3.7 Nicotine containing products (NCP)
NCP fall outside the scope of Directive 2001/37/EC and Member States have so far taken different regulatory approaches to address these products, including regulating them as medicinal products, applying certain provisions that are used for tobacco products or having no specific legislation.The proposal stipulates that NCP that either have a nicotine level exceeding 2mg, a nicotine concentration exceeding 4mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance. NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adopted health warning. The nicotine threshold identified in this proposal has been established by considering the nicotine content of medicinal products (Nicotine Replacement Therapies, NRTs) for smoking cessation which have already received market authorisation under the medicinal products' legislation.The proposal removes current legislation divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine Containing Products, increases legal certainty and consolidates the on-going development in Member States. It also encourages research and innovation in smoking cessation with the aim of maximising health gains. Given the novelty and rapid increase of the NCP market as well as their addictive and toxic character there is an urgency to act, before more people—unaware of the content and effects of these products—inadvertently develop a nicotine addiction.Where NCP below the identified threshold are allowed, the labelling requirement set out in this proposal will better inform consumers about the health risks associated with the products.
To all intents and purposes, this amounts to a de facto ban on e-cigarette use. Typical nicotine content in e-cigarette juice is around 10mg and it often goes up to 18mg and beyond. It needs to be at this level to work as an effective substitute for smoking. E-cig juice of 4mg or lower would be virtually useless. (The draft Directive would not ban the hardware of e-cigarettes and so a black market in medium and high nicotine juice is conceivable.)
The option for e-cigarettes to be clinically tested as medicinal devices is available. Aside from the fact that they are not medicinal devices, this process would take years and would cost millions of pounds. E-cigarettes would have to be off the market during that period and the anti-tobacco extremists, along with the pharmaceutical industry, would work hard to make sure they did not return. There is no guarantee that science would guide the decision to prohibit or legalise, to put it mildly. Snus clearly has "a positive risk/benefit balance" but that has not prevented its prohibition.
As reported this week, the Directive will also uphold the snus ban (except in Sweden, which now has the lowest rates of smoking and lung cancer in Europe).
The Commission proposes a ban on the sale of tobacco for oral use and to uphold the current ban on snus (moist tobacco, which is consumed by placing it under the upper lip) in all European countries except Sweden, which has a specific derogation in its accession treaty.
The Directive will ban all flavourings and will also mandate standardised packaging. Not quite plain packaging but, with 75% of the pack to be covered in graphic health warnings, not far off. (Expect the state-funded anti-smoking agitators to feign outrage and demand full plain packs.)
The Commission ... wants packs to be rectangular in shape (no round edges) and to contain at least 20 cigarettes. Health warnings should cover 75% of the front and back of packs (and be positioned at the top edge of the unit packet) and 50% of rolling tobacco packs.
The question is why has a Directive that was drafted by a sacked health commissioner who is under investigation for corruption been rushed out, apparently unchanged? (This could be a clue.) If Dalli was involved in soliciting bribes from the snus industry, how can the EC be sure he did not solicit bribes from other industries who stand to gain from the Directive? Dalli is discredited and the Directive is tainted with corruption.
Sweden's Trade Minister has threatened 'all out war' over the snus issue. It's likely that the UK will get an in-out referendum on EU membership in the next few years and at least one Southern European state will probably have to withdraw from the EU in the near future. With a bit of luck, the European project will collapse before the Tobacco Products Directive can do too much harm to the health of the continent.
(Read more about the Dalli case here. His pal Zammit has now confessed to soliciting a bribe from Swedish Match. As a commentator points out, if he was acting alone "what was he planning to do then, grab the 60 million and hide for ever since he was powerless to do anything to reverse the tobacco directive himself?")
