Friday 14 December 2012

EU wants to stamp out e-cigarettes

On December 19th, the European Commission will present a draft of the Tobacco Product Directive. A leaked copy has been circulating for several months and I have finally gotten hold of the page that is relevant to e-cigarettes. As I reported in September, it's not good news.

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?")


Jonathan Bagley said...

As you say, a black market in ejuice. This is alarming. It is currently a lot cheaper to mix your own eliquid using concentrated nicotine solution. I've seen 7.2% advertised. This is then diluted down to 2.4% (what you call 24mg) or 18% and brings the cost of 20ml of finished product down from 6 or 7 pounds per 20ml to around £3. This is about a weeks supply, but even so, I've read reports of people trying to save money by buying 98% nicotine from chemical suppliers. This is very dangerous and cannot be handled safely by the average punter. I dread to think what will happen if "normal" 18mg or 24mg becomes unavailable.

Unknown said...

Very, very, VERY depressing - and feelings of complete powerlessness overwhelm me. What to do?

Ivan D said...

These people are not fit for purpose and any directives that they issue should be viewed with the utter contempt that they deserve.

Unfortunately, the disease that they represent is not confined to the EU and afflicts our own national institutions to the extent that we cannot trust them either.

It is hard for anyone to respect the law when it is so obviously an ass.

Rursus said...

It´s still the leaked version, you´re talking about? Not the final draft, which is in charge for the next week, isn´t it?

Unknown said...

Quite interesting and different post.. Keep posting..Stay blessed!!

Electronic Cigarettes

Unknown said...

The amount of nicotine in electronic cigarettes is very less and it is not that much harmful to health as tobacco is, i don't know what it the purpose of imposing bans on ecigs.

Unknown said...

I guess there is a lobby behind all these things against electronic cigarettes which is controlled by the the tobacco companies, their sales is going down day by day as people are moving to ecigs.

Unknown said...

The blog and data is excellent and informative as well. best e-cigarette usa

Vocal EK said...

Can someone explain to me why health policy makers think it is a good idea to write a policy without finding out anything about the subject? Whoever drafted the EU's proposed regulation on e-cigarettes has obviously not read any of the research on the products, nor have they asked advice from researchers that have first-hand experience in conducting clinical trials using e-cigarettes or in conducting surveys of experienced users. They don't even understand the purpose of the products.

The average nicotine concentration in liquid used by e-cigarette consumers who no longer smoke is between 16 mg/ml and 24 mg/ml. Peak plasma concentration of successful quitters matches their peak plasma concentrations when smoking. Population level surveys show successful quitting rates between 31% and 80%. The purpose of the products is to serve as an low-risk alternative to smoking.

If they know all these facts and proposed these regulations anyway, then their goal must be to have as many e-cigarette consumers relapse to smoking, and make the products just as ineffective as NRTs so that no more smokers make the switch.

Unknown said...

It has been proved several times via researches that electronic cigarettes are safer than the real ones, i don't see a single reason to ban these things.

Unknown said...

I was looking this kind of post from long.. Thanks for sharing..God bless!!

Electronic Cigarettes

Green Avis said...

Observe that the above mentioned study really examined the ecigarette vapor. This is actually the best test, since it determines exactly what the user really inhales. The research found a maximum of trace amounts of the 59 priority toxicants.
best electronic cigarette

Anonymous said...

I was looking this kind of post from long time.Your blog completely match our expectation and the variety of our information. I’m really impressed with your writing skills & about
electronic cigarette nicotine.

Mark the X Smoker said...
This comment has been removed by the author.
Unknown said...

If you ask me I think it will be to late to ban ecigs now. There are already huge players in the market such as Ecig Wizard who are growing rapidly.

Unknown said...

I was a chain smoker thanks to electronic cigarettes.It is great thing for me its help me to remove my habit of smoking.Thank you very much
Electronic Cigarettes

dusan said...

I started using EGO C cigarettes several years ago, and since then I consider myself a non smoker. I find myself addicted to nicotine (that's what we all are), but much less, then I was when I was using traditional cigarettes.

Now, if devices such are electronic cigarettes are that helpful, with minimal impact on human health, and with no impact on passive smoker, they want to ban, I just don't understand how they support me to quit smoking!?

starlyte said...

After 45 years of smoking I stopped and became a Vaper, I use Electronic Cigarettes. I always make my own Eliquid, because it's a better taste, cheaper, and I enjoy finding flavors that are right for me. I am very careful in dosing nicotine, always. I find it an abomination that laws, based on corruption, may be passed by the EU Parliament, which wil make me a criminal. Why? Because I don't want to smoke widely available tobacco products, known to kill people, and want to use a substitute for my nicotine absorption, that is around 99% les dangerous. This prospective law is not based on consideration for my HEALTH, but on the consideration of others gaining MONEY.
I've made my choice, and am not going to be pushed back into smoking, or into using patches or gum quasi inutile, speaking from experience. The prospect of all this is really frightening. A law is going to be passed, based on the principles of a person already investigated, and no longer party of the comission, for corruption. Justice???