Technical Review and Analysis of FDA Report:“Evaluation of e-cigarettes”

Journal Article 1)

A recent report and press release issued by the Food and Drug Administration (FDA)2) assert that NJOY e-cigarette cartridges contain harmful levels of carcinogens and toxic chemicals. It was further implied that these chemicals are not found in other FDA-approved nicotine-containing products. Subsequently, a technical review and scientific analysis of the FDA’s report was performed by scientists at Exponent. Results of the review identified the following limitations:

  • The report failed to present standard protocols for proper study design with regards to the testing of the referenced control device, documenting the number of samples tested either within or across tests, or presenting statistical analyses when quantifiable results were obtained.
  • 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.
  • 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.
  • There is no indication in the published scientific literature that cotinine or β-nicotyrine are carcinogenic or have toxicity ratings of concern. These were the only tobacco-associated impurities found in trace levels in the vapor phase of (some of) NJOY’s products.
  • The report does not reflect the actual dose of nicotine delivered to the user from the “control” Nicotrol® inhaler device when used as recommended by the manufacturer (6–16 cartridges/day or 24–64 mg of nicotine, 50 mcg/100 mL puff). By comparison, NJOY devices delivered 46 mcg/100 mL in the highest-strength cartridge tested, according to the FDA report.
  • 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.

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.

z-ref: 4u66x3fp

Leadbeater & Lindsay (2009), Technical Review and Analysis of FDA Report:“Evaluation of e-cigarettes”, accessed: 2014-01-28
research/documents/4u66x3fp.txt · Last modified: 2014/03/29 19:05 by rainman