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