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

[DC2]

I'm going by what is actually in the docs, what is written as far as what requirements for applications are in the docs. And none of that says anything that indicates to me that there is collusion between "BT" and the FDA.

I don't necessarily disagree with your comment above.
And I do not firmly believed that Big tobacco has a seat at the table here.

But I do know that Bill Godshall is constantly telling us that Phillip Morris helped write the FSPTCA.
And if that's true, then one might consider what that means in the grand scheme of things.

 

[MacTechVpr]

Any regulations geared toward the following will, by definition, preclude open systems...

Planning For The FDA’s 'Deeming Rule' For E-Cigarettes - Law360

...requiring e-cigarettes to be manufactured in a way that assures product consistency, safety and quality...

Through the years the FDA's MO has been to liberally constrain the definition of what a tobacco delivery device is leaving customer retention as one of the few avenues of competition between the remaining players.
Why should we expect otherwise? A tiger doesn't change its stripes.
FDA has cast a broad net. They intend to catch fish and to hell with the human environment.
The only question in my mind is how quick the net will be dropped on the hapless population beneath it.

Perhaps K's right if I'm trackin' correctly and they won't go beyond enclosed systems in their initial enforcement. Then again, they may already think they have their one-size-fits-all unicorn.

Good luck all.



p.s. Couldn't read your link @DC2…here's an alt, hope same…‎www.thompsonhine.com/uploads/1137/doc/Law360_E-Cigarette.pdf

 

[Kent C]

But we're all different, and I don't doubt that some/many people might get a buzz from nicotine alone.

I just know that I do not, and never did.

There's a 2009 thread on the same subject and pretty much (by consensus) shows what you say - most people don't get a buzz but some do. If you do a search - you'll find - usually from some 'smokefree' group - that it's about how the nicotine affects the brain (certain recepters,etc. blah blah) and they make the same type of argument that they like to make with drugs - that once you get the buzz, then you don't get it OR it isn't as intense, so you keep smoking more, etc. etc. Sorry, that simply doesn't compute when you don't get the buzz in the first place :- ) So much of the buzz thing (not saying it doesn't exist with some) is more about anti-smoking junk science propaganda.

 

[Kent C]

I don't necessarily disagree with your comment above.
And I do not firmly believed that Big Tobacco has a seat at the table here.

But I do know that Bill Godshall is constantly telling us that Phillip Morris helped write the FSPTCA.
And if that's true, then one might consider what that means in the grand scheme of things.

I could see that since if vaping is banned entirely, the cigarette companies would - as only a by-product of the deeming - benefit. But as written wouldn't help in their vaping business - except as I've laid out.

 

[zoiDman]

I'm not sure how a RBA/RTA/RDA could fulfill this...

But I could see how a Vuse Cartridge could.

 

[DC2]

I'm not sure how a RBA/RTA/RDA could fulfill this...

Thanks for posting that, because I remember reading it...
But I never would have found it again myself.


SEARCH: open system

 

[zoiDman]

Thanks for posting that, because I remember reading it...
But I never would have found it again myself.


SEARCH: open system

No Problem DC2.

Just keep in Mind that that Screen Shot Snippet came from the TVECA "Draft" PMTA Guidance. So that exact wording May or May Not be in what the OMB/OIRA is Reviewing.

I would just be Surprised if the FDA would be Willing to Sign Off on any Atomizer where a User could Change to a Coil with an Ohms that would Exceed the Amp Limit of a Battery.

 

[zoiDman]

BTW - Some May see "Closed System Cartridges" as in some way Collusion between the FDA and BT.

If NJOY had a Closed System Cartridge in the works, would that Also be considered Collusion? Only this time, Collusion between a Vape Company and the FDA?

 

[zoiDman]

BTW2 - I bet the FDA has enjoyed Hours of Laughing their Azz's Off reading this Thread and watching us Trying to Figure Out what they are Up To.

 

[Myrany]

BTW - Some May see "Closed System Cartridges" as in some way Collusion between the FDA and BT.

If NJOY had a Closed System Cartridge in the works, would that Also be considered Collusion? Only this time, Collusion between a Vape Company and the FDA?

They have a closed nonrefillable prefilled tank system now. It just hit the market recently. It is in the Convenience vaping section of the NJoy site.

 

[nicnik]

I'm willing to buy that.

What I have trouble with is the idea that nicotine alone is what gives people a buzz.
But we're all different, and I don't doubt that some/many people might get a buzz from nicotine alone.

I just know that I do not, and never did.



I have vaped lots of nicotine at high levels and never got any buzz.
Even all the way up to the point where I get a headache and sick to my stomach.

But when I vape WTA liquid, I do get a slight light-headed feeling.
And it IS somewhat similar to the slight "buzz" I used to get from the first cigarette of the day.

Everything you say in this post fits right along with what RaltSig150 said. Very interesting what you mentioned here about how you experience WTA.

 

[Kent C]

BTW - Some May see "Closed System Cartridges" as in some way Collusion between the FDA and BT.

If NJOY had a Closed System Cartridge in the works, would that Also be considered Collusion? Only this time, Collusion between a Vape Company and the FDA?

Just because a company makes a closed-system cartridge doesn't show collusion with the FDA. Again, your speculations are misplaced. And the Vuse system has been hacked various ways, so that doesn't really pass the 'tamper' test either. In fact none will. The manufacture can recommend and state specifically what not to do, that doesn't stop people from doing that and no written regulation would either.

 

[Kent C]

BTW2 - I bet the FDA has enjoyed Hours of Laughing their Azz's Off reading this Thread and watching us Trying to Figure Out what they are Up To.

More bets - you keep making Stubby right

 

[Kent C]

BTW2 - I bet the FDA has enjoyed Hours of Laughing their Azz's Off reading this Thread and watching us Trying to Figure Out what they are Up To.

You've given them much to laugh about.

 

[zoiDman]

You've given them much to laugh about.

I don't think it is an Exclusive Club.

 

[WillyZee]

it will be BT and NJOY still in the game ... after the regs are passed, cigalike innovation will improve drastically.

NJOY will probably lead the way

 

[zoiDman]

They have a closed nonrefillable prefilled tank system now. It just hit the market recently. It is in the Convenience vaping section of the NJoy site.

It would seem to be a Very Prudent Move on NJOY's part.

 

[DC2]

I would just be Surprised if the FDA would be Willing to Sign Off on any Atomizer where a User could Change to a Coil with an Ohms that would Exceed the Amp Limit of a Battery.

I'll be surprised if they're willing to sign off on anything that can be changed by the user.
If for no other reason than it can no longer deliver a consistent dose.

 

[Kent C]

I'll be surprised if they're willing to sign off on anything that can be changed by the user.
If for no other reason than it can no longer deliver a consistent dose.

That would indicate they'd be in collusion with the black market

 

[zoiDman]

I'll be surprised if they're willing to sign off on anything that can be changed by the user.
If for no other reason than it can no longer deliver a consistent dose.

There are Many who believe this is going to be True.