Supreme Court to hear dispute over FDA rejection of flavored vapes

DISCUSSION OF CASE

The Supreme Court will hear oral arguments Monday in a dispute over the Food and Drug Administration’s denial of two companies’ applications to sell flavored liquids for use in e-cigarettes. A federal appeals court in Louisiana set aside the FDA’s rulings denying applications by Triton Distribution and Vapetasia, complaining that the agency had sent those companies and other makers of e-cigarette products “on a wild ride.”

The stakes in the case are high: Medical groups, including the American Medical Association, say youth use of flavored e-cigarettes is a “public health crisis.” Members of the vaping industry counter that such products can help adults quit smoking traditional cigarettes, adding that a ruling against the companies could “decimate the vaping industry.”

The law at the center of the case is the law on smoking prevention and tobacco control for the family. It was enacted in 2009 to regulate tobacco and requires approval from the FDA before a new tobacco product can enter the market. Such approval requires, among other things, that the applicant demonstrates that marketing the product will be “appropriate for the protection of public health.” FDA applies this standard by considering the “risks and benefits to the population as a whole,” including both the chances that people who currently use tobacco products will stop doing so and the prospect that people who do not use tobacco products will start using them.

E-cigarettes, also known as vapes, are battery-powered devices that heat a liquid and produce an aerosol, which the e-cigarette user then inhales. E-cigarettes generally contain nicotine, the addictive ingredient released by burning a traditional cigarette, but without some of the other chemicals released by burning tobacco.

In 2016, the FDA issued a rule classifying e-cigarette products as “new tobacco products,” requiring the manufacturers of these products to apply for approval to continue selling them.

That prompted Triton Distribution and Vapetasia to apply to the FDA for permission to market flavored liquids for use in e-cigarettes. With names like “Rainbow Road,” “Crème Brulee,” and “Jimmy the Juice Man Peachy Strawberry,” the liquids are flavored to taste like fruit, candy, and desserts.

The FDA rejected the companies’ applications in 2021, citing the “known and substantial risk to youth” from flavored e-cigarette products. Use of flavored liquids, the FDA explained, makes young people more likely to use e-cigarettes and ultimately tobacco; The FDA concluded, however, that it had found no evidence that flavored e-liquids would benefit adult smokers.

Triton and Vapetasia then went to the U.S. Court of Appeals for the 5th Circuit, asking that court to stay the denial while they appealed. A three-judge panel granted their motion, but another three-judge panel ultimately denied their request for review.

By a vote of 10-6, the entire 5th Circuit reversed. The opinion by Judge Andrew Oldham, often mentioned as a possible Supreme Court nominee if a vacancy arises under the second Trump administration, accused the FDA of pulling “regulatory switcheroos.” In the court’s view, the agency gave e-cigarette product manufacturers specific instructions that they followed, only to turn around and deny Triton and Vapetasia’s applications (as well as thousands of others), while ignoring those instructions and imposing, without acknowledging it, new requirements.

The FDA went to the Supreme Court in March, asking the justices to review the 5th Circuit’s decision. In July, the court agreed to take up the case.

The FDA emphasizes that under federal law governing administrative agencies, the 5th Circuit’s sole task was to determine whether the agency’s denial of Triton and Vapetasia’s requests to market flavored e-cigarette liquids was arbitrary and capricious—a standard that simply requires , that the agency’s actions be “reasonably and reasonably explained”.

Seven other federal appeals courts hearing similar cases, writes U.S. Solicitor General Elizabeth Prelogar, “have unanimously rejected” such challenges under the “arbitrary and capricious” standard. And notably, Prelogar notes, these courts make clear that the FDA did not change its policies or standards. Instead, although Triton and Vapetasia claimed that flavored e-cigarette products could help adult smokers switch from traditional cigarettes to e-cigarettes, neither company conducted a valid study to support this claim. The FDA did not reject the companies’ applications, Prelogar emphasizes, because they had not provided the studies, but instead because the review of the literature they had provided did not support their scientific claims: The literature showed the risks of flavored e-cigarettes. but did not show sufficient benefits.

The 5th Circuit was also wrong, Prelogar continues, when it ruled that the FDA should have considered the companies’ marketing plans, which outlined restrictions that would have mitigated the risks of e-cigarette products — for example, using age-verification technology for online sales and limiting of the quantity that can be purchased in a single transaction. While it was a mistake by the FDA, Prelogar says, it was a harmless one because the FDA has repeatedly concluded that these kinds of conventional marketing and sales restrictions are not enough to keep e-cigarettes out of the hands of young people.

Triton and Vapetasia are urging the court to let the 5th Circuit’s decision stand, calling the FDA’s denial of their applications “substantial arbitrary agency action.”

Characterizing e-cigarette products as “a less harmful alternative to traditional cigarettes” that “does not involve burning tobacco or inhaling smoke,” the companies told the judges that their filings included evidence showing that e-cigarette products “help reduce the overall negative health effects from tobacco products by shifting current tobacco users to less harmful tobacco products.”

But without any warning to the manufacturers, the companies claim that the FDA “secretly changed its requirements for flavored products,” deciding instead that it “would only approve flavored products if they were more effective than tobacco-flavored products in helping smokers to stop or reduce their use of cigarettes.” Furthermore, they add that the FDA did not give Triton and Vapetasia a chance to amend their applications to try to meet the new requirements.

And despite its suggestions to the contrary, Triton and Vapetasia argue that the FDA’s failure to consider the companies’ marketing plans and restrictions to keep e-liquids out of the hands of young people was not harmless. The FDA never indicated which plans and restrictions it had previously considered and found wanting, they write, so there was no way for the appeals court to know how closely the companies’ plans in this case resembled those plans.

Last year, i Loper Bright Enterprises v. Raimondothe Supreme Court overturned a landmark decision that had instructed courts to generally defer to an agency’s interpretation of an ambiguous statute that it administers, so long as that interpretation is reasonable. Those principles are not at issue in this case, which involves the more deferential “arbitrary and capricious” standard. What remains to be seen is whether in the wake of their decision i Loper Brighta majority of courts remain skeptical of agency actions more broadly.

This article was originally published on Howe on the Court.