Technical memorandum prepared by Exponent Health Sciences (July 30, 2009). Some exercepts:
Background:
Summary:
Concluding Statement:
Download: Technical Review and Analysis of FDA Report: Evaluation of e-cigarettes" [pdf, size:0.3 MB]
Background:
...Upon learning of the FDA report, njoy contracted Exponents Health Science practice to perform an independent third-party review and analysis of FDAs experimental methods and scientific findings. This review was performed with the intent of evaluating whether or not FDAs findings show a clear indication of health risks to the users of njoys 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 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.
Download: Technical Review and Analysis of FDA Report: Evaluation of e-cigarettes" [pdf, size:0.3 MB]