Ball in FDA’s Court as Official Review Cites Its Chaos, Opacity Over Vapes

December 20, 2022

On December 19, the Reagan-Udall Foundation, an independent nonprofit tasked by Congress to help modernize the Food and Drug Administration (FDA), released a commissioned report on the agency’s Center for Tobacco Products (CTP). The expert panel—which mainly consisted of former agency higher-ups—concluded that the CTP has to pivot from “a reactive mode to proactive mode.” It identified the lack of a coherent plan at the center charged with authorizing or rejecting vaping products, and called for transparency at an agency long characterized by its absence. Yet Reagan-Udall’s demand for an “operational roadmap” was accompanied by a call for more enforcement tools to be put at the FDA’s disposal.

The almost 40-page report highlighted that Reagan-Udall was “unable to identify a current comprehensive plan that clearly articulates CTP’s priorities, direction for the future, and its near-term and longer-term goals and objectives.” Its sweeping suggestions included improving communications and transparency, perhaps through a potential public meeting; adopting methods to allow more stakeholder input; developing clearer frameworks for “high-quality” marketing applications for nicotine products, and increasing “use of the Tobacco Products Scientific Advisory Committee (TPSAC),” an advisory panel that could help guide the center.

The most specific proposal, however, concerned CTP’s lack of plausible enforcement capabilities in dealing with the unauthorized vaping products flooding the market: Among other points, Reagan-Udall advised that the FDA “seek higher-level Administration involvement to establish an interagency task force to make enforcement of the tobacco laws a government-wide priority”—a move that some harm reductionists have already noted sounds like a future episode in the country’s long-failed “War on Drugs.” The prospect has been lauded by anti-nicotine, prohibition-minded organizations like the Campaign for Tobacco-Free Kids (CTFK).

The CTP’s premarket tobacco products application (PMTA) process has from the start been beset by delays and extreme controversy.

The CTP is charged, ultimately, with protecting “Americans from tobacco-related disease and death,” and has faced constant criticism from vocal sides of the issue. Its premarket tobacco products application (PMTA) process, designed to determine whether vaping products are “appropriate for the protection of public health” (APPH)—a standard read as assessing whether a product is more likely to help adults transition from cigarettes to a safer alternative than introduce a new generation to nicotine—has from the start been beset by delays and extreme controversy.

Any tactical or nuanced perspective has long since appeared to be lost: The “comprehensive approach,” first unveiled by then-FDA commissioner Scott Gottlieb, introduced the idea of the “continuum of risk”—the idea that certain nicotine products, like vapes and oral nicotine pouches, are much safer than others, like combustible cigarettes. But the outcry over soaring youth vaping rates drowned out this approach.

On the one hand, abstinence-oriented organizations and politicians have demanded that the agency swiftly reject all such products—which it largely has, with the exception of a few tobacco-flavored e-cigarettes. On the other, tobacco harm reduction (THR) proponents have demanded much lower barriers to authorization—particularly for the flavored products that many adults find most helpful to switch from cigarettes, which remain on the market without comparable scrutiny. Amid millions of rejections, the FDA has yet to authorize a single vaping product with a flavor other than tobacco.

At times, the two polarized groups have appeared to temporarily unite in condemning the agency for a chaotic, opaque and inconsistent procedure that has left no one satisfied.

At the end of July, Califf asked Reagan-Udall to conduct “a comprehensive evaluation” of the agency’s food and nicotine divisions. THR advocates, nicotine users and vape producers welcomed this tacit acknowledgement of problems, but said it came too late—emphasizing they have long been chastising the CTP for what they view as a confusing, expensive, and draconian regulatory strategy that inevitably favors only well-financed manufacturers, most of which have ties to (or are outright owned by) Big Tobacco. In the months since, Reagan-Udall has met virtually with a variety of stakeholders—ranging from prohibition-minded lobbyists to industry players and consumer advocates—to discuss CTP’s failings in regulation, compliance and enforcement, and public communications.

“At times, a lack of clarity about the distinction between, and the intersection between, policy and science has created controversy within CTP.”

The resulting report also “observed that some issues before CTP are fundamental policy questions that must be informed by science but are not, themselves, scientific issues.”

“Rather, they are policy issues with profound societal impacts,” the report reads. “One such question that scientific analysis alone will not resolve is how to weigh the public health benefits of the percentage of adults who use ENDS that will completely quit smoking combustible tobacco products against the potential public health harms that youth who use ENDS will acquire a lifelong addiction to nicotine or proceed to use combustible tobacco products. At times, a lack of clarity about the distinction between, and the intersection between, policy and science has created controversy within CTP and may lead to a perception that the Center’s scientific integrity is being challenged when, in fact, policy decisions that transcended the science are being made.”

THR proponents and industry observers broadly welcomed elements of the report, which echo what they’ve long been saying.

“The report offers a devastating critique of CTP’s strategic muddle, its lack of clear direction, transparency, and consistency,” Clive Bates, the former director of Action on Smoking and Health (UK), told Filter. “It is clear that the public health test that guides tobacco regulation is so vague and malleable that it allows FDA to do whatever it wants, making it a target for political advocacy that overrides science and public health.”

“Perhaps the most damning aspect of the report is its implication that the FDA has caused many of its own problems.”

“Reagan-Udall’s suggestions are strikingly similar to those made repeatedly by consumers and industry, which the agency has ignored for years,” Michelle Minton, a THR proponent and senior policy analyst at the Reason Foundation, who spoke at a Reagan-Udall session, told Filter. “Perhaps the most damning aspect of the report is its implication that the FDA has caused many of its own problems by its overly broad interpretations of its own powers, it lack of flexibility, and its squishy commitment to science over politics.”

“The report essentially says that, though the FDA is well-intentioned, it has to some degree been fiddling while Rome burns,” Cliff Douglas, the director of the University of Michigan Tobacco Research Network, told Filter. “Thirteen years after the agency received regulatory authority over tobacco products, the smoking epidemic rages on, as does the current rampant sale of unauthorized e-cigarettes. I’m confident the FDA can right this ship if it quickly acts on the reports recommendations to become more proactive and to let science, not outside threats and influences, guide it.”

But one industry insider, who requested anonymity so as not to affect their company’s PMTAs, expressed much more pessimism, telling Filter that the CTP “doesn’t want to modernize,” and instead “wants to use a broken system to break the industry.”

“This report mostly gets to the heart of what has driven dysfunction at the Center for Tobacco Products for the last half decade or more,” Greg Conley, the director of legislative and external affairs, at American Vapor Manufacturers, told Filter. “CTP has actively resisted any attempt to modernize its processes and has made no effort to develop a coherent regulatory strategy or consistently interpret its own standards.”

“We are committed to communicating any changes with clarity and transparency for our many stakeholders.”

The report arrives after a particularly tumultuous year for CTP, which saw the retirement of its longtime director, Mitch Zeller; the departure of its longtime Office of Science (OS) leader, Matthew Holman, to a high-profile role at a major tobacco company; and relentless criticism over its policy decisions—including the recent revelation, first reported by Filter, that newly installed CTP Director Brian King had disagreed with OS, and scientists consequently reversed their opinion on authorizing some menthol e-cigarettes.

And, most notably, CTP has continued to deny countless PMTAs. Its denial—immediately placed on hold—of Juul’s applications triggered even more discussions about an agency often accused of buckling under political pressure. Countless lawsuits have been filed arguing that the FDA acted “capriciously” and “arbitrarily” in issuing many of these marketing denial orders (MDOs).

“While we consider potential improvements to our operations and processes for tobacco product regulation, we are committed to communicating any changes with clarity and transparency for our many stakeholders,” Robert Califf, the FDA commissioner, said in a press statement. “For the FDA to build on this work in the ever-evolving tobacco marketplace, it’s also critical to ensure CTP has what it needs to adequately and efficiently address the recommendations in the report.”



Photograph via Public Domain Pictures

Alex Norcia

Alex was formerly Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in the New York Times Magazine, the Columbia Journalism Review, the Los Angeles Times and the New Republic, among other outlets. He was also previously a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received grants from the Foundation for a Smoke-Free World. He is currently based in Los Angeles.

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