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

[DC2]

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

Good question.

My reply was based solely on reading the rest of zoidMan's post that you quoted.
I have no responsibility for how the FDA acts with respect to what was written there.

 

[MacTechVpr]

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..

Agree. Entire objective. Cap and control what transition may occur. But conventionalized highly standardized designs, output with consolidated production, retail and supply lines. A great many will love that degree of technology. While holding much appeal to the middle they'll have very little in the way of adaptability…but as you say, effective. Good enough for government work.

G'luck.

 

[MacTechVpr]

My only guilt would be letting myself down --

First and foremost we have a duty to ourselves, families…then, to all the fine people who helped get us here in the community through their research, hard effort, trials, risks and investments personal or business. We owe the whole lot a debt of gratitude to likewise help others. But guilt, not for the dirtbags who're just making it that much harder and especially for the disadvantaged. Hypocrites all. G'luck.

p.s. Not hoarding if you need it.

 

[WillyZee]

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.

Then BG will tax them the same as smoking ... vaping cigalikes will probably cost more than smoking in the end

They already have a name for them ... ENDS (electronic nicotine delivery system).

 

[zoiDman]

Interesting. I wonder what the meaning of the word "act" is in this context? I doubt it means "Approve or Reject within 180 days".

Yeah... I don't think it falls under the "30 Minutes or Less or your Pizza is Free" thing.

The Big question I always Ask is what happens if the FDA Doesn't Act within 180 Days in a situation like this?

Have a Mark Made against them in their next Employee Performance Review?
Get Sanctioned by Senate R's and D's?
Forfeit their Game Check for Sunday?
Nothing?

 

[AndriaD]

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.

Then BG will tax them the same as smoking ... vaping cigalikes will probably cost more than smoking in the end

They already have a name for them ... ENDS (electronic nicotine delivery system).

Their "ban" will not cause my RDAs to dematerialize.

Andria

 

[zoiDman]

Hey... This is OT.

But have People seen what is going on in "My Sweet Home... Chicago"

Chicago to TAX 95 Cents Per ML!

 

[WillyZee]

Their "ban" will not cause my RDAs to dematerialize.

Andria

nope ... but you are a DIY vaper, and they know there are a few who will slip the noose ... it's the rest of the vapers who will be locked out when open bottles of eLiquid may no longer be available

 

[skoony]

If you think that someday there will be No Smokers because everyone Vapes, and If you think that the Only Way to keep people using e-Cigarettes is to Add an Addictive Chemical to e-Liquids, who's to Say your Not Right?

BTW - When do you think all this will start Happening?

Why am I not wrong?
my hypothesis stands as I have I have stated it. Stick to the point.

Yeah... Might want to see what kind of Numbers can be Found for Non-Adults.

Because Non-Adults do become Adults sooner or Later. That is One Thing I think Everyone can Agree on.

non sequitur.

Yeah... How Well did that work out for BT?

LOL

Another non issue that doesn't address the point.

I seem to Recall almost Barfing when I tried my 1st Cigarette.

But that didn't stop me from wanting the Buzz. Or the Desire to look "Cool".

LOL.

the learning curve proceeds the buzz.

It only takes one hit from an eGo type at 18mg to get someone who's got no tolerance for nic a good buzz. Early on, I was vaping some Belgian Cocoa and my wife (who's never used nicotine) remarked how good it smelled. So I suggested she try it. She had one puff. "Wow! I feel funny. Do you feel like this all the time?"

B as in b, S as in S.

So just to be Clear. Are you say'n you don't think the Feds are going to Tax e-Liquids?

That almost Defies Logic. Seeing that the Feds are like 19 Trillion in the Red.

the Feds are going to tax everything.
OK...

So the Federal Government, who is Made of States who are Just Begging to Tax the Living Snit out of e-Liquids, wants to Ban e-Cigarettes.

And that Same Federal Government, who is 19 Trillion or so in the Hole, is going to Turn Their Backs on a 4 Billion/Year (2015 Dollars) Taxable Market by Banning e-Cigarettes.

Why on God's Earth would they (anyone) Want to do That?

Deeming/GF Date doesn't need to be Changed for BT and a few BV's to control the Market. And with so few Players, and the Money goes in Less Pockets. But those Pockets get More. Much More.

Just Doesn't make sense for Anyone to Ban e-Cigarettes.

Yes,Yes,Yes. what part of e-juice being non additive to those that have never used tobacco products
you refuse to understand?

Mike

 

[sofarsogood]

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

You must be talking about Chicago which is about to impose a $0.95 per ml tax on e liquid. Let's have fun with the numbers. 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 witnessed the identical exchaange in another store a couple weeks earlier.

$0.95 / 6mg = 15.8 cents tax per mg of nic. A $50 1 liter bottle of 100mg nic has 100,000mg of nic. $50 / 100,000 = 1/20th of one cent per mg. 15.8 cents Chicago tax X 100,000mg = $15,800.00 for a $50 bottle of nic.

 

[zoiDman]

Why am I not wrong?
my hypothesis stands as I have I have stated it. Stick to the point.

non sequitur.


Another non issue that doesn't address the point.


the learning curve proceeds the buzz.


B as in b, S as in S.



Yes,Yes,Yes. what part of e-juice being non additive to those that have never used tobacco products
you refuse to understand?

Mike

So when do they Start putting the Addictive Chemicals in the e-Liquids to keep Vaper's Hooked mike?

 

[MacTechVpr]

So when do they Start putting the Addictive Chemicals in the e-Liquids to keep Vaper's Hooked mike?

Soon as they figure out what ammonia's for. G'luck.

 

[zoiDman]

You must be talking about Chicago which is about to impose a $0.95 per ml tax on e liquid. Let's have fun with the numbers. 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 witnessed the identical exchaange in another store a couple weeks earlier.

$0.95 / 6mg = 15.8 cents tax per mg of nic. A $50 1 liter bottle of 100mg nic has 100,000mg of nic. $50 / 100,000 = 1/20th of one cent per mg. 15.8 cents Chicago tax X 100,000mg = $15,800.00 for a $50 bottle of nic.

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?

 

[MacTechVpr]

You must be talking about Chicago which is about to impose a $0.95 per ml tax on e liquid. Let's have fun with the numbers. 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 witnessed the identical exchaange in another store a couple weeks earlier.

$0.95 / 6mg = 15.8 cents tax per mg of nic. A $50 1 liter bottle of 100mg nic has 100,000mg of nic. $50 / 100,000 = 1/20th of one cent per mg. 15.8 cents Chicago tax X 100,000mg = $15,800.00 for a $50 bottle of nic.

You just lit up smiles on just about every kinda lab glass vendor in the country.

G'luck!

 

[Rossum]

B as in b, S as in S.

So you're saying my wife was lying to me? Or are you accusing ME of lying? Either way, I'm not liking where this is going.

 

[Rossum]

What Chicago is Proposing Isn't Killing that Goose.
It is Killing It, Burning the Carcass, and then Spreading the Ashes in Multiple Locations.

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

 

[Kent C]

Some, sure. But "The Feds" are not a group with a homogeneous viewpoint.

In general yes, but specific to tobacco control - it's the FDA and HHS dept and the administration. So far a pretty homogeneous viewpoint. While the Dem majority that enacted the Family Tobacco Law is gone, the President who signed it into law is not.

 

[Kent C]

The FDA doesn't want to be seen as a "bad guy" to that extent. There's a mountain of evidence in favor of harm reduction that would come crashing down on them if they were to reject all applications.

Of course, that's your opinion and you may be right but I've seen this go down both ways - 'not wanting to be the 'bad guy' and no problem with being the 'bad guy'. I can site examples, but won't bother. Unless the deeming is altered - the 'wanting to be the bad guy' is winning at this point. I concede that may change but I haven't seen any indication so far from the personalities involved, that it will. (acknowledged as 'my opinion' based on reason guided by experience :- )

I do not think the FDA wants to risk a loss of face such as the one that the upstart Sottera handed them.

While Sottera was a 'win', it was highly specialized according to law and what areas of authority the FDA had. The deeming redefines that area of authority and doing so makes a harder court case or cases.... I'm sure there will be some to follow if the deeming goes as written and if the FDA rejects applications - that will be another 'fertile field' for lawsuits, and again - tobacco is the most likely to be able to afford that. I don't include BP in any of this. All that will happen with them if there's a banning is that they will be able to say that, even with 1% success, it's the 'best way' to quit cigarettes. lol And of course continue to push Chantix.

 

[Kent C]

Interesting. I wonder what the meaning of the word "act" is in this context? I doubt it means "Approve or Reject within 180 days".

I'd have to look, but it seems to me that Bill G. has cited many cases where applications were not approved or rejected - like a 'pocket veto', and it is seems that he said the time frame for some was well over 180 days - like 2 years maybe? I may have misremembered that though.

 

[DC2]

I'd have to look, but it seems to me that Bill G. has cited many cases where applications were not approved or rejected - like a 'pocket veto', and it is seems that he said the time frame for some was well over 180 days - like 2 years maybe? I may have misremembered that though.

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