Anyone ask Chinese manufacturers

[ramblingrose]

It is not what we think it is or isn't. FDA's position, and rightfully so, is that if you want to market a device that uses a volatilized chemical concoction it has to be approved as a combo. As such both have to go through the trials.

We think it's safe. But do we know the long-term effects of inhaling volatilized PG? What about chemicals leaching into vapor and/or liquid from the atomizer or surrounding plastic? Have anyone tested to see what chemicals are produced when vapor mixes with human saliva? ...and the list goes on and on.

I'm not being a naysayer. I just want members to recognize that unsupported evidence is not enough to get an FDA approval. Law is law and e-cigs are not exempt.

Tannerk, I didn't question that it has to go through trials; of course it does. I simply questioned why you're assuming the worst case scenario of a class III rating. In all the years I've been involved with analysis of studies and clinical trials, the assumption has been that class III is primarily reserved for devices with more direct risk to life. A pacemaker would be an example of a Class III device. As a comparison, last I knew steroid inhalers would be an example of Class I.

For all the speculating that goes on here, the bottom line is we don't know what the ultimate outcome will be.

By the way, we don't all assume it's completely safe. Many of us acknowledge that we don't know what longterm effects there may be.

[Bones]

It is not what we think it is or isn't. FDA's position, and rightfully so, is that if you want to market a device that uses a volatilized chemical concoction it has to be approved as a combo. As such both have to go through the trials.

We think it's safe. But do we know the long-term effects of inhaling volatilized PG? What about chemicals leaching into vapor and/or liquid from the atomizer or surrounding plastic? Have anyone tested to see what chemicals are produced when vapor mixes with human saliva? ...and the list goes on and on.

I'm not being a naysayer. I just want members to recognize that unsupported evidence is not enough to get an FDA approval. Law is law and e-cigs are not exempt.

Well - There have been tests done - Most notably and officially is the New Zealand health department - Passed with flying colors - As I understand it the products are more than half way through the approval process in Germany - And - As far as long term use goes - PG is the same stuff that has been being inhaled by Asthma patients in their inhalers for years with no problems reported - It is the same stuff used in fog-machines and if there were inhalation problems the Screen Actors Guild and other entertainment unions would have been all over it years ago - Take a look at the huge volume of data here Propylene Glycol Research Study Results A fabulous job done by Spikey to put it all in one place - When the FDA says there has been no testing - They mean that The FDA has not done it - And they are splitting hairs on that - They have most certainly tested PG for countless uses over the years - It is far from new - Time 1942 -Medicine: Air Germicide - TIME

My conclusion that it is safe is not based on what I "think" - It is based on documented data that I have read - I welcome further testing - But you must ask yourself this question - Since when does a product have to be proved 100% safe? - It normally works the other way around does it not? Cigarettes - for example - Took YEARS to be proven UNsafe - And still they are not prohibited even though they are KILLERS - Nothing is 100% safe - NOTHING - Water will kill you if you drink too much - Listen to the adds for FDA approved medications - 90% of the add is a list of side effects often pretty nasty and many times include death - There is no logical reasoning to the implied need to find e-cigs 100% safe - Overwhelming precedent dictates that even if it causes DEATH you just have to attach a warning label -