The only thing delayed/extended was the date PMTAs were due into the FDA. Now 8/2022
All other regulations stay the same as originally written.
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All other regulations stay the same as originally written.
Ah ok, so everything after 2016 needs a completed PMTA to be sold on the market and only the deadline for those PMTAs got pushed back? (after which no new products at all could be released on the market?)
So without a completed PMTA you're not supposed to sell anything right now?
Still a bit shaky on what exactly happened and what exactly will happen after 2022 (if not changed obviously).
So without a completed PMTA you're not supposed to sell anything right now?
Still a bit shaky on what exactly happened and what exactly will happen after 2022 (if not changed obviously).
I hope you are right. It is really asinine to approve a mod/board then expect a new payment and approval for a cosmetic change (which technically the housing is), or really even a firmware update (as long as the firmware complies with the regs and doesn't change major functionality). I mean with this crap if a firmware update is available to fix a bug/issue the FDA can't expect a whole new payment and approval process to fix the issue, but I am afraid they will expect just that.
In Simplified terms...
The FDA established that Any Tobacco Product that was not Commercially Marketed before 8-8-2016 would be consider a New Tobacco Product. And that No New Tobacco Products would be allowed to be sold in the USA without going thru an FDA "Approval" (PMTA, SE, MRTP) process.
But... If your Tobacco Product was Commercial Sold in the USA before 8-8-2016, then you would be Allowed to continue selling your product while you prepared your PMTA, SE and or MRTP application for FDA Approval. And you would have until 8-8-2018 to do so. But after 8-8-2018, Tobacco Products could be sold in the USA with a FDA PMTA, or SE, or MRTP, or your Tobacco Product was sold before Feb 2007 (Grandfathered) in the USA
Here's where the 2022 comes in.
What the FDA did though, was to Extend the 8-8-2018 Deadline for Pre 8-8-2016 Tobacco Products to give OEM's more time to prepare their PMTA, SE or MRTP.
But it Didn't change the 8-8-2016 New Product Cut-Off Date.
At least that is How I Understand it.
That sounds right, thank you very much, I think I got it now
One more thing to Note:
Say I released my Product after the 8-8-2016 New Product Date.
Some OEM's believed that since there was this 2 Year Period until 8-8-2018, which was later Extended to 8-8-2022, that they could just Keep Selling their Product. And even Release More New Products.
This Isn't True.
And this is what the FDA says it is going to start Cracking Down on.
FDA Crackdown....
And if you are selling a Pre 8-8-2016 product, the FDA can Also ask to see what you have accomplish and how far along you are in Completing a PMTA, SE or MRTP application.
And if the FDA feels that you are Not actually working on a PMTA, SE or MRTP application, and are just trying to sell you Product in the "Grace Period" provided so you can work on you PMTA, SE or MRTP application, the FDA can Issue a "Stop Order".
And that Means you can No Longer sell your product period. Until you receive an approved PMTA, SE or MRTP from the FDA.
Vast numbers of new products or new variations have come to market from offshore since 8/8/16, so there is likely quite a bit of material in many shops that isn't allowed at this point. We've had about a year and a half with no real enforcement, which is better than many of us suspected in early 2016.
It looks like 2018 is the year they tighten the vise, as they are attacking vaping on three fronts:
- proposed nicotine restrictions on cigarettes, which likely limits availability of liquid nicotine concentrates
- proposed restrictions on flavorings
- started to enforce the deeming regs
Springtime in Hell for US vapers.
It looks like 2018 is the year they tighten the vise, as they are attacking vaping on three fronts:
- proposed nicotine restrictions on cigarettes, which likely limits availability of liquid nicotine concentrates
- proposed restrictions on flavorings
- started to enforce the deeming regs
Springtime in Hell for US vapers.
Would the new designed inbox V3,which has been changed,be considered a new device ?
Unless it was marketed before 8/8/16 in the exact form it is now, it would be considered a new device.
Glad to see I'm not the only one confuzzled by this 
Effectively almost everything would be gone from the market, all newer mods, attys, liquids are unlikely to have completed one of those applications. Is there a list somewhere to see who has passed so far?
I mean you're paying tax money to run that circus there should be some information available.
Effectively almost everything would be gone from the market, all newer mods, attys, liquids are unlikely to have completed one of those applications. Is there a list somewhere to see who has passed so far?
I mean you're paying tax money to run that circus there should be some information available.
Another thing to Note:
Any Changes Made to a Pre 8-8-2016 Product, that occurred after 8-8-2016, would Automatically make the Changed Product a New Product.
So if I had a 65W Mod that was sold before 8-8-2016 and it is Now a 70W Mod, or I now put a Spring Loaded 510 in it, or Upgraded the Firmware Revision, or used 3 Magnets in the Door verses using 2, or just about anything it would Now be a New Tobacco Product.
And No New Tobacco Products are supposed to be sold after 8-8-2016 without a PMTA, SE, or MRTP.
Even if that Change was to make a Cosmetic Change. Or to Fix a Potential Safety Issue.
But that wouldn't serve their big Pharma masters interests.
2 of my liters in the freezer are glass
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Yea it is not the same. The tube is no longer atatched on the inside of mod now.
So I guess the vape industry just can not improve on anything from here on out.
Sure they can improve, just gotta pay up front and wait for one of the fartknockers at the FDA to read the application on toilet time and send you a glorious "ummmh... no" back, at which point you can start bankruptcy proceedings.
As far as I'm aware, no PMTAs for vape products have been submitted, much less approved yet.
I believe the only PMTA that has ever been approved was the one from Swedish Match for some SNUs.
I would suppose that Phillip Morris has submitted a PMTA in parallel with the MRTP application for IQOS.
Oh, I assumed Evolv had at least submitted one, according to a statement above they could be stopped from selling their product from one day to the other if they didn't.
Seems like a big gamble
Seems like a big gamble
No, I don't think they have.Oh, I assumed Evolv had at least submitted one, according to a statement above they could be stopped from selling their product from one day to the other if they didn't.
Seems like a big gamble
Moreover, I don't think they can easily be stopped from selling their existing products. Evolv currently only makes boards, not complete mods. First, a circuit board is not a "finished tobacco product", so even retail sales of such boards are unlikely to qualify for enforcement. Second, most of their customers are overseas mod-makers who incorporate those boards into mods in locations that outside of the FDA's jurisdiction.
Rumor has it that Evolv is working on some kind of complete mod/atty combination (one might call it a "pod mod") for which they plan to submit a PMTA, but nobody seems to have a good idea how far along that is, or if they do, they aren't talking.
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