FDA Has Now Denied PMTAs from 295 Vape Companies

The FDA announced today that 127 additional vaping manufacturers have received Marketing Denial Orders (MDOs) for products submitted in Premarket Tobacco Applications (PMTAs) since the last update on Sept. 10. The new MDOs represent about 100,000 products—almost all bottled e-liquids in flavors other than tobacco or menthol.

Since Aug. 26, 295 manufacturers have received MDOs for more than 1,089,000 products. Since the Sept. 9 deadline for unauthorized products to be removed from the market, the FDA Center for Tobacco Products has not authorized a single vaping product for marketing.

Products with denied PMTAs are supposed to be removed from the market or be subject to further FDA enforcement. The FDA has said its highest enforcement priorities include products that have received MDOs or were never submitted for review. However, all currently available products technically remain on the market at the mercy of the FDA’s enforcement discretion, including those of mass-market vape manufacturers like Juul Labs and Reynolds American’s Vuse brand.

Along with the first round of MDO’s, the FDA announced a previously unpublished standard requiring PMTAs for flavored products other than tobacco and menthol to show “sufficient product-specific scientific evidence to demonstrate enough of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.”

While plenty of these are micro-sized businesses with no national footprint, others are sizeable companies with dozens of employees and spent real money on their applications.

Fortunately for adult smokers and vapers, most are not just going to quit.

— Gregory Conley (@GregTHR) September 17, 2021

For the first time since the FDA announced that requirement, it has issued denials to open-system manufacturers with the resources to include such evidence in their PMTAs. Earlier today, we reported that Turning Point Brands and AVAIL Vapor were among the companies receiving MDOs this week for flavored vaping products.

Others believed to have submitted extensive scientific evidence in their PMTAs also received MDOs, including the manufacturer of the Bidi Stick disposable line. Some well-known and longtime e-liquid manufacturers received MDOs, including Beard Vape Company, Cosmic Fog, Ruthless and Mister E-Liquid.

List of Marketing Denial Orders (MDOs) through Sept. 17, 2021

Although the FDA say it has issued 295 MDOs, the list contains just 240 names. The agency says manufacturers 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.

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

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

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

Elite Brothers,9/15

Everything Vapor,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

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

Liquid Art Inc.,9/10

Liquid Nics LLC,9/3

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

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

New Orleans Cloud Alchemy,9/15

Nicquid,9/1

Northeast Vapor Supplies LLC,9/9

Northland Vapor Company,9/17

Nude Nicotine,9/7

One Up Vapors LLC,9/15

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

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

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 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

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

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 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