The FDA’s 2009 Evaluation of E-Cigs

Klaus Kneale
by Klaus Kneale
18 Comments
December 3, 2012

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

 

Comments

18 Responses to “The FDA’s 2009 Evaluation of E-Cigs”

      John on December 3rd, 2012 10:55 pm

      Wow, it’s kind of hard to believe that some of the namebrands out there are so inconsistent with their results. Thus why the standardization of ecig products will become more relevant!!
      Another reason why buying from USA vendors and liquid delivery systems as opposed to Chinese vendors and name brand disposable types!

        Johnathan Brown on December 3rd, 2012 10:58 pm

        I would like to see their next evaluation be done on some real QUALITY products. Not downing Njoy or anything, and i understand the reasoning to use it as a tester due to its availability – but im pretty sure they arent as concerned with quality as a lot of other manufacturers are. Hope the next evaluation is fully in our favor. Thanks for sharing this.

          MorrinB on December 4th, 2012 5:17 am

          Thanks for sharing this. Seems like the FDA is bound and determined to beat this horse until it breathes again.

            Pearl McLaughlin (moxie) on December 4th, 2012 5:51 am

            Another great article Klause, gives us pause… I wish the FDA would get off its hiney and start doing some worthwhile research, it’s 2012 now! I also wish more smoking cessations studies would see the benefit of ecigs over drugs. Never worked for me, since I needed to smoke. More studies are needed in that area as well. It’s great that the ecigs industry is moving towards self-regulating ejuice. Recently by the formation of AEMSA, American E-liquid Manufacturing Standards Association. Setting standards and good practice to use so that we can be assured our e-liquids are safe to vape. Though I can see that this will prevent a lot of mom&pop shops from operating, no more kitchen mixing…

              Steve Mitchell on December 4th, 2012 6:17 am

              wow, there is the feds getting into yet another thing they don’t belong in.

                Mike on December 4th, 2012 6:22 am

                I would like to see some testing done on equipment that is higher end in nature as well. At the same time though I don’t feel the government should be involved at all.

                  Sabrina Mitchell on December 4th, 2012 6:28 am

                  I still think big tobacco and big pharma is bribing them

                    saboinia on December 4th, 2012 1:50 pm

                    I THINK they need to do the study again with the ego and blu ciggies

                      kkneale on December 4th, 2012 3:59 pm

                      Thanks for all the comments! The FDA could certainly use some more up to date research into the industry. But we can hardly blame them for being the overzealous regulators that they are. When you’re a hammer, everything looks like a nail.

                        slap_maxwell on December 5th, 2012 5:00 am

                        I’m not surprised that the FDA would knowingly pick such a small sample size and use indicators supporting their *then* insistence upon regulating e-cigs while ignoring or choosing not to test for indicators that would go against what they hoped to find. That is hardly “science” at all and is nothing more than rigging tests to get a desired outcome. What’s shocking is that so many other smart people put stock in such an obviously flawed testing paradigm….

                          Chad on December 5th, 2012 8:03 am

                          The FDA allows poisons all the time. Why are they concerned about ecigs?

                            nicxvapor on December 5th, 2012 1:27 pm

                            Thank you guys so much for sharing this. This is exactly what I need for a piece that I’m writing about e-cigs.

                              kjpennell on December 5th, 2012 7:27 pm

                              wow

                                Karla Lyle (MsV8PR) on December 7th, 2012 12:10 pm

                                I would like to see a larger scale study done on products now. I am wondering what is causing these toxins? is it the nicotine or the PG, VG or flavorings? How harmful are these and what effects do they have?

                                  robovape on December 11th, 2012 2:47 am

                                  mistakes like “no-nic” ecigs containing nicotine pose a huge risk to the industry in general… i hope better controls are in place to prevent these kinds of issues, especially with the Chinese track record for accidentally using DEG in place of PG, a little nicotine is a party foul to a non-nicotine user, but DEG is poisonous… another great reason to buy American made from American materials…

                                    Adam on December 30th, 2012 5:18 pm

                                    The FDA is a bureaucratic disaster. They are bought and sold by corporate interest and not public health.

                                      walking dead season 3 free on February 28th, 2013 12:08 am

                                      Although I dislike Kristen’s personality, but I’m tired of the media trying to pit women against each other. So only women can be jealous of each other and men won’t??? I’ll buy tons of newspaper just to read about Shia Labeouf jealous of Ryan Gosling (just for example)??

                                        RCO67 on March 23rd, 2013 12:47 pm

                                        This is a perfect example of a study poorly done with the “findings” worded in a way to forward an agenda.

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