The U.S. Supreme Court upheld a series of decisions by the U.S. Food and Drug Administration to keep flavored vaping products off the market. This was a rare win for government regulators that could make it harder for people across the country to get these products.
Even though the FDA got some of what they wanted, it’s still not clear if President Trump’s administration will change its mind and let people get the products. When he was running for office, Trump promised to “save vaping.” Companies that make vaping products can also ask the FDA to approve them again. At the same time, the justices sent the case back to an appeals court to be looked at again.
Justice Samuel Alito wrote the opinion for the whole court, which agreed with it.
During the first year of the Biden administration, the FDA turned down a number of vaping products with flavors like “Pink Lemonade,” “Rainbow Road,” and “Jimmy the Juice Man Peachy Strawberry.” This caused a lot of controversy. As the FDA looked over the applications to market the products, the vaping companies said that the agency had changed the rules for approval.
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 decision, saying it was a big win for American kids and that it should give the FDA the confidence to keep closely watching the products.
“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 that its nicotine-delivery products help Americans quit smoking and that adults like the flavors that are based on desserts.
At the high court, Eric Heyer spoke for the vaping industry. He said that the companies were “obviously disappointed” with the decision, but they “continue to believe in the great harm reduction potential of their products for cigarette smokers.”
Heyer said that the companies would keep going to court in New Orleans to fight the FDA. The court is in the 5th US Circuit.
For years, people who work to protect public health have been warning about a rise in vaping among young Americans. In 2020, the FDA found that 19.% of high school students and 4.7% of middle school students vaped. This is a much higher percentage than the number of students who smoked.
Because Congress knew that smoking by teens was bad for them, they passed a law in 2009 that gave the FDA more power to regulate tobacco products. In 2016, the FDA said that e-cigarettes were tobacco products, so it started looking over requests to approve millions of new vaping products.
The huge industry claims that the FDA changed the way it was going to review the products in the middle of the process, making companies show through randomized trials that flavored products help smokers quit or cut back on cigarettes more effectively than tobacco-flavored products.
In January, the 5th Circuit Court of Appeals agreed with the industry and said that government officials had pulled a “regulatory switcheroo,” which made it hard for manufacturers to get approval. Similar challenges to the agency’s denials were turned down by seven other appeals courts.
Justice Sonia Sotomayor, who is on the liberal side of the court, wrote a short concurring opinion that seemed to disagree with one part of Alito’s opinion. She said that the FDA wasn’t “having a feeling” about how to review vaping products yet. Instead, it gave the businesses some room to show that their products would be useful.
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 case was sent back to the 5th Circuit to look at a related dispute again. The dispute has to do with marketing plans.
The FDA first asked the companies to show those plans to show how their advertising could stop kids from abusing the products. But the FDA later said it wasn’t going to look at those plans because marketing campaigns in the past had not worked to stop young people from vaping.
There was a technical legal question about whether the appeals court should have sent the denials back to the FDA for more review because of how they handled the marketing plans. Alito wrote that the 5th Circuit took past decisions of the Supreme Court “too literally” to say that the FDA’s choice not to look at the marketing plans was necessarily a mistake in the law.
But Alito also said that the FDA’s argument wasn’t quite right, so the FDA asked the appeals court to “decide the question afresh.” The case might have to go back to the Supreme Court next year because of that small detail.
But vaping companies may have an easier way out of their loss: they can try again with a different administration that might be more open to their case. During the December oral arguments, Justice Brett Kavanaugh pressed both sides on what would happen in real life if the case went 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.”
