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July 2, 20240

Supreme Court Will Hear Triton Appeal

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Jim McDonald

The Supreme Court has agreed to review a lower court decision that found the FDA acted improperly when it denied marketing applications by Texas-based vape manufacturer Triton Distribution. The FDA petitioned the high court to accept the case.

The decision to hear the case marks the first time the Supreme Court will consider a challenge to the fairness of the FDA’s vaping regulations. The court has previously declined to consider several vaping industry petitions.

The nine Supreme Court justices discussed the FDA-Triton petition—and petitions in three related cases—at its final conference of the current term yesterday. (Legal sources say the other cases will probably be held in abeyance (put on hold) until the Triton case is decided.)

The court will hear oral arguments in the fall from lawyers for Triton and the FDA, and rule on the appeal in 2025. How the court decides will have a profound impact on the future of vaping and nicotine use in the United States.

“Triton looks forward to having the Supreme Court review FDA’s surprise, after-the-fact imposition of new study requirements and failure to follow its own guidance for applicants for marketing authorization for flavored ENDS products,” said Triton attorney Eric Heyer after the announcement.

Chevron deference and vaping

The decision to hear the Triton case comes just four days after a long-anticipated Supreme Court ruling ended so-called Chevron deference—the doctrine that forced courts to give federal agencies the benefit of the doubt when challenged in court regarding their interpretations of ambiguous laws. Several courts have ruled against vaping businesses and in favor of the FDA, based on Chevron deference.

Both the Supreme Court’s future Triton decision and the overturning of Chevron deference could have major impacts on other vape industry legal challenges, and could even force the FDA to modify its regulatory processes.

Triton vs. FDA: a brief history

Triton Distribution—known in court documents as Wages & White Lion Investments, LLC—filed a petition for review of the FDA marketing denial order (MDO) the company received in October 2021 in the Fifth Circuit Court of Appeals. 

The Triton appeal was soon consolidated with sister company Vapetasia’s appeal, and the companies were granted a stay by a Fifth Circuit three-judge panel, in which Judge Andrew S. Oldham called the FDA’s shifting regulatory standards a “surprise switcheroo.”

However, Triton then lost in a 2-1 decision by a merits panel in 2022. Triton asked the court for a rehearing, and the Fifth Circuit granted Triton a rare en banc rehearing of its appeal.

In January 2024 the full court found 10-6 in favor of Triton.

The circuit court blasted the FDA in the decision, calling the agency’s premarket review process a “wild goose chase,” and finding it had acted “arbitrarily and capriciously” and violated the Administrative Procedure Act when it rejected Triton’s premarket tobacco product applications (PMTAs).

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Jim McDonald

Vaping since: 13 years

Favorite products:

Favorite flavors: RY4-style tobaccos, fruits

Expertise in: Political and legal challenges, tobacco control haters, moral panics

Jim McDonald

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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