The FDA’s 2009 Evaluation of E-Cigs

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In May of 2009 an official letter outlined the methods and conclusions of a study of electronic cigarettes.  It was meant to determine the Food and Drug Administration’s future attitudes towards the fledgling industry.  The letter came from the deputy director of the FDA’s Division of Pharmaceutical Analysis and has been a major source of frustration for e-cig advocates since its release to the public.

The study looked at the contents of electronic cigarettes from two major companies at the time and compared them to a Nicotrol inhaler (a nicotine replacement inhaler used to assist qutting).  The two companies were NJOY and Smoking Everywhere.

NJOY is now one of the largest companies on the market, built primarily on disposable models sold in convenience stores.  Smoking Everywhere still survives, but the reputation it built with shady business practices and shoddy, overpriced products hasn’t done it any favors.  Now it seems to exist primarily to hold on to its few loyal customers and catch smokers looking for electronic cigarettes that don’t yet know there are higher quality, lower cost products on the market.

It’s interesting that the study found two companies that would ultimately head to opposite ends of the market.  The market wasn’t huge at the time, given, but there were other candidates that could have been researched.  As it was, the FDA chose to study only two companies and assume that the results were indicative of the rest of the industry.  That this study is still used by lazy media and politicians to attack an industry–one that has developed significantly since–is a major reason for the frustration e-cig advocates experience with this study.

The Results

The study tested for nicotine, the four major tobacco specific nitrosamines (TSNAs), and a few tobacco related impurities.  The big impurity checked for was diethylene glycol (DEG–a toxic solvent).  It’s not uncommon to find DEG in shoddy products shipped in from China and it was found in one of Smoking Everywhere’s products.

All four TSNAs were detected in the NJOY products and two were detected in some Smoking Everywhere products.  The report, however, provided no information on how much of these compounds were found.

Where nicotine was concerned, levels compared roughly appropriately based on advertised levels of high, medium, and low with a few exceptions.  Several “no nicotine” electronic cigarettes from Smoking Everywhere contained nicotine (likely another oversight from manufacturing in China), and NJOY’s high nicotine menthol e-cig returned inconsistent results ranging from 26.8mcg of nicotine per 100ml puff up to 43.2mcg.  This was the only part of the testing at which the Nicotrol inhaler was put to significant use as a control, providing 15.2mcg of nicotine per 100ml puff.

Read the full study here.

In addition to the issues with holding an entire industry accountable for the results of a study so limited in scope, many experts have complained that the study made no effort (almost conspicuously so) to compare these numbers to that of smoking conventional cigarettes.  As well, there is some question as to whether researchers understood e-cig technology well enough to create a trapping device (image) capable of successfully drawing vapor from electronic cigarettes just like a person would.

It is a little late to burn up a great deal of time poking holes in testing that was likely offered up as preliminary, rushed, and limited in scope.  There are a great deal more up to date studies out that provide a far better understanding of electronic cigarettes.  For a quick rundown, take a look here.

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Snippet from E-Cig Advanced's Look at the FDA's 2009 Evaluation

Snippet provided by E-Cig Advanced, reviewing the FDA's 2009 Study


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