The road to hell is paved with good intentions …and amendment 1250

Noto1250

Graphic with thanks to the team at Vapour Trails TV

Updated: 29 May.

It has to be asked… Is Linda McAvan MEP, European Parliament rapporteur for the Tobacco Products Directive, in an unholy alliance with the tobacco industry?  Judging by amendment 1250, she might as well be.   

MEPs on her committee will look at amendments to the directive this week, and these include her amendment on e-cig regulation (number 1250), that takes the many provisions of medicines regulation out of the medicines directive and just pastes them into the tobacco products directive.  It is supposed to be a ‘simplified procedure’ but as we shall see, it is really juts more costs, burdens and restrictions on e-cig makers  that don’t apply to cigarettes.   So… say no to 1250

At the European Parliament hearing on e-cigarettes on 7 May, the ENVI committee rapporteur, Linda McAvan MEP expressed dismay that there are people who apparently think she is doing the dirty work of Big Tobacco (see the video below at 1’07).

She laments:

…I’ve read lots of things…  that we have an unholy alliance between myself and the tobacco industry.  Anyone who knows me might think twice about that comment …and also the pharmaceutical industry.

Let me say for the avoidance of all doubt or ambiguity, I absolutely do not believe Ms McAvan is in any sort of alliance with Big Tobacco or Big Pharma.    It just looks that way…. 

To see why a neutral observer may easily draw this conclusion, let us walk through the proposed amendments to the Commission’s proposal for regulating e-cigarettes (Article 18) and look at the key one on e-cigs she has put forward, number 1250.   Her proposed amendment to Article 18 are here (in MS Word format) is mostly contained in amendment 1250, a proposal for a simplified authorisation procedure. I have taken this and done a ‘side-by-side’ commentary below – looking at how well conceived they are, and what they do for the cigarette industry (noted in red).

Rapporteur’s Amendment 1250

Commentary: the Counterfactual

Article 18 a

 

Nicotine-containing products

Before a detailed critique, I must welcome the implicit rejection of the Commission’s version of Article 18 that this represents – with its strange thresholds and default medicines regulation for every form of e-cigarette that is a meaningful substitute for smoking. This is a good development in itself. It just needs to be taken through to its logical conclusion. 
1. Nicotine-containing products may only be placed on the market if they are authorised pursuant to: Unlike for cigarettes (and alcohol or caffeine), this defaults to a prohibition, subject to authorisation. All the other products have to do is comply with clearly transparent standards and they can enter the market at will.  This presents a greater barrier for e-cigarettes than for cigarettes. A win for the cigarette industry. 
(a) Directive 2001/83/EC, or This appears to leaves it open to medicines regulators or member states to classify e-cigs as medicines.  Any reference to the medicines directive (2001/83/EC) should clarify that this directive applies if, and only if, a therapeutic claim consistent with the definition of a medicine is made (ie. for treating or preventing disease). Preventing inappropriate misclassification of e-cigarettes as medicines would actually be a credible harmonising measure consistent with development of the internal market. Allowing multiple regulatory regimes to proliferate would not be. E-cigarette businesses are therefore facing arbitrary unpredictable regulation, whereas the cigarette makers know exactly what they have to do (…and that is not much). 
(b) The simplified procedure as set out in paragraph 2 and 3. At first glance, this looks like an improvement, but in fact the simplified procedure still contains many of the undesirable aspects of medicines regulation – only spelt out rather than just contained in the medicines directive. In practice there would be little difference between the burdens of the two options. Classifying these products as medicines explicitly (a) or by stealth (b) when they are actually consumer products, simply holds back innovation, diversity, and competitive edge and so, compared to the alternative, it impairs competitiveness with cigarette makers.
Simplified procedure It may be simplified but it isn’t simple. It is significantly more burdensome than bringing a new cigarette brand or novel tobacco product to market.
2. Under the simplified procedure, Member States shall require manufacturers and importers of nicotine-containing products to submit an application for a marketing authorisation, which shall contain the following: The ‘simplified procedure’ specifies requirements for making an application. But it does not specify the criteria that must be applied to allow or disallow authorisation – ie. what are the regulators looking for when they authorise or do not authorise a product?  The problem with that is that different criteria in different member states work against the operation of the internal market. More generally, this serious omission reflects the difficulty and undesirability of trying to design a credible regulatory regime on the hoof using an amendment. Regulation of such an important class of products needs a good policy-making effort – with proper problem definition, analysis of the market, options generation, consultation, options appraisal, impact assessment, costs, benefits, risks etc. This creates a regulatory and political risk for e-cigarette makers – it therefore raises costs and potentially deters investment. In doing so aids the cigarette industry.   
a) Evidence that the product is manufactured in accordance with the principles and guidelines of Good Manufacturing Practice; This is a costly and unnecessary application of a concept designed for medicines regulation. The ‘principles and guidelines’ are anything but simple – see directive 2003/94/EC  and related GMP Guidelines. Note these apply to medicinal products imported into the EU – so would require the current Chinese e-cigarette suppliers to meet this standard and be able to prove it.   These standards do not apply to manufacturers of cigarettes – which of course generate their own massive ‘contamination’ through burning tobacco at the point of use.  A much lighter touch – and far more appropriate approach – is to use the EU’s standard-setting power (see Regulation 1025/2012) used for food and beverages. This sets standards for contaminants in food (see European Commission guide: Food contaminants). It is important to recall that regulations designed by the European institutions must not be more restrictive and burdensome than necessary to meet the health objective and performance standards are preferable to design specifications (see Treaty on European Union Protocol 2 Art 5 and WTO Technical Barriers to Trade Treaty (TBT) Art 2.2 and 2.8 for example). But why do something proportionate and lawful when you can help the cigarette makers? 
b) A detailed description of the product in question, including all ingredients and quantities thereof, as well as information on emissions; What use will be made of this information? Unless it is part of regulatory decision- making what purpose is served by this? No purpose is specified in the justification.  It looks like it has just been borrowed from cigarette language.  What information on emissions would be required?  The concept of emissions is meaningless for an e-liquid per se. It only makes sense in combination with a vaping device.  It must involve some sort of puffing regime, but that is not specified. Again, just a randomly applied and poorly designed burden without a purpose. More dead weight and advantage to the cigarette industry.
c) A Risk-Management Plan, including a system for monitoring and recording any adverse reactions; Cigarette manufacturers do not have to track the annual 700,000 fatal ‘adverse reactions’ or millions of sub-lethal side effects associated with smoking annually in the EU. No such requirement is imposed on vendors of alcoholic drinks or caffeine products either. Adverse physiological reactions should be reported to a public authority (for example via the MHRA Yellow Card scheme), not the manufacturer. Physical problems with products should be reported via national trading standards bodies and ultimately the RAPEX system. This sort of regime is better suited to genuinely risky medical products like the smoking cessation drag Varenicline, where the are cardiovascular and neuro-psychiatric risks not associated with nicotine.  For e-cigarettes, where the role of the main active ingredient, nicotine, is well understood, systems exist to deal with consumer safety, without imposing new burdens.   Another gift to the cigarette makers, with a bonus for Big Pharma.
Member States shall be entitled to charge a fee for processing the application. They may also require manufacturers or importers to carry out additional tests or submit additional information. Each Member State shall take due account of authorisations previously granted by another Member State. Increases costs and bureaucracy. It would be better to have a complaint or inspection driven system.  Regulators can always find more work if they are paid for it. What are these ‘additional tests’ and ‘additional information’? How can this be part of a harmonising internal market measure? None of this applies to Big Cig.
3. For products authorised under the simplified procedure, Member States shall ensure that the following conditions are fulfilled:  
a) the product is clearly labelled with the nicotine content, instructions for use, instructions for reporting adverse reactions, and details of the manufacturer; This should include listing main ingredients. That is a more appropriate way to warn of allergies than specifying certain allergy risks (eg. associated with flavours) in a single health message. Are there instructions for reporting adverse reactions to cigarette smoking? No. 
b) each unit packet and any outside packaging shall carry the following health warning: This has been rolled over from smoking, but does it take account of how these products are actually packaged and sold in real life – eg. would this apply just to the liquids? Or to the hardware? What about very small packets? It only really makes sense for a certain sub-category of e-cgs. More confusion that can only benefit the cigarette industry.
This products is intended for use by existing smokers aged 18 or over as an alternative to tobacco cigarettes. It contains nicotine which is a highly addictive substance. Consult your doctor if you are pregnant, breast feeding, allergic to nicotine or propylene glycol, or have high blood pressure. Some sort of message is appropriate but this should be considered more carefully to provide the most relevant health messages to the user.  Why would you wish to prevent a 17-year old smoker using these products? What if propylene glycol is not used in the product? Is the wording about consulting a doctor the best health message? Noticeably longer than any cigarette warning. and does not point out the one things that matter – e-cigs are many times less dangerous than smoking. The cigarette industry shielded from the truth.  
c) flavourings shall not be allowed; Utterly self-defeating own goal. E-cigarettes consist of three basic ingredients – pure nicotine, a liquid or aerosol that forms the vapour, and flavourings to make the product interesting and palatable. If they aren’t interesting and palatable then people will not switch from smoking and more harm will be the result. The point is that flavourings are integral to the viability of e-cigarettes and their success in switching smokers.  There is no evidence whatsoever to justify banning flavours and a strong counter-case can be made that it would reduce the harm-reduction potential of e-cigarettes. Flavours are not integral to cigarettes – only 5% use some sort of flavour – this is because cigarettes are flavoured by thousands of products of tobacco combustion, many of which are toxic.   Of course there is no sign that any assessment has been made of the commercial or public health impact of this or whether it would be lawful.  So this would be a most generous regulatory gift to the cigarette industry, greatly diminishing the threat to the incumbent from e-cigarettes and not far from a de facto ban. 
d) the sale of the product shall be restricted in line with the legal age for sale of tobacco products in the relevant Member State; Fine sentiment, but the EU does not have competence for specifying ages and no age related limits were made in the Commission’s proposal. Nor is this consistent with developing the internal market, so there is no legal base. This conflicts with the warning label, which specifies 18 years.
e) the products shall be available to be sold outside pharmacies; The intent of this is good (I assume to make the products generally available) but the drafting is ambiguous.  Does this mean:

  • On ‘general sale’:  any retail outlet that wishes to sell them?
  • Anywhere where cigarettes are sold, as well as pharmacies?
  • In places other than pharmacies as specified by member states?
  • By someone operating from a folding table outside Boots?

In several countries classification as a medicine, as envisaged by the European Commission would restrict sales to pharmacies only. 

f) advertising and promotion shall be appropriately regulated; There are already EU directives and policies that cover marketing and promotion:

  • Distance Selling Directive 97/7/EC
  • Directive on Electronic Commerce 2000/31/EC
  • Misleading and Comparative Advertising Directive 2006/114/EC
  • Unfair Commercial Practices Directive 2005/29/EC

Does this clause add anything or is it just a vague statement of the obvious embodied in the bureaucrats’ favourite word ‘appropriate’?  Or is the intention to hand regulators powers to control marketing of e-cigarettes that goes beyond the normal regulations that govern advertising and promotion.  E-cigarettes have around 1 percent of the recreational nicotine market – if they are to grow rapidly into the nicotine market supplied by highly toxic cigarettes, the vendors need to be able to advertise quite forcefully. It would be better if the European Parliament protected the right to advertise these products from arbitrary member state regulations than encouraged it. That would actually assist the development of the internal market, increase competition and challenge the dominance of cigarettes.   Opening the way to more restrictive marketing regulation for e-cigarettes will please the cigarette makers.

4. Member States shall monitor the development of the nicotine-containing products market, including any progress made in harm reduction, as well as any evidence of gateway use amongst young people. Based on the evidence, the Commission shall report back to the European Parliament and the Council 5 years after the transposition date of this Directive. The report shall assess whether amendments to this Directive are necessary. This is sensible and worthwhile. In fact, along with the extensive base of existing regulation that already covers e-cigarettes, and some sort of health message, it is probably all that is needed.The ‘simplified procedure’ is too prescriptive, has not been the subject of consultation, there is no impact assessment (and the rapporteur has made no attempt to assess the impacts).
Justification: There is evidence that e-cigarettes may help with harm reduction strategies, and so they should be allowed to compete more freely with cigarettes – in terms of where they are sold etc. However products should still comply with appropriate safety and quality standards. The option of a simplified authorisation procedure takes elements from medicines regulation as well as tobacco regulation. We should proceed cautiously, given the lack of data, especially on long-term effects. There is a need for further monitoring, and the regulatory regime for NCPs should be reviewed in five years time. Of course e-cigarettes should be able to compete more freely with cigarettes – that is exactly what happens now – and so far no evidence of material harm has emerged but plenty of evidence of harm reduction. You would expect even hyper-active interventionists to proceed with caution when something is working well without their involvement.The time to define a new regulatory procedure is once there is material evidence of problems emerging that cannot be addressed by the existing consumer protection legislation. Given the rapporteur (rightly) proposes 36 months lead in time for this procedure, there is time to get this right, not jump to a hastily contrived regulatory regime proposed as an amendment to something that was itself poorly considered and probably unlawful. Poorly considered regulation, hastily drafted, without adequate consultation, and no assessment of the impacts can only aid the rivals of e-cigarettes – a win for Big Cig. 
   
Article 26 – paragraph 1
Member States may allow the following products, which are not in compliance with this Directive, to be placed on the market until [Publications Office, please insert the exact date: entry into force + 24 36 months]:[…](b) nicotine containing products below the threshold set out in Article 18(1); This is a particularly important and useful amendment – and should be included even if the Commission’s Article 18 is retained unamended (which would be a grave error). The Commission’s proposal can be interpreted as applying the medicines directive from entry into force of the TPD – and potentially creating a ban on all unauthorised products at that point. The Commission’s proposal would create commercial chaos and a black market.

Supporting cigarettes by protecting them from Swedish-style competition.  If only we could get smoking down from 28% to even close to 13%. That would really cut sales sales of cigarettes, as it has done in Sweden.  So we might also consider “assisting the cigarette industry by omission”.  Although she is the rapporteur for the proposal and has had every opportunity to familiarise herself with the scientific, ethical and legal case and to consider constructive proposals, she has not introduced any sort of amendment that would replace the ban on snus with regulation of ingredients as recommended by numerous experts.  Though a tobacco product, it is of the order of 95-99% less dangerous than smoking and could become a significant challenge to cigarettes.  I can’t seem to get answers to these two questions about the snus ban:

(1) why should the EU intervene to prevent a smoker saving their own life with snus just as thousands have done in Sweden?

(2) why would the EU protect cigarettes from the competitive pressure that has collapsed the cigarette market share in Sweden? 

What should be done?

I have set out how I think the TPD should be amended to provide appropriate and proportionate protection, and to develop a credible regulatory regime for the emerging nicotine market. See specific text proposals for e-cigs (MS Word) and an article about the whole directive: Amending the tobacco products directive: how to fix the harm reduction agenda.

Other MEPs see the world in similar terms (see amendments by Christian Engström, Chris Davies, Christofer Fjellner, Rebecca Taylor)  and have understood this basic truth: if you over-regulate a new, disruptive, low-risk alternative to the dominant and deadly cigarette, you simply protect the worst products from competition. To understand this just isn’t that hard.

As MEPs consider how to handle hundreds of amendments, here’s a rough guide to doing the right thing on e-cigarettes:

  • Strictly limit the application of  medicines regulation only to nicotine products where a health claim is made – ie ‘treating or preventing disease’ as specified in the medicines directive. It is important regulate e-cigarettes for what they are – and they are not medicines;
  • Rely on the 17 directives that already apply to e-cigarettes, and only go further if there is material evidence of a problem that cannot be addressed by the existing regulation;
  • Make sure the existing consumer regulation is actually applied and enforced by requiring member states to report on what they are doing. This can also inform a review of any problems arising that justify more intervention;
  • Subject to proper consultation, bring in a standard for maximum thresholds of contaminants in e-liquids, mirroring the approach used for food, rather than being prescriptive about manufacturing processes;
  • Avoid doing arbitrary things like banning flavours or applying marketing restrictions when you have no idea what this will do to the industry or relative strength of the cigarette category. Don’t make any changes without assessing the impact.
  • Don’t just jump in and try to design regulation on the hoof (see above): insist that a proper job is done to create regulation that is lawful, proportionate, non-discriminatory, subject to proper consultation and options analysis, supported by a decent impact assessment, and backed by scientific advice. Require the Commission to come back with a proper fully formed review by 2017.
  • If there are to be significant changes, bring them in with a 36 month lead in time.
  • If there are minor changes (printing a health message) bring them in sooner.

Above all, keep in mind the comparison with cigarettes. This is not a normal market in which the standard ideas of risk-based regulation can apply, because the riskiest product is not the most highly regulated.  That is an important to difference to most markets.  It means that well intentioned but misguided health and safety regulation can land you on the wrong side in public health – providing de facto support for cigarettes and causing more death and disease.

The road to hell is paved with good intentions

Attributed to Saint Bernard of Clairvaux (1091-1153)

Hell isn’t merely paved with good intentions; it’s walled and roofed with them. Yes, and furnished too.

Aldous Huxely

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30 comments to The road to hell is paved with good intentions …and amendment 1250

  • Indeed, there is not a shred of evidence that Mrs McAvan is assisted by the cigarette industry. Or, the pharmaceutical industry.

    Frankly, it’s amazing how many people there are in EU committees who cannot be shown to be ‘assisted’ in any way by Pharma or BigCig (I like that one – thanks), who nevertheless seem to be working 24/7 to protect smoking, promote widescale disease, protect pharma income, and remove any threats to cigarettes and pharma’s treatments for sick smokers. I have an ongoing, permanent argument with Bill Godshall on this – my contention is that 8 out of 10 of such people are funded either directly or indirectly by industry (often indirectly, by virtue of the organisations or institutions they work for being funded, typically, by pharma); he contends they mostly do it for reasons of idealogy. I have trouble understanding that argument, as it seems to be suggesting they are all barking mad.

    I believe I may have detected the presence of one or two ‘mad, swivel-eyed loons’ among their number (forgive the current parlance) – but it seems rather difficult to describe them all as raving bonkers. There has to a sane one or two in there somewhere, and I have a great deal of trouble trying to work out why a sane person would protect smoking from being made obsolete by ecigs while simultaneously helping to promote cancer and protect the chemotherapy drug trade. But maybe I’m missing something.

    After all, that would be like a cancer society helping to protect the chemotherapy drug trade, or something equally ridiculous ;)

    I would also be interested to see if there are any registered pharmaceutical industry contributions to the Labour Party, as that might clear up some confusion: the monstrous suggestion has been made that all Labour MEPs have been told to vote anti-ecig and therefore pro-pharma. I find that suggestion reprehensible, as it implies that the Labour Party would protect smoking in order to please their funders, which is clearly out of the question.

  • Zillatron

    The is one point I have a very bad feeling about:

    What exactly do they want to regulate, when they say “THE e-cigarette”?

    We assume, it’s the part that may contian nicotine: The liquid.
    But in the workshop they kept blabbering about “a thing with a light at the end”. Those “experts” don’t seem to have a clue what a typical e-cig is nowadays. The more “knowledgeable” talk about cartridges and refill bottles. Mostly ancient, useless toys. And propably stuff that the big players will swamp the market with.

    How will this proposed “regulation” affect seperate batteries and atomizers?

    Will they also be forced into “Good Manufacturing Practice”?
    Why?

    I think we most urgently need to explain to the MEPs the difference between the painted picture and the reality.

    • Clive Bates

      Absolutely right – they are mostly just borrowing language that works for cigarettes… but e-cigs is a catch-all title for everything from something that looks like a self-contained cigarette to something that looks more like an oboe and works in a completely different way!

  • Clive, thank you for your very comprehensive and strongly worded exposure of all the entrapments. However, I see one possible additional trap: The lack of a nicotine limitation. On the one side, Linda didn’t write that Art.18 would fall apart (or I didn’t find it), on the other side – even if Art.18 would fall apart, Memberstates like Germany would possibly use the missing nicotine limitation for taking their own limits (most likely 1%, derived from german chemical law). Hence this, a sensible EU-limitation could also be a factual permission…
    BTW it’s rather Big Pharma than Big Tobacco which I see influencing ENVI and the Commission.

    • Clive Bates

      Dear Dac – you raise an interesting point. But how does it work in Germany now… presumably people use 4.8% liquids as they do in other places?

      I have avoided specifying a recommended limit, but stress that we don’t deal with most moderately dangerous but useful substances (bleach, lime etc) by banning them. Instead we specify how they should be packaged and labelled. There is relevant EU law on this:
      Dangerous Preparations Directive 99/45/EC
      Classification, Labelling and Packaging of Substances and Mixtures – the CLP Regulation 1272/2008 – this applies from 2015.

      I think the only good argument for having a limit is so that countries like Germany and France could revise upwards to the UK level (7.5%) – but there must be a better way…!

      I don’t think either Big Pharma or Big Tobacco is that much involved – it doesn’t usually need outside help for some MEPs to act in ways that harm Europe’s people. The point is good intentions leading to bad outcomes…

      • Dear Clive,
        thanks for your reply. Most Germans use Liquids below 2.4%, the common maximum is 3.6% (market share below 10%). Big Pharma was involved making the first commission proposal by giving an OK for the proposed values (Dominik Schnichels admitted this, when I was there in January), but I just wanted to state, that – if there are major influences, then it’s rather Pharma (even indirectly). ;-)

        But you are right: The good intentions leading to bad outcomes are the problem, especially by the mono-sighted “experts”…

  • Dear Mr. Bates,

    I agree entirely with EVERYTHING you have outlined here and can find no fault at all in your argumentation. As a vaper who has been living in Germany for over 40 years, I am absolutely convinced that the German vapers would underline everything you have written here. It is the most sensible approach which would allow us to continue harm reduction (now 2,2 million vapers in Germany…all of whom were former smokers) by way of reducing the number of smokers. Some politicians over here, particularly from the Green Party, are attempting and succeeding (because they are usually in a coalition with the Socialist Party, SPD, who usually wave through any of their suggestions) to include the vaping of e-cigs in their local non-smoking legislation. On the other hand we have Frau Dr. Pötschke-Langer from the German Cancer Research Centre (and also the representative of the W.H.O. there) purposely gererating false allegations against the e-cig liquids in an attept to have them banned completely. Vapers suspect her of protecting the number of cancer cases in Germany and perhaps also securing funds from the pharma and BigCig industries.

    As to the proposed ban on flavours in liquids, we fail to see the point. All the flavours are approved for the food industry already. Some people (quite a number in fact) are already mixing their own liquids to save costs even further. It is a fact that practically all vapers are more aware of what they are vaping than cigarette smokers. Most German vapers stick to German-made liquids which are already sold in childproof plastic bottles marked with a skull and crossbones, the ingredients they contain (except for what is in the food flavouring), the nicotine concentration where appropriate…some liquids ccontain none) and general health warnings (do not swallow, avoid skin contact etc.). The same applies in the U.K. by the way. If the point is to make liquids/e-cigs less attractive to the youth, we could go along with that because we only sell to people of 18 or over. On the other hand and from a harm reduction standpoint. This practice could be rather counterproductive because the majority of people start smoking at an earlier age and are thus prevented from taking advantage of this less dangerous option. I would appreciate your views on this aspect and thank you for your support for the e-cig sector.

  • Clive Bates

    I agree with you about the age issue. It makes no sense. But then age restrictions make no difference anyway, just allow legislators to look as thought they are being responsible – they have never stopped a committed teenager doing anything. So we declare cigarette to be for over 18s, and 12 year olds use them if they want to. Same will apply for e-cigs if they want them (which they show little sign of) – whether we like it or not. That is just what kids do.

    Thanks for the view from Germany – I think pressure and awareness-raising from German vapers to German MEPs will be decisive in determining what will happen with the directive, because of German MEP’s influence in the EPP group. I would urge you and German colleagues to keep up the efforts – it is definitely working, but we have to keep the pressure on. Anything I can do to help (in English!), and I’ll do what I can.

  • Dodderer

    You perhaps could cast an independent legal eye over the definition of a NCP

    ‘nicotine-containing product’ means a product usable for consumption by consumers via inhalation, ingestion or in other forms and to which
    nicotine is either added during the manufacturing process or self-a
    dministered by the user before or during consumption;

    Ecigs can be bought intact and fully primed or in separate units, including juice.I have a ‘Wizard Stick’ – a ‘smoke’ producing toy using PG(plus nicotine and flavouring as required!) and,of course,commercial smoke machines produce their effect with PG.Technically, could either of these fall with the definition?

  • Jonathan Bagley

    Regarding regulations on ecig use. As an ecig user with both eyes grimly focused on the future, my only real practical concern is liquid strength. Everything else is more an inconvenience – like securing supplies of Belgian Golden Virginia once was. Currently, under UK chemical safety laws, 7.5% nicotine is legal. This, child-proof caps and clear labelling is, in a sane world, all that is needed. Propylene glycol and food flavouring will always be available. The devices are small, robust and light and will always be available online.
    I worry that the legislators don’t understand ecigs. When they talk about bans on flavourings and limits on strengths, I get the impression they are thinking of sealed cartridges, or at best 20ml bottles of premixed eliquid, and aren’t aware of home mixing using separate nicotine soln., PG and flavours – something users will gravitate towards for maximum satisfaction/enjoyment and minuscule cost. When they grasp what is going on, and reealise they have the excuse of much lower limits in other EU countries, they will attempt to do something about the 7.2% and 5.4% nicotine solution now becoming popular. Putting myself in their shoes, I might think of adding poison to all nicotine not sold to the pharmaceutical industry. Alternatively, put a massive duty, which can be reclaimed by certain businesses, on clean solution and sell the poisoned product duty-free. There are precendents for this. Methylated spirit is ethanol rendered poisonous by the addition of methanol and the US Government added poison to moonshine during the prohibition. Perhaps colour duty-free nicotine pink as in “pink diesel”.

    • Clive Bates

      This is a very good point Jonathan – I really think they barely thought about this. I think the idea on e-cigs was “hand it over to the medicines regulators, they’ll take care of the detail”… while we get on with the important business of designing cigarette packs. Not so easy it seems…

      The problem now is trying to invent a new regulatory system on the hoof and coming up with half baked ideas based on a wrong or incomplete understanding of e-cigs and vaping, drawing excessively on analogy with cigarettes.

  • Steve HAAS

    I think they already lost the “fight” against the ecig, till the directive will be in place in every member state, were talking about at least 2 years from now. The vaping Community will be huge then, there’ll be a huge network of shops, online and offline, there will be a ton of studies available and their so called arguments will be rubbish. As one said before, They will sooner or later realise that they are making fools out of themselves, I think they are already. They tried to regulate a product that they have completely misunderstood and they have completely underestimated the power of ecig users.

    In 2013, an interconnected modern world you won’t get away with that kind of lies anymore, the world is fortunately changing.

    All they are gonna do is try to get their asses out of this mess with as less political dammage for themselves as they can.

    Steve

    • Clive Bates

      Steve – I agree. This is a really fascinating, self-organising insurgency against the know-it-alls and prohibitionists that swarm around the Brussels establishment, usually untroubled by the views of those they are supposedly trying to ‘save’. My hope is that MEPs and officials will see through the vacuous arguments and pseudo-science that these lobbyists have been pitching and start to trust them a lot less. They deserve no less.

    • Jonathan Bagley

      Steve – Some days I agree, but I woudn’t say it was a certainty. If I were them I would do it bit by bit, each little bit not stirring up too much anger. Most people lead lives of quiet desperation. I’ve seen it on the discussion boards. “I could live with 18mg”, not much opposition to indoor smoking bans. Don’t start with pubs though. Start with air travel, as most airline now ban them. Then inside hospitals and schools. Ban TV adverts. Put on some tax. “20p a week – I can live with that”; then a bit more. Ban use in restaurants – harmless vapour or not, it puts people off their food. Best ban them on school grounds – sorry teachers, railway platforms, theatres, cinemas. None of these measures would raise more than a few grumbles but we would only then be 10 years from what is now the smoking ban.

  • Zillatron

    There is another health risk in the banning of flavourings that occurred to me.

    We experienced vapers know which flavours to use and what to avoid when mixing our own liquids. Most new users now are content (and busy enough) with sampling the plethora of available ready-to-use juices. Most will stay there because it’s convenient. When vapers consider hopping aboard the diy train they usually read a lot and get information from more experienced users in the forums.

    Now think about a fledgeling who tries vaping with an unflaoured base liquid. Well, it’s bland and not very satisfying. Next thought: “I heard there used to be flavours in them. Hmm, there’s some orange flavour left from making cookies … just a drop or two … Hey, tastes great!”. And he starts pimping the bland stuff with all kinds of baking flavour. Blissfully ignorant of the danger of a lipoid pneumonia that he may get from oil based flavours.

    Then he get’s it and blames it on vaping. And the so called “experts” have a field day yelling: “We told you so! It’s dangerous and should be banned!”

  • E CIG smokers need to start a petition.

  • Emilio Passaro

    Most people have missed the revenue agenda, the eu comission is funded by government handouts from our taxes. The reduction in revenue from taxes on cigarettes, caused by the increasing popularity of Ecigs, must have a knock-on effect that could threaten the income of the eu commission. The only way to protect that income is to protect the sales of tobacco and pharmaceutical products with restrictive regulation, or, tax the Ecigs and their production to a level that would fill the shortfall in the eu funds.

  • lilian flesher

    Last year i was diagnosed with COPD a result of 40 years cigarette smoking. My lung function test was appauling. I was distraught of course who wouldnt be, smoking had been my enjoyment, so i was unhappy at the thought of stopping. On the way home we stopped to do some shopping and I spotted the ECIG i prompty bought a kit (2 ecigs) one for me one for hubby. As smokers of 40 cigs per day EACH we were thinking if this works and gets us to kick that habit it will be a miracle. MIRACLES happen, we never touched a cig since and that was july 2nd 2012. Now i recently was tested and my lung capacity on 3 tests were improved by 10%, 10% and 11% so who the heck can tell me they are harming anyone ??? they have improved my lung function dramatically.

    • Not the ECig had improved your lung function! Quit smoking did that ;)

      That is important, because: If the ECig had improved your lung function, it will be a medical product. But the ECig is healing nothing! It´s an (“healthier” ) alternative to tobacco. Nothing more – nothing less.

    • My experience is similar to Mrs Flesher. Having smoked for 45 years my wife, afflicted with a hacking cough at the time, suggested I get a couple of e-cigs. We haven’t looked back and are now entering our 7th month. We both feel better and have more money in our pockets.
      The EU are like parliaments throughout the world, out to maximise their income at the expense of the voters.

    • Mike

      If you really quit entirely and get off Ecigs your lung function would absolutely be better again. Getting COPD should of scared to you quit putting everything unknown into your lungs. Try to taper off as Ecigs do clog up the lungs with phlem and stop you breathing as well as you could. Certainly a million times better than cigarettes but yeah if you have COPD get 100% off anything into those lungs if you can.

  • […] trivial amount of nicotine, save for ones which received medicinal regulation. More recent drafts (amendment 1250) have proposed to allow them on the market, but to remove flavorings and to establish regulatory […]

  • […] under the medicines directive, though retaining many features of medicines regulation (see my critique of this).  Other MEPs have uncritically followed the Commision proposal and seek full medicines regulation […]

  • Junican

    Let’s just look at the logic.

    If ecigs should be regarded as medicines because the help people to give up smoking, then anything that helps people give up smoking should be regarded as medicine.
    Spearmint and chewing gum are often used to help give up smoking and should therefore be regarded as medicines.

    Few people would not regard that last statement as silly.

    It follows therefore that the ecig, of itself, does not have the characteristics of a medicine. Is there anything about the ecig which could be regarded as a medicine? The ecig liquid could fit that description, and only the ecig liquid.
    The ecig liquid contains nicotine, glycerine, water and flavourings. Have any of these substances ever been used as medicines in the past? I would not know the answer to that question, but I do not know of any such. (I do not count nicotinic acid (niocin)as nicotine). If they have not, then there is no reason that they should be so regarded now.

    QED.

    Something that I find odd about these discussions of ecigs in the EU departments is the lack of any suggestions that toxicologists have been involved at any stage. Surely, only a toxicologist could say what level of nicotine in ecig liquid would become dangerous? Where is the toxicological evidence to justify any specific limit on the level of nicotine? Without such evidence, any imposed limit is arbitrary and unjustified.

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