Memos Show FDA Overruled Science-Office Call to OK Menthol Vapes

    New evidence provides the clearest signal yet that the Food and Drug Administration (FDA) is opposed categorically to authorizing non-tobacco flavored vapes—something indicated by reams of rejections under its premarket tobacco product applications (PMTA) process, but never explicitly stated.

    Two memos reviewed by Filter indicate that the office of Brian King, director of the FDA’s Center for Tobacco Products (CTP), intervened to push back against the CTP Office of Science’s recommendation to authorize menthol vaping products for the first time. These documents appear to reveal substantial disagreement within CTP, one that could be framed as the agency’s scientists battling against its bureaucratic upper ranks, who have the FDA commissioner, and ultimately Congress, to answer to.

    It can all be viewed, in other words, as a fight between science and politics. The news has angered tobacco harm reduction proponents, who point out that most adults who switch from cigarettes to vapes find flavors, in general, helpful—and sometimes even critical to their doing so. No non-tobacco flavored vapes have yet been authorized.

    At the end of October, the CTP denied the PMTAs for Logic’s menthol-flavored e-cigarettes. On December 6, Logic, which is owned by Japan Tobacco International (JTI), filed a petition for a review in a federal court of appeals, which granted a temporary stay—meaning the manufacturer could continue selling those products while the court weighed a motion for a full stay of its marketing denial order (MDO).

    Documents show that CTP’s Office of Science had recommended authorizing the menthol-flavored e-cigarettes—but eventually reversed course after pressure from the office of CTP Director Brian King.

    In March, the FDA had authorized Logic’s tobacco-flavored vaping products, finding that they were “appropriate for the protection of public health” (APPH)—a threshold that has come to be understood as a product’s deemed likelihood of transitioning adults from cigarettes without introducing a new generation to nicotine.

    Now, documents made available to Logic after it had filed the stay motion show that CTP’s Office of Science (OS) had recommended authorizing Logic’s menthol-flavored e-cigarettes—but eventually reversed course after pressure from the office of CTP Director Brian King (OCD).

    “These memoranda further support Logic’s argument that FDA denied Logic’s PMTAs for its menthol ENDS [electronic nicotine delivery systems] pursuant to an unpromulgated policy against the product category, not an evaluation of Logic’s product-specific evidence,” Logic’s December 12 supplemental filing with the appeals court states.

    “That is, under new leadership, OCD overruled OS’s initial recommendations to approve Logic’s products—recommendations that OS had based upon its science-based evaluation of Logic’s submission—because OCD concluded that all menthol-flavored ENDS should be treated disfavorably, as a category,” it continued. “As Logic has explained, basing product-specific decisions on unpromulgated, across-the-board policies that were never subject to notice-and-comment rulemaking is arbitrary and capricious.”

    A Logic spokesperson declined to comment on the ongoing litigation. The FDA is currently trying to prohibit menthol combustible cigarettes as well—an action that could make the availability of menthol-flavored vapes all the more important to people.

    The suggested narrative in these legal fillings relates to pending litigation, and FDA does not comment on pending litigation,an FDA spokesperson told Filter. As was noted in FDA’s press release issued in October 2022, the FDA conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard that considers the risks and benefits of the tobacco product to the population as a whole.

    But the two unearthed memos from October reviewed by Filter tell a rather different story.

    “OS concluded that the existing literature supports that menthol-flavored cigarette smokers show a preference for menthol-flavored ENDS relative to tobacco-flavored ENDS,” an OS memo from October 25 reads. “But OS did not find that the current literature supports that use of menthol-flavored ENDS by adult smokers is associated with greater likelihood of complete switching or significant cigarette reduction relative to tobacco-flavored ENDS. OS considered these findings from the literature together with product-specific evidence to assess the public health impact of particular menthol-flavored ENDS products.”

    As Logic’s PMTAs were among those “furthest along” in the review process, as the OS memo puts it, OS briefed the OCD “in the latter half of 2021” that it was offering a “preliminary recommendation to authorize the marketing of the products.” (Mitch Zeller, now retired, was still the CTP director at this point. He declined to comment, too.)

    “From a policy perspective, OS believed at the time that as long as menthol-flavored e-cigarettes remain on the market, menthol-flavored ENDS could be a direct substitute for them, providing a less harmful alternative for menthol-flavored cigarette smokers, who are less likely to successfully quit smoking than smokers of non-menthol flavored cigarettes,” the memo continues, adding that while menthol could appeal to youth, “it may not be at the same level as other flavors” and that documented preferences for menthol vapes among people who smoke menthol cigarettes “suggest a potential benefit.” 

    “OS considered that this suggested potential benefit, in the form of increased opportunity for use and transition, coupled with product-specific evidence of some benefit to smokers (even if not greater than that of tobacco-flavored ENDS products), amounted to a likelihood of greater cessation or significant reduction in smoking that would outweigh the known risks to youth from the marketing of the products, sufficient to meet the legal standard for authorization,” it continued.

    But according to the OS memo, OCD had some questions about “the role and sufficiency of the general scientific literature” that the preference of people who smoke menthols for menthol vapes could result in “behavioral change” (switching from cigarettes to the safer alternative). It also raised concerns about youth’s (perceived) attraction to menthol. (The second memo from King went into further detail about these preoccupations.)

    Discussions remained ongoing until July 2022, when Brian King assumed the role of CTP director following Zeller’s retirement. Right up until a mid-July meeting between OS and OCD.

    “This astonishing revelation demonstrates what many of us have been saying for over a year: The PMTA authorization process is a rigged political experiment where science has limited-to-no bearing.”

    After that meeting, OCD determined that “in light of the substantial risk to youth and the lack of robust evidence of actual differential use to quit or significantly reduce cigarettes per day, the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e. the products could be found to be APPH only if the evidence showed that that benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth.”

    OS then changed its opinion, based on this approach.

    “This astonishing revelation demonstrates what many of us have been saying for over a year: the PMTA authorization process is a rigged political experiment where science has limited-to-no bearing on the likelihood of success for an applicant,” an industry insider, who requested anonymity so as not to affect his companies PMTAs, told Filter. “It is the best example to date of political interference in what should be, but clearly is not, a science-based series of decisions by CTP and the FDA. It’s beyond time for Congress to step in and hold Brian King and CTP to account for their refusal to authorize life-saving products despite the recommendations from the experts within the agency to do just that.”

    It was also in July 2022 that Matthew Holman, the OS director, quit the FDA to take a job at Philip Morris International (PMI). Holman had recused himself from agency work since before King’s tenure. There is no direct evidence to suggest that his departure was related to the internal menthol debate.

    But both Robert Califf, the FDA commissioner, and King have come under political fire for not denying menthol vaping products: In September, King left early from a nicotine conference to meet with Senator Dick Durbin (D-IL), who called on him to remove flavored all e-cigarettes from the market; Durbin has similarly demanded that Califf do the same.

    “This is yet more evidence that the FDA Center for Tobacco Products is willing to ignore science if it allows career bureaucrats to avoid making politically difficult decisions,” Greg Conley, the director of legislative and external affairs at American Vapor Manufacturers, told Filter of the revelation. “Not only is this injurious to employee morale, but it is a bright and clear signal that the only paths to reform at CTP involve federal judges or a new administration in the White House.”


     

    Copies of Logic’s filing and the two October CTP memos are embedded below:

     


     

    Update, December 14: This article has been updated to include comment from the FDA received after publication.

    Photograph by Felton Davis via Flickr/Creative Commons 2.0

    The Influence Foundation, which operates Filter, has received grants from PMI. Filter‘s 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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