The Food and Drug Administration’s regulation of nicotine vapes came under close scrutiny by the United States Supreme Court on December 2, as justices heard oral arguments about the FDA’s decision to deny two companies permission to sell flavored vaping liquids.
Many harm reduction advocates have viewed the Triton case, as it’s known, as central to their hopes of keeping a wide range of vaping products available to aid smoking cessation.
For nearly 90 minutes, the Supreme Court justices peppered lawyers for the FDA and vaping companies Triton Distribution and Vapetasia with pointed questions, seeking to determine whether the agency had acted fairly and legally in 2021 when it denied the two companies permission to make e-liquids.
For the most part, the justices focused on narrow, procedural issues and not on the larger, life-and-death question of whether risks that flavored vapes pose to young people are outweighed by the benefits they deliver to adults who use them to quit smoking.
This case, as a result, is unlikely to resolve that debate or bring major changes to the FDA. It is significant, nevertheless, because a decision to either uphold or rebuke the FDA will send a message to new leadership. President-elect Donald Trump has nominated Dr. Martin Makary, a Johns Hopkins surgeon and critic of the agency, to lead the FDA.
“This case was never going to be the game-changer that would cause a million flavored vape products to be authorized,” Greg Conley, director of legislative affairs for the American Vapor Manufacturers Association, told Filter. “Regardless of the outcome, we have a new administration coming in.”
Indeed, during the hearing, Eric Heyer, a lawyer for the vaping companies, noted pointedly: “The president-elect is on the record as saying, I’m going to save flavored vapes.” He was referring to a September 20 comment by Trump on Truth Social.
Cliff Douglas, chief executive of the nonprofit Global Action to End Smoking, noted that the justices had sharply challenged Heyer’s claims that FDA had improperly changed the rules facing vaping companies between 2018 and 2021.
“One hopes for the justices to find that the system is broken, but that doesn’t seem likely.”
Nor did the justices seem to be interested in the broader critique of FDA, which has largely failed to create a regulated, functioning market for safer nicotine products. The vast majority of vapes sold in the US today have not been authorized by the agency.
Braving sub-freezing temperatures on the windswept marble steps of the Supreme Court building, Douglas told Filter, “One hopes for the justices to find that the system is broken, but that doesn’t seem likely.”
Instead, the case turns on the more limited question of whether the FDA’s guidance to vaping companies remained legal, even as it shifted following what the FDA invariably described as an “epidemic” of youth vaping in the late 2010s.
In January, the conservative Fifth Circuit Court of Appeals issued a stinging rebuke of the FDA, saying it had sent vaping companies trying to comply with its rules “on a wild goose chase.”
Heyer called the shifts in FDA guidelines “a massive sea change,” made without proper notice, as the agency came to the conclusion that flavored vaping products needed to show not just that they help adults quit smoking, but also that they are more effective than tobacco-flavored vapes at doing so.
This standard has had the effect of denying authorization to all flavored products except for a couple of outmoded menthol vapes made by NJoy, a unit of tobacco giant Altria.
“The agency absolutely flip-flopped,” Heyer said in court. “They certainly misled.”
But Curtis Gannon, deputy solicitor general, argued for the FDA that it was up to companies to prove that their products are “appropriate for the benefit of public health,” the standard set by the landmark Tobacco Control Act of 2009. Flavored vapes create heightened risks to kids, he said, so companies need to demonstrate that they provide heightened benefits to adults who want to give up cigarettes.
“Common sense tells us that a flavor like ‘Mother’s Milk and Cookies’ is going to be disproportionately attractive to children,” Gannon said. Triton and Vapetasia also make such flavors as “Killer Kustard Blueberry” and “Jimmy the Juice Man Peachy Strawberry.”
“They have the burden of proof,” Gannon said. “They need to supply the evidence. The data just wasn’t there.”
Heyer countered that two-thirds of adults who use vapes prefer flavors.
All nine justices participated in the oral arguments. Some showed a sophisticated understanding of the issues. Others, not so much.
“We know nicotine is addictive. You put it in to addict people. Presumably, you put it in to addict adults and children.”
Justices Neil Gorsuch and Samuel Alito, who are conservatives, delved deeply into the FDA’s procedures, seeking to understand whether the agency had acted arbitrarily.
By contrast, Justices Elena Kagan, Kentanji Brown Jackson and Sonia Sotomayor appeared to be disposed towards supporting the regulators.
Justice Kagan said: “There’s just not a lot of mystery here about what FDA is doing … FDA has been completely upfront about the role of flavors.”
“Everybody basically knows that flavors are particularly dangerous in terms of kids starting the use of smoking products,” she added.
For her part, Sotomayor seemed a bit confused about the role of vapes in the fast-changing marketplace for products that deliver nicotine. She asked: “Could you make a smoking product that didn’t have nicotine?”
Gannon seemed surprised by the question but allowed that, yes, you could make a vaping product without nicotine.
Sotomayor then asked: “Other than addiction, why would someone put nicotine into a product and then try to hide the flavor of tobacco? Meaning, I, I’m a little bit at a loss.”
Gannon again stumbled a bit, but Sotomayor persisted, saying: “We know nicotine is addictive. You put it in to addict people. Presumably, you put it in to addict adults and children.”
She didn’t appear to understand that vapes are designed, in part, to deliver nicotine to people who are already dependent on it—or for people who simply want to enjoy its benefits while avoiding the health harms of combustible products. Compared to combustible cigarettes, which kill about half of longtime users, vapes are relatively benign.
The justices are not expected to issue a ruling in the case for months. By then, vape companies may be looking at a very different FDA.
Photograph by Joe Ravi via Wikimedia Commons/CC-BY-SA 3.0
The Influence Foundation, which operates Filter, has received grants from both Global Action to End Smoking and Altria. Filter‘s Editorial Independence Policy applies.
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