Who will win FDA approval on vape devices / liquids - post ban?
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Philip Morris and Altria.
Not even sure what is being asked here. IS there even a methodology available for further vape products? I thought there was a deadline that had passed and only two products were even submitted.
No, the deadline for approval is May 11 of next year. I have not seen any list of what has been submitted.
Anyone can create a new product but cannot market it until it passes the PMTA process. There is technically a path forward. The problem is very few are willing/able to spend the big bucks to do all the testing and jump through all the hoops to even file the PMTA. Then there is always the chance the product is rejected and must be modified and the whole process and expense started again.
The 2 dates were one for grandfathered items (the 2007 date) which would not require a PMTA and a separate date for other items already on the market. We don't know of any grandfathered itemsthat would qualify though the FDA says there is ONE. The second date was that stuff on the market before that date could stay on the market provided the PMTA was filed and had not yet been rejected.
Vuse has submitted a PMTA, that's the only one I heard of.
Between the cost, legalize, and time required to submit, keeping in mind a submission may be denied on a whim, only a company with very deep pockets will even try, and... see below.
Just even reading through the submission requirements is a slog. There is so much that is vague, and good luck finding a lawyer that can really contribute more than a vague legal opinion.
I hate conspiracy theories, but other then big tobacco, I doubt few companies could get through it, let alone even bother trying. The BT companies can, because it is written for them. Still very costly.
Just even reading through the submission requirements is a slog. There is so much that is vague, and good luck finding a lawyer that can really contribute more than a vague legal opinion.
I hate conspiracy theories, but other then big tobacco, I doubt few companies could get through it, let alone even bother trying. The BT companies can, because it is written for them. Still very costly.
I think refillables and liquid will be a thing of the past... We will just be left with single use disposable garbage. My money is on Big Tobacco being the only ones left and it will be sub-par equipment. Other manufacturers who actually make quality product will just drop out of the US market and they will instead focus on countries that actually care about their citizens health (like the UK, etc..).
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People keep saying it’s so expensive to submit a PMTA but I have not heard how much. Does anyone know, even a rough guess?
I heard $300,000-500,000$ per skew(item)
There isn't an exact cost, but the FDA estimation is "The FDA currently estimates that it takes about 500 hours or $300,000 to process a single application.". This can vary based on how much of a case you want to make for the product. Supposedly juice makers need a separate application for every flavor and nic level combination. Hardware makers supposedly need a separate application for every color of the same device, every firmware version, every little change.
I say supposedly because there is so much legal jargon in the regs that no one seems to know for sure.
More and more it seems that Big government is protecting Big Tobacco for the tax money to states. Order more than a lifetime of your favorite hardware and learn how to DIY. Stock up on 100mg nicotine base.
You have to pay the FDA that amount? What about the cost of preparing the submission, research, legal expense, etc.? Wasn't Vuse's submission like 150,000 pages or something like that? Could have been 15,000... I have been known to exaggerate. lol
EDIT: Just checked, it was over 150,000 pages.
EDIT #2: And if that $300,000 is to the FDA, it's going to take a heck of a lot longer than 500 hours to get through 150,000 pages... probably at least 10x that amount of time.
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Interesting thought. Pharma has been very quiet, at least in public, but they have a large stake in nicotine. Cessation products currently, and nicotine as a medication could be a huge deal in the longer term, especially if smoking goes out of fashion. And given their size and influence if they want a PMTA they will get one. Nicotine vaping to ward off Alzheimer's could be the biggest earner in history.
It's been a thought I have entertained for a while. It would be hugely lucrative to have a corner on the nicotine market. The regs seem to be written to require the type of testing and documenting that the drug companies already have in place, and they also make medical devices.
They would more likely produce effective platforms for delivering nicotine vapor than the tobacco companies have been, and if the FDA is successful in destroying the domestic market, there will be a huge demand left unfilled. I bet they would even use some sort of temp control protections. Just a hunch, but it wouldn't surprise me if it plays out like that.
When you say "acquire the rights", if you mean Who will receive a PMTA Approval in the 1st round, that is Simple.
It will be BT and NJOY.
Where it gets kinda Sketchy is when one tries to predict Who might be able to Obtain an SE on a PMTA-ed product.
The problem with that is I am pretty certain that the submissions for things that will be classified as medical treatments take years of strict testing and studies before they can gain approval. So if they did decide to do that, it would be years before we would see anything. (I doubt they would go the route of the Deeming Regulations, because that would be branching out into business outside the scope of their current business model).
EDIT: But if they did do it, they would be the only ones that could market/advertise it as a smoking cessation device... Juul, Njoy, Vuse etc could not do that.
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If I were a betting man, NJOY is most likely the one that has the pre-2007 product.
Well, they could start with just approval as a prescribed smoking cessation system (they may well already have finished clinical trials and are just waiting for the
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