Justices hear FDA case on flavored vapes

The Supreme Court on Monday morning heard oral arguments in a challenge to the Food and Drug Administrations rejection of two companies applications to sell fruit-, candy-, and dessert-flavored liquids for use in e-cigarettes. A lawyer for the FDA urged the justices to leave the denials in place, citing the health and addiction risks of the products to 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 agencys prior position.

A federal law, the Family Smoking Prevention and Tobacco Control Act, requires the makers of tobacco products to obtain authorization from the FDA before introducing a new product on the market. To obtain that authorization, a manufacturer must show that marketing the product would be appropriate for the protection of the public health a standard that requires the FDA to consider the 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 begin 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, Crme 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, contending that the use of flavored liquids makes young people more likely to use e-cigarettes and, eventually, tobacco. The FDA had not, it said, found any evidence that the fruit- and candy-flavored e-liquids would provide a benefit to adults who already smoke.

The U.S. Court of Appeals for the 5th Circuit set aside the FDAs orders denying permission to market the 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, only to then ignore those instructions and deny authorization while imposing new requirements.

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

Justice Clarence Thomas pushed back against that argument, telling Gannon that Triton and Vapetasia insist that the guidance provided by the FDA was a moving target. Either the agencys instructions werent clear or it changed those instructions midstream, Thomas suggested.

Gannon countered that the companies were aware of the FDAs concerns about the attractiveness of flavored e-cigarettes and e-liquids to young people, and that they would therefore need to show that flavored liquids would provide a benefit to current adult smokers. But the data simply didnt support their claims, he maintained.

The courts liberal justices clearly agreed with Gannon. Justice Ketanji Brown Jackson pointed to what she characterized as announcements by the FDA, made before Triton and Vapetasia submitted their applications, about the significance of flavors.

Justice Elena Kagan echoed Jacksons point, in even more detail. I guess Im not really seeing what the surprise is here, she said to Eric Heyer, who represented the vaping companies. The companies applications show that they were aware of the FDAs concerns about flavored e-cigarettes and e-liquids, and the countervailing benefit would be getting adults to stop smoking. But the FDA in the end concluded that, based on the evidence that the companies had submitted, it was not convinced.

Justice Sonia Sotomayor also agreed. The FDA did not indicate, she told Heyer, that a particular kind of study was required. Instead, she continued, it said only that it would be helpful to have if the companies provide other evidence, and it determined that the evidence that they did provide wasnt sufficient. Im still at a loss as to how thats a change in position, she said.

Justice Brett Kavanaugh at times also appeared sympathetic to the agency. If the FDA says that the evidence doesnt outweigh the harm to young people, he observed to Heyer, thats kind of the end of it, isnt it? The companies may disagree with Congresss decision in the Family Smoking Prevention and Tobacco Control Act to give the FDA discretion to make these kinds of determinations, and they may disagree with how the FDA balanced the risks and benefits in this case, he said, but where is the legal error?

Heyer told Kavanaugh that the error was the FDAs 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 that it now says are required.

But Kavanaugh remained skeptical about what he described as the real world impact of such a ruling, noting that the companies could also simply reapply for authorization to sell their e-cigarette liquids. How would that be any different from what the companies are seeking now, he asked?

Heyer told Kavanaugh that a ruling reinstating the denial orders would be punitive for Triton and Vapetasia. The FDA, he stressed, is taking as long as three or four years to rule on applications for authorization to sell new tobacco products. His clients, Heyer said, cant afford to wait that out.

Justice Samuel Alito was more open to the companies arguments. He pressed Gannon on the kind of evidence that, in the FDAs view, the companies could have offered. When Gannon explained that the companies needed to provide sufficient scientific evidence to show that flavored e-cigarettes will lead to reduced use of conventional cigarettes by current adult smokers, Alito summarized his view of the FDAs position: You may succeed if you have two specific kinds of scientific studies. Its possible that you may succeed with something else, but were not going to tell you what that would be.  

Gannon also urged the justices to reverse the 5th Circuits ruling that the FDA should have considered the companies marketing plans, which outlined restrictions that would have moderated the risks from e-cigarette products, such as verifying the age of purchasers through online sales. Even if the FDA made a mistake, Gannon told the justices, that error was harmless because the agency has already concluded that the marketing restrictions wouldnt have made any difference in keeping these products out of the hands of minors. Sending the case back to the FDA for it to reconsider this same issue, Gannon said would not accomplish anything because the FDA has already revealed what it would have done here.

Justice Neil Gorsuch appeared to agree, suggesting to Heyer that it was pretty obvious what will happen on remand with regard to the marketing plans.

But other justices were not necessarily convinced. Chief Justice John Roberts observed that the courts usual practice when the agency makes a mistake is to send the case back so that the agency can deal with it.

Justice Amy Coney Barrett asked Gannon whether, even if the justices had a pretty high degree of confidence that agency would decide the marketing question the same way, the courts cases might nonetheless require it to send the case back to the FDA.  

Gannons response that it would not impose a big burden for the FDA to review Triton and Vapetasias applications again prompted Barrett to observe that the harmless-error question 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.

Toward the end of Heyers time at the lectern, Barrett sought to distill his argument. Is your position, she queried, that the FDAs change in position is clear, and thats all we would need to decide for you to win?

Heyer answered that it was, but its not clear whether there are five justices that agree with him.

This article was originally published at Howe on the Court.