Originally Posted by paradoxper
All I am saying is based on the current proposal: Article 18 of the Tobacco Products Directive.
Article 18 of the proposal prohibits nicotine-containing products (NCP) such as e cigarettes containing a certain nicotine level if they are not authorised pursuant to Directive 2001/83/EC (the Medicinal Products Directive). It is, however, quite unclear if these products (which are much less harmful than tobacco products) even fall under the scope of the Medicinal Products Directive.1 For products that do not fall under the Directive, this would effectively constitute a ban.
The solution is to have Article 18 removed from the Directive, thus leaving all regulations under the existing consumer protection laws.
I understand your opinion on the mater and do agree, I am just sifting out the facts.
Late last week the European Commission circulated a confidential new proposal for regulating e-cigarettes. The document was sent only to those negotiating the future of e-cigarettes behind closed doors in Brussels – representatives of the European Parliament and European Council. This isn’t a final proposal, but it provides the negotiators with something to discuss. The Nicotine Science and Policy website has obtained the document, and it is here. It is quite frankly appalling – lacking any legitimacy in public health or internal market policy-making… Make no mistake, if implemented this proposal bans every product on the market today and would severely limit options for future products - and may make it commercially unviable to develop in future.
The main troubling features include:
- Allows only single-use cartridges. No refillable units or tanks will be permitted and so the most effective devices will be removed from the market.
- Allows only flavours already approved for use in NRT. Hands control to pharma companies and against the view of the Parliament that recognised the importance of flavours.
- Limits nicotine density to 20mg/ml maximum with no justification, cutting out the stronger liquids that appeal more to heavily addicted smokers and those just switching
- Limits nicotine content of any container to just 10mg/unit – this is extremely low and arbitrary (see new paper on lethal doses for nicotine) and makes no sense
- Allows only devices that “deliver nicotine doses consistently and uniformly” – a completely unnecessary, severe and limiting technical challenge derived from medicines regulation – unlike with medicines, e-cigarette users control the dose.
- Bans advertising in press or printed publications (except trade), on radio, TV and other audiovisual services and the internet (through “information society services“) – this just protects incumbents (tobacco industry) and those who can rely on established distribution channels (tobacco industry)
- Bans e-cigarette sponsorships that have cross border impact (e.g. anything that might be shown on TV) – reduces competitiveness of disruptive technology
- Applies onerous and unnecessary warning, labelling and leaflet requirements that may be impractical and are disproportionate to risk deterring smokers who may wish to switch
- Bans cross border distance sales (internet etc) in clear contravention of the aims of the internal market
- Requires manufacturers to track so-called ‘adverse effects’ even though nicotine is widely used and understood
- Requires the submission of large quantities of seemingly irrelevant technical and commercial data despite recent high level commitments to reduce red tape
- Asserts (against the evidence) that e-cigarettes “simulate smoking behaviour and are increasingly used and marketed to young people and non-smokers” continuing the European tradition of smearing valuable harm-reduction option, notably snus, to the detriment of health in Europe.
Dr Farsalinos, an expert in the field, politely sums it up: The European Union ignores science and common sense by making proposals that will damage the health of smokers and vapers
Basically, the Commission has tried to smuggle in as much medicine-style regulation as possible, and then added the most restrictive commercial aspects of tobacco regulation on top – thus imposing the worst of both worlds for this most promising product. There are one or two acceptable things in the new draft, of course, but the very bad things listed above hugely outweigh them all. The total effect of this would be:
- to leave millions of smokers without an effective and reduced risk alternative to cigarettes;
- to close many businesses throughout the EU and beyond; and
- to greatly limit the potential for genuine harm reduction through alternatives to cigarettes in the future.
It’s a proposal based on ignorance of how e-cigarettes work and why they are increasingly successful. If anything, it looks like a spiteful tantrum from Commission officials who didn’t like having their really poor idea of mandatory regulation these products as medicines entirely rejected by the European Parliament in October – see 8 reasons why e-cigarettes should not be regulated as medicines Buzzfeed by Rebecca Taylor MEP (@RTaylor_MEP). When will they get it… regulation of harm reduction products involves a perilous ‘double negative’: tough on harm-reduction is… easy on harm… and therefore …tough on health.