The FDA has confirmed there will be no PMTA extension leaving vaping as we know it in America in turmoil.
There’s currently around 4 million vape devices on sale within the country and the vast majority of those will be removed from the shelves within a week.
The Pre Market Tobacco Application process means that all vape gear – including coils and merch – needs to have a PMTA submitted or it will not be allowed to sold within the USA.
The documents surrounding the application must include a mountain of scientific evidence proving the product is safe and each submission can cost up to $460,000.
Once a PMTA attached to a single product has been submitted, that item can remain on sale until the FDA gives it the green light which could take up to 12 months.
I’ve written at length about PMTAs as far back as July last year – see the articles below for more background:
- Vaping In America Faces Total Devastation As Anti-Vape Legislation Is Moved Forward
- Forget Flavour Bans the PMTA Process Is the REAL Threat To US Vapers
The Vaper Technology Association had asked for a 12th hour extension to the September 9th 2020 deadline for PMTA submissions.
However the FDA responded and refused adding:
The FDA has received many individual requests for a further extension of the September 9, 2020, premarket application deadline.
After considering your request, FDA has determined that it will not grant a further extension of the September 9, 2020, premarket application deadline set by the Court for members’ products.
Any additional delay would impede FDA’s critical public health priority to promptly require submission of premarket tobacco applications.
So that is pretty much that and as of next week close to 4 million vaping products will simply vanish from sale.
NO PMTA Extension – Chaos Expected
However, and with a tsunami of paperwork heading to the FDA, it doesn’t take a genius to work out it could be chaos to say the least.
As I’ve written before, there’s simply not enough scientists or indeed labs to test each submission and even the FDA admits that.
It told the VTA:
…there are over 400 million deemed products listed with FDA.
Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced.
Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.
It looks likely the FDA will need to extend the 12 month approved sale period for vape gear with an accepted PMTA as they simply don’t have the manpower or capacity to deal with the unprecedented number of applications …
Crazy to say the least.
In the meantime the FDA is planning to release a list of vape products with a PMTA attached and this will enable retailers to remove those without…expect that within a month or so.
Petition Launched To Help Smaller Vape Manufacturers
Whilst Big Tobacco, JUUL and Vaporesso has submitted PMTAs it’s the very many smaller vape manufacturers that are facing shut down.
The Consumer Advocates for Smoke Free Alternatives – CASAA – has organized a petition calling on the FDA to extend the September 9th deadline by 180 days.
It says the smaller companies are simply overwhelmed with the documents and scientific evidence needed for a submission, with COVID-19 making it even more difficult.
If granted, the extension would move the deadline for small, open-system manufacturers to March 8, 2021.
The request is predicated on a recent action taken by FDA in which small cigar manufacturers are being granted a similar extension due to complications and delays to completing PMTA’s associated with COVID-19.
To match the criteria of being classed as a ‘smaller vape company’ CASAA has issued these guidelines:
- Has less than 50 employees and/or 10MM in annual revenue;
- Only manufactures open system products (e.g., e-liquids) and does not produce products used in cartridge- or pod-based products;
- Has taken steps to prohibit access by and sales to underage consumers for brick-and-mortar stores and/or retail websites;
- Will only market to adults and not rely on kid-friendly advertising (e.g., using age-gated social media accounts);
- Is otherwise in compliance with TCA and Deeming Rule requirements (e.g., facility registration, product listings, etc.); and
- Has already made progress in completing PMTAs prior to the September 9, 2020 deadline, but has been materially delayed in one or more tasks due to COVID-19.
Read more and sign the PMTA petition.
For more information read the VTA release: PMTA UPDATE FOR MANUFACTURERS & RETAILERS