Who will win FDA approval on vape devices / liquids - post ban?

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Eskie

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Unless you can get an application approved based upon instructions for use that specify for example "this liquid is meant for use on a device that can supply 30-50W to an atomizer with a coil resistance of 0.3-0.5 ohm. Use in devices with different specifications may result in harm to the user". Who knows, it probably wouldn't fly but it might if such hardware were available. It could work in conjunction with the non-user accessible plastic tanks hitting the market. Specify what approved plastic piece of junk you can use it in and mount on a device with a non-user accessible battery.
 

zoiDman

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I understand where your'e coming from.

If I were a large e-liquid manufacturer, I suppose I would try to have my product tested for emissions in a wide range of devices and hope for the best.

...

I just Don't think it would Matter. Because I think a PMTA is Only going to be issued to a e-Liquid/Hardware pairing(s).

And the FDA has already stated that they expect to Summarily Deny a percentage of the PMTA Applications. So filling one is No Guarantee of being able to continue to Sell your e-Liquid while the FDA Evals your paperwork.

Like I said, I could be Wrong. And I hope I am. But even under the Last FDA Commissionaire, Bottled e-Liquids i think was a Bridge Too Far.

And He's gone.
 

DaveP

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Does anyone else think that government wants to see vaping die? We are a thorn in the side to the states who are spending cigarette taxes on everything else but smoking cessation.

If they saw vaping as the next transition from smoking, they would be urging people to vape instead of smoking and they would slap a federal tax on vaping products as a significant number of people began to switch.
 
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NGAHaze

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Hmm, given the recent activity on taxing nicotine, I'm thinking that lawmakers are indeed planning on juice makers surviving post deeming. Why else would you expect to generate billions from taxing it while exempting existing NRT's?
 

Rossum

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Hmm, given the recent activity on taxing nicotine, I'm thinking that lawmakers are indeed planning on juice makers surviving post deeming. Why else would you expect to generate billions from taxing it while exempting existing NRT's?
Well those taxes would still apply to BT's closed systems, some of which the FDA is likely to approve, no?
 

Eskie

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Hmm, given the recent activity on taxing nicotine, I'm thinking that lawmakers are indeed planning on juice makers surviving post deeming. Why else would you expect to generate billions from taxing it while exempting existing NRT's?

That's the left hand not knowing what the right hand is doing. That or they figure Vuse, Juul, and Blu will survive, and they'll get their tax revenue there.
 

NGAHaze

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Well those taxes would still apply to BT's closed systems, some of which the FDA is likely to approve, no?

True but I don't think vaping will be nearly as popular or successful in the long term absent the ability to offer glazed doughnuts ejuice.

:D
 
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Dacholiday Dach

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OK, maybe not at first. I'll grant you that much, but again, if CDC had really wanted to know what the cause(s) of the lung illnesses and deaths was(were), they would have been taking and examining blood samples all along, or at least once they started finding out about dead people, and they would have then required this same blood testing of the medical community, since they did not at first, or least should have once they learned about Deaths! But they did not do this themselves at any point and they did not require it of the medical community at any point. If they were really doing their job(s), they would be doing the job as thoroughly as possible, and doing it to the furthest extent possible, that is, if they really wanted to know! But they did not and they have not.

The thing is, they may very well have actually did blood testing, however due to privacy laws in the US, they could not legally say that all the cases involved thc products, because then they would have actually violated privacy of anyone tested. So they continue to say "most" or "many" and use that as a round about way to continue to go after nicotine vape products.
 

zoiDman

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Maybe the FDA is legitimately concerned about our health?

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100%VG

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Silly question... but did you remember to stock up on a lifetime of nicotine? I did not see that in your post.
Great question, maybe the only real question - not silly at all, in my opinion. If one has nicotine then the rest can be finessed.
No, it's not a silly question! I thought I had mentioned at some point that I recently bought a new Liter of 100mg nic from Vapers Tek. I only use 6ml of it to make 100ml of my Juice, so it will take me a good while to go through it.

But did you know that nic can go bad, even if stored in the freezer? Storage in a freezer allows for zero daylight/Sun exposure, unless being used to make Juice, and freezing helps to make it last longer. I mean, storing it in the freezer in glass is the best way for multiple reasons. Can't remember precisely, but I think it will last up to 1 year in the freezer (and please, anyone who knows better, correct me!), but this was said about 36mg nic, back in very early 2013, when 36mg was the highest concentration generally found in online vape shops. I'm buying 100mg now, but have never had an issue with it going bad before emptying the bottle.

Whatever the actual time frame is, it will ultimately go bad, even if stored in a freezer, and especially 100mg/ml. The higher the nic concentration, the more quickly it will go bad. I move mine from the dark blue plastic bottle it comes in into a 1L Cobalt Blue Glass bottle as soon as I can, to help prevent the plastic from tainting it. In case you didn't know, Cobalt Blue Glass is better to use than Amber Glass. Can't remember all of the reasons, but the main reason is that Cobalt Blue blocks sunlight exposure better. But this is why I won't stock up on it... because it will go bad. And here's another reason why...

Vapers Tek is the supplier I was talking about when I said that one supplier I wrote to already has a plan to be prepared for disaster, should that happen... if you saw this mentioned in one of my posts. It was the day after Trump's Flavor Ban announcement that I wrote to them, so I'm sure the plan is well on it's way to implementation now. But considering that this post may have been missed by some of you, and I did not say much then, I am going into detail about it now, plus the fact that I was asked about it. :D

Since I am fairly confident that I'll be able to get nic product, I won't be stocking up on it. I would advise you and everyone else to contact them and let them know that you want to be contacted if they go underground or whatever, and purchase your Nic and USP products from them now! That is, if you want to stock up on Quality product.

This is a link to their Premium Nicotine product page.
Select from 100% PG or VG. No 50/50 listed, but they can mix whatever you want.

They used to have a Throat-Hit Nicotine available, but I don't find it listed as for sale at the moment.

This is a link to their USP PG/VG product page.
Select from 100% PG or VG.

When Vapers Tek opened (or at least when I found them) in 2013, this was said to be the Best (purest, cleanest, smelling, no-taste) Nicotine product available on the American Market everywhere on the Internet, and I have been purchasing my Nicotine and USP from them since. I learned of them in an ECF easter egg contest, where I won a liter of 100mg nic, and as said, I've been using it ever since.
 
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jandrew

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But did you know that nic can go bad, even if stored in the freezer? Storage in a freezer allows for zero daylight/Sun exposure, unless being used to make Juice, and freezing helps to make it last longer. I mean, storing it in the freezer in glass is the best way for multiple reasons. Can't remember precisely, but I think it will last up to 1 year in the freezer (and please, anyone who knows better, correct me!), but this was said about 36mg nic, back in very early 2013, when 36mg was the highest concentration generally found in online vape shops. I'm buying 100mg now, but have never had an issue with it going bad before emptying the bottle.

Whatever the actual time frame is, it will ultimately go bad, even if stored in a freezer, and especially 100mg/ml.

...
Current thinking is that properly stored nic, in glass in a freezer will last a very long time, perhaps indefinitely. See these posts if you are interested:

Long Term Nic Storage

Nic Base Storage: Freezer vs. Room Temp Experiment
 

100%VG

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I don't think the FDA can reject all such applications quickly. If they did, I think there would be a flurry of lawsuits. I don't know how they'd be phrased in legal terms but basically, "Hey, if you were going to just reject these out-of-hand, why didn't you tell us not to bother instead of having us spend all that money preparing these applications in good faith?"

So if credible applications are filed, I think the FDA has to at least give the appearance of considering/evaluating them for something like a year or more before rejecting them.
Absolutely!!! VTA would be on them in a Heartbeat!!!
reading all of that, I agree. Just being in a bottle there is no way to predict how an end user might alter the product, and with open systems there are an exponential possible ways it could be vaporized. These rules read like an impossible labyrinth.
If the FDA was being reasonable about this, they would either issue guidance as to what appropriate and acceptable test methodologies for an e-liquid are, or they would unequivocally say: "Don't bother, we're not going to approve any bottled liquid". The fact that they have done neither of these things may not be viewed favorably in the court system.
And I'm sure VTA will be working on this, too!
I can see a time where sealed cartridges might be what the FDA prefers. Of course, the problem we are seeing with CBD oil stemmed from ill advised uses in vape devices. The public is largely unaware of the safe methods. Personally, I don't want oil in my vape for any reason.

Ran across this article recently. It's informative, but offers sketchy information about exactly how to use CBD oil safely.

Everything You Need To Know About CBD Oil - Vapor Works Online
Why are we talking about CBD now? Our concern is nicotine e-liquid. Unless you're saying that nicotine e-liquid in sealed cartridges might be better accepted by FDA, but is that really what we're after?
That kinda Sums Up things right there.

And about the Only way it would seem that a Bottled e-Liquid could comply with this FDA Guidance is it would have to be Tested/Studied using Every Type of Open System Atomizer, Coil Type, Wicking, Airflow, Volt/Watt setting(s) out there.

Hey maybe I'm wrong? And it would be Nice if I was. But I just Don't see the FDA going through All the Time and Effort to make the PMTA process so Difficult and Expensive to comply with, only to give Bottle e-Liquids some kind of pass.
Yup. It's been said that the PMTA process was created to discourage new cigarette product development, and now it's being used against us. Maybe that's why we were classed as a tobacco product to begin with, so they could use PMTA against us. The PMTA stuff that was quoted looks to be about as difficult to get through as possible. But Hey, if iQOS can get through it, then maybe we can, too. VTA has already sued FDA for the recent changes in, and now shorter time frame in, what I guess was, the new "guidance"? So maybe he/they can work on this, too.
 

Rossum

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Maybe that's why we were classed as a tobacco product to begin with, so they could use PMTA against us.
Well, originally the FDA wanted to classify vape-goods as "drug delivery devices", which would have had even higher hurdles to clear, but Judge Leon shot that down in the Sottera decision in 2010.
 

englishmick

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Since I am fairly confident that I'll be able to get nic product, I won't be stocking up on it. I would advise you and everyone else to contact them and let them know that you want to be contacted if they go underground or whatever, and purchase your Nic and USP products from them now! That is, if you want to stock up on Quality product.

Seems a little dodgy to me. Them sending out the details of their secret plan to anyone who contacts them and asks for a heads up.

Anyway, I know a guy who has 6 liters in a freezer. He doesn't worry at all because the latest research suggests it will last indefinitely. I mean, when I say I know him, I met him once and I don't know his name or where he lives. I wouldn't hang out with that type of person.
 

440BB

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Seems a little dodgy to me. Them sending out the details of their secret plan to anyone who contacts them and asks for a heads up.

Anyway, I know a guy who has 6 liters in a freezer. He doesn't worry at all because the latest research suggests it will last indefinitely. I mean, when I say I know him, I met him once and I don't know his name or where he lives. I wouldn't hang out with that type of person.
I know a guy like that too - what a coincidence!
 
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