Supreme Court wrestles with FDA’s attempt to curb access to flavored vapes

By John Fritze, CNN

(CNN) — The Supreme Court on Monday pressed the Food and Drug Administration on whether it followed the law in its effort to keep flavored e-cigarettes off shelves, weighing a lawsuit from a multibillion-dollar industry that has come under scrutiny because its products are popular with school-aged children.

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

Public health advocates have been sounding the alarm in recent 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.

At issue were a series of 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 appeal is also entangled with broader political pressures – President-elect Donald Trump, for instance, recently vowed 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 curtail.

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

“Either they weren’t clear or you changed the guidance as time went on,” Thomas said.

Curtis Gannon, a deputy solicitor general representing the FDA, disputed that framing 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 the agency told the vaping industry that they might be able to present some evidence of public health benefit to win approval but that “we’re not going to tell you concretely what that something else might be.”

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

“You agree that, at the end of the day, the agency has to make a choice and it’s going to be a choice with uncertainty?” Kavanaugh asked the lawyer arguing for the companies.

The court’s three-justice liberal wing appeared to be on the side of the agency.

“We know nicotine is addictive. You put it in to addict people,” Justice Sonia Sotomayor said. “Presumably, you put it in to addict adults and children.”

The vaping industry says its nicotine-delivering products help Americans transition off cigarettes and that the dessert-themed flavors are attractive to adults.

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

But Justice Elena Kagan, a member of the court’s liberal bloc, said that it was exceedingly clear that the federal regulators were skeptical about the stated health benefits of vaping. Given that, she said, it would have made sense for the industry to present as much evidence as it possibly could to win approval.

“There’s just not a lot of mystery here about what FDA was doing,” Kagan said.

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 vaping products.

The industry says that the FDA changed its method in the middle of the process, requiring companies to show that flavored products are more effective than tobacco-flavored products at helping smokers quit or cut back on cigarettes.

The conservative 5th US 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” in to get approval.

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

The case is one of several pending before the Supreme Court that faces an uncertain future in part because of Trump’s election last month. The former and future president has offered inconsistent guidance on the industry, at one point moving forward with a ban on flavored vaping products only to dial that effort back weeks later.

“We have a new administration coming in,” Eric Heyer, who argued on behalf of the vaping companies, told the justices. “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.”

Denny Henigan, vice president of legal and regulatory affairs for the Campaign for Tobacco-Free Kids, told CNN that any change by the Trump administration would face legal scrutiny and that FDA officials would need to demonstrate to courts that their changes are also based in science.

“The decisions FDA has been making on flavored e-cigarettes are solidly grounded in the science. There is no question that these flavored products have an enormous appeal to young people,” Henigan said. “We’re hopeful that if the Trump administration revisits this issue it will be clear that these are products that cause great harm to kids are highly addictive.”

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