Supreme Court challenges FDA attempt to limit access to flavored vapes

() – On Monday, the Supreme Court pressed the U.S. Food and Drug Administration on whether it followed the law in its effort to keep flavored electronic cigarettes off the shelves, weighing a lawsuit from a multibillion-dollar industry that has come under scrutiny because its products are popular with schoolchildren.

After more than an hour of oral arguments, the agency appeared to have support from the court’s three-member liberal bloc and possibly some of its conservatives as well, at least for a limited outcome that could give the incoming Trump administration the opportunity to review the FDA’s actions to block flavored vaping products.

In recent years, public health advocates have raised the alarm about a rise in vaping among young Americans. The FDA reported that 19% of high school students and 4.7% of middle school students vaped in 2020, a much higher proportion than students who smoked cigarettes.

At stake was a series of denials during the first year of the Biden administration for vaping products that officials say target minors with flavors like “Pink Lemonade,” “Rainbow Road” and “Jimmy the Juice Man.” “Peachy Strawberry.”

The appeal is also entangled with broader political pressures (President-elect Donald Trump, for example, recently promised to “save vaping” ), as well as a debate over the power of federal agencies that the court’s 6-3 conservative supermajority has repeatedly sought to restrict.

At least some of the court’s conservatives were concerned about the way the FDA reviewed companies’ marketing applications, questioning whether regulators had changed the type of evidence of health benefits required for approval. approval. In describing the industry’s argument, conservative Justice Clarence Thomas suggested that the method the FDA used was “a moving target.”

“They either weren’t clear or changed the guidelines as time went on,” Thomas said.

Curtis Gannon, a deputy attorney general representing the FDA, disputed that interpretation and said the law itself was clear about what evidence the agency required.

Conservative Justice Samuel Alito more directly questioned the FDA’s review process, suggesting that the agency told the vaping industry that they could present some evidence of public health benefit to gain approval, but that “we’re not going to tell them.” specifically what that something more could be.”

But Justice Brett Kavanaugh, another member of the court’s conservative wing, repeatedly signaled that he might support the FDA.

“Do you agree that, at the end of the day, the agency has to make a decision and it will be a decision with uncertainty?” Kavanaugh asked the lawyer defending the companies.

The court’s three-judge liberal wing appeared to side with the agency.

“We know that nicotine is addictive. We give it to addicts,” said Justice Sonia Sotomayor. “Presumably we give it to addicted adults and children.”

The vaping industry says its nicotine-delivering products help Americans quit cigarettes and that dessert-themed flavors appeal to adults.

The industry has argued that the FDA violated federal law by changing rules on how products were evaluated.

But Justice Elena Kagan, a member of the court’s liberal bloc, said it was abundantly clear that federal regulators were skeptical about the claimed health benefits of vaping. Given that, he said, it would have made sense for the industry to present as much evidence as possible to gain approval.

“There’s not much mystery to what the FDA was doing,” Kagan said.

In 2009, Congress recognized the harm smoking causes among youth and passed a law giving the FDA new powers to regulate tobacco products. In 2016, the FDA decided that e-cigarettes were considered tobacco products and began reviewing authorization applications for millions of vaping products.

The industry says the FDA changed its approach midway through the process, requiring companies to show that flavored products are more effective than flavored tobacco products in helping smokers quit or reduce cigarette consumption.

In January, the conservative U.S. Court of Appeals for the Fifth Circuit sided with the industry and concluded that officials had perpetrated a “regulatory change,” sending manufacturers on a “futile quest” to gain approval.

Seven other appeals courts have rejected similar challenges to the agency’s denials.

The case is one of several cases pending before the Supreme Court that face an uncertain future in part because of Trump’s election last month. The former president and future president has offered inconsistent guidance on the industry, at one point moving forward with a ban on flavored vaping products but then backtracking on that initiative weeks later.

“We have a new administration on the way,” Eric Heyer, who presented arguments on behalf of the vaping companies, told the judges. “The president-elect has publicly said, ‘I’m going to save flavored vapes.’ “We don’t know exactly what that will look like.”

Denny Henigan, vice president of legal and regulatory affairs at the Campaign for Tobacco-Free Kids, told that any changes by the Trump administration would face legal scrutiny and that FDA officials would have to prove in court that their changes would also They are based on science.

“The decisions the FDA has made regarding flavored e-cigarettes are solidly based on science. There is no doubt that these flavored products have enormous appeal to young people,” Henigan said. “We are hopeful that if the Trump administration addresses this issue again, it will become clear that these products cause great harm to children and are highly addictive.”