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Author Topic: What do we need to prove?  (Read 643 times)
Kate
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« on: February 28, 2009, 04:06:44 PM »

Can we try to focus our health efforts a little.  It's becoming increasingly clear that harm reduction, smoking cessation and health claims are not going to cut the mustard with authorities without proper scientific proof.  We need to study safety and probably effectiveness.  This is something we might be able to set up or speed up if we can be specific about what we are trying to do.  Vague outlines are ok to start off but let's try to be specific about what exactly we need to find out with research.

Here are some ideas:

We need analysis of second hand vapour.  Does it contain anything that might be considered harmful.
We need analysis of the effects of inhaling specific flavouring chemicals.
We need to study the health changes for people swapping from smoking to vaping.
We need to find out what happens when non-smokers start vaping.
We need to compile studies that show health benefits and risks of inhaling nicotine.
We need to study the effects of inhaling propylene glycol on lungs.  Are smokers lungs 'cleaned' by pg?

Please add questions you think we need to have researched and answered.  Thanks.
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frogbmth
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« Reply #1 on: February 28, 2009, 04:43:57 PM »

I think first we need to have discussion around what samples we are talking about. I know very little about the e-liquid manufacturing process in china, is any actually made in Europe or North America that we can contact?
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Kate
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« Reply #2 on: March 01, 2009, 04:00:30 PM »

That's what we'll be looking at on the Consumer Affairs board Andy, anything about eliquid and its formulation.  I'll post over there about different manufacturers.
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JustPuffin
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« Reply #3 on: April 04, 2009, 10:18:19 PM »

I ran across a study on PG when I first started to vape. Where the study claimed that PG  curtailed most of the air born virus that attack the lungs. I have spent quite a few hours trying to find this study with no success. Has anyone run across it and if so do you remember where?
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Kate
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« Reply #4 on: April 05, 2009, 08:00:00 AM »

There is talk about propylene glycol tests showing germ killing properties here - http://www.e-cigarette-forum.com/forum/health-safety-e-smoking/1734-germ-killing-vapor.html
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Boston George
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« Reply #5 on: April 05, 2009, 05:15:02 PM »

There is obviously a minimum burden of proof needed to be accepted as safe. I have no idea what that is but I am sure there is a litmus test out there.

I think the key  would be winning the moral hazard argument. Basically, we want e-cigs to stay on the market while the proper tests are being preformed.

We know for a fact that regular cigarettes kill. If people who are currently using e-cigarettes are forced to switch back to analogs. How many of them will die in the time it takes for e-cigarettes to be proven safe?

An argument like that may force the FDA to keep them legal so long as the tests are being done.

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Kate
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« Reply #6 on: April 05, 2009, 05:36:20 PM »

I don't know if we'll get away with a relative argument.  Vaping may have to be proven benign in absolute terms rather than in comparison with smoking tobacco.  Unless we're aiming to prove effectiveness as NRT.

The problem with making vaping an approved NRT is that the approval process would likely mean removing all the enjoyment from the habit - low nicotine levels, standardised devices, etc.

Some countries say eliquid is a poison and some say it's a medical product.  In the UK it's scraped by both categories so far by being below the poison threshold and not making health claims.

To me it looks like it's a legal toss up between unregulated, medicine (NRT) or poison.

Which do we aim for when we think of research requirements?

Are there other options?  Being categorised as a tobacco product might be possible I suppose.
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LaceyUnderall
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« Reply #7 on: April 05, 2009, 05:59:34 PM »

Hmmmm.... I wonder if the FDA decides it IS a medicine, will NASA still be able to use it?

http://www.flightglobal.com/articles/2007/06/05/214448/nasa-seeks-safer-cooling-for-orion-crew-exploration.html

Look at the percentage of PG to water...  There is your basic unflavored recipe for eliquid with no nic right there!
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Kate
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« Reply #8 on: April 05, 2009, 06:07:34 PM »

It's the nicotine that's making it a drug/poison.  I don't see there being many regulatory problems with inhaling propylene glycol, flavoured or not.

How many people want to vape zero nic?
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LaceyUnderall
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« Reply #9 on: April 05, 2009, 06:10:48 PM »

You know... that's what I thought.  But Sun kind of turned me on to the idea of switching back and forth and now, I vape on my no nic all day and have a couple of cigs worth of nic at nite!  HA!  (Do you have Nick at Nite in the UK?)  Sorry... stupid US tv programming reference there.

I have noticed that I also don't require nearly as much nic in the evening as I would have thought, but when I am on the no-nic I do vape more often.
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Boston George
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« Reply #10 on: April 05, 2009, 07:01:16 PM »

I firmly believe that at least in the US if we can be loud enough and make the government look foolish for banning e-cigs public opinion will force congress to force the FDA to play ball. If we can get people to say: hey I would rather have people vaping than have to walk through a cloud of secondhand smoke in front of the bar. We would be golden.

Also kate,
 
Quote
It's the nicotine that's making it a drug/poison.

Again it doesn't really effect you, but the FDA is currently arguing that even without nicotine its a 'new drug'. Which I agree is insane, and only time will show if they can actually enforce that belief.
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LaceyUnderall
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« Reply #11 on: April 06, 2009, 08:04:26 AM »

but the FDA is currently arguing that even without nicotine its a 'new drug'. Which I agree is insane, and only time will show if they can actually enforce that belief.


And if they do, then there is a healthy argument that all aromatherapy should therefore be banned as well.  This includes and is not limited to all forms of scented candles, incense, oils, etc.   

This also means that those toys at www.zerotoys.com should also be banned.  Oh, and let's not forget all fog machines including those used in every major stage show and the Disney parades.
 
We could also add perfumes to this list as technically, many are manufactured to cause specific reactions from those around the user.  IE:  some smells are meant to be an aphrodisiac.  Any scented deodorant and soaps would also be up for grabs. 

This list doesn't include the allergic reactions that people have to all of the above mentioned legal products.  This could go on and on and on.
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Boston George
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« Reply #12 on: April 06, 2009, 09:18:55 AM »

Quote
And if they do, then there is a healthy argument that all aromatherapy should therefore be banned as well.  This includes and is not limited to all forms of scented candles, incense, oils, etc.  

Lacey, I fully agree there is a case to be made. However, do you really want to make that case? If it comes down to a lawsuit the FDA will be a force to be reckoned with. We may be forced to engage them in the courts but its really not a favorable battlefield.

I am right now working on a PR project  to create a positive face for e-cigarettes. Because as I have said before: it's public opinion that will sink or save the e-cigarette.

« Last Edit: April 06, 2009, 09:51:45 PM by Boston George » Logged
bonniegirl
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« Reply #13 on: June 29, 2009, 06:25:38 PM »

I can say that we have 2 very large strikes against us
1. Big tobacco company= big money and big lobbyist
2. FDA requires 2 concurring double blind studies for phase I trials  (safe for humans), then same for phase 2 studies (safe dosage) then phase III (side effect profile= lots of research= lots of money we do not have
I think my greatest hope is that smoking Everywhere or Ruyan will reach deep in their pockets and do the research here in the USA or in the UK (US Docs like UK studies? I know not the reason)
Don't mean to be a negative Nancy but I am a realist and have been involved in clinical trials and the FDA  has banned drugs if too many people got hangnails! (a little exaggerated) If aspirin were to go before the FDA today, I am most certain it would be banned or at the least a RX only drug.
Sorry for the downer, our best need is to flood congress with letters and calls right before elections
Bonnie
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