Thursday, March 28, 2024

Who’s Left? 323 Vape Companies Have Received MDOs

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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.

Since the Sept. 9, 2020 submission deadline for PMTAs, the FDA has issued no marketing authorizations for any vapor products. 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.

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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