The European Commission has misinterpreted my scientific research on nicotine in e-cigarettes
By Dr Farsalinos
As everyone knows, the latest TPD proposal dictates a 20mg/ml upper limit for nicotine content in e-cigarette liquids. In their justification document, the European Commission cites 2 of my published studies to support that the scientific basis of their decision is that nicotine delivery from a 20mg/ml nicotine-containing liquid is equivalent to one tobacco cigarette and that this level is sufficient for smokers to completely substitute smoking.
Since it is more than evident that my research has been misinterpreted, leading to bad decisions, I decided to send a letter to the Health Commissioner and MEPs and release this letter here.
Here is the letter:
SANCO recently decided that 20mg/ml nicotine levels should be the highest level present in the liquids of e-cigarettes. To justify this decision, they have released a document (reference 1) where they have cited two medical studies performed by me as principle researcher (references 2 and 3). The Commission suggests that my research shows that 20mg/mlnicotine limit is equivalent to the nicotine delivered through the use of tobacco cigarettes and is sufficient for most smokers to completely substitute smoking.
Since my studies are the only scientific evidence quoted by SANCO, it is my duty to inform you that the interpretation of my research is completely wrong.
My research (cited by SANCO) specifically examined nicotine consumption and made absolutely clear that the determination of the upper limits needs to be determined based on nicotine absorption and delivery to the bloodstream (reference 2). My studies on nicotine absorption pharmacokinetics have shown that liquids with nicotine content similar to the upper limit decided by SANCO provides typically less than one-third of the nicotine delivered by one tobacco cigarette (references 4 and 5). We have calculated that a 50mg/ml nicotine-containing liquid is marginally equivalent to smoking one tobacco cigarette in terms of nicotine delivery to the bloodstream. In my second study cited by SANCO, I have clearly shown that 23% of smokers had to use higher than 20mg/ml nicotine-containing liquids in order to completely substitute smoking (reference 3, Figure 1). None can support that 23% of users is a small proportion; however, this has been ignored by SANCO. In fact, this study provides further support that 20mg/ml nicotine content in liquids is insufficient for smokers.
I have always been willing to provide consultation to the regulatory authorities. Regulatory organizations such as the US Food and Drug Administration (FDA) were more than willing to meet and consult with me on the science behind e-cigarettes and are open for any future meeting to present more research. It is highly important that regulators within the EU also realize the value of proper consultation for an issue which is of outmost importance for public health.
Regulatory decisions based on misinterpreting science are inevitably wrong. The Commission has no scientific justification for its proposed 20mg/ml nicotine limit.
1. European Commission. Revision of the Tobacco Products Directive. Factsheets for information on specific policy areas: E-cigarettes. Available at: http://ec.europa.eu/health/tobacco/docs/fs_ecigarettes_en.pdf
2. Farsalinos K. et al. Evaluation of electronic cigarette use (vaping) topography and estimation of liquid consumption: implications for research protocol standards definition and for public health authorities' regulation. International Journal of Environmental Research and Public Health, 2013.
3. Farsalinos K. et al. Evaluating nicotine levels selection and patterns of electronic cigarette use in a group of "vapers" who had achieved complete substitution of smoking. Substance Abuse, 2013.
4. Farsalinos K. et al. Nicotine absorption from electronic cigarette use: comparison between first and new-generation devices. (Submitted for publication – Presented to the FDA, December 19, 2013).
5. Farsalinos K. et al. Nicotine absorption from electronic cigarette use: comparison between naïve and experienced users. (Presented to the FDA, December 19, 2013).
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