FDA The paradigm shift - a potential exploitable hole in reason

[Dzaw]

Something has been bothering me about the whole idea of regulation concerning e-cigarettes.

When big tobacco finally had to buckle to -some- forms of regulation, it was because the evidence had mounted so high, so far and wide, and so powerfully that their products were very very bad for their customers.

When the FDA finally decided to ban ephedrine from dietary supplements for weight loss, it was (albeit on very sketchy and scarce evidence) because of "demonstrated harm"

This has been the paradigm most regulation (be it FDA / health related or otherwise) works under - if it's unregulated, and no specific damage or harm can be pointed to, there's no need for new regulation. Heck, this paradigm applies even to natural gas fracking - there's no national regulation yet, because there hasn't been enough proof of specific harm...

Why, then, is it backwards for us? Why do we have the burden of proof to show the product we choose to engage with is harmless? Why does the industry have to show lack of health risk? This isn't being marketed as a dietary supplement, quitting aid, medicine, or medical device. There is no specific harm to point to - noone has overdosed due to e-cig use, no cancer or emphysema can be even indirectly associated with e-cigs, etc.

This paradigm shift represents a double standard, where big money corporations like big tobacco, pharm, or oil can run amok until the evidence is so plain that they're destroying people that there is no choice but to -limit- their damage somewhat, but since the e-cig industry has no mega billion dollar giants in its corner, it cant even be allowed to proceed with reducing some risk on the periphery?

 

[Augmented Dog]

Yes. It is a double standard. This issue has little, if anything to do with health concerns. It's entirely politically motivated.
Welcome to the wonderful world of big money politics where the undeniably harmful can be ignored while that proven beneficial is as easily vilified.
This is not a new social/political paradigm. It's been going on since the first corporate lobbyist crawled out of the ooze.

 

[AndriaD]

Yes. It is a double standard. This issue has little, if anything to do with health concerns. It's entirely politically motivated.
Welcome to the wonderful world of big money politics where the undeniably harmful can be ignored while that proven beneficial is as easily vilified.
This is not a new social/political paradigm. It's been going on since the first corporate lobbyist crawled out of the ooze.

And The Ooze is exactly where they belong, and I wish they'd crawl back in! They have COMPLETELY subverted the entire US political system and government!!!

Andria

 

[ClippinWings]

Why, then, is it backwards for us? Why do we have the burden of proof to show the product we choose to engage with is harmless?

You answered your own question:

since the e-cig industry has no mega billion dollar giants in its corner, it cant even be allowed to proceed with reducing some risk on the periphery?

 

[Nana Gail]

I truely hate to burst your bubble but this has nothing to do with proven facts,It's about the MONEY (read Taxes here). The United States is so deep in debt from Social Welfare, Corporate Welfare, International Welfare and ridiculous Government payrolls not to mention Government (read Politicians) pensions that we are the new Fatted Calf to be slaughtered for a revenue source. We all see the writing on the wall for the Analog industry in almost every 1st world Country so at this point the government both Federal and State and Local have been seeking new tax resources ie POT(read Weed) so you know that they really do not care about underage consumption or health issues. The Money that comes from Taxes will keep them being re elected for the foreseeable future and thats the goal. The only way they can do this is by REGULATING (Controling)consumer goods so every thing within that industry can be counted and taxed (three times). The only safety we have is in numbers, so we had better get busy converting smokers and teaching non smokers about Vaping and what it is. Our only weapon is 1 on 1 interaction and combating ignorance in the public areana. Be Visible,Be Vocal, Be Nice and Teach,Teach, Teach! I know that most people have no idea about what Vaping is because I get approached everywhere by strangers asking me about my rig. We have been "STEALTH VAPING" too long to our own detrement. I wrote to the FDA on their web site to voice my comments as asked but this isn't worth the time it took to do it They do not Care about just Vapors there aren't enough of us out there we need an informed PUBLIC to stand with us. Alone we will be Regulated out of exhistance or they will hand the industry to their cronies in the Tobbacco Industry after they suddenly have proof it's healthier than smoking! I myself am educating myself on building my own gear and how to make Home Brew Juice just incase the sky falls on us. I don't wish to be the gray haired grandma in the dark alley arrested for trying to score 10ml of Wookie Cookie. Thats my morning rant please forgive me I've only had 1 cup of coffee and I'm out of Mango Pixie Keep on Vaping on

 

[Jman8]

When big tobacco finally had to buckle to -some- forms of regulation, it was because the evidence had mounted so high, so far and wide, and so powerfully that their products were very very bad for their customers.

I would say the perception of harm was far and wide for BT, and is why they caved to regulations. But not because of evidence. To this day, they (BT execs) would show up as in denial to some degree of the evidence.

This has been the paradigm most regulation (be it FDA / health related or otherwise) works under - if it's unregulated, and no specific damage or harm can be pointed to, there's no need for new regulation. Heck, this paradigm applies even to natural gas fracking - there's no national regulation yet, because there hasn't been enough proof of specific harm...

Why, then, is it backwards for us? Why do we have the burden of proof to show the product we choose to engage with is harmless? Why does the industry have to show lack of health risk? This isn't being marketed as a dietary supplement, quitting aid, medicine, or medical device. There is no specific harm to point to - noone has overdosed due to e-cig use, no cancer or emphysema can be even indirectly associated with e-cigs, etc.

Well, regarding the bold part, unless this is your first week or two in vaping, I can think of specific harms that have come up for discussion in vaping community. I think all of these are items I've characterized as taking a mole hill and watching some people (vapers) make mountains out of them. So the same thing that happened to BT (perception of harm) is plausibly reoccurring to vaping, though has a long ways to go for it to match that product.

This paradigm shift represents a double standard, where big money corporations like big tobacco, pharm, or oil can run amok until the evidence is so plain that they're destroying people that there is no choice but to -limit- their damage somewhat, but since the e-cig industry has no mega billion dollar giants in its corner, it cant even be allowed to proceed with reducing some risk on the periphery?

Thus far, all evidence I've seen (to date) is that eCig industry is being allowed to continue. And that what's so far stopping the shift from being plentiful is usage bans. These are things that some fellow vapers boldly support. Can find many threads on this site where fellow vapers will say that vapers are to blame for existence of these bans, and then further commentary along lines of "I would never ever vape where I couldn't smoke." The implication being that SHV is on par with SHS, and in public needs to be treated the same.

This perception of harm thing is near the center of what's really going on with paradigm shift from smoking to vaping. Right now, the perception is far safer than smoking, which in and of itself is a conundrum but seemingly makes crystal clear relativistic sense. Yet, in my 2.5 years of vaping there have been a few things floated out there about the 'harms' of vaping, some of which have stuck. Give it another 2 to 20 years and I'm sure we can all collectively build it up to the level of very harmful product. Though fairly confident that it will never ever manage the notoriety of harm that we've (ahem, cough cough) established for cigarette smoking.

 

[AndriaD]

Thus far, all evidence I've seen (to date) is that eCig industry is being allowed to continue. And that what's so far stopping the shift from being plentiful is usage bans. These are things that some fellow vapers boldly support. Can find many threads on this site where fellow vapers will say that vapers are to blame for existence of these bans, and then further commentary along lines of "I would never ever vape where I couldn't smoke." The implication being that SHV is on par with SHS, and in public needs to be treated the same.

This perception of harm thing is near the center of what's really going on with paradigm shift from smoking to vaping. Right now, the perception is far safer than smoking, which in and of itself is a conundrum but seemingly makes crystal clear relativistic sense. Yet, in my 2.5 years of vaping there have been a few things floated out there about the 'harms' of vaping, some of which have stuck. Give it another 2 to 20 years and I'm sure we can all collectively build it up to the level of very harmful product. Though fairly confident that it will never ever manage the notoriety of harm that we've (ahem, cough cough) established for cigarette smoking.

The one that I totally do NOT get, and will NEVER EVER get, is this "I won't vape in front of chiiiiildren" -- WHY THE HELL NOT??? Have these chiiiiildren never seen smoking??? Or do the people have some far-fetched idea that if kids don't see *them* do it, then the kids will never know about it, or --god forbid!-- do it themselves? How absolutely, totally, BLINDINGLY idiotic is that?!? I just don't get it.

And it just PLAYS to this ANTZ "for the chiiiiildren" campaign, which is another reason it infuriates me.

And I agree with you on that "won't vape where I wouldn't smoke" thing, too. I never smoked in our new home, because I didn't want the ashtray stink in here. The MAJOR reason I became interested in e-cigs was just so I didn't have to go outside to satisfy my habit! I did smoke in our truck, when I was a regular smoker, but during that month I was dual-using, my husband and I agreed that I wouldn't smoke in the truck anymore, so that stench wouldn't come back and have to be chased out again, since I knew full well I was going back to smoke-free vaping at some point. But certainly I vape in there! For a very good reason: it doesn't leave a smell, and it doesn't choke my non-smoking husband, no matter how thick the "cloud" becomes. I've vaped in indoor public spaces, with the consent of the operator of the premises, because it's NOT smoking. I've vaped in bathrooms in hospitals because behind a closed door, what I do is my own affair, especially when there is NO way anyone would ever know I'd done it -- and I vaped in the emergency room, after being stuck in there for hours and hours. No, I wouldn't have smoked in there; it's too easy for anyone with half a nose to smell it, and smoking really is dangerous around oxygen, but vaping is not, provided I'm not dry-burning my coil around active oxygen!

People who persist with the idea that they won't vape where they wouldn't smoke, just further the ANTZ agenda that vaping and smoking are the same, when they are definitely NOT, not even close.

Andria

 

[Anjaffm]

I truely hate to burst your bubble but this has nothing to do with proven facts,It's about the MONEY (read Taxes here). The United States is so deep in debt from Social Welfare, Corporate Welfare, International Welfare and ridiculous Government payrolls not to mention Government (read Politicians) pensions that we are the new Fatted Calf to be slaughtered for a revenue source. We all see the writing on the wall for the Analog industry in almost every 1st world Country so at this point the government both Federal and State and Local have been seeking new tax resources ie POT(read Weed) so you know that they really do not care about underage consumption or health issues. The Money that comes from Taxes will keep them being re elected for the foreseeable future and thats the goal. The only way they can do this is by REGULATING (Controling)consumer goods so every thing within that industry can be counted and taxed (three times). The only safety we have is in numbers, so we had better get busy converting smokers and teaching non smokers about Vaping and what it is. Our only weapon is 1 on 1 interaction and combating ignorance in the public areana. Be Visible,Be Vocal, Be Nice and Teach,Teach, Teach! I know that most people have no idea about what Vaping is because I get approached everywhere by strangers asking me about my rig. We have been "STEALTH VAPING" too long to our own detrement. I wrote to the FDA on their web site to voice my comments as asked but this isn't worth the time it took to do it They do not Care about just Vapors there aren't enough of us out there we need an informed PUBLIC to stand with us. Alone we will be Regulated out of exhistance or they will hand the industry to their cronies in the Tobbacco Industry after they suddenly have proof it's healthier than smoking! I myself am educating myself on building my own gear and how to make Home Brew Juice just incase the sky falls on us. I don't wish to be the gray haired grandma in the dark alley arrested for trying to score 10ml of Wookie Cookie. Thats my morning rant please forgive me I've only had 1 cup of coffee and I'm out of Mango Pixie Keep on Vaping on

Amen!
And welcome to ECF


@AndriaD:
(including the quote from Jman8)

Amen!

 

[DC2]

Something has been bothering me about the whole idea of regulation concerning e-cigarettes.

When big tobacco finally had to buckle to -some- forms of regulation, it was because the evidence had mounted so high, so far and wide, and so powerfully that their products were very very bad for their customers.

When the FDA finally decided to ban ephedrine from dietary supplements for weight loss, it was (albeit on very sketchy and scarce evidence) because of "demonstrated harm"

This has been the paradigm most regulation (be it FDA / health related or otherwise) works under - if it's unregulated, and no specific damage or harm can be pointed to, there's no need for new regulation. Heck, this paradigm applies even to natural gas fracking - there's no national regulation yet, because there hasn't been enough proof of specific harm...

Why, then, is it backwards for us? Why do we have the burden of proof to show the product we choose to engage with is harmless? Why does the industry have to show lack of health risk? This isn't being marketed as a dietary supplement, quitting aid, medicine, or medical device. There is no specific harm to point to - noone has overdosed due to e-cig use, no cancer or emphysema can be even indirectly associated with e-cigs, etc.

This paradigm shift represents a double standard, where big money corporations like big tobacco, pharm, or oil can run amok until the evidence is so plain that they're destroying people that there is no choice but to -limit- their damage somewhat, but since the e-cig industry has no mega billion dollar giants in its corner, it cant even be allowed to proceed with reducing some risk on the periphery?

Sounds like you understand the situation perfectly well.
And that you have already answered your own questions perfectly well.

Not saying that to discourage you though...
Just saying, yeah, now what?

Because now what is the question that has been facing us for years.

 

[skoony]

the OP is right about one thing. as i have pointed out my self in another post this e-cigarette controversy is 180 out of phase from what happened with smoking. when more and more science started showing the harm of smoking real or imagined, the more there was a cry for government to do something. when the out cry reached a certain momentum the fulcrum tipped. then came the regs and bans that where to follow, up to this present time. on the other hand with vaping,the more science that goes our way,the more the fulcrum remains firmly placed. we have the momentum of science going our way but,the fulcrum wont budge,as if there where giant slabs of granite being placed on our opponents side. there are many reasons for this and there are many threads already discussing them. i agree it defies all logic in this age of the internet how they think they can get by with it? that's the 64 dollar question that will be answered when the new regs are released.

in this to the end regards,
mike

 

[AndriaD]

the OP is right about one thing. as i have pointed out my self in another post this e-cigarette controversy is 180 out of phase from what happened with smoking. when more and more science started showing the harm of smoking real or imagined, the more there was a cry for government to do something. when the out cry reached a certain momentum the fulcrum tipped. then came the regs and bans that where to follow, up to this present time. on the other hand with vaping,the more science that goes our way,the more the fulcrum remains firmly placed. we have the momentum of science going our way but,the fulcrum wont budge,as if there where giant slabs of granite being placed on our opponents side. there are many reasons for this and there are many threads already discussing them. i agree it defies all logic in this age of the internet how they think they can get by with it? that's the 64 dollar question that will be answered when the new regs are released.

in this to the end regards,
mike

The fulcrum is held firmly in place by all those heavy moneybags... money outweighs everything, you know. Even good sense, apparently. The more science we produce in our favor... the more moneybags appear. I hope all those rich you-know-whats CHOKE on their money. I want to shove it down their throat and airway with my own hands.

Andria

 

[Dzaw]

OP here -

I understand that I answered my own question, and comprehend the involvement of money (with a capital M) in politics and policy far better than my original post may lead one to believe. I asked rhetorical questions specifically because this time the rhetorical questions are so glaringly obvious that they can be leveraged to help our cause.

For example, one of the salient points in my comment on the proposed "deeming regulation" centered on this paradigm shift from regulation of something known to be harmful to proposing regulation because something isn't known to be safe.

When enough people start asking these questions publicly and pointedly enough, even more people who -aren't- stakeholders will start to pay attention.

 

[Jman8]

For example, one of the salient points in my comment on the proposed "deeming regulation" centered on this paradigm shift from regulation of something known to be harmful to proposing regulation because something isn't known to be safe.

When enough people start asking these questions publicly and pointedly enough, even more people who -aren't- stakeholders will start to pay attention.

Yeah, this is kinda old news for many of us here. It is a decent point you raise, and I'll give you credit for the reminder.

But I'll (continue to) question those who claim "something known to be harmful" as to where you are getting that from? Because I continue to feel confident that same sources that will back up that claim of harm are also that which are blasting eCigs and lodging claims of perceived harm.