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Eric P. Gotting

Eric P. Gotting

Partner at Keller and Heckman LLP, a Washington, DC law firm, specializing in complex civil and appellate litigation and regulatory compliance.

Aug 22, 2026

3:14
What did you argue before the Fifth Circuit?
3:18
So we had a bunch of arguments and obviously our main one was the one that they ruled on, which was that both the Tobacco Control Act and what we call the Administrative Procedure Act, which is a statute that kind of sets forth your rights as a regulated entity, that those two things required FDA before it ever applied the comparative efficacy standard in the way that it did, that checkbox approach, it had to go through notice and comment rulemaking so that industry stakeholders, like the manufacturers, had a chance to comment on that and tell FDA, hey, this is a good thing or not such a good thing.
4:06
Here are the things you need to consider before that standard was ever applied to us.
4:13
And so the court's ruling focused more on the APA part, not the Tobacco Control Act.
4:20
But that was our main argument.
4:21
But we did have other arguments that are still out there.
4:25
The court didn't rule on them, but they're arguments that we will continue making.

11 MINS LATER

15:43
Eric, how important was that lack of notice and the lack of any opportunity to correct the applications to the court's decision?

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