Dear Andrew Brons, Timothy Kirkhope, Godfrey Bloom, Rebecca Taylor, Linda McAvan and Edward McMillan-Scott,
I am writing to you with regard to the upcoming
tobacco Products Directive vote.
I urge you to bear a few things in mind as this matter is discussed:
Tobacco products kill. Mercilessly. It is of the utmost importance that we as a society steer our citizens away from dependence on tobacco.
This can be achieved in two ways - abrupt cessation of smoking with its minimal success rates, or harm reduction by offering a less harmful alternative that allows the smoker the choice of a gentler path out of smoking.
It is my belief that harm reduction has far more to offer the general public, and that so called e-cigarettes or personal vaporisers (PV) are the safest and most effective method of delivering nicotine without the tar and carcinogens that are associated with smoking.
PV's, and the nicotine liquid they use, do not come from tobacco and as such contain no tar and no carcinogens. They are a mixture of food grade or British Pharmacopoeia grade ingredients that are already a part of many foodstuffs, with a BP grade dilution of nicotine added.
Regulating PV's as medicines is making an assumption that they are to be used as a nicotine replacement therapy device as part of a smoking cessation attempt. This is not their role. They are primarily a method for nicotine addicted smokers to ease their cravings in a far safer way than through tobacco based products.
Nicotine, while a toxin in high volumes, is about as harmful as a cup of coffee at the volumes presented by PV atomizers. As one of the side effects of having ingested too much nicotine is nausea, the devices are highly unlikely to lead to an unsafe dosage of nicotine being inhaled as the inhaler would stop using the device just as they would if they were still smoking (that "too many fags" feeling that is familiar to any smoker or ex-smoker).
There are existing regulatory frameworks which may be applied to PV's and their liquids. Art 5 TEU Protocol 2 requires the EU to use the least burdensome form of regulation to achieve the policy objective.
Regulation as a consumer product is the least burdensome, most proportionate and most cost effective way of ensuring safety for these devices, and I strongly urge you to resist any more stringent proposals.
It is vital that you do not lose sight of the end prize of getting people to stop smoking in haste at regulating an addictive but essentially harmless substance. The restrictive nature of medicinal regulation is far overblown for this market, and runs the risk of not only stifling innovation and industry, but of actively turning people back to smoking who have already quit by using these devices, due to the additional cost of meeting such stringent regulation, which will be passed on to the consumer.
Yours sincerely,
Me.
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And her response. Its pretty much a template letter that I'm sure you've seen before, but its slightly different from others I have seen.
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Dear You
Thank you for contacting me about e-cigarettes.
I have had many emails from people like yourself, who have found e-cigarettes to really work in helping them to cut down on smoking, and I am aware that many people feel strongly that their access to these products should not be limited in any way.
There has been a lot of misinformation circulating about a proposed ban on e-cigarettes. It might be worth underlining what has been said in Parliament so far: nobody wants to ban e-cigarettes, and that is certainly not my intention. On the contrary: I see e-cigarettes as a promising development in smoking cessation, and I have spoken to many doctors who specialise in tobacco related illnesses and who have been recommending them to their patients.
Since e-cigarettes are such a new development, there is no specific legislation to cover them, and at the moment they are largely unregulated. It is exactly because of the potential of e-cigarettes that I think it is important that consumers can be confident that the products they buy are tested, safe, meet quality standards, and deliver to users what they claim on the package.
The UK Government has been looking at the issue for several years, and has recently concluded that e-cigarettes should be regulated in the same way as nicotine gums and patches - i.e. under light-touch medicines legislation. In a vote in the Health committee of the European Parliament last Wednesday, a majority of MEPs agreed with this approach.
The "medicines" label would change very little in terms of the availability of e-cigarettes in the UK: over-the-counter products like paracetamol are already widely sold in supermarkets, corner shops and garages, as well as in pharmacies. As nicotine is already a well-known substance, e-cigarettes would not be required to undertake costly clinical trials, which may have pushed the price up, and there are even some advantages in terms of a lower VAT rate, and the possibility of e-cigarettes being available free to patients on prescription. Some constituents have raised concerns about extra-strong and flavoured e-cigs being banned under the medicines route, but this would be a decision for the UK regulator - I would be in favour of maintaining a wide choice for consumers, as long as the safety and quality of the product is proven. (Nicotine gum and inhalors in different flavours and in strengths of up to 15mg are already available in the UK.)
Health organisations including Cancer Research, the British Heart Foundation, ASH, and doctors associations all support the UK Government medicines approach, as this would ensure that e-cigarettes are not promoted to children or non-smokers, creating a new generation of nicotine addicts (there have already been some press reports about schools having to ban e-cigarettes from the classroom). It would also mean that the products are monitored, as little is known about long-term effects.
We are still a long way away from any changes - the final legislation will only be agreed following a negotiation process involving MEPs and national ministers. Even once a deal is reached, I am working to ensure that e-cigarette companies will have several extra years in which to adapt to the new rules, so that there are no interruptions on the market.
I hope this information is helpful.
Linda McAvan MEP
Yorkshire and the Humber
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Dont you love how she's in favour of choice for the consumer, when it was she who tabled a motion to remove it? I wasnt going to let her get away that easily, so this is my response.
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Dear Ms McAvan,
Thank you for your reply. I have a few questions, if I may.
You say that you see e-cigarettes as a promising development in smoking cessation. Is this backed up by any research into actual usage of the devices? My anecdotal experience would suggest that the devices are more commonly used to replace the cigarette in a harm reduction strategy, rather than as a traditional NRT in a smoking cessation attempt: to get away from smoking and the obvious associated health risks while still maintaining nicotine delivery. I would be very interested to hear the evidence supporting your views.
I would also like to ask how an e-cigarette is legally defined under the proposed regulation? Is it the battery? The atomiser? The liquid? All three are commonly available as separate commodities, so how are you to define what it is you seek to regulate? The exact same technology is also used and marketed as "e-shisha" pipes, which do not and are not intended to carry nicotine. Will these too be affected?
Will the regulations affect nightclubs and theatres who use smoke machines, as these are the same technology as e-cigarettes but on a larger scale, even as far as the base ingredients of the liquid they use?
Are you seeking to regulate nicotine containing products, other than tobacco? If so, are the EU's potato and aubergine farmers aware that their crops are about to be regulated as pharmaceuticals, as these too contain small amounts of nicotine?
As it is entirely legal to buy nicotine dilutions in strengths up to 72mg/ml without a license in the UK, which would require separate legislation to change, are you not concerned that such stringent regulation will lead to more people simply turning to do-it-yourself recipes that may lead to higher levels of contamination than professionally manufactured liquids?
I would appreciate a response to these questions at your earliest convenience. I am at your service if you have any questions you wish to ask me, or any help you may need with this subject.
Yours sincerely
Me.
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Now for the interesting one. This appears to be a personal response, and contains information I havent seen on here. Doesnt mean it hasnt been posted, just means I havent seen it!
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Dear You,
Thank you for your email and I note the points you make.
I should have said in my email that e-cigarettes are promising both for smoking cessation and to help smokers cut down, eg through substituting
vaping for smoking long-term, and the MHRA already licences NRTs not just for smoking cessation but also for harm reduction. You ask for the research into actual use of devices - ASH commissioned a survey very recently which can be accessed here:
http://www.ash.org.uk/files/documents/ASH_891.pdf. The UK regulators have also recently published their studies into e-cigarettes here:
Nicotine containing products : MHRA
To answer your question about how e-cigarettes are defined - only products which contain nicotine are due to be regulated as medicines, under the proposal so far. So this includes conventional NRTs, as well as disposable e-cigarettes which contain nicotine, or e-liquids. So in the case of re-useable e-cigs it would just be the e-liquid, not the devices themselves. E-shishas which do not contain nicotine would not be affected.
I know there are very strong views on this issue, and the last thing I want to do is restrict smoker's access to e-cigarettes especially as they have been so helpful.
There is widespread support for better regulation of e-cigarettes from many organisations. I include a letter from ASH - Action on Smoking and Health - which explains their position on this matter.
Thank you for your comments which I will take on board in the ongoing discussions.
Best wishes,
Linda
