On December 14, Dr. Robert Califf, President Joe Biden’s pick to be the commissioner of the Food and Drug Administration (FDA), faced questions from senators about how he would lead the agency over the next three years.
There had been some expectation that legislators would dig into Califf—a cardiologist who previously served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, President Barack Obama’s FDA commissioner, and the head of medical strategy at Alphabet, Google’s parent company—over his relationship with the pharmaceutical industry. But the initial hearing amounted to a largely collegial affair, as Dr. Califf explained how he would streamline COVID treatments and tests, tackle misinformation on social media, and address an overdose crisis that has worsened during the pandemic.
Anyone hoping for a clear indication of how Califf would position the FDA around tobacco harm reduction was disappointed, and observers were left to pick through limited past indications of his potential future impact in the field.
Biden’s FDA has oddly gone without a permanent head since his inauguration. Acting Commissioner Janet Woodcock, an FDA employee since the 1980s, has had to bear the brunt of the recent criticism levied at the agency. Under her stewardship, the FDA has controversially approved a new Alzheimer’s drug, struggled to communicate the efficacy of COVID booster shots for adults and children, watched overdose rates hit record highs, and bungled an already-confusing procedure for companies to receive authorization to sell e-cigarettes. In June, congressional Democrats criticized Woodcock for failing to take action on manufacturers, though evidence would later show that youth vaping rates—their primary concern—had substantially decreased.
Many news outlets anticipated that Califf would have to address what many politicians have labeled a vaping “epidemic” among middle schoolers and high schoolers at the Senate hearing. In late November, Politico called tobacco regulation “the overlooked public health issue that could make or break Biden’s new drug regulator.”
But largely absent from the hours-long testimony was how the incoming FDA head—if confirmed—would handle tobacco harm reduction and a premarket tobacco product application (PMTA) process that’s bound to put most small- and medium-sized vape shop owners and manufacturers out of business.
With thin evidence of Califf’s intentions, observers are left with the difficult task of guessing what he might do.
That onerous bureaucracy required companies to file extensive paperwork and costly research for every product they wished to remain on the marketplace by last September. Since the fall, the FDA has rejected millions of applications on the basis that they would not be “appropriate for the protection of public health”—a threshold that has come to be understood as helping adult smokers switch to safer alternatives without introducing a new generation to nicotine. So far, the agency has authorized exactly one outdated vaping product along with two tobacco-flavored cartridges. It has punted on decisions regarding the largest players. Several producers, meanwhile, have sued the agency for acting capriciously, applying standards that had not been made clear from the get-go.
Nonetheless, the hearing featured just a single question related to tobacco control. Senator Tammy Baldwin of Wisconsin asked Califf how he would tackle synthetic nicotine. In the wake of so many PMTA denials, several vape manufacturers have announced that they’ll be switching to synthetic nicotine—that is, nicotine made in a lab and not derived from tobacco—as it falls in a sort of regulatory loophole. (The FDA’s remit defines a “tobacco product” as anything “made or derived from tobacco,” which technically precludes synthetic nicotine.)
In his response, Califf emphasized the importance of installing “the right person” to replace Mitch Zeller, the current director of the FDA’s Center for Tobacco Products (CTP) who is soon retiring, and pledged to “close this loophole so that we make sure that we understand the risks and benefits, and particularly deal with the issues in children.” But that might be out of his hands: Though the FDA could regulate synthetic nicotine as any other drug, the agency will likely have to wait until Congress tweaks the definition to allow it to be regulated as a tobacco product.
Califf’s answer to Senator Baldwin’s limited question, even if it included intriguing reference to the “benefits” of synthetic nicotine, provides few clues to how he might handle the future of the vape industry, at a time when COVID will continue to occupy legislators’ attention over other public health concerns.
With thin evidence of Califf’s intentions for an agency that has never made tobacco control a massive priority, industry insiders, experts and harm reductionists are left with the difficult task of guessing what he might do. (Califf served for only a year as Obama’s commissioner.)
Some see promise in Califf’s experience and credentials. “He is the right person for this role at this time,” Cliff Douglas, the director of the University of Michigan Tobacco Research Network and the American Cancer Society’s former vice president for tobacco control, told Filter. “He appears to understand the big issues around tobacco and alternative nicotine products, and he has the intellectual heft and experience to be able to explain that while it is important to minimize youth uptake of any nicotine product, and they’ll continue to address that assertively, the much more immediate and larger problem stems from the tens of millions of adults who smoke.”
“His past comments on vaping do not inspire much confidence in his willingness to fairly examine the evidence.”
In contrast, Jim McDonald, a journalist for Vaping360, subscribed the senators’ lack of tobacco control questions to the idea that they might be “confident, based on Califf’s previous statements, that the nominee will be a reliable enemy of vaping and recreational nicotine use”—a hardline prohibitionist who would jeopardize tobacco harm reduction.
Greg Conley, the president of the American Vaping Association (AVA), also cited some evidence that points in this direction. “Califf has shown a heavy bias towards pharmaceutical inventions [for smokers], which is understandable for someone nominated to become FDA commissioner,” Conley told Filter. “His past comments on vaping do not inspire much confidence in his willingness to fairly examine the evidence on tobacco harm reduction.”
Those “past comments” mainly come from an op-ed published on the Association of American Medical Colleges’ website, in which Califf argued that “flavors in vaping products should be banned immediately and the campaign about the dangers of unregulated vaping should be dramatically increased,” and that “surveillance should be increased to identify individuals and groups selling products to minors.” He also seemed to support a prescription-only model for vapes, which Australia has adopted.
Such stances are anathema to tobacco harm reduction advocates. “At a time when millions of Americans are successfully using vaping to quit cigarettes,” Amanda Wheeler, the president of the American Vapor Manufacturers Association, told Filter, “Robert Califf’s backward-thinking, prohibitionist views about reducing smoking are badly out of sync with what the public wants and deserves from the FDA.”
Most in the tobacco harm reduction field assume that their uphill battle will only get steeper.
Califf’s 2019 article appeared near the height of “EVALI,” the mysterious vaping-linked illnesses, “EVALI,” that cropped up in the United States in the summer of 2019, and could be seen as outdated. The Centers for Disease Control and Prevention (CDC) has since, belatedly, identified that it was tainted, illicit THC cartridges—not nicotine vapes—that caused the lung diseases.
A generous reading, such as Douglas’s, might hold that Califf is capable of changing his mind as news develops, and could have adjusted his thinking in light of evidence that EVALI misinformation and resulting anti-vaping policy decisions boosted smoking rates.
Most in the tobacco harm reduction field, though, do not buy that analysis and assume that their uphill battle will only get steeper.
Photograph of Califf by Christopher Michel via WordPress/Wikimedia Commons/Creative Commons 2.0
AVA has provided donations to The Influence Foundation, which operates Filter. Filter’s Editorial Independence Policy applies.
Show Comments