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FDA releases PMTA Guidance

The Cromwell

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https://www.fda.gov/regulatory-info...ons-electronic-nicotine-delivery-systems-ends

This guidance is intended to assist persons submitting premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j). This guidance communicates FDA’s current thinking on these applications to improve the efficiency of application submission and review; however, the recommendations in this guidance are non-binding. When FDA reviews PMTAs for ENDS, it will base decisions on the obligations that arise from the FD&C Act and its implementing regulations. FDA anticipates that the experience gained through the publication of this guidance and review of PMTAs may contribute to future rulemaking and guidances.
 

JuicyLucy

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Looks tailor-made for BT being the only vape producers that will be able to afford all those hoops
 

The Cromwell

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Looks tailor-made for BT being the only vape producers that will be able to afford all those hoops
As those of us who have been following this for years expected.
All vape products not for sale on the US market prior to February 2007 including non nic ejuice require PMTA approval to legally be sold or imported into the USA.
Per my reading this includes any products sold to be used for vaping.
Ie wire, batteries, cotton, flavorings, cotton, etc labelled/sold for use for vaping requires PMTA approval.

Of course there will be cotton, wire and flavorings that are not sold specifically for or marketed/labelled for vaping available.

Things like Lightning vapes wire, Vapcell, etc will fall under PMTA approval process.
Capella flavorings for instance will not since they are marketed for beverage flavoring and such.

I expect for freebase nic to come under their regs soon.
 
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susieqz

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that raises a question.
how many mods are a lifetime supply?

also, how much time do i have to buy nic?
 

The Cromwell

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that raises a question.
how many mods are a lifetime supply?

also, how much time do i have to buy nic?

I dunno on either count.
If you have Smok mods... A LOT!
I have been using the same Kbox mini 50w daily for around 3 years.
And the same Pico squeeze daily for well over a year.
with the same atty on each of them.
also been using an OG Merlin on another Kbox mini daily as well for a year or so.
I have about 7 of each mod in reserve along with 15 or more other assorted mods.

Nic restrictions? Nothing yet but I cannot believe that they will not restrict the sale to commercial users only at some point.
Frankly I am surprised they have not yet, esp with the Teen nic toothpics and such...
I have close to 4 liters of 100 mg nic in the freezer. At my current consumption rate I am good for well over 30 years. And considering that I am 65....
 
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The Cromwell

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some of us have been prepping for a vapeapocalypse ever since the Deeming regs came out.
We were already supposed to have been cut off but they extended the deadlines.
Technically it is not legal to sell any vape product that was not on the US market before 8-8-2016 NOW.
They could start enforcing that at any time, that deadline was NOT extended.
 

The Cromwell

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Every flavor combo of ejuice and every nic strength of the flavor requires separate PMTA approval.
If the Deeming regs continues as is it means the virtual end of vape sales in the USA.
We will have maybe some cigalikes and maybe ego cells with clearos on them?

which is better than absolutely nothing. I kicked cigs with them.
 

JuicyLucy

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that raises a question.
how many mods are a lifetime supply?

also, how much time do i have to buy nic?

That is one advantage of being a mech user, some of these are built like tanks and can be rebuilt over and over

In my mind, the biggest weak spot a lot of folks ignore in serious vapocalypse prepping are 510 connectors and atomizers

I'd always had a few extra 510s laying around, but early last year I invested heavily in high quality 510s to be able to rebuild my mechs as needed

Also started focusing on spending on high quality rebuildable atomizers and cheap ones by the dozen as opposed to hoarding a lot of mods, though I do have plenty of them
 

DogMan

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Every flavor combo of ejuice and every nic strength of the flavor requires separate PMTA approval.
If the Deeming regs continues as is it means the virtual end of vape sales in the USA.
We will have maybe some cigalikes and maybe ego cells with clearos on them?

which is better than absolutely nothing. I kicked cigs with them.
Just a random memory that you sparked.

But, as a kid, I always heard about the Black Market. So, I'd ask Mum where it was. I wanted to go there. I had imagined similar to a flea market, but better.
 

The Cromwell

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n my mind, the biggest weak spot a lot of folks ignore in serious vapocalypse prepping are you 510 connectors and atomizers
That was my concern as well however I have yet to wear out a 510.
Even on a Kanger Kbox Mini with bottom fill tank on it used daily for 3 years or so.
with the proper orings and such squonk 510 should be repairable as long as the threads are good.

I did buy a bottoming 510 tap a year or so ago though...
 

The Cromwell

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Just a random memory that you sparked.

But, as a kid, I always heard about the Black Market. So, I'd ask Mum where it was. I wanted to go there. I had imagined similar to a flea market, but better.
What did she tell you?
 

susieqz

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i'm way behind you guys.
i do have 7 of my fav set ups, but i guess i need more.

now that i know that i can make acceptable juice. i'll move on the necessaries.
the govt can't hurt us much. but i feel bad for new people trying to improve their health.
 

lordmage

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well with Big T getting that Ios approved and and few others all is ee if a forced market for the unprepped and for the prepped not much... like prohibition there will be dryer times until cooler heads clean up the mistakes of the past.
 

inspects

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Nic restrictions? Nothing yet but I cannot believe that they will not restrict the sale to commercial users only at some point.
Frankly I am surprised they have not yet, esp with the Teen nic toothpics and such...
I have close to 4 liters of 100 mg nic in the freezer. At my current consumption rate I am good for well over 30 years. And considering that I am 65....

Fantastic, at least the test of time was to our advantage....my 5-yr old nic is still as good as the day it was delivered....:bliss:
 

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