Supreme Court to hear dispute over FDA rejection of flavored vapes

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The Supreme Court will hear oral arguments on Monday in a dispute over the Food and Drug Administration’s rejection of two companies’ applications to sell flavored liquids for use in e-cigarettes. A federal appeals court in Louisiana set aside the FDA’s orders 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 goose chase.”

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

The law at the center of the case is the Family Smoking Prevention and Tobacco Control Act. Enacted in 2009 to regulate tobacco, it requires authorization from the FDA before a new tobacco product can go on the market. Such authorization requires, among other things, the applicant to show that marketing the product would be “appropriate for the protection of the public health.” The FDA applies that 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 to use them.

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

In 2016, the FDA issued a rule classifying e-cigarette products as “new tobacco products,” which required the manufacturers of those products to apply for approval to continue to sell them.

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

The FDA denied the companies’ applications in 2021, citing the “known and substantial risk to youth” from flavored e-cigarette products. Using flavored liquids, the FDA explained, makes young people more likely to use e-cigarettes and, ultimately, tobacco; by contrast, the FDA concluded, it had not found any evidence that flavored e-liquids would provide a benefit to adult smokers.

Triton and Vapetasia then went to the U.S. Court of Appeals for the 5th Circuit, asking that court to put the denials on hold while they appealed. A three-judge panel granted their motion, but a different three-judge panel ultimately turned down their petition for review.

By a vote of 10-6, the full 5th Circuit reversed. The opinion by Judge Andrew Oldham, often mentioned as a possible nominee for the Supreme Court if a vacancy arises during the second Trump administration, accused the FDA of pulling “regulatory switcheroos.” In the court’s view, the agency gave the manufacturers of e-cigarette products 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 came to the Supreme Court in March, asking the justices to review the 5th Circuit’s decision. The court agreed in July to take up the case.

The FDA emphasizes that under the federal law governing administrative agencies, the 5th Circuit’s only job 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 the agency’s actions to be “reasonable and reasonably explained.”

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

The 5th Circuit was also wrong, Prelogar continues, when it held that the FDA should have considered the companies’ marketing plans, which outlined restrictions that would have mitigated the risks from e-cigarette products – for example, using age-verification technology for online sales and limiting the quantity that can be purchased in a single transaction. Even if that 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 urge the court to leave the 5th Circuit’s ruling in place, calling the FDA’s denials of their applications “quintessential arbitrary agency action.”

Characterizing e-cigarette products as “a less harmful alternative to traditional cigarettes” that do “not involve burning tobacco or inhaling smoke,” the companies tell the justices that their applications included evidence demonstrating that e-cigarette products “help reduce the overall adverse health effects from tobacco products by transitioning current tobacco users to less harmful tobacco products.”

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

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

Last year, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned a landmark decision that had instructed courts that they should generally defer to an agency’s interpretation of an ambiguous statute that it administers as 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 in Loper Bright, a majority of the court continues to be skeptical of agency action more broadly.  

This article was originally published at Howe on the Court. 

 

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