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FDA starts denying pmta

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Looks like 2015/16 prices will be coming back ??? I cant imagine with the high cost of TFN that conpanies wont jacke their prices way up…Will Congress and the FDA add TFN to their attack on Vaping ?

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Yeah @fidalgo_vapes

The FDA announced today it has rejected 55,000 Premarket Tobacco Applications (PMTAs) from three small e-liquid manufacturers. That eliminates about two percent of the more than two million remaining of the 6.5 million PMTAs originally submitted before last year’s Sept. 9 deadline.

More importantly, the federal regulator seemed to indicate that it will probably not authorize any bottled e-liquid in flavors other than tobacco. With two weeks before the Sept. 9, 2021 grace period is up, that will likely mean rejection for almost all of the remaining PMTAs.

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So…they were more than happy to take fees on 6.5 million applications!!! :neutral_face:

Maybe there is a link between this obvious scam and the attempting to recoup money from the loss of traditional leaf tobacco cigarettes. I would love to see this hit the Supreme Court and land in our favor. I’m guessing the odds for that are 0%.

text2image_F9935405_20210831_222727

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I have to be honest, seeing the Grimm show on this - got me a bit triggered. I do hope information will be released about why so many applications were denied. @fidalgo_vapes - like you said, prices will go up. I also think some vapers will convert to DIY, and sadly some will jump back to smoking. Which is a terrible thought…

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FDA claimed the people who filed the application did not address why the products were safe. My guess is that the FDA got ticked off because of number of applications they filed.

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But like give us the receipts about why exactly these pmta’s got denied. Are those available?

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They filed over 2000 PTMS’s. The filings were too broad in scope to pass anything FDA.
From the article I read they weren’t recipes but processes. According to the FDA they didn’t follow the rules.
There seems to be two sides in every story.
Over 2000 submitted filings from one company? How can the FDA take them seriously?

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https://vaping360.com/vape-news/110937/fda-signals-it-wont-authorize-flavored-e-liquid-pmtas/

The following excerpts are from the above referenced article

While possible, it’s unlikely that any independent vaping business has developed “product-specific evidence” of the value of flavors. The agency calls for randomized controlled trials. Designing and completing such a trial for a specific bottled e-liquid would cost millions of dollars.

The unpublished standard the FDA seems to be applying to most of the products submitted for review is attainable only for tobacco companies and possibly the largest independent companies, like Juul Labs and NJOY.

The FDA says it will “continue to review other premarket tobacco applications for non-tobacco flavored ENDS to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth,” but the agency is well aware that such evidence will not be found in those PMTAs—at least not for the more than 500 companies that don’t have billions of disposable dollars.

“If the applications contain evidence of this type, the FDA will conduct further in‐depth scientific evaluation as to whether the evidence satisfies that statutory standard for authorization. But in the absence of this evidence, the agency intends to issue an MDO.”

I think that this says it all! :arrow_down:

"but the agency is well aware that such evidence will not be found in those PMTAs—at least not for the more than 500 companies that don’t have billions of disposable dollars."

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This seriously boils my blood, turns out the almighty $ trumps our rights as citizens…sad day indeed

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Came across this tonight.

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The FDA’s decisions will technically come down to whether each e-cigarette product in consideration is “appropriate for the protection of public health”—the agency’s standard for assessing whether it has a net positive or negative effect on the nation’s public health. Crucially, the agency will assess each product’s potential effect on the entire U.S. population, not just adult smokers.

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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. :rage:

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 …
image

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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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