A Change in Administrations Underlines the Stakes of an E-Cigarette Case SCOTUS Heard This Week

An e-liquid manufacturer is challenging the FDA's "arbitrary and capricious" rejection of flavored vaping products.

The Food and Drug Administration (FDA) has never approved nicotine vaping products in flavors other than tobacco or menthol and probably never will unless it reconsiders the approach it has taken in recent years. But President-elect Donald Trump brags that he "saved flavored vaping" during his first term and promises he will "save vaping again."

The change in administrations underlines the stakes of FDA v. Wages and White Lion Investments, a case that the U.S. Supreme Court considered this week. Triton Distribution, a Dallas-based e-liquid manufacturer, is challenging the FDA's denial of its applications for "premarket" approval of its products, without which the company will be forced to shut down. If Triton prevails, it can stay in business while it submits new applications, and the FDA in the next administration is apt to be more receptive. That would be good news for adult vapers, including former smokers, who overwhelmingly prefer the flavors that the FDA has deemed an intolerable threat to the youth of America.

Last January, the U.S. Court of Appeals for the 5th Circuit ruled that the FDA had acted "arbitrarily and capriciously," in violation of the Administrative Procedure Act (APA), by changing the criteria for premarket approval after Triton's applications were submitted. The company's main complaint is that the FDA, which initially told applicants that no particular kind of scientific evidence was necessary, later decided that manufacturers had to cite long-term cohort studies or randomized trials indicating that vaping products with supposedly kid-friendly flavors are more effective than tobacco-flavored alternatives in helping smokers quit.

The FDA also changed its position on safeguards against underage access. Although the agency initially said such "marketing plans" were "critical," it explicitly ignored them in rejecting Triton's applications, saying age verification measures are not effective enough to negate the risk that minors might end up consuming the company's products.

Much of the questioning during oral argument focused on the issue of whether the FDA had in fact changed its criteria. Justices sympathetic to the agency suggested that manufacturers had adequate notice of its concerns about flavored vaping products.

The FDA "has been completely upfront about this," Justice Elena Kagan told Eric Heyer, Triton's lawyer. The agency "has tried to document" that "blueberry vapes are very appealing to 16-year-olds, not to 40-year-olds," she said. But as Heyer pointed out, that claim is inconsistent with survey data indicating that adult smokers who switch to vaping commonly favor fruit, dessert, and candy flavors.

Heyer also noted that his client's e-liquids, which are used with refillable vape systems, are not a common choice for teenagers. Deputy Solicitor General Curtis Gannon, representing the FDA, tried to rebut that point. "Seven percent of youth are still using
open tank systems or mod systems, according to survey results from earlier this year," he claimed.

That is not true either. According to the 2024 National Youth Tobacco Survey, 6 percent of middle and high school students were "current" e-cigarette users, meaning they reported vaping during the previous month. Among those current users, 7 percent said they used "tanks or mod systems." In other words, less than 0.5 percent of teenagers reported using such devices in the previous month, meaning Gannon's figure is inflated by a factor of more than 14.

Justice Sonia Sotomayor seemed even more clueless about the subject at the center of this case. "All of these products contain tobacco, right?" she asked Heyer, who corrected her: "They contain nicotine."

Even after learning that e-cigarettes do not contain tobacco, Sotomayor continued to assume they do. "Other than addiction, why would someone put nicotine into a product and then try to hide the flavor of tobacco?" she asked Heyer. "I'm a little bit at a loss."

More than a little. Contrary to what Sotomayor seems to think, the nicotine solutions used in vaping products do not taste like tobacco unless manufacturers deliberately add that flavor. And her premise that nicotine's presence in e-liquids can be explained only by a nefarious scheme to addict consumers is misguided in two ways. First, smokers who switch to vaping already have a nicotine habit, which they are trying to satisfy in a way that is much less dangerous to their health. Second, vapers like the psychoactive effects of nicotine; otherwise, the "addiction" that worries Sotomayor would be inexplicable.

Justices Clarence Thomas and Samuel Alito seemed more sympathetic to Triton's complaints. In response to Gannon's claim that Triton was "not unfairly surprised by FDA's denials," Thomas noted the company's argument that the FDA's regulatory guidance was "a moving target" because the agency "changed the guidance as time went on."

Alito quoted an internal FDA memo, written after the application deadline, that said "the evidence necessary for this evaluation would be provided by either a randomized controlled trial or a longitudinal cohort study." The memo added that "absence of these types of studies is considered a fatal flaw, meaning any application lacking this evidence will likely receive a marketing denial order."

As Heyer explained, the FDA had previously said it was willing to accept evidence from "single-point-in-time studies on 'consumer risk perception' and 'intentions.'" The FDA also said "it would make its determination based on the entire contents of the application." Yet in the end, "FDA admittedly did not assess anything in the applications beyond whether they contained longitudinal comparative efficacy evidence."

The FDA's shifting criteria "sent manufacturers of flavored e-cigarette products on a wild goose chase," 5th Circuit Judge Andrew Oldham noted in January. "Months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency's volte-face. Worse, after telling manufacturers that their marketing plans were 'critical' to their applications, the FDA candidly admitted that it did not read a single word of the one million plans. Then the FDA denied that its voluminous guidance documents and years-long instructional processes meant anything."

In addition to Triton's APA claim, Justice Neil Gorsuch noted, the company arguably had a due process right to "notice and a hearing." He drew an analogy to a restaurant suddenly confronted by a local edict requiring it to demonstrate that its food "provides a net benefit to public health." In both cases, he said, you have an "existing business" whose survival depends on compliance with a new rule.

Unlike a restaurant, Gannon noted, vaping companies are presumptively illegal without FDA clearance, and they continue to operate while their applications are pending thanks only to the agency's enforcement discretion. "I understand that," Gorsuch replied. "I'm not saying you have a right to continue it. I'm just asking: Would you have a right to notice and a hearing?" In this situation, Gannon argued, there is no such right under the Due Process Clause; the only procedural protections are those offered by the APA.

While criticism of the FDA's inconsistency and arbitrary rule changes seem amply justified, the root of the problem is the wide discretion that Congress gave the agency under the Family Smoking Prevention and Tobacco Control Act. That 2009 law charges the FDA with deciding whether approval of a nicotine product is "appropriate for the protection of the public health."

In making that judgment, the FDA is supposed to take into account "the risks and benefits to the population as a whole, including users and nonusers." That, in turn, entails considering "the increased or decreased likelihood that existing users of tobacco products will stop using such products" as well as "the increased or decreased likelihood that those who do not use tobacco products will start using such products."

Although that standard suggests a precise, scientifically informed cost-benefit assessment, it requires highly uncertain predictions and invites value judgments. The FDA concedes the harm-reducing potential of e-cigarettes, which are much less hazardous than combustible tobacco products. But in the FDA's view, the risk of underage use is so grave that it overrides the interests of adult vapers who demonstrably prefer the flavors that the agency refuses to approve.

While banning those flavors might result in more smoking and more premature deaths by undermining the appeal of vaping to smokers, the FDA says, that risk counts for nothing without conclusive evidence. And despite its statutory mandate to weigh "the risks and benefits to the population as a whole," the FDA outright refuses to consider the long-term public heath improvement that can be expected if teenagers who otherwise would be smoking decide to vape instead.

As Gannon explained it, the FDA worries that teenagers will get hooked on nicotine "at a time when nicotine is dangerous to their developing brains" and "may be…sentencing them to a long life of needing to satisfy that addiction." But the FDA's overriding concern about underage consumption is hard to fathom given that e-cigarette use by teenagers has been falling for years.

This year, just 6 percent of middle and high school students reported past-month nicotine vaping. Those teenagers overwhelmingly used disposables or pod-based devices rather than the e-liquids made by companies like Triton, which are sold mainly by specialty shops that exclude minors or online outlets that require age verification. That distinction, in fact, was the basis for the policy that Trump says "saved flavored vaping," which exempted open systems from FDA enforcement.

The FDA is currently taking a different approach, categorically rejecting flavored products regardless of whether they are commonly used by teenagers. That approach is neither fair nor sensible, but it would be legal if the FDA had announced the policy in a timely and straightforward way, instead of pretending that it might approve flavors other than tobacco and menthol if manufacturers managed to satisfy its vague and shifting criteria.

Under the Tobacco Control Act, Heyer conceded, the FDA was not obligated to issue any regulatory guidance at all. The agency could simply have pointed applicants to the statute and let them figure out what sort of evidence would be deemed adequate to satisfy its amorphous and malleable standard. But once the FDA decided to issue guidance, he argued, it created an expectation that applicants could rely on that advice, which it was not free to change without adequate notice and explanation.

Justice Brett Kavanaugh suggested that Triton's lawsuit was unnecessary, since the company could simply reapply to the FDA, perhaps after conducting the sort of expensive and time-consuming research the agency now says is necessary. That is what the company will have to do even if the Supreme Court agrees with the 5th Circuit, which set aside the FDA's marketing denial orders (MDOs) and remanded "the matters" back to the agency.

The crucial difference, Heyer said, is that leaving the MDOs in place would make Triton immediately subject to FDA enforcement. Without judicial relief, he said, "they're going to have to close their doors." And "even though the statute calls for decisions in 180 days," he noted, the FDA "is taking three or four years at least to make determinations on these. [Triton] can't afford to wait that out. If these MDOs are not vacated and remanded back to the agency, they're closing their doors and they're done. This was their one shot. That's why it was so important for FDA when it changed its position to communicate that and give them an opportunity to meet the new standard."

Given its broad discretion under the Tobacco Control Act, the FDA could always say no again. But the same wide leeway also means the FDA could say yes, preserving the flavor options that former smokers have come to take for granted. The outcome depends on whether Trump's pick to run the agency, Johns Hopkins surgeon Martin Makary, decides to change course.

Vaping360 says "little is known about Martin Makary's positions on vaping and nicotine use." But it notes that "vaping industry and consumer advocates" will welcome the departure of FDA Administrator Robert Califf, "a staunch foe of vaping and tobacco harm reduction." And given Trump's comments about flavored vaping products, the outlook seems brighter for companies like Triton and the consumers they serve.