And a follow up.
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GREAT linkage @rcleven. A very worthy read …
Backlash Against the FDA Grows as Vape Company Ramps Up Legal Fight
October 21, 2021
On October 20, My Vape Order (MVO) petitioned a federal court of appeals for “an emergency motion for a stay pending a review and for expedited consideration” on the company’s vapor products that have been removed from the market.
In early September, the Food and Drug Administration (FDA) had issued a marketing denial order for MVO’s products. Like all other vape companies in the United States, MVO had until September 2020 to file premarket tobacco product applications (PMTAs) to be able to keep selling its vapes and e-liquids; the FDA, in turn, had until September 2021 to review the PMTAs.
The FDA missed its deadline to make decisions on the biggest vape companies’ products; it has subsequently approved just one. The agency has meanwhile issued marketing denial orders (MDOs) to numerous smaller players—and many of them are now pushing back against a process that has caused widespread anger.
Court documents paint the PMTA process as even more chaotic and unfair than critics have long maintained.
MVO initially filed a petition for review in the Ninth Circuit Court of Appeals at the end of September, as dozens of other vapor companies have done. Most have argued, in part, that the FDA’s denials were “arbitrary and capricious,” and that, in rushing to meet a court-imposed deadline, the agency overlooked vital information. Many manufacturers, too, have repeatedly complained of the FDA shifting its goal posts—and offering guidance on certain studies only after PMTAs had been filed.
As a result, MVO, like many other smaller companies, sits on the brink of financial collapse. “This financial harm is unrecoverable, as FDA, as a federal government agency, enjoys sovereign immunity,” MVO’s lawyers write.
Now, MVO’s attorneys are demanding that the appeals court grant a judicial stay for the company’s denied products by the end of October. In court documents reviewed by Filter , they paint the PMTA process as even more chaotic and unfair than critics have long maintained.
“In preparing and submitting its PMTA, MVO understandably relied on FDA’s many representations, including FDA’s statements that long-term studies would not be required for a successful PMTA,” the petition reads. “Nevertheless, FDA based the MDO on MVO’s purported failure to include long-term comparative efficacy data for its flavored ENDS products versus tobacco-flavored ENDS products in the form of a randomized controlled trial or longitudinal cohort study. In so doing, FDA ignored four randomized controlled abuse liability studies included in MVO’s application and summarily rejected without consideration other observational studies MVO included.”
“FDA’s about-face from its prior representations violates fundamental principles of administrative law,” the document continues.
In the span of a few weeks, between MVO’s original petition and its emergency motion, there’s been a notable development: The FDA rescinded an MDO for Turning Point Brands (TBP) because it identified “relevant information that was not adequately assessed” in the PMTA. TPB, which had petitioned a federal court a few weeks earlier, then withdrew a similar appeal it had filed in a federal court. So far, this has been the only such rescission.
But as it turns out, lawyers for MVO revealed that their client had “collaborated extensively”—“shared studies and data”—with Twelfth State Brands, a CBD and vapor manufacturer, as well as TPB. (Twelfth State’s PMTA remains pending.)
In other words, counsel for MVO is essentially arguing that the company has not received the same treatment as TPB and TSB, even though the applications literally contained some of the same information. As competitors, the logic goes, this does not place them “on a level playing field.” (Through an attorney, MVO declined to comment on the pending litigation.)
The backlash to a derided process, on which millions of former smokers depend, is only growing.
Here’s the bureaucratic nightmare in a nutshell: Following the TPB reversal, as MVO’s lawyers explain, they approached the FDA to indicate that they planned to file an emergency motion for a stay. The agency then signaled that it “would entertain a request by MVO that FDA re-review its PMTA to determine whether a rescission of the MDO like that afforded to [TPB] was appropriate.”
The FDA appeared to want to head off legal action by dangling the prospect of a stay through its own internal procedure. The FDA did eventually grant the administrative stay, but would not define how long its “re-review” could last. Basically, it would be at the whim of the agency. In contrast, a judicial stay, which MVO is now seeking at an expedited pace, would guarantee the company can sell its denied products while its initial lawsuit works its way through the court.
Consumer advocates, vape producers and tobacco harm reductionists have looked to the FDA’s Turning Point Brands reversal as a precedent of sorts. The problem, though, is that TPB’s PMTA is not publicly available, so other manufacturers are left to guess how the company managed to get the agency to backtrack. If My Vape Order’s submissions contained some of the exact same information, that reduces the guesswork. But will it be enough?
It’s still unclear if the FDA will rescind any other MDOs. The extent to which other manufacturers may have shared PMTA information with each other is also unknown. But if some companies received MDOs on the basis of data that was also used by companies that didn’t get denied, how and why did this happen?
What is clear is that the PMTA saga is far from over—and that the backlash to a derided process, on which millions of former smokers depend, is only growing.
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It seems like the Cort of appeal has granted a stay.
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Thank you @rcleven translated and made my comments on my italian blog, so the italian readers can go there… and have a laugh! maybe.
I read the sentence, great judges!
They told Bloomberg and friends to F.O… told FDA: I can do what I want and not submitted to your whims. I love them… read the sentence, just the first page is enough to make you laugh…
Anyway, even if doesn’t “touch” EU is right to fight together and let people know what’s going on in the US:
https://dalla-foglia-al-tank.blogspot.com/2021/10/le-corti-dappello-statunitensi.html
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Thank you Frank. Our FDA has become a bully. Stay on top of this please. From what I have seen thru out the free world when the US catches a cold the free world sneezes.
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Defnitely going through this, started to do that since those stupid MDOs and guidelines changing to justify the fact that they were simply overwhelmed by the applications and couldn’t do the job…
plus something that people don’t talk about, like the “Youth epidemic” statistics…
and things like that, you’re bloody right, that we have to be careful, EU has the bad habit of copy/paste everything that the US does, still don’t understand why they copy the bad things, not the good… nevermind.
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The Triton stay explained a little better.
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Man, judge smacked the FDA so hard, absolutely beautiful. I can’t believe the FDA legal team had the balls to say the court doesn’t have the power to compell the FDA, boy were they wrong. 
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Let’s hope this case stays in this judge’s court.
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Some companies own numerous lines of liquid. I know that Liquid Art Inc owns G2 and Dripboy and bottle liquid for many other brands. Since they have to submit PMTAs for each product, that adds up. Hence all the numerous filings. Isn’t that insane that the FDA requests such a thing? It’s not like a company that makes cough syrup in 3 varieties which all three have to be accepted by the FDA. Some juice companies have 100s of flavors!
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Unequivocally so! I am no Scott Gottlieb fan but he wrote an extensive article on the FDA culture and details past and current events spelling out where and how the train derailed. Since he no longer works for them I guess he has nothing to lose by exposing the clinical trial errors, etc. where they royally screwed up costing loss of life or irreversible damage. If you have the time and the stomach here’s the link.
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Thank you, everyone, for posting the current articles about the FDA, PMTAs, etc. I was so grief stricken when I saw my old juice company (the juice that helped me quit cigs) was on the MDO list that I emailed it’s CEO, Clinton Legg. His company started in 2012 and is still going strong today adding another line called Dripboy and bottling liquid for numerous other brands. I can’t believe this would be the end! Sad, sad indeed.
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We know what happened to Mom and Pop, I wonder if the same thing will happen to Tasty Puff…
And this is why i got out of the ejuice business in 2014 when this shit was all starting. I wonder if they will ever come after ELR and ATF to try to stop diy
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ELR is registered in a different country so im not sure the FDA matters much…@Ken_O_Where can correct me if im wrong
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Hopefully the nic will still be available, and VG from various sources, and there will be flavor companies providing flavor extracts for me to make my “cupcakes”, in 736 different flavors.
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We just read the thread “The LARGEST Vape Study done in America” which debunks the epidemic child vaping propaganda. Because a few politicians loosely used the term “epidemic” now each manufacturer has to submit independent studies to counter this rhetoric? Call it a protection racket or extorsion the evidence is clear how corrupt our gooberment is.
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