The U.S. Supreme Court has heard arguments on whether the Food and Drug Administration (FDA) was right to block applications from the makers of flavoured vapes.
The crux of the legal battle is whether the FDA failed to correctly consider the requests of two manufacturers - Triton Distribution and Vapetasia - to sell flavoured e-liquids, putting it in violation of a federal law called the Administrative Procedure Act.
The FDA is appealing a decision by the Fifth Circuit Court of Appeals that its denial of the applications was “arbitrary and capricious.”
Now, the Supreme Court must weigh up its options at a time when former president Donald Trump - who pledged to “save vaping” - is set to take office again.
‘Moving goal posts’
Triton and Vapetasia argue that the FDA “moved the goal posts” late in the application process by adding a requirement for long-term studies.
They say this means the agency unfairly denied their applications to sell sweet or fruit-flavored e-liquids, which it says are an important aid in helping adult smokers to quit. Applications from various other companies for millions of similar products were also denied.
The FDA, meanwhile, says the manufacturers failed to show their products were more likely to help existing smokers switch to vaping than to hook young people on nicotine.
Proving health benefits outweigh risks
To secure regulatory approval, vape companies must show that their product would be "appropriate for the protection of the public health." This means that any health benefits - like helping smokers switch to generally less-harmful vaping - must outweigh the risks of bringing the new product to market.
Eric Heyer, lawyer for Triton and Vapetasia lawyer, told the court that the FDA engaged in “regulatory switcheroos” by unfairly changing its requirements for applications once the deadline had passed.
He said they initially gave guidance that no specific studies were needed to prove the positive impact of sweet flavoured vapes compared to tobacco on helping smokers to quit - but this changed once the applications had already been submitted.
He said: “FDA’s new longitudinal efficacy requirement directly contradicts the guidance FDA provided before the submission deadline, when FDA knew that roughly two thirds of adult ENDs users use flavoured products. Before, FDA said ‘no specific studies are required for an application’.
“After, FDA denied applications for over one million products and over 250 applicants because they lacked a randomised controlled trial, a longitudinal cohort study or ‘other evidence comparing the flavoured ENDs products at issue against tobacco flavoured ENDs products as to cigarette reduction over time’.”
He added:“Before, FDA said it would make its determination based on the entire contents of the application. After, FDA admittedly did not assess anything in the applications beyond whether they contained longitudinal comparative efficacy evidence.”
Conservative Justice Clarence Thomas asked Curtis Gannon, the Justice Department lawyer arguing for the FDA, about whether the requirements of the regulation was "actually a moving target - that either they weren't clear or that you changed the guidance as time went on."
"That is their argument, Justice Thomas," Gannon said. "But I think that the key point is that they knew from the statute that they needed to be making this comparison about what the benefits were with respect to existing smokers and weighing that against the potential costs with respect to non-smokers and attracting youth. They knew throughout that FDA was concerned about the fact that flavours are attractive to youth."
‘Harmless error’
Gannon repeatedly returned to the argument that the change in guidance had simply been down to “harmless error.”
The court questioned Gannon over whether the FDA had failed to give the vape companies fair notice of what kind of evidence it required to approve flavoured vapes.
However, it seemed mostly sympathetic to the agency’s position, with many of the justices appearing baffled by the suggestion that it had changed its position during the approval process.
“I’m not really seeing what the surprise is here, or what the change is here,” Justice Elena Kagan told Heyer. “Everybody basically knows that flavors are particularly dangerous in terms of kids starting the use of smoking products.”
Justice Sonia Sotomayor said she’s “at a loss” trying to understand how the FDA switched its position.
The FDA over the years has approved only 34 flavored e-cigarette varieties, all tobacco or menthol flavoured.
