FDA Head Orders a Review of Its Nicotine Division, to Mixed Response

    On July 20, Robert Califf, the head of the Food and Drug Administration (FDA), announced that he would commission external experts to conduct “a comprehensive evaluation” of the agency’s food and nicotine divisions.

    The move comes after the FDA’s Center for Tobacco Products (CTP) has been under relentless fire over its handling of its PMTA authorization process for vaping products—including a high-profile apparent reversal over Juul earlier this month.

    Califf, however, painted a rosy picture of a workforce eager to be rigorously reviewed.

    “I have discussed this evaluation with the relevant leadership of these centers and offices, all of whom welcome the opportunity to work towards organizational excellence,” he said in a press release. “Each of these areas are full of hardworking and talented individuals who have dedicated their careers to working across a variety of scientific, policy, legal and administrative activities. FDA employees deserve the best support possible so they can fulfill their strong commitment to public health—and the American public that we serve.”

    Over the span of just 60 days, the Reagan-Udall Foundation, a partnering nonprofit, will collaborate with a collection of unnamed outside experts to assess “processes and procedures, resourcing, and organizational structure” for the foods program and the CTP.

    As usual, many tobacco harm reductionists, consumers and independent vapor companies responded to the FDA’s action with a mix of skepticism and disdain, reiterating that they have for years criticized CTP and what they view as the draconian regulatory process that has driven small and medium-sized out of the industry entirely.

    Many culled through Reagan-Udall’s board of directors, searching to see if any members might be sympathetic to safer nicotine alternatives. If anything, they were left with even more uncertainty. (It’s not apparent, either, how much the board will be involved.) But intriguingly, the members include both Georges C. Benjamin, who also sits on the board of the prohibitionist-leaning Truth Initiative, and James E.K. Hildreth, a professor at Meharry Medical College in Nashville who has taken million-dollar research grants from Juul Labs.

    “I wouldn’t expect huge changes from this,” a former CTP employee told Filter.

    “It is unclear whether the Reagan-Udall Foundation is a prohibitionist collaborator or if it will be a genuine partner to the millions of adults who are using a vape product to quit combustible tobacco,” Amanda Wheeler, the president of American Vapor Manufacturers, told Filter. “The FDA has unapologetically failed to uphold its regulatory mandate to approve vape products that promote public health. It is not a matter of an overwhelmed system or inadequate funding—the agency collects almost a billion dollars annually in user fees. It is a reality that FDA bureaucrats refuse to take ownership of the facts.”

    A former CTP employee, who requested anonymity so as not to affect their career in the industry, recommended caution, wondering if the agency—mired with so much bad press around e-cigarettes and baby formula—merely had to “look like they are doing something.”

    “I wouldn’t expect huge changes from this,” they told Filter.

    That assumption seems reasonable, considering that nicotine policy and public health experts have tried to engage the FDA since at least March, not long after the Senate confirmed Califf as the agency’s new commissioner.

    In a previously unreported letter shared with Filter, Cliff Douglas, the director of the University of Michigan Tobacco Research Network and the former national vice president for tobacco control at the American Cancer Society, headed more than two dozen heavyweight signatures—including Neal Benowitz (a professor of medicine emeritus at the University of California San Francisco), Vaughan Rees (the director of the Center for Global Tobacco Control at the Harvard T.H. Chan School of Public Health), Steven Schroeder (a distinguished professor of health and health care at the University of California, San Francisco and the former president and CEO of the Robert Wood Johnson Foundation) and Nancy Rigotti (the director of the Tobacco Research and Treatment Center at Massachusetts General Hospital and a professor of Medicine at Harvard Medical School).

    “Harm reduction is too often misunderstood in the tobacco control community as conflicting with traditional tobacco control measures,” the letter, dated March 8, reads. “But tobacco harm reduction explicitly prefers nicotine abstinence to any nicotine use. Thus, both preventing underage nicotine use and promoting adult cessation from smoking and all other tobacco product use is ideal. This is reflected in the public health standard set forth in the agency’s authorizing statute, the Family Smoking Prevention and Tobacco Control Act.”

    The authors had listed a number of recommendations, too, which involved boosting capacity and competence in conducting scientific reviews of applications,” like PMTAs, “in a timely manner” and further embracing the agency’s own continuum of risk strategy by ensuring that “society’s understanding of the science of nicotine matches the FDA’s.”

    “I’m optimistic that the oversight committee can help the FDA strengthen the regulatory efforts of its tobacco center.”

    Despite only receiving a receipt for the letter, and no substantive response, Douglas remains hopeful that the agency could eventually shift course.

    “I’m optimistic that the oversight committee can help the FDA strengthen the regulatory efforts of its tobacco center,” he told Filter. “It includes some very well-informed members who appreciate the public health priority of reducing combustible tobacco use as rapidly as possible. They understand that the principles of harm reduction, based on FDA’s continuum-of-risk approach, can be more effectively leveraged to help adult smokers overcome their lethal dependence on cigarettes. The committee can also play the critical role of guiding the FDA to engage in more high-visibility educational campaigns that correct misperceptions about nicotine and the relative health risks posed by different tobacco and nicotine products.”

     


     

    Photograph of Califf by Christopher Michel via Flickr/Creative Commons 2.0

    The Influence Foundation, which operates Filter, has received grants from Juul Labs, Inc. Filters Editorial Independence Policy applies.

    • Alex is Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe 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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