Who’s Left? Vape Companies That Have Received MDOs

[Θðηα mάkαя]

Oct. 26, 2022 update
The FDA today issued its first MDOs for menthol-flavored vaping products—specifically, menthol refill cartridges for two Logic devices that had been authorized for sale previously with tobacco-flavored refills.

Nov. 1 update
We have noted MDOs rescinded by the FDA.

September 23, 2021

The FDA announced today that 28 additional companies have been added to its list of manufacturers that have received marketing denials since its last update on Sept. 17. All the products receiving Marketing Denial Orders (MDOs) were flavored vaping products.

The total number of companies receiving MDOs for flavored product Premarket Tobacco Applications (PMTAs) is now 323. (An alphabetical list can be found at the end of this article.) The FDA says the denials cover nearly 1.2 million flavored products.

All of the new listings are small manufacturers. Since the FDA began issuing MDOs on Aug. 26, the vast majority have gone to small companies, with just a few issued to larger open-system manufacturers like Turning Point Brands and AVAIL Vapor. One publicly traded company that makes closed-system prefilled devices, Bidi Vapor, has also received MDOs for flavored products.

With the first MDO’s issued in August, the FDA also announced a new standard that requires PMTAs for flavored products other than tobacco and menthol to show “sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.” All of the marketing denials issued so far have been based on that previously unwritten standard.

Shops that didn't bother to register or apply for PMTAs are in the most enviable of non-enviable positions.

FDA doesn't know you exist and, for the good of your customers who rely on your products to stay smoke-free, you should strive to keep it that way. https://t.co/kCQuyCUA7D

— Gregory Conley (@GregTHR) September 23, 2021

Since the Sept. 9, 2020 submission deadline for PMTAs, the FDA has issued no marketing authorizations for any vapor products. [EDITOR’S NOTE: On Oct. 12, the FDA issued marketing authorizations for the Vuse Solo and two tobacco-flavored cartridges.] The agency has also not made decisions on mass-market products from Juul Labs, Reynolds American, NJOY, Logic, or Blu, which FDA Center for Tobacco Products Director Mitch Zeller said would be prioritized in the review process because of their popularity.

The FDA was expected to announce some decisions on the large manufacturers’ products by Sept. 9, 2021—the deadline for unauthorized products to be removed from the market. All vaping products made with tobacco-derived nicotine are now technically illegal to sell, and only exist on the market through FDA enforcement discretion. That includes tobacco- and menthol-flavored vaping products and flavored products like nicotine pouches.

Some small manufacturers have begun reformulating their products with synthetic nicotine, which could skirt current FDA tobacco product authority. It isn’t known if the agency will attempt to regulate synthetic nicotine as a drug.

List of FDA Marketing Denial Orders (MDOs)

Although the FDA says 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.

We are updating the list by adding companies that receive MDOs after the first round—for example, Fontem US and Juul Labs. We are also adding notes explaining MDOs that have been rescinded or vacated by court rulings.

The list is alphabetical, with the date the MDO was issued noted to the right of each name. All dates are from 2021 unless otherwise noted.

10 Days Inc. dba Pod Juice – Sept. 14
611 Vapes dba Erie Shore Vapors – Sept. 16
7 Daze LLC – Sept. 8
A Perfect Vape – Sept. 16
AAA Strate Vape – Sept. 10
Abomination LLP – Sept. 13
Absolute Vapor Lounge LLC – Sept. 10
Absolute Vapor Inc. – May 12, 2023
ACH Group LLC dba Bomb Bombz E-liquid – Sept. 15
Al Khalifa Group LLC – Oct. 6 [added to FDA’s public MDO list Feb. 17, 2022]—MDO rescinded by FDA April 25, 2022
Alaska Elixirs Vape LLC – Sept. 8
American Vapor Group – Sept. 1
American Vapor Inc. – Sept. 8
Apollo Future Technology Inc. – Sept. 10
Arc LLC – Sept. 7
Ashlynn Marketing Group – Sept. 15
Avail Vapor LLC – Sept. 15
Awesome Sauce Vapor – Sept. 15
Axioco Corporation – Sept. 16
Baker White Inc. – Sept. 10
Balboa – Sept. 7
Bang Bang Vapors LLC – Sept. 9
Beard Vape Company – Sept. 16
Bidi Vapor Sept. 7—MDO vacated by court ruling Aug. 23, 2022
Big Time Vapes – Aug. 30
Big Time Vapes – May 12, 2023
BJC – Sept. 15
BMF Labs dba Bad Modder Fogger LLC – Sept. 10
Bogart Enterprises LLC – Sept. 16
Bombies Inc. – Sept. 8
Boomtown Vapors – Sept. 8
Boss Vapes – Sept. 13
Breeze Smoke – Sept. 16
Buckshot Vapors Inc. – Sept. 1
California Grown E-Liquid – Sept. 15
Cassadaga Liquids, LLC – Sept. 15
Central Vapors – Sept. 10
Cig Free Vape Shop – Sept. 15
CITTG dba Orgnx E Liquids – Sept. 1
Cloud House – Sept. 8
Cool Breeze Vapor LLC – Sept. 15
Cosmic Fog Vapors Operating Company LLC – Sept. 15
Creative Focus dba Red Devil Vapors – Sept. 7
CRFT Labs Tennessee LLC – Sept. 15
Custom Vapor Blends LLC – Sept. 7
Custom Vapors – Aug. 31
Decent Juice – Sept. 3
Desert Vapors LLC – Sept. 13
DFW Vapor Holdings Inc. – Sept. 8
Diamond Vapor Sept.1—MDO vacated by court ruling Aug. 23, 2022
DNA Enterprise LLC (Mech Sauce) – May 12, 2023
Dominant Vapor – Sept. 1
Doomsday Gourmet – Sept. 7
DR Distributors LLC – Sept. 17
Drippers Vape Shop LLC – Sept. 14
Drippers Vape Shop LLC – Sept. 10
E-Vapor Hut LLC – Sept. 9
ECBlend LLC – May 12, 2023
Ecig Charleston LLC – Sept. 15
ECS Global – Sept. 10—MDO partially rescinded Oct. 26
Einstein Vapes – Sept. 10
Ejuice Blvd LLP – Sept. 15
Electric Smoke Vapor House – Sept. 8
Element E-Liquid LLC – Sept. 15
E-Liquid Brands LLC – Sept. 17
Elite Brothers – Sept. 15
Everything Vapor – Sept. 16
Feel Life Co Limited – Sept. 16
Feel Life Health Inc. – Sept. 17
Flair Products, LLC – Sept. 10
Flavor Labs dba Mob Liquid Labs – Sept. 7
Fontem US, LLC (Blu) – Apr. 8, 2022 [Myblu device and most pods added to FDA’s public MDO list April 8, 2022]
Fontem US, LLC (Blu) – July 10, 2023 [Myblu menthol pods added to FDA’s public MDO list July 10, 2023]
Fuma International LLC – Sept. 16
Fuma International LLC – Sept. 17
FUMA Vapor, Inc. – Sept. 10
Fumee LLC – Sept. 14
Fumizer LLC – Sept. 9—MDO partially rescinded Oct. 22
Gentlemen’s Draw LLC – Sept. 7
Gothic Vapor – Aug. 31
Great American Vapes – Aug. 26
Great Lakes Vapor – May 12, 2023
Gripum LLC – Sept. 8—MDO vacated by court ruling Aug. 29, 2022
Grove Inc. – Sept. 15
Gundo Distro – Sept. 9
Heartlandvapes LLC – Sept. 17
Holy Cow ejuice – Sept. 13
HotSpot Caf� LLC dba VV-Juice – Sept. 8
Howard Enterprises – Sept. 16
Humble Juice Co., LLC – Sept. 15—MDO rescinded Nov. 2
Imperial Vapors – Sept. 1
Imperial Vapors LLC – May 12, 2023
Infamous E Juice – Sept. 15
Innevape – Sept. 15
J-Vapor LLC dba North Shore Vapor – Aug. 31
Jaded Vapors LLC – Sept. 8
Jai Mundi, Inc. Kai’s Virgin Vapor E-Liquid – Sept. 15
JD Nova Group LLC – Aug. 26
JDvapour LLC – Sept. 8
JMJL Global – Sept. 8
Johnny Copper – Sept. 7—MDO vacated by court ruling Aug. 23, 2022
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
Juul Labs, Inc. – June 23, 2022 [added to FDA’s public MDO list June 23, 2022]
Jvapes LLC – Sept. 9
K&C Aitken, LLC Dba Elysian Labs – Sept. 16
Kinghorn Holding – Sept. 9
KJJ Enterprises – Sept. 9
Kloc Vapor LLC dba The Vapor Edge – Sept. 8
Lady Boss Vapor – Sept. 8
LAS Ventures Limited – Sept. 15
Lazarus Vintage Corporation – Sept. 8
LDP Designs LLC – Sept. 14
Lead by Sales LLC dba White Cloud Cigarettes – Sept. 14
LeCig Enterprises Inc. – Sept. 15
Licensed E-Liquid Manufacturing – Sept. 10
Liquid Art Inc. – Sept. 10
Liquid Nics LLC – Sept. 3
Liquid Reign Inc. – Sept. 16
Logic LLC – Oct. 26, 2022
Lotus Vaping Technologies – Sept. 17
Loveli Design LLC dba Alice in Vapeland – Sept. 1
LXJ LLC – Sept. 13
Magellan Technology Inc. (Juno) – Sept. 8
Magellan Technology Inc. (Hyde) – Oct. 6, 2022 [added to FDA’s public MDO list Oct. 6, 2022]
Malicious Liquids Inc – Sept. 8
Maniac Vapor LLC – Sept. 17
Marina technology LLC – Sept. 7
Marlin Steam Company, LLC – Sept. 14
Matrix Minds – Sept. 8
MH Global LLC dba Steamline Vape Co. LLC – Sept. 16
Midas Vape LLC – Sept. 8
Midwest Vape Supply – Sept. 1
Mighty Vapors – Sept. 15
Millennial One Inc. dba The Finest E-Liquid – Sept. 2
Mister-E-Liquid LLC – Sept. 16
Mix Masters Inc. – Sept. 10
MJ Asset Holdings – Sept. 3
Mom and Pop Vapor Shop – Sept. 8
Mothers Milk WTA – Sept. 15
Mothers Milk WTA – May 18, 2023
Mountain Oak Vapors, LLC – Sept. 8
Mountain Vaporz – Sept. 1
Mr. Salt-E LLC – Sept. 15
MV Enterprises – Sept. 1
My Vape Order Inc. – Sept. 8—MDO partially rescinded Jan. 19, 2022
Nasty Worldwide SDN BHD – Sept. 7
Newhere Inc. dba Madhatter Juice – Sept. 8
New Orleans Cloud Alchemy – Sept. 15
Nicquid – Sept. 1
Northeast Vapor Supplies LLC – Sept. 9
Northland Vapor Company – Sept. 17
Nude Nicotine – Sept. 7
Ohm Slaw Juice LLC dba Justin Parrott – Sept. 14
One Up Vapors LLC – Sept. 15
Opt2mist Vapor Shop LLC – Sept. 9
Oueis Gas Inc. dba Oasis Vape – Sept. 10
Ovapes Ejuice LLC – Sept. 9
Paradigm Distribution – Sept. 15
Paradigm Distribution – Sept. 10
Performance Plus Marketing Inc. – Sept. 7
Pettee & D’Sylva Enterprises, LLC – Sept. 13
Phantasm Vapors – Sept. 9
Planet of the Vapes – Sept. 1
Pop Vapor Co LLC – Sept. 9—MDO partially rescinded Nov. 23——MDO vacated by court ruling Aug. 23, 2022
Pop Vapor Co LLC – Sept. 16
Prohibition Juice Co. – Sept. 13
Propaganda E-Liquid LLC – Sept. 8
Prophet Premium Blends, LLC – Sept. 15
Puff Labs LLC – Sept. 14
Puff Labs – Sept. 9
Quad City Vapers Club – Sept. 7
Red Rock Vapor – Sept. 7
Redwood Ejuice LLC – Sept. 13
Riot Labs – Sept. 9
Ripe Vapes – Sept. 15
R.J. Reynolds (Vuse Ciro and Vibe menthol refills) – Jan, 24, 2023
R.J. Reynolds (Vuse Solo menthol refill) – March 17, 2023
Rock Ridge Vapor LLC – Sept. 13
Royalty Premium E Juice – Sept. 1
RP Vapors – Sept. 9
Ruthless Vapor Corporation – Sept. 16
SadBoy – Sept. 3
Savage Enterprises – May 12, 2023
Seattle – Sept. 7
Securience LLC – Sept. 8
Shop Vapes – Sept. 9
Simple Vapor Company – Sept. 10
Simply Vapour – Sept. 10
Sir Vapes -A-Lot – Sept. 1
Smax International LLC – Sept. 14
SMOK – Jan. 16, 2024
Smokeless Smoking Inc. – Sept. 9
Soft Vape Inc – Sept. 10
South Coast Vapor Co. – Sept. 9
Southwest Smokeless – Sept. 15
SS Vape Brands Inc. Dba Monster Vape Labs – Aug. 31
SSY E-juice – Sept. 10
Stark Vapor LLC – Sept. 9
Steep Slope Vape Supply – Sept. 8
SV Packaging LLC – Sept. 10
SWT Global Supply – Aug. 31
SWT Global Supply – Sept. 7
SWT Global Supply – May 12, 2023
Tampa Vapor Inc. – Sept. 10
Tasty Cloud Vape Co. LLC – Sept. 9
Tasty Haze – Sept. 7
Tasty Puff LLC – Sept. 14
Teardrip Holdings – Sept. 14
Texas Select Ventures LLC dba Texas Select Vapor – Sept. 14
Texas Tobacco Barn dba TXVape Barn – Sept. 8
The Ecig Caf� LLC – Sept. 9
The Michigan Juice Company LLC – Sept. 8
The Plume Room LLC – Sept. 8
The Vape Lounge – Sept. 15
The Vaping Tiger – Aug. 31
The Vapor Vendor LLC – Sept. 9
The Zen Vaper E-Liquids LLC – Sept. 15
TPB International LLC – Sept. 14—MDO rescinded Oct. 7
Treehouse Vapor Company dba Flagship Vapor – Sept. 7
TrendSetters E-liquid LLC – Aug. 31
True Lab Creations – Sept. 10
TruVibe Inc. dba Vapor Station FDL – Sept. 8
Turncoat Industries – Sept. 15
Twisted Tongue Inc. – Sept. 13
UIS Manufacturing, LLC – Sept. 14
Underdog E-liquids LLC – Sept. 8
Union Street Brands – Sept. 15—MDO vacated by court ruling Aug. 23, 2022
Valley Vapors LLC – Sept. 8
Vape Craft – Sept. 9
Vape Crusaders Premium E-liquids – Sept. 8
VapeDaugz LLC – Sept. 14
Vape Element LLC dba BLVK Unicorn – Sept. 10
Vape Hut Inc. – Sept. 13
Vape n Juice – Sept. 16
Vape of a Kind – Sept. 8
Vape On – Sept. 7
Vaper Generation – Sept. 9
VaperMate LLC – Sept. 15
Vapetasia LLC – Sept. 16
Vaping Oasis – Sept. 2
Vapor Bank E-liquid – Sept. 10
Vapornine LLC dba New Leaf Vapor Company – Sept. 16
Vapor Outlet of Wyoming LLC dba Juicity Vapor – Sept. 8
Vapor Plus OK – Sept. 7
Vapor Rage LLC – Sept. 8
Vapor Salon – Aug. 26
Vapor Solutions & Labs – Sept. 8
Vapor Source Inc. – Sept. 3
Vapor Stockroom – Sept. 9
Vapor Stop – Sept. 15
Vapor Trail LLC dba Mig Vapor – Sept. 8
Vapor Unlimited – Sept. 10—MDO vacated by court ruling Aug. 23, 2022
Vapor Ventures Inc dba Innovated Vapors – Sept. 15
Vaporized Inc. – Sept. 8
Vapors of Ohio Inc. dba Nostalgic Vapes – Sept. 1
VDX Distribution – Sept. 15
Verdict Vapors – Sept. 15
Vertigo Vapor – Sept. 8
Victory Liquid LLC – Sept. 10
VIM Blends – Sept. 8
Vintage & Vapor Marketplace Inc. – Sept. 17
Viper Vapor – Sept. 3
Viper Vapor – Sept. 3
VPR Collection – Sept. 8
VR Labs – Sept. 9
Wadina Distribution LLC DBA GOST Vapor – Sept. 9
Wages & White Lion Investments dba Triton Distribution – Sept. 14
Walker Enterprises – Sept. 9
Warlock Vapes dba Zuluvapes – Sept. 8
Wyoming Vapor Company – Sept. 3
Xtreme Vapors – Sept. 8
Yogi’s Vape – Sept. 9
Yoshicon LLC dba Vapergate – Sept. 13
Zen RVA LLC – Sept. 7

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