The FDA has asked the Supreme Court to review the Fifth Circuit Court’s decision against the agency in the Triton Distribution appeal. If the court accepts the FDA’s petition, it could forever alter the agency’s premarket review process—or it could validate the FDA’s current practices.
In January, the Fifth Circuit ruled 10-6 for Triton in a rare en banc rehearing of the company’s MDO appeal. The decision overturned a 2022 decision by a three-judge panel of the same court. In the 2024 decision, Fifth Circuit Judge Andrew S. Oldham harshly criticized the FDA, referring to the premarket review process as a “wild goose chase.”
Triton, an e-liquid manufacturer formally known as Wages & White Lion Investments, LLC, filed a petition for review of its FDA marketing denial order (MDO) on Oct. 6, 2021—one of the first companies to challenge a denial order. The Triton appeal was consolidated with sister company Vapetasia’s appeal that same month. Dozens of vape manufacturers have since challenged MDOs in federal courts.
The petition for a writ of certiorari was filed today by U.S. Solicitor General Elizabeth Prelogar, the Justice Department’s supervisor of litigation, on behalf of the Department of Health and Human Services and the FDA. The Justice Department represents federal agencies in court.
To be accepted for review, four of the nine Supreme Court justices must agree to grant the writ. The high court accepts very few cases each year—just two to four percent of the petitions submitted. But there has been serious speculation recently that the court could accept a vaping appeal soon. With three circuit courts now having ruled fully or partially against the FDA, enough of a “circuit split” exists that the Supreme Court is likely to want to step in and address the issues.
Two other Supreme Court petitions were filed recently by Magellan Technology and Lotus Vaping Technologies. The FDA petition asks the court to hold those appeals pending resolution of the Triton case.
In February, the Fifth Circuit granted a motion from R.J. Reynolds to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (for Vuse Vibe, Solo and Alto models) “pending resolution of any further proceedings” in the Triton case, “including potential proceedings before the United States Supreme Court.”
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