ClearStream Protocol: individual flavouring cytotoxicity.
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That is really very cool of them. It is nice to see a company that cares about the people who use their products. Thanks for linking the article! 
This was a hard-fought battle, and it is indeed nice to see FA step up to the plate. Next up in a perfect world; the same level of transparency and refusal to use those 'marked' flavors by vendors! (Someone else feel free to take up that banner. I'm toast. )
)
I am really pleased to see this, thanks for posting it! This sort of behavior by vendors is exactly what will give us the ammunition we need to fight laws being pushed by Big T. I hope others take similar steps!
A very positive move and one to be universally welcomed.
I'm glad to see FA doing this research and appreciate the high costs involved. Effectively, it is leadership in the flavorings business and to be applauded.
FA did make a minor mistake a while back when they announced that diacetyl had been removed from their vape range, but some flavors in the vape list on their website clearly still contained it. No doubt this was a technical issue with the website, these things can be hard to eliminate entirely.
However I would like to draw attention to a serious issue with the research trial methodology. I downloaded a PDF with the results for the Cuban Supreme flavor, and was pleased to see photos of the test set up, as is required for full appreciation of the experimental conditions, since without knowing the precise mechanics of the test arrangements you cannot decide on whether the received data is of any use.
I am afraid that, yet again, we see the e-cigarette being operated inverted. Many e-cigarettes do not work at all in this position, and most (if not all) will deliver anomalous results. This is because an e-cigarette works in exactly the same way as an electric kettle: the heater element works (and only works) while immersed in a liquid bath. Since the e-cigarette is a gravity-fed liquid-feed device, if it is inverted then it will not work correctly. Some models will work exactly as an electric kettle will in these circumstances: the element will overheat and all sorts of unwanted events will then occur, such as:-
1. Unusual chemicals may be created, such as acrolein, that would not normally be present in the vapor.
2. The extra heat will start to melt the plastics and adhesives surrounding the atomiser (heater coil), adding additional non-normal components to the vapor. This is a well-known effect of 'running dry'.
3. The atomiser will overheat and start to burn the wick material, adding additional non-normal components to the vapor.
4. The vapor becomes partly composed of hot smoke.
5. The atomiser service life is reduced.
In essence, an e-cigarette atomiser will work exactly the same as a kettle does if inverted - badly or not at all; and damage will occur to the device.
There may be some models where this effect is reduced, such as certain types of cartomiser. Nevertheless, even they are not designed to be operated inverted for extended periods.
It is impossible to accept the results of these 'tests' when the researchers were clearly not advised by an e-cigarette expert. There is no operation of an electronic cigarette that exactly equals that for a tobacco cigarette, except for insertion into the mouth. In all other areas, there are significant differences in operation. This is why the advice of an expert, present during test initiation, is imperative. In fact we can go so far as to say that tests where an expert did not advise the researchers, at least during the early parts of the procedures, are worthless.
I have commented on this before, in a discussion and analysis of tests on e-cigarette vapor:
http://www.e-cigarette-forum.com/fo...9160-analysis-electronic-cigarette-vapor.html
I also communicated this information to the NVC with regard to their vapor testing procedures. Use of standard testing methods for tobacco cigarettes does not work when applied to e-cigarettes.
And finally, for proof of the inaccurate results that will be obtained when carrying out research rials managed entirely by beginners, please see the Vansickel and Eissenberg 2010 study, where they found that zero or insignificant amounts of nicotine were obtained from e-cigarettes - thus proving that those who know nothing whatsoever about the subject of their research are not the best qualified to manage that research.
http://www.e-cigarette-forum.com/forum/pdf/vansickel-eissenberg-ecigarette-clinical-trial-2010.pdf
Unfortunately the current FA test results have sufficient grounds for dismissal by any technical consultant or legal challenge, since they clearly cannot be 100% valid.
When will it be accepted that to research something, you have to have a tiny bit of knowledge about the subject of your research - otherwise Trial #1 is a complete waste of time and the results are likely to be invalid. This is what Vansickel and Eissenberg have now acknowledged, and they will have to re-run their trials - if they ever receive the funding to do so.
Such ignorance on the part of researchers is always being demonstrated, by the way - it is nothing new. Here, in the 1982 trial which tested 136 people for nicotine, because of course all tested positive, the researchers decided that everybody everywhere must be exposed to secondhand tobacco smoke.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1497991/pdf/bmjcred00600-0012.pdf
They did not know that nicotine is present in the diet and everyone tests positive for it. The later CDC test of 800 people who again all tested positive for nicotine probably came as a shock to these types of researchers (those who do not know anything about what they are supposed to be gathering data on).
www.nejm.org/doi/full/10.1056/NEJM199308053290619
It seems necessary when performing any kind of research on e-cigarettes, whether technical or medical, to arrange for the services of an expert - at least for the initial stages. Otherwise, the results cannot be taken seriously. More importantly, the results can be dismissed as incorrect or irrelevant. If photos or data are provided that clearly show that the methods were faulty, no other conclusion can be drawn.
I am sorry to have to post such a negative assessment of what is, after all, a very positive move forward - yet again destroyed by the amazing arrogance of medics and academics who assumed they were capable of understanding the issues.
I'm glad to see FA doing this research and appreciate the high costs involved. Effectively, it is leadership in the flavorings business and to be applauded.
FA did make a minor mistake a while back when they announced that diacetyl had been removed from their vape range, but some flavors in the vape list on their website clearly still contained it. No doubt this was a technical issue with the website, these things can be hard to eliminate entirely.
However I would like to draw attention to a serious issue with the research trial methodology. I downloaded a PDF with the results for the Cuban Supreme flavor, and was pleased to see photos of the test set up, as is required for full appreciation of the experimental conditions, since without knowing the precise mechanics of the test arrangements you cannot decide on whether the received data is of any use.
I am afraid that, yet again, we see the e-cigarette being operated inverted. Many e-cigarettes do not work at all in this position, and most (if not all) will deliver anomalous results. This is because an e-cigarette works in exactly the same way as an electric kettle: the heater element works (and only works) while immersed in a liquid bath. Since the e-cigarette is a gravity-fed liquid-feed device, if it is inverted then it will not work correctly. Some models will work exactly as an electric kettle will in these circumstances: the element will overheat and all sorts of unwanted events will then occur, such as:-
1. Unusual chemicals may be created, such as acrolein, that would not normally be present in the vapor.
2. The extra heat will start to melt the plastics and adhesives surrounding the atomiser (heater coil), adding additional non-normal components to the vapor. This is a well-known effect of 'running dry'.
3. The atomiser will overheat and start to burn the wick material, adding additional non-normal components to the vapor.
4. The vapor becomes partly composed of hot smoke.
5. The atomiser service life is reduced.
In essence, an e-cigarette atomiser will work exactly the same as a kettle does if inverted - badly or not at all; and damage will occur to the device.
There may be some models where this effect is reduced, such as certain types of cartomiser. Nevertheless, even they are not designed to be operated inverted for extended periods.
It is impossible to accept the results of these 'tests' when the researchers were clearly not advised by an e-cigarette expert. There is no operation of an electronic cigarette that exactly equals that for a tobacco cigarette, except for insertion into the mouth. In all other areas, there are significant differences in operation. This is why the advice of an expert, present during test initiation, is imperative. In fact we can go so far as to say that tests where an expert did not advise the researchers, at least during the early parts of the procedures, are worthless.
I have commented on this before, in a discussion and analysis of tests on e-cigarette vapor:
http://www.e-cigarette-forum.com/fo...9160-analysis-electronic-cigarette-vapor.html
I also communicated this information to the NVC with regard to their vapor testing procedures. Use of standard testing methods for tobacco cigarettes does not work when applied to e-cigarettes.
And finally, for proof of the inaccurate results that will be obtained when carrying out research rials managed entirely by beginners, please see the Vansickel and Eissenberg 2010 study, where they found that zero or insignificant amounts of nicotine were obtained from e-cigarettes - thus proving that those who know nothing whatsoever about the subject of their research are not the best qualified to manage that research.
http://www.e-cigarette-forum.com/forum/pdf/vansickel-eissenberg-ecigarette-clinical-trial-2010.pdf
Unfortunately the current FA test results have sufficient grounds for dismissal by any technical consultant or legal challenge, since they clearly cannot be 100% valid.
When will it be accepted that to research something, you have to have a tiny bit of knowledge about the subject of your research - otherwise Trial #1 is a complete waste of time and the results are likely to be invalid. This is what Vansickel and Eissenberg have now acknowledged, and they will have to re-run their trials - if they ever receive the funding to do so.
Such ignorance on the part of researchers is always being demonstrated, by the way - it is nothing new. Here, in the 1982 trial which tested 136 people for nicotine, because of course all tested positive, the researchers decided that everybody everywhere must be exposed to secondhand tobacco smoke.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1497991/pdf/bmjcred00600-0012.pdf
They did not know that nicotine is present in the diet and everyone tests positive for it. The later CDC test of 800 people who again all tested positive for nicotine probably came as a shock to these types of researchers (those who do not know anything about what they are supposed to be gathering data on).
www.nejm.org/doi/full/10.1056/NEJM199308053290619
It seems necessary when performing any kind of research on e-cigarettes, whether technical or medical, to arrange for the services of an expert - at least for the initial stages. Otherwise, the results cannot be taken seriously. More importantly, the results can be dismissed as incorrect or irrelevant. If photos or data are provided that clearly show that the methods were faulty, no other conclusion can be drawn.
I am sorry to have to post such a negative assessment of what is, after all, a very positive move forward - yet again destroyed by the amazing arrogance of medics and academics who assumed they were capable of understanding the issues.
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these are good points rolygate.
I'm not involved in any way with FlavourArt but i know Max (the company owner) and he has posted on the italian forum (esigarettaportal.it) about the ClearStream protocol last week.
After reading your post I have posted there (in the italian forum) about your good points on the trial methodology.
In particular i expressed the necessity of re-doing, if possible, some of the test for the flavours that showed some cytotoxicity, using an horizontal position of the device this time.
I also adviced on the chance of using a technical support from an ecig expert as well.
i know they had the support from a US toxicologist that is also an ECF user here, but i don't know who is him.
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I hope this works out well in the end for FA as they deserve congratulation. The trouble is, when you are at the front, you will take some hits...
The lab could maybe add some tubing to attach the e-cigarette with, to allow it to work at a 45-degree downward angle. That could be the best single angular attitude. A user tends to move it around, some of the time it will be tip down, some of the time horizontal. If a single angle has to be chosen, perhaps a 45° down angle is best.
The lab could maybe add some tubing to attach the e-cigarette with, to allow it to work at a 45-degree downward angle. That could be the best single angular attitude. A user tends to move it around, some of the time it will be tip down, some of the time horizontal. If a single angle has to be chosen, perhaps a 45° down angle is best.
"And finally, for proof of the inaccurate results that will be obtained when carrying out research rials managed entirely by beginners, please see the Vansickel and Eissenberg 2010 study, where they found that zero or insignificant amounts of nicotine were obtained from e-cigarettes - thus proving that those who know nothing whatsoever about the subject of their research are not the best qualified to manage that research." - Rolygate
From firsthand experience I could tell that they weren't getting the nicotine levels right in their studies. I've over-vaped numerous times and can tell you exactly what isn't labeled right, too. Some quality-control on this stuff is to be applauded! Nice input, Rolly!
From firsthand experience I could tell that they weren't getting the nicotine levels right in their studies. I've over-vaped numerous times and can tell you exactly what isn't labeled right, too. Some quality-control on this stuff is to be applauded! Nice input, Rolly!
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?
this FA protocol is about citotoxicity of flavourings, nicotine is not important for this study.
They want to understand if there are different citotoxicity levels from flavouring to flavouring.
They do not want to know what's in the vapor (there are plenty of tests like those), they want to study if and how much different flavourings do kill lung cells and at what degree.
I originally quoted Rolygate comment but the forum ate my post and I had to retype it and forgot to quote him again and now fixed it. However, I did note that it was his input I was talking about.
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@ Roygate
The doubts about the correct operation of the electronic cigarette during the tests are justified, but this could be seen also a different interpretation of the results.
There are differences of cytotoxicity between the liquids tested under the same conditions. Substances that have been created for the atomizer warming would be present in all tests.
How do you explain this?
I agree that you have not used the tilt-ideal of the cigarette. This ideal condition of correct feeding of the liquid is not very often you get. I mean that testing the boundary conditions is more important than ideal testing conditions of use.
Sorry for my English but I am hard to explain ......... Ournature ...... if you help me with English language I can explain some technical concepts.
Regards
Luciano
The doubts about the correct operation of the electronic cigarette during the tests are justified, but this could be seen also a different interpretation of the results.
There are differences of cytotoxicity between the liquids tested under the same conditions. Substances that have been created for the atomizer warming would be present in all tests.
How do you explain this?
I agree that you have not used the tilt-ideal of the cigarette. This ideal condition of correct feeding of the liquid is not very often you get. I mean that testing the boundary conditions is more important than ideal testing conditions of use.
Sorry for my English but I am hard to explain ......... Ournature ...... if you help me with English language I can explain some technical concepts.
Regards
Luciano
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Luciano,
All I am saying is that if an e-cigarette is shown to be operated in a manner in which it cannot work 100% correctly, then the results may be wrong.
If I was involved in a legal case in which these tests were used, I would be able to show that the results may be invalid.
All you have to do is test this concept yourself. Take a new 510, with a fully-charged battery, with a good new atomiser and a pre-filled cartridge. Then turn it upside down (inverted), with the tip at the top and the mouthpiece at the bottom. Keep the e-cigarette at exactly this angle (vertical, mouth end downward).
Then have a person puff on it for ten minutes, inhaling deeply. See how long they can go before they choke on the hot, melted plastic containing smoke
Of course, a special model may have been used that can be operated upside down. Unfortunately this was not mentioned in the specifications for the test - so it is not valid for the test.
So.. Max from FlavourArt did reply in the italian forum about the issue,
i'm translating his reply here:
"what have been discussed on the ecf forum is correct, we haven't thought about this issue.
this is what's good of operating within a community, more brains can see things better.
We contacted the lab asking them to do new tests with a correct pv position.
we'll republish results as soon as possible.
For now we can say that, if the new results will be different and better for some flavours, a dry coil or too hot coil can cause a rilevant increase of citotoxicity."
i'm translating his reply here:
"what have been discussed on the ecf forum is correct, we haven't thought about this issue.
this is what's good of operating within a community, more brains can see things better.
We contacted the lab asking them to do new tests with a correct pv position.
we'll republish results as soon as possible.
For now we can say that, if the new results will be different and better for some flavours, a dry coil or too hot coil can cause a rilevant increase of citotoxicity."
I think they mention 120 puffs somewhere in the test? I hope they are not trying to get 120 puffs from one cartridge... About 30 is probably the maximum safe number, as there is no human intervention to say when the taste has deteriorated and therefore the liquid has run dry. After that you are partly burning the interior materials to create smoke, not creating an all-liquid based vapour. It may look the same in a glass flask but the content is different.
Protocol
We should probably try to help the vendors by designing a correct testing protocol for this type of research. The results of the FA trial cannot be published in a peer-reviewed journal because there is no description of the test equipment, materials, timings or procedures.
We could design a protocol for future trials - a specification for materials, procedures and timings - that would stand up to scrutiny. However there are variations required for different equipment types, so we would probably have to do two versions: one for 3-piece atomiser and cartridge models, and one for 2-piece cartomiser models. Also a decision would need to be made on auto or manual batteries.
Protocol
We should probably try to help the vendors by designing a correct testing protocol for this type of research. The results of the FA trial cannot be published in a peer-reviewed journal because there is no description of the test equipment, materials, timings or procedures.
We could design a protocol for future trials - a specification for materials, procedures and timings - that would stand up to scrutiny. However there are variations required for different equipment types, so we would probably have to do two versions: one for 3-piece atomiser and cartridge models, and one for 2-piece cartomiser models. Also a decision would need to be made on auto or manual batteries.
FA said they also will reduce the number of puffs to 50 x 3" for a full 510 cartridge loaded with a flavoured 50-40-10 juice.
Still i agree a protocol shoud be designed by a group of experts for future trials as there are many elements and variations to be considered.
I really do hope they change things around because the results for some of these flavors (MTS Vape Wizard and Virginia that i've seen so far) don't seem all that great.
Good to see the update on the site. Are there plans to test all the flavors? I'd even like to see the flavors with diacetyl tested.
As a FA Virginia vaper I'd like to understand the implications. Cells die even when you breath polluted air in a city. How to put these results in context?
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