The U.S. Supreme Court on Dec. 2 took up an important case on the regulation of vaping products with candy and fruit flavors that the Food and Drug Administration views as harmful to the nation’s youth.
“Seven percent of youth are still using open-tank systems or mod [vaping products], according to survey results from earlier this year,” Deputy U.S. Solicitor General Curtis E. Gannon, representing the FDA, told the justices. “That’s more than 114,000 middle and high school students who are using devices that could use liquids like the ones that [manufacturers in the case] want to market.”
E-cigarette use among middle and high school students has declined recently, with the FDA in September reporting a slightly lower figure—5.9 percent of middle and high school students who had used a vaping product in the previous 30 days, down from 7.7 percent in 2023 and 20 percent in 2019.
However, schools and their allies continue to view youth vaping as a major concern, with some school districts suing e-cigarette manufacturers, and the nation’s largest provider, Juul Labs, reaching settlements with districts, states, and other plaintiffs in 2022 worth more than $2 billion.
“E-cigarettes pose unique health risks for youth, as adolescent brains are more susceptible to nicotine’s effects due to ongoing neural development,” says a friend-of-the-court brief filed in support of the FDA by the Campaign for Tobacco-Free Kids, the American Medical Association, and other groups. “Adolescents are thus especially vulnerable to nicotine addiction, which can lead to permanent effects on the developing brain.”
The issue in Food and Drug Administration v. Wages and White Lion Investments is the federal agency’s decisions in 2021 to deny applications by two e-cigarette companies to sell flavored vaping products. Under the Family Smoking Prevention and Tobacco Control Act of 2009, manufacturers must seek FDA approval to market their products, and the agency has approved some tobacco-flavored vaping products based on industry claims that they help some people cease smoking traditional cigarettes.
But the FDA has generally denied applications to market vaping products with candy and fruit flavors, though many such products were on the market by the time the agency adopted its view on the dangers and delayed enforcement and court orders have kept many of the products available.
“FDA is legitimately concerned that youth are chasing the flavors that they want,” Gannon said during the oral arguments.
Colorful and fruity names for vape products raise concerns about youth use
Two companies are directly involved in the case before the high court, Triton Distribution, a Dallas manufacturer owned by Wages and White Lion Investments, and Vapetasia, a Las Vegas-based manufacturer whose trade names for its flavored products have attracted attention. They include “Killer Kustard Blueberry,” “Iced Blue Razz,” and “Suicide Bunny Mother’s Milk and Cookies.”
“Common sense tells us that a flavor like ‘Mother’s Milk and Cookies’ is going to be disproportionately attractive to children,” Gannon said during the Dec. 2 argument.
At least one member of the court appeared to agree.
“You give people blueberry vapes, the difficulty with that—and FDA, I think, has tried to document this—is that blueberry vapes are very appealing to 16-year-olds, not to 40-year-olds,” Justice Elena Kagan said to Eric N. Heyer, a Washington lawyer representing Triton and Vapetasia. She added that FDA’s point of view “was that blueberry vapes are really problematic in terms of youth smoking.”
Heyer alluded to different forms of e-cigarette delivery systems and suggested that his clients’ products were e-liquids used to fill “open tank” vape devices and were generally not used by youths as much as cartridge-based or disposable vape devices.
Triton’s and Vapetasia’s “products have no history, zero history, of youth usage,” Heyer said. “That’s the case for bottled e-liquids generally. The devices with which they are used don’t have any sort of a track record of being substantially attractive to youth.”
A question of whether FDA followed proper procedure, and comments about President-elect Trump
The legal issue in the case is technical—whether the FDA followed proper administrative procedures in denying Triton’s and Vapetasia’s applications in 2021.
The FDA concluded that while there was some variability in the popularity of various vaping devices among youths, there was “consistency” in that young people were attracted to flavored products. FDA demanded “robust and reliable evidence” of “the magnitude of the potential benefit to adult smokers” of the applicant’s products, but it found the companies’ applications lacking in that evidence.
The full U.S. Court of Appeals for the 5th Circuit, in New Orleans, voted 10-6 to set aside the denial of the applications. The court said the FDA had engaged in a “surprise switcheroo” of the type of evidence it required the applicants to show to support their claims that flavored vaping products helped smokers stop using traditional cigarettes.
Several other federal appeals courts have upheld the FDA’s actions in this area, leading to a circuit split that the Supreme Court took up to resolve.
Vaping industry trade groups filed friend-of-the-court briefs supporting the two companies and urging the justices to uphold the view that the FDA acted arbitrarily and capriciously with its denials of the applications. The case, to them, is the latest opportunity for the Supreme Court to rein in the power of administrative agencies.
Some justices who have been in the majority in recent decisions reining in federal administrative power expressed concerns about whether Triton and Vapetasia had received proper procedures before the FDA.
“In fairness to [the companies], I think their argument is that the guidance [was] actually a moving target … or you changed the guidance as time went on,” Justice Clarence Thomas told Gannon.
But it was hardly clear by the end of the 80-minute argument just how the court might rule.
Heyer directly addressed the elephant outside the room, as it were, when he noted that President-elect Donald Trump was about to take office and that his administration might be more sympathetic to the vaping industry.
“We have a new administration coming in, the president-elect is on record saying ‘I’m going to save flavored vapes,’” Heyer said. “We don’t know exactly what that’s going to look like.”
Trump said in a Truth Social post this year that he would “save vaping again,” a reference to comments he has made that he saved e-cigarettes from stronger regulation during his first term. But then-President Trump in 2019 said he favored banning all flavored vapes, and it was his administration that adopted the policy requiring manufacturers to show evidence of benefits to those seeking to cease smoking to have their applications approved.
Heyer later made another reference to the coming political change in Washington, suggesting it might be unclear how the FDA might decide if the court held that the agency must reconsider his clients’ applications.
Justice Neil M. Gorsuch, a Trump appointee, cut Heyer short and sought to steer him back to a more technical point.
“Putting aside the obvious …” Gorsuch said to a few mild laughs in the courtroom.
“Yeah. Yeah,” Heyer said.
A decision in the case is expected by late June.
