12/07/2025
Praying for a win!
Just settled in Washington DC, preparing to explain to a panel of the D.C. Circuit tomorrow morning why FDA's entire civil money penalty regime for to***co products violates the Seventh Amendment right to a jury trial. This is the first case to reach argument in a federal circuit court seeking to apply the Supreme Court's Jarkesy decision in the context of "to***co product" enforcement by FDA.
This will be the third oral argument I've had the privilege of presenting in federal circuit courts in 2025. I argued a First Amendment case against Houston (attorneys fee issue) and another case against FDA (USVA's challenge to the PMTA rule under the Regulatory Flexibility Act) in the Fifth Circuit, back in August and then Dec. 2, respectively. It is an honor to have the confidence of my clients and the opportunity to present our arguments at this level.
I'm looking forward to the argument tomorrow, and for a victory for the va**ng industry, especially the small business v**e shops and manufacturers, which have been unfairly maligned and misunderstood for years. If we get the court to understand why FDA cannot constitutionally impose debilitating civil fines through its in-house administrative court system, it will be a landmark victory, and I think will be an inflection point that will force the agency to start thinking more clearly about what enforcement in this industry should look like.
I'll give some substantive reaction to both arguments against FDA (in the Fifth and DC Circuits) later this week.
