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Post-PMTA Updates


Ms. Trixy

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@VaporJoe posted an amazing article I thought needed more exposure. And in light of more information to come I thought a thread should be started for us to share links on any articles or information that is worth sharing. Please use Bold during discussions to make your links are easier to see.

From VaporJoe:
Is it legal? ~
VapePMTA
 
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The Cromwell

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Of course BT will dominate post PMTA enforcement vaping.
How many companies can afford just 1 PMTA process let alone several? How could they survive with just a few products for sale?
items that pass will be bought up by BT becuase they have the deep pockets for it.
And yet to be determined is how many PMTA apps will even wind up being accepted in the next 90 days? And of them how many will be approved for sale?


And there is no foreseeable post PMTA, it is is an ongoing process for the foreseeable future or until laws change regarding vaping and such.
who knows? laws for vaping in the future could totally ban it or even the act of vaping not just the sales.
Or things could reverse?

And with that cheerful thought have a wonderful evening :)
 

The Cromwell

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Yes a very sad time for vaping...
Been coming a long time... which I am grateful for as it allowed me to prep properly on mediocre income.
Had it happened as originally scheduled I would now be out of vape stuff. And it would have been somewhat pithy stuff too.
But hey better than smoking and felt lots better with vaping.
 

5150sick

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Saveurvape has had Hemp Enhancers for sale for a while now.
You'll notice that they are the same flavors as the old eliquid line.
People who vape hemp need flavors.
Be sure to only mix it with CBD eliquid now ;)


There are ways around this.
it's just going to take a bit of effort just like it did for me in August 2012.
Back when people made elquid in their kitchen, we bought it, and it was good.
You had to find the right people and know the right spots.
Either that or order dekang, hangsen, or liqua through a China vendor
It would take 3 months worth of research just to get to eliquid back then. lol

You all are already way ahead of the game.

You already found the right people and you're already in the right spot. :)
 

The Cromwell

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Curious as to how what if any effect that the Deeming regs/PMTA will have on vape stuff for other substances..
I suspect that if it can be used to vape regular ejuice then it is subject to the deeming regs.

But really do not know.
 

5150sick

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Curious as to how what if any effect that the Deeming regs/PMTA will have on vape stuff for other substances..
I suspect that if it can be used to vape regular ejuice then it is subject to the deeming regs.

But really do not know.


They seem to love selling flavored shit that they deem worthy.
Well, they love taxing flavored shit that other people sell, that they deem worthy.
Case in point.
the medicinal version of the opposite of CBD.
Comes in flavors, Thin Mints, Girl Scout Cookie, etc... Even CBD comes in those flavors.
That's all already deemed as something else.
one a schedule 1 :rolleyes:
the other Farm Bill Approved
 

hellcatrydr

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Saveurvape has had Hemp Enhancers for sale for a while now.
You'll notice that they are the same flavors as the old eliquid line.
People who vape hemp need flavors.
Be sure to only mix it with CBD eliquid now ;)


I'm just gonna ask... WTH is a hemp "enhancer"? :huh:
.
 

gsmit1

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Yep. This is what I've been saying for a good while now. Once they kill off all the competition and only the giant corporations that can line the pockets of the politicians are left, vaping will become everything advocates have been saying all along.

This is what happens in a nanny state. It began decades ago. Vaping as we know it was doomed from the start.
 
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The Cromwell

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Outside the shop, I have not one personal friend who even knows this is going on.

Especially with everything else going on, this is miles off the public radar.
Yep and one big reason why we cannot expect any help from any politician for a long time at least.
 

5150sick

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I just saw this from an email.
DWF Vapor


1599766304121.png
 

5150sick

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Sorry, I didn't mean for the screen shot to be all huge like that. :facepalm:
 
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SteveS45

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Vaping isn't going anywhere although some vendors are throwing in the towel.

 

The Cromwell

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Vaping in the US is certainly going downhill. No question about that. Only question is how far.
 

The Cromwell

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On page 94 (Table 14) of the "deeming" Regulatory Impact Analysis (RIA), the FDA has estimated the average cost for each premarket review pathway for newly regulated tobacco products to be:

  • an SE exemption report = around $1,500
  • an SE report = anywhere from around $3,500 to around $22,700
  • a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others

Each tobacco product application is a unique situation. However, generally speaking, a manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA. Where the same information applies to multiple products, it should be noted.

FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product

My comments below.
I have trouble believing that the above post saying 80 PMTA apps will hold up. At the low end of the PMTA cost estimate that is over 9 million dollars!

Yep filing is cheap pursuing thru to completion is EXPENSIVE.

yes as things get passed it can become lots cheaper by riding on the backs of things that have passed. But so far nothing vape has passed PMTA.

About Sweedish Snus. Not vaping but something that actually passed the PMTA process.

Swedish Match, the sole company that has received approval through the PMTA pathway (for eight General Snus products), says the process is more expensive, more time-consuming and requires more resources than the FDA predicted:

  • Costs: Swedish Match didn’t keep a running tally of the costs, but Teller says, “it was a lot more than the [FDA] estimate,” and resulted in a 100,000-page-plus application.
  • Time: The FDA gave manufacturers two years from the August 8, 2016, implementation of the deeming rule to submit to PMTA. “If companies hadn’t already started on this process before the law was announced, who knows if there’s enough time to get it all done,” Teller warned.
  • Resources: PMTA requires significantly more research, data and information than the SE pathway. “Only so many entities can do that research,” Teller said. “There’s probably been a mad scramble to find these companies.”
 
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The Cromwell

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Had not checked this since about Feb 2020. Finally some more updates.

NOTE: these are total PMTA applications and not broken out by vape or actual tobacco product.
Which also have to file for PMTA or SE if not on market prior to Feb 2007.
different cigarettes, cigars, etc..
Vape stuff will be virtual 100% PMTA with no SE applications.

 

Ms. Trixy

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Had not checked this since about Feb 2020. Finally some more updates.

NOTE: these are total PMTA applications and not broken out by vape or actual tobacco product.
Which also have to file for PMTA or SE if not on market prior to Feb 2007.
different cigarettes, cigars, etc..
Vape stuff will be virtual 100% PMTA with no SE applications.

Yes, I saw this in one of the links I posted.

Also, I spoke to WetVapes the other day. He said they can still sell what they have as long as the manufactures are supplying. And he said he can still sell eliquid. I sure as hell didn't understand that but I wasn't going to argue with him since he was issuing me loyalty points.

But then places like RedStarVapors who make custom e-liquids are only filling up to 6mg on select flavors. The rest is 0 nic. And ECBlends is only making a handful of flavors with nic.
 

The Cromwell

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Yes, I saw this in one of the links I posted.

Also, I spoke to WetVapes the other day. He said they can still sell what they have as long as the manufactures are supplying. And he said he can still sell eliquid. I sure as hell didn't understand that but I wasn't going to argue with him since he was issuing me loyalty points.

But then places like RedStarVapors who make custom e-liquids are only filling up to 6mg on select flavors. The rest is 0 nic. And ECBlends is only making a handful of flavors with nic.
NOPE they are not legally allowed to sell any unapproved stock after 9-9-2020 without either an accepted pending PMTA application or approval.
there has never been a sell out your existing stock provision.

And technically nothing not on the US market prior to 8-8-2016 has ever been legal to be sold in the US without first getting FDA approval.

will many keep on selling? Yep until they start getting hammered after 90 days...
 

The Cromwell

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If anyone is interested here is a link to PMTA requirements.

 

Ms. Trixy

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NOPE they are not legally allowed to sell any unapproved stock after 9-9-2020 without either an accepted pending PMTA application or approval.

And technically nothing not on the US market prior to 8-8-2016 has ever been legal to be sold in the US without first getting FDA approval.
That is my understanding too.

I got my first rejected order from China yesterday.
Cannot ship to your country 9.9.20.JPG
 
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gsmit1

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Well, for whatever it's worth a VERY well known, instantly recognizable U.S. vendor sold me juice this morning. I don't know how long that will last though.
 

The Cromwell

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Oh and the Deeming regs covers zero nic juice as well. And the one shots thing as used in the UK and such was to get around the 10 ml bottle size restriction not to get around ejuice being banned. which is was not there.

apples and oranges compared to here.
 

The Cromwell

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My thoughts exactly.

i have been stocking up on juice and nic since the killer vape hoax last fall.
Been well over 5 years since I bought any premade juice.
Need 1 more gallon of VG and I will not need to buy any vape related stuff for 3-4 years. then just PG/VG and flavorings and maybe some batteries.
 

gsmit1

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FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product
That alone will put 99% of juice companies outta business. The cost of compliance would be many many times their annual gross income.
 

CaFF

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My thoughts exactly.

i have been stocking up on juice and nic since the killer vape hoax last fall.

Yup, I spent a lot of my RonaCheck on nic...I'm good for life. I'd already stocked up in 2016 too, so let it all burn....
 

Carambrda

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Oh and the Deeming regs covers zero nic juice as well. And the one shots thing as used in the UK and such was to get around the 10 ml bottle size restriction not to get around ejuice being banned. which is was not there.

apples and oranges compared to here.
Wrong. To get around the 10ml bottle size restriction, here in the EU we use 50-in-60ml (and 80-in-100ml) shortfill plastic bottles. The one shot flavor concentrates are to get around the extra burden of DIY mixing that is finding decent recipes, getting a whole plethora of different flavorings, measuring all the various many different percentages accurately that isn't particularly straightforward to do for many especially in cases where the numbers are rather small, steeping before making the necessary adjustments to a recipe and then steeping all over again, and possibly still not liking the end result so that all the time that went into this experiment is wasted with just the sole exception of maybe learning from that experience. They're just an easier and faster way to DIY, and, if the one shot flavor concentrate in question also has a commercially available, finished juice matching counterpart, then it allows one to optionally get a sample of that first, and to use that for a reference of how the DIY result should taste like. They often tend to be a great choice for those who lack the patience to wait for unknown surprises, but who still want to keep things cheaper by taking the DIY route away from the finished juices that they think are too expensive.
 

Carambrda

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In any event, if it pans out youse muricans can no longer vape made in USA premium juices, we'll be happy to vape 'em for ya... ;)
 

eSMOKA

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Vaping isn't going anywhere although some vendors are throwing in the towel.


Liquid and hardware offerings are going to be severely limted compared to what we've been used to and innovative products will be few and far between, in the USA.
 

eSMOKA

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Also, I spoke to WetVapes...aid they can still sell what they have as long as the manufactures are supplying. And he said he can still sell eliquid. I sure as hell didn't understand that but I wasn't going to argue with him

Smells like denial. It doesn't take a law degree or much intelligence to get information to the contrary.
 

eSMOKA

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I got my first rejected order from China yesterday.

Gearbest has been doing this for a while now. They started sometime after Alibaba, Aliexpress and DHGate started blocking vape on US IP addresses (not sure if they still are). Has nothing to do with the PMTA. Had to do with the vaping deaths in the USA from the THC carts right before COVID was being reported in China.

The Chinese govt supposedly ordered Chinese retailers to not sell vape to the USA. Only very few followed the order - it was an empty order to make the USA think something was being done lol. Ali had to, they are the Amazon of China and in fact I believe they are bigger.
 

The Cromwell

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In any event, if it pans out youse muricans can no longer vape made in USA premium juices, we'll be happy to vape 'em for ya... ;)
Yep it is not illegal to export em, just to sell em here if not approved.
However I am pretty suyre they still have to meet all the tobacco manufacturer specifications.
 

The Cromwell

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Wrong. To get around the 10ml bottle size restriction, here in the EU we use 50-in-60ml (and 80-in-100ml) shortfill plastic bottles. The one shot flavor concentrates are to get around the extra burden of DIY mixing that is finding decent recipes, getting a whole plethora of different flavorings, measuring all the various many different percentages accurately that isn't particularly straightforward to do for many especially in cases where the numbers are rather small, steeping before making the necessary adjustments to a recipe and then steeping all over again, and possibly still not liking the end result so that all the time that went into this experiment is wasted with just the sole exception of maybe learning from that experience. They're just an easier and faster way to DIY, and, if the one shot flavor concentrate in question also has a commercially available, finished juice matching counterpart, then it allows one to optionally get a sample of that first, and to use that for a reference of how the DIY result should taste like. They often tend to be a great choice for those who lack the patience to wait for unknown surprises, but who still want to keep things cheaper by taking the DIY route away from the finished juices that they think are too expensive.

Ahh yes shortfill was the name I could not think of.
Pretty much the same thing as selling zero nic juice.

If shortfill is just a way to get around DIY why do regular juice makers sell both 10 ml bottles and shortfill bottles of the same flavor/name?
 

Carambrda

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Ahh yes shortfill was the name I could not think of.
Pretty much the same thing as selling zero nic juice.

If shortfill is just a way to get around DIY why do regular juice makers sell both 10 ml bottles and shortfill bottles of the same flavor/name?
No, nic-free shortfills are a way to get around the 10ml bottles restriction that applies to nic juice, not a way to get around DIY. By pouring one 10ml bottle of 20mg nic base (what we call a "nic booster") into a "50-in-60" shortfill, we get ~60ml of ~3mg juice. But if you need stronger than 3mg, then, especially if you don't consume that much juice, that's when the 10ml bottles of the same juice at 6mg/9mg/12mg become an option worth considering, as you can't just pour more than one booster right into a 50-in-60 shortfill of course, albeit you can still work around that, if─also of course─you happen to have stronger nic base (72mg/100mg) sitting in the freezer.
 

Carambrda

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@The Cromwell

One shot flavor concentrates are not to be confused with shortfills. The former need to be diluted with PG/VG after which they need to be steeped, whereas the latter are nic-free juice that can immediately be vaped, and, adding nic is optional for both.
 

The Cromwell

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One shot flavor concentrates are not to be confused with shortfills. The former need to be diluted with PG/VG after which they need to be steeped, whereas the latter are nic-free juice that can immediately be vaped, and, adding nic is optional for both.
My point was always intended to be about the shortfills ie no nic over here and would they bypass the deeming regs.
Apologies for any confusion since one shots are not much of a thing over here.
Or so i think anyway, may be totally wrong since I have not bought any premade juice stuff for over 5 years.
Since the vast majority of it causes me extreme distress.

But then neither shortfills or flavor shots are equal to zero nic juice...
since the nic shots have pg and or VG in them.
short fills take into account adding pg/vg.
 

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