September 23, 2021
The FDA reported today that 28 more firms have been added to its list of manufacturers who have received marketing denials since the previous update on September 17. All of the Marketing Denial Orders (MDOs) were for flavored vaping goods.
The total number of companies receiving MDOs for flavored product Premarket Tobacco Applications (PMTAs) has now reached 323. (An alphabetical list appears at the end of this article.) The FDA claims the denials affect approximately 1.2 million flavored items.
All of the new entries are for small manufacturers. Since the FDA began giving MDOs on August 26, the great majority have gone to tiny businesses, with only a few being awarded to larger open-system manufacturers like as Turning Point Brands and AVAIL Vapor. Bidi Vapor, a publicly traded firm that manufactures closed-system prefilled devices, has also received MDOs for flavored goods.
In August, the FDA issued the first MDOs and announced a new standard requiring 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 marketing denials made thus far have been based on the previously unwritten standard.
Since the PMTA application deadline of September 9, 2020, the FDA has not issued any marketing authorizations for vapor products. [EDITOR'S NOTE: On October 12, the FDA granted marketing authorization for the Vuse Solo and two tobacco-flavored cartridges.] The government has also yet to make a decision on mass-market products like Juul Labs, Reynolds American, NJOY, Logic, or Blu, which FDA Center for Tobacco Products Director Mitch Zeller stated will be priority in the assessment process because to their popularity.
The FDA was scheduled to make determinations on the large manufacturers' items by September 9, 2021, the deadline for removing unapproved products from the market. All vaping devices containing tobacco-derived nicotine are now theoretically unlawful to sell and are only available on the market due to FDA enforcement discretion. This covers vaping items with tobacco and menthol flavors, as well as flavored products like as nicotine pouches.
Some tiny producers have begun reformulating their goods with synthetic nicotine, potentially circumventing current FDA tobacco product authority. It is unclear whether the EPA will attempt to regulate synthetic nicotine as a medication.
List of FDA Marketing Denial Orders (MDOs)
Although the FDA claims to have issued 323 MDOs, its public list only has 260 names. According to the FDA, manufacturers who received denials for products that are not yet on the market are not named.
We are updating the list by including companies that received MDOs after the initial round, such as Fontem US and Juul Labs. We're also including remarks clarifying MDOs that have been repealed or overturned by court rulings.
The list is alphabetical, with the date the MDO was issued shown to the right of each name. Unless otherwise specified, all dates begin in 2021.
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 (flavored Bidi Sticks) Sept. 7—MDO vacated by co
urt ruling Aug. 23, 2022
Bidi Vapor (tobacco-flavored Bidi Stick-Classic) – Jan. 22, 2024
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]
Fontem US, LLC (Blu) – Jan. 19, 2024 [blu PLUS+ device and refill cartridges]
Fontem US, LLC – Feb. 5, 2024 [blu Disposable in four flavors; myblu 1.2% menthol pod]
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
R.J. Reynolds (Vuse Alto menthol pod) – Oct. 12, 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
Shenzhen Youme Information Technology Co. Ltd. (Suorin) – Jan. 19, 2024
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
Suorin – see Shenzhen Youme Information Technology Co. Ltd.
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
