Hundreds of millions of dollars !.
It'll take any vendor about ten thousand years to make that back.
- Status
Hundreds of millions of dollars !.
It'll take any vendor about ten thousand years to make that back.
I think you're now getting in to "Man never landed on the moon" territory and I am not sure how to respond.
The lunar buggy can clearly be seen with a decent industrial sized telescope.
Those who post unbeleiveably and ridiculously high estimates are the ones you must be referring to.
Once they do the main PMTA they do not need separate ones for each mg available... there is a separate less extensive/expensive app that can refer to the main one.Hundreds of millions of dollars !.
It'll take any vendor about ten thousand years to make that back.
Quote 1 from Black Note Successfully Registers All of Its E-Liquids With the FDA - Black Note
"The only viable alternative is the PMTA approach. This isn’t ideal. Not only is the estimated cost of each application $1.3 million, it isn’t a process that was ever really intended to be successfully navigated. Among many other requirements, companies have to show that “permitting this product to be marketed would be appropriate for the protection of the public health.”" End quote.
Quote 2 from What is a PMTA? A Simple Explanation of How It Will Affect Vapers - Black Note
"It’s estimated that each PMTA will cost $117,000 to $466,000. That is for every product you want to keep on the market, including different e-juice flavors and nicotine levels. For many businesses, this is an insurmountable hurdle and they will undoubtedly have to close up shop. The actual cost might also be even higher than this, depending on the amount of original research and analysis is needed to support the application". End quote.
One point three million !, hundred and seventeen thousand !, four hundred and sixty six thousand !.
I realise there "is" a cost for each application. But ever since this has been an issue i've read many different estimates. The only people who know the real cost are those who apply.
Just seems to me that these "estimates" are total crap !. And in reality it probably costs a few hundred per app, if that !.
Unless Black Notes has actually just paid out say for 100 apps one hundred million dollars. Or two hundred apps, it goes on !. Imagine a thousand apps, that's a billion dollars !.
Who's going to believe that one app for one e liquid is going to cost 1.3 million or hundreds / tens of thousands.
These estimates are an insult to the reader. Why can't these vendors just be honest for once.
Work it out for yourself, it's ridiculous.
Just a Note on Multiple PMTA's...
Say I'm an OEM and want to file a PMTA on my "XYZ" Model 900mAh Pod Mod. These Top-End FDA cost estimates may be correct.
But at the same time, or sometime down the road, I decide to do a PMTA for my "ZCR" Model Pod Mod which uses the Exact Same Pod with the Exact Same e-Liquid with the Exact Same Functions with the Same Basic Styling and the Exact Same Packaging. Only the "ZCR" is a 1,500mAh Pod Mod.
In this case, "Bridged Data" from my Original "XYZ" PMTA could be used. Because the Only thing that had changed would be a Bigger Internal Battery. So in this case, the Cost of doing the "ZCR" PMTA would be Dramatically Less.
Not say'n that PMTA costs are going to be Reasonable. Or that the VAST Majority of OEM are going to be able to Fork Out the Money involved when there is No Guarantee or even Predictable Standards for Success.
But Bridged Data will be used for Incrementally Similar Closed System e-Cigarettes.
Oooooh !.
Well no one mentioned that before now. But in my defence it does say quite clearly those estimates are for each product..
There's no reason for a PMTA rejection. Unless there really is something iffy about the company (and their products - probably e lqiuid) who are applying.
No one, no matter how big a company they are, are going to pay out half a million quid for a PMTA on a mod. NO ONE !.
It's crap !.
Last edited:
I mean, who's been rejected ?. Are we going to hear about those who have been rejected i wonder ?.
I Can't see Any Stand-Alone e-Liquid receiving a PMTA.
And I would say the Majority of PMTA Applications with be either Summarily Dismissed, or Dismissed withing 90 Days of being Submitted.
It depends on what the actual cost is and the amount of money to be made. I believe that, even if unregulated products are allowed to stay on the market, to be the only, or one of a few, products with actual FDA approval could be immensely profitable. If all other products are taken off the market, then approval becomes the only game in town, of course.
Agreed, of course that leave small businesses in a tight spot but leaves everything wide open for the big players. One thing is for certain, our options will be nowhere even remotely close to what they are today... only a fraction of what there is now. The big players (Big Tobacco, etc) will have the market cornered.
- Status
Similar threads
- Locked
