The U.S. Supreme Court has agreed to hear the FDA's appeal of the Fifth Circuit's landmark ruling. This decision will set critical precedent for regulatory agency fairness.
The U.S. Supreme Court has granted certiorari in FDA v. Wages and White Lion Investments, LLC—the case stemming from Triton Distribution's challenge to the FDA's PMTA denial orders. The nation's highest court will now weigh in on fundamental questions of regulatory fairness.
The Supreme Court Accepts the Case
On July 2, 2024, the Supreme Court agreed to review the Fifth Circuit's landmark ruling in our favor. This decision elevates what began as a dispute over e-liquid applications into a case with potentially broad implications for administrative law.
The Legal Questions at Issue
The Supreme Court will consider whether the FDA acted arbitrarily and capriciously when it:
- Changed its evidentiary requirements after applications were submitted
- Failed to provide fair notice of what evidence would be required
- Ignored manufacturers' marketing plans designed to prevent youth access
- Applied inconsistent standards across different applicants
"This case is about more than e-liquids. It's about whether government agencies must play by the rules they set, or whether they can change those rules midstream without consequence."
What This Means for the Industry
The Supreme Court's decision to take this case signals the importance of the issues involved. Regardless of the outcome, the ruling will likely affect:
- Administrative Law: How agencies must communicate regulatory requirements
- Due Process: What constitutes fair notice in regulatory proceedings
- Reliance Interests: Whether companies can trust agency guidance
Industry Support
We are not alone in this fight. Multiple industry groups and trade associations have indicated they may file amicus briefs supporting fair regulatory treatment. The case has attracted attention from legal scholars and regulatory experts across the political spectrum.
Timeline and Next Steps
The Supreme Court has set a briefing schedule, with oral arguments expected in December 2024. We anticipate a decision by spring 2025.
We remain confident in the strength of our position and the principles of regulatory fairness that underpin our case. Triton Distribution has always been committed to compliance—but compliance requires knowing what the rules actually are.
We will continue to keep our partners and the public informed as this historic case proceeds.