At 3pm, 7/22/09, the FDA made an announcement to media regarding the status of the electronic cigarette. The call was headed by Judy Leon of the FDA Office of Public Affairs.
Due to the recent litigation between two electronic cigarette companies, Smoking Everywhere and nJoy, and the FDA, the FDA tested 18 cartridges from the two companies. From the testing done by the FDA on the electronic cigarette, it was noted that they found inconsistencies in the manufacturing process and that in some of the cartridges there were small amount traces of known carcinogens (Tobacco-Specific Nitrosamines) and Diethylene Glycol found in one cartridge from Smoking Everywhere, which is harmful to humans. What they also withheld from the announcement is that diethylene glycol is used for drying tobacco products and is found in tobacco products. They also failed to mention that Tobacco Specific Nitrosamines (TSNAs) are also found in the currently FDA approved NRT’s.
From the conclusions of these lab tests performed by one FDA lab, it was noted that the electronic cigarette cartridges differ from one manufacturer to another and therefore, quality control is of great concern to the FDA. We can’t disagree. The whole industry is already moving towards implementing better manufacturing processes.
The rest of the discussion was led by some heavy anti-smoking hitters in the public health industry. Jonathan Thomas of the Institute of Global Health, Dr. Jonathan Winickoff, Chair of the American Academy of Pediatrics and Dr. Matthew Mikenna of the CDC’s Office of Smoking and Health, all noted that their greatest concern is how the electronic cigarette is marketed and also how it has the ability to be a gateway to tobacco use.
The marketing concerns raised were that the ecig is marketed heavily to children through the enticing use of candy/fruit flavors and also that by putting “Adult Use Only” on a product such as the electronic cigarette, is a direct marketing tactic to children.
When asked if the electronic cigarette was a legal product to be sold in the US, Michael Levi, counsel for the FDA, noted that all of the products that have been held or seized have been new drug and drug delivery devices due to the marketing of them as smoking cessation devices. He also noted that in order to continue marketing them as NRT’s they would need the proper documentation and studies to sell them as such. He could not further comment due to the current litigation.
When further asked if anything has changed due to this call, if this announcement was actually to announce anything, Levi simply noted that the FDA wanted to make the public aware that the electronic cigarette is cause for concern based on the tests they had performed and that there was definitely a need for regulation to ensure that each and every product on the market is equal to what it says it is.
There is no doubt that the electronic cigarette needs to be regulated. But in what capacity and who is going to take on this huge task? It was very clear from the discussion that the FDA takes one stance: This is not a proven smoking cessation product and the only way they want to see this on the market is if it is.
It was clear from the lack of having any doctors/groups such as Dr. Joel Nitzkin, Chair of the Tobacco Control Task Force for the American Association of Public Health Physicians or Dr. Michael Siegel of Tobacco Analysis, both prominent anti-smoking advocates but also FOR the electronic cigarette as a tobacco harm reduction strategy, that the FDA needs to be open to further discussions and also to acknowledge testing that has been done to date.
Hopefully, the FDA will not be blindsided by their defensive position due to their current litigation to see that even with the above testing on two of hundreds of different cartridges/liquids available on the market that there are a group of suppliers who do wish to be regulated, but regulated fairly.
It is interesting also that the doctors who were against the electronic cigarette and noting it as a “gateway to nicotine use”, did not voice any concerns regarding the recent overdose of nicotine by the 12 year old boy on a playground in the UK. A direct result of an anti-smoking group giving children nicotine without parental consent.
Or the fact that in another article today, Iayad Hasan, Director of the Cleveland Clinic Tobacco Treatment Center, declined the use of the ecig as a smoking cessation device because it does in fact leave the hand-to-mouth habit in tact and that does not aid in smoking cessation.
The facts are very clear. The electronic cigarette does need to be regulated. It does need quality control on the manufacturing side and it does need regulations for marketing. It is evidently clear that the electronic cigarette has helped thousands of tobacco cigarette users and it is equally clear that the Electronic Cigarette Association is needed now, more than ever. It is needed to implement standards. It is needed in order to keep the market free and open and not run by pharmaceutical and tobacco interests.