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.

 

[grimmer255]

wow you have a good point.....i hope this report hits the media at scale stronger than the FDA's. Make the FDA wish they just let the ecigs go...grab them by the balls and make them cry. We need this because this is our last chance....they might as well go all out because if they dont........ kiss this product good bye.

 

[wv2win]

wow you have a good point.....i hope this report hits the media at scale stronger than the FDA's. Make the FDA wish they just let the ecigs go...grab them by the balls and make them cry. We need this because this is our last chance....they might as well go all out because if they dont........ kiss this product good bye.

It's really incumbent upon Njoy and the ECA to get this into the media's hands and for both Njoy & the ECA to make some very strong statements about the bias of the FDA, forcing them to respond.

When will the ECA get serious?

 

[Belushi]

My opinion, FDA isn't going to role over in the public media. If there isn't any behind the scene discussions going on then the e-cig is on it's why out from public view for now.

Basically, the FDA has laid down their statement and can't back down from those statements without something to hang their hat on. Any reports/comment I've hear, seem to always have some hint regarding no studies from the manufacturer has been submitted.

The FDA just isn't going to say "oh man, I screwed up, we are just a big blotted bureaucratic agency catering to big tobacco as laid out by congress and anti-smoking groups. You are right just go ahead and market your e-cigs".

Rather, the manufactures are going to have to come up with some numbers and submit a proposal to the FDA. After a-bit of back-and-fourth (e.g in private) the FDA says ok you can market with these rules (e.g . can't say that, proof of quality controls, pretty study to present to the public, .....). Any other resolution is going to have to go through the courts.

 

[HighTech]

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.

BRAVO MARKARICH!

 

[Sun Vaporer]

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.

The issue here goes to longevity of use. The Clinical Data on the baseline product that was used---that being Nicotrol is straight forward and very well spelled out:

[FONT=Arial,Bold]

WARNINGS​

[/FONT]

Nicotine from any source can be toxic and addictive... the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement​

[FONT=Arial,Bold]

PRECAUTIONS​

[/FONT]

Sustained use (beyond 6 months) of NICOTROL NS by patients who stop smoking is not recommended and should be discouraged. The clinical findings is not for extended use of the product beyond six months .

It can be readily scene that the use of NRT's balances the harm to the benefit and that the use of these products is not for an indefinate period of time like the e-cig. So it is that not that the clinical trials of approved drugs like Nicotrol dismissed the carciniginic by-products, rather they weighted the risk to benefit for short term use of these products in an effort to get the patient off of cigarettes.

On the otherhand the e-cig is marketed for an "indefinate use" time and hence must withstand the scrutinity of these by-products being induced over a long period of time by human consuption.

Sun




​

 

[deewal]

Here in the UK you can buy NRT's in a Chemist shop over the counter without a prescription. Gum (flavoured), cig type's, patches of all different brands and the chemist will sell it to your for as long as you want. I know a lady who has been chewing Nicorette Gum for 3 years and smoking at the same time! 8-o

 

[CJsKee]

Here in the UK you can buy NRT's in a Chemist shop over the counter without a prescription. Gum (flavoured), cig type's, patches of all different brands and the chemist will sell it to your for as long as you want. I know a lady who has been chewing Nicorette Gum for 3 years and smoking at the same time! 8-o

I've got an aunt that's been chewing Nicorette gum for 20+ years...she's 87...bet she'd love my e-cig

 

[webtaxman]

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.

1) How could have this report been prepared prior to the FDA releasing the report? It was a Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes”

2) Any reference to lab testing refers to FDA lab testing. No lab tests were performed by Exponent in this Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes”

We should all try and keep the facts straight here. I don't know what happened to Njoy's lab tests--or even if they were ever performed. They are still in litigation. That's all I know.

Mike

 

[DuneBuggy]

IMO,Its the best response to the FDA "report" yet. Mainly due to the scientific data provided to back up their claims. I felt my habit was relatively safe before.This managed to not only reinforce that, but show its likely even MORE SAFE than what I thought.
They even brought to light other information ive never read anywhere else in regards to safety.
My first PV was a NPRO. I havent been especially kind to the unit as far as recomendations go, but I feel good that I helped support NJOY in some small way.

 

[gatsby]

I've got an aunt that's been chewing Nicorette gum for 20+ years...she's 87...bet she'd love my e-cig

Honestly the only people I have ever met who have quit with Nicorette gum still chew the stuff like their life depends on it. The idea that the other NRT plans are short term crutches to quit nicotine is such a scam IMO.