FDA FDA's leaked guidance for PMTAs confirm deeming reg would ban >99.9% of nicotine vapor products

[Kent C]

what they are basically trying to do ... is ban open tank vaping and hand the industry over to BT in the form of tamper-proof cartridges.

If by 'they' you mean the FDA, there is no reason to believe that to be the case. The whole 'closed-system' idea was brought up in RAI (Reynolds) 'deeming comment' to the FDA suggesting that they allow closed-systems and ban open systems. IOW, it was a tobacco company idea, not the FDA's. See here when we first saw this on ECF:

RJ Reynolds (RAI) files FDA comment asking for its competition to be banned

But don't feel like the Lone Ranger - many people are under this assumption - it bolsters the collusion theory. But it's simply not the case. IF the deeming is altered to only include closed-systems, then and only then could serious doubts be raised. And should be, I might add. :- )

 

[Kent C]

A few links...

“Substantial Equivalence”: Massive Backlog at the FDA Center for Tobacco Products,bBy Micah Berman

FDA Law Blog: When is a Very, Very Long Delay the Same Thing as a Ban? FDA’s Review of Tobacco Product Submissions Under the Microscope

Thanks! I underestimated - 4 1/2 years not 2 It helps in the point I was making

 

[AndriaD]

What Chicago is Proposing Isn't Killing that Goose.

It is Killing It, Burning the Carcass, and then Spreading the Ashes in Multiple Locations.

What can they be Thinking?

They're thinking, who cares if smoking kills people, as long as we keep getting MO MONEY! They want to extort smokers and yet still have it be a crime to smoke anywhere. When disgruntled smokers finally understand it, I foresee widespread slaughter of gov't employees who sponsored the tax. I may even help.

Andria

 

[Kent C]

The last time I was in a vape shop I was horrified to witness a clerk insisting that a newbie shouldn't be vaping more than 6mg nic per ml. They said there was nothing higher than 6mg for sale in the store.

I see this too but in all fairness - at least with the customers I've seen - they were sub-ohm high watt vapers already - newbies learn quickly :- ) and the 6ml is the tops in nic they have in the high max VG usually used with that type of vaping. And they get double flavoring lol...

 

[zoiDman]

If by 'they' you mean the FDA, there is no reason to believe that to be the case. The whole 'closed-system' idea was brought up in RAI (Reynolds) 'deeming comment' to the FDA suggesting that they allow closed-systems and ban open systems. IOW, it was a tobacco company idea, not the FDA's. See here when we first saw this on ECF:

RJ Reynolds (RAI) files FDA comment asking for its competition to be banned

But don't feel like the Lone Ranger - many people are under this assumption - it bolsters the collusion theory. But it's simply not the case. IF the deeming is altered to only include closed-systems, then and only then could serious doubts be raised. And should be, I might add. :- )

If just about Every e-Ciagrette has to go down the PMTA Pathway, do you think a "Closed System Atomizer" has a Greater Chance of achieving PMTA Approval over an "Open System Atomizer"?

 

[Kent C]

Multiple Locations outside of Crook County. Where they will fertilize new growth, at least for a while.

Yep. Corporations aren't the only ones who can 'go elsewhere' :- )

 

[WillyZee]

If by 'they' you mean the FDA, there is no reason to believe that to be the case. The whole 'closed-system' idea was brought up in RAI (Reynolds) 'deeming comment' to the FDA suggesting that they allow closed-systems and ban open systems. IOW, it was a tobacco company idea, not the FDA's. See here when we first saw this on ECF:

RJ Reynolds (RAI) files FDA comment asking for its competition to be banned

But don't feel like the Lone Ranger - many people are under this assumption - it bolsters the collusion theory. But it's simply not the case. IF the deeming is altered to only include closed-systems, then and only then could serious doubts be raised. And should be, I might add. :- )

I think you might be underestimating the influence BT is playing in all this ... BT is going to buy/payoff whatever suits their agenda

and open bottles of nicotine are not their idea of vaping/smoking.

 

[Kent C]

If just about Every e-Ciagrette has to go down the PMTA Pathway, do you think a "Closed System Atomizer" has a Greater Chance of achieving PMTA Approval over an "Open System Atomizer"?

Not sure. I would think that if the application is able to pass all the requirements and the FDA doesn't have the intent to just not pass any application, that it wouldn't matter as long as all aspects are handled in the application itself. At any rate, I don't see the regulations as stated as 'tipping' toward either - but tipping against both with the amount of studies needed - some of which are irrelevant (imo) whether something should pass the test or not - the part that I underlined in my posts that have the whole regulation concerning that from the deeming doc.

 

[Stubby]

I'm reasonably confident that BT and a number of BV companies will submit PMTAs. I could also see the FDA not acting on these applications for a long, long time, using the excuse: "We're still engaged in studies because all the evidence isn't in yet," thereby leaving those products on the market more-or-less indefinitely. They may very well reject some, for example those with flavors that appeal to The Precious Children™ in order to appease the ANTZ who are pressuring them to "do something- but an outright ban by means of rejecting all PMTAs for vapor products? I don't see that happening.

There is lots of doubt about the above. The extremely difficult application process for a new tobacco product is so onerous there is real doubt as to if anyone will bother to apply. The studies are essentially impossible to do. Read Carl Phillips take on the one new tobacco product that has successfully gone through the process, which is the snus applications from Swedish Match

FDA's snus PMTA approval -- what it seems to mean

This is from a company that has lots of resources and already had decades of studies to back them up. The road for vaping would be far more difficult.

Then why do we keep hearing stories of applications for more conventional tobacco products that have been stuck in limbo for years?

You are confusing two very different types of applications. The first is the substantial equivalency application (which is what you are actually referring to) and the new tobacco product application (what you think you are referring to). New product applications are far more difficult and that is what vaping products would have to go through.

As for the rest of the chatter in this thread, it is nearly all nothing more then mental .........ion. It is all wild speculation and pretty much a waste of time and energy. There is about a 99% chance that if you think you know what is going to happen under any given scenario, it is highly likely you are wrong. The more sure you are, the more likely it is you are wrong. Why bother playing this guessing game. I would have about as much chance of being right reading taro cards or looking at the lines on my hand. What a waste of time.

 

[Rossum]

FWIW, does anyone think Reynolds would be pouring money into next-gen Vuse products if they didn't think they could get PMTAs approved?

http://www.csnews.com/product-categories/tobacco/rai-reveals-next-gen-vuse-products

VUSE Port: Liquid tank system that uses a Dock & Lock system to refill the device. The closed system prevents users from opening the top or the tank. To refill, the port and bottle must be locked together.

VUSE Pro: Closed cartridge system that provides the performance of a tank system in an easy-to-use, cartridge-based format.

 

[Kent C]

I think you might be underestimating the influence BT is playing in all this

I'm not underestimating anything - just pointing out that there is nothing in the current deeming that favors closed-systems (or open ones for that matter). The idea that there is, is what is used by some, to make a spurious connection between the FDA and tobacco. And if you want to imagine that to be the case, I'm fine with that.

The deeming doc has nothing in it regarding that. Only the comments from the tobacco companies mention it. CASAA's and others comments mentioned allowing for open systems, but that doesn't mean they're in bed with the FDA.

 

[zoiDman]

Not sure. I would think that if the application is able to pass all the requirements and the FDA doesn't have the intent to just not pass any application, that it wouldn't matter as long as all aspects are handled in the application itself. At any rate, I don't see the regulations as stated as 'tipping' toward either - but tipping against both with the amount of studies needed - some of which are irrelevant (imo) whether something should pass the test or not - the part that I underlined in my posts that have the whole regulation concerning that from the deeming doc.

I hope you are Right.

Because when I see wordage like on Lines 904 & 905 of the TVECA "Draft" PMTA, it does make a Person Wonder.

 

[zoiDman]

FWIW, does anyone think Reynolds would be pouring money into next-gen Vuse products if they didn't think they could get PMTAs approved?

http://www.csnews.com/product-categories/tobacco/rai-reveals-next-gen-vuse-products

I've said the Same thing So Many Times, I think people just Tune it Out.

 

[WillyZee]

I'm not underestimating anything - just pointing out that there is nothing in the current deeming that favors closed-systems (or open ones for that matter). The idea that there is, is what is used by some, to make a spurious connection between the FDA and tobacco. And if you want to imagine that to be the case, I'm fine with that.

The deeming doc has nothing in it regarding that. Only the comments from the tobacco companies mention it. CASAA's and others comments mentioned allowing for open systems, but that doesn't mean they're in bed with the FDA.

let's just say ... I can see the writing on the wall.

we shall see where vaping is 5 years from now

 

[zoiDman]

FWIW, does anyone think Reynolds would be pouring money into next-gen Vuse products if they didn't think they could get PMTAs approved?

RAI Gives Sneak Peek of VUSE's Next Generation

BTW - Vuse uses a Non-510 Proprietary Connection, Right?

 

[Rossum]

BTW - Vuse uses a Non-510 Proprietary Connection, Right?

But of course!

"Encryption" too. Which probably makes it a DMCA violation to try to make anything compatible with their crap.

 

[zoiDman]

But of course!

"Encryption" too. Which probably makes it a DMCA violation to try to make anything compatible with their crap.

Yeah... It also gives a Whole New Meaning to "Tamper Proof".

And Tamper Proof is a Buzz Phrase that is Kicked around a Lot when talking about people putting "what we can Not talk about here" into an e-Cigarette.

Something the FDA is Evaluating Closely.

 

[zoiDman]

BTW - Can't wait to see the 1st Generation Vuse Atomizer Chip Re-Setters. LOL

 

[Stubby]

FWIW, does anyone think Reynolds would be pouring money into next-gen Vuse products if they didn't think they could get PMTAs approved?

RAI Gives Sneak Peek of VUSE's Next Generation

You are thinking to small on this. I am sure it fits well within the coming regulations of the EU market, which may be a bigger market then the US.

Even with all the restrictions in the EU, at this point in time it is a more stable situation then the US. That alone is a very good reason to spend a whole lot on development.

 

[Ca Ike]

ok, now just think about it...

I say we dont know what they put into ejuice
you say read their ingredients or you say just google it (like that would be an answer) would any company say we make this juice in a rat infested basement and use whatever we have on hand when we run out (including pee, and seman (like some young high boy wont really think thats funny), or even worse some kind of addicting drug)
you say all other ingredients are more expensive so why would they, people also said this of tobacco and we found out why they would - to make them more addictive, to keep the market base, etc

I say we dont know that they even know how to mix it right
you say recipes are not rocket science, but I still say we dont know if they know how to read them

I say, it might be a good thing that they are regulated
you say regulation is the killer of this business, you say we are adults and know how to look out for ourselves, but I still say having something that is ingested by people should at least be looked at by some regulating body to make sure they are actually using the ingredients they put on their bottles or that they are doing this in a clean way, or that they handle nicotine properly. We ar adults but we dont go visit all the companies to see how they make it and if their rooms are clean and proper procedures are used. We dont have machines in our homes to test ingredients to make sure they are what they put on the label.

I originally posed this as a question - why it this bad, wouldnt it be good to have someone make sure the ingredients are safe? And every one that commented came on real strong trying to make me feel small for asking. But all you have done is show me that you are the ones that need to think about it a little more. Ask yourself, wait "just think about it", how could this go wrong? When big pharma or big tobacco take over (which sooner or later we all know its a possibility) what will they do to ejuice? Do we really want a product that we ingest to NOT be reviewed? To have no regulations?

Being the only voice asking the question with so many of you coming on quite strong to tell me I am wrong, kind of sucks. But when you say "just think about it", I actually AM just thinking about it, and I actually was just asking why you felt it would shut down the industry and the responses I got didnt quell my questions, they actually made me wonder why in the world, with everything we have seen happen with other industries, you believe that nothing untoward will happen in this one without regulations?

I'm way behind and don't know if shameless is still active. To answer this we do have ISO standards for clean room facilities that almost all juice makers are following or are working to get to that standard, at least here in the US. Small labels are starting to work with bigger labels to make thier blends. The thing is there are regs already in place that cover a lot of the manufacturing practices used by juice makers. Why do we need more?

Look at companies like provape and HOH. They already set a very high standard for safety and quality on mods WITHOUT regulation telling them to. The vaping public demanded things and companies stepped up. Companies that haven't are failing or have failed. Free market at its best.

What these regs won't do is have ANY effect on over seas manufacturers. And that is where the majority of problems are coming from