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