FDA states its position on e-cigarettes
Thursday, July 23, 2009
Jonathan Foulds, MA, MAppSci, PhD
The FDA has continued to state that e-cigarettes are being marketed as a combination drug and drug delivery device and so clearly full under its jurisdiction in that capacity. Not only have the manufacturers not submitted a New Drug Application, they have not provided FDA with any appropriate data to show that e-cigarettes are safe and effective. Furthermore, recent small-scale studies by FDA scientists show that e-cigarettes contain toxins including known carcinogens (albeit at much lower levels than traditional cigarettes). The studies also found that the e-cigarettes appeared to be rather inconsistent in the amount of nicotine they contain (within the same claimed dose), which raised questions about product quality and consistency).
So the bottom line with e-cigarettes is that we know very little about them, but there is enough information to suggest that they may be neither harmless nor reliable. I have previously commented that in addition to these concerns about what is contained in the product and the vapor it produces, there are also doubts that the product is effective in delivering nicotine to the consumer.
The message from FDA and others to consumers is that these devices have not been properly evaluated with regards to safety and efficacy and people who want to use a nicotine product to help them quit smoking are recommended to use one that has been approved as safe and effective by FDA (i.e. nicotine patch, gum, lozenge, nasal spray or inhaler).
Full details of FDA’s analysis of e-cigarettes can be found at:
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm
Previous posts on e-cigarettes:
http://www.healthline.com/blogs/smoking_cessation/2009/03/what-is-e-cigarette.html
http://www.healthline.com/blogs/smoking_cessation/2009/04/does-e-cigarette-deliver-nicotine.html
Labels: e-cigarette, FDA, jonathan foulds
2 Comments:
At Mon Aug 10, 10:04:00 AM 2009,
electronic cigarette said…
Over 400,000 American Citizens Die every year! So if the FDA really cares about it's citizens then it should Ban Traditional Tobacco smoking before Closing it's Doors on a Simple device called an Electronic Cigarette which Has not yet harmed a single human since it was introduced in 2004. I've been a tobacco smoker all my life and this simple device made me quit smoking Tobacco for good so I can freely suggest to those who are considering a much better & safer alternative to give an electronic Cig a try. Please care about your health & the environment, :) I purchased my electronic Cig from http://www.ElectronicCig.com
At Wed Oct 07, 03:58:00 PM 2009,
Vocal EK said…
I commend you for noticing that the FDA report indicates that the electronic cigarettes deliver carcinogens at much lower levels than traditional cigarettes. The FDA totally failed to make that clear. Their misleading spin on the test results created an unnecessary panic that, unfortunately, succeeded in convincing many people that continuing to smoke their cancer sticks is safer. It also succeeded in generating the fear necessary in some countries to implement bans on the products, thereby preventing their citizens from enjoying the benefits of smoking cessation.
I disagree with your statement “there is enough information to suggest that they may be neither harmless nor reliable.” Perhaps you have been getting your information from the wrong sources. Try getting the information from the people who are actually using the products. Read some of the comments left at the Electronic Petition Site http://www.thepetitionsite.com/1/keep-life-saving-electronic-cigarettes-available#
Tens of thousands (perhaps hundreds of thousands) of people have successfully substituted the electronic products for their tobacco smoking. Furthermore, rather than reporting any sort of harm from doing so, they are reporting measurable improvements in lung health, blood pressure, blood sugar, and cholesterol--in many cases verified by their doctors.
The FDA has tried to smear the products as being aimed at children. But these users are people who smoked for decades and tried everything from Acupuncture to Zinc for quitting, to no avail. Your recommendation to use a nicotine product that has been approved as safe and effective by FDA is well-intentioned. But if you read the comments left by electronic cigarette users, you will discover a recurring theme: “Been there, done that, didn’t work.”
The so-called nicotine replacement therapy products don’t replace enough nicotine to ward off the cognitive and emotional impairments that keep driving people back to smoking tobacco. Therefore they fail to be therapeutic.
In 1996, Scottish researchers David Balfour and Karl Fagerstrom wrote in "Pharmacology of Nicotine and Its Therapeutic Use in Smoking Cessation and Neurodegenerative Disorders," Pharmacol Ther. 1996;72(1):51-81.
"If nicotine preparations could he developed that were acceptable to smokers, there is the possibility of eliciting a substantial reduction in tobacco smoking, while not necessarily maintaining complete abstinence.
Such use of NRT, although controversial for those hoping for a total extinction of nicotine use, without doubt would do more service to mankind and public health than what NRT could contribute in smoking cessation."
Because the user can control the amount of nicotine derived from an electronic product, these things work! They work, and they work well. These are, in my opinion, the long awaited nicotine preparation that is acceptable to smokers and they are eliciting a substantial reduction in tobacco smoking. What a terrible waste it will be if the FDA succeeds in throwing away an enormous public health opportunity. What’s worse is that making these products unavailable will drive some users back to the only adequate source of nicotine: tobacco.
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