The FDA has asked the Supreme Court to step into a long-standing appeals process involving Triton Distribution, an e-liquid manufacturer located in Dallas. Despite following the ever-changing Premarket Tobacco Product Application (PMTA) guidelines and submitting mountains of evidence, Triton received a Marketing Denial Order (MDO) from the FDA.
According to regulations issued by the FDA, Triton can no longer legally sell vape products in the U.S. Like many vape manufacturers, Triton has been hit hard by the FDA’s ruling, despite going above and beyond to meet the guidelines. As of today, the FDA has rejected millions of applications and only approved PMTAs for 23 vape products.
In 2021, Triton filed a petition for review, making it one of the first companies to challenge the model of PMTAs and MDOs. Sister company Vapetasia appealed later in the same month, consolidating the appeal.
In January of this year, a federal appeals court voted 10-6 to reverse the MDOs issued to Triton and Vapetasia. The rehearing was en blanc, a rare situation where all active judges on the court weighed in on the case.
The ruling was accompanied by a 52-page report1L. Cayce, “United States Court of Appeals for the Fifth Circuit,” 2024. Accessed: Apr. 03, 2024. [Online]. Available: https://vaping.org/wp-content/uploads/2024/01/bb9i.pd criticizing the logic behind the FDA’s decision, which the judges believe was made “arbitrarily and capriciously.” It reversed a decision made by a three-judge Fifth Circuit panel that ruled against Triton in July 2022.
On top of the reversal, the court also ordered the FDA to review the application process for vape manufacturers.
Onlookers were shocked to see a ruling in favor of a vape manufacturer, rather than the FDA. While many wonder whether the ruling was influenced by e-cigarette lobbyists with vested interests, Judge Oldham is adamant that the ruling is just.
In the report, Oldham wrote that the FDA tends to send e-cigarette manufacturers “on a wild goose chase.” He went on to say the FDA advises manufacturers to compile and submit their future marketing plans, with the “false promise that a flavored-product manufacturer could, at least in theory, satisfy the FDA’s instructions.”
The decision to reverse the MDO does not appear to be influenced by pro-vape sentiments, but rather by a desire for the FDA to be more transparent. This is not the first time the FDA has come under fire for its methods. Just last month, I reported on PMTA Registry Bills, a new and (unsurprisingly) senseless reformulation of the current PMTA application route.
In more recent news, the FDA has asked the Supreme Court to review the ruling. On the 19th of March, U.S. Solicitor General Elizabeth Prelogar filed the petition for a writ of certiorari. The petition will only be discussed in the Supreme Court if at least four Supreme Court Justices agree that there is sufficient public importance.
Regardless of the Supreme Court’s decision, I suspect that Triton’s perseverance will empower other e-liquid and e-cigarette manufacturers to pursue legal recourse. Bidi Vapor and IVPS Technology are just two of the manufacturers currently appealing against MDOs.
