These Memos Show That FDA Regulation of E-Cigarettes Is Driven by Dubious Value Judgments Rather Than Science
The agency is determined to ban the flavors that former smokers overwhelmingly prefer. For the children.
It has long been clear that the Food and Drug Administration (FDA) is leery of approving nicotine vaping products in flavors other than tobacco because the agency worries that they appeal to teenagers. Two recently disclosed FDA memos not only confirm that impression; they indicate that the agency is determined to ban all other flavors, no matter how popular they are among former smokers and no matter what evidence a manufacturer presents in favor of a particular product.
The memos came to light thanks to a lawsuit that Logic Technology filed against the FDA after the agency approved the marketing of the company's tobacco-flavored e-cigarettes but rejected applications for menthol-flavored versions. The documents show that higher-ups in the FDA overrode staff scientists who initially recommended approval of the latter applications.
Filter's Alex Norcia, who wrote about the memos yesterday, presents that episode as an example of how political considerations shape regulatory decisions that supposedly are driven by data. But the root of that problem in this context is a nebulous statutory standard that invites subjective judgments, allowing regulators to cloak preexisting policy preferences in the garb of science.
Last March, the FDA granted "marketing orders" for the Logic Pro and Logic Power vaping systems and the tobacco-flavored capsules and cartridges they use. In October, the FDA issued "marketing denial orders" for the menthol versions of those products, saying "the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act."
The memos show what was going on behind the scenes during that seven-month lag. Both are dated October 25, the day before the FDA told Logic Technology it had to stop selling menthol-flavored capsules and cartridges.
The first memo is from Benjamin Apelberg, deputy director of the Office of Science (OS) in the FDA's Center for Tobacco Products (CTP), and Todd L. Cecil, the office's acting director. "In the latter half of 2021," they say, the Office of Science made a "preliminary recommendation to authorize the marketing of the [menthol-flavored] products."
The office "did not find that the current literature supports that use of menthol-flavored ENDS [electronic nicotine delivery systems] by adult smokers is associated with greater likelihood of complete switching or significant cigarette reduction relative to tobacco-flavored ENDS." But it "concluded that the existing literature supports that menthol-flavored cigarette smokers show a preference for menthol-flavored ENDS relative to tobacco-flavored ENDS." The Office of Science "acknowledged that menthol-flavored ENDS appeal to youth but suggested the appeal may not be at the same level as some other flavors."
In deciding how to weigh these competing concerns, the Office of Science thought it was best to err on the side of giving menthol cigarette smokers access to vaping products they demonstrably prefer, even though it was not completely clear whether that preference translated into higher odds of switching to a far less hazardous nicotine habit. The office "considered the documented preference for menthol-flavored ENDS among adult menthol-flavored cigarette smokers to suggest a potential benefit: that menthol-flavored cigarette smokers would be more likely to try menthol-flavored ENDS (relative to tobacco-flavored ENDS), creating an opportunity for some to use menthol ENDS and ultimately transition away from combustible cigarettes."
That is precisely the sort of harm-reducing shift that the FDA is legally required to consider when it reviews applications from vaping companies. "From a policy perspective," Apelberg and Cecil say, "OS believed at the time that as long as menthol-flavored 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 Office of Science got pushback from the office of CTP Director Mitch Zeller (OCD). The OCD "raised questions about OS's recommendation, including questions about the role and sufficiency of the general scientific literature on adult menthol smokers' differential preference for menthol ENDS in demonstrating likely behavioral change, and underscored its concerns about the substantial appeal of menthol to youth." Discussion of those issues "continued over the course of several months into 2022."
The Logic Technology menthol applications were still pending in July, when Brian King succeeded Zeller as the CTP's director. The Office of Science "engaged in an open discussion" with King and his staff, who thought the office's initial recommendation was wrong. "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," King thought, "the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e., the products could be found to be [appropriate for the protection of the public health] only if the evidence showed that the benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth."
The new boss, in other words, overruled the Office of Science, although that is not the way Apelberg and Cecil put it. "OS, on its own initiative, then reassessed," they say, and decided King was right! "Based on new awareness and understanding of the OCD position by OS leadership at that time," the memo says, "OS determined it was scientifically appropriate and consistent to adopt the approach applied to other non-tobacco-flavored ENDS, which present a similar risk to youth."
Note that the Office of Science, after conferring with King, suddenly decided that the "risk to youth" from menthol vapes, which it previously argued "may not be at the same level" as the risk from other flavors, was "similar" after all. That reversal, in turn, doomed Logic Technology's menthol applications.
The second memo, also dated October 25, is from King, who explains that there was nothing untoward about what happened here. "Supervisors routinely discuss matters that are under review with their subordinates, and they, in turn, keep their supervisors informed about those matters," he writes. "For many decisions, discussions can reach well above the level of delegated authority. The more significant or noteworthy the matter, by reason of science, policy, law, or level of public interest, the more likely such discussions will occur up the supervisory chain. This type of collaboration has been routinely employed in CTP's decisions on matters of first impression, which have arisen frequently given the newness of CTP's authorities."
Nothing to see here, in other words. King knew that the FDA's decision was bound to provoke a lawsuit, and he presumably wanted to get ahead of complaints about a politicized process. Although it might look like the FDA was responding to pressure from anti-vaping politicians and activists who have long demanded a ban on flavored vaping products, King's memo implies, the agency was just following the science.
Logic Technology unsurprisingly takes a different view. "These memoranda further support Logic's argument that FDA denied Logic's [applications] for its menthol ENDS pursuant to an unpromulgated policy against the product category, not an evaluation of Logic's product-specific evidence," the company's lawyers say in a letter to the U.S. Court of Appeals for the 3rd Circuit, which is considering its lawsuit and issued a temporary stay against the FDA's marketing denial orders two days after they were issued. "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."
That approach, Logic argues, plainly violates the Administrative Procedure Act (APA). "As Logic has explained," the letter to the 3rd Circuit says, "basing product-specific decisions on unpromulgated, across-the-board policies that were never subject to notice-and-comment rulemaking is arbitrary and capricious, in violation of the APA."
However the appeals court assesses that claim, it seems clear that Congress invited arbitrary and capricious decisions by charging the FDA with deciding which products are "appropriate for the protection of the public health." Under the Family Smoking Prevention and Tobacco Control Act, that analysis is supposed to consider "the risks and benefits to the population as a whole, including users and nonusers of the tobacco product." That means taking into account "the increased or decreased likelihood that those who do not use tobacco products will start using such products" and "the increased or decreased likelihood that existing users of tobacco products will stop using such products."
In the context of vaping products, the FDA has interpreted that standard as requiring it to weigh the risk of underage vaping against the benefit of helping smokers quit by allowing the sale of e-cigarettes. But given all the uncertainties that analysis entails, the FDA has broad leeway to ban any products it does not like, saving Congress the trouble of making policy through potentially controversial legislation.
Theoretically, the FDA is weighing costs and benefits. But as the internal debate about menthol-flavored vapes vividly demonstrates, the FDA is actually making value judgments. It has decided that the risk of underage nicotine consumption is grave enough to outweigh the interests of adult consumers, who overwhelmingly prefer the e-liquid flavors it is determined to ban. Given the enormous lifesaving potential of vaping, that judgment is highly dubious on its face.
The FDA makes no attempt to compare the cost of smoking-related disease and death to the cost of adolescent vaping. Under its policy, a product that could appeal to teenagers is presumptively prohibited unless the manufacturer has conclusive evidence that a particular flavor facilitates the transition from smoking to vaping.
The ass-covering memo from Apelberg and Cecil says the Office of Science "had already determined that menthol-flavored ENDS pose a substantial risk of youth use greater than tobacco-flavored ENDS and similar to flavors such as candy, desserts, sweets, and mint." Actually, according to Apelberg and Cecil, the office had "suggested the appeal may not be at the same level as some other flavors," and there was a sound basis for that position.
According to the 2022 National Youth Tobacco Survey, 85 percent of adolescent vapers used e-cigarettes "with flavors other than tobacco." The "fruit" category was by far the most popular, mentioned by 69 percent of respondents, compared to 27 percent for menthol.
If 27 percent is "similar" to 69 percent, why isn't 15 percent—the share of teenaged vapers who used tobacco-flavored e-cigarettes—"similar" to 27 percent? By this logic, the wisest course would be a complete ban on vaping products, since even "tobacco-flavored ENDS" pose "a substantial risk of youth use." Assuming that the FDA succeeds in banning all other flavors, that risk will look even bigger, because tobacco-flavored e-cigarettes will then account for a larger share of underage consumption.
More to the point, the supposedly kid-friendly flavors that terrify the FDA are the ones that adults also favor. According to survey data, three-quarters of adult vapers prefer flavors other than tobacco. A 2020 study of 383 adult vapers found that "preference for tobacco and menthol or mint decreased over time," while "preference for fruit remained stable" and preference for "chocolate/candy or other sweets" increased.
A 2022 study asked 851 vapers how they would respond if the government banned the flavors they prefer. While 29 percent said they would switch to whatever flavors were still allowed, 28 percent said they "would find a way" to obtain forbidden flavors, which suggests that the FDA's policy could drive consumers toward potentially dangerous black-market options; 17 percent said they would "stop vaping and smoke instead," which would expose them to potentially deadly hazards; and 13 percent said they were not sure what they would do.
The FDA is betting that, when push comes to shove, former smokers will switch to the one flavor it is willing to approve rather than going back to cigarettes. It is also betting that eliminating flavor variety will have no impact on current smokers who might be interested in switching. But if the FDA is wrong, the upshot will be more smoking-related deaths than would otherwise occur. You might think that danger would weigh more heavily on the FDA than the much more modest and speculative risks of adolescent nicotine consumption. But you would be wrong.
While the criticism that the FDA has provoked is amply justified, much of the blame for this situation lies with Congress, which granted the agency the sweeping powers it is now exercising. The "appropriate for the protection of the public health" standard is not just vague but also morally indefensible. That collectivist calculus means adults are not allowed to buy products they want from businesses that want to provide them because the FDA is worried about what teenagers might do. Since those products can help smokers avoid premature death, that imposition is all the more outrageous.
