SMOKING tobacco sends perhaps half of its long term addicts to an early grave, and inflicts chronic diseases on many of the rest. The filthy habit is on the wane in rich countries, though it is still worryingly popular with many of the young. Electronic cigarettes look like a promising substitute power from a small battery vaporises a solution containing purified nicotine, delivering the hit that smokers crave without the toxins in tobacco smoke. So you might imagine that the increasing demand for e cigarettes would be welcomed, and encouraged.

Not at the European Parliament. On October 8th it is due to vote on a new tobacco control directive. Its intent is to cut smoking and keep children from taking it up (see article). But one of its main provisions would have the opposite effect. It would treat e cigarettes like medicines, which includes requiring their makers to seek approval from the agencies that regulate pharmaceuticals when they bring a new product to market. This would greatly reduce the range of products available and increase their price. Even the European Commission, which first proposed the approach, admits that this is likely to slow the uptake of e cigarettes. A vote for more curbs in Europe will also surely send a signal to America s Food and Drug Administration, which is contemplating its own regulations.

In this section

• The new face of terror
• Has Brazil blown it?
• Sending the wrong smoke signal
• Angela s dilemma
• Curb your enthusiasm
• Remember what you once were

Reprints

E cigarettes are not entirely risk free. Little research has yet been done about their long term health effects. Nicotine is, in implausibly large doses, a poison. Even in small ones it is addictive and the amount of the chemical dispensed by e cigarettes varies from one brand to another. But it is already clear that whatever health risks may emerge in studies of e cigarette use, they are vastly less lethal than traditional smokes.

Given the prospect of weaning the world s billion or so smokers onto something much less harmful, as well as protecting children and others from second hand smoke, there is a more sensible approach. Europe should tighten the existing rules on labelling and quality control that affect e cigarettes. America should also increase oversight. Governments should then invest in rigorous testing and see how the product evolves. For e cigarettes are changing rapidly in response to consumer demand. In America around 300m of them will be sold this year, three times the figure in 2012.

This seems to worry pharmaceutical firms, which in Europe are lobbying for curbs on e cigarettes, a competitor to their nicotine patches and other quitting aids. Big tobacco firms are working on e cigarettes of their own, as well as cigarettes that heat rather than burn the tobacco. But they have an interest in slowing the switch to smokeless smokes. If the innovative smaller firms that make most e cigarettes have to seek a licence every time they want to offer a new flavour or strength, the move towards safer nicotine consumption will be slowed.

Careless regulation costs lives

So far it seems that most regular vapers of e cigarettes are smokers or ex smokers. But over time the prospect of a relatively harm free nicotine kick could draw in many new users. This risk, and the lack of long term research on the residual risks of nicotine, argue for restricting the sales of e cigarettes to children. But as far as adults are concerned, they should be subject to less regulation than alcohol (which is far more harmful) and perhaps to no more than caffeine, another addictive and mildly poisonous substance whose widespread use governments see no need to curb. The risk of getting more people addicted to something relatively harmless is well worth taking, given the opportunity for curbing dramatically the world s single most harmful voluntary activity. Politicians should stand back and let a thousand e cig brands bloom.

The european commission has misinterpreted my scientific research on nicotine in e-cigarettes

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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.

References

1. European Commission. Revision of the Tobacco Products Directive. Factsheets for information on specific policy areas E cigarettes. Available at

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 na ve and experienced users. (Presented to the FDA, December 19, 2013).

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