The American Legacy Foundation had an “open” discussion on electronic cigarettes on September 16th, 2009. Since their panel was all made up of those who have the same positions, we thought we would respond to some of the information they presented. For full disclosure, we sell electronic cigarettes. For further disclosure, American Legacy Foundation gets money from tobacco company settlements (although they will not give grants to anyone who accepts money from tobacco companies) and receives contributions from Pharmaceutical companies who make nicotine replacement products, specifically Pfizer.
If you want to watch the almost two hour panel discussion, click here. If you prefer, you can watch the excerpts below and read our responses. We attempted to ensure that any clips we provide are not taken out of context, although at times the context is obscure and contradictory, which you will find out for yourself if you watch the whole thing.
NOTE: You will often hear the panel reference ENDS or Electronic Nicotine Delivery Systems which is their renaming of the electronic cigarette.
They hope this will be a lively discussion? That would imply that some of the panel members disagreed on the major points. The discussion opens with:
And ends with:
The panel is enthusiastic about agreeing with each other, I’ll give them that. But as for the opposing views, it is clear that this panel all agree on the major issue of what the electronic cigarette should be; a FDA sanctioned, pharmaceutical Nicotine Replacement Therapy.
Here is a clip of Dr. David Abrams (who is the Executive Director of the Steven A. Schroeder National Institute for Tobacco Research and Policy Studies at the American Legacy Foundation® i.e. he works for the American Legacy Foundation) who raised questions about why the electronic cigarette companies haven’t gone the NRT route via the FDA:
First, let’s be clear; the FDA approval Dr. Abrams wants for the electronic cigarette is as an NRT for people to use to quit smoking. Therefore users would be required to eventually stop using the electronic cigarette altogether. That is one route. Another is to say that smoking is a legal activity and smokers should have the right to use electronic cigarettes as much as they have the right to smoke tobacco.
He also makes it sound very easy to get FDA approval as a NRT which is contrary to Tufts Center for the Study of Drug Development, Outlook 2009, available at http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2009.pdf which shows the average time to get approval of a new drug (which is what a new NRT would likely be classified as) is 8 years. In the meantime, they want the e-cigarette or ENDS pulled from the market and presumably smokers to go back to smoking tobacco.
This is not to mention the FDA fees associated with a new drug approval and the device approval fee. Assuming they want clinical trials, the total cost would be around 2 million not including any consulting, legal fees, and the actual cost of the testing and clinical trials. I am no expert in this field and may have overlooked some requirements or loopholes, but in any case it is extremely likely the cost is going to be more than 1 million dollars, which is out of the reach of almost all the electronic cigarette suppliers on the market right now. The electronic cigarette industry in America is predominantly small US based businesses. Yes, much of the hardware is made in China, but I challenge you to find an American retail industry that doesn’t have their products built overseas. And remember, this would all be in the name of testing a “new drug”, specifically inhaled nicotine.
If we get past the rights of smokers to choose an alternative and the time and cost associated with getting approval, we soon run into the real issue with making the electronic cigarette a nicotine replacement therapy (NRT); competing with tobacco. NRTs are sold only in pharmacies at costs outside of market influence. If you doubt this, price out some nicotine gum. So now we have a competing product with tobacco that can’t be sold where tobacco is sold, at a higher price, and with more restrictions. This will make it incredibly hard for the e-cigarette to properly compete with tobacco. Reputable e-cigarette suppliers are not asking for special treatment, but rather to have the opportunity to compete with tobacco fairly.
Lastly, there is no proof the electronic cigarette would be a good NRT. If marketers don’t make cessation claims, then why would they go through testing to try and prove something they don’t want to claim. The FDA doesn’t make Coke-a-Cola test their product for it’s effectiveness as a way to stop using caffeine. Why? Coke doesn’t want to make that claim.
Dr. David Abrams whose conclusion was that he wanted the electronic cigarette to be a NRT, at one point discusses how he believes the e-cigarette is actually a tobacco product. So I am actually not sure what he wants:
He states that all nicotine products contain traces of the same organic substances, but then reverts to a scare tactic that e-liquid may be using pesticide grade nicotine. What he doesn’t mention is that nicotine itself is a poison. Even pharmacological grade nicotine in proper doses would kill bugs. Again, the devil is in the dosage. Please note that tobacco cigarettes do not use pharmacological grade nicotine. With that said, I agree pharmacological grade nicotine should be used and in the majority of products on the market, it is being used. Current testing being done will show the actual levels of TSNAs and we will release it as soon as we have it.
This is not about zero regulation, it is about reasonable regulation. The industry is only “adversarial” because those with vested interests in competing industries are determined to take this product off the market. Those who are truly for public health should be more interested in the science behind the electronic cigarette, comparing it to tobacco cigarettes, and it’s future potential rather than with taking it off the market until someone pays the FDA.
More analysis of the American Legacy Foundations “Open” Discussion will be coming over the next week.