European Tobacco Products Directive – Last minute attempt by the European Commission to introduce medicines regulation in all but name

Gerry Stimson | 25 November 2013

The European Parliament voted on October 8th voted to reject medicines regulation for e-cigarettes. Instead it passed Amendment 170 which sought to regulate e-cigarettes as consumer products. The main elements of this amendment were that medicines legislation would apply to products where a health claim is made i.e. that the product can be used for treating or preventing disease.

For all other products Amd 170 proposed:

  • a maximum limit of nicotine density at 30mg/ml.
  • a health warning that nicotine is addictive
  • that flavourings are allowed
  • application of the directives on tobacco advertising – the products will be subject to many of the same advertising bans as normal cigarettes
  • that manufacturers and importers of nicotine-containing products submit to national authorities a list of ingredients and emissions
  • and a ban on sales to under 18s.

From a science and public health policy perspective this proposal has some merits. Flavourings are crucial for the consumer experience. Most public health people and suppliers and distributors would support a ban on sales to under 18s. But it also has difficulties. It makes no sense to limit nicotine density or content, since consumers choose the products that suit them and use them in a way to get their preferred level of nicotine. It makes no sense that adverts for e-cigarettes are controlled in the same way as for tobacco cigarettes: from a public health perspective these safer products needs to be made well known.

For those unfamiliar with the EU legislative processes, the fact that the Parliament adopted Amd 170 meant that it was now at variance with the European Council of Ministers (the national governments) and the European Commission (the policy and administrative body responsible for drafting legislation – in fact a very powerful role) – both of which support medicines regulation. Where there are differences between the three, the legislative route goes into a ‘Trilogue’ process to see if a common position can be negotiated and agreed. In this process the European Commission has a key role in trying to work out what all parties will accept – its role includes technical and legal advice, but more than this it has to seek a position that can be accepted by the Council and Parliament. But it also can also abuse this remit exceeds by inserting its own position. This is what has just happened.

On 22nd November the Commission circulated its own confidential proposal – which NSP has seen and published – it can be viewed here: http://nicotinepolicy.net/documents-all/policy. We have published this because of our concerns that those negotiating the future of e-cigarettes in Brussels are doing so without transparency and consultation with all those affected by this legislation. Consumers, parliamentarians, producers and distributors, and the general public need to knwo what is being done in their name but behind closed doors in Brussels.

The Commission proposal overtly supports the idea of consumer legislation – and so is apparently in accordance with the will of the European Parliament. But the devil is in the detail – and the detail shows that this is medicines regulation in all but name.

The Commission fails to understand both the product and consumer enthusiasm. In the ‘recitals’ make a mischievous unscientific claim that e-cigarettes are ‘tobacco-related products’. This enables them to propose controls over e-cigarettes (such as advertising bans as for tobacco cigarettes).

The proposals by the Commission, if adopted, would mean that only single use prefilled cigarettes with a maximum of 0.5ml of 20mg/ml nicotine concentration liquid will be allowed to the market. The details are:

  • a maximum nicotine density at 20mg/ml and a maximum threshold nicotine content of any container at 10mg/unit
  • only single-use cartridges – with no refillable units or tanks permitted
  • only flavours that already approved for use in NRT
  • bans on any advertising in press or printed publications (except trade), radio, TV and other audiovisual services and the internet (information society services)
  • bans e-cigarette sponsorships that have cross border impact (e.g. anything that might be shown on TV)
  • that e-cigarettes be free from contaminants and deliver nicotine doses consistently and uniformly
  • large warning, labelling and leaflet requirements
  • bans cross border distance sales
  • that manufacturers track adverse effects
  • requires large quantities of technical and commercial data

It is hard to see the science behind this. Indeed, the neglect of science is shown in the Commissions ‘recitals’ – the statements used to support the proposals. The Commission makes several mischievous claims - for example:

  1. That e-cigarettes are ‘increasingly used and marketed to young people and non-smokers’ that ‘electronic cigarettes can develop into a gateway to normal cigarettes’. This harks to the claims made by US Centers for Disease Control about increased use of e-cigarettes by young people and the supposed risk that through this young people might be introduced to smoking. The CDC claims were subsequently challenged and CDC later produced data that showed that e-cigarette use was almost all confined to young people who were already smokers, and cigarette use among young people had in fact declined in the period when e-cigarette use had increased – an indication that e-cigarettes are a gateway out of smoking.
  2. That refillable tanks pose a risk to public health. This risk is supposedly because this would get round the EC proposed ban on refillable tanks (see below), risk of contamination, and risk to inexperienced users or children. It is hard to see what scientific evidence can be adduced for this. There seems to be an unsubstantiated fear here that large quantities of nicotine fluid are a threat to health. This may be linked to the ‘scientific fact’ that the lethal dose of nicotine is 60mg. This ‘fact has since been shown to be a myth – the lethal dose of nicotine has not been established and is likely to be in the region of .5 to 1g – a quantity that in fact could not be ingested because nicotine induces vomiting. The importance of refillable e-cigarettes is that vapers adjust to their own needed level of nicotine.
  3. That e-cigarettes ‘normalise the action of smoking’. This assertion belongs to the realm of ‘sending the wrong message’ and the possible impact on smoking. Sending the wrong message is untestable – but is a line often offered by scaremongering pundits (think of historical objections to contraception). The case (backed by ethnographic observations and surveys of e-cigarette users) would suggest that e-cigarette users are actually denormalising smoking (most e-cigareetes users are anti-smoking) and normalise vaping as a safer alternative. The denormalising hypothesis is also of shaky ground given the evidence that the increase in e-cigarette use coincides with a marked reduction in tobacco sales, that as Robert West has shown, declines in the use of cigarettes; and that e-cigarettes help quitting. E-cigarettes are in fact a threat to smoking.

What the Commission proposals amount to is medicines regulation for –e-cigarettes by the back door. Regulating e-cigarettes in such a quasi-medicines framework would - perversely - make it easier to make and market tobacco cigarettes than the much safer e-cigarettes.

For further critiques of the Commission proposals see Clive Bates and Konstantinos Farsalinos.