May 7th, 2013

Tobacco products directive – poor legislation harmful to health

I felt moved to write to MEPsenvelope2

To: the ENVI committee rapporteur for the Tobacco Products Directive, Linda McAvan MEP

CC: ENVI MEPs

7 May 2013

Dear Ms McAvan

I wanted to make a few points about the draft tobacco products directive, your draft report and some of the points raised by you and other members on 24 April (from 16:43) I hope this will be useful additional input in advance of your hearing on e-cigarettes on 7 May and deadline for amendments the following day. I apologise for the length of this communication, but there is rather more to say than I would have hoped. 

fake diseaseHearing on 7 May.  The list of invited experts and lobbyists is heavily weighted to those who favour more regulation or prohibitions.  What no-one should assume is that more regulation of low-risk alternatives, even in the name of health and safety, will mean better health overall, when high risk cigarettes are freely available and largely unregulated as products. I have just seen the presentations to be given by two health lobby groups (the European Respiratory Society and European Society of Cardiology). I cannot see what MEPs will gain from such poor analysis.  The presentations are unscientific advocacy directed against e-cigarettes, full of vacuous conjecture, fabrications, no serious attempt to approximate the scale of risk, no comparisons with cigarettes (the key issue), and grossly overstated uncertainties. In one particularly mendacious slide (see chart), a disease risk is projected into the future that has been entirely made up.  It is simply not the case that because we do not know everything that might happen over 50 years, we do not know anything – we know that e-cigarettes do not contain burning organic matter, and therefore do not create the hazards associated with thousands of products of combustion.  To claim, incredibly, that most e-cigarette users say their health has worsened, on the basis of an obviously flawed internet survey, would be laughable if it was not such a serious deception. I think most Members will recognise this from the accounts they have received from constituents and from common sense.   I hope Members will see through these shallow presentations and recognise that what matters is the dramatic reduction in risk and immediate health gains experienced by switching from smoking to e-cigarettes.

Update: an equally ludicrous presentation from WHO became available later. Further update: a terrific takedown of these absurd presentations has been done by ECITA’s excellent chief scientific officer Tom Pruen: see his analysis of the World Health OrganisationEuropean Respiratory Society and European Society for Cardiology presentations.  Note to tobacco control community: this is your collective professional shame – you own this.  Note to European Parliament – your time was wasted by these people as part of the flagging effort to justify excessive regulation, when you could have heard more from knowledgeable users.

E-cigarettes as tobacco products. You appeared minded to label e-cigarettes as tobacco products.  That is unnecessary and would be counter-productive. It would do nothing to protect and inform the consumer or to improve public health.  The FDA had to define e-cigarettes as tobacco products when its attempt to define them as medicines was struck down in court (see FDA letter).  It is a peculiarity of American legislation, which doesn’t allow a third way, and we should not pursue this in Europe.  In Europe, we have the opportunity to craft regulation that reflects the reality of e-cigarettes – they are nicotine-containing consumer products that compete with cigarettes but with many superior characteristics, mainly by virtue of not using combustible tobacco.   We would not classify an energy drink as a coffee product if it contained pure caffeine extracted from coffee.  E-cigarettes are best considered as ‘nicotine products’ for the purpose of regulation.

E-cigarettes as medicines.  It is not just the FDA that failed in the attempt to classify e-cigarettes as medicines. Four courts have now rejected this definition in Europe, and there is ECJ case law that suggests it would fail at a European Union measure too. That legal perspective is also supported by common sense and the fact that users do not see themselves as ill or in treatment and vendors do not claim they are offering a therapy. NRT products are mostly sold to relieve cravings from nicotine withdrawal. E-cigarettes on the other hand, meet the demand for nicotine as a recreational drug that is not especially harmful itself.  NRT and e-cigarettes are totally different in character and purpose, as the European Parliament Library briefing on electronic cigarettes makes abundantly clear in its table.  You can follow these arguments in depth in my briefing: Are e-cigarettes medicines?.   You were precise in referring to e-cigarettes as medicines ‘by function’, but it is this definition (as opposed to ‘by presentation’) that has repeatedly failed. It is obvious why.  Several widely used products modify physiology and metabolism – nicotine in tobacco, alcohol, and caffeine for example –  but they do not do this to treat any sort of medical condition, and are so not regarded as medicines. E-cigarettes are no different.

Excessive regulation. Classifying e-cigarettes as medicines and would not have the effects its proponents believe. It would be damaging to health and support the cigarette market by protecting it from competition from superior nicotine products.    The key health benefit of these products is determined by how many smokers switch to using them or use them as a staging post to quitting completely.  Whether e-cigarettes are 99% or 99.5% less dangerous than cigarettes matters much less than whether they are attractive to smokers.  To be attractive to smokers we need diverse, customisable products and lots of innovation – I recommend this video Open message to European MEPs from e-cigarette user David Dorn to help with understanding how this works.  Medicines regulation works against diversity and innovation – it adds costs, imposes burdens, applies restrictions and holds back innovation. Unlike cigarettes, which have easy access to the market, medicines regulation creates a default prohibition and requirement for approval. Why make it easier for cigarettes and harder for e-cigarettes? I have explained the risks of excessive regulation in this post: Medicines regulation for e-cigarettes: when caution can kill.

Light touch regulation.  A representative from the UK medicines regulator (MHRA)  is invited to the hearing. Though they promise a ‘light touch’, they haven’t so far managed that with the products they are currently evaluating.   Medicines regulation would also hand very significant powers to regulators in other EU states, who could take a much less progressive approach than the MHRA – not least making these products ‘pharmacy only’ or banning flavours (a move anticipated by the Commission).  Even ‘light touch’ medicines regulation starts from the position that the products are banned unless approved, whereas cigarettes can be placed on the market if they comply with rudimentary standards for tar, nicotine and carbon monoxide ‘yields’.  There is a role for medicines regulation where a vendor wishes to make a health claim and/or where they see advantages in having the approval of a medicines regulator, for example in accessing healthcare providers. But this should be optional – a ‘premium’ option alongside a robust mandatory ‘floor standard’ set by consumer protection legislation.

E-cigarettes as consumer products. It is much more realistic and proportionate to consider e-cigarettes as consumer products.  That does not mean they are unregulated.  Far from it:  they are covered by at least 17 directives (I have set these out here).  This is not to say that the regulation is currently perfect – though there is little sign of any problems that are not addressed by the current consumer protection system. For example, security and packaging of e-liquids is covered by the Dangerous Preparations Directive (99/45/EC) and CLP Regulation (1272/2008) from 2015. What problem do you see that needs additional regulation?   There may be scope to set specific standards, for example for e-liquids, and member states could develop proper enforcement regimes.  But developing regulation within the broad framework of consumer protection legislation should be the focus of efforts in Europe.  It is important to recall that the Treaty on European Union (Art 5 Protocol 2) requires:

Draft legislative acts shall take account of the need for any burden, whether financial or administrative, falling upon the Union, national governments, regional or local authorities, economic operators and citizens, to be minimised and commensurate with the objective to be achieved.

This means that unless the European institutions can show that consumer protection legislation is inadequate, there is no basis for applying the much more burdensome medicines regulation. The Commission has not shown this to be the case, and nor have any rapporteurs.

The Commission proposal on e-cigarettes and nicotine containing products. The Parliament and Council have been let down by the Commission’s proposal in Article 18. It is poorly thought through, contains an arbitrary and pointless threshold, it takes an easy short cut by applying medicines regulation rather than designing appropriate and proportionate regulation, and it has failed to consult on its proposal or listen to the industry and users. The best that Parliament could do is to insist that the Commission starts again and does a thorough job, looks properly at all the regulatory options and comes back with sound, legally robust, proportionate and non-discriminatory proposals once it has done the necessary work.  In the mean time, member states should enforce the existing legislation properly and report on what they are doing.

Snus and smokeless tobacco. I noticed you barely mentioned snus or oral tobacco in your report or speech, simply reaffirming that it should be banned, but not providing any justification for this.  No MEP seemed willing to attempt a justification for the ban.   The reason is obvious: there is no justification, and the case for the ban made by the Commission has been comprehensively discredited.  Can any MEP suggest any reason at all why smokers outside Sweden should be prevented by the EU from saving their own lives by switching to snus as a way of quitting or as a substitute for smoking?  The evidence on snus in  Sweden is very compelling, as I hope you know by now.  In Sweden smoking prevalence and disease  is by some distance the lowest in Europe and there is no evidence of gateway effects.  As Professor John Britton and Ilze Bogdanovica argued last week in their Lancet article: Tobacco control efforts in Europe.

The rationale of tobacco harm reduction is to make nicotine products that are more satisfying as a smoking substitute available to smokers at least as easily as cigarettes, and at competitive prices, hence providing all smokers with an easily obtainable lower-risk alternative to smoking. Proof of concept is provided by Swedish snus, an oral smokeless tobacco product that delivers high doses of nicotine, is culturally accepted in Sweden and freely available alongside cigarettes in tobacco retailers, and has been used increasingly during recent decades as an alternative to cigarettes by existing smokers and new tobacco users. Sweden has the lowest prevalence of smoking in the EU, and, in 2008, a European Commission expert committee concluded that the availability of snus has contributed to that. Legitimate concerns exist that snus might be a gateway into smoking for some people, and that it sustains nicotine addiction and could perpetuate smoking in dual users. However, the low health risk of the product compared with smoked tobacco, and predominant use as a gateway from smoking, indicate that at population level wider availability of this product would reduce harm to society from tobacco use.

It is true: snus in Sweden is ‘proof of concept’ for harm reduction and many thousand Swedish lives will be saved as a result. It is a travesty to deny this to others for supposed political reasons. It looks to me like everyone involved believes everyone else involved is immovable. But the scientific, ethical and legal arguments are so strong, and the solutions so easy and sensible, that it may just need some political leadership to unlock the huge potential health gain. You are well placed to provide this.

Novel tobacco products. Your draft report proposes a mandatory authorisation process for novel tobacco products.  While at first glance this might seem like a good idea, it will in practice become a highly politicised unscientific process, and will be likely to create more arbitrary anomalies like the snus ban.  Some loud but misguided campaign groups do not believe there should be any novel tobacco products – even ones that are 10-100x lower risk than cigarettes. For example Cancer Research UK arguesThere is no legitimate reason to introduce a new tobacco product on to the market“. These views should be dismissed as unscientific and unethical.  To assist in the development of the internal market an authorisation process would need harmonised objective criteria, but none are suggested in your draft report.  Given that any novel tobacco products are likely to be novel due to their significantly reduced risk, it is hard to see what justification there would be to keep these products from the market, when it is possible to introduce a new cigarette brand simply by complying with a crude and easy ISO standard (Art 3-4 of the TPD).  The right approach here is to have a notification system as envisaged in the proposal and to establish a safeguard – if a members state has reason to believe a novel tobacco product is more dangerous than conventional cigarettes, they should have the power to prevent it entering the market pending further investigation.  The bureaucratic blockage of developments in this area is not a theoretical concern.  There are ‘heat not burn’ tobacco products under development that would be significantly lower risk than smoking, and may have the appeal to get many smokers to switch.

Flavours. 5% of cigarettes use some sort of characterising flavour, but 70% of smokeless tobacco products use flavours. An across the board ban on flavours in all tobacco products looks even handed, but in fact it is much more restrictive on the much lower risk category.  It defies belief that the European institutions would wish to ban important ingredients in the products that have contributed to the great success that Sweden has had in reducing smoking related disease, and against the will of the Swedish government.  The answer is to confine this ban to smoking tobacco products.

Descriptions. The idea that it would not be permitted to describe one tobacco product as less harmful than another would be to codify a life threatening deceit into European law.  We know that some tobacco products are 90-99% less risky than cigarettes. That difference is too great to legitimately conceal from users.  The JURI rapporteur correctly expressed this in his draft opinion:

By prohibiting any labelling that suggests that a particular tobacco product is less harmful than others, the proposal causes an additional problem. The development and promotion of less harmful means of tobacco use is essential in order to support tobacco users to stop smoking cigarettes and the like. Manufacturers must be able to communicate that a certain product is less harmful than others if this is scientifically proven and if it is not misleading.

Conclusion. The draft TPD fails to provide a sound basis for regulating the emerging range of nicotine products in a way that reflects their dramatically different risks.  In just about every way that directly affects the product, the directive is discriminatory and disproportionate towards the lower risk products. Until this is addressed, the directive will do more harm than good overall.   Please see my guide to amending the TPD for in depth suggestions on how it should be improved.

Yours sincerely

Clive Bates

Disclosure: no competing interests.  I am former director of Action on Smoking and Health 1997-2003 and a civil servant from 2003-2012. My only concern is to secure maximum possible health benefits from enlightened regulation of tobacco and nicotine products.  Any views expressed are mine not necessarily shared by former employers.

25 comments to Tobacco products directive – poor legislation harmful to health

  • ed west

    Great job Clive.

  • Lordbarby

    Perfect, Clive

  • Vince Wooll

    Well said Clive.

  • Ian Coombs

    Excellent as usual Clive a brilliant, sensible and logical summary of the issues. shame you couldn’t be at the workshop to address all the MEP’s.

    Thanks for your contribution.

  • James

    Aside from that purely made up graph, Charlotta Pisinger is also using this study as evidence for the need to heavily regulate e-cigarettes;

    From the study :


    Methods:

    A Google Internet search was performed using the words “electronic cigarette forum” to identify online e-cigarette forums with “health and safety sections” that allowed posts on the health effects experienced when using e-cigarettes. The three websites with the highest number of posts in health and safety sections were selected for study (Electronic Cigarette Forum posts = 543, Vapers Forum posts = 34, and Vapor Talk posts = 55). Data were collected from posts on these websites through July 15, 2011, and the Electronic Cigarette Forum, which had the most entries, was analyzed in detail. Only data reported directly by an e-cigarette user were included.

    She then posted up a piechart to show that 81% of people reported negative symptoms.

    It’s very rare that people would bother to post how wonderful e-cigarettes have been to their health in those forum subsections – they usually post that kind of postive gratitude in the general vaping subsections.

    People only post in those forum subsections when they are concerned about symptoms they are feeling. No one knows if their symptoms are related to e-cigarette use or not. It’s only because it’s often the only obvious recent change in their life at the time, that they point to it and ask questions.

    Point in case : Myself. 3 months into using an electronic cigarette, I was getting very strong chest pains. I put the e-cigarette away for a week, but the pain continued. Turned out to be nothing related to e-cigarette use. Fixed my Diet up, continued to use my electronic cigarette, and haven’t had any symptoms since. But I did ask about it on the Vape forums at the time. And it probably made it’s way into this statistic that is being used to over regulate e-cigarettes. This is ludicrous.

    Pisinger also notes whether Harm Reduction is “Good Enough?”. That she wants “smokers to quit”. They are quitting. This is purely prohibitionist rhetoric.

    MEPs need to understand that not smoking tobacco is quitting.

    • Jonathan Bagley

      Many of these mainly temporary negative symptoms are a result of giving up or cutting down on smoking. For example, coughing. In any case, no sane person would continue using an ecig were its effects unpleasant. Some people take up jogging and find their feet and ankles aren’t built for it, so they stop. They don’t have the benefit of forums involving thousands of people discussing their problems in minute detail and providing useful information. These contrived objections are laughable. Unfortunately we are funding them.

    • James – thanks for this. It must be one of the worst ‘studies’ ever published.

      • Yes, it has to be one of the worst, and in such an esteemed publication as the ‘Journal of Internet Studies’ no less! One wonders just how many journals they took this to which flat-out rejected it.

        Not to mention the dubious ethics of flatly contravening the Terms and Conditions of at least on of the websites in question (ECF) and using people’s data without their consent.

        I do wonder whether Pru Talbot’s ethics panel even saw the methodology.

    • And did you notice how she followed up her presenting it by saying, “but of course, it’s not science…..”

      So why on earth are you even referencing it? Astonishing.

      Honestly, some of the behaviour I’ve seen from these tobacco-control professionals would have had me thrown off my undergraduate degree course if I’d engaged in similar.

  • As usual: Excellent Clive!

    @James
    Indeed… MEPs need to understand that not smoking tobacco is quitting tobacco!

  • Adrian

    Clive- a devastating critique of a fatally flawed process, just brilliant. How those railroading through the proposed revision to the TPD get away with it is simply beyond me. Can those MEPs on the ENVi committee really be so blinkered as to let them??

  • Zillatron

    Seems some MEPs have read a lot of letters and began wondering. Thanks for your excellent mail. It may have been the straw that broke this desert ship‘s back. There were rather a lot of good questions from them and the audience. She seemed increasingly unhappy when her fellow prohibitionists didn’t have any convincing answers and could only parrot their unfounded conjectures. Her plan – alotting just 10 minutes to pro speakers and parading them as the devil’s advocate or clueless imbecils – obviously misfired.

    Even Ms Ries from France who seemed firmly in support of prohibition before showed some serious doubts.

    I even tried to caution Ms McAvan to get real scientists for this workship. Well, I didn’t really expect my mail to matter much. So when the biased selection met my eye I also put forth some cautionary mail to all MEPs of ENVI where I referred them to you for some words of wisdom.

  • The list of invited experts and lobbyists was heavily weighted to those who favour more regulation or prohibitions.

    Ms McAvans has forgotten one thing about “professionals with reputation”:

    If you invite a pro like this – he will tell the TRUTH, nothing else!
    So Dr. Etter has balanced the scale very well :)

  • James

    Dr Jean-François Etter absolutely nailed it when he pointed out that there are thousands of people who are addicted to nicotine gum.

    It’s not well known or talked about because it’s not a Public Health issue.

    That, just because something is addictive, doesn’t mean it is harmful.

  • […] point-by-point demolition of the revised directive is provided by Clive Bates, a former director of the UK anti-smoking group […]

  • Bill Godshall

    Excellent letter and analysis Clive.

    Snus and e-cigarette prohibitionists (and their Big Pharma financiers) are a far greater threat to public health than the tobacco industry.

    We have similar situations here in the US, especially since Obama stacked DHHS agencies with “quit or die” activists who are so opposed to THR that they’ve conspired to grossly misrepresent the scientific and empirical evidence to confuse and scare the public to get their extremist policies enacted.

    This will go down in history as the most egregious, unethical and inhumane public health malpractice ever committed by public health officials and
    agencies, private health organizations and researchers.

    But first, more public health officials and experts must grow a backbone and speak out against these barbaric bans on snus and e-cigarettes.

    • Big Pharma financiers and the “usual Health lobby” are a great threat to public health, indeed.
      But there might be another player: The Goverments!

      Average 7,8% loss in tobaccotax in Italia!
      Average 6 % loss in tobaccotax in Germany!
      Average 5 % loss in tobaccotax in the USA!

      That´s a hughe loss of money for the goverments. Italy has recently asked the EU Council, what it intends to take to address the loss of income. [1]

      I thought that it was the aim of the FCTC to cut down the amount of smokers and that there will be absolutely no problem with loss of tobaccotaxes, due to a better gross national product and much better health for the residents.

      Goverments fear the loss of tobaccotaxes?

      This subject frightens me!

      [1] http://www.europarl.europa.eu/sides/getDoc.do?type=WQ&reference=E-2013-004672&format=XML&language=EN

  • Geoff Brewis

    Thanks for all your hard work on this, Clive. As a recent convert to e-cigs I would be disappointed to see then banned, over-regulated, or too controlled and commercialised by big business, who may determine the form and price of products available.
    I have written to my MEPs to express my views, and have always emphasised that I have changed to e-cigs because I realised that I didn’t really want to give up nicotine, but entering my 60s I was concerned about my health if I’d continued with tobacco. Soto me, e-cigs are a satisfactory, less risky alternative nicotine delivery system.
    I also pointed out the analogy with coffee, where decaffeinated versions are sold alongside regular, and caffeinated products like Red Bull are perfectly acceptable. Nicotine is very similar in effect, after all.
    Since I did manage to give up for a while a long time ago, one of the things I missed was having something to do with my hands, which e-cigs avoids (in fact as I mix my own liquids it has become a bit of a hobby). The point being that the more smokers who may be inclined to take up e-cigs because they don’t want to give up, who cannot give up, or who may use them as a more preferable way of giving up, the greater the diminution of the tobacco market. Surely then we can reach a tipping point where tobacco products can finally be banned, and that in itself is a powerful argument for facilitating a viable market.

  • richard kirk

    Clive firstly may I just say thankyou for all your hard work regarding this issue, How can a so called panel make informed decisions when they have not carried out any true study. they quote about e-cig users going on forums saying about health issues regarding ecigs, well I for one went on a forum when i first started using, under health, and typed ” why is my throat sore while using e cigs” guess what, it was a normal thing we all get when getting used to them, they have not quoted on the numerous posts where people have stated how much better people feel by using these instead of over the counter death sticks…nar they would rather miss lead the general public by using scare tactics, they omit to mention things like one of the main ingredients is one used in inhalers!!…so are they going to take them off the market..time they woke up to the fact that everything changers, it’s called evolution, well cigs have done this to a far safer why than before,…making me think that they are only thinking of the tax’s they are losing and not the big picture of all the money saved by hospitals with cigarette related illness. please get some proper studies done, and think about the big picture from all sides, and if it is the case they are worried about the nicotine content, we can always buy that separate after showing prof of age and add this ourself…

  • […] than people's lives. This is Big Pharma's attempt to grab the nicotine pie. As Bill Godshall said "This will go down in history as the most egregious, unethical and inhumane public health […]

  • Zillatron

    There is another vexing statement by Martin Seychell at the workshop:

    13:19:57 Rebecca Tylor asks for proof and cites a survey by ASH that found that less than one percent of children who have tried them weren’t already smokers.

    13:20:51 Martin Seychell evades to that obscure hungarian study. […] Even if they were smoking, they wouldn’t be really addicted yet. To be addicted with age 13 they must have started at 9 or 10.

    And that’s supposed to be proof for a “gateway”?

    So, if nicotine takes even in combination with the scientifically proven addiction boosters MAO inhibitors and acetaldeyde three years of use to establish an addiction, what about pure nicotine as in e-cigs?

  • […] really are dong harm.  Which gets back to points I’ve made a number of times [eg here and here]: WHO and many of the public health campaigners  might as well be working as lobbyists for the […]

  • Emilio Passaro

    Hi Clive, this article was so good I emailed my MEP and added my two pence worth, I will post it here if anyone is interested. ref the post by Zillatron, about the comment from Martin Seychell, I am 55 years old and a regular smoker since the age of 12 . I took my first puff at age 8 because that was what the big boys were doing, and by 12, yes I was addicted and still am,even though I am at the early stage of COPD, but its not just nicotine, its the whole thing, the throat hit, the hand to mouth, the exhale, the plume of smoke, the great smell, thats right the smell is great to a smoker he doesn’t even know he stinks. I converted to e-cigs three weeks ago and never want to go back to tobacco, I have already moved on to a modified device and experimenting to find the flavour and nicotine level that suits me and my health improved after only a couple of days, so everything that the EU is proposing is a threat to my continued well being. I think its not just the interests of the tobacco and pharmaceutical industry that are being protected by the EU but also the future loss of revenue that their funding comes from, unless they can stem the growth of the e-cig market. IMHO the only regulation needed is to comply with existing consumer product regulations and a ban on sales to under 18’s, end of !

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