FDA Leaders’ Smoking Cessation “Care Package” Article Draws Fire

At the end of December, Robert Califf, the commissioner of the Food and Drug Administration (FDA), and Brian King, the director of the agency’s Center for Tobacco Products (CTP), published an op-ed outlining a new framework to maximize smoking cessation.

In the piece, published in the Journal of the American Medical Association (JAMA), the authors argue for a so-called smoking cessation “care package.” This includes encouraging health systems to provide social and clinical support, offering medication and nicotine replacement therapy (NRT), and moving forward on plans to ban menthol combustibles and lower the nicotine levels in cigarettes.

Though vapes are brought up—“further high-quality research,” they write, is needed on how e-cigarettes “may facilitate smoking cessation among adults”—there is scant mention of tobacco harm reduction (THR). Tobacco use, Califf and King correctly note, is the leading cause of preventable death in the United States, but they fail to make it abundantly clear that the overwhelming majority of these fatalities are a result of smoking.

“They dramatically overweight the risks of youth initiation, seemingly ignoring that it is smoking adults who can benefit from e-cigarettes.”

“In their one paragraph referring to e-cigarettes, the authors state that ‘the potential benefits of these products among adults who smoke must be weighed against the risks of youth initiation,’” Kenneth Warner, the former dean of the University of Michigan’s School of Public Health, told Filter. “This is absolutely correct. Unfortunately, the authors dramatically overweight the risks of youth initiation, seemingly ignoring the fact that it is smoking adults who can benefit from e-cigarettes who are at great and immediate risk of death.”

“The FDA appears to have adopted an absurd precautionary principle that will never recognize e-cigarettes as beneficial to public health until there is an overwhelming body of unequivocal proof of e-cigarettes’ utility for smoking cessation,” he continued. “Note that that body of proof apparently must be far greater than that characterizing the risks of youth initiation. The one body of proof that is clearly unequivocal is that cigarette smoking is killing more Americans than any other consumer product ever invented.”

While Califf and King cite a study by Cochrane, an institute considered the gold standard of research on evidence-based public health interventions, they do not go so far as to explain that this recent review found “high certainty” evidence that e-cigarettes are better at helping adults who smoke quit than FDA-approved NRT. Other studies—like one published in JAMA at the end of 2021—have found that people who did not intend to stop smoking but nonetheless began vaping drastically increased their likelihood of quitting.

The timing of the op-ed is either serendipitous or a purposeful tactic, as it arrives just weeks after an avalanche of criticism closed out the year. As revealed by Filter in mid-December, King had disagreed—and, consequently, intervened—with the CTP’s Office of Science when it recommended that certain menthol-flavored vaping products be authorized through the agency’s premarket tobacco product application (PMTA) process.

The ensuing backlash took something of an “I told you so” form—as THR advocates reasserted that politics had infiltrated the science and that perhaps no non-tobacco flavors, which are preferred by most people who switch from cigarettes, would ever legally make it to market.

The op-ed “seems to be [the FDA’s] attempt at filling the strategy void highlighted by Reagan-Udall.”

Days later, many of those same critiques resurfaced: The Reagan-Udall Foundation, an independent nonprofit tasked by Congress to help modernize the FDA, put out a report commissioned by Califf that found the CTP did not have a “coherent regulatory strategy,” solicit enough stakeholder input or give transparent communication.

Timed as it is, the op-ed “seems to be [the FDA’s] attempt at filling the strategy void highlighted by Reagan-Udall,” Clive Bates, the former director of Action on Smoking and Health (UK), told Filter.

Another op-ed, recently authored by King and published in HPHR, highlighted how the CTP is “bringing health equity to the forefront of tobacco product regulation,” leading some, including Bates, to speculate whether the center was trying to stave off judgment by appearing busy. (At publication time, the FDA had not responded to Filter’s request for comment.)

Kenneth Michael Cummings, a professor in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina who once taught the CTP director, said that the JAMA article looked “very similar” to a commentary that accompanied the 2020 Surgeon General’s Report focused on smoking cessation. (King, then a higher-up at the Centers for Disease Control and Prevention, served as senior associate editor.)

“The message was the same: We can do better in helping smokers quit with evidence-based treatments,” Cummings told Filter. “E-cigarettes don’t have the blessing from the FDA or other health agencies as ‘evidence-based’ cessation treatments.”

“The absence of discussion about e-cigarettes is, of course, disappointing,” he continued. “But steering the FDA battleship back to cigarettes and getting adult smokers off them is refreshing and the right thing to do.”

“It ignores harm reduction, and seems to be a radical reframing of CTP’s mission and focus.”

Others, however, have a more pessimistic outlook, and suggested the article was yet another signal that CTP would not embrace THR anytime soon.

“This JAMA op-ed is a monumentally bad article,” one industry insider, requesting anonymity so as not to affect his company’s PMTAs, told Filter. “It ignores harm reduction, and seems to be a radical reframing of CTP’s mission and focus.”

“It is frightening that those overseeing FDA actions on nicotine fail to show even a basic understanding of the public health challenges and opportunities,” echoed David Sweanor, an independent tobacco industry expert and adjunct professor at the University of Ottawa. “The apparent adherence to an ideological commitment to abstinence and a focus on coercive policy measures misses the extraordinary opportunity to empower people who smoke cigarettes to dramatically reduce their risks.”

Photograph by Matt Trostle via Flickr/Creative Commons 2.0