Dear Herr Groote and Mrs McAvan,
We are the Electronic Cigarette Consumer Association of the UK and we, along with our European counterparts, represent millions of consumers throughout the EU who have stopped (or significantly reduced) smoking tobacco cigarettes through the use of electronic cigarettes.
We are writing to you both - in your capacities as Chairman of the European Parliament’s Environment, Public Health, and Food Safety Committee and as Rapporteur for the revision of the Tobacco Products Directive.
You have the opportunity to positively impact the lives of the 28% of the EU adult population that smoke.
According to the opening ‘context’ statements justifying the need for a revision to the TPD, tobacco cigarettes are responsible for the deaths of 700,000 EU citizens each year. That is nearly 2,000 EU citizens per day or 80 EU citizens every hour.
The TPD ‘Citizens Summary’ states that 1 in 2 smokers will die prematurely – on average 14 years earlier. Frédérique Ries raised this point in the May 7 2013 EU workshop on electronic cigarettes and asked what the comparative figure was for electronic cigarettes – is it 1 in 10? 1 in 1,000? It is a moot point. Although it is too early to tell if electronic cigarettes are safe in absolute terms, they are recognised by independent academics as orders of magnitude safer than tobacco cigarettes. Quite how many orders of magnitude safer matters much less than whether users will adopt them instead of the dominant nicotine delivery method – the tobacco cigarette – a product that is freely available – one that you say is responsible for 80 deaths every hour.
Although we don’t have precise figures regarding how many users are making the switch, Martin Seychell advised at the May 7 workshop that the market in the EU currently sees monthly growth rates of 30%. We know that this growth has seen between 5 and 7 million people throughout the EU switch to electronic cigarettes in order to either wholly, or partly replace, tobacco cigarettes. We also know that, in the United States in 2013, Morgan Stanley’s tobacco analyst, David Adelman, estimated that 1.3 billion fewer cigarettes will be smoked as a direct result of electronic cigarette use. In the UK, the MHRA have stated that the percentage of smokers using electronic cigarettes increased from around 2% in 2011 to around 11% as of May 2013.
So, we do know how successful the electronic cigarette story has been so far.
What we do not know is the impact of requiring electronic cigarettes to be authorised pursuant to Directive 2001/83/EC. However, we can speculate on how this might affect this public health success story. By regulating e-cigarettes as a medicinal product, and by banning flavours, the Commission and its supporters in Parliament and Council are effectively placing a de-facto ban on existing products, as the Parliament’s own Legal Affairs Committee has made clear. You will hand the tobacco companies a virtual monopoly to “cure” the “disease” they cultivate. Your actions will result in the closure of many SME's and the loss of thousands of jobs among the member states. Most disastrously your actions will lead to a market containing a limited number of homogenised products that, like traditional NRT, may be a great idea in theory but not efficacious in practice.
We are all individuals and our old smoking habits varied considerably. No two smokers follow the same patterns of cigarette use and the wide variety of brands suggests that individuals choose a particular brand for lots of different reasons. Amongst these reasons are flavour and nicotine level. The same is true of the electronic cigarette. The current diversity of product offerings allows users to find a product that best matches their requirements for the replacement of cigarettes. Users can find a device that enables them to effectively self-titrate their nicotine blood plasma levels. The user experience is further enhanced by the wide selection of alternate flavours available. Although many users start with a tobacco ‘flavour’, huge numbers move on to other flavourings. They have left tobacco behind and it would be perverse to insist that, having chosen not to smoke, they must only use a flavour designed to remind them of the habit they no longer wish to continue.
The Commission appears to be unable to place pragmatism before ideology. The fact that a small number of consumers that switch to electronic cigarettes go on to stop their nicotine intake entirely is not a reason to conflate electronic cigarettes with smoking cessation devices. One of the key reasons behind the success of electronic cigarettes is that the user is not “giving up” or “quitting” smoking – they are simply switching to a significantly safer nicotine delivery system and carrying on. If total nicotine abstinence occurs it is a secondary outcome.
Electronic cigarettes are not a medicinal product and as users we do not see ourselves as ill or in treatment; we are not. Nicotine, of itself is probably no more harmful than the caffeine in coffee and it is widely believed to have some beneficial effects.i Nicotine does not cause the social problems that result from the use of many other addictive drugs. So whether or not one considers addiction to nicotine to be 'bad' is a moral judgement. Where in the treaties does it say that the Commission can introduce legislation on moral grounds?
Even for smokers that only use electronic cigarettes to reduce the number of tobacco cigarettes smoked, there is still thought to be a health benefit. Sir Richard Doll advised the MHRA in the UK that “…there is a dose related effect on mortality with increasing cigarette consumption…” and that although “…there is no direct evidence of a graded fall in mortality with partial reduction … the logical argument is that there should be. Certainly it is possible to show improvement in lung function with partial reduction…”ii
We believe that requiring medical authorisation will render effective products useless, result in many current users returning to smoking and prevent many millions of potential users from making the switch. Please do not allow yourselves to be the authors of a public health disaster.
Please consider these three questions as you make your choice on the future of electronic cigarettes.
1. Are the Commission confident that a massive reduction in the current use and future uptake of their ‘medical’ products will be more than offset by the increase in “safety and efficacy” they claim will come with medicines regulations?
2. Has the Commission calculated what percentage point increase in “safety and efficacy” they can achieve through medicines regulation?
3. Do the Commission know how many existing and future electronic cigarette users you can afford to ‘lose’ to smoking traditional cigarettes and achieve a net public health benefit?
If you do not have a firm evidence base to confidently answer “yes” to these questions, you are in no position to introduce legislation at this time.It is fair to say that not all of the currently available products are created equal. Some manufacturers make devices that are not as reliable or effective as they could be. However, market forces will inevitably lead to their failure. As a consumer association, we would like to see manufacturers and importers be required to conduct quality testing of liquids and for the results of such gas chromatography/mass spectrometry tests to be displayed at point of sale (or on websites for internet sale). We would like to see age restriction upon sales. We would also like to see the existing regulation and inspection regime brought to bear on these products to ensure, for example, the electrical safety of batteries and chargers. As time passes, and researchers have the opportunity to analyse and study this market properly, without looming parliamentary deadlines, it may become apparent that additional regulation would be beneficial. However, that time is not now.
You have the opportunity to make a real difference to the lives of more than a quarter of the citizens you represent. Your strong leadership on this matter will change citizens lives. On behalf of millions of current electronic cigarette users and the many, many millions yet to switch, we urge you to make the right choice and support Amendment 58, the ALDE-ECR-EFD consolidated amendment that protects electronic cigarettes from the disastrous imposition of medicines regulations.
Please find the letter on our blog page and feel free to comment.