Here is my letter to MEPs who are members of the ENVI committee of the European Parliament. ENVI meets on 22 January to consider the Tobacco Products Directive text (PDF). The sections that deal with electronic cigarettes are mostly Article 18 with cross-references to other articles. This letter is my best shot at saying what’s wrong with how the directive addresses e-cigs, please make further suggestions in the comments.
__________________ LETTER TEXT ________________
To: Members of the ENVI committee, European Parliament
CC: Substitute members of the ENVI committee
From: Clive Bates
19 January 2014
On Wednesday 22nd January members of the ENVI committee will consider the text for the revised Tobacco Products Directive that has emerged from the trilogue process. I would like to draw your attention to the significant weaknesses in the text as it applies to e-cigarettes (primarily Article 18, with cross references to other articles).
I hope you will consider speaking, voting or persuading colleagues in favour of recasting the part of the directive relating to e-cigarettes as a new legislative proposal built on credible science, due process and adequate legal base.
The underpinning science is flawed and misrepresented. Two individual scientists and a group of scientists have rejected the underlying science in letters to the Commission and key MEPs:
10 January 2014. Dr Konstantinos Farsalinos wrote to the Commision: The European Commission has misinterpreted my scientific research on nicotine in e-cigarettes
12 January 2014. Dr Lynne Dawkins wrote to the Commission: Please do not distort my words to justify your policy
17 January 2014. A group of eminent international experts in nicotine and tobacco science have made a broader challenge: Scientific Errors in the Tobacco Products Directive. This group includes: Professor Jean-François Etter, Dr. Konstantinos Farsalinos, Professor Peter Hajek, Dr. Jacques Le Houezec, Dr. Hayden McRobbie, Professor Chris Bullen, Professor Lynn T. Kozlowski, Dr. Mitchell Nides, Professor Riccardo Polosa, Dr. Karl Fagerström, Professor Martin Jarvis, Dr. Lynne E. Dawkins, Dr. Pasquale Caponnetto, Professor Jonathan Foulds.
The scientific errors listed are not trivial and in fact underpin the most controversial aspects of the directive. They related to:
- Incorrect assertion of ‘equivalence’ between smoking and e-cigarette use
- Greatly exaggerated toxicity of nicotine
- Poor understanding of nicotine using behaviour to justify inappropriate tests
- Inappropriate assertion of user requirement for consistent dosing based on misunderstanding of consumer behaviour
- Inappropriate approach to risk management (by limiting container size)
- Incorrect assertions regarding ‘gateway effects’ to exaggerate risks and to justify advertising bans
- The requirement to consult – there has been no consultation on the new proposals, though the new regulation will affect millions of users and thousands of business and are subject of great controversy among experts. The 2010 consultation simply asked if nicotine containing products should be included in the directive.
- The requirement to provide reasons – virtually no argument has been offered to justify the measures, and to the extent there is any, it is based on scientific misunderstanding (see above).
- The requirement to provide an impact assessment – no new assessment has been produced to support the new proposals, yet they could have serious negative effects on users, distort competition in favour of smoking, impose high and unnecessary burdens on businesses and consumers, and have an overall negative impact on health in Europe.
- The requirement to allow scrutiny – legislative proposals and amendments should be sent to national parliaments for scrutiny with time for parliaments and governments to react. The proposal has changed beyond recognition since it was circulated in December 2012. If they see it at all, national parliaments will only see it at the very last minute before a deal is done and not through the proper process.
- Advertising bans. The directive bans many forms of advertising, promotion and sponsorship in many media. Why? Advertising is a service in its own right and integral to free movement of goods. The 2003/33/EC tobacco advertising directive recital (3) refers to 500,000 deaths among Europeans as part of the justification for banning tobacco advertising. There is no equivalent rationale for e-cigarettes – indeed e-cigarette advertising may drive switching from smoking and be beneficial to health. A more proportionate approach would apply the type of restrictions applied to alcohol advertising in member states, not tobacco. Verdict: disproportionate, no health rationale, no legal base.
- Limiting the strength of liquids. Based on a flawed assertion of the equivalence between cigarettes and e-cigarettes a limit of 20mg/ml has been set for e-liquids, yet 20-30% consumers currently use stronger liquids. What is the health rationale for imposing this limit and denying consumers and producers of stronger liquids access to the internal market? Stronger liquids matter to more heavily addicted smokers and those just beginning to switch, so this arbitrary limit is more likely to increase relapse and protect the cigarette category. Verdict: discriminatory, no health rationale, no legal base.
- Imposing small container sizes. The proposal aims to control acute toxicity risks by limiting the container size. The reasoning greatly overstates toxicity risks and ignores the widespread practice of controlling hazardous substances through labelling and packaging, not least under the EU Classification, Labelling and Packaging Regulation 1272/2008. Verdict: discriminatory, no health rationale, no legal base, risk covered by other legislation.
- Ban on mentioning flavours on flavoured products. The interaction between 18.4(b)ii and 12.1(c) has the effect of banning any reference to flavours on e-cigarette or refill containers, even on products that are flavoured – so depriving everyone involved of legitimate information about the product. Verdict: in legal terms, disproportionate, no legal base. To everyone else, a fiasco.
- Insisting on consistent ‘dosing’. This is a matter for consumer preference and has no health rationale given the way consumers use nicotine (see flawed science above), yet it is technically difficult to do. This has been imported from medicines regulation, where drug dosing to passive patients is an important requirement, but it is not appropriate here. Verdict: disproportionate, no health rationale, consumer protection covered by other legislation.
- Excessive warnings and information leaflets. The warnings are factually incorrect (nicotine is not ‘highly addictive’, it depends how it is administered), excessively large, bold and off-putting given the risks are so low, and potential health benefits so high. The requirement to include an ‘information leaflet’ is not a requirement on cigarette makers. Verdict: discriminatory, disproportionate, no legal base.
- Requirement for surveillance and pharmacokinetic testing. There are several costly burdens placed on e-cigarette producers that are not applied to cigarettes. Much information is requested, but it is unclear what will be done with the information supplied. Verdict: discriminatory, disproportionate (fails to meet the requirement to minimise burdens to achieve objectives).
- Member state discretion. Member states are left with discretion to ban flavours, regulate these products as medicines (another form of ban for most products) or to remove refillable devices from the market. What is the purpose of an EU internal market directive that does little to uphold the principle of free movement of goods? Verdict: will create more arbitrary protection of the cigarette market and defeats for member states in national courts.
Missing elements. At the same time, regulation that would actually be useful has been omitted – for example, purity standards for e-liquids or relevant technical standards (eg. operating temperature ranges) for devices.
This focus on e-cigarettes and liquids in this letter reflects the high degree of controversy over the subject during the trilogue. It is not intended to endorse the rest of the directive, notably the ban on snus (Article 15), for which there is no basis whatsoever. Twelve experts recently wrote to the UK Secretary of State to call for the snus ban to be lifted on scientific, ethical and legal ground.
What to do?
The right approach
Article 18: After completing broad consultations and no later than [31 December 2014] the Commission shall report on the market for non-tobacco recreational nicotine containing products, taking account of health implications and impacts on tobacco consumption. The report shall include policy options and appraisal, and, as appropriate, proposals for legislation to develop the internal market in these products, with the aim of securing a high level of health protection.
The wrong approach
It would be wrong for MEPs to wave through an important component of a directive, knowing it is based on flawed science, following irregular procedures and comprising measures of unlikely legal validity. How could that be justified? The European Union needs to win trust and respect, not to haemorrhage credibility by passing bad laws and sidestepping the proper constraints of the treaties.
Please contact me if I can provide further information or if you wish to discuss any of the points raised.
__________________ LETTER ENDS ________________
What’s happening? For guidance on the process that follows next, I recommend the ‘saveecigs’ posting of Martin Callanan MEP: TPD timeline and what happens next. For a guide to the politics, I recommend the posting of Rebecca Taylor MEP: A deal on e-cigarettes – what next. Her option 1 is the most realistic means of challenging the worst aspects of the directive.
What you can do. MEPs and MPs can never receive too many tweets, e-mails, letters, phone-calls, visits or any other form of authentic, polite and well-informed representation from constituents and others with a legitimate interest. The ENVI committee membership is here (note there are tabs for members and substitutes. Please handle with care: I recommend carefully targeted mailing).