Making sense of the proposed new e-cigarette regulations

Making sense of the proposed new e-cigarette regulations
Guest post by Clive Bates.

Half full or half empty?
Half full or half empty?
 
As the final negotiation over e-cigarettes in the tobacco products directive drew to a close. a nameless ‘senior diplomat involved in the negotiations’ was quoted in The Guardian. They were talking about e-cigarettes: It’s inhaled. It’s direct inhalation of nicotine into the lungs. That creates an addiction very fast… It encourages a switch to real cigarettes.” 
This is wrong in every respect – and not one scintilla of evidence justifies it, but plenty confounds it. So how come someone so ignorant is meddling in legislation to regulate products that are in fact amazingly positive alternatives to smoking? Why did the Guardian feel obliged to conceal the identity of this person?  So that a public official could remain unaccountable for their rogue opinions or propaganda statements?  People look at that sort of thing and rightly ask: “what do they know? And why are they in the room deciding on something important to me, when I’m shut out and no-one is listening to me and my experience?”.  I agree completely with this view – the e-cigarettes parts of the directive have been negotiated in secret, in insular meetings, where any old nonsense is treated as fact, and where evidence is brought in to support political decisions, not to inform policy.  Above all, they do not seem aware of the astonishing arrogance of agreeing something like this without consulting the millions of users and thousands of businesses affected or the dozens specialists who do the science and know the evidence?  For me, poor policy-making process is the reason why we end up with poor policy.  I’ve argued on my own blog that ‘embarrassingly poor policy-making‘ is the primary problem – poor legislation is the result of that. The right thing to do would have been to take out the e-cig proposals and do the job properly. But politicians and civil servants see themselves as heroic actors and don’t easily recognise the shortcomings of the processes in which they are playing a central role.
So what have they some up with?   
The e-cigs text, like the rest of the directive is a sprawling mess, with many arbitrary and disproportionate measures fiddling around with product design and commercial freedoms.  As a public health measure it is poor.  As a consumer protection measure it is poor.  As an EU internal market measure it is poor.  The main defence for the text as it stands is that it could have been much worse – and this is true.  We do owe thanks to MEPs like Chris Davies, Rebecca Taylor and Martin Callanan who have fought the good fight for vapers…  I only wish they’d succeeded in pulling it out and getting a new directive.
The main problem in general has been the obsessive focus on minor or implausible risks at the expense of the potential huge gains to smokers if the e-cigarettes can be made attractive enough to encourage switching.  Instead they have tried to make e-cigs deliberately unattractive, supposedly to protect non-smokers – but this is a serious public health miscalculation, given the minimal risks to the latter and huge benefits to the former. The public health establishment has done much to encourage that and has shown it has not learnt any lessons from its 21 year lethal error in supporting a ban on snus.
Compared to the darkest days of the worst proposals, the final text is not all bad and some of the most ridiculous ideas have been seen off in the negotiations.  In the end it has came down to frantic late night negotiation over rather weird things:
  • Maximum nicotine density for e-liquids now at 20mg/ml.  Completely counterproductive – limiting e-cig appeal to heavier smokers, preventing more compact energy efficient devices, and blocking future innovations.  And cuts through the ranges of the major manufacturers.  But significantly lower thresholds were under discussion at one point – the Germans wanted 5mg/ml!
  • Maximum nicotine quantity per single use cartridge – at one point an unfeasible 10mg – now specified as 2ml (therefore up to 40mg if the liquid is 20mg/ml) in a single use cartridge. There was no need to limit this quantity at all as safety concerns are addressed through packaging standards.
  • Maximum refillable container size of 10ml has been agreed.  Stupid and pointless, but not fatal as I think quite a common refill size.  We would normally control risks from hazardous liquids by packaging and labelling – not by reducing the size. Imagine if we took that approach to bleach or drain cleaner.
  • No EU ban on refillable (2nd and 3rd generation) devices.  This was in prospect but has been successfully thwarted – though with some strings. The Commission will have powers to ban them if three members states do and they can justify it on proportionality grounds – though this is more likely to apply to a specific dodgy product than the entire refillable category.
  • No EU flavour bans. Regulations are to be left to the members states. At one point they wanted to allow only flavours approved for use in NRT, which would have been absurdly limiting.  But now we will probably end up with lots of arbitrary rules based on the wrong assumption that adolescents want to use flavours that are childish.  I reckon if there was anthrax flavour it would be more popular with them than strawberry sherbet or. whatever…
  • Many forms of advertising, sponsorship, promotion, product placement – TV, radio, cross-border – are banned.  This is ridiculous and disproportionate – and will cause all sorts of damage (eg. to sponsored forums).  The products are much less dangerous than alcohol and could be regulated with a code – as the UK is planning to do.
  • Cross border distance sales - these can be banned by member states, but are not automatically banned.
  • Lots of testing, reporting and compliance requirements – but no pre-market authorisation regime, which would have created major political and administrative barriers
  • Age limits. Not included as these are a matter for member states.
  • Medicines regulation – they seem to want the flexibility to regulate e-cigs as medicines at national level.  Heads in the sand on this, given they keep losing in court. 
  • Timing.  Looks like intent is to bring in the measures 24 months after entry into force (likely May 2016) with possible additional 12 months for non-compliant products already on the market – this is one area that is unclear in the drafting.
  • A number a strange statements are made in the recitals to justify the measures,  for example about a gateway effect – something there is no evidence for at all.
Missing things
They don’t seem to have set up a proper basis for setting agreed purity standards or operating standards for devices.   That might have been useful. 
They don’t seem to have given any thought to unintended consequences – black or grey market, DIY, non-nicotine products, internet trade etc
 
An end to free speech?
Many people have picked out what sounds like a draconian curtailment of free speech in paragraph 5 of Article 18  “any form of public or private contribution to [media] with the aim or direct or indirect effect of promoting electronic cigarettes is prohibited“.  It isn’t actually – the key word is ‘contribution’, which means ‘paid for’ with the aim of promoting a product.  Brussels speak for advertising, sponsorship and promotion – as already used in the directives that ban tobacco advertising.
Legal challenges?
i mention the EU internal market above, because that is the legal base for this measure – it is supposed to support the free movement of goods around the EU, albeit with a high level of health protection.  But departures from free movement principle on health grounds do need to be based on evidence and be proportionate and non-discriminatory – and many of these are not.  It remains to be seen if anyone has both the intent and muscle to challenge any of it in court.
What happens next? 
It’s not law until both the full European Parliament and European Council (member states) agree the text.  The EP is likely to vote on it at its January or February plenaries (w/c 13 Jan, 4 Feb, or 24 Feb) but a date is not yet set. If EP agrees it goes back to the European Council for final rubber stamping – then becomes law. If the EP amends or votes it down, then it goes to a second reading or the Council can accept the EP amendment.  The UK government will also have to go into the Westminster parliament and defend its approach before it can sign up to the text at the European Council.
E-cig industry
Industry attention will turn to what many of the more vaguely expressed measures actually mean in practice….
- What will the definition of “consistent dosing” be? Will there be a standard deviation? What will this be and do current product lines respect it?
- How will manufacturers be asked to report nicotine uptake? Does this require a PK study? Are there other ways it can be done?
- How will the technical standards of the refill mechanism foreseen for bottles be drawn up?
- What kind of toxicity data will be required?
- What kind of emissions data will be required?
 
What can vapers do…? 
1. At every opportunity write to MPs, MEPs and ministers and keep making the case relentlessly. Watch forums for tactical advice on when and who to contact and on what theme.
2. Consider political strategy for the directive  – come out fighting or move with the punch…?
Come out fighting? Should we try to get this rejected at the European Parliament plenary? One approach would be a simple ‘delete’ amendment, replace with “The Commission shall consult and publish a review the risks, benefits and regulatory arrangements for e-cigarettes within 12 months and bring forward legislative proposals as appropriate”.  The value of this depends on the prospect of securing a majority in the European Parliament – that is still hard to gauge at present.  It would be necessary to show some fairly blatant unintended consequences or harms to convince MEPs to go out on a limb for this.
Move with the punch? Focus on making the implementation work and pressing for flexibility where there are obviously errors. Working out what it means in practice and focussing on implementing regulations.   We would need some key flash points to tackle with this,
3. Recognise that product regulation is one battle of many.  There is still huge work to be done on many fronts: vaping in public places: the attitude of NHS, Directors of Public Health and local authorities; keeping the MHRA in its box; and generally winning a propaganda war in which supposedly respectable organisations are playing dirty and elements of the media are taking every opportunity to have a go.
Clive Bates

Twitter: Clive_Bates

25 thoughts on “Making sense of the proposed new e-cigarette regulations

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  2. My2cents: This is one of your best articles, chapeau. And I would like to add that the tobacco industry may have convinced the EU arguing that refill containers are as easy to tax as cigarette packages. They offer suitable e-cigs which provide the rquired constant amount of nicotine per puff (e.g. Vuse). If this is true a lot of other topics are easily understandable.

    We must understand that a few vapers are not enough to force the EU in whatever direction. We need the help of smokers and nonsmokers. And we have to find common ground. Imo the resistance against the nanny state and against any kind of arbitrary law making may forge us together. We had very successful twitter actions during the last weeks. Just imagine what we can do together!

  3. As I predicted a long time ago, the medicalisation proposals were a stalking horse for the real endgame: classifying ecigs as a tobacco product, and then shutting them down via a two-part strategy in which (1) regulations can be deemed to have the least-favourable interpretation, and (2) a wedge method in which more strict measures can be introduced.

    If we allow this text to pass, you can guarantee a 50% reduction in legal sales, followed by incremental enforced drops year by year, until ecigs are virtually 100% black market.

    The current proposal should be resisted. Representatives should be encouraged to vote against it: they have done a wonderful job so far, but are not capable of seeing that the EU strategists cannot accept ecigs reducing/removing cigarette sales and will therefore use any measures possible to enforce as close to a total ban as they can arrange.

    Our strategy, therefore, must be to resist the the TPD as strongly as possible. Our *fallback* position is to live with the proposals (as these two positions are not mutually exclusive). If the TPD goes through, it will be turned to the advantage of the smoking economy protectionists, and used to gradually restrict ecigs to the point where they are useless – which is what this is all about.

  4. We should find a rich sponsor who pay every vaper the travel-ticket and a night in a hotel. Then we should get as many vapers to brussel as possible (50000 should be ok) and just storm that idiotic EU, get those few guys ruining our lifes and show them what we want. As long as they do not fear us, they will never listen to the people. For decades now the always tell the people to demonstrate in a friendly way. WHY? They just want to be able to do what they want without personal risks. In former times the bad kings got their paycheck by the people… But now everybody is just sitting at home, twittering useless messages to EU-politicans and hope they will listen. THEY WON’T! THEY NEVER DID!

  5. - What will the definition of “consistent dosing” be? Will there be a standard deviation? What will this be and do current product lines respect it?

    With my pedant hat on,the equivalent NRT product – the inhalator – has a widely varying dose dependent on temperature – from the assessment:

    “The biologically available dose is increased by approximately 29% at 30°C and 48% at 40°C as compared with the available dose at 20°C”

    It would seem perverse to require a higher standard from a tobacco product than from a medicine?At least,the temperature range for an ecig is known – even if it falls in proportion to battery discharge

  6. One might reasonably ask, “Why are these people who hate tobacco militating against a non-tobacco product?” One answer is that they want to protect their remunerative industry. But I think that there is a simple explanation which does not require dishonesty, which is that the Tobacco Control Industry does not want to lose control.
    Enormous amounts of effort, time and money over the past several decades have been spent on gaining control over the tobacco industry and people who enjoy tobacco. E-cigarettes are spoiling the party. People who enjoy tobacco have found their own way to control themselves by taking up vaping and removing practically ALL the reasons which enabled The Tobacco Control Industry to control their actions.
    That, in my opinion, is the reason that The Tobacco Control Industry wants to get its hands on ecigs.
    A serious problem for vapers is that the so-called representatives of the UK Government are actually working for The Tobacco Control Industry. And I suspect that the same holds true for most of the representatives of other States. I do not understand why The Cabinet of the UK Government is allowing this misrepresentation.
    ———-
    I do not know if it is possible, but it would be a good idea to go through the proposals very carefully looking for those provisions which are based upon “a risk of a risk”. By that I mean provisions which do not deal with known risks which exists NOW, but which are considered to be possible risks in the future, but for which there is no evidence NOW. Describe them simply and make sure that your MEPs are aware of them.

    • Junior public health ministers come and go with indecent haste – here today,gone tomorrow – to quote Robin Day.Policy is controlled by the senior civil servants like Andrew Black and,no doubt,the senior figures in the MHRA.The degree of influence the pharma and tobacco industries have on them is open to speculation – there is no doubt about the level of influence that the tobacco control alliance have on them – who could gainsay ASH,CRUK,RCP,BHF BMA et al, even if they wanted to?There is an APPG on smoking and health to generate and maintain an appearance of democratic input from MPs and the lords.

      All ‘i’s dotted and ‘t’s crossed – what could possibly go wrong?

    • A bunch of us are planning an analysis including conflicts with other regulations, mad or impossible demands, implementation issues, conflicts with the treaties – essentially to respond to the consultation they haven’t held. Hopefully quite quickly.

      • There is a revised ecig factsheet from the Commission which sets out some justifications for the agreed text

        http://ec.europa.eu/health/tobacco/docs/fs_ecigarettes_en.pdf

        The fundamental argument is which form of regulation will lead to the highest level of health protection – real improvement for 125m EU smokers versus an unquantifiable hunch that some children will only become smokers via the ecig route.

  7. We have known for decades that if we could deliver the nicotine without the smoke we would essentially end the epidemic of smoking-caused disease. We now appear to have products that can do that in a way that is acceptable to a great many smokers, and R&D efforts that are rapidly increasing the ability of these products to reach far more smokers. It has the makings of a ‘seize the moment’ opportunity on par with the eradication of smallpox in terms of the lives that can be saved. If those seeking to put barriers in the way of such products cannot instead see the potential public health opportunity that would come from more informed policy making, we are witnessing a collective failure of imagination of epic proportions and truly deadly consequences.

  8. This legislation doesn’t just hit DIYers. This effective bans all current ecigs on the market.

    requirements from P3:

    f) electronic cigarettes deliver the nicotine doses consistently;

    h) electronic cigarettes and the refill containers are protected against breakage and leakage and have a mechanism ensuring leakage free refilling.

    know any current products like these? E-cigs are banned when this becomes law.

  9. Another excellent article, please keep up the good work.
    I am planning to write a my MP emphasising EU bureaucrats making bad legislation. She is anti EU so this is the method that will best get her attention. That and the restriction on small innovative UK businesses by over burdensome legislation.
    I can argue that quite well but the problem is,the ace in the hole that will always be pulled out by those justifying this type of ban is children’s welfare. It requires no evidence what’s so ever and is virtually unassailable. My MP may hate the EU but she will not be associated with anything that could harm the children. Link that with words like gateway and addiction and nobody wants to be seen on the other side of the argument.
    The example in the daily mail last week saying ”12% of students who use them have never smoked a conventional cigarette’ been used to reinforce this view. The atrocious level of numeracy clearly helps them.
    How to we get the headline 88% of Students using e-ciggertes are using it as an alternative to cigarettes. Now my headline is not very good, I have problems like wanting to be accurate in what is been implied and cite sources, the daily mail been what it is never bothers with details like that.
    So how do we get headlines showing that Personal Vaporising is a gateway to escape the dangers of cigarette smoking and the deaths caused by that addiction. That this legalisation is an attempt to close that gateway. Does the data exists (i have no idea whether the daily mail article is based on any real facts and figures) which could be used to project potential numbers of lives saved among today’s school children.
    I hate this sort of thing, but Journalists are predominately lazy (my apologies to the exceptions) and will quite happily grab any story that as some currency and does there work for them. Somehow we need to change this from been a danger to children to something that helps those who fall prey to the evil cigarette etc. The obvious danger is to be seen in any way as encouraging children to use e-cigarettes. The other problem showing the effectiveness of Personal Vaping as smoking prevention device is falling back into the hands of medical legislation.
    Anyway that’s my bit of ramble, I still think the Satanica Fake Public Relations memo http://dropproxy.com/f/554 was the best analysis of the legalisation. Unfortunately the people behind the scenes understand the Screwtape Letters better than the victims.

    Again thanks for the outstanding work you do

    Tony

    • Following my last post , The Daily mail could write
      ‘In Secret Meetings EU Bureaucrats devise laws that will cause the deaths of Hundreds of Thousands of Britain’s’
      Future generations of British Children will be deprived of the benefits of e-cigarette and left at the mercy of Big Tobacco. Fred from Hartlepool who successfully escaped is 60 a day addiction using e-cigarettes says, what will my children do.
      Doctor Harry says etc. etc

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  12. Take a closer look what the ‘refill container’ means. It is the same e-liquid in a bottle which has been tested with the device described in the section 2. So this directive will remove quite a lot e-liquids from the market since there is no rules to certify e-liquids only.

    So this is the way they will ban e-cigs. It is just hidden into the directive. Also it is the reason why there is no need to ban 2nd or 3rd generation devices because you cannot find nicotine liquid for those devices anymore.

  13. I was filling (re-filling?) my wife’s lighter this morning and I thought …. Oh!!!

    The container (as people will be aware) is a pressured can of inflammable gas/liquid. The gas is emitted when the nozzle is compressed, thus opening a valve. The nozzle is inserted into a valve in the bottom of the lighter, which opens when the nozzle is pushed into it.
    The can of gas comes with a variety of small variants on the standard nozzle, but, these days, it is rare to find a lighter valve which is not standard.
    So, there you have the beginning of a solution to the silly demands of the Zealots. The simplest solution? Very simple – a container similar to super glue – provided that the contents are not acidic, and I don’t think that nicotine is acidic, is it?

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  15. Pingback: EU tobacco directive and e-cigarettes: maladministration complaint to European Ombudsman « The counterfactual

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  17. I think that the creation of e-cigarettes is one of the single best ways to kick the habit, and I’m a huge advocate for the industry. Unfortunately when something is successful, our government has to get their paws on it as they do anything that can make money on.

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