Turning Point Brands Sues FDA Over MDO’s

While the ‘vapocalypse’ seems to be worsening by the day, a few companies are fighting back, and fortunately, they are big ones. 

This week Turning Point Brands (or TPB for short) petitioned the sixth U.S Circuit Court of Appeals to ‘vacate or modify’ the Food and Drug Administration’s marketing denial order (MDO), citing that the ruling is ‘not in accordance with the law’. 

Turning Point Brands is a huge company, with brands including Zig-Zag, Solace, and Nu-X. They also operate the online vape shops Direct Vapor, VaporFi, and Vapor Beast.

Their original filing, without a lawyer’s brief, raises some interesting points. It is heartening to see that the FDA’s latest rulings are being challenged and will hopefully offer smaller, less prominent brands to raise a challenge. 

The FDA: “Arbitrary” and “Capricious”?

The petition filed by Turning Point Brands states:

“TPB seeks review of the (marketing denial) order on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.”

Why is it, according to TPB, so ‘arbitrary’ and ‘capricious’?

Well, for a start, the strict standard and ‘failings’ cited by the FDA in their MDO’s were not made clear before the applications were made. This has resulted in several businesses and potentially thousands of people throwing away their life savings in the hope of gaining the ability to carry on selling these lifesaving products. 

To date, the FDA has issued 323 marketing denial orders. Once receiving such an order, a manufacturer or supplier is forbidden from selling, marketing, or providing lifesaving vaping products.

Twitter users and vapers were extremely keen to express their dismay echoing TPB’s sentiments:

Please identify the scientist and the science used to determine that these MDO’s are necessary for the good of public health since vaping nicotine is at least 95% safer than smoking cigarettes???????? Or was it just arbitrary and capricious?

— South Tampa Vape (@SouthTampaVape) September 23, 2021

The only review needed is combustible nicotine delivery kills almst half a million US citizens every year while non combustible nicotine delivery saves tens of thousands. Combustible nicotine delivery gets a free pass while life saving vapor products are removed from the market.

— tomh6219 (@tomh6219) September 23, 2021

FDA’s arbitary & capricious MDOs of PMTAs are based on a standard that was never articulated prior to the deadline for PMTA submissions, or requestd in deficiency letters. PMTA’s enter sci-review an hour before denying them? The courts will frown on this behavior. Buckle up!

— David P Forsyth (@DavidPForsyth) September 24, 2021

Many have accused the FDA of ‘propping up’ cigarette sales in a move that, if it succeeds, will push hundreds of thousands of people back to smoking. 

Hope you all at FDA sleep better at night knowing you just got rid of THE MOST SUCCESSFUL WAY TO QUIT SMOKING CIGARETTES. You are there to protect us so why do you wish death on so many who switched to vaping and who could have? #vapingsaveslives #vapingsavedmylife #flavorsmatter

— 73sparkle (@JamiRakes) September 24, 2021

Interestingly, the FDA’s jury is still out on the ‘big’ manufacturers such as Juul. This means that, at present, they are in a legal grey area and are technically selling their products illegally.

How Bad are the MDO’s?

Bad.

When viewing the FDA’s most recently published list of manufacturers who have been served MDO’s the extent of the problem is obvious. 

The FDA boasts that it has effectively withdrawn 1.1 million vaping products from the market due to its actions.

Appropriate for the protection of public health?

Hardly, especially when you take a more rounded view of the available evidence. 

Here’s a list of those manufacturers affected so far…

• 10 Days Inc. dba Pod Juice
• 611 Vapes dba Erie Shore Vapors
• 7 Daze LLC
• A Perfect Vape
• AAA Strate Vape
• Abomination LLP
• Absolute Vapor Lounge LLC
• ACH Group LLC dba Bomb Bombz E-liquid
• Alaska Elixirs Vape LLC
• American Vapor Group
• American Vapor Inc.
• Apollo Future Technology Inc.
• Arc LLC
• Ashlynn Marketing Group
• Avail Vapor LLC
• Awesome Sauce Vapor
• Axioco Corporation
• Baker White Inc.
• Balboa
• Bang Bang Vapors LLC
• Beard Vape Company
• Bidi Vapor
• Big Time Vapes
• BJC
• BMF Labs dba Bad Modder Fogger LLC
• Bogart Enterprises LLC
• Bombies Inc.
• Boomtown Vapors
• Boss Vapes
• Breeze Smoke LLC
• Buckshot Vapors Inc.
• California Grown E-Liquid
• Cassadaga Liquids, LLC
• Central Vapors
• Cig Free Vape Shop
• CITTG dba Orgnx E Liquids
• Cloud House
• Cool Breeze Vapor LLC
• Cosmic Fog Vapors Operating Company LLC
• Creative Focus dba Red Devil Vapors
• CRFT Labs Tennessee LLC
• Custom Vapor Blends LLC
• Custom Vapors
• Decent Juice
• Desert Vapors LLC
• DFW Vapor Holdings Inc.
• Diamond Vapor
• Dominant Vapor
• Doomsday Gourmet
• DR Distributors LLC
• Drippers Vape Shop LLC
• Drippers Vape Shop LLC
• E-Liquid Brands LLC
• E-Vapor Hut LLC
• Ecig Charleston LLC
• ECS Global
• Einstein Vapes
• Ejuice Blvd LLP
• Electric Smoke Vapor House
• Element E-Liquid LLC
• Elite Brothers
• Everything Vapor
• Feel Life Co Limited
• Feel Life Health Inc.
• Flair Products, LLC
• Flavor Labs dba Mob Liquid Labs
• Fuma International LLC
• Fuma International LLC
• FUMA Vapor, Inc.
• Fumee LLC
• Fumizer LLC
• Gentlemen’s Draw LLC
• Gothic Vapor
• Great American Vapes
• Gripum LLC
• Grove Inc.
• Gundo Distro
• Heartlandvapes LLC
• Holy Cow ejuice
• HotSpot Café LLC dba VV-Juice
• Howard Enterprises
• Humble Juice Co., LLC
• Imperial Vapors
• Infamous E Juice
• Innevape
• J-Vapor LLC dba North Shore Vapor
• Jaded Vapors LLC
• Jai Mundi, Inc. Kai’s Virgin Vapor E-Liquid
• JD Nova Group LLC
• JDvapour LLC
• JMJL Global
• Johnny Copper
• JT Wood Investments LLC dba Vape It
• Juice Guys Distribution LLC
• Juice Roll Upz Inc.
• Juicemafia Inc.
• Jungle Nation
• Jvapes LLC
• K&C Aitken, LLC Dba Elysian Labs
• Kinghorn Holding
• KJJ Enterprises
• Kloc Vapor LLC dba The Vapor Edge
• Lady Boss Vapor
• LAS Ventures Limited
• Lazarus Vintage Corporation
• LDP Designs LLC
• Lead by Sales LLC dba White Cloud Cigarettes
• LeCig Enterprises Inc.
• Licensed E-Liquid Manufacturing
• Liquid Art Inc.
• Liquid Nics LLC
• Liquid Reign Inc.
• Lotus Vaping Technologies
• Loveli Design LLC dba Alice in Vapeland
• LXJ LLC
• Magellan Technology Inc.
• Malicious Liquids Inc
• Maniac Vapor LLC
• Marina technology LLC
• Marlin Steam Company, LLC
• Matrix Minds
• MH Global LLC dba Steamline Vape Co. LLC
• Midas Vape LLC
• Midwest Vape Supply
• Mighty Vapors
• Millennial One Inc. dba The Finest E-Liquid
• Mister-E-Liquid LLC
• Mix Masters Inc.
• MJ Asset Holdings
• Mom and Pop Vapor Shop
• Mothers Milk WTA
• Mountain Oak Vapors, LLC
• Mountain Vaporz
• Mr. Salt-E LLC
• MV Enterprises
• My Vape Order Inc.
• Nasty Worldwide SDN BHD
• New Orleans Cloud Alchemy
• Newhere Inc. dba Madhatter Juice
• Nicquid
• Northeast Vapor Supplies LLC
• Northland Vapor Company
• Nude Nicotine
• Ohm Slaw Juice LLC dba Justin Parrott
• One Up Vapors LLC
• Opt2mist Vapor Shop LLC
• Oueis Gas Inc. dba Oasis Vape
• Ovapes Ejuice LLC
• Paradigm Distribution
• Paradigm Distribution
• Performance Plus Marketing Inc.
• Pettee & D’Sylva Enterprises, LLC
• Phantasm Vapors
• Planet of the Vapes
• Pop Vapor Co LLC
• Pop Vapor Co LLC
• Prohibition Juice Co.
• Propaganda E-Liquid LLC
• Prophet Premium Blends, LLC
• Puff Labs
• Puff Labs LLC
• Quad City Vapers Club
• Red Rock Vapor
• Redwood Ejuice LLC
• Riot Labs
• Ripe Vapes
• Rock Ridge Vapor LLC
• Royalty Premium E Juice
• RP Vapors
• Ruthless Vapor Corporation
• SadBoy
• Seattle
• Securience LLC
• Shop Vapes
• Simple Vapor Company
• Simply Vapour
• Sir Vapes -A-Lot
• Smax International LLC
• Smokeless Smoking Inc.
• Soft Vape Inc
• South Coast Vapor Co.
• Southwest Smokeless
• SS Vape Brands Inc. Dba Monster Vape Labs
• SSY E-juice
• Stark Vapor LLC
• Steep Slope Vape Supply
• SV Packaging LLC
• SWT Global Supply
• SWT Global Supply
• Tampa Vapor Inc.
• Tasty Cloud Vape Co. LLC
• Tasty Haze
• Tasty Puff LLC
• Teardrip Holdings
• Texas Select Ventures LLC dba Texas Select Vapor
• Texas Tobacco Barn dba TXVape Barn
• The Ecig Café LLC
• The Michigan Juice Company LLC
• The Plume Room LLC
• The Vape Lounge
• The Vaping Tiger
• The Vapor Vendor LLC
• The Zen Vaper E-Liquids LLC
• TPB International LLC
• Treehouse Vapor Company dba Flagship Vapor
• TrendSetters E-liquid LLC
• True Lab Creations
• TruVibe Inc. dba Vapor Station FDL
• Turncoat Industries
• Twisted Tongue Inc.
• UIS Manufacturing, LLC
• Underdog E-liquids LLC
• Union Street Brand
• Valley Vapors LLC
• Vape Craft
• Vape Crusaders Premium E-liquids
• Vape Element LLC dba BLVK Unicorn
• Vape Hut Inc.
• Vape n Juice
• Vape of a Kind
• Vape On
• VapeDaugz LLC
• Vaper Generation
• VaperMate LLC
• Vapetasia LLC
• Vaping Oasis
• Vapor Bank E-liquid
• Vapor Outlet of Wyoming LLC dba Juicity Vapor
• Vapor Plus OK
• Vapor Rage LLC
• Vapor Salon
• Vapor Solutions & Labs
• Vapor Source Inc.
• Vapor Stockroom
• Vapor Stop
• Vapor Trail LLC dba Mig Vapor
• Vapor Unlimited
• Vapor Ventures Inc dba Innovated Vapors
• Vaporized Inc.
• Vapornine LLC dba New Leaf Vapor Company
• Vapors of Ohio Inc. dba Nostalgic Vapes
• VDX Distribution
• Verdict Vapors
• Vertigo Vapor
• Victory Liquid LLC
• VIM Blends
• Vintage & Vapor Marketplace Inc.
• Viper Vapor
• Viper Vapor
• VPR Collection
• VR Labs
• Wadina Distribution LLC DBA GOST Vapor
• Wages & White Lion Investments dba Triton Distribution
• Walker Enterprises
• Warlock Vapes dba Zuluvapes
• Wyoming Vapor Company
• Xtreme Vapors
• Yogi’s Vape
• Yoshicon LLC dba Vapergate
• Zen RVA LLC

That’s some list, right? 

The legal claim made by TPB could actually hold some weight. If the MDO’s were, perhaps, limited to a couple of outliers or charlatans, the process could be deemed ‘fair’. 

Instead, the extent of this list (considering that the FDA has been pressed for time) should indicate the scythe-like nature with which they have applied their’ abuse of discretion’.

It is hard to believe that out of the above list of 260 companies (the latest publication didn’t include the other 73), not a single one satisfied the minimum requirements. 

But then again, how could they? It was the MDO received after the application that told them what they should have done.

In essence, the blanket issuing of the FDA’s MDO’s seems the legal equivalent of an autogenerated email response.

“We aren’t available in the office right now…”

Sadly, people’s livelihoods, and lives, hang in the balance while they await a proper and well-thought-through response.

What the MDO’s State and Why They are Wrong

Interestingly, TPB’s petition also featured details of the Marketing Denial Order issued by the FDA. There are a few choice passages that might be worth reviewing.

From the petition: –

“Alternatively, FDA would consider other evidence but only if it reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.”

How’s about this? 

A decline of smoking rates from 20.9% in 2005 to a historical low of 14% in 2019? 

You don’t need to see it in an ‘official’ document. It was already plain for all to see. 

There have been numerous studies performed that prove that electronic cigarettes help people to quit. Across the pond in the U.K., the government is releasing reports that state unequivocally that vaping products could play a crucial role in reducing the enormous health burden caused by cigarette smoking. 

Furthermore, in recent weeks other big players have waded into the debate in support of vaping. Who exactly? Oh, only 15 former presidents of the Society for Research on Nicotine and Tobacco. A Professor Emeritus amongst them… What is it that the FDA needs to demonstrate what most right-minded individuals already know?

“All of your PMTAs lack sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth.”

The risk to youth? 

On the FDA’s very own shores, there are already studies that have been completed by esteemed Universities (in this case, Yale) that demonstrate, admirably, that by banning vaping products, you push people, particularly the young, back towards conventional cigarettes. 

Combine this with a study (by NIH) detailing those teens who vape would have otherwise smoked conventional cigarettes. You’ll see that instead of protecting both public health and the youth, the FDA has actually protected neither. 

The perfect storm to start, or allow people to resume, smoking? 

It is starting to look like it.

And there’s more: –

“Your products are misbranded”…

It seems to be the FDA who are confused with regards to branding. 

Why?

Even the definition of the requested submissions is incorrect. PMTA, short for “Pre market tobacco application”. While some electronic devices do contain nicotine, there is no tobacco. In most states, vaping products carry the same warning labels as conventional cigarettes (which is kind of amusing when may are sold ‘virgin’ without nicotine included, it has to be added later by the user.)

The entire thing is a mockery. 

A dedicated lawyer could argue that as most current products feature tobacco-derived nicotine, vaping should still fall under the definition. It will be interesting to see the outcome when (as several enterprising manufacturers have already begun to do) synthetic nicotine is used instead.

Perhaps the disdain with which the FDA wields its misguided power is most evident in one of the FDA’s closing remarks in the MDO: –

“FDA finds that it is not practicable to identify at this time an exhaustive list of all possible deficiencies.”

So more of the same ambiguity as before then?

Many manufacturers and vape suppliers have tried to do the right thing in good faith, spending considerable (and often unaffordable) sums against a set of criteria that wasn’t fully disclosed. 

By failing to provide the guidance and means to satisfy the requirements to gain approval, the FDA is at continued liberty to ‘make the rules up as it goes along to suit their agenda’. If only one team knows the rules, then it isn’t a fair game.

In Closing…

By seeing an MDO, any reader should be able to ‘read between the lines. The FDA has indeed been “arbitrary” and “capricious”. It has also been unclear in its guidance. The only consistency in its applications has been the blanket rejection of those who have tried their best to satisfy them. The recent petition filed by Turning Point Brands highlights the hypocrisy and thoughtlessness of the FDA’s actions. Hopefully, with sensible judgment and a favorable wind, the FDA can be made, legally, to see the light, which will open the door for others to plead their case. Here’s to hoping.