Friday, June 21, 2024

FDA Has Now Issued PMTA Denials to 168 Vape Companies


The day after announcing that no vaping products have been authorized so far 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 for market authorization. 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.

The updated MDO list (reproduced below) only includes 124 names. The FDA it did not name companies that received MDOs for products not currently being marketed to “protect confidential commercial information.”

Great American Vapes
JD Nova Group LLC
Vapor Salon

Aug. 30
Big Time Vapes

Aug. 31
J-Vapor LLC (North Shore Vapor)
SS Vape Brands Inc. (Monster Vape Labs)
Custom Vapors
The Vaping Tiger
Gothic Vapor
TrendSetters E-liquid LLC
SWT Global Supply

Sept. 1
Diamond Vapor
American Vapor Group
MV Enterprises
Planet of the Vapes
CITTG (Orgnx E Liquids)
Vapors of Ohio Inc. (Nostalgic Vapes)
Buckshot Vapors Inc.
Royalty Premium E Juice
Imperial Vapors
Midwest Vape Supply
Dominant Vapor
Mountain Vaporz
Sir Vapes -A-Lot
Loveli Design LLC (Alice in Vapeland)

Sept. 2
Millennial One Inc. (The Finest E-Liquid)
Vaping Oasis

Sept. 3
Liquid Nics LLC
Decent Juice
Wyoming Vapor Company
Viper Vapor
Vapor Source Inc.
MJ Asset Holdings

Sept. 7
Gentlemen’s Draw LLC
Custom Vapor Blends LLC
Nasty Worldwide SDN BHD
Johnny Copper
Flavor Labs (Mob Liquid Labs)
Quad City Vapers Club
Marina technology LLC
Creative Focus (Red Devil Vapors)
Doomsday Gourmet
SN Holding
Tasty Haze
Treehouse Vapor Company (Flagship Vapor)
Vapor Plus OK
Nude Nicotine
Vape On
Red Rock Vapor

Sept. 8
Malicious Liquids Inc
Vertigo Vapor
Lady Boss Vapor
Vapor Outlet of Wyoming LLC (Juicity Vapor)
Propaganda E-Liquid LLC
JMJL Global
Matrix Minds
Alaska Elixirs Vape LLC
Gripum LLC
VIM Blends
HotSpot Café LLC (VV-Juice)
Mountain Oak Vapors, LLC
Mom and Pop Vapor Shop
Xtreme Vapors
My Vape Order Inc.
Midas Vape LLC
American Vapor Inc.
Securience LLC
VPR Collection
Underdog E-liquids LLC
Steep Slope Vape Supply
Electric Smoke Vapor House
7 Daze LLC
Warlock Vapes (Zuluvapes)
Lazarus Vintage Corporation
DFW Vapor Holdings Inc.
Juice Roll Upz Inc.
Jaded Vapors LLC
Valley Vapors LLC
Vaporized Inc.
Bombies Inc.
Vapor Trail LLC (Mig Vapor)
Boomtown Vapors
TruVibe Inc. (Vapor Station FDL)
Vapor Rage LLC
Kloc Vapor LLC (The Vapor Edge)
Texas Tobacco Barn (TXVape Barn)
Vapor Solutions & Labs
Vape of a Kind
Vape Crusaders Premium E-liquids

Sept. 9
Bang Bang Vapors LLC
Kinghorn Holding
RP Vapors
Riot Labs
Walker Enterprises
Vaper Generation
Vapor Stockroom
Stark Vapor LLC
VR Labs
The Ecig Caf� LLC
Smokeless Smoking Inc.
South Coast Vapor Co.
Puff Labs
Gundo Distro
Fumizer LLC
The Vapor Vendor LLC
KJJ Enterprises
Shop Vapes
Vape Craft
Jvapes LLC

Sept. 10
Flair Products, LLC
SSY E-juice
Apollo Future Technology Inc.
Vapor Bank E-liquid
FUMA Vapor, Inc.
Simply Vapour
Simple Vapor Company
Victory Liquid LLC

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