Not Over Yet: SCOTUS to Rule on Triton v FDA

Earlier this week, the Supreme Court heard oral arguments in the case of FDA v. Wages and White Lion Investments, L.L.C. - a landmark case pitting one of the largest vapor product distributors in the United States against the Food and Drug Administration (“FDA”). Wages and White Lion Investments, L.L.C. (Triton Distribution), (hereinafter referred to as “Triton”) sought to uphold the decision made in the 5th Circuit Court of Appeals. The lower court argued that the FDA improperly issued broad Marketing Denial Orders (“MDO”) for flavored vapor products without conducting a thorough review. The FDA contends that there is insufficient scientific evidence showing a connection between flavored vapor products and smoking cessation. Triton claims that the regulatory agency repeatedly changed its criteria during the approval process, which jeopardizes the harm reduction industry.

Eric Heyer represented Triton, while Deputy Solicitor General Curtis Gannon fought for the FDA. Both saw some support and contention from the Justices, leaving the decision mostly up in the air by the end of the proceeding. Justice Clarence Thomas pushed back against the agency, while Gannon argued that the Denial Orders came as no surprise, Thomas agreed that the instructions issued to Triton were either unclear or changed in process. Justice Ketanji Brown Jackson, on the other hand, said to Heyer “I guess I’m not really seeing what the surprise is here,” pointing to prior publications made by the FDA in regards to flavored vaping products.

When Justice Brett Kavanaugh argued for the FDA, calling for re-application from the vapor company, Heyer argued that the resulting Marketing Denial Orders would be punitive. These tobacco product applications, after all, are taking 3-4 years to process, and vapor companies cannot afford to wait that out in an already established industry.

Justice Amy Coney Barrett, in a pivotal moment, asked Heyer if the Court’s recognition of the FDA’s sudden change in positions would be all he needed to win. Heyer answered in the affirmative, but it remains to be seen whether the majority of Justices will see things the same way. The Supreme Court is expected to rule on this case in the coming months.