Judges hear FDA case over flavored vapes

ARGUMENT ANALYSIS

The Supreme Court heard oral arguments Monday morning in a challenge to the Food and Drug Administration’s denial of two companies’ applications to sell fruit-, candy- and dessert-flavored liquids for use in e-cigarettes. A lawyer for the FDA urged the judges to leave the denials in place, citing the health and addiction risks of the products for young people. The attorney representing the vape companies complained that the agency had “misled” his clients and that the denial was a “massive sea change” from the agency’s previous position.

A federal law, the Family Smoking Prevention and Tobacco Control Act, requires manufacturers of tobacco products to obtain approval from the FDA before introducing a new product to the market. To obtain this authorization, a manufacturer must show that marketing the product will be “appropriate to protect public health”—a standard that requires the FDA to consider “risks and benefits to the population as a whole,” including both the likelihood that people , who currently use tobacco products, will stop using them, and the chance that people who do not use them will start to do so.

The two companies involved in the case before the Supreme Court, Triton Distribution and Vapetasia, applied to the FDA for permission to market flavored liquids for use in e-cigarettes. Their products include the flavors “Rainbow Road,” “Crème Brulee,” and “Jimmy the Juice Man Peachy Strawberry.”

The FDA rejected both companies’ applications. It pointed to the “known and substantial risk” to young people from flavored e-cigarette products, and argued that the use of flavored liquids makes young people more likely to use e-cigarettes and ultimately tobacco. The FDA had not, it said, found any evidence that fruit- and candy-flavored e-liquids would provide a benefit to adults who already smoke.

The US Court of Appeals for the 5th Circuit overturned the FDA’s orders denying permission to market e-liquids. It characterized the FDA as pulling a “regulatory switcheroo”: The agency, in its view, had given Triton and Vapetasia specific instructions that they followed, then ignored those instructions and denied approval while imposing new requirements.

Representing the FDA at the Supreme Court on Monday, Deputy Attorney General Curtis Gannon told the justices that the FDA had done no such thing. Triton and Vapetasia had not been “unfairly surprised” by the rejection, he claimed. The agency had simply rejected their applications because they had not provided enough evidence to support their claims that flavored e-cigarettes are essential in getting adults to switch from conventional cigarettes to e-cigarettes, which also contain nicotine and toxins , but exposes users to fewer toxic chemicals than traditional tobacco smoking.

Judge Clarence Thomas pushed back against that argument, telling Gannon that Triton and Vapetasia insist the guidance from the FDA was a “moving target.” Either the agency’s instructions weren’t clear or it changed those instructions midway, Thomas suggested.

Gannon countered that the companies were aware of the FDA’s concerns about the appeal of flavored e-cigarettes and e-liquids to young people, and that they would therefore have to show that flavored liquids would be of benefit to current adult smokers. But the data simply did not support their claims, he maintained.

The court’s liberal justices clearly agreed with Gannon. Judge Ketanji Brown Jackson pointed to what she characterized as announcements by the FDA, made before Triton and Vapetasia submitted their applications, “about the importance of taste.”

Justice Elena Kagan echoed Jackson’s point in even more detail. “I guess I don’t really see what the surprise is here,” she told Eric Heyer, who represented the vaping companies. The companies’ filings show they were aware of the FDA’s concerns about flavored e-cigarettes and e-liquids, and the countervailing benefit would be getting adults to quit smoking. But the FDA ultimately concluded that, based on the evidence presented by the companies, it was not convinced.

Justice Sonia Sotomayor also agreed. The FDA did not indicate, she told Heyer, that a particular type of study was required. Instead, she continued, it said only that it would be “helpful” if the companies provided other evidence, and it ruled that the evidence they provided was not sufficient. “I’m still at a loss as to how it’s a change in position,” she said.

Justice Brett Kavanaugh also appeared sympathetic to the agency at times. If the FDA says the evidence doesn’t outweigh the harm to young people, he noted to Heyer, “that’s kind of the end of it, isn’t it?” The companies may disagree with Congress’s decision in the Family Smoking Prevention and Tobacco Control Act to give the FDA discretion to make these kinds of decisions, and they may disagree with how the FDA balanced the risks and benefits in this case, he said, “but where is that legal error?”

Heyer told Kavanaugh that the mistake was the FDA’s change in position. When the FDA changes its position, as it did in this case, Heyer argued, it needs to acknowledge that change and give applicants like Triton and Vapetasia a chance to conduct the studies it now says are necessary.

But Kavanaugh remained skeptical of what he described as the “real world” impact of such a ruling, noting that the companies could also simply apply for permission to sell their e-liquids. How would that be different from what companies are looking for now, he asked?

Heyer told Kavanaugh that an order reinstating the denial orders would be “punitive” for Triton and Vapetasia. The FDA, he emphasized, takes as long as three or four years to rule on applications for authorization to sell new tobacco products. His clients, Heyer said, “can’t afford to wait.”

Justice Samuel Alito was more open to the companies’ arguments. He pressed Gannon on the kind of evidence the companies believed the FDA could have offered. When Gannon explained that the companies would have to provide “sufficient scientific evidence” to show that flavored e-cigarettes will lead to reduced use of conventional cigarettes by current adult smokers, Alito summed up his view of the FDA’s position: “You can succeed if you has ” two specific kinds of scientific research. “It’s possible that you could be successful with something else, but we’re not going to tell you what it would be.”

Gannon also urged the justices to overturn the 5th Circuit’s ruling that the FDA should have considered the companies’ marketing plans, which outlined restrictions that would have moderated the risks of e-cigarette products, such as verifying the age of buyers through online sales. Even if the FDA made a mistake, Gannon told the justices, that mistake was harmless because “the agency has already concluded that the marketing restrictions would have made no difference in keeping these products out of the hands of minors.” When he sent the case back to the FDA to reconsider the same issue, Gannon said nothing would be achieved because the FDA “has already revealed what it would have done here.”

Judge Neil Gorsuch appeared to agree, suggesting to Heyer that it was “pretty obvious what’s going to happen on remand in terms of the marketing plans.”

But other judges were not necessarily convinced. Chief Justice John Roberts noted that the court’s usual practice when the agency makes a mistake is to send the case back for the agency to consider.

Judge Amy Coney Barrett asked Gannon whether, even if the justices had a “fairly high degree of confidence that the agency would decide the marketing issue the same way,” the court’s proceedings could nonetheless require the case to be sent back to the FDA.

Gannon’s response — that it would not impose a “huge burden” on the FDA to review Triton and Vapetasia’s applications again — prompted Barrett to observe that the issue of harmless error was a “pretty low-stakes” issue.

Gannon resisted slightly, emphasizing a desire to avoid what he characterized as an “endless game of ping pong” between the courts and the agency.

Towards the end of Heyer’s time at the rostrum, Barrett sought to distill his argument. Is your position, she asked, that the FDA’s change in position is clear and “that’s all we need to decide you win”?

Heyer responded that it was, but it is not clear whether there are five justices who agree with him.

This article was originally published on Howe on the Court.