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 NJOYs 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
