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September 10, 2021

Sept. 10th: FDA Has Issued 168 PMTA Denials So Far

The day after announcing that, so far, no vaping products have been authorized for legal marketing, the FDA Center for Tobacco Products says it has issued Marketing Denial Orders (MDOs) to 168 manufacturers since Aug. 26. The denials cover nearly 1 million flavored products—mostly bottled e-liquid—for which Premarket Tobacco Applications (PMTAs) were submitted.

The agency announced in August that PMTAs for products in flavors other than tobacco and menthol would be denied if they don’t contain “sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”

Many companies that received MDOs have other products—mostly tobacco- and menthol-flavored e-liquid— with PMTAs still being considered by the agency. Receiving an MDO does not mean a company will close.

Products with denied PMTAs must be removed from the market or manufacturers and sellers may be subject to further FDA enforcement. The FDA said yesterday that products “for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities.”

However, the FDA admitted “that we are unable, as a practical matter, to take enforcement action against every illegally marketed tobacco product, and that we need to make the best use of Agency resources.”

Many e-liquid manufacturers have indicated they will continue selling flavored products reformulated with synthetic nicotine, which is a legal gray area. The FDA hasn’t yet attempted to take action against synthetic nicotine products, and may be unable to under its current authority.

List of Marketing Denial Orders (MDOs) through Sept. 10, 2021

The updated MDO list (reproduced below) only includes 124 manufacturers. The FDA says it has issued MDOs to 168 companies, but did not name the companies that received MDOs for products not currently being marketed to “protect confidential commercial information.”

Aug.26
Great American Vapes
JD Nova Group LLC
Vapor Salon

Aug. 30
Big Time Vapes

Aug. 31
Custom Vapors
Gothic Vapor
J-Vapor LLC (North Shore Vapor)
SS Vape Brands Inc. (Monster Vape Labs)
SWT Global Supply
The Vaping Tiger
TrendSetters E-liquid LLC

Sept. 1
American Vapor Group
Buckshot Vapors Inc.
CITTG (Orgnx E Liquids)
Diamond Vapor
Dominant Vapor
Imperial Vapors
Loveli Design LLC (Alice in Vapeland)
Midwest Vape Supply
Mountain Vaporz
MV Enterprises
Nicquid
Planet of the Vapes
Royalty Premium E Juice
Sir Vapes -A-Lot
Vapors of Ohio Inc. (Nostalgic Vapes)

Sept. 2
Millennial One Inc. (The Finest E-Liquid)
Vaping Oasis

Sept. 3
Decent Juice
Liquid Nics LLC
MJ Asset Holdings
SadBoy
Vapor Source Inc.
Viper Vapor
Wyoming Vapor Company

Sept. 7
Arc LLC
Creative Focus (Red Devil Vapors)
Custom Vapor Blends LLC
Doomsday Gourmet
Flavor Labs (Mob Liquid Labs)
Balboa
Gentlemen’s Draw LLC
Johnny Copper
Marina technology LLC
Nasty Worldwide SDN BHD
Nude Nicotine
Quad City Vapers Club
Red Rock Vapor
Seattle
SN Holding
Tasty Haze
Treehouse Vapor Company (Flagship Vapor)
Vape On
Vapor Plus OK
Zen RVA LLC

Sept. 8
7 Daze LLC
Alaska Elixirs Vape LLC
American Vapor Inc.
Bombies Inc.
Boomtown Vapors
DFW Vapor Holdings Inc.
Electric Smoke Vapor House
Gripum LLC
HotSpot Café LLC (VV-Juice)
Jaded Vapors LLC
JMJL Global
Juice Roll Upz Inc.
Kloc Vapor LLC (The Vapor Edge)
Lady Boss Vapor
Lazarus Vintage Corporation
Malicious Liquids Inc
Matrix Minds
Midas Vape LLC
Mom and Pop Vapor Shop
Mountain Oak Vapors, LLC
My Vape Order Inc.
Propaganda E-Liquid LLC
Securience LLC
Steep Slope Vape Supply
Texas Tobacco Barn (TXVape Barn)
TruVibe Inc. (Vapor Station FDL)
Underdog E-liquids LLC
Valley Vapors LLC
Vape Crusaders Premium E-liquids
Vape of a Kind
Vapor Outlet of Wyoming LLC (Juicity Vapor)
Vaporized Inc.
Vapor Rage LLC
Vapor Solutions & Labs
Vapor Trail LLC (Mig Vapor)
Vertigo Vapor
VIM Blends
VPR Collection
Warlock Vapes (Zuluvapes)
Xtreme Vapors

Sept. 9
Bang Bang Vapors LLC
Fumizer LLC
Gundo Distro
Jvapes LLC
Kinghorn Holding
KJJ Enterprises
Puff Labs
RP Vapors
Riot Labs
Shop Vapes
Smokeless Smoking Inc.
South Coast Vapor Co.
Stark Vapor LLC
The Ecig Caf� LLC
The Vapor Vendor LLC
Walker Enterprises
Vape Craft
Vaper Generation
Vapor Stockroom
VR Labs

Sept. 10
Apollo Future Technology Inc.
Flair Products, LLC
FUMA Vapor, Inc.
Simple Vapor Company
Simply Vapour
SSY E-juice
Vapor Bank E-liquid
Victory Liquid LLC

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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Glenn Charlsen
Glenn Charlsen
15 days ago

Still no mention of IVPS/SMOK, Vaporesso, Innokin PMTA results?

Tony Mathis
Tony Mathis
14 days ago

I can’t tell what Juice brands are being listed. Ex. Juice Head, Air Factory, ???

C Cas
C Cas
14 days ago

Planet of the Vapes is a dry herb vaping and concentrate they don’t currently sell e liquid ,510 mods, or pod systems that I can find.

Anthony
Anthony
13 days ago

Are tobacco flavors in the clear

Faisal
Faisal
12 days ago
Reply to  Jim McDonald

Can someone still send application for the PMTA review.

P Cannon
P Cannon
11 days ago

how does this affect retail store owners? we own 2 stores, we do not make juice here. we order from our distributers and sell it in our store. do we have to pull all these juices off our shelves also or what do we have to do?

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