter.com/zuDUhzXcb5
— FDA Tobacco (@FDATobacco) September 27, 2019
“Mitch must be horribly frustrated by their failure to issue substantial rules during his years at CTP,” Eric Lindblom, who served as the director of the CTP’s Office of Policy from 2011 to 2016, told Filter.
Lindblom, now a senior scholar at the O’Neill Institute for National and Global Health Law at Georgetown University, believes that failure is largely the fault of White House politics and the byzantine process of administrative clearance. He noted that it is virtually impossible to get substantive rules approved unless the White House wants it. But there were things Zeller could have done to try to build that support if he’d been willing to take a more unorthodox approach.
“The greatest disappointment is that [Zeller] left CTP without first speaking up publicly about the fact that FDA hasn’t been allowed to use the authority Congress gave them to save millions of lives by issuing science-based rules on tobacco,” Lindblom said. “He should’ve made them fire him for speaking out if they were not going to let the FDA issue any meaningful rules.”
For a while, though, things had looked promising. Or at least more promising than they’ve become.
In 2017, under Commissioner Scott Gottlieb, the FDA announced a major shift in how it would approach the issue of tobacco, saying that it would aim at “striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.” In his own statement published in 2019, Zeller echoed this, noting that “nicotine-containing products are not equally harmful” and that the FDA’s new approach was aimed at “helping people move away from the tobacco product that causes the most harm—cigarettes—and encouraging industry resourcefulness in developing potentially less harmful products for adults who seek nicotine.”
“That announcement was true leadership,” Ballin said. And, if the FDA had truly committed to this shift, it could have meaningfully improved public knowledge about the relative risks of nicotine, paved the way for a more open and civil dialogue and made it easier for the FDA and Zeller to do what they said they wanted.
“It was hard for Mitch to acknowledge that we got screwed over by the FDA law because he had helped promote it.”
But nothing really changed after 2017, and Zeller didn’t do any of the things he could have when he had the chance. Now that he has retired, failing to seize the opportunity to affect the real-world change he seemed to always want, many are left wondering, why?
“It was hard for Mitch to acknowledge that we got screwed over by the FDA law because he had helped promote it,” Sweanor said. “Mitch and Matt let Altria pull them in as accomplices when they wrote a law that protected cigarettes, and now they aren’t willing to admit they messed up or go back and try to fix their mistakes, because that would be an admission that they screwed up.” (Through a spokesperson, Altria told Filter it was “focused on Moving Beyond Smoking and believe[s] science-based FDA regulation is an important part of evaluating and transitioning adult smokers to potentially lower risk smoke-free products.”)
Pressure from the public health community may also have played a role in Zeller’s apparent abandonment of the continuum-of-risk messaging. Ballin thinks that Zeller received significant pushback after his 2017 statement in support of a harm reduction approach to nicotine regulation—both from the Matt Myers-led anti-tobacco activists and from other agencies, like the Centers for Disease Control and Prevention (CDC), National Cancer Institute and National Institute on Drug Abuse. “Matt managed to get everything labeled as Big Tobacco, even the noncombustibles produced by little companies … putting Mitch in a difficult position to not appear like he’s kowtowing to the industry,” Ballin said.
Then there was the public relations nightmare of the supposed “epidemic” of youth vaping that activists, like Myers, blamed on the FDA. The centering of concerns over teenage vaping has obscured the continuing deaths of almost half a million, disproportionately marginalized smokers every year in the United States. Most of those people remain misinformed about safer alternatives like vaping.
“He might have had the best intentions, but just got sucked into this political nightmare.”
That disaster was greatly exacerbated by the “EVALI” scare of 2019, when the FDA and other agencies did far too little to publicly counter the initial misattribution of lung injuries to nicotine vapes. And that was followed by the FDA’s challenge of reviewing more than 6 million PMTAs submitted by thousands of small vapor companies—many more than the agency had expected or had the resources to manage. Amid long delays, all sides of the tobacco control debate united in condemnation of the agency.
And, throughout it all, there were lots and lots of lawsuits.
Health groups led by Matt Myers sued the FDA for delaying the regulation of e-cigarettes. And once the FDA implemented those regulations and began rejecting or denying thousands of PMTAs from small- and mid-sized vapor companies—often without fully reviewing their applications and for failing to include evidence the FDA told them they did not need to include—a number of those manufacturers sued the agency, too.
“This might have been the last straw,” Ballin speculated. “[Zeller] might have had the best intentions, but just got sucked into this political nightmare.”
Photograph by Michael J. Ermarth via Flickr
Correction, April 27: This article has been edited to reflect that Cliff Douglas, not Matthew Myers as originally stated, introduced the FDA to “Deep Cough.”
The Influence Foundation, which operates Filter, has received grants from Altria and Reynolds American, Inc. Pinney Associates works with Juul Labs, which has also provided grants to The Influence Foundation. Filter’s Editorial Independence Policy applies.