December 10th, 2013

Do a proper job – take e-cigs out of the tobacco products directive and have a new science-based legislative proposal

trialogue negotiation

Trilogue – policy-making in secret

I’ve written to MEPs involved in negotiating the tobacco products directive to argue they should remove the provisions relating to e-cigarettes from the Tobacco Products Directive.  It is important to frame this positively as a way of achieving better policy and in favour of good regulation, rather than merely as a rejection of the current text.  So I prefer ‘bring forward a new legislative proposal’ to ‘take Article 18 out’ – though they are two sides of the same coin.

This follows up my post on embarrassingly poor policy making.

Here is the letter.

10 December 2013
Dear European Parliament trilogue negotiators
I would like to make a few comments in advance of the next stages of the Tobacco Products Directive (TPD) trilogue negotiations.
In summary, the best course of action is to complete the all tobacco parts of the TPD under the Lithuanian presidency, and to insist on a new science-based legislative proposal for nicotine containing products like e-cigarettes. The issue is sufficiently important to justify a high-quality expedited policy-making process, including: evidence-based justification; impact assessment; consultation with users, businesses and public health experts; and proper scrutiny.  In the interim, more could be done more quickly by purposeful application and enforcement of existing legislation in member states.
1. Views of users. I would like to start with a comment from a e-cigarette user left on my web site. This is typical of the sentiments expressed by consumers. They are looking to the European Parliament to defend their health and welfare from inept and inappropriate regulation. Feelings are very strong:

I smoked tobacco for 45 years – the first and only thing that has helped me stop is vaping, which is not smoking. If the EU pass this legislation I will either break the law or go back to tobacco smoking. This is only a “tobacco related product” in the sense that it is helping people like me to give up tobacco. Big pharma and the tobacco industry want control and it looks like unelected bureaucrats in the EU are in their pocket. These proposals are utterly ridiculous and fly in the face of any kind of common sense. We have to hope that the European Parliament continues to treat this garbage with the contempt that it deserves. 

2. Unintentionally supporting the cigarette industry. Many features of the proposals will have unintended consequences that strengthen the cigarette-based business model of the tobacco industry and protect the pharmaceutical industry. There is a double negative at work: tough on e-cigarettes and harm reduction means easy on cigarettes and harm.   Specifically, some examples:
  • Nicotine density limits set at a low level make it easier to obtain a satisfactory intake of nicotine from smoking rather than vaping (a win for cigarettes). If needed at all, the limit should be set at 50mg/ml to allow for innovation and better products for more addicted smokers. It is not really a sensible quantity to regulate.
  • Nicotine caps (e.g. 10mg/unit) can make the e-cigarette products unviable, amounting to a de facto ban, or make it much more convenient to be a smoker than a vaper (a win for cigarettes). There is no need for a cap at all – compliant packaging is the priority.
  • Advertising bans give advantages to incumbents and companies with already established distribution channels (a win for cigarettes). A more proportionate approach would regulate advertising with controls of content and placement – perhaps similar to alcohol.
  • Flavour bans reduce attractiveness, personalisation and experimentation with e-cigs and are likely to reduce switching and increase relapse to smoking (a win for cigarettes). It is an elementary error to believe that teenagers will be attracted to ‘childish’ flavours: they are actually trying to emulate adult behaviour.
  • Product design standards such as constant dose delivery that do not apply to cigarettes are very burdensome and limiting, but completely unnecessary (a win for cigarettes).  Consumers should decide what a good product is, regulators should stick to safety and consumer protection.
  • Warnings, leaflets and labelling that are disproportionate to risk create unnecessary fear and do not communicate relative risk in a way that is meaningful to consumers (a win for cigarettes).
  • Pharmaceutical interests have been active in misleading MEPs about nicotine. A letter from a company full of misinformation and a robust response from three European nicotine experts is (here)
3. Poor analysis underpinning proposals. Much of the analysis that leaks out of the discussions is based on poor understanding – especially on the Council or Commission side.  For example:
  • Extremely naive figures are used to assert equivalence between e-liquid volumes and cigarettes.  It is important to distinguish between two quantities: nicotine in the liquid/vapour and nicotine absorbed – they are very different in both cigarettes and e-cigarettes. Calculations presented by the Commission misunderstand this: 5 minute use of an e-cigarette with 20mg/ml liquid does not equate to smoking a 1mg yield cigarette. The yield is an absorption measure – it would more likely take 30 minutes to achieve the nicotine equivalent of cigarette smoking through vaping. One of the critical weaknesses of e-cigarettes is their inability to compete with nicotine delivery of cigarettes – a regulator that further weakens them is doing no-one any good.
  • Fears are raised of nicotine overdose – this is impossible other than with industrial strength liquids (eg. >300mg/ml) never found on the market. There are numerous misunderstanding about the accident potential with nicotine liquids (see this recent assessment by Professor Bernd Mayer showing that many claims date back to flawed 19th Century experiments and that the generally assumed risks are 10-20x overstated)
  • The assertion that ‘nicotine is highly addictive’ is incorrect and incomplete: it is addictive when delivered in a way that causes it to ‘spike’ rapidly in blood plasma – ie. through pulmonary delivery. It is the cigarette that makes it especially addictive. NRT and e-cigarettes are not as addictive as cigarettes.
  • The recitals contain wild allegations about e-cigarettes for which there is no supporting evidence.  There are no signs of harmful gateway effects, let alone anything that justifies banning advertising or other restrictions and it is important to recognise that a much safer and less addictive product creates many desirable gateways (diverting young people from smoking, substituting for smoking or assisting in quitting completely – see here). The experience of snus – where gateway fears were raised to justify a ban but all the gateways are in fact beneficial – should be a cautionary tale for EU legislators as many have died as a result of this 21-year error (see expert views on this).
  • There is minimal use by children and even where surveys have found children using e-cigarettes it is most likely to be displacing smoking (as with the heavily spun US CDC survey – see critique).
 4. Consumers and most of the industry want well crafted protective regulation – but these proposals do not deliver.  Most of those directly involved want to see the EU and member states establish a stable and proportionate regulatory regime and to deal decisively with any rogue products or vendors. The directive proposals under discussion would not do this.   For example, what is is needed is:
  • a set of standards for e-liquids (e.g. a requirement to use pharmaceutical grade nicotine and excipients and overall purity standards)
  • operating standards for devices (e.g. maximum temperatures, what happens when they run dry).
  • testing protocols that reflect the range of real-world use.

At this stage a process that would develop such standards and testing protocols is essential. This is the normal way to regulate: set reasonable proportionate standards; expect the industry to comply, which it will; adopt a risk-based approach to inspection and compliance.  I have set out some ideas for a broad regulatory framework in paragraph 8 below.

 
5. Medicines regulation is now a distraction. The arguments against regulating e-cigarettes as medicines have been well rehearsed (e.g. here), but are more familiar to the Parliament than to the Council, which appears determined to work around the Parliament’s position either by making the alternative to medicine regulation impracticable or by using Article 24. This is now a distraction from achieving a proper regulatory grip on e-cigarettes. The medicines approach has been repeatedly struck down in member state courts, the Parliament’s Legal Affairs Committee found it to be disproportionate, and there is solid evidence that a challenge is likely and likely to succeed. There are even rumours that the Council Legal Service believes there is no legal base for regulating e-cigarettes as medicines. What is needed now is regulation that is fit for purpose and designed for e-cigarettes – not something designed for medicines or tobacco products.
 
6. The wrong way to make new policy. The most serious concern about the trilogue process is that it is a very unsatisfactory way to make new policy for important products that could provide benefits to millions and pose little risk in themselves. Trilogue works best when it is used to close differences in well-developed positions that are conceptually similar but not identical.  Such a closed process is poorly suited to defining new policy. The trilogue process lacks four fundamentals of EU policymaking – and these are requirements under the treaties: (see more on this here):
  • Evidence based justification – especially to justify departure from the principle of free movement of goods on health grounds.  The evidence base for the proposed measures is poor to non-existent.
  • Impact assessment and options appraisal – there has been no attempt to gauge the impact these proposal on users and businesses, or the wider population, including for unintended consequences – such as closing businesses, black market support or more smoking.
  • Consultation – it is extraordinary to see the legislature defining entirely new measures with consulting the millions of users, thousands of businesses and dozens of experts with a legitimate point of view. It is not surprising that the EU can seem high handed and remote when this happens.
  • Scrutiny – national parliaments scrutinised the Commission proposal and some may have scrutinised the Council General Approach.  But since the Parliament’s very welcome intervention, the proposal has changed beyond recognition and expanded to five times the length.
7. The right thing to do. The most appropriate course now is as follows:
  1. Complete the Tobacco Products Directive for tobacco products – all but Article 18 – in December under the Lithuanian presidency.
  2. In the interim ensure members states purposefully apply and enforce the existing body of safety and consumer protection legislation and expect the industry to comply and raise its own standards. This would deliver immediate benefits and should prompt the industry into raising its own game.  For example it should be assumed that the general safety requirement means use of pharma grade nicotine and excipients and food grade flavourings – and there are other standards that could be applied from now.
  3. Bring forward and expedite a new science-based legislative proposal with a proper legislative process, involving: evidence based justification, impact assessment, consultation and scrutiny as discussed above.  This should conclude rapidly, and be implemented quickly.  The EU legislature, Commission and members states have much greater knowledge of these products than only one year ago.
8. Develop an health-optimising regulatory framework. To give some idea of of what should be included, I have listed elements below  – this should be designed carefully and implemented at EU and member state level as appropriate. It should develop over time and include:
1. Advertising. Limits on advertising content and placement roughly comparable to controls on alcohol advertising – not a complete ban – with appropriate role to member states for advertising that does not cross borders. The aim of this policy should be to discourage advertising that appeals to children, but encourage smokers to switch.
2. Age restrictions. A ban on sales to persons under age of 18 – likely to be a member state issue.
3. Testing and notification regime – covering testing of liquids and vapours for harmful and potentially harmful substances.  There is a similar requirement in Article 17 of the revised tobacco products directive for novel tobacco products – the testing demands should be no greater than these.
4. Product standards – e-liquid purity. Limits to contaminants or purity standards for e-liquids (eg covering carbonyls, volatile organic compounds, nitrosamines and heavy metals), with requirements to use pharmaceutical grade excipients and nicotine, and food grade flavourings.
5. Product standards – liquid ingredients. A negative list of prohibited flavours where there is evidence of harm either to the user or where there are signs of disproportionate or deliberate appeal to children (this can only be determined ex-poste – once products are on the market) and other additives (eg. stimulants, vitamins) set out in a schedule with a mechanism to update in the light of advancing knowledge.
6. Product standards – devices. Standards could be set for maximum operating temperature and behaviour when liquid levels are low – and other relevant design parameter to assure safe operation or to limit changes to the chemistry of vapour. These could be developed as CEN/ISO standards for vaping devices with CE markings for consumer information. There is no reason to prevent refillable devices – if superior products can be made with cartridges.
7. Packaging. Safe packaging for e-liquids (comparable with bleach) and compliance with the Classification, Labelling and Packaging Regulation where appropriate.  This is a better safeguard than limiting total nicotine in a container.
8. Labelling. Warnings and other communication proportionate to risk and recognising significant potential benefits to smokers who switch.  Consumer information should be helpful to consumers and be even handed about risks and benefits. This should also include traceability requirements to allow for product recalls.
9. Accountability arrangements – designation of a responsible person(s) in manufacturers, importers and distributors to discharge regulatory obligations.
10. Product file  and safety assessment – a dossier on the product characteristics, tests done etc. and assessment of risks and measures taken to mitigate.
11. Surveillance. Members states should conduct or support independent surveillance of the evolving nicotine market – this is preferable to each vendor doing it, though members states should recover costs.
12. Technical committee and delegated powers – advisory machinery as appropriate to advise on standards and update in the light of advancing knowledge
13. Rapid implementation – aiming to have this in force as soon after 2017 as possible – it does not all have to be complete out the outset if there are powers to amend.
I must emphasise that this framework is indicative.  The disciplines of proper policy-making, consulting users, businesses and experts is the right way to reach the most appropriate framework.
I hope these views are of interest – please do contact me if I can be of further assistance.
I wish you well in the negotiations. It isn’t too melodramatic to say that thousands of lives depend on the outcome. 
 
Yours sincerely
….

18 comments to Do a proper job – take e-cigs out of the tobacco products directive and have a new science-based legislative proposal

  • Junican

    Better still:
    1. In view of the new evidence which is appearing almost daily that SHS is harmless for all intents and purposes, drop the whole fraudulent directive and stop persecuting adults who enjoy tobacco.
    2. Investigate the chain of command which exists between the WHO, EU Tobacco Control Dept and NGOs generally with a view to revealing the fraud and bribery.
    3. Propose a new directive making the fraudulent claims of junk science a criminal offence.

  • Zillatron

    I agree. This would be the most sensible course.

    While the Parliament has shown more common sense than I dared to hope after that grootesque ENVI debacle, I can’t see any improvement in Commission or Council.

    Even for Parliament to see a spark of the light, there had be a lot of nonsensical “regulations” in AM 170 to satisfy a lot of craving for actionism. As a compromise AM 170 is quite stifling and far from what I would consider “good”. But at least it’s bearable, not totally crippling.

    So I guess even the partially enlightened Parliament wouldn’t leave the e-cig “totally unregulated”.

    So my proposal for a compromise, that would pass the Parliament, is:
    Accept AM 170 as it is as a temporary solution until a sensible separate regulation – like you delineated – is enacted.

  • Jonathan Bagley

    A small technical point. “….operating standards for devices (e.g. maximum temperatures, what happens when they run dry)”.

    With clear refillable tanks, you can see when you are almost out of liquid. With disposable cartridges, you can’t. That’s why kettles with a visible column of water down the side have become popular. These things solve themselves. Nobody wants to vape burnt liquid.

  • lizzie

    Taking e cigs out the TPD is the common sense answer. Especially as the EU commission doesn’t seem understand e cigs or the people that use them. They say nothing of what the consequences will be if their proposals are allowed to go ahead. Obviously they don’t care.

    As one American Politician said, “we’re punishing people who are trying not to smoke”.

  • Mike Brown

    It is clear to me these spokesmuppets (McAvan and Chums) have been bought and paid for by Pharma and Tobacco, the TPD is a farce and it does absolutely nothing to stop children taking up smoking, at the same time it kills their competition snus and soon ecigs.

    Children don’t care what brand or colour packaging cigarettes come in, they don’t care for flavours, just like with adults warnings and scary pictures have no effect either, they’ll just continue to buy the cheapest brand.

    Thanks to the new amendments soon it will be easier for them to steal a cigarette from their parents pack of 20’s than a 10 pack making it easier to go unnoticed too.

    The only things that need to be done if they really were thinking of the children and the health of the population would be:

    Laws requiring for the sale of Alcohol, Cigarettes, Adult Mags/DVD/Video, all NCP (includes ENDS) etcetera to persons 18 years of age and over, ID card required if they look under 21. A 10,000 euro fine for each breach.

    Police powers to arrest under 18’s in possession of items covered in the 18+ Age Laws, with a 50 euro fine payable by Parent/Guardian of the child. School teachers required to report incidents.

    Advertisement of age restricted products not to be targeted to persons below that age.

    Enforcement of existing consumer product laws already in place for ENDS.

  • Kurtis

    The age restriction has also been removed from the new draft of Article 18 … strange. What about the ‘gateway’ arguement? And protecting the kids? But obviously there must be some public health arguement for this.

    A comment on ukvapers: “As how I read the proposal it is tailor made for Big T’s disposable e-cigs which are used by smokers in situations where smoking is not allowed.”

    Certainly looks like it.

    • Clive Bates

      Age restrictions are the preserve of member states – no EU competence.

      • Kurtis

        Mildly surpised that the officials drawing up the original draft were not aware of this …

        As regards the removal of the restrictions on the use of tobacco brand names: I suppose one could argue that it would attract brand loyal smokers to e-cigarettes of their usual brand and thus reduce smoking … and no doubt this was argued …

        But the main points I think are the ban on refillables and the liquid content issue … and it’s important not to lose sight of that as it would ‘ban’ pretty much anything attractive out there.

        You are abolutely right about this whole e-cigarette issue not belonging in the Tobacco Products directive in the first place.

  • Kurtis

    The age restriction has also been removed from the new draft of Article 18 … strange. What about the ‘gateway’ arguement? And protecting the kids? But obviously there must be some public health arguement for this.

    A comment on vukvapers: “As how I read the proposal it is tailor made for Big T’s disposable e-cigs which are used by smokers in situations where smoking is not allowed.”

    Certainly looks like it.

  • Graham Clark

    This totalitarian nonsense must stop. It is simply incredible that devices which are widely believed to be significantly less harmful face a Dr facto ban whilst killer cigarettes remain largely unaffected. If this were a plot from a film it would be torn apart as too far fetched to be credible. Anyone who fails to see how corrupt this is are blind. I’ve always smirked at conspiracy theories but I have followed events closely for a year now and I am truly sickened to think that the EU commission is either this ignorant/misguided or outright corrupt.

  • Linda

    Very realistic and sensible proposal.Once again Many Thanks Clive.

  • Kurtis

    Curiously enough the following has been dropped completely from the newest text of Article 18 of the Directive:

    “Brand names have the potential to attract consumers and maintain their brand loyalty. The strength of tobacco brands names could lead to attracting people – especially young people – to buy and use electronic cigarettes marketed under the same brand. Moreover the use of tobacco trademarks, brand names and symbols for electronic cigarettes could indirectly promote smoking and encourage parallel use of traditional cigarettes and electronic cigarettes.Their use could also undermine national legislation limiting the advertising for tobacco products. Therefore the use of tobacco trademarks, brand names and symbols for electronic cigarettes is prohibited under this Directive.”

    It has been replaced with a pretty vague paragraph that basically leaves national advertising to members states.

    No e-cigarette companies I know are actually using tobacco brand names. And I don’t recall any pro-vaping groups or individuals demanding e-Marlboros and e-Dunhills. Somebody must have objected though. One wonders who. But obviously it must have been on public health grounds … Scrathing my head here, just can’t thing what they might be. Can anyone help?

    Or am I halucinating?

    • Zillatron

      Well, the latest leak was the Council‘s sales pitch. The equally appalling junk before was from the Commission.

      The apparently just copied it and tweaked a few bits and pieces so that is better palatable for their pals from Big Tobacco. The Commission obvious would prefer to serve the ruins of the e-cig market to Big Pharma on a silver platter.

      So the Big vultures are already circling and jostling for a bigger share, while their friends, the jackals are still trying to kill the intended victim.

  • Dan

    Intelligently and well written as ever.

    I hate to be cynical but I just can imagine that Pharma will go for your ideas and it seems they are the ones who truly hold the power here. I truly hope to be proven wrong on this point.

    Thank you on behalf of all vapers and future vapers for working so hard on this.

  • Would I break the law to continue vaping?
    Yes.
    Would I support a black market to maintain the availability of a proven safe product?
    Yes.
    Will I fight until my dying breath to preserve our right to choose a safe option?
    Yes.
    Are my lungs 21 years older than me due to 40 years of smoking?
    Yes.
    Have I vaped safely for over FIVE YEARS?
    Yes.
    Do the Eurocrats have a clue what they are doing?
    NO.

    Vape Free Europe – we will not accept anything less.

  • Kurtis

    Nicely argued.

    Danish pharma companies (the letter to the MEPs) and French tobaconists (Toulouse court case) both doing their best to restrict vaping decices and liquids … strange bedfellows indeed … hopefully the MEPs and the general public will see this and draw some fairly obvious conclusions.

    This petition needs to be signed:

    https://secure.avaaz.org/en/petition/The_European_Parliament_Save_electronic_cigarettes_from_excessive_EU_regulation/

    For readers who can speak German:

    http://www.youtube.com/watch?v=kA8bKZcoz-Y

    Keep calm and keep vaping … and write a letter to your MEP and other representatives.

    Kurtis

Leave a Reply

You can use these HTML tags

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>