Whilst the current swathe of flavour bans sweeping across America is of course bad for vaping, there’s a far greater threat and that is the implementation of the FDA’s PMTA process.

Given the current hysteria over flavoured pods and e-liquids whipped up by the mainstream media and sound bite hungry, virtue signalling politicians, advocacy groups and protesting vapers may have taken their eye off the main event.

pmtas

The FDA will announce tomorrow [Wednesday September 25th 2019] its “proposed rule for premarket tobacco product applications” – once published it will be open to public consultation for 60 days ending on November 25th 2019.

I wrote an detailed article on PMTAs: Vaping In America Faces Total Devastation As Anti-Vape Legislation Is Moved Forward – it might be worth a read to say the least 😉

This time consuming and expensive process has never gone away, instead it had been pushed back until May 2022.

This on the heels of the outcry over the supposed ‘teen vaping crisis‘ in the States and following a judge ordering the FDA to act.

After talks, the two sides brought the process forward – meaning vape companies from across the world have now just 9 months to get their PMTAs submitted and passed if they want to sell any of their products in the USA.

In a nutshell every single post February 2007 vape product from a drip tip to flavoured e-liquid will need to pass through the FDA’s eye-wateringly expensive approval process called the PMTA.

And when I say expensive I mean each one costing up to $460,000 each!

That’s nearly half a million bucks per product that has been on the market this past 12 years!

Fail at any point in the process and poof – cash gone and back to square one with extra costs racked up.

FDA approved drugs

And in this case it isn’t just flavoured e-liquids – as I’ve said, it can be anything from a stock coil – to a little blue screwdriver and even that ubiquitous vape hoody [yes really].

Now how many of even the biggest vape companies across the world can afford that cash – time and effort?

Not many – indeed none of the China based companies I’ve spoken to have any idea about this!

The simple question is – will the likes of SMOK or Augvape want to spend millions making sure their stock coils or tanks brought out in say 2015 are worth spending almost $500,000 on EACH item so they can still be sold ‘legally’ in the USA?

Do the math and like me you’ll come to the same conclusion…highly unlikely.

FDA Says PMTAs Will ‘Protect the Kids’

Acting FDA commissioner Ned Sharpless urged companies to not wait for the May 2020 deadline, but instead begin completing PMTA applications now:

Our review of premarket product applications will help evaluate the public health benefits and harms of a tobacco product to ensure that those authorized for marketing are appropriate for the protection of public health.

This will include understanding the likelihood that those who do not use tobacco products – such as kids – will start using them, as well as the likelihood that tobacco users will stop. And as I’ve said before, responsible manufacturers certainly don’t need to wait to act. We encourage industry to use available FDA resources as a guide for their submissions to the agency.

ned sharpless fda
via: FDA newsroom – Norman Ned Sharpless

This proposed rule follows our announcement last week that we intend to finalize a compliance policy in the coming weeks that would prioritize enforcement to clear the market of unauthorized, non-tobacco-flavored e-cigarette products.

These important regulatory actions are part of our ongoing oversight of e-cigarettes and other tobacco products that is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine addiction and tobacco-related disease and death.

The FDA is also holding a public meeting on all things vape and say:

This meeting is intended to provide information on the agency’s expectations for tobacco product applications with a particular focus on deemed tobacco products (e.g., cigars, waterpipe, and Electronic nicotine Delivery Systems (ENDS) including e-liquids and electronic cigarettes) including product review policies, procedures, and general scientific principles.

The information will improve public understanding and assist persons considering submitting marketing applications for tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act)

fda pmta public meeting

Put this date in your diary:

October 28-29, 2019
08:30 AM – 04:30 PM EDT
White Oak Campus: The Great Room
Conference Center
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States

You can find out more: Deemed Tobacco Product Applications – A Public Meeting

So Are Flavour Ban Protests A Complete Waste Of Time and Money?

Probably…and here’s why.

It’s really quite simple.

All the energy, money and public protests being thrown at flavour bans is, and will be, a complete waste of time come May 2020 – the deadline date for the FDA’s Pre-Market Tobacco Product Applications [PMTA].

Unless of course every single e-liquid manufacturer in America or indeed the world, submits a PMTA for every single flavour or vape item they make and sell, AND every single one passes through the mind boggling FDA red tape.

It’s a gamble and an expensive one at that.

san fran vape ban

So what’s the answer?

Whilst its great to see a tiny part of the USA vape industry and vapers coming together – it’s all a bit late.

Being the old cynic that I am I wrote back in 2017 in the State of the Vape and following the FDA’s announcement it was pushing back the PMTA deadline 2 years – that it was way to early for the advocacy back slapping and high fives saying ‘we’d won the war on vaping’.

I hate to keep banging on about it – but – The PMTA process has been with us for an age – no-one seems to be either taking it seriously OR are anywhere near prepared enough.

Sure the knee jerk grass roots reaction to local and state flavour bans is admirable and I hope campaigners score a few victories, of course I do.

However, win a couple of rounds by all means, but trust me, the PMTA process is the knockout blow and vaping in America will NEVER be the same again.

Note: Once the FDA publishes it’s proposals on the new vape legislation I shall of course look at them in more detail.

Find out more about the PMTA Process

Neil Humber
I began vaping in 2012 and found it easy to give up a 40 per day roll-up habit! DTL: Lost Vape DNA75C BF - Dead Rabbit SQ - MTL: JacVapour Sandstorm DNA 75 + Savour RTA...Beater set-up Lost Vape DNA 250c and Reload RTA I'm a former journalist and now a writer and author.. I'm an Army veteran - adore dogs and never happier than with a good book on a beach.

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