How about WE pay for E-Cigarette lab testing

[Effex]

You know, with these things being FDA unapproved right now, and other countries already banning e-cig's, it is unfortunate that these products, which are being reported to help so many people, have a chance of being shut down without at least the proper justice of lab tests.

My proposal - Gather donations on these forums which would be used to pay for lab tests by real doctors and real lab techs.

Granted, I do not even have a ballpark figure of how much a day-long lab test would cost, and I definitely don't have a ballpark figure of how much a week-long or month-long test would cost, but with so many members on these forums, I figured I'd atleast mention it.

Of course there is always the trust issue, because who's to say (no offense to the admin) that someone holding $10,000 of our donated money a few months down the line wouldn't simply run off w/ it. But hopefully someone can suggest an idea as to how we can get around that and know where our donated money is at all times?

But anyway, I know this is a long-shot suggestion, I know that it would take some work to get started and we would have to spread the word, but I feel as if us e-smokers owe it to ourselves to know the long-term effects of the stuff we're inhaling, and also (hopefully) prove it to the world that what we are smoking is 10x healthier than tobacco smoking. And the only way to prove that is hard, cold evidence.

We don't have to donate 500.00 or 200.00 dollars, if the majority of us pitches in and donates 5, or 10 or 50 dollars to the cause, we would easily be in the 10,000's within a month I assume. There can be a banner on the top of the page with the option to donate 5, 10, 20, 50, 100 or 200 dollars, and we ca take it from there.

What do you guys think?

 

[Nuck]

I think I should hold the money.

 

[Programmer]

I think I should hold the money.

LOL, Nuck, always the logical one aren't you?

Effex: Sorry, but that wouldn't work. Ruyan has already paid for such studies, and even now those studies are being dismissed for the funding agency having a vested interest. Imagine what folks would say if a hodgepodge study were performed, financed by members on an internet forum who were wholly in agreement that e-cigs should be allowed?

The only way I see this working at all is if the big time USA distributors stepped up to the plate for themselves. I'm talking about the guys who are charging $150 per kit for a substandard product. They _might_ be able to afford it. But then why should the basement-business guys get to tag along on their dime?

I just don't see an easy solution to this. The distributors aren't going to pay for it, the Chinese manufacturers sure as hell aren't going to pay for US red tape on no-name brands, and everybody at every government level wants their cut regardless.

The FDA can either ask for funding to do it themselves (and not get it), or just ban it and problem "solved".

 

[fatman]

Disclaimer: I am not a lawyer or regulatory expert, not do I play one on TV. But I have been intensly involved in two FDA studies, one in the late 90s and another in the 2001-2002 eras.

FDA approval doesn't quite work that way for regulated medical devices and products. The company that markets the product is responsible for the study and publishing its results. Indeed, the FDA only accepts submissions for actual products from a company. If you were to just submit a study, they would reject it as having no purpose or regulatory application.

The study is not just used to approve a product, buit also to set the regulatory standards for it. For instance, when a drug makes it through the approval process, the study also defines what the actual recipe is and that recipe is all that is approved. Any changes to it must be approved as well. Further, the studies are also used to develop the quality tests that make sure that the drug is pure. Only a manufacturer can do that. If we, as a community, were to fund a study, the finding would not be usable because we could not gaurantee that manufacturers could actually meet the standards set by the study. IOW, what is getting approval is not the drug or device, but your right to produce it or license it. We have no such standing as a community because we have no IP to license or facilities to produce it.

The FDA does not fund these studies, the applicant does. They analyze the protocols used for the study and determine the appropriateness of the study design and then design the protocols to determine regulalatory adherence. On the two studies that I was involved in, one for a US pharmaceutical maker and another for a German medical device company, the costs of the studies exceeded any paltry sum we could raise by enormous factors. The drug study alone costs millions of dollars. The medical device study still ended up in the 100s of thousdands USD.

None of this may be relevant if these devices are not regulated as medical devices and the liquids are not considered drugs. But then if they are not, there will be no need of a study, or at least not that kind of study.

So, I would say hold on to the cash and buy atomiozers instead.

 

[thatguyjeff]

I would think - and I'm only guessing here - that if there were some sort of FDA issue it would be with only the juice/cartridges themselves. The batteries, atomizers, and empty cartridges wouldn't fall under the jurisdiction of the FDA so long as they don't contain any drug.

Folks would be left with making their own juice - sharing recipies on the web - and probably a new black market for juice, until such time as someone got the coin together for a study and approval.

Then the juice would be available again from a "legitimate" source at much higher prices.

just my $.02

 

[TropicalBob]

Fatman: A huge thanks for injecting some fact-based reality into the wails of angst, denials and vitrol on this forum. Everything you pointed out is 100% correct. We cannot fund a study; that's laughable. It is solely up to the makers to conduct and submit scientific studies that prove their product/drug is safe and efficient.

So glad to see a knowledgeable person post on this. Your experience is invaluable.

And the devices are very much at stake. They can be called "medical devices" since they are patented and designed to deliver a drug. If unapproved, they can be banned. Let's not deceive ourselves that we'll just go underground and make our own (dangerous or impotent) liquid.

It is all at stake here.

 

[chuckie]

Remember if money is involved, where there's a will there's a way.Just ask one of the Kennedys.(a live one)

 

[fatman]

And the devices are very much at stake. They can be called "medical devices" since they are patented and designed to deliver a drug. If unapproved, they can be banned. Let's not deceive ourselves that we'll just go underground and make our own dangerous or impotent) liquid.

It is all at stake here.

Tropical Bob is right. It could be called a medical device. I suspect the grounds for that would be that we inhale. Personally, I use 0 nic juice and frankly find that I just end up puffing sometimes, especially since my 901s feel more like a pipe than a cigarette. An argument could be made that if the packaging says in clear markings that it is not a nic delivery device and that you should never inhale it or you will grow antlers that you may be able to make an argument that it is not a medical device. But you would need a lot of money and political weight to make it stick. Make sellers check for age (not one supplier has asked me to confirm my age) and this may all work. But we need to be organized, the suppliers need to lead the charge, and we need to engage our lawmakers.

Would you be willing to pay a premium for each dollar spent to a supplier to have that supplier donate the extra premium to a lobby or a fund to drive clarification of the status of these things? That may be an interesting poll. Anyone think it is worth pursuing or is it all just too emotional around here right now?

 

[thatguyjeff]

TB may well be right, and I don't know how the FDA works or any of that stuff. Just playing devil's advocate here to promote discussion...

What about syringes? Are they medical devices? I can get syringes at bait shops (used for fishing to pump air into bait to get it to float).

And just FYI - I did a google search for "FDA e-cigarette" just out of curiosity and saw an article from 2007 that said Ruyan started toward FDA approval back then. At least that ball is already rolling. Not sure of the end result, but there it is.

 

[TropicalBob]

As I've read between some lines, there likely are three companies working quietly for approval: Ruyan, Janty and nJoy. There will be no "updates" on the progress of their petitions, but a lot of money rides on obtaining approval to become the sole approved supplier for the E-Cig Nation. It's smart business to try to do things the right way!

 

[thatguyjeff]

And I just thought of a possible upside...

IF tagged as a "drug" AND tagged as an NRT by the FDA, then your health plans may wind up covering e-cigs.

Granted, there are some plans with limits, some unlimited, and some with no smoking cessation coverage at all.

In looking at my plan, I could be on the gum or patch (any FDA approved NRT is covered by my ins) indefinitely and it would be covered. Imagine your health insurance paying for juice!

 

[Kate]

Anyone who wants to take an active interest in testing of vaping and eliquids is welcome to join us at Right To Vape - Index

 

[Cymri]

The only hope of these devices as I see it is to have them officially be designated as a tobacco product - an area that high courts have historically prevented the FDA from regulating. If the FDA gets involved then it's a real mess. Even so, there is legislation right now working its way through the US system to place tobacco under control of the FDA anyway so the whole argument is likely moot.

I think the vaporizers will stay in that grey area where the govt could prosecute their sales under drug paraphernalia laws just as they can do so for water pipes or "bongs" if they choose to. So far, except for some high profile cases like the one against Tommy Chong, the government has not really pursued the paraphernalia laws much.

The liquid will probably be much more of a sticky legal issue and I can foresee that we may have to all start making our own.

If these devices get under FDA control they will make it very difficult and expensive to have, especially for people who have no intention of quitting using them.

 

[Elle]

effex you had a wonderful idea, your heart is in the right place, and i think most of us are wanting the same bottom line here.

tbob that was a little OTL saying it was a "laughable" idea, imho.

anyways, now that ive gotten my unsolicited praise and reprimands out of the way... i'm out!

 

[z3r0]

It would be a shame for these things to get banned ...however, if they do try it, they might want to ... like now... because in two three years ... I'm sure it will be as hard to rid America of it as alcohol... Either way ... I will Vape2theGrave