Fight To Delay the PMTA Process – Appeal Court Will Decide

Vape lawyers are hoping an appeal to delay the PMTA process will mean America’s vaping industry and vapers will have more time to fight what is a devastating piece of legislation.

The Pre Market Tobacco Application is due to come into law in May this year and as I’ve reported a number of times, it will spell the end of vaping in the USA as we know it today.

Please note this legal challenge is limited to ‘stalling‘ PMTAs and not ending the process – I’m no lawyer but am pretty sure only an act of Congress could get rid of it.

More on the legal challenges in a moment, but first a quick reminder exactly what a PMTA is – how it will impact vaping in the States and how we got to this point where the future of vaping in America rests on the legal system.

Delay the PMTA Process – How We Got Here

I’ve written a more detailed explanation of what PMTA’s are all about: Vaping In America Faces Total Devastation As Anti-Vape Legislation Is Moved Forward – and I urge you to read it.

OK, and in a nutshell, all vape products in the USA come under the 2009 Tobacco Control Act.

Part of that legislation says any new tobacco products – including all things vape – needed FDA approval BEFORE they could be sold, any product that came out before 2007 was exempt – or grandfathered.

The FDA had quite literally turned a blind eye to all the vape gear released since 2007 and were relying on the PMTA process then set for 2022. However and under intense pressure from the media and anti-vape groups, former FDA supremo Scott Gottlieb pulled the date forward to 2021.

Anti-vape and health organizations banded together in a law-suit that claimed the FDA had sat idly by leading to the alleged ‘teen vaping epidemic‘.

Maryland Federal Judge Paul Grimm agreed and not only that was scathing at the FDA’s approach to all things vape adding it had been:

…so extreme as to amount to an abdication of its statutory responsibilities.

The FDA had the right to appeal, however behind the scenes negotiations led to Gottlieb bringing the implementation of the PMTA process forward to the current date May 12th 2020.

Now the fight is on to delay the PMTA process through the federal court appeals procedure.

What Is the PMTA Process?

Once again I urge you to read the larger article I wrote and have linked to above.

In simple terms, every single vape related item from a drip tip to individual e-liquids – every single coil and even vape styled hoodies [yes really] will need to pass through the PMTA process if it wants to remain on sale in the USA.

This will involve submitting a mind boggling amount of scientific data proving the device/juice/accessory is safe at an astronomical cost of up to $480,000 PER ITEM!

Yes that is per item.

As you can see, smaller, if you like mom and pop businesses, simply cannot afford that and in effect means they will stop trading at the loss of thousands of jobs and livelihoods.

Indeed some of the larger companies such as say SMOK, will find submitting a PMTA per coil would put them out of business pretty quickly!

Any device that has a PMTA submitted will be allowed to remain on sale in the USA for 12 months whilst the FDA reviews the application.

Fail at any stage and poof – money gone and the item will not be allowed to be sold and the PMTA will need to be submitted again.

Costly to say the least.

Legal Challenge To Delay the PMTA Process

I’ll say it again – I’m no lawyer and reading the submissions from all sides in the delay the PMTA process appeal is very legaleeze in its wording!

From what I can gather, the original motion to stay the PMTA process was filed back in mid December 2019.

Vape lawyer Azim Chowdhury tweeted at the time:

You can read the full motion via the link on the tweet.

On December 31st the legal team for the public health interest group, made up from parties such as the American Academy of Pediatrics – American Cancer Society – the Truth Initiative and the Campaign for Tobacco Free Kids, filed its counter motion arguing why the stay should be refused.

They claim there’s x4 main pillars as to why the stay should be refused:

• No likelihood of success
• Not shown irreparable harm – there’s no legally cognizable harm in being prohibited from selling products without the authorization required by law
• A stay would make it more difficult to counsel and treat the victims of the epidemic of youth usage
• The public interest weighs heavily against a stay

Delay the PMTA – FDA Motion In Opposition

On the same day as the motion above was filed – the FDA submitted their own.

As you can imagine they are vehemently opposed to a delay in the PMTA process and hung their hats pretty much on…yeah you guessed it…protecting the children with part of the motion a little shall we say emotional for a legal document:

…the public interest militates against the requests for stays pending appeal.

Data show that young Americans are using e-cigarettes in alarming and increasing numbers, and cast doubt on many of the assertions made by the industry groups.

The agency is taking aggressive action to curb this trend and opposes any attempt to restrain FDA’s ability to enforce the Tobacco Control Act.

Tough words indeed.

Latest Motion FOR the Stay

Confused yet?

I am, kind of lol.

Anyone watching a US court based TV show or film has a basic grasp of motions being filed at every turn lol.

So in reply to the last two motions and arguing against them, a fresh motion was filed a couple of days ago…

Not sure about you – but I’m getting bloody motion sickness here.

I know, I know this is serious stuff…but blimey!

OK, this fresh motion arguing against the other motions also attacks the FDA’s new guidelines on vape products being used to moot/stop the whole appeal process.

I covered those guidelines here: Trump Bans Flavoured Pods.

Read the full guidelines: FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.

So, and in a nutshell, the counter motion argues:

• The guidance, moreover, does not moot this litigation
• The Vapor Associations Have Established A Likelihood Of Success
• Vapor Product Manufacturers Will Suffer Irreparable Harm
• Plaintiffs Have Not Shown Substantial Harm

The motion concludes with a another counter-argument that vaping does not help smokers quit:

Indeed, there is extensive research demonstrating that vaping helps adults fully transition away from cigarettes.

For example, a recent one-year clinical trial published in the New England Journal of Medicine found that vaping is nearly twice as effective as other cessation products (i.e., nicotine replacement therapies).

At a minimum, even assuming arguendo that additional research is required to confirm those benefits, jeopardizing such potential through the denial of a temporary stay would be unwarranted.

Well said.

What’s Next and Final Thoughts

More motions lol.

The FDA and pro-vaping legal teams will now need to submit further motions on January 14th 2020 – or at least that’s my understanding – like I said a bit of motion sickness going on in my addled brain!

I can see this one going on for a while and I have a feeling the judges will tire of it all and come down on the side of the FDA and anti-vaping lobby.

Also a stay is just that – a delay in the PMTA process.

Sure it could give the beleaguered vape industry and vapers in America breathing space [pun intended] but it’s really sticking a band aid on gaping wound.

I hope I’m wrong and sure it would be great to get a delay, but the current anti-vape climate in the USA doesn’t look like going away any time soon.

And as I’ve said before, individual states will if they continue to come under enough anti-vape public pressure – will ban 99% of vape products anyway.

The key here is to sort out the PMTA process from the root up.

It’s cumbersome – expensive and as I’ve already written – there’s simply NOT enough laboratories around to cover even a small percentage of the scientific studies required on each item submitted for PMTA and FDA scrutiny.

It’s a complete shit show to say the least and unless vaping’s image gets a major boost over the pond – which is unlikely – it doesn’t matter if its May 2020 or May 2022 – the writing is sadly on the wall.

Let’s hope I’m talking out of my ample ass…again.

So what are your thoughts on the motions and the PMTA process?

Let me know in the comments below.