In a landmark decision, the Fifth Circuit Court of Appeals has ruled 10-6 against the FDA's handling of PMTA applications, delivering a blistering critique of the agency's regulatory approach.
The Fifth Circuit Court of Appeals has delivered a resounding victory for Triton Distribution and the vaping industry. In a 10-6 en banc decision, the court found that the FDA acted "arbitrarily and capriciously" in denying our PMTA applications.
A Historic Ruling
This decision represents one of the most significant administrative law rulings in recent memory. Writing for the majority, Judge Andrew S. Oldham did not mince words about the FDA's conduct:
"Over several years, the Food and Drug Administration sent manufacturers of flavored e-cigarette products on a wild goose chase."
The court's 52-page opinion delivered a blistering critique of how the FDA handled the PMTA review process, particularly for flavored e-liquid manufacturers like Triton Distribution.
The "Surprise Switcheroo"
Central to the court's decision was the finding that the FDA engaged in what the judges called a "surprise switcheroo"—changing the rules for PMTA approval after manufacturers had already submitted their applications.
The court found that:
- FDA guidance documents suggested certain evidence would be sufficient
- The agency then rejected applications for lacking evidence never clearly required
- FDA failed to consider the marketing plans that manufacturers submitted
- The agency did not properly weigh evidence of harm reduction benefits
"The FDA's actions represent a regulatory 'bait and switch' of the highest order."
Literary Flair in Legal Language
In an unusual move, Judge Oldham's opinion included literary references to emphasize the court's points. Referencing Shakespeare's Romeo and Juliet, the opinion noted that labels alone cannot substitute for substantive regulatory fairness—a rose by any other name, after all.
Implications for the Industry
This ruling has far-reaching implications:
- For Triton Distribution: The MDOs denying our products have been vacated
- For the Industry: Other manufacturers may cite this precedent in their own cases
- For Regulatory Practice: Agencies must provide clear, consistent guidance
What Happens Next
While we celebrate this victory, we recognize the FDA may seek further review. We remain prepared to continue defending our position and our products. Our commitment to regulatory compliance and consumer safety has never wavered.
We thank our legal team, our partners who stood with us, and the court for recognizing that fair regulatory treatment is not just expected—it's required.