The European Commission has published a draft directive on tobacco products. Unfortunately it bans and obstructs much lower-risk alternative to cigarettes, such as smokeless tobacco and e-cigarettes, so its effect would to protect cigarettes and harm health. However, it is not too late to do something about it.
1. What has happened?
On 19th December 2012, the EU produced a proposal for new laws controlling tobacco and nicotine products like e-cigarettes. The proposal includes a justification for the measures with draft legal text and comes with supporting documentation. It covers a wide range of issues, including: labelling and warnings on cigarette packs; branding restrictions; control of flavours and additives; tracking and tracing to prevent smuggling and counterfeiting; and measures that apply to smokeless tobacco products and nicotine-containing products like e-cigarettes. The proposed directive contains measures that could make it harder or impossible for smokers to switch from cigarettes to much less dangerous nicotine products – an approach that will cause more death and disease than it prevents. If you smoke, use e-cigarettes, or if have friends or relatives that smoke, or if you are concerned about the health damage from smoking, then this directive matters to you.
If you want to write to your MP or MEPs, the main information you need together with my advice is set out below. More detailed briefing on the directive is available here and on influencing the scrutiny process is here. A good political article on the directive here and letter here. A good background video on tobacco harm reduction here.
2. Why do you need to act?
The European Union has proposed legislation that would ban, or effectively ban, nicotine products that people can (and do) use as much less dangerous alternatives to smoking cigarettes – for example, smokeless tobacco, e-cigarettes, vapour devices, or other novel ways of taking nicotine that don’t involve burning tobacco. Although the risk is reduced by 95-99% if there is no smoke, Europe still thinks it is better to ban these products even though they are a potential life-saver for people who can’t or don’t want to give up nicotine. If you use these products yourself, they are restricting your options and adding to your health risks. Background information on ‘tobacco harm reduction’ here
3. What are they doing?
The proposed new law (an EU directive) does three main bad things:
1. Bans the safest tobacco products. It bans the least hazardous form of tobacco known to mankind – snus – whilst allowing cigarettes to be widely sold. Snus (or oral tobacco) is much less dangerous than cigarettes, and widely used in Sweden, where it is the main reason why Sweden has much lower rates of cancer and other smoking-related disease than anywhere else in Europe. According to the official survey (Eurobarometer 2012 – page 7) Sweden has by far the lowest rate of smoking in Europe, just 13% of adults compared to the EU average of 28%.
Why ban these products when they have been so successful at reducing harm in Sweden? Why deny people in other countries access to tobacco products that dramatically reduce risk and may save them from cancer, lung damage or heart disease?
2. Treats e-cigarettes as though they are medicines – potentially banning or marginalising them. It places most non-tobacco nicotine products, like e-cigarettes, under the highly restrictive regulation regime used for medicinal products. This requires the manufacturers or distributors to justify them for their therapeutic effect and to demonstrate that benefits outweigh the risks and comply with potentially expensive and burdensome regulation. Even though that may be obvious to most people, it is potentially difficult to do it to scientific standards. In fact these are really consumer products chosen by consumers as an alternative to smoking the most unhealthy forms of nicotine rather than medicines – and should be judged as alternatives to cigarettes. Depending on the attitude of medicines regulators this type of regulation could have the several negative effects. It could:
- amount to an effective ban if regulators demand impossibly high standards of proof or
- take these products off the market as early as 2013 as there is no ‘transition’ period to allow manufacturers to apply for and get the necessary authorisation and it would be illegal to sell them as soon as the directive comes into force, which could be as soon as 2013 and likely to be before May 2014
- take these products off the market for many years as most or all manufacturers will struggle to get the necessary ‘marketing authorisation’ from regulators, who may all disagree with each other around Europe
- apply restrictions that make these products unattractive to smokers through packaging requirements, marketing restrictions, bans on flavours, technical limitations imposed;
- greatly close down competition, limit innovation, raise costs leaving the market to big players, such as tobacco or pharma companies, that can cope with the potentially huge burdens that comes with medicines regulation.
The directive treats e-cigarettes below a certain threshold as consumer products. The very weakest form of e-cigarettes (with liquids below threshold of nicotine density 4mg/ml) might escape medicines regulation. But these are extremely weak in e-cigarette terms, and not regarded as adequate substitutes for conventional cigarettes and unlikely to do much to help people switch from smoking. More on this in my briefing on the directive.
Why would governments make it harder to put these products on the market than the much more dangerous products they are designed to replace or compete with? Read novelist Lionel Shriver (We need to talk about Kevin) on Puritans and the powerful – and tobacco smokers – can’t take the fact that electronic cigarettes are harmless and enjoyable . For more background on e-cigarettes this ASH fact sheet is good. [Update Feb 2013… an in depth posting on medicines regulation and e-cigs: Medicines regulation and e-cigarettes: when caution can kill.
3. Prevents any claim that one tobacco product is less harmful than another. The trouble is that the boring old truth is that smokeless tobacco products may be many times less harmful than cigarettes, perhaps 10-1000 times less harmful. So what looks like an attempt to stop false or excessive claims, is actually going to do real harm:
- It denies consumers the most relevant information about lower risk tobacco products – information they could use to reduce their own risk and protect their health This is misleading by omitting the most important information.
- Why should a manufacturer bother to make or market these products or invest in innovation if they can’t say the one (truthful) thing that makes them valuable as alternatives to cigarettes? All this does is reinforce the market for the most harmful tobacco products by shielding them from competition from less harmful forms.
This makes a law out of misleading consumers – who benefits from it?
4. Does it matter?
Yes it does – the health of real people is at stake. Smoking already kills 700,000 and costs €25 billion in health care costs in Europe annually (about 100,000 and £3.7 billion for the UK) [source]. Quit rates remain stubbornly low despite years of effort and drug development. The 2012 Eurobaromter survey of attitudes towards tobacco shows 28% of European adults still smoke (about 27% in the UK) despite almost universal knowledge of the dangers and millions spent. But only 13% smoke in Sweden. The difference is harm reduction: many Swedes use oral tobacco (snus) as their chosen way of taking nicotine – but snus carries only minor risks compared to cigarettes. Sweden is dramatic ‘proof-of-concept’ for a market-based, user-driven personal harm reduction approach… in other countries smokers may choose to turn to e-cigarettes, novel nicotine devices, or even snus – but regulators have to stop getting in the way, and start encouraging and enabling this trend. Most smokers say they would like to quit and most say they wish they had never started. Some like a nicotine hit and some of the ritual that goes with smoking, but we know that if safer alternatives to cigarettes can be found many people will use them. There is a grave danger that people denied much safer alternatives will either lapse back to smoking or never be able to try these ways of giving up smoking. I have never seen a directive where the evidence so clearly points to it causing more death and disease – it is reckless, irresponsible, unscientific and unethical.
5. What to do: write to your MP and MEPs
Your Member of Parliament (MP) represents you in the UK, and several Members of the European Parliament represent you in matters to do with the European Parliament. Both MPs and MEPs have a role to play on the tobacco directive, so it is best to to write to both. Your MP can approach UK government ministers and ask them to influence the directive as it passes through the European Council (comprised of ministers of the member states). Your MEPs can influence the European Parliament scrutiny of the directive, propose amendments and influence the stance taken by political groupings in the European Parliament. If they are members of the Environment, Public Health and Food Safety Committee (usually known as the ENVI committee), they will be involved more directly in scrutinising the directive.
The simplest way to do this is to access www.writetothem.com. This is an excellent service: you enter your postcode; it works out who your MP and MEPs are (you will have several MEPs) then sets up e-mails for you to send them. You enter your own text and address details and then follow the procedure on the site and it will send your letter. Once you have drawn up a good letter that covers most of the points you want to get across you can use it for lots of different purposes – customising and personalising for each if you want to make an impact.
For non-UK readers. For non-UK readers, I have less information – but all MEPs can be located here – and information on how different national parliaments scrutinise EU legislation can be found here. Your can follow many of the tips here and tailor for your national situation.
Some tips on writing to MPs and MEPs
1. Decent. Always be polite and dignified, don’t make accusations or pre-judge their motives – most representatives want to do a good job for you.
2. Engaging. Work on the basis that the the MP or MEP is open-minded but might need some persuading. Don’t dismiss other views, tackle them.
3. Authentic. Write your own views in your own words -MPs and MEPs want to hear genuine heartfelt views, and not standard letters or borrowed text.
4. Natural. Don’t feel you need to use formal or legal language – it is their job to understand you, not your job to understand the technicalities of EU legislation
5. Concise. Concentrate on the things that really matter to you and stay focussed – if you are writing about e-cigarettes, don’t dilute your message with views on other issues or even other aspects of the directive unless they really matter to you. Keep it short (max 2 pages or 800 words) and to the point.
6. Personalised. Even though the web site allows you to send a single letter to all your MEPs in one go, I would advise emailing each individually. You an use the same basic text with each, but a little bit of a personal touch goes a long way.
7. Relevant. Only write to your own MP or MEPs.
If you want to write on proper paper and post a letter, you can use the www.writetothem.com site to find out their names and then post a letter (stamp to Brussels is 87p for a letter). The addresses are:
Their Name MP
House of Commons
London SW1A 0AA
Their Name MEP
6. What to say
It is important that you write in your own words, based on your own experience and express your own views. I must stress this – authenticity really matters.
6.1 A good letter to an MP or MEP might have the following main components:
1. About you and your experience – eg. have you tried to quit smoking? What effect has vaping had on you? What experience have you had of e-cigarettes? What you think of the threshold e-liquids?
2. Why you think what is proposed will be bad, especially if it is bad for you personally
3. What you think should be done, and what you would like them personally to do
4. Questions that make sure you get a response: ask questions, ask for a reply and/or ask for a meeting
6.2 Reasons why the directive might be bad
You don’t need to use any or all of these, but they might help you construct a letter. Remember to personalise these to reflect your own situation where possible.
1. The proposed directive seems to deny or obstruct smokers options to quit cigarettes by switching to nicotine or tobacco products that are much less risky. This is very risky and irresponsible, and will probably cause more death and disease.
2. It looks like it is designed to tie up e-cigarettes and their makers in medical red tape, which could amount to banning them by the back door – and it makes no sense to ban them whilst leaving real cigarettes on the market. We need light-touch regulation that builds confidence in the safety and quality of the products, and no more.
3. Even if medicines regulation doesn’t stop these products getting to the market, it may place restrictions on them making them less attractive, more expensive and less innovative – for example by banning flavours, making the packing look like medicines, and strictly limiting advertising and marketing. We don’t really know how medicines regulators will treat these these products.
4. It could mean e-cigarettes are taken off the market while the makers apply for permission – there should be 2-3 years transition to give existing products time to comply with the directive.
5. It is wrong to pretend that all tobacco and nicotine products are the same – smokers should have true and relevant information about risks so that they can make informed choices.
6.3 What should be done?
These are a few suggestions from me.. please pick ones that matter to you, add your own views and use your own words.
1. There should be no ban on oral tobacco (snus) – instead all smokeless tobacco should be regulated to reduce any toxic substances in the tobacco. This product is much safer than cigarettes and is a viable substitute for smoking. Smokers should not be denied this option, which has worked incredibly well in Sweden.
2. E-cigarettes should be regulated for what they are – consumer products, placed on the market as alternatives to cigarettes. The appropriate regulatory regime is that used more generally for products – ‘General Products Safety Regulation’, which is governed by an EU Directive and UK regulations.
3. Only where an e-cigarette maker wants to make a health or ‘therapeutic claim’ should medicines regulation apply – otherwise treat it like a consumer product. If they don’t make a therapeutic claim, how can they provide evidence for it? It makes no sense to apply really tough regulation to these products and much weaker regulation to cigarettes when they are just competing to be alternatives to appeal to consumers. Some manufacturers may choose to get a medicines marketing authorisation, but that should be up to them.
4. If the EU is determined to press ahead with applying medical regulation there should be three year transitional period to allow the makers to submit applications to sell these products and to ensure they don’t disappear from the markets overnight when the directive enters into force, thus forcing many users back to smoking.
5. That products like e-cigarettes should remain on the European market – otherwise there will just be a flood of internet sales and all the business will be done with traders outside the EU.
6. The European Union should find ways to encourage smokers to switch to e-cigarettes or smokeless tobacco, not ban or marginalise these products through regulation.
6.4 What you could ask your MP or MEPs to do…
Write to your MP and MEPs – you need slightly different letters because they have different roles and can do different things:
1. Ask your MP and MEPs to reply to you… ask them to give their views on the parts of the proposed directive that deal with smokeless tobacco products and nicotine containing products.
2. If you are an e-cigarette user, ask your MP and MEPs to give an undertaking that they will not support an EU directive that removes most or all e-cigarettes from the EU market, and point out this is important for your own health.
3. Ask to meet your MP and MEPs, and tell them you would like them to understand why this matters to you by explaining it in person.
4. Ask your MP to raise your concerns with the Secretary of State for Health (Rt Hon Jeremy Hunt MP) and Secretary of State for Business, Innovation and Skills (Rt Hon Dr Vince Cable MP). Ask your MP to ask them to press for amendment of the directive as it will harm health and works against the EU single market.
5. Ask your MEP to raise your concerns with the Commission and to speak out in the debate in the European Parliament.
6. Advanced! Ask your MEP to contact the relevant MEPs on the ENVI committee and to make their views known. If your MEP is on the ENVI committee, ask them to raise your concerns in the committee sessions that scrutinise the directive. This is a list of members of the ENVI committee or you can consult my more detailed guide on how this will all work.
7. What else?
If you do write to a representative, then you could leave a copy of your letter here in the comments as an inspiration for others.
If you have questions about the directive or disagreements with my interpretation or advice, please comment and I’ll respond, and change as necessary.
Watch me discussing the issue with Dave Dorn of VapourTrails TV.
93 thoughts on “EU draft Tobacco Products Directive: who to write to and what to say (a short guide)”
Thank you Clive for an excellent analysis and response, together with an ideal plan of action.
All I could add to this is that emails have limited use, many recipients will never see them as their PAs will spam bin them. If an email is sent, please follow it up with a letter or phone call. People will need to actually do something physically in order to make a difference on this.
Chris – thanks for this… I agree totally the more you commit to it, the better result. So do e-mail, but write, phone, meet as well…
Most MPs and MEPs will triage their incoming mail (1) from constituents, (2) party and political business, (3) other interests, campaigns, policy etc. So make sure your address is on it and your are identified as a constituent: (http://www.writetothem.org only lets you write from a post-code relevant to any MP or MEP and includes your address automatically). As you say, they are tired of mass e-mail spam campaigns from organisations – but authentic e-mails from constituents still count.
Like many recreational nicotine users I too extend my thanks to you Clive for taking the time to structure a process of action. The ball as they say is now in our court.
Once again, a laudable post Clive. However, I believe you are pissing in the wind again, since the Lords and Masters in Brussels have no interest in what anybody else thinks.
Chris Snowdon posted this link on Twitter earlier:
and it pretty much sums up the disdain in which we are held by the high and mighty.
“The proposal relies on cherry-picked conclusions from the expert consultation summary, rather than the actual scientific findings.
The DG received over 85,000 comments, more than in any other consultation.
Yet, instead of taking into account the overwhelming response, the DG delegitimised public opposition, painting comments as the result of citizen “mobilisation campaigns” organised by tobacconists. You’ve got to ask yourself: if pro-ban activists had been effective at encouraging the opposite response, and in such strong numbers, would the DG have treated that exercise in democracy as dismissively?
I think we’re on a hiding to nowhere, Clive. They’ve got their fingers planted firmly in their ears while chanting loudly “Na na nana na, I can’t hear you”. Nothing short of a length of 4×2 applied with some force to their collective head will make any impression at all. Even then I wouldn’t guarantee a positive outcome.
Ideologues will always deny any truth that disagrees with their ideology, even when that truth is yammering in their faces.
You might be right about aloof and remote Eurocrats… but one thing is certain: we can guarantee the wrong result if no-one tries to change it. The failures that led to this are many and long-running: most blame should attach to the most vocal elements of the ‘health’ lobby (which must always be written in quotes now) and their years of casual negligence on these issues combined with virtually no accountability for the death and disease they are busy spreading.
Yes, you are right, of course. Doing nothing is not an option. I’ve become something of a cynic, having bashed my head against a brick wall for a few years now. As you are doubtless aware, I’m not exactly in your camp, but on this issue we must put aside differences of opinion.
The EU approach is so counter-intuitive, it beggars belief. How can they be so obtuse? Are they really in the pocket of Big Pharma? It looks that way.
“Are they really in the pocket of Big Pharma?”
Of course they are. What other industry profits from the spreading of disease, while at the same pretending they are promoting health? I can think of no one.
The directive not only creates a monopoly for Big Pharma – as Clive says it also makes it more difficult to quit smoking. The smokers are stuck. This means more money for Big Pharma & more money for the member states. The pharmaceutical giants have corrupted & manipulated the political system – not just in the EU-commission but in the world.
Clive, just a quick word of thanks for all the effort you’re putting in to highlight the fallacy of this directive.
I smoked for 29 years. Tried many, many times to give up using the usual over the counter remedies but because I actually enjoy smoking nothing worked for me.
In November of 2012 for the hell of it I ordered an e-cigarette kit online, and from the moment of my first vape I haven’t touched a real cigarette since. Indeed, the packet of rolling tobacco I was using at the time still lies, half used, beside me on my desk. I am, and continue to be amazed just how painless this switch has been.
So, imagine I and my girlfriend’s feelings, having so recently found a way we can both give up the weed forever, to discover that this incredibly poor directive is threatening to make it virtually impossible for us to get nicotine juice in the levels we need to make the switch worthwhile. There can be absolutely no doubt, that if it goes through we will definitely go back to smoking cigarettes if we can’t get quality nicotine juice to continue vaping.
Naturally, I’ve emailed my MP and MEPs, but so far haven’t heard anything back yet. Frankly, I’m not holding my breath.
Again, keep up the good work. If it fails to be heard by those with the ability to effect change, it won’t be for lack of trying.
Many thanks for writing and posting.
I’ll forward and circulate widely.
Banning the least hazardous smokefree tobacco/nicotine products while keeping the deadliest tobacco product (cigarettes) is insane, inhumane, unethical and immoral.
The proposed EU Tobacco Products Directive protect cigarettes at the expense of public health.
Brilliantly put, CLive – I’m so looking forward to our discussion on VT Talk tonight – hopefully, it will spur the kind of action we need to hopefully do something about this ghastly mess.
Hi. You say that the TPD “Treats e-cigarettes as though they are medicines – effectively banning or marginalising them”. You then say that “could amount to an effective ban if regulators demand impossibly high standards of proof”.
This seems to me to be begging the question. In the UK, for example, what is your reason for thinking that regulators would demand “impossibly high standards” of proof/ I had thought they were likely to opt for a principle of like effect, so that e-cigs could be licensed without the usual process of clinical trials because they have like content and effects to other non-smoked nicotine products.
Can you supply reasons to the contrary?
Thanks for this – it’s a really good point. The optimists say that the UK regulator will take a ‘light-touch’ approach and that the evidential demands will be moderate. I don’t know much about the ‘principle of like effect’ or how it has been applied in practice. If you know about this, please write more it…
So it is possible you are right… but there are some reasons for caution:
1. The e-cigarette is quite different in design to existing NRTs (though likely to be more effective), so it is possible that they will demand other evidence. There may be issues about flavouring, long term use, the idea that it could be used to avoid situational pressures to quit.
2. These aren’t really medicines at all – the users don’t buy them for a therapeutic effect and the vendors don’t sell them for that. They are more realistically, rival commercial products to cigarettes – albeit with some vastly superior characteristics in terms of health, passive smoking and fire risk. But medicines regulation requires proof of ‘therapeutic efficacy’ and a positive risk-benefit balance. I don’t see why something like the arrangements for labelling and guaranteeing the safety of alcoholic drink could not be used, together with the general obligations to put safe products that are fit for purpose on the market.
3. The mutual recognition process (getting common agreement in all 27 member states) is complex and will mean that unless all regulators agree with a light touch approach, the issues will be decided through a central European-level committee and the European Commission. That is likely to make the process more risk averse and less light touch.
4. This will be contested territory – for competitive reasons the pharmaceutical companies have an interest in making the regulatory framework as tough as possible. They certainly don’t accept ‘like effect’ and showed their hand in their responses to the UK regulator’s consultation. I don’t think we should assume that these companies will be passive actors in the process.
I hope the regulators don’t throttle this market – but they definitely have the means to, and they will be under some pressure to do exactly that.
You say that e-cigs are not “medicines” at all, but that is a semantic issue since the same point could be made about nicotine gum and patches. All are in reality “clean” nicotine delivery systems, and all are much preferable to smoking. It makes no sense to me to have a separate regulatory regime for e-cigs from gum and patches, therefore “light touch” medicine regulation is an obvious way to go.
“Like effect” simply means that the regulator could license products containing nicotine(e.g. e-cigs) without clinical trials if there was clear evidence that it had equivalent content and effects to an existing product. The implication would be that e-cigs could be sold over the counter in a wide variety of retail outlets in the same way as, say, ibuprofen and asprin. This approach is consistent with the latest NICE guidance and the likely content of the MHRA decision expected next year.
Therefore the question remaining (for me) is just: does the Directive in its current form permit the UK to develop this approach or not? In my opinion it already does, but amendments might be sought to put this issue beyond doubt. This position in relation to the Directive will in my opinion be the one adopted by the key players in tobacco control in the UK and across the EU and is likely to succeed.
So this half of your original post is unnecessarily alarmist.
Hope this helps.
Again, thanks for this perspective – very helpful. I guess my concern is whilst light-touch is possible, it may not turn out that way.
I think what makes something a medicine is not its substance, but a claimed therapeutic effect, for which marketing authorisation is necessary. That is the case with NRT, which claims efficacy as a smoking cessation aid. But it is not with e-cigarettes, which are marketed as consumer alternatives to smoking – ie. a different way of taking nicotine, not as a smoking cessation aid. If I sold orange juice claiming it would help to prevent colds and flu, I would be making a therapeutic claim and would expect that claim to be subject to medicines regulation. If just sell orange juice, I’m still selling beneficial vitamin C but not making any claim and don’t expect to be regulated as a medicine.
If the regulators simply extend the harm reduction indication already agreed for the Nicorette Inhalator, without needing further evidence from the e-cigarette vendors, then that would be encouraging. But I can’t find reasons to be confident that will be the case.
The NICE guidance you mention actually says: “little is known about the effectiveness, quality and safety of unregulated nicotine-containing products (such as electronic cigarettes) however, they are likely to be less harmful than cigarettes.” (p.9)
The guidance focusses on recommending NRT: Recommend 1 or more NRT products to help them cut down to quit or smoke less. […] Advise that it may be possible to continue using licensed nicotine- containing products for as long as they need after they have stopped, or reduced, their smoking. (p.13)
As far as ‘Like effect’ is concerned, NICE raises a possible detriment: The PDG recognised that electronic cigarettes and similar products could be marketed in a way that ultimately promotes smoking (p.29). It would be difficult to design trials to test this – at least over a moderate time-scale.
It also suggested studies of efficacy would be needed: The technology of nicotine delivery systems is likely to develop further in the near future. The PDG identified the need for ongoing evaluations of the efficacy and safety of both new nicotine-containing products and the delivery systems used. (p.30)
The MHRA has also made statements to similar effect. When the Nicorette Inhalator was authorised for a harm reduction indication, MHRA said: The extension of the indication for NRT to harm reduction marks a major shift in approach in medicines regulation. NRT has to date not been licensed for harm reduction and the decision to do so raises the question of the regulation of other unlicensed nicotine containing products on the market such as electronic cigarettes, which have not been assessed for safety, quality, and efficacy.
I may well be missing the point here… but doesn’t this all point to the e-cigarette vendors having to provide some evidence of efficacy in harm reduction (even though they don’t make that claim explicitly)? Wouldn’t it be better to regulate health claims, but regulate the product when sold as a legal drug using an approach more like that used for alcohol – a powerful drug for which no health claims are made, but subject to safety regulation and labelling requirements.
Finally, I’ve still got the nagging doubt that even if MHRA take an enlightened view of all this and wave e-cigs through with a light touch, there are still the other medicines regulators, the EMA and the Commission involved in reaching a common European approach. Any views on how that might play out?
Anyway, you are obviously familiar with this regulatory world, so please do keep contributing views…! They are very welcome here…
Clive, do you have any more details about the process through which mutual recognition among the member states for e-cig medicines regulation would be likely to operate?
I’m interested in how much sovereignty the MHRA would have in terms of labeling, allowable product designs etc, even in the event of disagreement with other member state regulators. Struggling to find accessible reading on this, maybe an email to the MHRA is the best way?
Rory – Very interesting point. Some say the UK’s MHRA has an enlightened view and plans light touch regulation. But what if others don’t see it that way? Mutual recognition and the decentralised procedure is dealt with in Article 28-39 of the medicines directive 2001/83/EC (page 42) – as you might imagine it is a bit of a bodice-ripper. But as far as I can see:
(1) one regulator takes the lead and if all agree with that assessment, it is authorised in all countries(Art 28);
(2) If one or more member state regulators disagree, they seek advice from a member state co-ordination committee under the auspices of EMA and the Commission advises on what constitutes serious public health risk (29);
(3) If they still can’t resolve their difference, the process switches to a more centralised one (under article 32-34).
(4) Under this process, the application is considered by the Committee for Medicinal Products for Human Use – which is an advisory committee of the European Medicines Agency (Article 32).
(5) The Committee gives an opinion, the European Commission is the decision maker (article 33)
(6) This is all done with rules of procedure set out in Art 121 (article 34) – which I haven’t looked at in detail.
I’m not a lawyer, and that’s just my reading of the directive – so do ask the MHRA if you want a more authoritative answer.
My concern is that other regulators may take a very negative view of e-cigarettes. If you want an example of how bad it can be – look at this (absurd) paper by WHO: Electronic nicotine delivery systems,including electronic cigarettes (see especially 33-40) prepared for the international tobacco treaty meeting in November For all practical purposes, this is essentially pressing for e-cigarettes to be banned or marginalised – so the dangers are live and real. (Note: my response to WHO in the form of a letter to delegates: is here and a lot of expert commentary on this was added in the comments).
But what if a couple of medicines regulators in Europe or the European Commission adopted this stance? What if they drew on this WHO paper to make their case. I can only see the regulatory process becoming more risk averse, restrictive and burdensome.
Thanks for guesting on VT Talk, Clive – I think many folks will find the programme interesting – it’s at http://www.vapourtrails.tv/?p=4940
they will want to ban e cigarettes because if true facts are published the tobacco industry would take a hit, governments around the world would lose billions in tax, corporate investors would lose millions, and the current companies themselves would be a shell of themselves. e cigarettes themselves are beneficial to people who want to give up smoking, and much less harmful than tobacco, also it does not affect passive smokers. The public should have a choice of whether to tolerate e cigs or not, but by banning it altogether without some sort of referendum would be undemocratic and go against our human right.
Clive a good article but you are wrong about the time of application. The Directive does not have “direct effect” therefore it has to be “transposed” by legislation in each Member State. Article 25 says that the Member States must do this within 18 months of “entry into force” (which will be some time – possibly not long – after its adoption and publication in the EU Official Journal). So even if adopted today it could not become law in the UK before July 2014 at the earliest.
Kevin – many thanks for this observation. But I had some doubts about this, which I’ll explain below. You are certainly right about transposition of the directive as a whole: 18 months is given in Article 25 of the proposed directive to transpose the TPD directive. But it is Article 26 that determines when the provisions of the directive actually gain legal force in member states.
So when I looked at it, I considered what this would mean for Article 18 as applied to e-cigarettes above the threshold (which is the important concern from a harm-reduction point of view). I had two reasons to think it would be immediate (at entry into into force of the TPD):
The first reason is that Directive 2001/83/EC is already in force, and all the domestic laws, regulations and administrative provisions to implement it are already in place. It’s not obvious, to me at least, that new domestic legislation is needed for this to apply to e-cigarettes – MHRA is already considering bringing nicotine containing products under its jurisdiction and believes it already has powers to do that (and from the definition of ‘medicine’ that looks reasonable) without new legislation. So I’m not sure what would need to be transposed. When MHRA consulted, one of its options (initially its preferred option) was to apply medicines regulation and take non-compliant products off the market from the moment these were to be considered medicines – see MHRA consultation document (Option 1 on page 5).
The second reason for doubt is that e-cigs above the threshold in Article 18.1 are conspicuously missing from the explicit transitional arrangements in Article 26, which applies to all other products covered by the Directive. This article allows for synchronised application in all members state (24 months after the directive enters into force) – what you would expect with a single market measure. The up-to-18 months allowed for transposition (art 25) is about the process of legislating and ensuring compliance with the directive in sufficient time, not about when the domestic laws actually take effect. If the intent was to have a transitional period, it would have been expressed in Article 26, so that all member states would apply medicines regulation to e-cigs on the same day. So I read Article 26 as meaning the medicines directive would apply to e-cigs above the threshold at entry into force of the TPD. It follows therefore that e-cig products without marketing authorisation under 2001/83/EC would be taken off the market (unless there are some provisions in medicine regulation that allow for a transition delay – I doubt this).
The earliest that could happen is in 2013 if the European Council and European Parliament agree. However, I suspect it is likely to be controversial and require more time, so more likely to complete passage before the 2014 European elections.
Let me know your thoughts… I’m definitely open to persuasion!
Thanks Clive, you make some good points. But Article 26 explicitly says that Directive 2001/83/EC is repealed on entry into force of the new Directive. And new legislation is needed in the Member States, which under Article 25 must explictly refer to the new Directive.
Also the Directive cannot take effect legally in the Member States until it has been transposed into national legislation. This is why it is important that the Directive is not stated to be “directly applicable in the Member States” (which would invoke the principle of direct effect which I mentioned before).
Further under the wonderfully named “doctrine of the occupied field”, once the Commission has legislated in an area, it is not open to Member States to enact their own legislation, unless specifically reserved to them by the EU legislation. This is a well-established principle of Community law. Therefore, they have to operate within (currently) Directive 2001/83/EC and can only operate on the basis of the new Directive once it comes into force, by adopting into national law and enacting further regulations in order to implement its provisions.
I would therefore say that the MRHA’s hands are now tied. IF the Directive is enacted, they will need to consider and draft appropriate measures. The actual transposition of the the Directive into UK legislation is quite simple and doesn’t require any parliamentary time.
Kevin – I don’t think that’s right. Let me try to set out the argument more logically.
1. Article 26 doesn’t repeal 2001/83/EC or refer to it. But Article 27 does repeal 2001/37/EC (not 2001/83/EC). 2001/37/EC is the existing tobacco products directive that the proposed tobacco products directive would replace. 2001/83/EC is the medicines directive, which of course remains in force.
2. As you say, the provisions of directives do not apply directly to citizens or organisations in the member states until implemented in domestic law for which time is allowed to develop domestic law (Article 25 allows up to 18 months) and dates provided for when the provisions of the directive must be applied in domestic law (Article 26 specifies 24 months after entry into force).
3. However, directives are legally binding on the member states at the point they enter into force (see Article 29 – this directive is addressed to the member states – standard directive text). Article 18.1 as it applies to e-cigs is addressed to member states – it is about which bit of EU law should apply.
4. The proposed directive instructs member states to apply the existing medicines directive (2001/83/EC) to nicotine containing products above the threshold (Article 18.1) and provides no transitional period for this in Article 26 or anywhere else.
5. This means the member states must apply the medicines directive to e-cigs above the threshold from entry into force of the tobacco products directive. But all the domestic legislation and administrative provisions that already exist to implement this directive would therefore apply at the point. As you say, that ties the hand of the government / MHRA – but that does not start 18 months or 24 months later.
6. The ‘doctrine of occupied field’ doesn’t bear on this issue as far I can see. The existing tobacco products directive (2001/37/EC) will be repealed as when the proposed tobacco products directive enters into force (article 27) – with a 24 month transition to bring in the provisions of the new directive (Article 26). The existing directive does not regulate e-cigs (nothing does explicitly, though they are covered by General Product Safety Regulations and other consumer protection legislation by default). The new tobacco products directive would apply a different directive, 2001/83/EC, to e-cigs above the threshold. In doing so, it introduces EU-wide regulation with a view to harmonising different regulatory approaches taken in member states around the EU, supposedly for single market reasons.
I hope that helps – it’s certainly helped me clarify a few things!
Worst case remains: new directive agreed quickly by European Council and Parliament at first reading and enters into force in 2013; medicines directive applies to e-cigs at that point; vendors can’t comply quickly enough or at all; European medicines regulators argue about criteria for marketing authorisation; products come off the market as they are non-compliant without marketing authorisation. More optimistically, it will take longer to settle the directive, medicines regulators will take a light touch approach, and a way will be found to allow some sort of transition so that “useful products are not removed from the market” – the stated intent of MHRA (see q3).
Clive you are right it is 2001/37/EC is repealed not 2001/83/EC. In mine you should read 2001/83/EC as 2001/37/EEC.
However, your point 3 on the binding effect of the Directive on the member states is not right. The legally binding effect in this case is that the member state governments must take the required actions to give effect to the legislation. Article 25.1 applies to the whole of the Directive, and that Article gives the member states up to 18 months to achieve this. Crucially, the Directive does not have “direct effect” in the member states, so legally cannot create rights or obligations on the part of member state citizens.
What this means is that the existing regulatory regimes (in all the member states) with regard to NCP can remain in place for up to 18 months. The doctrine of the occupied field does bear on this, because it prevents, or will prevent, subject to Article 24, the member states from creating their own regulatory schemes for NCP once the Directive takes effect.
Very good and useful guide, thank you as a vaper for the information, I identified the MP from Romania member of the ENVI-Committee on the Environment, Public Health and Food Safety- and I will send her an official letter with my complains regarding the Directive :)
I had an idea about contacting not only our MP (which can take or not into consideration our letters..I am afraid some of them will make them lost:()but also the The Committee on Petitions of the European Parliament.
According to Article 227 of the Treaty on the Functioning of the European Union any citizen may at any time exercise his right of petition to the European Parliament. Such petitions give the European Parliament the opportunity of calling attention to any infringement of a European citizen’s rights. The Committee on Petitions of the European Parliament is composed of 34 Members and is headed by a Chairman and 4 Vice-Chairmen.
So, if you think it is a good idea just submit your petition to the European Parliament (Committee on Petitions) following the link: https://www.secure.europarl.europa.eu/aboutparliament/en/petition.html
Subject of the petition must be concerned with issues of European Union interest or responsibility, in this case consumer protection and your rights as a European citizen, as set out in the Treaties.
Don’t pre-judge the purpose of the Directive as a whole, just refer to the art.3.7. Nicotine containing products (NCP) which is highly restrictive for you as a consumer. Do not forget to mention the name/code of the Proposal for a Directive (listed above) and the article. Remember , your petition can be on the table of the members of the European Parliament that will vote for the Directive! I think is a good idea to also write directly to the European Parliament, they have to give you an aswer and take into consideration your petitions! If we, the vapers, are united and make our voice heard maybe the members of the European Parliament will vote against this absurd art. 3.7. Nicotine containing products (NCP).
Sorry to be so slow in replying… this is a really good idea.
Thanks for info I got this reply from MEP
Thank you for your email setting out your thoughts on a proposal issued
by the European Commission to amend current European law concerning the
manufacture, presentation and sale of tobacco and related products. In
responding to you I have been in touch with my Conservative colleague
and leader of the European Conservatives and Reformists Group here in
the European Parliament, Martin Callanan MEP, who sits on the
Environment, Public Health and Food Safety committee. He has been
dealing with the legislation you refer to.
Among the products to be affected by the proposed changes are electronic
inhalers, commonly known as personal vaporizers or e-cigarettes, which
vaporize a liquid solution containing nicotine into an aerosol mist
which is then inhaled to simulate the act of smoking tobacco. The
Commission proposes to limit the amount of nicotine in solutions sold
for use in electronic cigarettes to four milligrams of nicotine per
millilitre, unless the products have been classified as for medicinal
use. This would render the solution too weak to be a viable source of
nicotine for smokers or ex-smokers, or would require manufacturers to
apply for a costly licence to manufacture medicinal products. Mr
Callanan has provided the response below which I hope you will find
“You are not alone in contacting me on this issue – many constituents
feel similarly strongly. I have examined the arguments and I see the
potential e-cigarettes offer as harm-reduction devices to improve human
health. I am particularly convinced by the fact that e-cigarettes offer
concentrated nicotine to addicts without the 4000 toxins and carcinogens
found in tobacco smoke, that use of e-cigarettes removes the risk posed
to non-smokers (and especially to children of smokers) by second hand
generally to children or those not yet addicted to nicotine, that
traditional nicotine replacement therapies proposed by the NHS and the
pharmaceutical industry have had very limited success in helping smokers
quit permanently, and that thousands of British e-cigarette users (and
millions across the EU and the world) are likely return to smoking if
the directive is amended as foreseen and nicotine concentrations are
limited to 4mg/ml. I have no doubt that this will lead to a large
percentage of such users dying of smoking-related diseases they might
otherwise have avoided, with all the personal and societal consequences
this would mean. Such arguments have led me to conclude that the
proposed changes to limit permitted concentrations of nicotine solution
sold in the EU are counter-productive and will do much more harm than
Changes to EU tobacco legislation have been expected for some time but
were delayed by the recent resignation of the previous European
Commissioner for Health and Consumer Affairs, John Dalli. His
replacement, Tonio Borg, has expressed a desire to change the law before
his mandate expires in June 2014. To prevent the proposed changes
concerning e-cigarettes and all the negative consequences that would
arise, we must work hard in the year ahead to build solid majorities in
both the Parliament and the Council.
As a member of the Parliament’s Committee on the Environment, Public
Health and Food Safety I will do everything in my power to make the
arguments and convince other MEPs of the foolishness of diluting
nicotine solution to the point of uselessness.
I would also encourage you to raise awareness among others in the
vapourizing community. The internet offers considerable opportunities to
draw the attention of a wide audience to the issue and to contact your
elected representatives quickly and easily. If you have not already done
so I would encourage you to write to your MP and request him to raise
the matter in Westminster, and persuade other e-cigarette users to do
the same. If we bring to the attention of the public, the political
world and the media the strong arguments in favour of e-cigarettes as a
harm reduction device and the number of lives which can be saved through
their use, we have a very strong chance of winning the argument.”
With very best wishes for a happy and prosperous 2013,
Martin Callanan MEP
Conservative Member of the European Parliament for the North East
Leader, European Conservatives and Reformists Group
Thank you for contacting me about this issue. I too wish you all the
best for 2013.
Emma McClarkin MEP
Martin Callanan seems to understand the whole issue and speaks very eloquently and logically on the issue. I hope there are plenty more that can think through the consequences as sensibly as he does.
Leo – this is an encouraging reply, especially that your MEP it raised with a senior MEP on the Environment, Public Health and Food Safety committee (known as the “ENVI committee”). Note his encouragement to contact Westminster MPs and to ask them to take the issue up with ministers.
This is because the next stages of the decision-making process are done jointly by the European Parliament (MEPs, with the above mentioned ENVI committee in the lead) and the European Council (mostly health ministers from the member states). More information on how this all works is here
Clive, like Leo I wrote to my MEP. I still await a reply. I also wrote to my MP, who has sent a not-unsympathetic and considered reply, in which he tells me that he has written to Health Secretary Jeremy Hunt, and will inform me when he receives a reply from Mr Hunt.
Good advice here, we do all need to do as much as we can to prevent bad policies being brought in for totally the wrong reasons.
I would add a further action to what’s described. I would also urge ecig users to visit their GPs (and even other medical professionals beyond that if you have contacts) and discuss it with them.
When I informed my GP I had quit smoking, she was naturally very pleased. When I told her of the way I had managed it (bearing in mind that everything she had prescribed – gum, patches, pills – had all failed, and even given me some bad side effects in the case of one type of tablet), I did so with some trepidation and no idea if she was aware of ecigs or how they work or their relative safety.
I was pleasantly surprised to find that she without prompting told me she was much happier with me vaping to get my nicotine than smoking. On that basis, we then discussed potential dangers and health issues, and the conclusion was that whilst she, like me and I guess all of us, would like to see further research, she was so sure that any potential harm from it would be near insignificant compared to the absolutely known harm from tobacco smoking that she fully backed my switch to and continued use of ecigs.
Once that part of the discussion had come about, I simply informed her of the EU directive and other policy threats to my continued use of ecigs and asked if she would be prepared to write a letter or add a part to my own letter to our MP/MEP explaining her support for me being able to viably use ecigs in the way I can currently.
Subsequently, I had similar discussions with other health professionals I am in contact with and similarly urged them to do the same.
Now, your GP is not likely to want to commit to given an ‘all clear’ ‘healthy’ endorsement to your vaping, but I think it very likely (with the exception of those too ignorant or with interests contrary to purely putting your health first) that the majority of reasonably informed doctors will agree that they at least prefer their patients vaping rather than smoking – and if you can gently encourage them to write that down (however qualified and arse-covered it may likely be), it will still help ensure that politicians have less of a leg to stand on in efforts to inhibit the use of ecigs.
Talk to your GP, explain the situation, explain how better your health is, and how that is under threat and they can help preserve your better health by writing as medical professionals to policy makers.
This is of course in addition to the other action recommended in the article above. We can make it so the politicians would have to effectively be skiing up-hill and their biases and corruption would stand out like a giant sore thumb should they persist in their planned course of action.
Wrote to my MP and MEPs, got this reply within 10 mins from one MEP (Labour). As you can see it’s an interesting tissue of distortions and pol-speak, but i thought it was interesting that they must have enough queries to have a prepared response so readily to hand.
Many thanks for writing to me about the important issue of the EU Tobacco
Products Directive, and how it will affect electronic cigarettes.
Because e-cigarettes are a relatively new product they are regulated
differently in each EU country. Some countries allow e-cigarettes to be
sold without any regulation at all. Others have banned the sale of
e-cigarettes. As the UK is part of the EU’s internal market it is important
that we harmonise the way we deal with this product, otherwise consumers
could be buying unregulated products which do not conform to basic safety
standards, either within their own country, or by easily purchasing it over
the internet from a neighbouring country.
The European Commission has proposed that all ‘nicotine containing products’
with more than 2mg per unit should not be classed as tobacco products.
Instead, under the Commission’s proposals, nearly all e-cigarettes will need
to get authorisation as a pharmaceutical product, in the same way as
nicotine patches, sprays and gums.
Of course there is a balance to strike. On one hand e-cigarettes have the
potential to be a helpful way to help somebody quit smoking entirely and
greatly improve their health. On the other hand e-cigarettes currently can
contain up to 48mg of nicotine – far more than a regular cigarette, making
them highly addictive. As nicotine is the drug that makes cigarettes
addictive, somebody that tries e-cigarettes could be much more likely to go
on to smoke regular cigarettes. Furthermore, there is no evidence that
e-cigarettes are safe, and it is concerning that they are being marketed as
a ‘healthy’ alternative to smoking.
Currently we do not have any conclusive evidence either that e-cigarettes
are helpful for giving up smoking, or that they encourage it.
While we do not have this scientific evidence to rely on I think it is wise
to have a cautious approach to e-cigarettes. If they are
effective in helping people to stop smoking, then it is appropriate that
they are regulated in the same way as other smoking cessation tools, such as
The Commission proposal is not final and there will be many months of
negotiations by the European Parliament, as well as health ministers from
the UK and other EU countries, before the legislation is agreed.
During this time Labour MEPs will be looking carefully at all of the
measures and trying to find the best way to ensure that we effectively
reduce smoking rates in the UK and across Europe.
Thanks again for writing to me on this important issue.
Brian Simpson MEP
This is the stock email that all Labour MEPs are replying with.
The comment about 48mg really rankles me and shows they don’t understand how electronic cigarettes work. It should be 48mg per ml. It seems they think you will be vaping this quantity in the same time it takes to smoke one analogue cigarette. A cigarette contains 9 to 11mg of nicotine so a pack of 20 would be 180 to 220mg. Therefore 3.75 to 4.58ml would have the same nicotine as a pack of cigarettes.
If we assume that the average vaper uses around 3ml a day then it is actually less nicotine than in cigarettes.
Of course you can’t really compare the amounts as they are carried into the body differently but if they can throw numbers around then so can I.
Paul / Thistle2 – would you mind writing to him to make this point (likewise others who have received the same response)? Ask him to take it up with whoever produced the stock response: [email protected]
Then post your letter on here, to encourage others (including me) to do the same…
Remember, most MEPs want to do the right thing, but don’t always have time to understand the technicalities, so rely on briefing. It is quite unfamiliar territory for most of us.
Many thanks for efforts prompted me to complain – latest reply:-
ALL THEY ARE AFTER IS YOUR VOTE and political back biting
Thank you for informing us of your concerns.
Mr Helmer is indeed supportive of your views. Our office will be monitoring the Tobacco Directive and raising when possible concerns similar to your own. We view this piece of legislation as controversial for many reasons, because it seeks to limit smokers rights, and as you have mentioned even goes against tobacco related products that can help smokers quit smoking.
We are also extremely worried about the tone this document takes, when it states that nicotine containing products exceeding 4 mg per ml should be accessed and controlled as medicinal products, and Mr Helmer will be unsupportive of this legislation in its current form.
However, we do fear that the UKIP vote is often outnumbered by those within the EU who continue to push for more overarching European regulation and ‘nanny-state’ policies that limit the freedom of choice of the individual. This is why UKIP have determined that the only way to stop the UK from being subjected to this kind of legislation is for the UK to take back control by opting out of the EU.
Stagiaire to Roger Helmer MEP
United Kingdom Independence Party │East Midlands Region, United Kingdom │European Parliament
From: Leo Wood [mailto:[email protected]]
Sent: 17 January 2013 17:51
To: HELMER Roger
Subject: Letter from your constituent Leo Wood
This message was also sent to: Glenis Willmott MEP, Emma McClarkin MEP,
Bill Newton Dunn MEP, Derek Clark MEP
Email: [email protected]
Thursday 17 January 2013
Dear Roger Helmer, Glenis Willmott, Emma McClarkin, Derek Clark and
Bill Newton Dunn,
The European Union has proposed legislation that would ban, or
effectively ban, nicotine products that people can (and do) use as much
less dangerous alternatives to smoking cigarettes – for example,
smokeless tobacco, e-cigarettes, vapour devices, or other novel ways of
taking nicotine that don’t involve burning tobacco. Although the risk
is reduced by 95-99% if there is no smoke.
I have unsucesfully tried to stop smoking for years, the e-cigarettes
are my only option
(Signed with an electronic signature in accordance with subsection 7(3)
of the Electronic Communications Act 2000.)
[ This message was sent by WriteToThem.com. If you have had any
problems receiving this message, please email [email protected]
and we’ll get back to you. See http://www.writetothem.com for more details
about the service. We have sent this email to
[email protected]; if this address is out of date please
email us so that we can update our records. ]
One thing is for certain they will ban e-cigarettes.
But I have no doubt that within a set period of time big pharma will announce they have developed a’safe’ e-cigarette and campaign for the ban to be lifted, and it will be.
BTW: This isn’t really an EU edict, it comes straight from the UN/WHO and it must not be forgot that the WHO receives big pharma funding.
It’s money & big business as usual, always, but always follow the money.
Thank you for writing and posting this important proposal.
I want to translate this into german and will forward and publish it in my blog to circulate widely.
If you have anything against the translation, pls send me an email.
Dear Rursus – I would be honoured – thanks. But my suggestion is that you use this selectively and create your own page for a German audience – rather than just a translation…
Dear Mr. Bates,
thank you for the permission!
Dr. Michael Siegel has given his permission to translate and publish the posts of his blog and spread the word, too.
So… I’ve already started a page with such content. The main page (http://rursus.de/) has only one link to an PDF containing “a fact-based elaboration about e-cig” which offers an accurate viewing based on scientific results (http://www.rursus.de/docs/Fakten_zur_eZigarette_1.0.pdf – german text).
Furthermore, there is a link to my blog (http://blog.rursus.de/), which revolves around tobacco and pharmac lobby (and especially the incomprehensible fight against e-cigarette!).
In response to queries about e-cigs, my (very large) employer has announced that it is treating e-cigarettes exactly the same as cigarettes, and refers employees to this from the BMA: http://bma.org.uk/working-for-change/improving-and-protecting-health/tobacco/e-cigarettes .
With such a response from the BMA, and the prospect of imminent action against e-cigs from the EU and MHRA, it strikes me that what’s needed is to persuade appropriate media (The Today Programme, Channel 4 News, The Guardian/Telegraph etc)that they are missing out on a big story. Ideally, we need a head-to-head debate between Clive and a representative from an organization that wants a clampdown on e-cigs.
Of course, we all need to act individually by contacting our MPs/MEPs, but we also need to get a genuine public debate going.
That BMA briefing is very poor – and it illustrates a ‘straw man’ tactic.
1. Define e-cigarettes as medicine
2. Not enough evidence to show these are effective medicines
3. Declare not fit to be classed as medicines
4. Draw alarming conclusions about ‘safety and efficacy’
I think the ASH briefing, which is more recent and reflects developing understanding is much better: ASH Briefing: E-cigarettes – January 2013.
I recently tried to contact Vivienne Nathanson regarding a misinformed argument that she made in the media, particularly with regard to her interpretation of research. Needless to say, they referred me only to the previous BMA briefing and refused to comment on the points I made (The current BMA brief was updated Jan 2013).
It does seem sad that (to paraphrase Jacob Sullum) they would have the victims of a shipwreck avoid the lifeboats as they hadn’t been fully tested and then give the advice to those already in the lifeboats that they should leave them and swim, as this was the approved survival method
I saw a piece today saying that the first TV ads for e-cigarettes are due to be aired soon (always assuming they’re cleared in the first place, of course). Assuming this creates a stir, this would also be an ideal opportunity to build up media interest and informed debate (on our side, that is). But we really need to get in first to reach the wider public, otherwise the debate risks being hijacked by the usual suspects, as we’ve seen already in some newspaper coverage.
Dear Sir, I have read all of the “undersigned” and at the end of it all is…THERE’S NO REVENUE IN AN E-CIG!…..YET!! yOU CARRY ON PAYING £6 FOR 20!
Every little helps I guess. Via WriteToThem.
FOR THE ATTENTION OF:
William (The Earl of) Dartmouth MEP
Trevor Colman MEP
Sir Graham Watson MEP
Ashley Fox MEP
Friday 8 February 2013
Dear Ashley Fox, Trevor Colman, William (The Earl of) Dartmouth and Sir Graham Watson,
Firstly, many thanks for taking the time to read this email. As a constituent in your arrea, I know yours are time-consuming and important jobs and I appreciate the time spent reading about my concerns.
I write regarding my concerns about the forthcoming vote on the EU Draft Tobacco Products Directive that is coming up in a few weeks and my fear that it could have a serious negative impact on the health of people like myself who have managed to quit smoking due to the possibility of extremely harsh, ill-thought out and unjustifiably severe legislation that may be imposed on e-cigarettes.
I am 38 years old and started smoking aged 17 due to serious stress. For over 15 years I’ve suffered from a severe anxiety disorder and for 7 years have suffered from acute diabetes. Throughout all of it I smoked, despite the severe health issues & my tight budget being unable to work. I tried counselling and other NRT-replacement prescribed products to no avail.
10 months ago, in desperation, I turned to E-cigarettes.
I haven’t smoked a cigarette since. My health is improving, my breathing is better, my fitness is better. My GPs are thrilled that, though I may not be nicotine-free, I’ve found a suubstitute that is 99% less harmful to me. I no longer smell or inflict the smell and smoke on others due to E-cigarettes exuding an odourless water vapour no more harmful then steam. They’re also 1/4 of the price meaning I’m no longer on the poverty line due to my habit.
Having read about the proposals, the effect this legislation would have on myself and the thousands (if not more) of people like me would be disasterous. A reduction in the amount of nicotine in these devices would render them useless and, with other NRT-replacement therapies ineffective and/or expensive, the possibility of having to go back to smoking tobacco is very real. As someone whose attempts to quit previosuly led to a severe worsening of his anxiety disorder, being without a harmless and necessary alternative would be impossible.
I find it hard to accept the sense in allowing actual cigarettes to be far more easily obtainable then an alternative that encourages people to be healthier to themselves & those around them.
Also…these are not medicinal. They are a consumer alternative. Please think before classifying them as such, burying them in medical regulations and making them unavailable to those who need them most.
I know there are concerns regarding the nicotine content too. A standard cartridge I use has 18mg nicotine. Nothing else. It lasts me 3 days. In that time, I would have smoked 30-40 normal cigarettes containing not only twice as much nicotine but also a huge amount of tar and other harmful chemicals and paid £10 to do so rather then approx £2.
And remember…I am an addict. this is not something I can choose not to do at the moment. Believe me, like many other ex-smokers, I’ve tried.
I know some view these things with suspicion. They ‘look’ like cigarettes, they expel a ‘smoke-like’ vapour. Please, I ask you to just look into the feedback of scientists and the respectable medical profession. Banning these or burying them will simply force more people back to smoking and ultimately cause an incredible amount of harm to people. Also anti-smoking group ASH approve of e-cigarettes as an alternative and have no issue with them.
I ask you to not support an EU directive that removes most or all e-cigarettes from the EU market and to please see this Bill amended before people like myself are left to pay for it both financially and in terms of our own health.
For more info, I’d ask you to read http://clivebates.com/?p=739 but, for now, I simply thank you for reading this and hope you will represent me and other constituents fairly and with our best interests at heart in this matter.
Matt – that’s a terrific letter. Personal, original, authentic and with a great mix of asks…
Thanks Clive. Took your advice and spoke from the heart. First response from my Conservative MP today, and a positive one:
Dear Mr Drew
Thank you for your email regarding the Tobacco Directive. I do appreciate the concerns that you have raised, and may I commend your efforts in stopping smoking.
I am aware that the European Commission would like to extend the scope of the Tobacco Directive to new products such as electronic cigarettes. According to their proposal, nicotine containing products below a certain nicotine threshold would be permitted on the market providing they had health warnings, but products above this threshold must be authorised as medicinal products before they can be placed on the market.
The nicotine threshold would appear to be insufficient for smokers like you who want to stop smoking, and it will likely be expensive for manufacturers to apply for a licence to manufacture medicinal products. Given the potential of e-cigarettes to improve human health, and the lack of appeal of these products to non-smokers and children, it would seem that the Commissions proposals are ill-judged.
My Conservative colleague, Martin Callanan MEP, is leading on the scrutiny of this piece of legislation for our delegation in the European Parliament and will ensure that your arguments are put forward.
I only reacently found this blog (excellent work Clive, thank you), and decided to write to my MEPs:
8th February 2013
Dear Malcolm Harbour, Mike Nattrass, Anthea McIntyre, Philip Bradbourn OBE, Michael Cashman, Nicole Sinclaire and Phil Bennion,
I’m writing regarding the EU draft Tobacco Products Directive which was published late last year. I would like to express my concerns over its negative implications for e-cigarettes.
I have been a traditional smoker for around 30 years. I have always quite enjoyed smoking, but have had real fears about its negative effects on my health and the health of those around me. I have tried to quit the habit a few times over that period, but had failed.
In November last year I took up e-cigarettes and stopped smoking traditional cigarettes. Initially I was very sceptical that e-cigs would be an adequate replacement for traditional cigarettes, but I’m very pleased to say that I haven’t smoked a traditional cigarette since. Nor do I want to. By using e-cigs the nicotine addiction is satisfied. I am now to all intents and purposes, a non-smoker, and I’m reaping those benefits while suffering none of the ills of nicotine withdrawal.
Before I took up the e-cig, I did some research to satisfy myself that e-cigs were safer and less harmful than cigarettes, which they certainly are. At worst e-cigs are 95%-99% less harmful to the user than cigarettes, and they have no harmful effects what-so-ever on people around the user. In essence e-cigs deliver nicotine and emit water vapour.
One of the unforeseen and pleasantly surprising things with the brand of e-cig that I use is that the liquid you buy that contains the nicotine comes in many different flavours! You can also buy different levels of nicotine strength, with 11-18mg per ml nicotine being the widely accepted equivalent of traditional cigarettes.
The EU directive sets out to harm e-cig use in a number of ways. The particular points that I am concerned about are:
1. It seeks to treat e-cigs as medicine: The problem with this is that treated as medicine and therefore to ask product manufacturers to show benefits and out-comes as a cessation aid, is not why I’m using e-cigs. They are not a means of quitting smoking; they are an alternative to smoking. Pure nicotine is thought to be about as harmful as caffeine. Smoking traditional cigarettes delivers that same nicotine as well as around 4000 other toxins, carcinogens and chemicals.
Medical regulation could mean that e-cigs are taken off the market until they can gain approval. The reason I use e-cigs is not to end my nicotine addiction, but to satisfy it in the least harmful way. I think we should be encouraging smokers to switch to e-cigs.
2. In order for an e-cig to escape medical regulation it must deliver no more than 4mg per ml of liquid: This is nowhere near the nicotine strength necessary to replace the traditional cigarette. This would mean that people like me would be left with the option of either black market suppliers or a return to tobacco. Neither of which is appealing or beneficial to anyone.
E-cig use, the delivery products and liquids certainly need regulation to ensure safety, but to attempt to make them completely harmless is to miss the point. They are an alternative to the already legal, widely used and extremely harmful tobacco cigarette. Even if e-cigs were only 10% less harmful than tobacco they would be a better alternative…
Thank you very much for taking the time to read this and I hope that you will be doing all you can to keep me and many other satisfied e-cig users, leading infinitely more healthy lives.
I’ve so far had two replies. One was identical to thistle2 above but from Michael Cashman Labour MEP. The other is below from Philip Bradbourn Conservative MEP.
Dear Mr. Griffiths,
Please note that I also respond on behalf of Malcolm Harbour MEP and Anthea McIntyre MEP as I take responsibility for all constituency enquiries from your area.
Based on your correspondence I have made further enquiries and I have received the following information on this issue:
I can confirm that there are no plans to directly ban e cigarettes at an EU level. Instead e cigarettes, which are above the threshold of 2mg of nicotine, are going to be re-classified as cessation medical products rather than tobacco products and therefore they will be covered by Medical Device legislation which is also under consideration by the EU institutions rather than being encompassed with the revision of the Tobacco Products Directive that you referenced.
It should be clear that although this reclassification will not ban e-cigarettes. It will necessitate a prolonged period of research, and require many more complex certification standards to be reached in order allow sales in a number of outlets . Furthermore, since they will be viewed as medical products it is likely that they will not be as widely available in everyday retail stores and instead they will probably have restrictions to which points of sale they can appear.
Thank you again for your email.
Philip Bradbourn OBE MEP
Several of the responses from MEPs point out that the directive would not actually ban e-cigarettes explicitly. This is true and we never said it would. But it misses the point – it may have the same effect, or otherwise limit the products available, drive out many existing suppliers, restrict flavours and personalisation, and raise costs. It’s a gift to the tobacco and pharma industries for which this is a powerful new competitor.
People who have written to their MEPs and had these well-intentioned but unsatisfactory replies should write back pointing out that the 4mg/ml threshold is too low to be meaningful for most e-cig users. Emphasis that the main issue is applying extremely burdensome medicines regulation to everything above the threshold. These are consumer products with very low risk and huge health and wellbeing benefits to their users. Why treat them like medicines and smother them with red tape, compliance costs and marketing and design restrictions?
I have since written about this in much more detail: Medicines regulation for e-cigarettes – when caution can kill
Great! And I miss the best argument: Nicotine alone is not addictive! Only tobacco is addictive due to its cocktail of nicotine PLUS MAOI. The proof for my statement is on any package insert of Nicorette products like patches, gums, inhalers amd so on.
Nicotine is not addictive. Vapers never miss nicotine, they miss MAOIs.
So, are you saying that the e-liquid vapers use also contains MAOI’s?
If so, I think you make a good point. If not, I’m afraid that I am addicted to nicotine not MAOI’s.
Dave what you have, what we all have is a dependence on nicotine not an addiction to it, there’s a subtle yet often blurred distinction.
Now that the hearing is past us, what can people do to take action… or is writing to MPs and MEPs still usefull?
I read the post by Matt Guggler and I am quite worried and I would like to do something.
Thanks for your advice,
Yes – keep writing. Follow up with new letters, pick up any disagreements you have ask for more assurances… I’ll do a new post soon on what is going on.
Hmmm… okay you see this directive ‘would’ affect e-cigs if the oil induced an increased blood plasma level of nicotine above 4mg. And there have in fact been studies into this by no less than the American Association for Cancer Research.
As it turns out in their studies no participant in the study had any increase in nicotine in blood plasma at all… none. Not 1mg, not even 0.5mg…none whatsoever above the background noise…which is tiny.
Certainly nowhere near 4mg.
So this directive is a smokescreen, just go on selling the e-cigs, there’s no increase in nicotine in blood plasma, so e-cigs don’t count. That is not an opinion either its actaully been demonstrated (see below), so this directive has no effect on sales of oil or e-cigs.
The first person to have their import of oil stopped would result in that person stating this, with scientific backup and with no evidence to the contrary, becasue its not possible for nicotine to cross into the bloodstream using this oil as a base with no combustion.
Only products which indice an increase of nicotine in blood plasma are covered like gum and patches and of course cigarettes (you’d imagine cigarettes would be top of the list, but I think cigarette and other tobacco products get a free pass, even though they certainly DO increase nicotine in blood plasma above 4mg per ml)
I draw your attention to “A Clinical Laboratory Model for Evaluating the Acute Effects of Electronic “Cigarettes”: Nicotine Delivery Profile and Cardiovascular and Subjective Effects” by Andrea R. Vansickel, Caroline O. Cobb, Michael F. Weaver, et al. 2010
I have a fully copy of it, and read it. The science is pretty clear on this too.
That’s because they used smokers unfamiliar with e cig use.
I wrote the following letter to everyone that, I could, and so far have had only one reply.
Dear Nigel Farage,
I am writing to you today in reference to the proposed new EU laws
controlling tobacco and nicotine products. Whilst I agree that smoking
is a major issue, not just in the UK, but worldwide, I do think that
the proposed laws will do more harm than good, as they place far too
many restrictions on the sale and use of electronic cigarettes. If the
new laws come to pass, then electronic cigarettes will be placed under
the highly restrictive regulation regime used for medical products, and
this will in turn have devastating consequences for anyone who, like
myself, relies on electronic cigarettes as a method to cut down on
traditional tobacco use.
It will amount to an effective ban if regulators demand impossibly high
standards of proof. It will also mean that it will not be possible to
buy as these products could be off the market for years as manufactures
struggle to get the necessary marketing authorisation from regulators.
It will also impede competition in the electronic cigarette market, as
it is likely that only the larger companies, mostly owned by large
multinational tobacco companies, will be able to afford to get their
products authorised. This will mean the end of some fantastic small
businesses, and have a negative effect on the economy.
But the worst thing about this is is that, in this day and age where we
are always being told about the dangers of smoking, one of the most
successful ways of quitting will be banned. I know of many people
personally, as well as myself, who have been able to quit smoking using
electronic cigarettes. Whilst I know that there are other products out
there that can also help, such as nicotine patches and gum, I simply
cannot get by with these. Should there be a ban on electronic
cigarettes, I fear that many people, myself included, will find it hard
to resist smoking again. For many people it is not just the nicotine
that they crave, but the whole act of smoking, such as having something
to do with their hands, or the excuse for a break at work. It has been
shown that nicotine on its own is a safe drug, that can stimulate the
mind and calm the nerves.
I agree that more studies need to take place into the long term effects
of electronic cigarettes, and there should be regulation in place. At
the moment, they are not subject to any age restriction or minimum
quality control. But the proposed laws are not the way to go about
I would like to thank you for your time, and I hope that you are able
Dear Mr. Cox
Thank you for your email outlining your concerns with the EU draft
Directive on tobacco and smoking. UKIP, being strongly libertarian,
agrees with your personal rights to take tobacco and the like for
whatever personal pleasure you take from it. We believe that the EU
should have no jurisdiction over us either as persons or as the United
Kingdom in these matters, and that we are entirely able to take these
decisions for ourselves as responsible individuals and as an independent
nation. We will certainly oppose this legislation at all levels, from
votes in committee, speeches as opportunity arises, meetings with
industry lobbyists (BAT are in contact with us), and final votes in the
In a more rear-guard manner, it may also be possible for UKIP to put
down amendments to the legislation to water it down in progress, or
loosen the limits for such things as milligrams allowed for OTC sales.
Unfortunately, our chances of success in these votes and amendments are
small as the three old parties all vote against us and in line with the
EU band-wagon. The EU is entirely against personal liberty and freedom,
and certainly wishes you to be forced to be healthy in the way it
decides for you, which is for your own good, in their view. Of course,
eventually the EU will see fit to ban all tobacco, let alone other
nicotine products, so then only the black market will exist, much as
things went in the USSR and Red China.
As a further fall-back position it may be useful to prepare yourself for
the worst with research into non-EU controlled sources of nicotine fluid
and the like which may spring up in a free market response to the EU Big
Brother-Big Nanny State approach to these things, or even be available
now. The UK alone does an excellent job of regulating such things, and
the EU intrusion is as unnecessary as it is unwelcome.
Please support UKIP by voting thoughtfully in all available situations,
we are the only party fighting the EU on these and all other aspects of
being ruled by unelected bureaucrats in Brussels. As you did not elect
them you cannot vote them out, withdrawal is the only way.
Office of Nigel Farage, Brussels
I don’t speak english very well, I’m brazilian and my native language is portuguese, so I will write my considerations using my native language. I hope all of you can understand me, case not try to use google translator.
1. Eu tenho hoje 47 anos de idade, comecei a fumar tardiamente, por volta dos 30 anos de idade, logo, sou fumante há aproximadamente 17 anos. Fumante do Marlboro durante todos esses anos, acumulei sem dúvida uma série de doenças aparentes e outras que nem ouso descobrir, mas com certeza estão dentro de mim esperando o momento oportuno de se manifestar.
2. Doenças visíveis: ao longos desses anos como fumante estraguei meus dentes, devo gastar por volta de R$ 7.000,00 para ter meus dentes de volta consertados, ou cerca de 2,500 euros para ter um sorriso bonito novamente; não sinto mais o cheiro das coisas; tenho cansaço para realizar atividades físicas; estou com pressão arterial elevada, sendo obrigado a fazer uso contínuo e diário de medicamentos para controlar a pressão arterial; impaciente; ansiedade; irritabilidade, entre outros são sintomas pela falta de nicotina e o hábito de fumar.
3. A cerca de um ano atrás tomei ciência do cigarro eletrônico. Busquei informações na internet, li e re-li vários sites, assisti vários reviews, ponderei a opinião de várias pessoas, pesquisei sobre inúmeros produtos para ver se realmente valeria a pena investir qualquer quantia de dinheiro para parar de fumar.
4. Fiz meu cadastro em um site inglês: the totally wicked, fiz até o cadastro para ser revendedor, porém eu meu país não é permitido a comercialização e a alfândega impôs restrições ao comércio e divulgação do e-cig. Logo todo o comércio aqui se faz através de fronteiras livres de produtos oriundos da China via Paraguai.
5. Há 20 dias atrás consegui em meu país, Brasil, através da internet comprar meu primeiro e-cig. A satisfação foi imediata, consegui ficar sem fumar o meu Marlboro. O prazer que sinto em fumar foi substituído de imediato pelo e-cig. Investi mais alguns trocados e comprei e-liquids para continuar a fumar o e-cig largando de vez o cigarro convencional. Comprei e-liquids de vários teores de nicotina e sabores diferentes. Atualmente sinto que a minha saciedade para largar o vício é utilizando e-liquids com composição de 18mg/ml.
6. Feliz da vida em ter conseguido largar definitivamente o maldito vício de fumar, investi mais alguns trocados e comprei mais produtos, e-cig, e-liquid, cartomizador, claromizador, rebuildables, voltagem variável, tudo em busca de manter o prazer e a saciedade da falta do cigarro: veja são mais de 4,700 substâncias que fazem mal a saúde e que viciam. Sempre me pergunto: onde está a lista de cada uma destas substâncias e quais males que fazem ao meu organismo? Por que fazem parte do cigarro? Enfim.
7. Hoje me sinto, apenas 20 dias sem cigarro, mas, me sinto feliz, livre do vício, respirando melhor, melhor humorado, menos ansioso, voltei a sentir o cheiro de tudo, estou encorajado a arrumar meus dentes por que sei que vou investir mais de 2,500 euros e não irão estragar novamente, mais disposto fisicamente, as pessoas notaram por si só que parei de fumar por que não sentem o mau cheiro do cigarro em minha roupa, meus filhos e minha esposa estão felizes por ter largado o cigarro.
8. Meus caros amigos, vapers, e todos os fabricantes que se empenharam em cada vez mais fazer e divulgar melhores produtos: e-cig e acessórios, e-liquids, sabores e teores. Agradeço por de fato ter parado de fumar e pela vida melhor que estou experimentando agora.
9. Faço um apelo: não proíbam a fabricação nem a divulgação, pois sei por experiência própria o quão bom está sendo para mim trocar o cigarro pelo e-cig.
10. Um ponto forte que vejo também: meus hábitos de fumar pela manhã; após as refeições; durante o consumo de café; em trânsito; etc. tem diminuído muito; estou conseguindo ficar horas sem vaporar e sem ficar ansioso pela falta de cigarro.
11. Avaliem com carinho e cuidado as decisões que forem tomar. Ponderem os prós e contras.
12. Que Deus ilumine o coração e a mente dos MP e MEPs que tomarão a decisão sobre a lei para controlar, inibir, ou o que seja, do e-cig e demais produtos relacionados.
Obrigado a todos pelo espaço de poder falar, e peço desculpas de não dominar o idioma inglês para poder expressar meus pensamentos.
I do not think that they should stop anyone who supplies the electronic cigarettes because I know people who have used these and it has helped them to stop smoking. It has helped me to stop smoking and if the government ban this altogether then they will start smoking again and so will I. I have a range of health problems and this has helped me to improve my health drastically.
It is the customers who buy these to help them stay in business. I think the government should not stop these changeselectronic cigarette
It is up to the individual if they want to buy these to help them stop smoking.Why s they the businesses and the wholesalers be affected
I have been heck loads healthier on these ecigs. I got a PHD doctor in portland oregon to back that up solid. these people trying to do this are nothing but judgemental power hungry over judgemental jerk weeds with nothing better to do. Worried about their minds a change that might bug them out oh my big deal. Because there so used to the world the way it is we the people have to pay a price for their limited creative imagination they have. Because they can’t form a healthy accepted picture of this being ecigs being a part of the future. They might have power now but the true form of justice honore and good along with respect will one day be victory for all us amercans who are survivors of these poor non legitimate and emotional based decisions that are made. These old folks who should be retired not making decisions based on their judegmental limited mind abiltiies. Put the educated imaginative well though out young adults in their position with good fresh thinking working minds. Not old and getting broken down.
oops sorry for the minor spelling mistakes just caught on to. Though computer would correct mistakes made.
I go to see each day some websites and sites
to read content, however this weblog offers feature based posts.
ive contacted all mp’s and mep’s only had this reply as of yet but just to share my response.
Thank you for your email about e-cigarettes.
The European Parliament and Labour MEPs are in no way attempting to ban e-cigarettes. We want products on the market that can help people give up smoking. However, these products must be properly regulated to ensure that they are safe.
The European Commission has proposed that all ‘nicotine containing products’ with more than 2mg per unit should not be classed as tobacco products. Instead, under the Commission’s proposals, nearly all e-cigarettes will need to get authorisation as a pharmaceutical product, in the same way as nicotine patches, sprays and gums.
The European Parliament has only just started to scrutinise this draft legislation and discussions on e-cigarettes and related issues have only just begun. MEPs will be looking carefully at all the issues to do with e-cigarettes to ensure that they are safe, properly labelled and function as they should.
Thank you for taking the time to contact me on this important matter.
Derek Vaughan MEP
OK I’ve used the service and posted to my MEP – I’ve also told him that I will be visiting him in person should this not work out for us.
Fucking rediculous that this should come up and shows just how bent out political class are.
I’ve stopped smoking shame everyone else around me doesn’t try e-ciggs too.
Me and my wife went on to e.n.i (ecigs)about a year ago since then have not brought not even one packet of cigs ecigs have not shown any signs of harm nor do they stink the house out ect the point is why try and ban them i feel and sure alot of other people who vape feel so much better for it YOU BAN THE REAL CIGS AS THEY KILL PEOPLE
Writing to odious Nick Griffin as my MEP was a strange task, but I’ve done it. These products have changed my life for the better. I’m aghast at these proposed laws.
thanks for all the advice! e-cigarettes have been a major improvement in my lifestyle, for interest here is the letter i sent, no politics talking just the improvements to my life, and my horror at the proposal!!
I am writing to you concerning the EU proposal for new laws controlling tobacco and nicotine products like e-cigarettes.
At the beginning of this year I purchased an “e-cigarette” as a replacement for tobacco burning cigarettes!
As well as, i am sure, the risk to my health is lessened, i find “VAPING” a much more socially acceptable method of tobacco usage, I dont cough as much, I can breathe a lot better, I dont spread second hand smoke to my 10 granchildren, or anyone! and I dont get smelly clothes!
I enjoy Vaping and have not had a cigarette since i bought my e-cigarette but i can still enjoy the tobacco, in as it is a much safer delivery system, and i can cut down the amount of nicotine,until eventually no nicotine whatever.
My experience is that a lot of what a smoker does is down to habit!, make a coffee, light a cigarette!, get in the car light a cigarette! eat a meal finish with a cigarette! however with my e-cigarette that habit is not a problem, and the flavours make the experience a lot more enjoyable!! The loss of use of these products would be a bad thing for me, as I do not want to restart using conventional fire burning cigarettes, with all their obvious possible dangers to my health
I would ask you to make my views known in the appropriate ways and would ask if you could contact me with your views on this and your intentions regarding the upcoming proposals?
No matter if some one searches for his necessary thing, so
he/she wants to be available that in detail, therefore that thing is maintained over here.
Leave the people to decide for what is best for them!!!
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