FDA Urges Supreme Court to Reconsider Triton Decision

The FDA has requested a review of the Fifth Circuit Court's ruling versus the agency in the Triton Distribution appeal by the Supreme Court. Should the court grant the FDA's petition, the premarket review procedure at the agency may be permanently changed, or the agency's present procedures might be upheld.

In January, Triton won an unusual en banc reconsideration of their MDO case, with the Fifth Circuit voting 10–6 in favor of the business. A 2022 ruling by a three-judge panel of the same court was reversed by the ruling. Judge Andrew S. Oldham of the Fifth Circuit Court severely chastised the FDA in the 2024 ruling, calling the premarket review procedure a "wild goose chase."

One of the first businesses to contest a denial order was Triton, an e-liquid maker formerly known as Wages & White Lion Investments, LLC, which filed a petition for reconsideration of its FDA marketing denial order (MDO) on October 6, 2021. In the same month, the appeals from sibling firms Vapetasia and Triton were combined. Since then, MDOs have been contested in federal courts by several vape producers.

U.S. Solicitor General Elizabeth Prelogar, the Justice Department's supervisor of litigation, filed the petition for a writ of certiorari today on behalf of the FDA and the Department of Health and Human Services. Federal agencies are represented in court by the Justice Department.

The writ must be approved by four of the nine judges of the Supreme Court in order to be accepted for review. Only two or four percent of all petitions are accepted by the top court each year. However, there have lately been strong rumors that the court would soon hear an appeal from someone who vapes. There is now enough of a "circuit split" amongst the three circuit courts that have decided either entirely or partly against the FDA that the Supreme Court will probably wish to intervene and take up the case.

Recently, Lotus Vaping Technologies and Magellan Technology filed two more Supreme Court petitions . The FDA has petitioned the court to stay those appeals while the Triton case is being resolved.

A motion from R.J. Reynolds to halt the consolidated attraction of MDOs for Vuse menthol refills (for the Vuse Vibe, Solo, and Alto models) was granted by the Fifth Circuit in February. The reason given was that the proceedings would be halted "pending resolution of any further proceedings" in the Triton case, which included possible proceedings before the US Supreme Court.