Clive Bates - EU draft Tobacco Products Directive: who to write to and what to say (a short guide)

[Bill Godshall]

Clive Bates - EU draft tobacco Products Directive: who to write to and what to say (a short guide)
EU draft Tobacco Products Directive: who to write to and what to say (a short guide) « Clive Bates blog


[h=1]EU draft tobacco Products Directive: who to write to and what to say (a short guide)[/h]
[h=2]1. What has happened?[/h]On 19th December 2012, the EU produced a 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 make it harder or impossible for smokers to switch from cigarettes to much less dangerous nicotine products – an approach that will cause much 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 and 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 article on the directive here.

[h=2]2. Why do you need to act?[/h]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
[h=2]3. What are they doing? [/h]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.
Why ban these products when they have been so successful at reducing harm in Sweden?
2. Treats e-cigarettes as though they are medicines – effectively 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 – 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 in 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
• 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 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?

3. Prevents any claim that one tobacco product is less harmful than another. The trouble is that the truth is that smokeless tobacco products may be many times less harmful than cigarettes, perhaps 20-100 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 information – who benefits from it?
[h=2]4. Does it matter?[/h]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 (about 100,000 and £3.7 billion for the UK). Quit rates remain stubbornly low despite years of effort and drug development – and 28% of European adults still smoke (about 21% in the UK) despite almost universal knowledge of the dangers. 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 can be found people will use them 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.
[h=2]5. What to do: write to your MP and MEPs[/h]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, 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.

[h=3]Some tips on writing to MPs and MEPs[/h]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
European Parliament
Rue Wiertz
B-1047 Brussels
Belgium
​

[h=2]6. What to say[/h]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.
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.
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.
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. [members of the ENVI committee] or consult my more detailed guide on how this will all work.
​

[h=2]7. What else?[/h]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.

 

[Bill Godshall]

I strongly urge e-cigarette companies and consumers in the EU to follow Clive's excellent advice to keep e-cigarettes legally accessible throughout Europe.

 

[Gamekeeper]

THANK YOU!

A very helpful post that I will certainly use to contact my MP and MEP.

 

[sebt]

Great guide! I actually only came across it after looking through other related materials, and composing an email to all my MEPs (all the Scottish ones). We've got to stop this!

Here's my email:



Dear [MEP]

I am very concerned about the proposed change to the EU Tobacco Directive, and its potential effect on the legality and availability of electronic cigarettes and the nicotine-containing liquid (e-liquid) used in them. I believe that the inclusion of e-liquid in this directive would be thoroughly misguided, rests on unsound conflations rather than scientific fact, and will result in worse health outcomes.

My interest and concern arise from the great benefit I've gained from using e-cigarettes. I smoked heavily (c.20-30 per day) from the age of 17, up until February 2012, when I was 40. This 23-year addiction to cigarettes ceased overnight when I started using an electronic cigarette. Thanks to e-cigarettes, I'm now enjoying the immediate health benefits of stopping smoking, as well as the knowledge that I'm improving my future health prospects (or, at the very least, not worsening them). Best of all is the knowledge that, unlike the vast majority of smokers who stop smoking or try to stop smoking, I am now a non-smoker for good. As long as e-cigarettes are available, I can't imagine ever smoking again, or even wanting to.

Like many users of these devices, I refer to what I do not as "smoking" or "e-smoking" but as "vaping". This is not an empty affectation. It reflects the fact that these devices do not produce smoke, but vapour. Likewise, the preferred term "personal vapouriser" for the equipment - more accurate than "electronic cigarette" - reflects the fact that the only thing these devices have in common with cigarettes is that they deliver nicotine by inhalation. No combustion products are produced, as the temperatures reached by the vapouriser are far below combustion temperatures; thus, unlike cigarettes, the relation between what is in the product and what gets inhaled is far simpler (close to, if not actually at, identity). The possible adverse health effects of vaping are thus identical to the effects of nicotine (since the glycol propellant is proven to be have a neutral or even mildly beneficial effect).

Vaping is not smoking. Vapourisation is not combustion. Nicotine is only one out of the 4,000 chemicals that smokers inhale. Taken on its own, it is far less harmful than smoking (though zealots love to conflate nicotine consumption and smoking). It has some beneficial effects, such as that on ulcerative colitis (1), to which I can testify as a sufferer.

And e-liquid is not a tobacco product. Unlike a smoker, who would complain loudly if his cigarettes were made of something other than tobacco, I couldn't care less where the nicotine in my e-liquid comes from. For all I know it might be synthesised, or extracted from eggplant or tomatoes.

It thus makes no sense for e-liquid to be included in an EU directive on tobacco products. But I get the impression that the real, significant differences between smoking and vaping, and between cigarettes and personal vapourisers, have not even been considered by the drafters of this amendment to the directive.

"Given the novelty and rapid increase of the NCP [nicotine-containing-product] market as well as their addictive and toxic character there is an urgency to act, before more people – unaware of the content and effects of these products – inadvertently develop a nicotine addiction." (2)

This supposed justification bear little relation to the facts. The picture being painted is of people falling prey, from a state of non-addiction, to a toxic addiction to e-cigarettes. But, in fact, electronic cigarettes are not marketed to, nor used by by people who have never smoked: they are used by smokers and ex-smokers, to replace or reduce a far more toxic addiction. And the EU proposal does nothing to state, evaluate and weigh up the actual toxicity and addictiveness of e-cigarettes: it simply asserts it, and rhetorically "establishes" it by association with cigarettes.

Another image conjured up by the text quoted above is of ignorant, vulnerable consumers being tricked into using e-cigarettes, unaware of their true nature. This too is a caricature. Suppliers do not sell to people under 18. There is a culture of responsibility in the independent suppliers - the ones I use have clear statements on their website that e-cigarettes contain nicotine, which is toxic. There is an active community of vapers, informing each other about their experiences, including discussion of undesired side-effects (3).

The attempt to classify e-liquid as a pharmaceutical product - by assertion - is equally unjustified. For a start, the criterion proposed makes no sense:

"The proposal stipulates that NCP that either have a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance. NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adapted health warning. The nicotine threshold identified in this proposal has been established by considering the nicotine content of medicinal products (Nicotine Replacement Therapies, NRTs) for smoking cessation which have already received a market authorisation under the medicinal products' legislation." (2)

Controlling products according to the volume of nicotine is clearly nonsensical. A limit of 2mg per what? Per drop? Per bottle? Per pack of bottles? Per purchase? Nicotine concentration is a slightly better measure; but the figure of 4mg/mL has clearly been plucked out of the air for the purpose of legislative convenience - or laziness. To classify a wide variety of products according to their concentration of nicotine, for the purposes of public health, is utterly unscientific, as it takes no account of the differing proportion of the nicotine that is actually absorbed into the body from different products. To illustrate: you might enjoy drinking a dram containing 45% alcohol - but you wouldn't inject it.

Finally, in the criterion of actually effects (>4ng/mL nicotine level in plasma), we have at least a coherent criterion. But not a reasonable one. By this criterion, cigarettes themselves should also be subject to pharmaceutical licensing as beneficial, demonstrating safety and a positive risk/benefit balance. The absurdity of applying this onerous standard to vaping products - which, prima facie at least, are far less harmful than cigarettes - but not to cigarettes themselves, is beyond my ability to describe.

It would be far more sensible to refer to studies on the actual health effects experienced by vapers (many of whom use use 18mg/mL, or even 36mg/mL liquid) - or, if such studies don't exist, to commission them.

A case might then be made for controlling or banning e-liquid, or e-liquid over a certain strength, on a scientifically founded basis, resting on actual, identified harmful effects. First of all, the harmful effects would have to be significant enough to justify legal interference in the freedom of individual to consume what they like. But even given this, the case would still have to meet and overcome a strong harm-reduction argument.

Any harmful effects of e-smoking would be discovered by comparing the vaper group to a group who neither smoke nor vape. But - and this is the principle of harm reduction - even such proven, adverse health effects cannot be decisive in mandating legal control or proscription: the health of the vaper group, relative to their probable health had they continued smoking (rather than relative to the non-smoker non-vaper group) would have to be put in the balance on the other side. Even if e-cigarettes were very bad for you, the fact that they're far less bad than cigarettes, and are used instead of cigarettes by countless smokers and ex-smokers, is surely something to be taken into account.

Without hard data on the harmful nature of e-cigarettes or e-liquid, or evidence that they're being marketed through false claims of medical effectiveness (for instance, that they cure lung cancer), there is no basis for treating them as pharmaceutical products. It's unnecessary to do this, when the adverse effects include:

a) Killing off the thriving market in e-liquids, safely used by thousands of people, provided by a large number of independent suppliers (who all employ staff);
b) Concentrating the supply in the hands of large pharmaceutical companies, who alone can afford to underwrite the costs of the licensing process. It's thus an anti-competitive measure, needing strong justification;
c) Possibly making e-liquids unavailable for some time, given how long it takes to license a pharmaceutical; many vapers (myself included) might well return to smoking;
d) Increasing the cost of e-liquid, through decreased competition and the need to include the cost of licensing into the price. The lower cost of vaping when compared to smoking is a strong factor encouraging smokers to switch, and to stick to vaping;
e) Normalising a status of "controlled/suspect substance" for e-liquid, without anything more than rhetorical justification, making it more likely for taxes to be raised on it - which again, would make it less likely to be used by smokers as an aid to giving up smoking.

I strongly suspect that the major effect of this directive would not be to promote public health, but to facilitate the capture and control of the market in e-liquids by pharmaceutical: an attempt at regulatory capture dressed up as a public-health issue (4). The lack of disciplined argument justifying the measure, and the absurdity of the arguments that are presented, strongly encourages this view.

I hope I have shown that, when properly considered, the facts of the matter cannot possibly justify the measures proposed in the amendment to the EU directive. In its provisions regarding e-cigarettes, the amendment is misguided. The EU could play a positive role in relation regard to e-cigarettes - for instance by harmonising laws preventing sale to minors; by encouraging high-quality production; by encouraging research into improving e-cigarettes, or even by encouraging European production (most e-cigarette equipment is currently imported from China). But this directive is not useful.

I urge you to use your voice in the European Parliament, in any committees, and in contacts with members of the UK and Scottish parliaments, to remove electronic cigarettes and liquid from the scope of the EU Tobacco Products Directive. They are not tobacco products. They are not cigarettes. Neither are they pharmaceutical products. If legislators are concerned about the safety of these products, they'd do well to start by investigating them as they really are: recreational products, with possible health effects (minor by comparision with smoking), and with proven effectiveness in tobacco harm-reduction.


Yours sincerely,



[name and address]

References:
(1) Nature Clinical Practice Gastroenterology & Hepatology | Mechanisms of Disease: nicotine[mdash]a review of its actions in the context of gastrointestinal disease | Article
(2) http://ec.europa.eu/health/tobacco/docs/com_2012_788_en.pdf
(3) Health and Medical Issues
(4) http://www.e-cigarette-forum.com/fo...sition-e-cigarettes-health-risk-analysis.html
(5) EUROPA - PRESS RELEASES - Press Release - Speech - Tobacco Products Directive: Making tobacco products and smoking less attractive

Further information:
ECCA UK - E-Cigarette Consumer Association of the UK