High Court Suggests Flavored E-Cigarettes’ Fate Up to Trump (1)

US Supreme Court justices were skeptical that they could give any relief to companies whose applications to sell flavored vape products were denied by the Food and Drug Administration, suggesting that their best hope was with the incoming Trump administration.

The FDA said it denied the applications because the companies hadn’t adequately shown that the benefits of flavored tobacco products in helping current smokers quit was greater than the risk that non-smokers, particularly children, would be attracted to those products.

During arguments on Monday, some of the justices were critical of how the agency considered the applications, which the companies said changed the rules after they had already submitted their applications.

The FDA had previously said “no specific studies were required for an application,” said Eric Heyer, who argued on behalf of vaping manufacturers. After, the “FDA denied applications for over one million products and over 250 applicants” because they didn’t have those studies, he said.

“Their argument is that the guidance were actually a moving target,” said Justice Clarence Thomas told Justice Department lawyer Curtis Gannon. Either that the guidance wasn’t “clear or you changed the guidance as time went on.”

The US Court of Appeals for the Fifth Circuit agreed, saying that it expected the FDA to give the companies “the benefit of a full and fair regulatory proceeding on remand, notwithstanding its prior promises to reject their applications no matter what.”

Other justices, though, said the FDA had been clear all along that the concern was that children would be particularly attracted to flavored products.

Even the companies’ applications tried to show how flavored products could be beneficial for current smokers looking to transition to a less harmful habit, Justice Elena Kagan said.

“So I guess I’m not really seeing what the surprise is here or what the change is here,” Kagan said.

Regardless, it wasn’t clear what the companies could get from the court.

“As a practical matter,” Justice Brett Kavanaugh said, “I’m curious what relief looks like in this case, because the companies can always reapply.” Whether the companies prevail, “either way it’s going to be that they can reapply and hope to succeed.”

Justice Neil Gorsuch said it was “pretty obvious what will happen on remand if we bother,” referring to the fact that the FDA has already said it will deny the applications again.

It’s “just going to be the idle and useless formality,” Gannon said.

In response to questions from Justice Amy Coney Barrett, Gannon said that the FDA could go back and review the applications, if that’s what the court says it needs to do. It’s not going to be “a big burden on the agency in order to have to decide the applications” and “confirm that there’s nothing in there that changes its mind about the bottom-line conclusion here,” Gannon said.

“So it’s pretty low stakes,” Barrett said.

But Heyer said it wasn’t low stakes for the companies, especially if they had to start the process all over again.

The “FDA is taking three or four years, at least, to make determinations on these,” Heyer said. The companies “can’t afford to wait that out.”

If these applications aren’t remanded back to the agency, the businesses are “closing their doors and they’re done,” Heyer said.

Moreover, he said it wasn’t all that clear what the FDA would do. “We have a new administration coming in,” he said, noting that “the president elect is on record saying ‘I’m going to save flavored vapes.’”

“We don’t know exactly what that’s going to look like,” Heyer said.

The case is Food and Drug Administration v. Wages and White Lion Investments, LLC, U.S., No. 23-1038, argued 12/2/24.