The Big Tobacco backed Vuse Solo pod kit could be the first e-cigarette to get complete FDA approval.
Owned and manufactured by Reynolds American Inc. – a subsidiary of multi-national corporation British American Tobacco, the Vuse Solo is the first vaping product to be submitted to the FDA’s controversial Premarket Tobacco Product Application [PMTA].
It is this expensive and time consuming process every single vape product that has been on the market since February 2007 will need to pass through IF it is to remain on sale within the USA.
I’ve written a number of articles around the PMTA process and suggest you read them as a matter of urgency!
- 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 Fight To Save Vaping In America Has Begun
In simple terms all vape companies that want to sell its products in America MUST submit a PMTA BEFORE May 2020. Each individual product will then be allowed to remain on sale for 12 months whilst the FDA reviews the application and then carries out a substantive review and only IF the initial paperwork is deemed acceptable!
OK, with an estimated 3 million [and rising daily] individual vape products on sale in the USA from coils to drip tips – e-liquids to sub-ohm tanks, that have been on the market since February 2007, ALL of them need to be submitted to the FDA via the PMTA process.
Hence my use of the word ‘controversial’ especially as each individual PMTA can cost close to $500,000.
As I’ve said before, this is most definitely a ‘backdoor vape ban’ by any other means.
And as I’ve also said, it’s going to be Big Tobacco vape products and market leader JUUL that can afford not only the cost – but also have the manpower and pull to comply with the PMTA process.
Big Tobacco Getting the Drop On Vape Companies
Reynolds are ahead of the game so let’s see what hoops its had to jump through and how much red tape is involved to get to the first stage of complete FDA approval for an e-cigarette.
For a start the company has been working on this for years – the PMTA process is not new – the deadline has just been altered.
Remember the PMTA process has been around a long time and has been pushed backwards and forwards on numerous occasions.
The new deadline date of 2020 came into being following a ruling by Judge Paul Grimm back in May this year.
In response to a law suit brought by among others, the American Academy of Pediatrics and the Campaign for Tobacco-Free Kids, Judge Grimm decided the FDA needed to act swiftly to ‘protect the children’ – the so called ‘teen vape epidemic’.
In effect the plaintiffs felt by moving the deadline back to 2022 and then 2021, the FDA had acted improperly and the judge agreed adding it had been:
…so extreme as to amount to an abdication of its statutory responsibilities.
What’s clear here is the PMTA process has been a ticking time bomb for the global never mind US vape industry and vapers – and as I said whilst big and small vaping companies from across the globe have buried their collective heads in the sand, Big Tobacco has beaten them to the drop.
It’s quite staggering to think that one HUGE China based vape company for instance has NO knowledge of the PMTA process and others simply haven’t responded to my queries…
I shall definitely be talking to them at Vaper Expo!
Reynolds Files PMTA For VUSE Solo and More To Come
The Vuse pod kit is one of the few we haven’t reviewed and it looks like your bog standard set-up with pod popping onto the battery.
For us here in the UK and under the rules of the TPD, the Vuse Solo has a high level of nicotine in the pods of 48mg – less than the US JUUL but still strong stuff.
It currently has a number of flavoured pods including Original Tobacco – Menthol – Melon and Nectar.
Reynolds say they have submitted over 150,000 pages to support its application adding:
FDA has issued guidance explaining criteria for PMTA submissions, which make clear that manufacturers must provide not only information on the composition, design and manufacturing process associated with the product, but also chemistry, toxicological and behavioral studies that demonstrate the product − when used − is appropriate for the protection of the public health.
To support the applications and meet this guidance, Reynolds’ submission to FDA includes more than 150,000 pages of documentation.
That’s a lot of work, even for a tobacco giant, so based on that and that alone, what hope does a small vape company based in the USA or one hoping to sell its products in America have?
And remember – the initial submission is just that – if it doesn’t follow EXACTLY what the FDA stipulates, it will be thrown out. And even if it passes through the first phase it then goes under ‘substantive review’ which I guess means they will go over everything with a fine tooth comb and then some.
And a reminder this is only for the Vuse Solo and individual pods – Reynolds plans to submit more PMTA’s and I guess that means the Alto – Vibe and Ciro kits and any others currently in the R and D stage…an expensive business!
Dr. James Figlar, Executive Vice President of Scientific and Regulatory Affairs at Reynolds was in an upbeat mood:
Today’s application marks the culmination of years of hard work across multiple teams, involving more than 100 individuals, including dozens of Ph.D. team members collaborating every day, with a substantial financial investment.
This is an important first step in a long process for the millions of adult cigarette smokers who may want a legal alternative to combustible cigarettes, thus we look forward working with the agency as the process moves forward.
Ricardo Oberlander, CEO of Reynolds said:
We have long worked to build a broad portfolio of competitive options for the adult tobacco consumer, and today’s application is a strong next step for us in that journey.
We continue to support the FDA’s efforts to create, implement and enforce a science and rule-based regulatory regime to protect the public health.
Our regulatory applications, including those submitted for Camel Snus along with other future submissions for products in our Modern Oral Portfolio like VELO, are positioned to transform the market through a range of dynamic alternatives to traditional combustible cigarettes.
Big Tobacco is not only moving in – it’s planning to outgun any other vaping manufacture in the world that wants to sell its products in America – including as it stands now China.
Unless something radical happens, come May 2020 vapers in America look likely to be faced with no choice when it comes to what they want to vape on unless it comes from Big Tobacco.
Let that sink in…
First of all it’s kind of poignant that a Big Tobacco company is the first to submit a PMTA given they arrived late on the vaping scene – and many say shouldn’t be in the industry at all lol.
But then poignancy has no place in this corporate world we live in – dog really does eat dog and the market speaks.
And I’m at that stage now where whatever ‘proven safer’ vape or HNB product helps folks quit smoking then that’s OK with me…to some extent even JUUL [grudgingly].
My fear, OK some might say my doomsday message, that vaping in the USA is on the brink of complete and utter devastation – and not just from vape and flavour bans – is wrong need to wake the f**k up.
The PMTA process is HERE and I have no doubt it looks more and more likely to leave Big Tobacco and possibly JUUL the ONLY companies allowed by law to market their usually sub standard vaping products in America – it’s really that simple.
The massive Chinese vape companies need to act and act now before it’s too late…or not a single product of theirs will be sold in the USA post May 2020!
Is there even the slightest beacon of light out there?
Not really, though as I’ve reported the Vapor Technology Association along with the Vapor Stockroom has filed a lawsuit challenging the now 9 month PMTA deadline.
It’s hoping to stop or at least alter the deadline yet again.
The gist of the suit is:
… amongst others, over its unreasonable and arbitrary Pre-Market Tobacco Application (“PMTA”) process and the recently grossly accelerated PMTA filing deadline.
Plaintiffs are taking action to require FDA to publish and complete the long-promised “foundational rules” describing the specific requirements for PMTAs.
In addition, Plaintiffs are asking the court to enjoin FDA from enforcing the May 2020 PMTA deadline or taking enforcement action against companies that do not have a PMTA on file until a reasonable period of time after the actual foundational rules are finalized.
With over 3 million vapor products registered with FDA, the arbitrary May 2020 PMTA deadline which FDA is currently enforcing is simply impossible to meet for thousands of small and mid-sized vapor businesses, particularly in the absence of a draft or final PMTA Rule.
Any final PMTA Rule must allow sufficient time to conduct the many complex and time-consuming tests and studies currently being required by FDA.
Since 2016, FDA has provided five different PMTA submission deadlines: August 8, 2018; November 8, 2018; August 8, 2022; August 8, 2021; and now May 12, 2020.
The most recent deadline was only just established on July 12, 2019 – leaving a scant ten months for vapor industry manufacturers to attempt to comply, which is now 27 months earlier than previously set by FDA.
Again not being a ‘doomsday merchant’ but I doubt this will achieve its purpose – but I guess at least the VTA is doing something and recognizing that ticking time bomb the PMTAs are.
Tony Florence, President of Vapor Stockroom, LLC summed it up:
Our company complied with every regulation imposed by FDA and invested in our business while waiting for FDA to deliver on all of the promised PMTA rules, guidance and standards.
We never thought that FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business.
It’s a devastating one-two punch to small businesses all over the country.
The FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette.
Whatever FDA calls its ‘rules of the road’ simply cannot be relied upon in the absence of a real PMTA rulemaking process that gives all stakeholders the opportunity for notice and comment, not just those interested parties that file lawsuits.
Absolutely – as I’ve said before this is vape bans by the backdoor and the only one’s left standing will be Big Tobacco companies and their in general awful vaping products.
The FDA – the anti-vape groups and media have been acting as Big Tobacco and to some extent Big Pharma’s hit men.
A case of kill off the competition and keep those Big Tobacco profits rolling in.
Not forgetting of course, the more Big Tobacco profits – the more shareholders earn and states relying on those pesky Tobacco Master Settlement Agreements will see the cash cow continue to roll in.
Sadly it’s NEVER been about smokers health or the BS of the so called teen vaping epidemics – it’s been about money…as always.
Vape companies or individuals looking for more info on PMTAs should read the FDA guidelines: