FDA What happens if/when…

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Krashman Von Stinkputin

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-- Although controversial, be willing to tackle the issue of tobacco/nicotine product use by minors. This is the foundational item that rules them all, and for sure rules FSPTCA. It is a political football that the opposing sides of the debate want to pin to the other side via hyperbolic and misguided applications of what is truly at stake. Understand this issue thoroughly and be prepared to address it squarely. Failure to do so, will make it confusing to navigate through what is truly going on within this particular political battle.

This is an absolute non-starter.

Cigarette commercial 40+ years ago when I was a lad:

The rugged & virile Marlboro Man riding his horse through the wide vistas of Marboro Country.

Cigarette commercial now:
The Marlboro Man showing you how to take a shower and not get water down your Tracheostomy Hole.
or
A young girl at the Quik Stop ripping off a hunk of her face to pay for a pack of smokes.

Good luck arguing "tobacco for Timmy"
 
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dragonpuff

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Would you be okay if this policy was put in place for those adults that government feels doesn't have the intellectual capacity to make the purchasing decision for themselves? Cause, you know, some adults don't seem to realize that nicotine is highly addictive and will become visibly temperamental when someone conveys that notion to them. Therefore, for (some) adults we could say it is okay for you to use this product, but never okay to buy it.

At least we'd be consistent with what you've put forth.

Would you be ok with children being allowed to drink liquor, drive cars, get tattoos and piercings, or join the military? Because that would be consistent with the argument you're putting forth.

And with that, I am done feeding trolls for the day. :closedeyes:

Ok, I guess I can go along with that; kids that have vape gear or are seen vaping should not be treated as criminals, because maybe if they weren't vaping, they'd be smoking, which is so much worse I'm not sure it can even be quantified.

I agree that kids don't have good judgement, or why would they have been smokers?

I'm just really concerned about the very real damage that smoking does to young brains, and I think that no effort to prevent that damage is too much. Because if they have ever smoked, then some of the damage of the MAOIs is already done; if perhaps they were *inclined* to try smoking, but decided to vape instead because hey, it's way cooler and doesn't stink, then I see that as a real win, for that child's brain and later life, no matter the ridiculous cool factor that a child might use to make that choice.

Andria

I feel strongly that the best thing to do is to try to keep the kids from getting addicted to smoking in the first place. It is much harder said than done, but the whole "talk to your kids about smoking" thing really does work for a lot of kids. As for the ones who smoke anyway, it's all on an individual basis. A lot of parents are reasonable enough to do whatever they can to get their kids off cigarettes. For the rare few who smoke, can't quit, and their parents won't let them vape - let them try it when they turn 18. Realistically speaking, smoking for only a few years doesn't do a whole lot of damage.

As it stands now, fewer kids are trying cigarettes these days anyway. It's just not as cool as it used to be.
 

HgA1C

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I would stock up on whatever you need because my business partner works with a bio-chemist who works directly with the FDA and he claims the slap down is coming in 2015 for sure, regardless of who protests the regulations.

Well I guess it is a good thing we have courts that can grant things like injunctions. The courts already put the smack down on the FDA once, don't be surprised if it happens again. FDA has not followed the laws for public health policy changes. It should be forced to the Supreme court if the FDA thinks they can do an end around the laws of this country.
 

csardaz

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I don't know the rules so well, but it seems like for drugs you prove it works for what you say it does - and thats pretty loose like works better than a placebo then prove that it doesn't do more harm than good for a very limited set of people. For tobacco you now have to prove it is good for public health including will people use it other than intended and psych/social junk like is your product sufficiently unattractive that nobody will use it? So who will spend a million to get permission to sell a product that repels customers? For herbal stuff its completely different as you can't claim it works since they won't let you claim it does anything meaningful, and lots of them are dangerous if misused so they just let you get by with a 'safe dosage' and a warning to discontinue use if it makes you feel bad.

But the legal aspects of vapor are more. Their deeming broke a lot of rules for new regulations that go beyond public health like not considering the impact on small business, or is there a less onerous means of regulating them, the effect of creating black markets and defining the good to come of the regulation vs the cost. It somehow got past the regulators of regulations - OMB and another? to get this far, but has to pass them again. It could be completely different the next time we see it, but I expect it will still be full of problems that are challengeable in a court.
 
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HgA1C

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I don't know the rules so well, but it seems like for drugs you prove it works for what you say it does - and thats pretty loose like works better than a placebo then prove that it doesn't do more harm than good for a very limited set of people. For tobacco you now have to prove it is good for public health including will people use it other than intended and psych/social junk like is your product sufficiently unattractive that nobody will use it? So who will spend a million to get permission to sell a product that repels customers? For herbal stuff its completely different as you can't claim it works since they won't let you claim it does anything meaningful, and lots of them are dangerous if misused so they just let you get by with a 'safe dosage' and a warning to discontinue use if it makes you feel bad.

But the legal aspects of vapor are more. Their deeming broke a lot of rules for new regulations that go beyond public health like not considering the impact on small business, or is there a less onerous means of regulating them, the effect of creating black markets and defining the good to come of the regulation vs the cost. It somehow got past the regulators of regulations - OMB and another? to get this far, but has to pass them again. It could be completely different the next time we see it, but I expect it will still be full of problems that are challengeable in a court.

The laws are setup so that if a public health policy is going to be changed that there needs to be substantial scientific merit backing that it benefits society, individuals, and makes economic sense for the country. As vaping is currently legal the FDA is required to comply with these laws, as vaping is a public health issue that produces more than $750m per annum in our economy. They are ignoring the laws, and trying to pull an end around. I have a feeling this will not be settled for 5-10 years, unless the courts intentionally speed up the process. In which case I expect the supreme court to deny the FDA regulations. Overall, the FDA would need congress to pass new laws, and have the sitting president sign them into effect.

There are people in the know and public health sectors pushing this perspective.
 

Jman8

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Would you be ok with children being allowed to drink liquor, drive cars, get tattoos and piercings, or join the military? Because that would be consistent with the argument you're putting forth.

Yes, I would be okay with these things. Glad to elaborate on this if the intellectual discourse merits such a discussion. Children are people who are under the age of 18. Could you imagine a child driving a car? Preposterous, right?

I feel strongly that the best thing to do is to try to keep the kids from getting addicted to smoking in the first place. It is much harder said than done, but the whole "talk to your kids about smoking" thing really does work for a lot of kids. As for the ones who smoke anyway, it's all on an individual basis. A lot of parents are reasonable enough to do whatever they can to get their kids off cigarettes. For the rare few who smoke, can't quit, and their parents won't let them vape - let them try it when they turn 18. Realistically speaking, smoking for only a few years doesn't do a whole lot of damage.

As it stands now, fewer kids are trying cigarettes these days anyway. It's just not as cool as it used to be.

IMO, if we are going to go with an age cut off, and base it on when person has enough life experience to make a decision on certain things, and we aren't just setting some arbitrary age, then I'd think age 35 or 40, would be the time to start allowing certain things to be tried. Age 18 really means age 15 when you realize how age limits work for a bunch of things (i.e. smoking, drinking) and so in a very real way we do allow children to do these things, but then pretend like we would never ever allow it. Nor should we. Except for all of us who just so happened to be 15, or maybe even younger, when we tried these things.

Son, do exactly and only what I say, but never ever do as I do. Or did.
 

zoiDman

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A resort to semantics.

woohoo.gif

I noticed that you have been Non-Committal on the Topic of a Age Limit.

Do you believe that there should be No Age Limit for Buying e-Liquids that Contain Nicotine?
 

Kent C

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So does Clive Bates believe that there should Not Be an Age Limit on Buying e-Liquids that Contain Nicotine?

Briefing: the case for e-cigarettes « The counterfactual

12. Clive: you state that:
“We have to be careful not to be overprotective of children if it means we are careless with the health of adults for no real reason.”

Dr Farsalinos has stated to me related to this issue that:
“The ban on sales to youngsters (<18) is rational, however we should not forget a very important fact: most of smokers start smoking (and become addicted to it) before the age of 18. These people become the most addicted smokers in the future. Thus, banning sales at this age group will deprive us from a golden opportunity to reduce the nr of new smokers. However, i am not sure there is another way to control marketing of e-cigarettes in this age group.”
 

zoiDman

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Briefing: the case for e-cigarettes « The counterfactual

12. Clive: you state that:
“We have to be careful not to be overprotective of children if it means we are careless with the health of adults for no real reason.”

Dr Farsalinos has stated to me related to this issue that:
“The ban on sales to youngsters (<18) is rational, however we should not forget a very important fact: most of smokers start smoking (and become addicted to it) before the age of 18. These people become the most addicted smokers in the future. Thus, banning sales at this age group will deprive us from a golden opportunity to reduce the nr of new smokers. However, i am not sure there is another way to control marketing of e-cigarettes in this age group.”

So it sounds like Mr. Bates has some Reservations, but Agrees that there Should Be an 18 or Older Age Limit on Individuals Buying e-Liquids that contain Nicotine.

And that was what I thought after reading this Letter that Mr. Bates Wrote that Bill Godshall later posted.

...

8. Develop an health-optimising regulatory framework. To give some idea of of what should be included, I have listed elements below - this should be designed carefully and implemented at EU and member state level as appropriate. It should develop over time and include:


1. Advertising. Limits on advertising content and placement roughly comparable to controls on alcohol advertising - not a complete ban - with appropriate role to member states for advertising that does not cross borders. The aim of this policy should be to discourage advertising that appeals to children, but encourage smokers to switch.


2. Age restrictions. A ban on sales to persons under age of 18 - likely to be a member state issue.

3. Testing and notification regime - covering testing of liquids and vapours for harmful and potentially harmful substances. There is a similar requirement in Article 17 of the revised tobacco products directive for novel tobacco products - the testing demands should be no greater than these.


4. Product standards - e-liquid purity. Limits to contaminants or purity standards for e-liquids (eg covering carbonyls, volatile organic compounds, nitrosamines and heavy metals), with requirements to use pharmaceutical grade excipients and nicotine, and food grade flavourings.


5. Product standards - liquid ingredients. A negative list of prohibited flavours where there is evidence of harm either to the user or where there are signs of disproportionate or deliberate appeal to children (this can only be determined ex-poste - once products are on the market) and other additives (eg. stimulants, vitamins) set out in a schedule with a mechanism to update in the light of advancing knowledge.


6. Product standards - devices. Standards could be set for maximum operating temperature and behaviour when liquid levels are low - and other relevant design parameter to assure safe operation or to limit changes to the chemistry of vapour. These could be developed as CEN/ISO standards for vaping devices with CE markings for consumer information. There is no reason to prevent refillable devices - if superior products can be made with cartridges.

...

http://www.e-cigarette-forum.com/fo...te-letter-eu-tpd-negotiators-clive-bates.html

I don't want to speak for Mr. Godshall. But I also believe that he Favors an 18 or Older Age Limit for the Purchase of e-Liquids that Contain Nicotine.
 

Kent C

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So it sounds like Mr. Bates has some Reservations, but Agrees that there Should Be an 18 or Older Age Limit on Individuals Buying e-Liquids that contain Nicotine.

And that was what I thought after reading this Letter that Mr. Bates Wrote that Bill Godshall later posted.

http://www.e-cigarette-forum.com/fo...te-letter-eu-tpd-negotiators-clive-bates.html

I think the message is mixed at best. It totally makes sense that if children are using cigarettes, they are better off using ecigarettes instead. There is a ban on cigarettes of course and a ban on ecigs will have the same results - children will find a way around that. Bate's and even Dr. F's comments speak to that.

The Bate's comment:

Clive Bates: "There is no evidence that these products appeal to children - but even if they did, they may be used as an alternative to smoking and in any case cause minimal harm." was also posted by Bill here. And in the link you provide there is this:

"There is minimal use by children and even where surveys have found children using e-cigarettes it is most likely to be displacing smoking"

"The aim of this policy should be to discourage advertising that appeals to children, but encourage smokers to switch."

This is a rather soft 'policy' - if the children are, in fact, smokers. IOW, 'discourage but encourage' if they already are smokers.

Why someone who purports to 'care' for children would prohibit a 14 year old smoker of having the benefits of ecigarettes for at least 4 years in which continuing to smoke could cause great harm, is why I said in my first post - "Their 'caring' only goes so far. :) "

Unfortunately that seems to fit you to a 'T'. You want to make sure everyone knows how much you care, by spouting the politically correct maxim, but where it may really count - where a child has taken up cigarettes and would have a chance to break the smoking habit, you could care less, and would implement a policy that would virtually ensure he or she doesn't have the same opportunity as you and I have. The only 'caring' that implies is what you think others may think of you, and like the FDA, CDC, and most of gov't - where children are only a PR ploy used to implement control over adults.
 

zoiDman

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I Agree with Mr. Bates view having 18 Year Old Age Limits for the Buying of e-Liquids that Contain Nicotine. I agree with it 100%

2. Age restrictions. A ban on sales to persons under age of 18 - likely to be a member state issue.


And as you mentioned Earlier, you Also believe with Mr. Bates on having an 18 Year Old Age Limit for the Buying of e-Liquids that Contain Nicotine.

Not sure where the "Care" thing comes in?

If a Parent wants to Provide e-Liquids to Their Children, whether they Smoke or Not, I Don't Really Care.

If a Parent Doesn't wants to Provide e-Liquids to Their Children, whether they Smoke or Not, I Don't Really Care Either.

It just Isn't a Huge Issue with me. If or If Not a Parent Wants to provide e-Liquids that Contain Nicotine to Their Children is a "Choice Issue". And I am a Big Pro-Choice believer on Many Topics. This is One of them.

If this makes me a "Uncaring" person, so Be It.
 

Kent C

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zoiDman:I Agree with Mr. Bates view having 18 Year Old Age Limits for the Buying of e-Liquids that Contain Nicotine. I agree with it 100%

A suggestion:
"this should be designed carefully and implemented at EU and member state level as appropriate. It should develop over time and include'


And as you mentioned Earlier, you Also believe with Mr. Bates on having an 18 Year Old Age Limit for the Buying of e-Liquids that Contain Nicotine.

I agree with his rationale that children who are smoking should have an alternative - ecigs.

Not sure where the "Care" thing comes in?

I know you don't.

If a Parent wants to Provide e-Liquids to Their Children, whether they Smoke or Not, I Don't Really Care.
If a Parent Doesn't wants to Provide e-Liquids to Their Children, whether they Smoke or Not, I Don't Really Care Either.

So you don't really agree 100% as you say above. Those limits would include people buying for minors.

It just Isn't a Huge Issue with me.

Evidently it is, since you're the one who continues to ask questions on the issue. I was done with my first comment, which I thought was quite clear but you continue to question me and others on the issue. Something that usually doesn't occur when someone 'doesn't care' or where it isn't a huge issue.

If or If Not a Parent Wants to provide e-Liquids that Contain Nicotine to Their Children is a "Choice Issue". And I am a Big Pro-Choice believer on Many Topics. This is One of them.



Big pro choice? On guns? politically incorrect speech? Free trade? Allowing owners to determine rules within their private property that does no harm to others? Drilling for oil? Building new coal plants or nuclear plants? Death penalty? Or just 'pro choice' in what some may say is killing the innocent?


If this makes me a "Uncaring" person, so Be It.

I think it does.
 

Kent C

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You have said the Believe the Same thing.

Whatever that means - I'm guessing that you think I believe the same thing as you - that is incorrect. I obviously don't, no matter how you would interpret, extrapolate, outright lie, in order to make it so. I was done on pg 21 but I also try to answer questions that are directed at me... to a point ....where the person asking doesn't really want answers or just makes their own up to fit themselves and has no relation at all to what I've said. That point has been reached. :)
 

zoiDman

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Whatever that means - I'm guessing that you think I believe the same thing as you - that is incorrect. I obviously don't, no matter how you would interpret, extrapolate, outright lie, in order to make it so. I was done on pg 21 but I also try to answer questions that are directed at me... to a point ....where the person asking doesn't really want answers or just makes their own up to fit themselves and has no relation at all to what I've said. That point has been reached. :)

So Again.

Do YOU Believe there should be a 18 Years or Older Age Limit for Individuals to Buy e-Liquids that Contain Nicotine in the USA?

Yes or No.

That's all I want to Know. And the Rest of this I Consider Beating a Dead Horse.
 

Kent C

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So Again.

Do YOU Believe there should be a 18 Years or Older Age Limit for Individuals to Buy e-Liquids that Contain Nicotine in the USA?

Yes or No.

That's all I want to Know. And the Rest of this I Consider Beating a Dead Horse.

You've been beating the dead horse since page 21 - and you can continue all by yourself.
 

AndriaD

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Why someone who purports to 'care' for children would prohibit a 14 year old smoker of having the benefits of ecigarettes for at least 4 years in which continuing to smoke could cause great harm, is why I said in my first post - "Their 'caring' only goes so far. :) "

Unfortunately that seems to fit you to a 'T'. You want to make sure everyone knows how much you care, by spouting the politically correct maxim, but where it may really count - where a child has taken up cigarettes and would have a chance to break the smoking habit, you could care less, and would implement a policy that would virtually ensure he or she doesn't have the same opportunity as you and I have. The only 'caring' that implies is what you think others may think of you, and like the FDA, CDC, and most of gov't - where children are only a PR ploy used to implement control over adults.

AMEN!

I keep seeing this... "if their parents won't allow it, then they can just wait till they're 18 and buy their own." But what about the damage that's done to their neurotransmitters in the meantime? People don't take brain physiology into much account, because you can't SEE it -- until the person is suicidal, at which point a lot of the same people would say something truly ignorant like "snap out of it!" :facepalm:

A *LOT* of damage can be done to the brain's neurochemistry between the ages of 13 and 18, or even between 15 and 18, or even between 16 and 18! Adolescence is when that neurochemistry is really developing, and if you insert some foreign agent that influences those neurotransmitters, such that this person can no longer function normally WITHOUT that neurotransmitter-influencing foreign agent, then permanent brain damage has already occurred, and starting to vape when they're 18 won't fix it. They'll be like me, and need WTA in their vape, just to be able to stick with smoking cessation without becoming suicidal.

I agree that Harm Reduction is valuable at ANY age, but how much better if that brain damage could be averted completely? As I mentioned, kids might choose to vape rather than smoke for ridiculous reasons like "it's cool and doesn't stink" -- but who cares WHY they choose it! The long-term consequence of being unable to make that choice, for WHATEVER reason, is a lifetime of emotional dysfunction, up to and including suicidal depression -- for which some ignoramus will likely tell them, "snap out of it!" :grr:

This politically-correct, arbitrary-rule thing is a huge steaming load of horse manure, and only serves to make sure that kids who want to vape will instead choose to smoke, and give themselves a lifetime of heartache. Vaping *IS* cooler than smoking, for so many reasons beyond the "cool factor" that influences kids... so why not allow them the opportunity to choose the cooler option?

Andria
 

Kent C

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This is only on a matter of simple logic.

When someone (you in this instance) says: "I believe in X."

And then someone else says: "you think I believe the same thing as you - that is incorrect."

There is a conclusion that anyone with half a brain ....even in a vat... could come to. That they don't, would be telling you something really important about further communications with them.
 
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