Report Also Concludes that FDA Failed to Adequately Support Claims of Dangers of NJOY E-Cigarettes Compared to FDA-Approved Nicotine Replacement Products
A new scientific report - commissioned by NJOY and conducted by Exponent, Inc., a scientific consulting firm - reviewed the FDA report and other studies of electronic cigarettes and concluded that the FDA failed to provide evidence that NJOY products are more dangerous than any FDA-approved nicotine replacement products currently on the market. The report also concluded that the FDA report actually confirms that NJOY electronic cigarettes are much safer than conventional ones and should therefore be welcomed rather than cause for concern.
Exponent Inc. is a large engineering and scientific consulting firm with substantial expertise in the areas of toxicology and mechanistic biology, including chemical risk assessment. Exponent has extensive experience in the development of toxicity criteria and safety levels for chemicals. Its analyses have been incorporated into risk assessments conducted by OSHA and the EPA, and its scientists serve on a number of expert government panels.
The report made a number of important points, many of which I have been making over the past two weeks:
- "In the lots that were tested by the FDA, none of the key chemicals of concern in this study such as TSNAs and tobacco-associated impurities were able to be quantifiably measured in the liquid of NJOY’s cartridges because they were all below the limits of quantification (LOQ)."
- "All of the tobacco-associated impurities found in the NJOY products were “present but at less than the level of the Nicotrol® inhaler [manufacturer] specification” according to the FDA report."
- "The chemical content of similar nicotine-containing FDA-approved products was not completely described with respect to the presence of tobacco-specific nitrosamines (TSNAs) and other tobacco-associated impurities that have also been found in nicotine replacement therapy (NRT) devices at similar, if not higher, levels."
- "Data presented in the report does not adequately support the opinion that users of NJOY products would actually be exposed to TSNAs and tobacco-specific impurities in the vapor phase during normal device use; and if exposed, that those levels would be a health concern as compared to other FDA-approved products."
- "The FDA-approved Nicotrol® inhaler was presented as a “control” for their studies, but was only used for some of the experiments. The device was never tested for the presence of the same “carcinogens and toxic chemicals” that were found in some of the e-cigarette cartridges. When it was indicated that the Nicotrol® inhaler device did contain some levels of tobacco associated impurities, it was never discussed in the report or even mentioned in the results section. These tobacco-specific impurities in the Nicotrol® inhaler were also not discussed in comparison to the values obtained for NJOY’s or Smoke Everywhere’s products. With respect to the TSNAs, the report did not mention that these substances are found in nicotine gum, the patch, nasal spray, and lozenges in concentrations that are at the very least similar to, or higher than those found in the NJOY cartridges (Stepanov et al. 2006; Osterdahl et al. 2004)."
- "Key carcinogenic and toxic chemicals that were found in the liquid phase were not examined in the vapor phase. From a human health exposure perspective, it would have been beneficial to determine if the same chemical constituents found in the liquid phase analysis were also found in the vapor phase, especially considering that the vapor phase is the pathway of exposure to the e-cigarette user."
The report concludes as follows:
1. "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."
2. "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 Rest of the Story
This independent scientific report by an expert consulting firm in the area of toxicology and risk assessment confirms many of the critical points I have been making in commentaries over the past two weeks.
First, the FDA's presentation of its own laboratory results was very misleading because the Agency failed to mention the levels of the carcinogens that were detected in electronic cigarette cartridges (which were at trace levels) and failed to mention that these same carcinogens are also present (at similar trace levels) in FDA-approved nicotine replacement products.
Second, the FDA inexplicably failed to test the nicotine inhaler - which was the control device in the study - for the presence of the same carcinogens as in the electronic cigarettes. Such testing would likely have revealed the same trace levels of carcinogens, and would have nullified the FDA's and the anti-smoking groups' major points at the press conference.
Third, the FDA failed to compare the carcinogen levels in electronic cigarettes with those in real cigarettes which the FDA now approves. Such a comparison would have revealed that the real ones are 1400 times more dangerous. Thus, the FDA lab testing actually supports a conclusion that electronic cigarettes are much safer than the FDA-approved tobacco cigarettes and that electronic cigarettes should be embraced in the regulatory environment, rather than banned (as anti-smoking groups are widely calling for).
The Exponent report also notes that all of the NJOY electronic cigarette cartridges tested were negative for diethylene glycol. This suggests that propylene glycol cartridges that are derived from pharmaceutical grade propylene glycol are not a problem, and that the source of the problem with one electronic cigarette brand that contained diethylene glycol at a level of 1% is most likely the failure to use pharmaceutical grade propylene glycol, a problem that could (and should) be easily corrected.
The rest of the story is that an independent scientific expert report has now confirmed that - at least in the case of NJOY electronic cigarettes - there is no evidence that these products pose any increased health risks compared to FDA-approved nicotine replacement products and that they pose much less health risk than FDA-approved tobacco cigarettes.
Is it not inappropriate that while the FDA has had jurisdiction over both electronic cigarettes and tobacco cigarettes for the past several months, it has already held an alarmist press conference about the electronic ones, but has yet to put forward any warning to the public about the deadly real ones?