ECA Response to the fda

[nycsublimegirl]

ECA & NJOY RESPOND TO THE FDA Technical report please click the link and distribute as you see fit!



http://pdfvia.com/showfile-4355/responsetothefdasummary_8_09__2_.pdf

[UptownRiot]

I see only where this was prepared for NJOY, I didn't see anywhere that it said ECA.

[TheIllustratedMan]

NJOY is a member of the ECA... also, haven't we seen this already?

[nycsublimegirl]

NJOY is chairman of the board of the ECA and has handed this over to the ECA for their use as well.

Considering NJOY was named directly in the FDA study this report was best served to come out from them directly. Secondly the FDA has its plan of attack as do we.

[Sun Vaporer]

The problem lies right in the conclution:

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.

First---NJOY was suppose to have a study that was done prior to the FDA's release that they stated was "clean as a whistle"---where is that study"?

Second--While NJOY's results do in fact look good, there is not much merit to contend that they are exempt from the approval process.

Third--NJOY et al, do not market their products as NRT's. All NRT's state that they are for short term use (6 months or less). That standard of approval is not applicable to a product like the e-cig as the e-cig is for "indefinate use".

Any drug always uses a Risk to Benifit analysis. While the "regulatory acceptability" of these trace by-products may indeed be totally acceptable for short term use, long term duration opens up the door to a whole new panapoly of issues that need to be studied in the approval process.-------Something that NJOY or SE should have been on the ball addressing a long time ago but never did. The "just throw it on the market and pocket the profits simply does not work and only hurt us as consumers, instead of getting the approval process going a long time ago.

Sun

[stevo_tdo]

Can I Get a AMEN at that statement. Thank you sun

[UptownRiot]

NJOY is chairman of the board of the ECA

This explains a lot to me.

[nycsublimegirl]

he was voted into that position by the rest of the board...including myslef... has simply to do with his product knowledge length of time in the marketplace etc....

The ECA is about to release the official approvals of at least 5 more companies that have joined and in the next few weeks consumer memberships...

[Janetda]

Can I Get a AMEN at that statement. Thank you sun

AMEN Brother!

[webtaxman]

Perhaps if NJOY did indeed do their testing prior to the FDA report, the issue goes to relevance. NJOY may have used a tobacco cigarette as a control, rather than the FDA's surprisingly and inexplicable approach of using the FDA approved nicotine inhaler as a control. NJOY had to respond to the FDA's testing using a nicotine inhaler. If their testing used a tobacco cigarette, not relevant, nothing to compare.

I see many more surprises coming as this is not such a black and white an issue as it appears to some. That does not mean I believe 100% that e-cigs will be saved, of course. I simply don't know.

Mike