Who will win FDA approval on vape devices / liquids - post ban?
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Yeah... But there is a small Problem with it.
And that is if someone was around Way Back when, they would remember just how Piss Poor all that stuff worked as compared to Pod Mods now.
So a 150mAh Battery with a 2 Piece Atomizer that holds 11 Drops of e-Liquid might be Grandfathered. But I'm Not sure how well it is going to do Even in a Regulated Market?
BTW - Once we pass the Rubicon in 200 Days or so, do you think there is going to be Bottled e-Liquids sold so you can Fill Up a circa 2007 2-Piece Atomizer?
No, but Njoy sold those wonderful pre-filled cartridges that lasted for at LEAST 3 puffs...
Yeah... I remember the Big Sales Pitch back then was that 1 Cartridge was Equal to a Pack of Smokes.
LOL
And what made it even More Comical was that most people Needed like 3 or 4 Batteries to get thru a Day.
No, they're classified in a an entirely different part of the FDA. If these had to pass as new drug application you can multiply the cost by 100. A PMTA is far easier than any drug application despite being so daunting.
But they can't market it for that without FDA approval. It's hard to make money on off label use on products that already have generic equivalents on the market like NRT.
Why did you say "No" when you are basically agreeing with me? lol
All the reason to stock up on hardware (mods and attys) and supplies, and learn to DIY. If you don't get it now you won't have it then. Or, wean yourself from nic and call it quits.
supplies=nicotine! The most important item.
True, but when vaping all but disappears, an approved 'smoking cessation' vape device could be released into to a near vacuum, so they can already make money. Once on the market as an "approved" NRT, they won't market for off-label use directly, just encourage and fund studies that show other benefits (there are a number already) and let it happen.
You're right. I read it backwards. My bad.
Yes, but there are already a nasal and now a mouth spray (the mouth spray I believe is pretty new so they're protected on that one as brand name only for quite a while) as well as a nicotine inhaler, which is shaped like a fake cigarette and was a lousy product as it was like sucking though a straw with no real satisfaction trying to get the nic out.
For a smoking cessation device that works like a current vape system of heating and vaporizing a nic solution they'd have to go the NDA route, which is a fortune. The only difference to say IQOS, would be instead of modified risk harm reduction product, is the ability to say it's smoking cessation product. I'm not sure how many people would even be able to tell the difference if both are for sale without any prescription and even sold next to each other (assuming the Nicotrol Vape went for mass market sales). And if stuff like Vuse (already filed a PMTA for) and Blu are out there, I'm not sure Pfizer would want to even get into the kind of mega marketing campaign they'd need to.
The idea behind the whole Tobacco Institute PMTA structure was to avoid smoking cessation claims, as that belonged in another part of the FDA, and they were already told you couldn't treat something like vaping as a new drug. While a PMTA appears mountainous to tackle for a small vape company (even the big players who are non-BT) is a fraction of an NDA and something BT is more than happy to generate. While that 150,000 page submission for Vuse likely cost in the low eight figures, it's less than a tenth of an NDA, and a perfectly acceptable amount for a BT company. Is Pfizer really going to jump in with their own nic vape for smoking cessation device when it will cost them nine figures for the approval process? I can't see them bothering with it.
That said, you're right, they have enough nicotine delivery products on the market that should studies support new, off label uses, they'll still benefit without tackling the "vaping as a smoking cessation" approval process. Let alone nicotine for Alzheimer's. Unless they can come up with a synthetic nicotine derivative that's just a different enough molecule for patenting, but that works in clinical studies. Then they would get to selling it for a ridiculous amount of money as a new drug approved for Alzheimer's disease. Which I have no doubt they're already working on.
For those of us who enjoy the actions of smoking without the 500 or so chemicals vaping will continue. I can't see myself buying a new piece of throwaway hardware each week (or buying a new cartridge daily).
After the CBD debacle with oil based ingredients we are looking at an increase in control by government. They can always say that vaping is a good way to quit smoking, but we have to control the market for the personal safety of those who choose to use vaping as a quit smoking tool. That means they hand it over to big tobacco because they don't have the manpower to ride herd on every vape shop in the country. Controlling vaping through corporate officers is much easier and less costly than visiting every vape shop in the country on a scheduled basis.
Maybe I'm seeing something that won't occur. Before the CBD scare I was confident that vaping would continue to be regarded as a good thing.
After the CBD debacle with oil based ingredients we are looking at an increase in control by government. They can always say that vaping is a good way to quit smoking, but we have to control the market for the personal safety of those who choose to use vaping as a quit smoking tool. That means they hand it over to big tobacco because they don't have the manpower to ride herd on every vape shop in the country. Controlling vaping through corporate officers is much easier and less costly than visiting every vape shop in the country on a scheduled basis.
Maybe I'm seeing something that won't occur. Before the CBD scare I was confident that vaping would continue to be regarded as a good thing.
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No, not the approval deadline. The submission deadline.
As things currently stand, no newly deemed tobacco product that wasn't on the market by 2007-02-15 may remain on the market after 2020-05-11 unless a PMTA has been submitted by that date. Once an application is submitted, the Deeming Regs allow an additional year on the market while the FDA reviews the application for that product.
Caveats:
The Tobacco Control Act clearly allows the FDA only 180 days to review an application. Yet the FDA has consistently dragged its feet taking two or more years with the PMTAs that have been submitted to date. One was for IQOS and one was for Swedish snus. Both were eventually approved. Now in the case of existing products that already on the market, my personal opinion is that the FDA will not require them to be removed from the market for however long their PMTAs remain under review.
There are a whole lot of products currently on the market that aren't supposed to be on the market without a PMTA having been submitted and approved first because those products were introduced to the market after 2016-08-08. Yet on the market they are, and the FDA has done virtually nothing about it. This makes me wonder just how vigorous their enforcement will be after 2020-05-11, especially since they were forced to pull that deadline forward by a court, and they clearly didn't want to.
No, the money doesn't go to the FDA. This how much the FDA expects it to cost a manufacturer to prepare an acceptable application.
Note: Just because an application is "acceptable" doesn't mean it will be approved. It just means that the FDA is willing to review it, rather than reject it out-of-hand.
Absolutely. Although I don't know how vigorously any of it will be enforced after next May, the safest course is to become self-sufficient before then. Even if the FDA doesn't do much enforcement, look at what's currently happening in various states and localities and take it as a warning.
Perish the thought!
LOL... true... not "me".. I should have said: "others who are unprepared".What do you mean, "We"?
In those deeming regs, does it spell out an exception for tobacco flavored liquid?
No. However, it's pretty clear that tobacco-flavored products will have a better chance than flavors that supposedly only "appeal to children".
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