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

[Kent C]

I expect that once they believe they have the market cornered, BT will will introduce more effective stuff. They want the customers they've already lost to the independent vape market back..

Again, that would depend on what the FDA allows as far as applications for new products goes. If the FDA wanted to shut down vaping, they simply would reject applications on various grounds. All the studies that are required - not only to show no harm but how other forms wouldn't be as effective, etc. etc. etc. And they'd be up against studies that show harm and in some cases, more harm than cigarettes.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM273425.pdf

Section 910(b)(1)(A) of the FD&C Act requires that a PMTA contain "full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products." FDA interprets the information required under this provision to include, not only investigations that support the application, but also any investigations that do not support, or are adverse to, the application. Information on both nonclinical and clinical investigations should be provided, including, but not limited to, any studies assessing constituents of tobacco or tobacco smoke, toxicology, consumer exposure, and consumer use profiles. Further, information on investigations concerning products with novel components, ingredients, additives or design features that are similar or related to those of the new tobacco product and investigations concerning products that share novel components, ingredients, additives or design features with the new tobacco product should also be provided so that FDA may adequately assess the health risks of the product. To the extent the information is available, you should indicate the source of funding for all studies provided.

 

[DC2]

IF the tobacco companies get a product that is grandfathered - still in question, imo, then some collusion might be indicated. If they happen to be the only ones with enough money to apply for and get new products approved - I don't think that "proves" collusion, but will be a 'by-product' (perhaps even an unwanted one on the part of the FDA) of the deeming and decimating the rest of the ecig industry.

I don't think Big Tobacco is even close to getting anything grandfathered.
Just like nobody else is.

But yeah, they'll get their PMTAs in with all the requisite crap that goes along with that.
Getting some of their products approved, if it should happen, would not be a sign of collusion in and of itself.

But having the regulations favor them, and their closed-systems, will look a bit funny.
And not in an amusing way.

 

[DC2]

Consider this. We know from
clinical studies where nic was used to assess its medicinal qualities in the treatment
of various illnesses that it doesn't cause dependency in life time non-users of tobacco
products. The myth of nicotine addiction - Formindep
This means they can't count on new entry level e-cig users whom have never smoked
to maintain a customer base. If every smoker transitions to vaping sooner or later
that base will dwindle to nothing years down the road. Could this mean the end not
only to cigarettes but, eventually vaping? The only way they can maintain a customer
base over the long haul is to have a steady stream of cigarette users entering the market.

This is exactly right.

And this is why they are looking to kill vaping rather than tax it.
But I know some will disagree here.

 

[zoiDman]

...

Getting some of their products approved, if it should happen, would not be a sign of collusion in and of itself.

...

This, inandof itself, would not be Collusion.

What would be Collusion is If BT had Advanced Knowledge of what the e-Cigarette Rule Set looks Like. And others Didn't.

I would Find it Funny that TVECA would be the Only One who might be able to Gain Access to FDA Documents not meant for the Public Domain. Or even Other Stakeholders.

 

[DC2]

It will take some time to figure out whether never smokers who take up vaping at say, age 18, and vape nic for decades, become "dependent".

I'll go ahead and say, for the most part, no they won't.
But that's the exact point on which I lay all of my beliefs on these topics.

And again, I know many here won't agree with that.
And the ANTZ certainly will think I'm entirely full of crap.

 

[zoiDman]

This is exactly right.

And this is why they are looking to kill vaping rather than tax it.
But I know some will disagree here.

Not going to Disagree with you DC2. If that is what you Feel, that's Cool.

But here is a Question. Did you ever ride this Book when you were Young?

Just Replace the word "Eggs" with the word "Taxes". And then the word "Goose" with "e-Cigarettes".

Now that is a Story that Many/Most Legislators would like to Read their Children.

 

[Kent C]

I don't think Big Tobacco is even close to getting anything grandfathered.
Just like nobody else is.

Agreed.

But yeah, they'll get their PMTAs in with all the requisite crap that goes along with that.
Getting some of their products approved, if it should happen, would not be a sign of collusion in and of itself.

Agreed.

But having the regulations favor them, and their closed-systems, will look a bit funny.
And not in an amusing way.

That would have to be a change in the deeming. Pretty sure the deeming doesn't mention 'closed-systems' - only the comments by some tobacco companies to the deeming, suggested it. But yeah, if the deeming changes to include closed-systems, (something I don't expect), that would indicate a bias. But even then, they would still have power over any new product applications.

 

[DC2]

But that didn't stop me from wanting the Buzz.

Do some people actually get a "buzz" from nicotine?
I know I never did.

 

[Kent C]

Just Replace the word "Eggs" with the word "Taxes". And then the word "Goose" with "e-Cigarettes".

The "Goose" right now is cigarettes. And for reasons sofarsogood has laid out, ecigarettes won't be the new Goose. Not saying they won't try to clone it into one though

 

[Kent C]

Do some people actually get a "buzz" from nicotine?
I know I never did.

Only after a 9 hour flight from Maui to Chicago Otherwise - No.

 

[zoiDman]

Do some people actually get a "buzz" from nicotine?
I know I never did.

In the Beginning, as a Never Smoker, I know did.

And I know that many "Kids" hit on 36mg at Low Ohms to do just that.

They may call it "Buzz". I would Call it "Nic Sick". But then again, I haven't been a Kid since B&W TV.

 

[Kent C]

In the Beginning, as a Never Smoker, I know did.

And I know that many "Kids" hit on 36mg at Low Ohms to do just that.

They may call it "Buzz". I would Call it "Nic Sick". But then again, I haven't been a Kid since B&W TV.

I get hiccups and a bit racey heart at 24mg nic. Don't call it a buzz either - agree with your tag.

 

[zoiDman]

The "Goose" right now is cigarettes. And for reasons sofarsogood has laid out, ecigarettes won't be the new Goose. Not saying they won't try to clone it into one though

"Now" is a Relative Term.

 

[DC2]

The only "buzz" I ever got from smoking was the first one of the day.

It was more of a light-headed feeling than a buzz though.
And it was from carbon-monoxide.

 

[Kent C]

"Now" is a Relative Term.

Now - begets the luxury, state, sales and MSA taxes today. Not as much as earlier but it is still the Goose now. If there's an attempt to replace those taxes with ecigs, I think you'll see more and more people taking on the view of Mac, Rossum, jman and others (including me) to simply not give them the pleasure of our taxes - via stocking up or the black market.

I don't think they'll ever reach the point of cigarette taxes. Not that they won't try - but just like the 'luxury boat/car' tax of the 90's where they projected iirc a $9 billion windfall, they lost $3 billion from the yachting community not buying new boats and no one buying $30,000 cars (which in todays market would be about $80-90,000 cars and trucks). They abandoned the 'luxury tax' from the onslaught of 'unintended' (by them only lol) consequences. Many jobs (from executive to the minimum wage level) were lost along all coasts and waterways, and businesses went under, never to recover. Central planning at it's worst.

 

[DC2]

Just Replace the word "Eggs" with the word "Taxes". And then the word "Goose" with "e-Cigarettes".

The entire concept of tax revenue form cigarettes versus smoking is a very interesting one.
And I know we are on opposite sides of that topic.

I think it is long overdue to have a thread dedicated to such a discussion.

 

[zoiDman]

Now - begets the luxury, state, sales and MSA taxes today. Not as much as earlier but it is still the Goose now. If there's an attempt to replace those taxes with ecigs, I think you'll see more and more people taking on the view of Mac, Rossum, jman and others (including me) to simply not give them the pleasure of our taxes - via stocking up or the black market.

I don't think they'll ever reach the point of cigarette taxes. Not that they won't try - but just like the 'luxury boat/car' tax of the 90's where they projected iirc a $9 billion windfall, they lost $3 billion from the yachting community not buying new boats and no one buying $30,000 cars (which in todays market would be about $80-90,000 cars and trucks). They abandoned the 'luxury tax' from the onslaught of 'unintended' (by them only lol) consequences. Many jobs (from executive to the minimum wage level) were lost along all coasts and waterways, and businesses went under, never to recover. Central planning at it's worst.

We'll see.

I think it would have been an Easy Sell with Reps/General Public if Ohio had gone after a $1 Tax on 30ml of 1 ~ 24mg e-Liquid. Doesn't make up for All Lost Taxes on Tobacco use. But hey, you don't have to get it Back in One Shot, Right?

 

[zoiDman]

The entire concept of tax revenue form cigarettes versus smoking is a very interesting one.
And I know we are on opposite sides of that topic.

I think it is long overdue to have a thread dedicated to such a discussion.

Not really sure we are on Opposite Sides or Not?

But you are Right. It would make for a Good Dedicated Thread.

 

[nicnik]

The only "buzz" I ever got from smoking was the first one of the day.

It was more of a light-headed feeling than a buzz though.
And it was from carbon-monoxide.

I don't believe that to be a reaction to carbon monoxide. I think it's misinformation probably originating from anti-nicotine zealots.

 

[DC2]

Not really sure we are on Opposite Sides or Not?

The bottom line is that you think they want to tax it, and I think they want to kill it.
But then again, it depends on who "they" is.

The states probably want to tax the hell out of it.
The Federal Government (FDA) probably wants it dead and gone.

The states might be perfectly happy with a "dead and gone" outcome though.
And it's clear that is what Big Pharma and the ANTZ and Tobacco Control want most of all.

I do often have a hard time determining what Big Tobacco REALLY wants.
But I think they are playing both sides and hoping for whatever falls their way.

But you are Right. It would make for a Good Dedicated Thread.

I'm not starting it.
At least not today anyway.