Fifth Circuit Schedules Oral Argument in RFA Challenge — A Major Step Forward for Small Vape Businesses

Update 10/23/25: ORAL ARGUMENT IN RFA CASE: DEC. 2, 2025 IN NEW ORLEANS.

The long fight for regulatory fairness just hit an important milestone. The U.S. Court of Appeals for the Fifth Circuit has officially scheduled oral argument in the challenge to the FDA’s PMTA Rule for the first week of December 2025 in New Orleans. 

This is big news. The Court only grants oral argument in roughly 30% of civil cases where both sides are represented by attorneys — and far fewer when you count all cases together. That means at least one judge on the three-judge panel believes the petitioners have raised serious, legitimate questions about the FDA’s handling of the Premarket Tobacco Product Application (PMTA) rule. 

Why This Matters 

For years, small and independent vapor businesses have argued that the FDA’s PMTA process unfairly burdens them while favoring the largest tobacco corporations with massive compliance budgets. The Regulatory Flexibility Act (RFA) was designed to prevent exactly that kind of one-size-fits-all rulemaking — requiring federal agencies to assess and minimize the impact of regulations on small entities. 

In this case, the argument is clear: FDA failed to consider the economic consequences of its PMTA rule on small businesses, despite being required to do so under the RFA. The Court’s decision to hold oral argument signals genuine interest in examining whether the agency overstepped its authority and ignored its obligations to America’s independent vape manufacturers and retailers. 

A Step Toward Accountability 

The upcoming hearing offers an important opportunity to shine a light on how FDA’s refusal to acknowledge small business realities has damaged innovation, entrepreneurship, and adult consumer access to harm reduction products. 

“FDA’s refusal to recognize the small business effects of the PMTA Rule is absurd—and a clear misreading of its obligations under the Regulatory Flexibility Act.” Attorney Jerad Najvar

Chalmers, Adams, Backer & Kaufmann LLC Litigation counsel, USVA 

In short: we’ve cleared a critical hurdle. The Fifth Circuit wants answers, and the FDA will have to defend its actions in open court. 

What’s Next 

The exact date and courtroom details will be released soon. Follow the USVA for updates as they become available. For now, the message is clear — small vapor businesses are being heard. 

This December, the industry heads to New Orleans not just to argue a case, but to stand up for fairness, accountability, and the future of the industry in America. 

Join the USVA here.