The Supreme Court on Wednesday backed a series of decisions by the US Food and Drug Administration to deny market access for flavored vaping products in a rare win for government regulators that may limit access to those products across the nation.
Though a partial win for the FDA, it remains uncertain whether President Donald Trump’s administration will shift gears and free up access to the products. During the campaign, Trump vowed to “save vaping.” The vaping companies are also entitled to reapply to the FDA for approval of their products. Meanwhile, the justices sent the case back to an appeals court for further review.
Justice Samuel Alito wrote the opinion for a unanimous court.
At issue were a series of FDA denials during the first year of the Biden administration for vaping products that officials said are geared toward minors with flavors like “Pink Lemonade,” “Rainbow Road” and “Jimmy the Juice Man Peachy Strawberry.” The vaping companies claimed that the FDA had changed the requirements for approval as it was assessing the applications to market the products.
The companies “express frustration about the lack of clear prior notice regarding the type of scientific evidence that was essential for approval of an application,” Alito wrote. “But we cannot agree with their argument that the FDA went back on any commitments made in the guidance it provided before ruling on respondents’ applications.”
Public health groups praised the Supreme Court’s ruling, calling the decision a significant win for American youth and asserting it should embolden the FDA to continue to police the products closely.
“Today’s ruling is a major victory for the health of America’s kids and efforts to protect them from the flavored e-cigarettes that have fueled a youth nicotine addiction crisis,” said Yolonda Richardson, president and CEO of Campaign for Tobacco-Free Kids. “It affirms that the FDA’s marketing denials for flavored e-cigarettes have been legally and scientifically sound and should encourage FDA to stay the course.”
The vaping industry says its nicotine-delivering products help Americans transition off cigarettes and that the dessert-themed flavors are attractive to adults.
Eric Heyer, who represented the vaping industry at the high court, said he was “obviously disappointed” in the decision but that the companies “continue to believe in the great harm reduction potential of their products for cigarette smokers.”
Heyer said the companies would continue to fight the FDA in the New Orleans-based 5th US Circuit Court of Appeals.
Public health advocates have been warning for years about a spike in vaping among young Americans. The FDA reports that 19% of high school students and 4.7% of middle school students vaped in 2020 – a far higher share than students who smoked.
Recognizing the harm caused by youth smoking, Congress passed a law in 2009 giving the FDA new powers to regulate tobacco products. In 2016, the FDA decided that e-cigarettes qualified as tobacco products and it began reviewing authorization applications for millions of new vaping products.
The multi-billion-dollar industry says that the FDA changed its method for that review in the middle of the process, requiring companies to show, with randomized trials, that flavored products are more effective than tobacco-flavored products at helping smokers quit or cut back on cigarettes.
The 5th Circuit Court of Appeals sided with the industry in January, finding that officials had perpetrated a “regulatory switcheroo,” sending manufactures on a “wild goose chase” to get approval. Seven other appeals courts rejected similar challenges of the agency’s denials.
Justice Sonia Sotomayor, a member of the court’s liberal wing, wrote a short concurrence that seemed to take issue with a line from Alito’s opinion. The FDA was not “feeling its way toward a final stance” on how to review vaping products, she said. It was, instead, giving the companies some flexibility to prove their products would be beneficial.
In light of the law, she wrote, “and the well-documented and serious risks flavored e-cigarette products pose to youth, it should have come as no surprise that applicants would need to submit rigorous scientific evidence showing that the benefits of their products would outweigh those risks.”
The Supreme Court sent the case back to the 5th Circuit to reconsider a related dispute in the case that deals with marketing plans.
At first, the FDA asked for the companies to provide those plans to demonstrate how its advertising could reduce misuse of the products by minors. But the FDA then said it didn’t consider those plans because past efforts to address the problem of youth vaping through marketing were not effective.
The FDA’s handling of the marketing plans prompted a technical legal question about whether the appeals court should have sent the denials back to the agency for further review. Alito wrote that the 5th Circuit read Supreme Court precedents “too broadly” to conclude that the FDA’s decision to not consider the marketing plans necessarily amounted to a legal error.
But Alito also wrote that the FDA’s argument on the point wasn’t quite right and so it asked the appeals court to “decide the question afresh.” That technical point could bring the case back to the Supreme Court next year.
On the other hand, the vaping companies may have an easier way out of the loss: They can reapply for approval with an administration that may be friendlier to its position. During the oral arguments in December, Justice Brett Kavanaugh pressed the parties on the practical effect of a decision either way.
“I’m curious what relief looks like in this case, because the companies can always reapply, correct?” Kavanaugh asked.
Curtis Gannon, an attorney with the Justice Department, agreed that they could.
“They can reapply without a fee,” he said. “And some other applicants have reapplied.”
But an attorney for the vaping industry countered that the FDA sometimes takes years to resolve applications.
“They can’t afford to wait that out,” Heyer said. “This was their one shot.”
This story has been updated with additional details Wednesday.