NJOY released third-party “Technical Review and Analysis of FDA Report”

[Tom09]

Technical memorandum prepared by Exponent Health Sciences (July 30, 2009). Some exercepts:

Background:

...Upon learning of the FDA report, NJOY contracted Exponent’s Health Science practice to perform an independent third-party review and analysis of FDA’s experimental methods and scientific findings. This review was performed with the intent of evaluating whether or not FDA’s findings show a clear indication of health risks to the users of NJOY’s products as compared to users of FDA currently-approved nicotine delivery products such as the Nicotrol® inhaler and Nicorette® gum.

Summary:

...In summary, the report „Evaluation of e-cigarettes" suffers from several limitations, that taken together result in it failing to adequately support the FDA claims of potential adverse health consequences from the use of NJOY e-cigarette products tested as compared to other FDA-approved nicotine containing products.

Concluding Statement:

The detection of trace and non-measurable levels of TSNAs and tobacco-associated impurities in the liquid, rather than the vapor phase of NJOY’s products, at levels that are many orders of magnitude below conventional cigarettes, and at or below FDA-approved nicotine containing products, should be considered as indicators of the regulatory acceptability of the NJOY products rather than reason for concern. When considering the relative potential health risks posed by these trace levels, it is worth noting that the approved NRTs, which have been shown to contain these substances, were not judged to contain levels sufficient to warrant toxicity information or reference to these substances in their own product literature.

Download: Technical Review and Analysis of FDA Report: „Evaluation of e-cigarettes" [pdf, size:0.3 MB]

[DaMulta]

So you don't get them in the vapor ROFL....Way to spin the report then.

[Sun Vaporer]

While I find this a very good report---I note two things.

(1) NJOY did this report subsequent to the FDA's report, while they stated that they had already done a study? So where is the first study?

and

(2) NJOY stated that their report did not contain any of the chemicals found by the FDA and their lab results were as clean as a whistle---this is not the case here. It appears the results are acceptably reasonable by all means.

The problem will come here:


"The detection of trace and non-measurable levels of TSNAs and tobacco-associated impurities in the liquid, rather than the vapor phase of NJOY’s products, at levels that are many orders of magnitude below conventional cigarettes, and at or below FDA-approved nicotine containing products, should be considered as indicators of the regulatory acceptability of the NJOY products rather than reason for concern. When considering the relative potential health risks posed by these trace levels, it is worth noting that the approved NRTs, which have been shown to contain these substances, were not judged to contain levels sufficient to warrant toxicity information or reference to these substances in their own product literature"

The FDA will always allow risk to benifit undesirable by-products in drugs like NRT's as the indended use is not for continued use---rather for short term durations.

All in all though---these results are very promising when compared to cigarettes.

Thanks NJOY---better late then never.


Sun

[BigJimW]

LOTS of things the FDA convieniently left out of their bogus report. Like:

Nitrosamines are known to volatilize poorly into the vapor phase (Hoffman et al. 1979). Therefore, it is speculative as to whether they are actually are bioavailable to the user of e-cigarette through normal use of the device. In contrast, FDA-approved NRT products, Nicorette and NicoDerm CQ, do not volatilize their products for delivery so it is quite possible, and indeed shown in the case of Nicorette gum, that users may be receiving measurable amounts of these compounds through normal use of these products (Osterdahl et al. 1990).

Interesting.

[SudokuGal]

I waded through the whole report -- as best I could given all the technical stuff. Very, very, very interesting. Can't wait to see if and how the FDA responds to this.

[DC2]

I waded through the whole report -- as best I could given all the technical stuff. Very, very, very interesting. Can't wait to see if and how the FDA responds to this.

My guess is that they respond to it by ignoring it completely.

[Nestran]

Good read.

The fact that they only tested the liquid (Vapor was only tested for Nicotine delivery), disqualifies they whole safety claim. We are not drinking the liquid and it's intended purpose is to be vaporized. They tested the liquid phase which is not valid.

There is a lot of stuff in there that does not bode well for the report.

Sun, is it possible that Njoy is sitting on their test results so the other side does not have a chance to do what was just done to the FDA report? I'm not sure how disclosure works at this stage.

Nestran

[Sun Vaporer]

Good read.

Sun, is it possible that Njoy is sitting on their test results so the other side does not have a chance to do what was just done to the FDA report? I'm not sure how disclosure works at this stage.

Nestran

Nestran--Yes it is possible, but not likely--as in this report they conceed that there are undesirable chemical by-products but state that they are at very low levels. If the other report was clean as a whistle---they would never have conceeded here.

Sun

[Drewsworld]

My guess is that they respond to it by ignoring it completely.

That was my first guess also!! You read my mind?!?

[markarich159]

"The detection of trace and non-measurable levels of TSNAs and tobacco-associated impurities in the liquid, rather than the vapor phase of NJOY’s products, at levels that are many orders of magnitude below conventional cigarettes, and at or below FDA-approved nicotine containing products, should be considered as indicators of the regulatory acceptability of the NJOY products rather than reason for concern. When considering the relative potential health risks posed by these trace levels, it is worth noting that the approved NRTs, which have been shown to contain these substances, were not judged to contain levels sufficient to warrant toxicity information or reference to these substances in their own product literature"

The FDA will always allow risk to benifit undesirable by-products in drugs like NRT's as the indended use is not for continued use---rather for short term durations.

All in all though---these results are very promising when compared to cigarettes.

Thanks NJOY---better late then never.


Sun

I disagree, I feel the bolded statement is the most powerful in the entire summation. The FDA labeling, adverstising and package insert requirement is different for direct to consumer ads as opposed to medical professional literature. For direct to consumer ads, literature there only has to be "fair and balanced" disclosure between good and bad(which is why at the end of every Rx commercial they quickly mention a list of the 5 or 10 most reported side effects). For the medical professional ads, literature, labeling and package insert info, a much higher standard of "FULL DISCLOSURE" is REQUIRED by law. Therefore, in medical literature, EVERY pertinent fact, good or bad, ever found, must be included by the manufacturer. . So the Fact that the manufacturers of NRT's did NOT include ANY info about TSNA's in their medical literature(doctor ad's, professional package inserts, labeling etc..) shows, without a shadow of a doubt, that FDA did not consider this fact to have any clinical significance AT ALL in the past. Therefore, they did not require the manufacturers of NRT's to have to even mention it in their professional literature. If the FDA truly thought TSNA's were any type of short or long term threat, they would have required every NRT manufacturer to specifically reference the TSNA content and warning in their professional literature. So basically the bolded statement you referenced in the summation proves the FDA is just making this TSNA hysteria up after the fact.