What would be the Advantage of Submitting a PMTA now verses a month or so before the Deadline Date? Attempting to get Approval before a potential FDA Leadership change?
What might be the Downside?
Deeming Regulations have been released!!!!
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What would be the Advantage of Submitting a PMTA now verses a month or so before the Deadline Date? Attempting to get Approval before a potential FDA Leadership change?
What might be the Downside?
All products put on the market after 8/2016 are illegal if they don't have an approved PMTA so you'd need one to sell them regardless of that deadline, the deadline only applies to products released before 8/2016. Or be OK with the FDA taking it off the market in an instant if they decide to stop looking the other way.
If I go into a German vape shop then the number of products on the market before 8/2016 (and not modified in any way since) is very small in comparison to newer devices. I myself use only 1 such device today (a joyetech Cuboid 150).
Would it be significantly different in the US?
The downside is it probably costs millions of $$$ for every single device you submit and there's no telling if it even has a chance of getting approved. Nobody in their right mind would be willing to lo-flush that much money down the toilet for notten.
I probably Phrased my post poorly.
I probably should have said...
If an OEM is planning on submitting a PMTA, what would be the Advantage of Submitting a PMTA now verses a month or so before the Deadline Date? Attempting to get Approval before a potential FDA Leadership change?
What might be the Downside?
Presumably very little. I also doubt there's great interest from the manufacturer side to get pre-8/2016 old crap approved for millions to sell it. They'd rather sell their new products, most of the old stuff isn't even made any more and only stock exists. Plenty of countries other than the US to get rid of that stock.
Would be interesting to see a list of devices still frequently used today that are from before that ominous date. I can only think of the Nautilus right now but sure there's more.
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The Whole thing is just One Big Cluster
.And with 2020 kinda right around the corner, I dunno what I would be Planning if I was an OEM?
For manufacturers it's a nightmare, ridiculously expensive application with no fixed time frame (as far as I can tell) so even if one of your products makes it through it might already be outdated by then. In the EU we have the fixed 6 months waiting period so they at least know how long it will take.
Doesn't look like it's terribly worth it to sell on the US market if present regulation would be enforced.
Just imagine SMOK would have to get a PMTA for every single device, they'd have to submit one all 2 weeks or so, for every color option they have. Even if it's not in the millions and "only" a couple of 100,000s per device it still seems unreasonable. Also, what do you do if your tank gets approved but your coil doesn't? What if you have to fix the firmware or do a recall to change internal batteries to different ones, wouldn't that mean a new application?
Doesn't look like it's terribly worth it to sell on the US market if present regulation would be enforced.
Just imagine SMOK would have to get a PMTA for every single device, they'd have to submit one all 2 weeks or so, for every color option they have. Even if it's not in the millions and "only" a couple of 100,000s per device it still seems unreasonable. Also, what do you do if your tank gets approved but your coil doesn't? What if you have to fix the firmware or do a recall to change internal batteries to different ones, wouldn't that mean a new application?
I really think the "process" was designed to wipe out most of vaping, and most vaping innovation. I really hope it does not remain, another "artifact" of the Obama administration. It needs to be junked, IMO.
But, I guess, as always, we'll see what "happens."
Anna
But, I guess, as always, we'll see what "happens."
Anna
Doesn't seem to be a lot of those these days.
I can readily think of another. It's the one on the right in this pic, which I took in 2015:
But personally, I much prefer the general sort of device on the left.
The DNA 75C board was "released" before the 8/2016 date so the raw boards will be available. With that, I can make my own mods if need be. So screw 'em (the FDA that is). I would be totally fine using homemade mods with this board for the rest of my life. If it looks like they may try to ban the boards, I'll buy 10 raw boards before it takes effect and will be set for life.
I have jotted down designs on how to make dual battery (or single battery squonkers) out of a chunk of 2x4. Just needs a bit of fine tuning, a 510 connector, some buttons, and some magnets. I also have some ideas on how to make my own RDAs from various things. So I am at least sort of prepared for the worst, hardware wise.
I have jotted down designs on how to make dual battery (or single battery squonkers) out of a chunk of 2x4. Just needs a bit of fine tuning, a 510 connector, some buttons, and some magnets. I also have some ideas on how to make my own RDAs from various things. So I am at least sort of prepared for the worst, hardware wise.
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15 DNA250s - check
5 DNA 250Cs - check
About 20 Evolv 510s - check
20 various billet aluminum enclosures - check
12 NIB Merlin attys - check
20 NIB Aromamizer attys - check
All stored in a Rubbermaid tote labeled VAPOCOLYPSE
5 DNA 250Cs - check
About 20 Evolv 510s - check
20 various billet aluminum enclosures - check
12 NIB Merlin attys - check
20 NIB Aromamizer attys - check
All stored in a Rubbermaid tote labeled VAPOCOLYPSE
A clarification. All items released after 2007 (forgot the exact date) require an approved PMTA or SE application. There was a grace period of 2 years after 2016 to file one and have it approved (2018). No new items after 2016 can be sold without an approved application before reaching the market. Those dates for compliance have been pushed back by Gottlieb. As there really isn't much if any stuff out there and still on use from prior to 2007, every single item will require approval.
I believe the primary reason no PMTAs have yet to be filed is the lack of guidance on just what it's supposed to contain, which was a big problem with the deeming regs. Who wants to spend hundreds of thousands of dollars on filing a PMTA that won't pass as they failed to perform required testing?
Someone like Smok can take a different tack. If they get an approved PMTA for say an Alien, then if the only change is cosmetic, but the internals are the same, regulation board, 510 connector,and whatnot, they can file a SE application which should be way shorter as the changes don't really affect performance.
Edit forgot to mention another reason to delay the application under the original rules. If you file a PMTA for a product, you can continue to market it for up to 12 months awaiting approval or rejection. So if you waited until the last month of the grace period you could sell it for an additional year pending FDA action. Otherwise it had to be off the market period as of that last deadline in August of 2018. So by waiting to the last minute you have an additional period of time to sell your stuff for up to an additional year.
I believe the primary reason no PMTAs have yet to be filed is the lack of guidance on just what it's supposed to contain, which was a big problem with the deeming regs. Who wants to spend hundreds of thousands of dollars on filing a PMTA that won't pass as they failed to perform required testing?
Someone like Smok can take a different tack. If they get an approved PMTA for say an Alien, then if the only change is cosmetic, but the internals are the same, regulation board, 510 connector,and whatnot, they can file a SE application which should be way shorter as the changes don't really affect performance.
Edit forgot to mention another reason to delay the application under the original rules. If you file a PMTA for a product, you can continue to market it for up to 12 months awaiting approval or rejection. So if you waited until the last month of the grace period you could sell it for an additional year pending FDA action. Otherwise it had to be off the market period as of that last deadline in August of 2018. So by waiting to the last minute you have an additional period of time to sell your stuff for up to an additional year.
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Seems to me to me this additional 12 month grace period would only apply to products that were available prior to 2016-08-08. Come 2022, I rather doubt a whole lot of PMTAs will be filed for 6 year old products.
I'm really not sure. From what I remember, if it was on the market prior to 2016 you had two years to file your PMTA and up to a 12 month period to remain on the market after the PMTA was filed. Anything after 2016 was supposed to be approved via a PMTA or SE application before reaching the marketplace. After 2018 nothing, including pre 2016 but later than 2007 had to be approved. All that got pushed back by Gottlieb.
Other parts of the deeming regs already came into effect and are enforceable such as registering your products, providing the FDA with the ingredients of retail juice, and obviously age restrictions.
A lot more sudden than I was hoping (although, I didn't necessarily NOT expect it) but I was hoping. Sigh.
Teenagers always have been (some of them) the scourge of the Earth and now that the government is using them and has been for some time, it's only going to get worse. Teens (some of them) can be so problematic, but I really don't want to blame the teens so much. If there is any one on here who never did something "forbidden" as a teen, well I guess you could scourge them. I just have a hard time, as I know teen behavior is not going to change, period. It's just... a thing, and a thing you usually grow out of.
I'm not going to ask any teens to quit Juuling and take up smoking either. Unlike the government I actually CARE about their future health.
Anna
Teenagers always have been (some of them) the scourge of the Earth and now that the government is using them and has been for some time, it's only going to get worse. Teens (some of them) can be so problematic, but I really don't want to blame the teens so much. If there is any one on here who never did something "forbidden" as a teen, well I guess you could scourge them. I just have a hard time, as I know teen behavior is not going to change, period. It's just... a thing, and a thing you usually grow out of.
I'm not going to ask any teens to quit Juuling and take up smoking either. Unlike the government I actually CARE about their future health.
Anna
Hey, I used to be quite a genuine one of those "scourge of the Earth" teens, and now I am a pillar of the community (more\less).
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