RegWatch by RegulatorWatch.com
Aug 22, 2026 · 32 min · 8 segments
After years of bruising court battles, the U.S. vaping industry has finally scored a major win against the U.S. Food & Drug Administration. The Fifth Circuit ruled this week that FDA violated the…
Eric P. GottingGuest
Brent StaffordHost
The rationale and the holding that the court put forth in that decision applies to the industry as a whole.
Who were the companies, the vaping companies that were involved in this case? So
So the two lead cases were Nickwood and Breeze Smoke, but we also had Vertigo Vapor, White Cloud, VaporMate, Elite Brothers, and American Vapor.
It's a consolidated case, and they consider them all together because they were similar.
So these are the marketing denial orders, or MDOs as we call them, that most people are probably familiar with.
And because of that shortcoming, FDA then issued these MDOs without ever actually reviewing the applications themselves, what we would call full scientific review.
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.
Here are the things you need to consider before that standard was ever applied to us.
And so the court's ruling focused more on the APA part, not the Tobacco Control Act.
The court didn't rule on them, but they're arguments that we will continue making.
One is that it was arbitrary and capricious for FDA to apply the comparative efficacy standard to these particular applications.
And so related to that argument is a broader argument that we have been making and no court has really address this on its face, but that the Tobacco Control Act requires FDA to do a full scientific review.
The rationale and the holding that the court put forth in that decision applies to the industry as a whole.
Who were the companies, the vaping companies that were involved in this case? So
So the two lead cases were Nickwood and Breeze Smoke, but we also had Vertigo Vapor, White Cloud, VaporMate, Elite Brothers, and American Vapor.
It's a consolidated case, and they consider them all together because they were similar.
So these are the marketing denial orders, or MDOs as we call them, that most people are probably familiar with.
And because of that shortcoming, FDA then issued these MDOs without ever actually reviewing the applications themselves, what we would call full scientific review.
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.
Here are the things you need to consider before that standard was ever applied to us.
And so the court's ruling focused more on the APA part, not the Tobacco Control Act.
The court didn't rule on them, but they're arguments that we will continue making.
One is that it was arbitrary and capricious for FDA to apply the comparative efficacy standard to these particular applications.
And so related to that argument is a broader argument that we have been making and no court has really address this on its face, but that the Tobacco Control Act requires FDA to do a full scientific review.
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