Fifth Circuit Court Rips FDA, Grants Triton Appeal

In a long-awaited decision, a federal appeals court has reversed the marketing denial orders (MDOs) issued to Triton Distribution and Vapetasia, and ordered the FDA to conduct new reviews of the companies' marketing applications. The en banc panel of judges voted 10-6 to grant the Triton and Vapetasia petitions for review.

In a 52-page decision dripping with sarcasm, 10 judges of the Fifth Circuit Court of Appeals found the FDA acted “arbitrarily and capriciously” when it rejected Triton’s premarket tobacco product applications (PMTAs).

“Over several years, the Food and Drug Administration sent manufacturers of flavored e-cigarette products on a wild goose chase,” wrote Judge Andrew S. Oldham for the majority. Oldham then described the agency’s “wild goose chase” in some detail, before rejecting the FDA’s defense.

“FDA justifies its behavior with two principal arguments,” wrote Judge Oldham. “First, FDA argues that its years’ worth of regulatory guidance was not worth the paper it was printed on because it was hedged with cautious qualifiers and never guaranteed that any particular submission would be granted. Second, and most disturbingly, FDA argues that its capriciousness should be forgiven as harmless because the agency promises to deny petitioners’ applications even if we remand to make the agency follow the law.

“Today we reject both propositions.”

The decision came in a rare en banc rehearing of the case, in which all active judges on the court took part. (One judge joined the court after the case was submitted and sat it out.) Oral arguments were heard on May 16, 2023.

The ruling reversed a 2022 decision against Triton by a three-judge Fifth Circuit panel. That 2-1 opinion shocked observers who expected the court to take the FDA to the woodshed after a previous Fifth Circuit panel had granted Triton a stay, saying the company's appeal was likely to succeed. In the stay opinion, Judge Oldham had ripped the FDA for repeatedly moving the PMTA goalposts, and called the agency’s shifting regulatory standards a “surprise switcheroo.”

Other circuit courts have mostly supported the FDA in MDO appeals, but vape manufacturers prevailed in the Eleventh Circuit, meaning the Supreme Court could soon decide to step in and settle the “circuit split.” There are still multiple MDO appeals in progress in various appeals courts.

The Fifth Circuit is considered the most conservative of the nation’s 13 federal appeals courts. All 10 judges voting in favor of Triton were appointed by Republican presidents, as were three of the dissenters. The other three who voted for the FDA were appointed by Democrats.