From CNN.com Today/Eissenberg study with feedback

[Mister]

I received my Nicalert kit today to test for cotinine in urine.

My ecig use has been a steady ~2.5 mL/day of 15 mg/mL with a 510 at 3.7 volts.

Result: Level 6 (max reading)
1000+ ng/mL

Very interesting!

Knowing how careful you are, this is one of the most useful bits of info so far.

Since a level 3 reading from that strip is considered to indicate a smoker, we now know that you are getting a pretty good nicotine fix from your e-cigs.

Since the highest indicator on that strip is level 6 (and is clearly not a very high bar, I expect that TropicalBob would make the strip wither up and disappear in a cloud of smoke since you measure at 6) your result will only allow us to work out a lower limit on your nicotine absorption. Still, a lower limit will be very interesting. (I imagine that's why you are now interested in blood vs. urine cotinine levels )

 

[teissenb]

For the record, VCU did issue a press release, that I approved, along with video clips. While this thread has made clear to me that I cannot repeat enough the very specific phrase "under the conditions in which we tested them", the VCU press release and video accurately portray my thoughts on the matter.

Study reveals a need to evaluate and regulate ?electronic cigarettes? – VCU News Center

Someone suggests that an interviewee should call up a media outlet and ask them to amend their story because they were misquoted or quotations were taken out of context. The interviewee can ask, but the media outlet won't (and I don't record my interviews, so what proof would I have? I can't even satisfy you; how could I satisfy the reporter who's story I am criticizing?). Nor will they present their copy to me before publishing it. I speak to them and hope for the best. Please be aware that if a statement is not surrounded by quotation marks in the original story, then the reporter is indicating as clearly as is possible that the statement is the reporter's interpretation of our conversation. I appreciate that some folks here do not accept my explanations regarding my interactions with the press and am very sorry if I am being perceived as anything less than honest.

DVap's results *are* interesting and I look forward to more reports.

 

[LLOTEK]

When I started looking into e-cigs a while back, I came across this website, Now I may be repeating what others already know of have seen, but this sight not only sells the equipment, but they have also compiled a few recent studies on e-cigs as well as an older study done on the effects of PG on the body ie. lungs,kidneys, liver etc. so maybe this will help a bit.

the site is zigcigs, but I cant put think cause I have reached my 15 post minimum yet. good luck all...


Further, up here in Canada(and I dont speak for my canuck brethren but..) we dont generally believe CNN or Fox... Damn, many of us thought that Obama would bring more security to the world, and he seems to be floundering at that as well. after spending alot of time analyzing CNN and Fox, I realized that not only do they often simply leave out the truth, but in fact lie. then once the damage has been done, will offer an apology and retraction down the road...welcome to Corporate "North America"

 

[Vocalek]

Dr. Eissenberg: Please take a look at my post #570
http://www.e-cigarette-forum.com/forum/e-cigarette-news/69409-cnn-com-today-57.html#post1057438 and address how you picture "regulation" working. Who would do the regulating and what actions would that group take?

The VCU article mentions protecting consumers. IMHO, regulation as a consumer product would be fine -- by an organization such as the Consumer Product Safety Commission.

But the FDA has already demonstrated to my satisfaction that they have no intention of allowing e-cigarettes to remain on the market.

Surveys and polls have shown that ~80% of e-cigarette users have completely replaced their tobacco cigarettes with the product. Polls on this forum have shown that more than half of us require a higher strength liquid (above 24 mg) to achieve smoke-freedom. More than 60% of users say that they would return to tobacco smoking to obtain adequate levels of nicotine if e-cigarettes are banned.

So while you are addressing your vision of regulation, please try to factor in the devastating effect FDA-style regulation will have on those of us who struggled for decades to quit and finally achieved that goal. Also factor in the remarkable success rate of this product and the effect that it could have in the next few years on smoking prevelance -- if it remains available, and is allowed to remain effective.

 

[teissenb]

Vocalek:

I am not a regulator, so I don't claim to know all the options or possibilities.

At the least, I would hope for strict standards on nicotine doses (you should be confident that the contents label is correct), clear labeling as a toxic substance, child proof caps, sales to adults only, etc.

From what I have learned here, regulation would also include instructions that allow new users to use the device correctly in order to achieve the stated claim. Many products come with user instructions and there is an expectation (well, *I* have the expectation) that following the these instructions correctly leads to safe and effective use.

And, I hope it goes without saying, the products should be demonstrably safe and effective when used as intended.

Too much to ask?

Tom E.

 

[curiousJan]

Vocalek:

I am not a regulator, so I don't claim to know all the options or possibilities.

At the least, I would hope for strict standards on nicotine doses (you should be confident that the contents label is correct), clear labeling as a toxic substance, child proof caps, sales to adults only, etc.

From what I have learned here, regulation would also include instructions that allow new users to use the device correctly in order to achieve the stated claim. Many products come with user instructions and there is an expectation (well, *I* have the expectation) that following the these instructions correctly leads to safe and effective use.

And, I hope it goes without saying, the products should be demonstrably safe and effective when used as intended.

Too much to ask?

Tom E.

With the caveat that "strict standards on nicotine doses" means only that confidence in the labeled mg concentration is absolutely correct ... NOT that the mg concentration available is reduced to the ineffective levels that the FDA allows in currently regulated cessation products ... no, that is not too much to ask. And it is something that would be most welcome by the vast majority of vapers.

Please clarify regarding "use the device correctly in order to achieve the stated claim". I use Joye 510 stock batteries, atomizers, and refillable carts. In my opinion I _am_ using the device correctly ... and, yet, because I drip nic-liquid on the atty (i.e. prime when it's become dry) when refilling the cart, I get the impression that you would classify me as a high-risk user who's not using the product as intended. I beg to differ ... and hope that I'm incorrect in my interpretation of your opinion.

Jan

 

[teissenb]

Jan:

To clarify, there is a big discrepancy between what I read at ECF about how these devices are to be used in order to achieve their stated claims and what I read on the the instructions that came with the two products that I tested (see below). Wouldn't the logical approach be to include instructions with the product that allow the novice user to achieve the stated claims by following those instructions?

Regardless of how I might classify your behavior, I am having a hard time imagining the regulation that prevents you from behaving as you describe...I would rather see a device that works so effectively and safely that you are not motivated to do as you describe.

Regarding instructions that came with NPRO and Hydro:

TB posted the NJOY instructions on this thread. I have since scanned the Crown 7 instructions but don't know how to post them. They say "Regular smokers take an average of 14-16 puffs to smoke a regular cigarette, we recommend that you stop inhaling after a similar amount of puffs."

 

[Oliver]

Regarding instructions that came with NPRO and Hydro:

TB posted the NJOY instructions on this thread. I have since scanned the Crown 7 instructions but don't know how to post them. They say "Regular smokers take an average of 14-16 puffs to smoke a regular cigarette, we recommend that you stop inhaling after a similar amount of puffs."

In all honesty, this is just an arbitrary number that has been inserted by company employees naive to the actual amount of nicotine that is being absorbed.

I suspect they've inserted it as a caveat to try to mitigate the fallout if someone were to overdose.

When you think about it, the new "proper use" is something that has only really been derived by the continued communication between users on this (and other) forums. In other words, from ongoing trials that individual companies could not possibly instate, where users experiment at their own risk. We now have a situation where the suppliers must still advocate usage that covers their behinds, and users must find out how to effectively use e-cig from various independent sources.

This is clearly not the best situation, to say the least, but the reason it has ended up this way is quite clear.

 

[Meat]

Jan:

To clarify, there is a big discrepancy between what I read at ECF about how these devices are to be used in order to achieve their stated claims and what I read on the the instructions that came with the two products that I tested (see below). Wouldn't the logical approach be to include instructions with the product that allow the novice user to achieve the stated claims by following those instructions?

Regardless of how I might classify your behavior, I am having a hard time imagining the regulation that prevents you from behaving as you describe...I would rather see a device that works so effectively and safely that you are not motivated to do as you describe.

Regarding instructions that came with NPRO and Hydro:

TB posted the NJOY instructions on this thread. I have since scanned the Crown 7 instructions but don't know how to post them. They say "Regular smokers take an average of 14-16 puffs to smoke a regular cigarette, we recommend that you stop inhaling after a similar amount of puffs."

I think you've proven that those products you tested do nothing for a smoker trying to use them as NRT, when used as the manufacturer instructs. It'd be nice if they could get the written documentation that ships with these e-cigs up to the same standard that I recieved with that 4mg nicotine gum that didn't work for me at all... it did come with good instructions though!

If you don't mind answering, do you have plans plans or hopes for doing future research on e-cigs? I'd like to see more research done on these devices, preferably using a better regarded e-cig model, and of course using a much higher strength e-juice if you need to stick with comparing puff for puff. Do you have to have manufacturer written guidelines to follow, or can you set your own methods for testing e-cigs, using some of the feedback written here?

 

[teissenb]

Meat:

I have hopes and plans and I very much intend to incorporate suggestions made by ECF members. There are certain things that I cannot do/test due to issues that I am fairly certain my IRB/ethics board would raise (e.g., dripping) and there are certain things that the results of the already completed study allow me to propose with more confidence (e.g., much less restricted use). At the moment I am working on funding, and these things rarely happen quickly.

Tom E.

 

[Belletrist]

mister--yes, dr. e is planning more research, he mentioned earlier he'd like to do a 5 day test.

Vocalek:

I am not a regulator, so I don't claim to know all the options or possibilities.

At the least, I would hope for strict standards on nicotine doses (you should be confident that the contents label is correct), clear labeling as a toxic substance, child proof caps, sales to adults only, etc.

From what I have learned here, regulation would also include instructions that allow new users to use the device correctly in order to achieve the stated claim. Many products come with user instructions and there is an expectation (well, *I* have the expectation) that following the these instructions correctly leads to safe and effective use.

And, I hope it goes without saying, the products should be demonstrably safe and effective when used as intended.

Too much to ask?

Tom E.

i'd be well in favor of this type of regulation. my concern, however, is that the FDA is going to demand testing of their own, and take e-liquid and whatever equipment they can regulate off the market until such testing is done to their 'satisfaction.' and while i am more than in favor of taking a skeptical scientific perspective when dealing with personal vaporizers, nicotine delivery, and other risks, i have a skeptical (ex-military, ex-intel, mind you--i'm a liberal but hardly a tree-hugging pacifist) perspective myself on the intentions of any government agency when it comes to this. both pharma and tobacco represent very powerful lobbies.

i'm not afraid of a fair, skeptical take on these devices. i am afraid of a biased, lobby-fueled type of regulation.

also--i agree about instructions and testing on the devices so that new users can experience the promised effects. part of the reason we love ECF and part of the reason i started a blog is that buying a PV cold with no other information is fraught with potential for failure--user "error" but not error that new users could be aware of. it's made for a fabulous community of vapers helping each other out, but it's also left a lot of people disappointed with vaping. we don't see them because if they were here, at ECF, they would have gotten the help they needed to succeed and enjoy it.

 

[Meat]

Meat:

I have hopes and plans and I very much intend to incorporate suggestions made by ECF members. There are certain things that I cannot do/test due to issues that I am fairly certain my IRB/ethics board would raise (e.g., dripping) and there are certain things that the results of the already completed study allow me to propose with more confidence (e.g., much less restricted use). At the moment I am working on funding, and these things rarely happen quickly.

Tom E.

Good to hear! Look forward to seeing it in the coming months or years.

The only reason I and many others took to "dripping" is because most of the pre-made cartridges seem to do a very poor job of getting consistent and sufficient quantities of e-liquid to the vaporiser part of the e-cig.

If the e-cig model you test has a better cartridge, like some already reviewed pre-made models, and a lot of custom jobs people seem to be making, you shouldn't need to do any dripping to get the same results that many here claim to. I still think dripping is good for getting a measurable quantity of e-juice from the bottle to the vaporiser so to speak, as even the best cartridges will absorb a lot of e-juice.

 

[deewal]

mister--yes, dr. e is planning more research, he mentioned earlier he'd like to do a 5 day test.

God help us. Can he possibly do it somewhere else ?

 

[slybootz]

Vocalek:

I am not a regulator, so I don't claim to know all the options or possibilities.

At the least, I would hope for strict standards on nicotine doses (you should be confident that the contents label is correct), clear labeling as a toxic substance, child proof caps, sales to adults only, etc.

From what I have learned here, regulation would also include instructions that allow new users to use the device correctly in order to achieve the stated claim. Many products come with user instructions and there is an expectation (well, *I* have the expectation) that following the these instructions correctly leads to safe and effective use.

And, I hope it goes without saying, the products should be demonstrably safe and effective when used as intended.

Too much to ask?

Tom E.

Nope, not too much to ask! This is the type of regulation I hope will happen: correct and standardized labeling, strict nicotine dosage labeling standards[without limiting consumers ability to purchase high(100mg/ml+) strength liquid if they choose to do so(for mixing purposes)], safety regulations for manufacturers, child-proof caps, age restrictions...

As others have stated, some companies already incorporate many of these safety initiatives, but not all are doing so. If there were regulations stating that the e-liquid companies had to follow these rules in order to legally distribute product, then it should definitely have a positive impact on consumer safety, without limiting product availability. I would feel more at ease knowing that my 60mg liquid is actually 60mg/ml, and not just an estimate. Regulations such as these should help.

The only reason I and many others took to "dripping" is because most of the pre-made cartridges seem to do a very poor job of getting consistent and sufficient quantities of e-liquid to the vaporiser part of the e-cig.

This is the same reason I decided to 'direct drip'. Cartridges are inconsistent, and more costly. I assume a significant reason that many companies do not include 'dripping' instructions with their PVs, is because they can make more money by selling cartridges, instead of selling e-liquid.

 

[slybootz]

God help us. Can he possibly do it somewhere else ?

I don't know why you are against more studies, unless it is a fear of hearing something you don't want to hear. Dr. E has been posting on the forum, frequently on this thread, and has mentioned that his future studies will include a wider variety of PV models, a longer study, and educating the user on proper PV usage. Dr. E has been very helpful in addressing our concerns and questions, and he has stated that his future studies will be influenced by the information that ECF posters have contributed. For the most part, this thread has been very positive in the communication between ECF users and the doctor, but it's defensive posts like the one above that give the e-cigarette community a negative public image. Embrace a doctors interest in studying the product that has worked for many thousands of us.

 

[Bill Godshall]

On posting 585 of this thread, Tom Eissenberg wrote:
"And, I hope it goes without saying, the products should be demonstrably safe and effective when used as intended."

"Safe and effective" is clearly a term that refers to FDA regulating e-cigarettes as "drug devices", not as tobacco products (as no tobacco products are considered "safe", while "effective" clearly references nicotine gums, lozenges and skin patches that FDA has approved as smoking cessation aids).

Meanwhile, clinical trials on NRT products (that have been approved and are regulated by the FDA as "safe and effective" smoking cessation drug devices) have consistently found a 93% failure rate after six months.

Virtually all of the individuals and organizations that have been urging the FDA to ban e-cigarettes also have insisted that e-cigarettes be proven (to the FDA drug office's satisfaction) "safe and effective" smoking cessation drug devices.

And of course, the FDA continues to maintain that e-cigarettes are "unapproved" smoking cessation drug devices, which is why the agency has seized and blocked e-cigarette shipments.

So it appears that Tom Eissenberg is actually urging the FDA to continue down its already chosen policy of e-cigarette prohibition.

Tom Eissenberg wrote:
"This thread has been very instructive and informative to me. I do not want
it to degrade into an argument between Bill and I, as there is no value to
anyone in that outcome. Please do not take my silence in response to Bill's
comments as agreement. Instead, please understand that the safe bet is that
Bill and I are unlikely to convince each other when we differ in this
manner, and so I prefer not to tire myself and others by trying."

Unless/until Tom answers and addresses my questions and comments, nobody but Tom will know what he and I may agree or disagree upon. In the past week, Tom has contradicted himself so many times that only he knows what he truly believes and what are his true motives and goals.

At least my views on e-cigarettes have been consistent and unambiguous for more than two years: e-cigarettes should be reasonably and responsibly regulate by the FDA as a new category of tobacco products to ensure that products are correctly labelled, remain affordable and legally accessible, don't emit harmful levels of chemicals, and aren't marketed to youth.

And for the past decade, I've consistently urged government health agencies, private health organizations, researchers and others to truthfully inform smokers (and the public) of the comparable health risks/benefits of different tobacco/nicotine products (because it is their ethical duty to do so and because smokers have a human right to truthful health information).

 

[yvilla]

Originally Posted by deewal
God help us. Can he possibly do it somewhere else ?

I don't know why you are against more studies, unless it is a fear of hearing something you don't want to hear.

What she is against, I believe, is more studies done by someone with a closed mind - and who proceeds on the initial premise that the ecig must be evaluated and regulated solely as an FDA approved NRT or smoking cessation "drug" device.

We want studies done by someone who understands the concept of harm reduction, and who has a clue as to what ecigs actually are intended for.

See Bill G's post immediately above - it says it all!

 

[anim8r]

Jan:

To clarify, there is a big discrepancy between what I read at ECF about how these devices are to be used in order to achieve their stated claims and what I read on the the instructions that came with the two products that I tested (see below). Wouldn't the logical approach be to include instructions with the product that allow the novice user to achieve the stated claims by following those instructions?

Regardless of how I might classify your behavior, I am having a hard time imagining the regulation that prevents you from behaving as you describe...I would rather see a device that works so effectively and safely that you are not motivated to do as you describe.

Regarding instructions that came with NPRO and Hydro:

TB posted the NJOY instructions on this thread. I have since scanned the Crown 7 instructions but don't know how to post them. They say "Regular smokers take an average of 14-16 puffs to smoke a regular cigarette, we recommend that you stop inhaling after a similar amount of puffs."

What we need is a doctor that is willing to actually research the e-cig phenomenon and the products we use to get a rudimentary understanding of general e-cig use.

Using the excuse that the Chinese can't write proper instructions as one of the reasons for arriving at your finding that e-cigs are as good as sucking unlit cigarettes, is possibly the lamest thing you've stated so far.

I don't know of ANYONE that bought a pack of REAL cigarettes and taught themselves to smoke by following the enclosed instructions. It is generally accepted that people learn the habit by studying others and mimicking the activity or, more commonly, they are actually shown how to smoke. Regardless of the methods, learning is involved, and some people take longer than others. Surely you would agree that non-smokers would make terrible subjects for testing the nicotine intake potentials of real cigarettes.

How could you possibly think e-cigs would be any different?

Or are you saying the opposite side of the room had non-smokers reading the instructions included in every pack of cigarettes?

Of course not... that would be stupid.

Even the inventor of the e-cig DEMONSTRATED the use of his new invention to other people and didn't just pass one along with an enclosed two-sentence instruction manual. Unless you believe otherwise


IF you couldn't find anyone to demonstrate how to use an e-cig properly, why the hell didn't you just go to you-tube or look at ANY of the videos posted on this forum? If you weren't getting their amounts of vapor, then you need to find out what you're doing wrong.

Seriously, do you really think we're this stupid to believe that you have no idea how to do the most basic forms of research?


When is comes to safety. I can understand you saying something like, "This NRT has been shown to help thousands of people, but, like other products, it could use some safety regulation and include better instructions for beginners, which we found lacking..."

Instead of making off the cuff baseless statements about overdosing. I mean, really.

And did you see how I worked in a comment about the weak instruction manuals?



Personally I don't think you're stupid. I think you're very clever and that you know exactly what you're doing.

Only a very clever person can pit real cigarettes against our vps and then have our vps end up getting portrayed as the loser.

Good job on that. That should dissuade at least some potential new users and keep them on the real thing.

 

[anim8r]

I don't know why you are against more studies, unless it is a fear of hearing something you don't want to hear. Dr. E has been posting on the forum, frequently on this thread, and has mentioned that his future studies will include a wider variety of PV models, a longer study, and educating the user on proper PV usage. Dr. E has been very helpful in addressing our concerns and questions, and he has stated that his future studies will be influenced by the information that ECF posters have contributed. For the most part, this thread has been very positive in the communication between ECF users and the doctor, but it's defensive posts like the one above that give the e-cigarette community a negative public image. Embrace a doctors interest in studying the product that has worked for many thousands of us.

Trust me when I say, I really don't want to hear about another study by Dr E.

The next collection of quotes from him will likely include his fears of us using "modified" electrical devices with High Voltage Liquids and that the electrocution hazards to the user is entirely worriesome.

(excuse the edit)

...

At least my views on e-cigarettes have been consistent and unambiguous for more than two years: e-cigarettes should be reasonably and responsibly regulate by the FDA as a new category of tobacco products to ensure that products are correctly labelled, remain affordable and legally accessible, don't emit harmful levels of chemicals, and aren't marketed to youth.

And for the past decade, I've consistently urged government health agencies, private health organizations, researchers and others to truthfully inform smokers (and the public) of the comparable health risks/benefits of different tobacco/nicotine products (because it is their ethical duty to do so and because smokers have a human right to truthful health information).

If only people actually thought like this in our FDA (and other testing) labs instead of generating useless garbage and speculation because they are either; too busy, bought and paid for by lobbyists, or have their own personal agendas.

I also agree that e-cigs have stayed in the "use at your own risk" level for too long. I don't think they are entirely "safe", but I don't think they are nearly as dangerous as real cigarettes. My intent is to continue to use these at lower and lower Nicotine ratings until I get to 0mg and can finally quit my nicotine habit.

This has been impossible in the past with real cigarettes.

My wife and I are now at 24mg (down from 36mg) and will be using 16-18mg next month.

Our plan is to quit entirely, as should everyone imo, but that decision will always be up to the individual as far as I'm concerned.

 

[anim8r]

double post