This week, something pretty significant went down in the ongoing fight over vaping regulation in the United States. The U.S. Court of Appeals for the Fifth Circuit heard arguments in a consolidated case involving seven independent vape companies challenging the FDA’s widespread denial of flavored e-liquid applications.
If you’ve been following the PMTA mess at all, this is one of those cases that could have real ripple effects across the entire industry.
The Short Version
These companies are fighting back against the FDA’s Marketing Denial Orders (MDOs) — essentially the agency telling them they cannot legally sell their flavored products.
At the heart of the case is a simple but massive question:
Did the FDA change the rules after companies already submitted their applications?
What the Companies Are Arguing
The vape companies claim the FDA pulled a bit of a bait-and-switch.
According to them:
- They followed the guidance that was available at the time
- Submitted extensive PMTAs
- Then got denied based on standards that weren’t clearly communicated upfront
Specifically, they argue the FDA required evidence that flavored products help adult smokers quit better than tobacco-flavored options — something they say was never clearly spelled out beforehand.
This “hidden standard” issue came up repeatedly during arguments. Coverage from the hearing highlighted judges pressing the FDA on whether companies were given a fair shot:
https://www.courthousenews.com/fifth-circuit-grapples-with-flavored-vape-regulations
What’s Different About This Case
This appeal zeroes in on procedural issues:
- Were the rules clear?
- Were companies judged by standards that weren’t formally established?
- Did the FDA fairly evaluate the evidence that was submitted?
There’s also increasing attention on whether the agency effectively created unwritten rules during the review process:
No matter how this shakes out, it’s another reminder that the future of vaping in the U.S. is being decided as much in courtrooms as it is in labs or legislation.
And right now, all eyes are on the Fifth Circuit.
I’ll be keeping a close eye on this one as it develops.