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

[MacTechVpr]

This consistent dose BS is what got us 7000 friggin chem's. No way goin' back to that model. A great many at risk individuals are more concerned re food flavoring additives that might fall under this act and regs. GMP's (MSG) being one that is massively hurtful to many, is acceptable to FDA now and hugely abused in the marketplace. Going to trust FDA to be responsible there? Nicotine's not a problem or issue. It's what they're likely to approve that's been known to be the hazard. The unintended consequences of brand preference justifying technology and producer consolidation instead of user education and choice. Just say no folks.

Good luck all.

 

[Kent C]

Going to trust FDA to be responsible there?

The Federal Hazardous Substance Act (FHSA) (Pub L No. 86–613 [1960]) was amended in 1994 by the Child Safety Protection Act (CSPA) (Pub L No. 109–248). The CSPA requires choking-hazard warning labels on packaging for small balls, balloons,


The Consumer Product Safety Commission4 (CPSC) works to ensure the safety of consumer products such as toys, cribs, power tools, cigarette lighters

 

[AndriaD]

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.

And I really don't interpret the dizzy feeling I get from too much nicotine, as a "buzz" -- it's not nearly pleasant enough for that word! I've never minded dizziness, particularly -- I used to be one of those kids that would spin round and round just to get that dizzy feeling. But with too much nicotine, I know that following the dizziness comes nausea, if I don't leave off the nic consumption just as soon as I perceive the dizziness.

But the only thing I get from WTA is "normal" -- which is exactly what I get from nicotine, when it's in the proper dosage for this body. Bear in mind that I started smoking when not yet 14 -- so my brain learned that the presence of MAOIs was normal, MANY years before it was anything close to maturity, so the presence of MAOIs is in fact my own "normal" -- and it's taken me 11 months to get from 10% to 1.2% WTA in my ejuice, and obviously still not finished. I think this is the biggest reason I've had such a terribly hard time with trying to quit smoking, my brain really needed not just the nicotine, but the full tobacco alkaloid cocktail, and until vaping and WTA, I had no way of getting it, except smoking.

This is the primary reason I'm so militant about adolescents being able to vape -- it's crucial to try and prevent them EVER smoking, or at least ever taking it up as a habitual pastime, because once the immature, developing brain gets accustomed to those MAOIs from tobacco... it may or may not ever be able to do without them. If vaping, even vaping with nicotine, can prevent that, then it's a useful and wonderful thing for teens to do, rather than smoke. Without the co-administration of the MAOIs with nicotine, they are very unlikely to establish nicotine dependency.

Andria

 

[MacTechVpr]

The Federal Hazardous Substance Act (FHSA) (Pub L No. 86–613 [1960]) was amended in 1994 by the Child Safety Protection Act (CSPA) (Pub L No. 109–248). The CSPA requires choking-hazard warning labels on packaging for small balls, balloons,


The Consumer Product Safety Commission4 (CPSC) works to ensure the safety of consumer products such as toys, cribs, power tools, cigarette lighters

Guess that falls under the guidelines of an inadequate environmental impact study. Time to ban lighters, flambé torches and BBQ starters.

Good luck all.

 

[Rossum]

Guess that falls under the guidelines of an inadequate environmental impact study. Time to ban lighters, flambé torches and BBQ starters.

OK, but they ain't getting my flame thrower.

 

[Luke matt]

Well, let's hear it for the black market then. If they're too stupid to avoid creating it, then they deserve to miss out on all that sales tax.

Andria

Right on. VAPE STRONG AND GOD BLESS. Peace

 

[skoony]

Hey you were the One who Suggested that "they" would have to put Addictive Chemicals in e-Liquids to keep Never-Smokers hooked not me.

You say that Most Never-Smokers use 0mg. Great. Post where you are Getting this Data From.

Lastly, You want to talk about Theoretics if the e-Cigarette market was "allowed to mature". But that Isn't going to happen. The e-Cigarette market Is going to be Regulated.

Again,I never said that they will put any thing in the e-juice. I suggested that to keep the market share
from disappearing if in fact they leave an e-cigarette market at all that they would have have to come
up with some kind of hook.
Look I am trying to have a discussion. You know very well what I said about lifetime non-tobacco users
is true. This has come up in other threads many times. Threads you were participating in.
One study indicated about 1%,another 3%,I believe the latest studies from England indicated
5%( ?) of vapers never used tobacco products. In all those studies the majority used zero nicotine
juice. This link below is an interesting study of under age usage. 72% of first time e-cig usage was
with zero nic juice. This also backs up what I have always said about the increase of underage
usage. The majority of under age usage is from fruit flavored,zero nic,disposable cigalikes called
party hooka's that are a must have party favor at any respectable teenage party.
Ever Use of Nicotine and Nonnicotine Electronic Cigarettes Among High School Students in Ontario, Canada
As far as the Deeming reg.'s and how they will affect the industry is any ones guess right now.
I leaning towards they will be so onerous as to effectively be a ban with a different name handing
a lot of vapers and most future vapers back into the arms of BT. Then my speculation becomes
moot.
Last but not least I am not interested in a adversarial argument. I am more interested in a
hypothetical discussion of possible future outcomes. If there is a future.

Regards
mike

 

[zoiDman]

Again,I never said that they will put any thing in the e-juice. I suggested that to keep the market share
from disappearing if in fact they leave an e-cigarette market at all that they would have have to come
up with some kind of hook.
Look I am trying to have a discussion. You know very well what I said about lifetime non-tobacco users
is true. This has come up in other threads many times. Threads you were participating in.
One study indicated about 1%,another 3%,I believe the latest studies from England indicated
5%( ?) of vapers never used tobacco products. In all those studies the majority used zero nicotine
juice. This link below is an interesting study of under age usage. 72% of first time e-cig usage was
with zero nic juice. This also backs up what I have always said about the increase of underage
usage. The majority of under age usage is from fruit flavored,zero nic,disposable cigalikes called
party hooka's that are a must have party favor at any respectable teenage party.
Ever Use of Nicotine and Nonnicotine Electronic Cigarettes Among High School Students in Ontario, Canada
As far as the Deeming reg.'s and how they will affect the industry is any ones guess right now.
I leaning towards they will be so onerous as to effectively be a ban with a different name handing
a lot of vapers and most future vapers back into the arms of BT. Then my speculation becomes
moot.
Last but not least I am not interested in a adversarial argument. I am more interested in a
hypothetical discussion of possible future outcomes. If there is a future.

Regards
mike

Here’s the Problem I have with Statistically implied inferences about a Population derived from Survey Questions. Does the Survey Question yield Meaningful information that can be used to Support a Conclusion?

From the Survey Link you provided:

"Ever use of e-cigarettes was derived from the question, “Have you ever smoked at least one puff from an electronic cigarette?” All analyses included appropriate adjustments for the complex study design."

(BTW – I Didn’t put the word “ever” in Italics. That was from the Original Link Text.)


So if a Person Takes 1 Puff off an e-Cigarette, they can/are included in the Ever Use percentile. Should people who use an e-Cigarette 1 Time and then never use an e-Cigarette again be included in a Inference about what “Regular” users of e-Cigarettes do?

How about people who do Not Own an e-Cigarette? But will take some hits off a Friends e-Cigarette occasionally. Should this group be Included also? Statistical Preferences of “Ever Use” might be a Very Poor reflection of the Preferences of the “Regular Use” group.

So does the 72% 0mg use in the Results reflect the Percentage of Nicotine use in Regular users of e-Cigarettes? Because if I use an e-Cigarette on time with 0mg and then never use an e-Cigarette again, aren’t I part of the 72%?

Maybe we need some More Inclusive Information than just an Ever Vaper?

Something more like this…

http://www.cdc.gov/nchs/data/databriefs/db217.htm


When I look at the numbers of Regular User who were Never Smokers, 2 Things stand out.

One, there was a Large Fall-Off from Ever Use to Regular Use of Never Smokers.
And Two, the number of Regular Users who were Never Smokers is Miniscule by any standard.

So I just don’t see a Reality in the Thought that “they” are going to need to put “something” into e-Liquids because Never Smokers can’t become “Hooked” on e-Cigarettes.

 

[skoony]

So I just don’t see a Reality in the Thought that “they” are going to need to put “something” into e-Liquids because Never Smokers can’t become “Hooked” on e-Cigarettes.

Lets not forget all the current ex-smokers that have weaned themselves off of nicotine. Another thing
to remember is if vaping continues to take market share away from from cigarettes ( if its allowed of course)
at some point down the road there will be only so many non-smokers/vapers left to enter the market.
What choice will they make? Smoking or vaping. Current trends seem to indicate it will be vaping as we
can see right now first time e-cigarette use in those never users of either is trending upwards. Unless
something changes I think its a safe bet to assume that the majority of these will be zero nic users.

Regards
Mike

 

[zoiDman]

Lets not forget all the current ex-smokers that have weaned themselves off of nicotine. Another thing
to remember is if vaping continues to take market share away from from cigarettes ( if its allowed of course)
at some point down the road there will be only so many non-smokers/vapers left to enter the market.
What choice will they make? Smoking or vaping. Current trends seem to indicate it will be vaping as we
can see right now first time e-cigarette use in those never users of either is trending upwards. Unless
something changes I think its a safe bet to assume that the majority of these will be zero nic users.

Regards
Mike

I think an easy trap to fall into Mike when looking at Trends is to Assume that a Trend will continue on at the same ROC (Rate of Change). Sometimes they Do. But Sometimes the Level Off and reach a state of Equilibrium.

 

[skoony]

I think an easy trap to fall into Mike when looking at Trends is to Assume that a Trend will continue on at the same ROC (Rate of Change). Sometimes they Do. But Sometimes the Level Off and reach a state of Equilibrium.

I think it's foolish not to look at the trends and pay no attention to them. In this case it's what the
underage usage is. Most people started smoking and drinking when they were underage. It's reasonable
to assume the same will hold true with vaping. At any rate I see nothing so far coming close to
counteracting this trend. One should take into account the vagaries of what the young folk consider
hip next week.

Regards
Mike

 

[zoiDman]

I think it's foolish not to look at the trends and pay no attention to them. In this case it's what the
underage usage is. Most people started smoking and drinking when they were underage. It's reasonable
to assume the same will hold true with vaping. At any rate I see nothing so far coming close to
counteracting this trend. One should take into account the vagaries of what the young folk consider
hip next week.

Regards
Mike

Didn't say it was Foolish to Look at trends. Only to Think Closely about where a Trend may end up.

I started Vaping in 2009. At that time, there was Very Few Vapers. I have Watched the Amount of Vapers Increase Year after Year.

So can I say that if this Trend Continues, that Sooner or Later ever person in the World will be a Vaper? No. That would be Silly.

The Concept of Increasing at a Decreasing Rate has to be Considered.

 

[roxynoodle]

It is true that surveys are poorly written, often to indicate a bias. And many will still lie on a survey even though its anonymous.

 

[MacTechVpr]

All we do from the next step we take to the evaluation of our complex future lives is extrapolation based on the given facts. You shall know a man by his acts. We go with what we know about the FDA's behavior even as it's no guaranteed indicator of its future actions. There's enough there to derive an informed prognosis.

Good luck, and…

May the forces of evil become confused on the way to your house. —George Carlin

 

[Kent C]

http://www.ash.org.uk/files/documents/ASH_891.pdf

 

[MacTechVpr]

Awesome. Thx K. G'luck.

p.s. I'd be 2nd tier on that list and presumably one of the experiments least likely to yield success. Now look at me. Two days brotha, two days! And no lookin' back. Yippey-kay!!!

 

[skoony]

Didn't say it was Foolish to Look at trends. Only to Think Closely about where a Trend may end up.

I started Vaping in 2009. At that time, there was Very Few Vapers. I have Watched the Amount of Vapers Increase Year after Year.

So can I say that if this Trend Continues, that Sooner or Later ever person in the World will be a Vaper? No. That would be Silly.

The Concept of Increasing at a Decreasing Rate has to be Considered.

What does that have to do with my point?
Regards
Mike

 

[zoiDman]

What does that have to do with my point?
Regards
Mike

That trends Today aren't always Realities in the Future.

 

[Luke matt]

I agree with you on the trends for today. Won't be necessarily reflect the future of the vaping industry. That's what I was trying to say.

 

[englishmick]

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.

I seem to recall similar but more explicit language in some of the EU documents.