In a legal setback to the regulatory regime surrounding vape pens, the 5th U.S. Circuit Court of Appeals has sided with vape companies challenging the Food and Drug Administration’s (FDA) rejection of its product applications, criticizing the federal agency for sending e-cigarettes makers “on a wild goose chase.”
“Over several years, the Food and Drug Administration sent manufacturers of flavored e-cigarette products on a wild goose chase,” wrote Judge Andrew Oldham, an appointee of President Donald Trump, for the circuit court’s 10–6 majority opinion.
According to Judge Oldham, the FDA first gave vape companies “detailed instructions for what information federal regulators needed to approve e-cigarette products,” essentially creating a “false promise” that their products could, at least in theory, satisfy the FDA’s requirements.
“The agency said manufacturers’ marketing plans would be ‘critical’ to the success of their applications,” the judge wrote, noting that the FDA hosted public meetings and posted hundreds of pages of guidance documents and presentations over the years, many of which are still available for download on its website.
However, after the manufacturers “dutifully spent untold millions” to provide what the FDA required, the agency “turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice,” denied all one million applications, and “admitted that it did not read a single word of the one million plans” that it previously said were “critical.”
FDA’s Arguments
In defense of its behavior, described by the court as “regulatory switcheroos,” the FDA argued that there was no guarantee that any particular submission would be granted. The federal regulator also claimed that, even if it arbitrarily and capriciously denied submissions, that error was harmless.“Today we reject both propositions,” the court’s majority opinion read.
“If men must turn square corners when they deal with the government, it cannot be too much to expect the government to turn square corners when it deals with them,” Judge Oldham wrote, quoting from a 2021 U.S. Supreme Court decision in the case of Niz-Chavez v. Garland.
“No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people. And FDA’s regulatory switcheroos in this case bear no resemblance to square corners,” the judge wrote.
Joining Judge Oldham’s opinion were Chief Circuit Judge Priscilla Richman and Circuit Judge Jennifer Walker Elrod, both appointed by President George W. Bush; Circuit Judges Edith Jones and Jerry Smith, appointed by President Ronald Reagan; and Circuit Judges Don Willett, James Ho, Stuart Kyle Duncan, Kurt Engelhardt, and Cory Wilson, appointed by President Trump.
Dissenting Opinion
According to the dissenting judges, Triton has failed to prove that its products would “so sufficiently assist adults that it would overcome the harm to youth.” Therefore, they said, the FDA was acting reasonably to deny the products’ approval.“E-cigarettes are not safe,” Judge Haynes argued. “Just as being shot in the stomach might be less likely to cause death than being shot in the head, but neither one is wanted, neither e-cigarettes nor cigarettes are safe.”
“Our country is in the throes of a youth vaping epidemic that has reached crisis proportions,” she continued, noting that in 2020, 3.6 million minors in the United States reported using e-cigarettes, including 20 percent of high school students and 5 percent of middle school students.
Circuit Judge James Graves, an Obama appointee, offered a separate dissent that focused on the FDA’s handling of marketing plans submitted by the vape companies. He said it was well within the agency’s right to not review any of those plans.
The latest ruling reversed a 2022 decision by a three-judge 5th Circuit panel. In that 2–1 decision, the panel upheld the FDA’s rejection of Triton’s applications on the merits, over a passionate, 14-page dissent from Judge Jones.
“If this meandering administrative course is not an administrative switcheroo, it is hard to know what is,” she wrote at the time.
In 2022, vape manufacturers were also victorious in the 11th Circuit in suing the FDA for ignoring their marketing plans. In that same year, however, the D.C. Circuit Court found that the FDA’s decision to not review those plans was a “harmless error,” saying that the e-cig makers challenging the agency had “failed to identify how individualized review of the plans they submitted could have made any difference.”
This circuit split could mean that the U.S. Supreme Court might step in and settle the issue, although the high court has shown little, if any, interest in taking up a case challenging the FDA’s denial of vape company applications.
