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

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Spazmelda

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but pay careful attention to the numbers along the vertical axis. They make it look like the same amounts found, because the visual spike is the same height - but the amount at the top of the spike in the graph for the cigarettes is 100, and the amount for the e-cigarette is 5

This is true, but they are looking at the area under the curve for impurities compared to the area under the curve for nicotine. They say, "The impurity level as a percentage of the area
for nicotine appears to be lower in the trapping solution from the electronic
cigarette than in the trapping solution from a traditional cigarette."
 

kristin

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This is true, but they are looking at the area under the curve for impurities compared to the area under the curve for nicotine. They say, "The impurity level as a percentage of the area
for nicotine appears to be lower in the trapping solution from the electronic
cigarette than in the trapping solution from a traditional cigarette."

Lost me completely. LOL!
 

yvilla

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Spazmelda, I didn't mean they were necessarily labeled mg per ml. What I meant was that when any label says a given quantity of nicotine, such as 18 or 12 mg, what is meant is 18 or 12 mg per ml. We all know this, but the researchers apparently didn't (but they should have made it their business to know). Most websites certainly do carry this information, but not all carts or bottles of eliquid do, so this mg per ml labeling standard has caused confusion among new consumers from the beginning.

So I'm not disputing your premise that labeling must be improved - most of us have been saying that for years now, and again my take is that the percentage standard should be implemented industry-wide.
 
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Spazmelda

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Gotcha! Sorry for the misunderstanding. I agree either percentages (or mg/ml should be standard).

One thing that just confused me... for example in Table 5, they are looking at ug nic/puff, and they list the total mg present in the cart. How did they do that? If they had to take apart the cart to determine nic content, how did they then put it on their puffer apparatus? I guess I should read the materials and methods section more carefully. LOL. But I'm not going to tonight. I'm going to go to bed. :)
 

rothenbj

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I have a question about why this study is only available as an abstract and the need to pay for the entire study. In the document itself, it states, "This article is not subject to US copyright law". Is the charge coming from the site itself to feed you what should be a readily available study?
 

Spazmelda

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I don't think so. Many scientific journals require a subscription to view the entire article. Some are open access, but I'd say that most are probably not. I wish it wasn't that way, because it makes it hard for interested people to get access to anything other than a mainstream media summary or interpretation of the data, but it's also just the way things work. It costs money to review and publish a journal, and the publishing companies generally want to make a profit or at least break even.
 
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Bill Godshall

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Although the FDA's new lab report found no hazardous levels of anything in the e-cigarette samples they tested (its most important finding), the authors chose to NOT acknowledge that critically important fact in the article or in the abstract (just as Westenberger failed to acknowledge that same finding in his 2009 lab test).

Please remember that Westenberger has not yet corrected or clarified the inaccurate and grossly misleading fearmongering propaganda that Josh Sharfstein and others at FDA made about Westenberger's 2009 lab report (which FDA continues to post on its website even after they claimed they'd comply with Judge Leon's ruling, which has has been repeated hundreds of times in the news media even to this day, and which has been cited by virtually everyone who has introduced and advocated local and state legislation/regulations to ban the sale of e-cigs and to ban the use of e-cigs in workplaces).

When reading the full text, I also noted (as Yolanda pointed out) that the FDA authors confused mg/ml with mg/cartridge when claiming that SE and njoy products inaccurately listed the amount of nicotine. About a year ago, I encouraged/convinced njoy to switch its nicotine labeling from mg/ml to % of nicotine. So it appears that the FDA tested NJOY cartridges that were marketed at least a year ago. The FDA authors didn't cite the dates these products were purchased, and its possible that the FDA tested SE and NJOY products that it had bought way back in 2009 (when FDA did its first lab test on SE and NJOY products to retaliate against those companies for suing the agency).

My biggest concerns are that the FDA authors of this new report falsely and repeatedly refer to smokefree e-cigarette vapor as "smoke", which is likely to prompt other e-cigarette prohibtionists to begin referring to vapor as "smoke" in their ongoing attempts to redefine the term "smoking" in smokefree workplace laws to also include the use of e-cigarettes.

Over the decades I've read hundreds of published scientific studies on/about nicotine, but I've never (until this report) seen/heard cotinine, myosmine, anatabine or B-nicotyrine referred to as "impurities", which implies that the nicotine in e-cigarettes is contaminated.

I suspect the FDA authors used the term "impurities" repeatedly in this report (and in the abstract) to confuse the public to believe that the nicotine in e-cigarettes isn't as "pure" as nicotine in cigarettes, smokeless tobacco or NRT products.

Finally, another huge problem with this new lab report and its abstract (which was the same problem in the 2009 FDA lab report) is that the FDA authors feign concern for the health and wallets of e-cigarette consumers (e.g. the three findings in the abstract - 1. the nictoine 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.) and only report negative findings (which are relatively insignficant) while remaining silent on the positive findings (which are extremely important).

If Westenberger (who authored the 2009 FDA lab report) and/or other authors of this FDA report and misleading abstract were even slightly concerned about the health or wallets of e-cigarette consumers, they would never have participated in FDA's e-cigarette propaganda and prohibition campaign, as black market e-cigarettes are costlier (than legal e-cigarettes) and are more difficult to achieve quality control.

The only new piece of information that FDA's new lab report found was that consumers should avoid CIXI products (and instead should by e-cigs from other companies). But of course, the FDA authors never mentioned that in their report or abstract.
 
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Bill Godshall

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For clarification, I strongly support efforts by consumers, vendors and importers to improve quality control by e-cigarette manufacturers, and to improve accuracy and reliability of labels.

In contrast, the FDA authors of this report (and everyone else who advocated FDA banning e-cigs from 2009 until earlier this year) were never concerned about mislabeled e-cigarettes or poor quality control by e-cig manufacturers, as improving labeling and quality control would be far more difficult if FDA had succeeded in banning e-cigarettes.
 

Bill Godshall

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For those who didn't click on the weblink posted above, here is the full text of the American Council on Science and Health's commentary at http://www.acsh.org/factsfears/newsID.2968/news_detail.asp
on the new FDA e-cigarette lab report.


September 1, 2011

Smoke and mirrors behind FDA report on e-cigarettes

An FDA-authored analysis of electronic cigarette contents has just appeared in the Journal of Liquid Chromatography and Related Technologies. The agency has, in the past, gone out of its way to find hypothetical dangers of e-cigarettes — even going so far as to try to bar their importation (a Federal judge stopped that attempt). This most recent article’s slant is in keeping with the FDA’s enduring prejudice against this clean nicotine delivery device.

The study, performed by the the agency’s Division of Pharmaceutical Analysis, aimed to determine the levels of nicotine and nicotine-related by-products in the cartridges, refill solutions, and vapor of e-cigarettes from three different manufacturers. They report that nicotine content labeling was not always accurate, that nicotine is present in the “smoke” emitted, and that nicotine-related impurities in the contents of cartridges and refills varied from one manufacturer to another.

Unfortunately, observes ACSH friend and colleague Bill Godshall, Executive Director of Smokefree Pennsylvania, the findings are stated in a misleading and negative way, unnecessarily obscuring the actual benefits of e-cigarettes as a smoking cessation device. (For instance, the agency’s consistent referral to e-cigarette vapor as “smoke” suggests that it is similar to the carcinogenic combustion of cigarettes — which is not at all the case.) Such official misrepresentation is not surprising, he notes, considering that the report was written by those involved in the FDA’s biased 2009 report during their ill-fated attempt to ban such products.

“The variable level of nicotine in e-cigarettes doesn’t mean that they’re less helpful, or dangerous,” says ACSH's Dr. Gilbert Ross. However, he notes, there is almost always some level of agenda-based misinformation present when the FDA discusses e-cigarettes. (See, for instance, the agency’s often cited — yet incorrect —claim to have detected one of the ingredients of antifreeze in some e-cigarettes.)

“The truth is,” says Dr. Ross, “the amount of so-called ‘carcinogens’ in e-cigarette vapor is no greater than in any other nicotine replacement product. The e-cigarette happens to be a very useful smoking cessation device that is much, much less toxic than cigarettes. We don’t yet have all the answers about their benefits and risks; these data are being accumulated now. For government authorities and other groups to condemn and attempt to ban them makes no sense: it blocks a product that’s clearly safe in the short term, while another, highly dangerous one remains on the market.”

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Vocalek

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In the first FDA lab report Table 1 shows "D" (for detected) in all FOUR Njoy cartridges tested and in most of the SE cartridges. http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

The Nicotrol inhaler shows a value of (NMT 0.5%) for Cotinine, Myosmine, and β-nicotyrine. So we can assume that there was less than 0.5% in the cartridges? Otherwise, why only use "D" for the other products?

A footnote on Table 1 reads: Limit of detection Cotinine 20 ppb. Anabasine 10 ppb; myosmine 69 ppb; β-nicotyrine 170 ppb – present but at less than the level of the Nicotrol specification.

I'm not figuring out how this is supposed to be dangerous for users.

The last sentence on page 6 reads, "TSNA content is reported as weight of TSNA per weight of nicotine/flavorant cartridge (ng/g)." This is followed by a table labeled MRM transitions for TSNAs with two columns containing values. The columns are labeled "Primary MRM" and "Qualifier MRM." Nowhere in the document is there a table showing ng/g of TSNAs. If the MRM info is supposed to translate into ng/g, no instructions are provided. Were this paper being published in a scientific journal, I guess that would be fine -- as long as chemists can figure out how to translate the MRM into ng/g of TSNAs??

But this is a document (supposedly) meant to explain scientific stuff to the public.

OK, fine. So they found some undisclosed quantity of TSNAs and detected some "impurities" in the liquid of the cartridges. What about the vapor state...the only way the product makes its way into the body of the user?

Screening for the possible tobacco specific impurities cotinine, nicotine-N-oxide, nornicotine, anabasine and myosmine was negative. β-Nicotyrine was detected in all Njoy cartridges but was not detected in the Smoking Everywhere cartridges.
Emphasis Mine

How harmful is this β-Nicotyrine stuff?

The pretreatment with nicotyrine resulted in a significant dose-dependent increase of nicotine concentrations in the liver, blood, and brain. Concomitantly, there was a significant decrease in the cotinine concentrations suggesting an inhibition of nicotine liver metabolism. Despite the higher concentrations of nicotine in the brain of the pretreated mice, the LD50 after an ip injection of nicotine was not different from the untreated animals. On the other hand there was complete protection against the lethal effect of iv-injected nicotine in the pretreated animals suggesting a direct protective interaction of nicotyrine with nicotine in CNS.
ScienceDirect - Toxicology and Applied Pharmacology : Nicotyrine inhibits in vivo metabolism of nicotine without increasing its toxicity

Hmmm... so it has a protective effect. Ooooo. Scary!
 

Bill Godshall

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Spazmelda wrote:

Oh, heh... the previous poster, Bill, was quoted. I guess he's aware of it. LOL.

I sent the FDA lab report's abstract to 1,800 folks on my e-mail list yesterday, including the folks at ACSH, who subsequently asked me for a more detailed analysis of the report and abstract.

If anyone would like to be added to my e-mail list, simply send me an e-mail to smokefree@compuserve.com and asked to be subscribed. And if you mention that you are interested in e-cigs, I'll also add you to my e-mail list of e-cigarette advocates, to whom I forward important information.
 

Bill Godshall

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It appears that there are several significant discrepencies in FDA's measurements of nicotine in e-cigarettes.

If you look on Table 5, the FDA's measured levels of nicotine found via its smoking machine (i.e. ug Nicotine/100mL Puff) for NJOY products is consistent with NJOY's reported nicotine content (although the FDA authors apparantly, as Yvilla previously indicated, thought the labeled nicotine content was mg per cartridge instead of mg/ml).

6mg = 9.9 ug/100mL Puff
12mg = 15.7 ug/100mL Puff
18mg = 31.5 ug/100mL Puff

Just as 12mg is twice as much as 6mg, and just as 18mg is three times as much as 6mg, 15.7 ug/100mL is about twice as much as 9.9 ug/100mL, and 31.5 ug/100mL is about threee times as much as 9.9 ug/100mL.

But the third column on Table 5 indicates the FDA found far greater inconsistencies in the same NJOY samples when it measured the mg/cartridge.

6mg = 1.57 mg/cartridge
12mg = 5.15 mg/cartridge
18mg = 5.98 mg/cartridge

If FDA researchers accurately measured the samples, there would be similar constistencies between their ug nicotine/100mL Puff measurements and their mg nicotine/cartridge measurements.

I don't know why these FDA measurements are inconsistent, but it raises doubts about their accuracies.
 
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Spazmelda

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If FDA researchers accurately measured the samples, there would be similar constistencies between their ug nicotine/100mL Puff measurements and their mg nicotine/cartridge measurements.

But wouldn't this be dependent on the method of measurement? I mean, they are actually measuring two different things. One is total content (which they flubbed due to lack of cartridge volume determination) and the other is nicotine delivery. Nicotine delivery is going to be dependent on the concentration of the nicotine solution. If they were to puff each cartridge until they were used up, you'd expect to see a) the total delivery from the entire cartridge to be somewhat proportional to the total nic content of the cartridge and b) the cartridges to be exhausted at different time points (puff numbers) depending on how full they are.

I guess I wouldn't say that it raises doubts about their accuracies, but rather raises doubts about what exactly they are measuring and why. If that makes sense...

ug/puff is much more relevant to the actual use of the cartridge.

Thinking out loud here.
 

yvilla

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Just want to enourage anyone who wants to keep informed on both the legislative and scientific fronts to take Bill up on his offer to be on his mailing lists. His updates never fail to contain an immense amount of extremely useful short summaries and links to all there is to know and that is being published about THR and smoke-free in general and e-cigs in particular. They represent a tremendous amount of dedication and hard work, that he shares with anyone who asks.

In fact, Bill's work is the reason I was able to send you that PDF, Spazmelda.
 

nopatch

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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.

Just curious.How do you know that Vapor is the perfect descriptive word for what you inhale from ecig?.
 

Vocalek

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Just curious.How do you know that Vapor is the perfect descriptive word for what you inhale from ecig?.

Simple facts of science, my dear. Smoke is created by setting a substance on fire--the process of combustion, aka rapid oxidation. Setting an organic material on fire creates tar, carbon monoxide, airborne particles of partly burned material (aka "particulates"), and thousands of newly created chemical compounds, since combustion is a chemical process.

It isn't just tobacco smoke that contains these constituents. They are created whenever any substance is burned. So the smoke from a charcoal fire, from wood fires, from forest fires, and from burning buildings all contain toxic constituents.

E-cigarettes do not burn solids; they evaporate a liquid. Evaporation is not a chemical process. It is a physical process that changes the state of matter from liquid to gaseous. No new chemicals and no airborne particulates are created. Hence, vapor is the only appropriate term--unless you prefer "mist" or "fog." But those words tend to carry a connotation of weather phenomenon.

The word "smoke" is scientifically inaccurate, and, in the case of this particular journal article, purposely misleading.

Does that help?
 
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