What I don’t understand about this process is putting the burden of proof on the company’s. These products have been sold for close to two decades without detrimental effects to the public.
The FDA will quote foreign sources for other studies but when it comes to vaping they refuse to recognize any information outside the US. It seems to me that the FDA has become rubber stamp for the political system and not a true health organization.
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There is the key battle point that should be taken all the way to the Supreme Court imo.
The FDA most assuredly DOES NOT hold the drug companies to the same standard. 
They know that they don’t have a fucking leg to stand on if it’s e-cigarettes vs traditional tobacco.
The only concern here (as we all know) is the means for smokers (et al) to have a safer, more viable means of reducing the risks affiliated with combustible tobacco, as well as quitting smoking COMPLETELY.
GOD THIS PISSES ME OFF.
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And now this.
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Kevin raises a very interesting point so you have to prove that the flavours are better than no flavours to save the children yet …
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If it’s not tobacco flavored it looks like it won’t be approved.
“Who’s Left? 323 Vape Companies Have Received MDOs - Vaping360” Who's Left? 323 Vape Companies Have Received MDOs - Vaping360
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List of Marketing Denial Orders (MDOs) through Sept. 23, 2021
The List
Although the FDA say it has issued 323 MDOs, the agency’s published list contains just 260 names. The FDA says manufacturers that were issued denials for products not currently being marketed are not named.
The list is alphabetical, with the date the MDO was issued noted to the right of each name. Products newly added to the list since Sept. 17 are listed in bold type .
10 Days Inc. dba Pod Juice,9/14
611 Vapes dba Erie Shore Vapors,9/16
7 Daze LLC,9/8
A Perfect Vape,9/16
AAA Strate Vape,9/10
Abomination LLP,9/13
Absolute Vapor Lounge LLC,9/10
ACH Group LLC dba Bomb Bombz E-liquid,9/15
Alaska Elixirs Vape LLC,9/8
American Vapor Group,9/1
American Vapor Inc.,9/8
Apollo Future Technology Inc.,9/10
Arc LLC,9/7
Ashlynn Marketing Group,9/15
Avail Vapor LLC,9/15
Awesome Sauce Vapor,9/15
Axioco Corporation,9/16
Baker White Inc.,9/10
Balboa,9/7
Bang Bang Vapors LLC,9/9
Beard Vape Company,9/16
Bidi Vapor,9/7
Big Time Vapes,8/30
BJC,9/15
BMF Labs dba Bad Modder Fogger LLC ,9/10
Bogart Enterprises LLC,9/16
Bombies Inc.,9/8
Boomtown Vapors,9/8
Boss Vapes,9/13
Breeze Smoke,9/16
Buckshot Vapors Inc.,9/1
California Grown E-Liquid ,9/15
Cassadaga Liquids, LLC,9/15
Central Vapors,9/10
Cig Free Vape Shop,9/15
CITTG dba Orgnx E Liquids,9/1
Cloud House,9/8
Cool Breeze Vapor LLC,9/15
Cosmic Fog Vapors Operating Company LLC,9/15
Creative Focus dba Red Devil Vapors,9/7
CRFT Labs Tennessee LLC,9/15
Custom Vapor Blends LLC,9/7
Custom Vapors,8/31
Decent Juice,9/3
Desert Vapors LLC,9/13
DFW Vapor Holdings Inc.,9/8
Diamond Vapor,9/1
Dominant Vapor,9/1
Doomsday Gourmet,9/7
DR Distributors LLC,9/17
Drippers Vape Shop LLC ,9/14
Drippers Vape Shop LLC,9/10
E-Vapor Hut LLC,9/9
Ecig Charleston LLC,9/15
ECS Global,9/10
Einstein Vapes,9/10
Ejuice Blvd LLP,9/15
Electric Smoke Vapor House,9/8
Element E-Liquid LLC,9/15
E-Liquid Brands LLC,9/17
Elite Brothers,9/15
Everything Vapor,9/16
Feel Life Co Limited,9/16
Feel Life Health Inc.,9/17
Flair Products, LLC,9/10
Flavor Labs dba Mob Liquid Labs,9/7
Fuma International LLC,9/16
Fuma International LLC,9/17
FUMA Vapor, Inc.,9/10
Fumee LLC,9/14
Fumizer LLC,9/9
Gentlemen’s Draw LLC,9/7
Gothic Vapor,8/31
Great American Vapes,8/26
Gripum LLC,9/8
Grove Inc.,9/15
Gundo Distro,9/9
Heartlandvapes LLC,9/17
Holy Cow ejuice,9/13
HotSpot Caf� LLC dba VV-Juice,9/8
Howard Enterprises,9/16
Humble Juice Co., LLC,9/15
Imperial Vapors,9/1
Infamous E Juice,9/15
Innevape,9/15
J-Vapor LLC dba North Shore Vapor,8/31
Jaded Vapors LLC,9/8
Jai Mundi, Inc. Kai’s Virgin Vapor E-Liquid,9/15
JD Nova Group LLC,8/26
JDvapour LLC,9/8
JMJL Global,9/8
Johnny Copper,9/7
JT Wood Investments LLC dba Vape It,9/10
Juice Guys Distribution LLC,9/9
Juicemafia Inc.,9/10
Juice Roll Upz Inc.,9/8
Jungle Nation,9/15
Jvapes LLC,9/9
K&C Aitken, LLC Dba Elysian Labs,9/16
Kinghorn Holding,9/9
KJJ Enterprises,9/9
Kloc Vapor LLC dba The Vapor Edge,9/8
Lady Boss Vapor,9/8
LAS Ventures Limited,9/15
Lazarus Vintage Corporation,9/8
LDP Designs LLC,9/14
Lead by Sales LLC dba White Cloud Cigarettes,9/14
LeCig Enterprises Inc.,9/15
Licensed E-Liquid Manufacturing,9/10
Liquid Art Inc.,9/10
Liquid Nics LLC,9/3
Liquid Reign Inc.,9/16
Lotus Vaping Technologies,9/17
Loveli Design LLC dba Alice in Vapeland,9/1
LXJ LLC,9/13
Magellan Technology Inc.,9/8
Malicious Liquids Inc,9/8
Maniac Vapor LLC,9/17
Marina technology LLC,9/7
Marlin Steam Company, LLC,9/14
Matrix Minds,9/8
MH Global LLC dba Steamline Vape Co. LLC,9/16
Midas Vape LLC,9/8
Midwest Vape Supply,9/1
Mighty Vapors,9/15
Millennial One Inc. dba The Finest E-Liquid ,9/2
Mister-E-Liquid LLC,9/16
Mix Masters Inc.,9/10
MJ Asset Holdings,9/3
Mom and Pop Vapor Shop,9/8
Mothers Milk WTA,9/15
Mountain Oak Vapors, LLC,9/8
Mountain Vaporz,9/1
Mr. Salt-E LLC,9/15
MV Enterprises,9/1
My Vape Order Inc.,9/8
Nasty Worldwide SDN BHD,9/7
Newhere Inc. dba Madhatter Juice,9/8
New Orleans Cloud Alchemy,9/15
Nicquid,9/1
Northeast Vapor Supplies LLC,9/9
Northland Vapor Company,9/17
Nude Nicotine,9/7
Ohm Slaw Juice LLC dba Justin Parrott,9/14
One Up Vapors LLC,9/15
Opt2mist Vapor Shop LLC,9/9
Oueis Gas Inc. dba Oasis Vape,9/10
Ovapes Ejuice LLC,9/9
Paradigm Distribution ,9/15
Paradigm Distribution,9/10
Performance Plus Marketing Inc.,9/7
Pettee & D’Sylva Enterprises, LLC,9/13
Phantasm Vapors,9/9
Planet of the Vapes,9/1
Pop Vapor Co LLC,9/15
Pop Vapor Co LLC,9/16
Prohibition Juice Co.,9/13
Propaganda E-Liquid LLC,9/8
Prophet Premium Blends, LLC,9/15
Puff Labs LLC,9/14
Puff Labs,9/9
Quad City Vapers Club,9/7
Red Rock Vapor,9/7
Redwood Ejuice LLC,9/13
Riot Labs,9/9
Ripe Vapes,9/15
Rock Ridge Vapor LLC,9/13
Royalty Premium E Juice,9/1
RP Vapors,9/9
Ruthless Vapor Corporation,9/16
SadBoy,9/3
Seattle ,9/7
Securience LLC,9/8
Shop Vapes,9/9
Simple Vapor Company,9/10
Simply Vapour,9/10
Sir Vapes -A-Lot,9/1
Smax International LLC,9/14
Smokeless Smoking Inc.,9/9
Soft Vape Inc,9/10
South Coast Vapor Co.,9/9
Southwest Smokeless ,9/15
SS Vape Brands Inc. Dba Monster Vape Labs,8/31
SSY E-juice,9/10
Stark Vapor LLC,9/9
Steep Slope Vape Supply,9/8
SV Packaging LLC,9/10
SWT Global Supply,8/31
SWT Global Supply,9/7
Tampa Vapor Inc.,9/10
Tasty Cloud Vape Co. LLC,9/9
Tasty Haze,9/7
Tasty Puff LLC,9/14
Teardrip Holdings,9/14
Texas Select Ventures LLC dba Texas Select Vapor,9/14
Texas Tobacco Barn dba TXVape Barn,9/8
The Ecig Caf� LLC,9/9
The Michigan Juice Company LLC,9/8
The Plume Room LLC,9/8
The Vape Lounge,9/15
The Vaping Tiger,8/31
The Vapor Vendor LLC,9/9
The Zen Vaper E-Liquids LLC,9/15
TPB International LLC,9/14
Treehouse Vapor Company dba Flagship Vapor,9/7
TrendSetters E-liquid LLC,8/31
True Lab Creations,9/10
TruVibe Inc. dba Vapor Station FDL,9/8
Turncoat Industries,9/15
Twisted Tongue Inc.,9/13
UIS Manufacturing, LLC,9/14
Underdog E-liquids LLC,9/8
Union Street Brand,9/15
Valley Vapors LLC,9/8
Vape Craft,9/9
Vape Crusaders Premium E-liquids,9/8
VapeDaugz LLC,9/14
Vape Element LLC dba BLVK Unicorn,9/10
Vape Hut Inc.,9/13
Vape n Juice,9/16
Vape of a Kind,9/8
Vape On,9/7
Vaper Generation,9/9
VaperMate LLC,9/15
Vapetasia LLC,9/16
Vaping Oasis,9/2
Vapor Bank E-liquid,9/10
Vapornine LLC dba New Leaf Vapor Company ,9/16
Vapor Outlet of Wyoming LLC dba Juicity Vapor,9/8
Vapor Plus OK,9/7
Vapor Rage LLC,9/8
Vapor Salon,8/26
Vapor Solutions & Labs,9/8
Vapor Source Inc.,9/3
Vapor Stockroom,9/9
Vapor Stop,9/15
Vapor Trail LLC dba Mig Vapor,9/8
Vapor Unlimited,9/10
Vapor Ventures Inc dba Innovated Vapors,9/15
Vaporized Inc.,9/8
Vapors of Ohio Inc. dba Nostalgic Vapes,9/1
VDX Distribution,9/15
Verdict Vapors,9/15
Vertigo Vapor,9/8
Victory Liquid LLC,9/10
VIM Blends,9/8
Vintage & Vapor Marketplace Inc.,9/17
Viper Vapor,9/3
Viper Vapor,9/3
VPR Collection,9/8
VR Labs,9/9
Wadina Distribution LLC DBA GOST Vapor,9/9
Wages & White Lion Investments dba Triton Distribution,9/14
Walker Enterprises,9/9
Warlock Vapes dba Zuluvapes,9/8
Wyoming Vapor Company,9/3
Xtreme Vapors,9/8
Yogi’s Vape,9/9
Yoshicon LLC dba Vapergate,9/13
Zen RVA LLC,9/7
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Let the legal argument begin.
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@rcleven Thanks for posting this. The whole thing is a mess and is so anti-vaping it’s laughable. Except that the decisions will affect a number of folks and those decisions may lead some people back to smoking cigarettes. That makes me both sad and angry. I wish they would base their decisions on science adresearch and not on opinion and politics.
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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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