Scientific Publication: Analysis of Electronic Cigarette’s Cartridges (Trehy et al. 2011)

[Tom09]

Michael L. Trehy, Wei Ye, Michael E. Hadwiger, Terry W. Moore, James F. Allgire, Jeffrey T. Woodruff, Shafiq S. Ahadi, John C. Black & Benjamin J. Westenberger (2011): ANALYSIS OF ELECTRONIC CIGARETTE CARTRIDGES, REFILL SOLUTIONS, AND SMOKE FOR NICOTINE AND NICOTINE RELATED IMPURITIES, Journal of Liquid Chromatography & Related Technologies, 34 (14): 1442-1458.
Authors affiliation: Food and Drug Administration, Division of Pharmaceutical Analysis, Saint Louis, Missouri, USA

Abstract:

The objective of this study was to determine nicotine and the nicotine related impurities, that is, cotinine, myosmine, anatabine, anabasine, and b-nicotyrine, in electronic cigarette cartridges, the liquid used to fill the cartridges, and from smoke generated using the electronic cigarette devices. An HPLC method was validated for the determination. Samples of nicotine containing products were purchased via the internet from njoy, Smoking Everywhere, CIXI, and Johnson Creek. Electronic cigarette devices were purchased from njoy, Smoking Everywhere, and CIXI. The results from the testing found that (1) the nicotine content labeling was not accurate with some manufacturers, (2) nicotine is present in the ‘‘smoke’’ from electronic cigarettes, and (3) nicotine related impurities contents in cartridges and refills were found to vary by electronic cigarette manufacturer.

 

[Vocalek]

Did you notice?

Author affiliations
a Food and Drug Administration, Division of Pharmaceutical Analysis, Saint Louis, Missouri, USA

All of the authors had the ^a next to their names.

I would be most curious to learn how much nicotine was "present in the 'smoke'". Oh, wait, I forgot! FDA toxicologists only perform qualitative analyses. Quantitative analyses are not important.

 

[sqirl1]

Did you notice?

Author affiliations
a Food and Drug Administration, Division of Pharmaceutical Analysis, Saint Louis, Missouri, USA

All of the authors had the ^a next to their names.

I would be most curious to learn how much nicotine was "present in the 'smoke'". Oh, wait, I forgot! FDA toxicologists only perform qualitative analyses. Quantitative analyses are not important.

as a St. Louisan I am ashamed of this.

 

[Uncle Willie]

why are posts like this poo pooed immediately .. ??

 

[rothenbj]

I don't think the post was poo pooed, perhaps the authorship of the study may be questionable. What I find as questionable are these abstracts where you get a brief conclusion without the data or who paid for the study. If it was the taxpayers the entire study should be available IMHO.

 

[Bill Godshall]

If anyone has/gets the full text article, please send to me at smokefree@compuserve.com

Since the authors inaccurately referred to e-cigarette vapor as "smoke", it appears that FDA still has a policy to intentionally deceive the public about the health/safety risks and benefits of e-cigarettes, and to otherwise criticize e-cigarettes.

Notice how the authors (in the abstract) feign concerns about e-cigarette consumers by citing discrepencies between the labeling and content of some e-cigarette products.

But if the FDA was truly concerned about e-cigarette consumers, the agency would never have attempted to ban the products, would never have lied and mislead the public about their health/safety risks, would have corrected those lies and misrepresentations after they conceded to go along with Judge Leon's ruling, and would have removed their inaccurate and misleading claims from their website.

 

[YKruss]

Abstract:
<<

“Electronic cigarettes” are a recent entry into the market place. The marketing of electronic cigarettes as a healthier alternative to smoking traditional cigarettes has raised some concerns. In addition to the claim to deliver nicotine, the electronic cigarette manufacturers also claim electronic cigarettes are able to deliver other products including pharmaceuticals. Electronic cigarettes have been reported to have different smoking characteristics from conventional cigarettes and to have…
.........................................................
The findings and conclusions in this article have not been formally disseminated by the FDA and should not be considered to represent any Agency determination or policy.
This article is not subject to US copyright laws.
Address correspondence to Michael L. Trehy, Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market St., Saint Louis, MO 63101, USA. E-mail: Michael.Trehy@fda.hhs.gov

>>

Taylor & Francis Online :: ANALYSIS OF ELECTRONIC CIGARETTE CARTRIDGES, REFILL SOLUTIONS, AND SMOKE FOR NICOTINE AND NICOTINE RELATED IMPURITIES - Journal of Liquid Chromatography & Related Technologies - Volume 34, Issue 14

 

[rothenbj]

Now I'm not much of a scientist, actually far from it. However, my conclusions are if you study three bad vendor products, you'll get bad results. They did review Johnson Creek where you were getting what you paid for and their results indicate that. I find it abrasive for scientists to continue to use the term "smoke" when there is a perfect descriptive word, vapor, for what they were observing.

The one point they made that was correct was nicotine delivery is greatly controlled by the vaping ("smoking") habits of the consumer.

 

[rothenbj]

Almost forgot- correct me if I'm wrong, for those reading the actual study. They are talking about tobacco impurities and referring to those other alkaloids found in tobacco as the impurities. I'm not sure what they were getting at, but obviously they weren't finding much in there analysis which is why vendors are attempting to add these alkaloids for those that find "something missing" in traditional nicquid.

 

[Vocalek]

You would think that for a study of this type that the FDA would have determined which are the top brands, because those would affect the largest number of consumers. I don't think the brands they selected are among the top sellers. I could be wrong because maybe NJOY is selling a gazillion units a month at gas stations and those folks don't show up here to discuss pros and cons of their products.

Nevertheless, although I realize that it's not very scientific, I created a poll just to satisfy my own curiosity as to whether any of the four companies have been patronized recently by our readers.

http://www.e-cigarette-forum.com/forum/polls/218903-popular-brands.html

I noticed that the FDA (once again) decided to pick on the two companies that were parties against the agency in the federal court case: Smoking Everywhere and NJoy. The other two companies whose products they tested, CIXI and Johnson Creek, were among the companies that received warning letters from FDA during the time that the law suit was in progress.

E-Cig Technology Inc.
Johnson Creek Enterprises, LLC 9/8/10

So I would have to say that the FDA's motive in performing this testing and publishing the results was the same as testing they have perfomred in the past: try to discredit the companies, as opposed to trying to protect consumers. Or do I have this wrong?

 

[zoiDman]

why are posts like this poo pooed immediately .. ??

Because some people cannot bare to think that there might be Anything wrong with e-Cigarettes or what every is in their e-Liquids.

____


Maybe I missed it, But can someone post the link to the Full Text? I’d like to read the Entire document before I comment on it.

 

[cskent]

I read through the entire article and didn't see too much to be concerned about. Yes, impurities were found in e-liquids, but they were at much lower levels than you'd find in tobacco products. The nicotine contents in the SE, NJOY, and CIXI brand of cart's and carto's were inconsistent, but the Johnson Creek was right at the level marked on the bottle give or take a few percentage points. The study doesn't state who manufactured the liquid in the SE, NJOY, or CIXI brand, but it's probably Dekang. This doesn't necessarily mean Dekang juice is to blame, however, as it could be negligence or an error anywhere along the line of production or distribution. It does make a case for buying US mixed juices though.

This study, as with most, makes both good and bad points if you read it carefully. Much more research is needed to determine whether vaping is as innocuous as we hope it is. While studies such as this one may bring up some points we don't want to hear, it's the building of knowledge that's important. We need this knowledge to make a determination as to whether we are making a valid lifestyle choice.

 

[Vap0rJay]

... We need this knowledge to make a determination as to whether we are making a valid lifestyle choice.

Let’s see, not only do I have money in my pocket... I don't cough up a gallon of brownish green crap every morning. Not only can I run up the stairs once again without being short of breath, I don't reek like smoke and my love life's taken off again since the g/f isn't kissing an ashtray anymore! Not only can I taste flavors in food that I've been missing out on, I have more energy and I sleep better. I personally know that I am not putting 4000 some odd chemicals into my body anymore including known carcinogens, known toxins/poisons, as well as known radioactive substances such as Polonium-210 and lead (Pb210).

I suppose one could argue "We need this knowledge to make a determination as to whether we are making a valid lifestyle choice" but in my mind it’s so blatantly obvious a blind man could see it 100 miles away in total darkness while drunk. I suppose I could have some paid monkey tell me its good or bad or even indifferent however I know firsthand the impact and change in my life -- and that is knowlege THEY NEED to know so others can CONTINUE to make the choice.

 

[Uncle Willie]

IMO, as a community of folks with a common interest, we should welcome any and all data .. whether that be good or bad .. while many may feel the need to defend and trumpet the benefits they seem to have gained using a PV, it's real information that is needed ..

Unfortunately, a common thread I see throughout much of ECF is

1) Immediate attempts to discredit any post that is negative / FDA related / etc
2) Immediate attempts to convince any poster with a possible health issue that it is not PV related

I find this ironic .. I joined this Forum to gain a source of information .. and I don't expect all that information to be positive ..

 

[Vocalek]

Because some people cannot bare to think that there might be Anything wrong with e-Cigarettes or what every is in their e-Liquids.

____


Maybe I missed it, But can someone post the link to the Full Text? I’d like to read the Entire document before I comment on it.

Most of us would react in a much more objective manner if, in the past, we had been receiving objective, science-based reports instead of propaganda pieces. Once burned, twice shy.

I give you the first case of e-cigarette testing conducted and reported on by the FDA. We are STILL fighting the "carcinogens" and "antifreeze" BS.
FDA and Public Health Experts Warn About Electronic Cigarettes

And the lab report had selective omissions that appeared to be geared to lead folks to the wrong conclusions. If you can find the spot in this document where Dr. Westenberger reveals the nanograms/gram of "carcinogens" measured in the cartridges and, for purposes of comparison, measured in the control (Nicotrol inhaler), please point it out.

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

This new report comes out of the same lab. Again, Dr. Westenberger is one of the authors. We're supposed to trust them?

I used to take things at face value. Not any more. I have just seen too much trickery used. It's unforgivable, because people are dying as a result.

How many smokers have continued smoking for the past two years because the news reports about e-cigarettes causing cancer and poisoning the users kept them from giving a much less hazardous alternative a try?

And then there is research that may have been conducted with skill and accuracy, but the results are twisted to fit an agenda.

In June, the American Heart Association came out with a policy statement on the impact of smokeless tobacco products on cardiovascular disease. They do not recommend the the use of smokeless tobacco as an alternative to cigarette smoking or as a smoking cessation product.

Is Snus Harmful? | Primary Issues

This policy statement was based on research that compared snus users who were never-smokers with people who never used any type of tobacco. Based on what was studied, the only reasonable recommendation the AHA might have made would have concerned whether or not a non-user of tobacco should take up the use of snus. Since the study did not compare the health outcomes of smokers who switched to snus to the health outcomes of continuing smokers, the AHA had no basis on which to recommend for or against the use of smokeless tobacco as an alternative to smoking. http://circ.ahajournals.org/content/122/15/1520.full.pdf

Here is another example:

Henley SJ, Connel CJ, Richter P, Husten C, Pechacek, Calle EE, Thun M. Tobacco-related disease mortality among men who switched from cigarettes to spit tobacco. Tob Control 2007;16:22-28 doi:10.1136/tc.2006.018069

You would expect to find out from this study whether the men who switched to "spit tobacco" (notice the propaganda technique of employing pejorative language) fared better health-wise than those who continued smoking. Instead, the study compared those who switched to those who gave up all tobacco.

Results: After 20 years of follow-up, switchers had a higher rate of death from any cause (HR 1.08, 95% confidence interval (CI) 1.01 to 1.15)...Conclusion: The risks of dying from major tobacco-related diseases were higher among former cigarette smokers who switched to spit tobacco after they stopped smoking than among those who quit using tobacco entirely.

Notice that the Hazard Ratio (HR), aka Relative Risk, is insignificant. But that's beside the point. Most of us might have expected there to be some risk involved in continuing to use tobacco. The real question that needs to be answered is "How does the health of switchers compare to the health of continuing smokers?"

I commented on this shortcoming, as did Jonathan Foulds and Lars Ranstrom. Brad Rodu also commented, calling for the CDC to release the data in the U.S. that would allow such analyses to be made here.
Replies to Tobacco-related disease mortality among men who switched from cigarettes to spit tobacco

Here is a portion of Dr. Rodu's comment:

The data from which the CDC estimates prevalence of tobacco use are publicly available from the National Health Interview Surveys. In stark contrast, the data from which the CDC estimates deaths from tobacco use are not available to researchers outside the agency or its collaborator, the ACS. Instead, the CDC takes a black-box approach of filtering information on mortality through its online program called Smoking- Attributable Mortality, Morbidity, and Economic Costs (SAMMEC).

The bottom line is that there is a lot of chicanery going on among government agencies, non-profits involved in tobacco control, and researchers. It needs to stop.

 

[bwood12043]

We are STILL fighting the "carcinogens" and "antifreeze" BS.

A fine anecdotal example of the statement above happened to me just last week. I was vaping happily when someone walked up to me and asked why I would buy all that junk when I could just inhale from my radiator and get the antifreeze contained in the juice ! I did take the time to try to educate this person, but not sure he was listening. BTW, I was vaping in a smoking area outside and the person who questioned me was smoking, so I guess he was just trying to justify his smoking by being critical of the PV. Seen it before many times.

 

[rbuck9]

ya don't really have to try and discredit the fda, they have done that all by themselves

 

[Vocalek]

I can't wait to read Dr. Rodu's blog post on this study.

In this post, he ripped apart the pack of lies being promoted as "scientific findings" regarding modern smokeless tobacco products.
Tobacco Truth: CDC Propaganda Gets Wide Visibility; National Library of Medicine Assists

 

[Uncle Willie]

from Brad Rodu's Blog that is so often quoted ...

"This study assessed the effects of short-term exposure to PG vapor, but the effects of long-term (months or years) exposure are unknown and unknowable. "

"Deyton-Woodcock letter indicates, FDA regulation of e-cigarettes will subject them “to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for ‘new tobacco products’ and ‘modified risk tobacco products.’” These requirements will promote the marketing of safe and quality-controlled products.

Smoking has been the problem; smoke-free tobacco and nicotine can be the solution. In making the right call on e-cigarettes, the FDA has facilitated that solution. "

I do not subscribe to the general conspiracy theory regarding the PV and what not .. the timeframe of use has been too short, the in depth information is still too little, and as Rodu himself has stated, FDA regulation is a good thing .. I would like to see some forced consistency, some degree of standardization which will both go a long way in the area of general public perception and acceptance, IMO ..

This early in the history of the PV, flawed information on both sides of the table should not come as a surprise .. as yes, support of an internal agenda by deliberately skewing results can and does happen .. however .. how are we to achieve a meaningful, legal, safe and consistent activity without Governmental action of some sort .. ??

 

[Vocalek]

I agree with you about the need for meaningful, legal, safe, and consistent standards. However, I fear that we will get more than we bargained for from the Government. It would be great if the standards said that nicotine must be expressed as a percentage and X% of samples tested must fall at that percentage, plus or minus Y.

Unfortunately, what is more likely to happen is that the government will dictate the permissible "dosage", and it will be significantly lower than what some of us require to maintain normal mood and cognitive abilities.

Why do you suppose that the maximum dose of nicotine patch in this country is 22 mg, which actually delivers a much lower blood level of nicotine than the smoke from 22 cigarettes? There have been studies conducted that compared a starting dose of two 22-mg patches (44 mg) with lower starting doses (e.g. 22 mg) and the cessation rate was much higher in the group getting the 44 mg. Yet the maximum dose and the recommended way of using the patch remain unchanged.

From what I have observed, the government will always tend to bow to concerns about "safety" at the expense of "effectiveness".

This is why it would have been fabulous if all the small businesses who are e-cig vendors could have pooled their resources and come up with an agreed on set of industry standards before the government got too deeply into regulation mode. Now, I'm afraid that we will be stuck with whatever the FDA wants to throw at us.

But mark my words, Uncle Willie, if we don't watch the FDA like a hawk and be ready to protest, they are going to be regulating the product you know and love so tightly that it may become just as ineffective (if not more ineffective) as that cute little blue bottle with the Nicorette mini-lozenges.