3,000mg of nicotine allowed for tobacco products, yet only 200mg for e-cigs? Has tobacco labelling confused MEPs?

When e-cigs first came onto the market in 2008, vendors told customers that one pre-filled e-cig cartridge equalled 20 tobacco cigarettes.

This myth was soon exposed and done away with.

Today, responsible vendors will do their best to give customers an indication of equivalency, but this has never been an exact science as people vape and absorb nicotine at different rates.  We also have to be aware that when we take the stated mg of nicotine from a tobacco cigarette and compare it to the stated mgs in e liquid, we are actually comparing apples to oranges.  Why?

Tobacco cigarettes – the nicotine content stated on a packet of cigarettes is produced on a scale of nicotine being delivered in the body.  This is known as yield.

The yield means that if you smoke a cigarette that has stated 1mg nicotine content, your body will pretty much receive that 1mg of nicotine. This figure though bears no resemblance to the amount of nicotine in dry weight that is in the actual cigarette.  Put simply, manufacturers account for two factors in being able to state significantly lower ‘yield’ figures than the true contained nicotine content: an agreed average percentage of the maximum amount of smoke that can be produced by a fully burned cigarette which is inhaled, and the percentage of this inhaled nicotine that is actually absorbed by the body.

If you took a King Size cigarette for example, and worked out the dry weight nicotine content of said King Size cigarette, the dry weight nicotine of the complete packet of 20 King Size cigarettes, and then the dry weight nicotine content of 200 King Size cigarettes, what would you find?

The weight of the tobacco in the cigarette is in the region of a gram, and with the dry weight of nicotine being at 0.6 – 3.0 per cent of tobacco, each cigarette in the packet would contain between 6 and 30 mg of nicotine.  After some modest research and with a median of 1.5 per cent dry weight of nicotine in cigarette tobacco, an average cigarette will contain 15 mg of nicotine, with a packet of 20 containing 300 mg of nicotine.  As cigarettes are routinely sold in cartons of 10 packets, the sale of 3,000 mg of nicotine in a single carton is allowed.

Again, the nicotine stated on the side of a packet of cigarettes only refers to the amount of nicotine that will be delivered to the median user’s body – the yield, but the actual dry weight nicotine content will be far higher, in this example 15 mg per King Size cigarette.

Electronic cigarettes – 20 mg/ml of e liquid will tell you how much nicotine is in the liquid (much like the dry weight of nicotine in tobacco cigarettes), but it will not tell you how much nicotine is delivered to an individual’s system – the yield.

Looking at the nicotine absorption rates for smoking compared with vaping: smoking tobacco cigarettes is the fastest and most efficient way for an individual to get nicotine into their system.  With vaping however, it takes longer, and, like smoking, you are not absorbing all the nicotine you inhale, as is shown in the chart below taken from Matt Gluggles blog.

nicotine delivery rates

nicotine delivery rates

The tmax above states the time taken for the nicotine to enter the blood stream, the Cmax is the concentration of nicotine delivered to an individual’s blood stream.  Comparing that Cmax of a cigarette to that of an e-cig (ENDD) you see that the individual is absorbing 10 times less nicotine from vaping than smoking.

With the 16 mg ENDD you can see that from the 16 mg/ml nicotine content, (equivalent to the dry weight) only 1.3 ng/ml of nicotine concentration in the blood is produced, about 10 per cent of the nicotine concentration produced by a tobacco cigarette.

There is no easy way of directly comparing nicotine content of e-liquid with the yield of tobacco cigarettes, but during the above research it’s clear that a 16 mg/ml e-liquid gave the users just one tenth of the peak nicotine concentration provided by a “1.0 mg” tobacco cigarette.  Perhaps it would therefore be fairer to label 16 mg/ml e-liquid as “0.1 mg cigarette equivalent”.

This raises an interesting question…

The revised TPD will continue to allow tobacco cigarettes to be sold in cartons containing 3,000 mg of dry weight of nicotine, with a yield of 200 mg of nicotine, yet the highest nicotine content proposed in the TPD for e-cigs is 20 mg/ml, in a bottle no larger than 10 mls, meaning 200 mg nicotine content at its highest.  That is 3,000 mg versus 200 mg for a product that is several orders of magnitude less harmful.

We have to ask where is the level playing field, where is the rationality?

The more we look at the TPD, the more evident it is that it is about protecting the tobacco and pharmaceutical industries and nothing to do with public health.  How else can this 3,000 mg of nicotine limit versus 200 mg be justified?

Finally, what about the policy makers in all of this?  Whilst they have focussed all their attentions on the size and colour of a tobacco cigarette packet, they have paid no real attention to the labelling on the packet and what it means.  We suspect that this is because they have no real understanding of nicotine and how it is absorbed into the system.  That they did not have the courage to recognise this and seek expert advice is a shocking dereliction of duty and yet another example of the truly appalling way our elected representatives and their officials have gone about revising the TPD.

Although not relevant in this document, it is worth considering a smoking survey completed in 2001 that concludes the nicotine yield displayed on cigarette packs are misleading.

http://www.ncbi.nlm.nih.gov/pubmed/11208883

The survey concludes: “Current approaches to characterising tar and nicotine yields of cigarettes provide a simplistic guide to smokers’ exposure that is misleading to consumers and regulators alike and should be abandoned”

 

 

 

 

 

 

 

 

 

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Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health reasons.

dr-riccardo-polosa-italie+

Guest post by Dr Riccardo Polosa.

I was positively surprised when Members of European Parliament voted  against the pharmaceutical regulation of e-cigs proposed by the European Commission, during the first reading of Tobacco Products Directive (TPD), on 8th October 2013. It seemed as if they finally figured out the risks of over-regulating a product designed to reduce the health damage caused by tobacco smoking. Or so I thought.

 

Hurriedly, behind closed doors, and with restricted consultation, the EU legislators managed to introduced substantial modifications in the revised TPD, producing a profoundly mutated document that takes a completely different approach for e-cigs. The newly approved document is riddled with many arbitrary and disproportionate measures. And it could have been much worse thanks to the determination of a handful of brave MEPs who have fought hard to limit the damage.

 

In essence, this new document makes e-cigs much less attractive for those tobacco smokers contemplating to switch to a much reduced risk product. In particular, introduces the arbitrary limit of 20 mg/ml on the max strength of nicotine allowed in e-liquids, advertising bans as stringent as those currently in place for conventional cigarettes, plus several (yet, poorly defined) lab testing, reporting and compliance requirements.

 

Unfortunately, no consideration was given to setting up useful agreed purity standards for e-liquids or operating standards for devices. A simple regulatory framework that ensures consumer protection and product quality and that may work for these products already exists.

For example, e-liquids may be marketed as dietary supplements or cosmetics, whereas marketing and safety of e-cigarettes’ electronics, batteries, and spare parts are already regulated by the existing directives about electronic products design.

 

The minor or implausible health concerns that have constituted the main obsessive focus of EU legislators in the e-cig debate may sound like stupid excuses, when in fact they are not stupid at all. To tell the truth, they are clever excuses. So clever that they succeeded in their purpose of dictating rules in line with the precautionary principle. Hence, the fact that the new document makes e-cigs much less appealing for new smokers is deliberate…

 

Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health  reasons. After weeks and weeks of fierce debate with the EU “legislators” I came to the conclusion that this has very little to do with a medical issue or science, it is a political and financial one. I briefly addressed this point in the concluding paragraph of my opinion letter

in the Lancet:

http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70175-9/fu

lltext

 

Similar conclusion can be drawn from the current situation in Italy.

From 1st January 2014 e-cigs will be regulated as tobacco products. Measures will include: excise taxes, lengthy bureaucratic process to obtain marketing permission from the national tobacco authority, vaping bans in public places, and advertising bans. No scientific debate was allowed, no input from vapers and their families was taken into consideration, the political agenda being “destroy e-cigs as soon as possible”. These draconian measures are already driving the prosperous and active national e-cig industry outside Italian borders, thousands of vape shops are closing, and current vapers will either have to turn into black market to stay off tobacco smoking or return to their own tobacco brand. Italy is well known for its lengthy legislative processes. For the e-cigs this was completed in less than 6 months ! A word to the wise is enough….

 

Clearly, the rapidly expanding popularity of e-cigs represents a threat to the interests of many, including national governments – because of the fat revenues generated by tobacco excise taxes. Only if these obstacles can be overcome, a truly sensible and rational regulation of e-cigs will be agreed upon, and millions of lives saved.

 

 

Musings from a vaping Scottish MSP

 

Guest post from Mike Mackenzie, MSP.

I like smokers. They are honest. They aren’t hypocritical. They aren’t afraid to admit they have faults. They don’t pretend to be perfect. Having at least this one very public fault, they are often understanding and tolerant of the faults of others.

I used to be one. Not a part time smoker, not an occasional smoker, but a hard bitten, life long, full blown smoker. I smoked roll ups. I didn’t use filters. I smoked an ounce of tobacco every day for over thirty years. I enjoyed every lungful.

Tobacco was my best friend. It was with me in the best of times and the worst of times. I never had a cup of coffee without a cigarette. I never had a glass of whisky without one. In triumph or disaster a cigarette was called for or came to the rescue, reassuring and consoling. Every problem had a solution when a cigarette was at hand.

Smokers often have this reflective quality. They don’t panic or lose the plot in the face of problems. They light up. They inhale. They think. They are philosophical in the face of all the ups and downs of life and all of its uncertainties.

My addiction as you may have gathered was by no means only physical. I started smoking at 12 years old; just an occasional secret fag shared with friends. Until I left school I was a weekend smoker only, but I got going in earnest when I went to University. I rolled cigarettes without conscious thought or effort. I could roll them in the dark or riding a bike. I could roll them with one hand if a party trick was called for.

Newly elected in 2011, perhaps because of the stresses of a new job, perhaps because of the amount of driving I was now doing, I found I was smoking more and getting less exercise. I began to think about cutting down my smoking. As a lifelong fitness fanatic friends were often confounded at the apparent anachronism I presented. I would breakfast on two cups of coffee and four cigarettes and then head off to the gym or go for a run. I kidded myself that somehow being fit would protect me against the worst effects of tobacco.

Perhaps it did but when I turned fifty I began to notice these effects. I couldn’t run as fast or as far. I couldn’t yet feel his hot breath on my neck but I began to sense the grim reaper gaining ground on me. Still I didn’t want to stop smoking. I didn’t want to abandon my lifelong friend. It was merely as an aid to cutting down that I thought I would give e-cigarettes a try.

Within two days and without really wanting to I had stopped smoking altogether. Eighteen months on I feel ten years younger. I get less exercise than I used to but I feel fitter. I have more energy, I sleep less and my powers of concentration have increased. Friends say I look younger.

Nicotine, as drugs go, is benign. It may even have some beneficial properties. How else do you explain our five hundred year habit of smoking? It was always the delivery system that was at fault, but even wrapped up in the cancerous cocktail of tobacco, for many people the pros still outweighed the cons. They chose to smoke knowing the risks. Life, after all, is not merely a competition to see who can live the longest.

Still the health costs of smoking tobacco are high, far too high and the technological solution, the e-cigarette, is one of those triumphs of the ingenuity of humanity. It gives me hope that we will solve many of our other problems.

The debate surrounding the regulation of e-cigarettes, is perhaps inevitable, but it has some unfortunate undertones. Those with little understanding seek to ban them or regulate them out of existence. Often these are the same people who have campaigned so avidly against tobacco. The logical inconsistency of holding these two antipathies seems lost on them. There is risk that the baby will be thrown out with the bathwater.

Proponents of e-cigarettes should see regulation as an opportunity. Proportionate and reasonable regulation will put many of the fears to bed. For responsible manufacturers it will provide a quality hallmark and for consumers, confidence that their health is not put before profit. It is not regulation itself which is bad but bad regulation and care should be taken on both sides of this argument that such regulation that emerges is as good as it can be.

European Union regulating e-cigarettes based on ideology and theories, but not science

Guest post by Dr Farsalinos

It is unfortunate for a scientist to see how politics work and how decisions are made. For public health issues, especially for the very sensitive issue of smoking, one would expect that common sense and scientific facts would prevail. Instead, we are seeing decisions made on the basis of theoretical concerns, fear-mongering tactics and intimidation.

The pending regulation for electronic cigarettes seems to be a characteristic example of applying theory on top of real evidence. There has been an astonishing effort to mis-present science, misinform regulators and the society by distorting the results of scientific studies and eventually kill a product which will probably revolutionize tobacco harm reduction. Recently, we are overwhelmed by stories demonizing nicotine. Suddenly, after so many years of research and hard evidence coming from population studies, we are seeing the news media discussing about nicotine causing cancer and heart disease. We are seeing journalists trying to interpret cell studies, while in reality I doubt if they understand a single word of what they read. Obviously, they should not be the only ones blamed; it is scientists who give the information to the news media and they push for publicity. The result is a complete distortion of truth. It is shocking to see someone support that a cell study is good enough to discard all hard evidence from population studies showing that nicotine does not cause heart disease or cancer.

However, there are other questions raised by such tactics. First of all, why is every study on nicotine targeting e-cigarettes? Don’t NRTs also have nicotine? Why don’t we hear anyone discussing about nicotine in NRTs? Well, probably because e-cigarettes are a hot topic. However, few years ago, studies showing nicotine to be harmful were strongly opposed by scientific groups (such as Cancer Research UK), stating that: “The interpretation is highly speculative and contradicted by evidence that many millions of people have been using nicotine replacement therapy with no increased risk of oral or any other cancer. If reports like this stop people using what for many would be a life-saving medication it would be very unfortunate.” They are absolutely correct, but the same statement should be done today for e-cigarettes.

All this intimidating publicity has only one result: it harms the health of smokers by discouraging them from using a less harmful alternative like e-cigarettes and it harms the health of vapers some of whom have relapsed to smoking after hearing all this misinformation.

Coming back to regulatory decisions, it is unprecedented that a product is regulated based on theoretical concerns, especially when such concerns are completely contrary to any available evidence. It is a big “victory” of the antismoking advocates (who in fact have become anti-smokers) that the agenda is not evidence but theories; theories about normalization, theories about use by youngsters, theories about health effects. Every scientific study shows the exact opposite from what they support, but none cares. Theory is more important that evidence. We have come up to a point when a professor is supporting that “We are witnessing the beginning of a new phase of the nicotine epidemic and a new route to nicotine addiction for kids” while at the same time his own study mentions that “Students who had smoked every day in the past 30 days had the highest rate of current e-cigarette use (50.8%), compared with .6% among those who not currently smoking cigarettes (p < .001).” (emphasis added).

How should this be called? Science? It is really sad that scientists are so disrespectful of smokers and their need to find a getaway from smoking. They believe they should be punished for initiating smoking and for medicine’s inability to develop an effective smoking-cessation medication. It is a dangerous path that should be condemned.

Regulators should stay away from propaganda tactics. They should be properly informed and base their decisions on facts, not on theories. Regulating based on anything besides evidence is like opening the floodgates; it will have severe consequences and will definitely harm public health.

 

Transcript of Viscount Ridley’s debate on e cigs in the House of Lords – how it should be done!

Viscount Ridley (Con):
 
My Lords, I congratulate my noble friend Lord Astor, on securing this debate. It is an issue of much greater importance than the sparse attendance might imply and one that is growing in importance. I have no interest to declare in electronic cigarettes: I dislike smoking and have never done it. I have only once tried a puff on an e-cigarette, which did nothing for me. I am interested in this issue as a counterproductive application of the precautionary principle. I should say that I am indebted to Ian Gregory of Centaurus Communications for some of the facts and figures that I will cite shortly.
There are, at the moment, about 1 million people in this country using electronic cigarettes, and there has been an eightfold increase in the past year in the number of people using them to try to quit smoking. Already, 15% of ex-smokers have tried them, and they have overtaken nicotine patches and other approaches to become the top method of quitting in a very short time. The majority of those who use electronic cigarettes to try to quit smoking say that they are successful.
Here we have a technology that is clearly saving lives on a huge scale. If only 10% of the 1 million users in the country are successful in quitting, that would save £7 billion, according to the Department of Health figures given in answer to my Written Question last month, which suggest that the health benefits of each attempt to quit are £74,000. In that Answer, Minister said that,
“a policy of licensing e-cigarettes would have to create very few additional successful quit attempts for the benefits to justify its costs”.—[Official Report, 18/11/13; col. WA172.]
But who thinks that licensing will create extra quit attempts? By adding to the cost of e-cigarettes, by reducing advertising and by unglamorising them, it is far more likely that licensing will create fewer quit attempts. Will the Minister therefore confirm that, by the same token, a policy of licensing e-cigarettes would have to reduce quit attempts by a very small number for that policy to be a mistake?
Nicotine patches are also used to reduce smoking and they have been medicinally regulated, but there has been extraordinarily little innovation in them and low take-up over the years. Does the Minister agree with the report by Professor Peter Hajek in the Lancet earlier this year, which said that the 30-year failure of nicotine patches demonstrated how the expense and delays caused by medicinal regulation can stifle innovation? Does my noble friend also agree with analysts from Wells Fargo who this month said that if e-cigarette innovation is stifled,
“this could dramatically slow down conversion from combustible cigarettes”?
We should try a thought experiment. Let us divide the country in two. In one half—let us call it east Germany for the sake of argument—we regulate e-cigarettes as medicines, ban their use in public places, restrict advertising, ban the sale of refillable versions, and ban the sale of e-cigarettes stronger than 20 milligrams per millilitre. In the other half, which we will call west Germany, we leave them as consumer products, properly regulated as such, allow them to be advertised as glamorous, allow them on trains and in pubs, allow the sale of refills, allow the sale of flavoured ones, and allow stronger products. In which of these two parts of the country would smoking fall fastest? It is blindingly obvious that the east would see higher prices—and prices are a serious deterrent to attempts to quit smoking because many of the people who smoke are poorer than the average. We would see less product innovation, slower growth of e-cigarette use and more people going back to real cigarettes because of their inability to get hold of the type, flavour and strength that they wanted. Therefore, more people would quit smoking in the western half of the country.
What are the drawbacks of such a policy? There is a risk of harm from electronic cigarettes, as we have heard. How big is that risk? The Minister confirmed to me in a Written Answer earlier this year that the best evidence suggests that they are 1,000 times less dangerous than cigarettes. The MHRA impact assessment says that the decision on whether to regulate e-cigarettes should be based on the harm that they do. Yet that very impact statement says that,
“any risk is likely to be very small”,
that there is,
“an absence of empirical evidence”
and “no direct clinical evidence”, that “the picture is unclear”, and—my favourite quote—states:
“Unfortunately, we have no evidence”,
of harm.
There is said to be a risk of children taking up e-cigarettes and then turning to real cigarettes. Just think about that for a second. For every child who goes from cigarettes to electronic cigarettes, there would there have to be 1,000 going the other way, from e-cigarettes to cigarettes, for this to do any net harm. The evidence suggests, as my noble friend Lord Borwick has said, that the gateway is the other way. Some 20% of 15 year-olds smoke, and evidence from ASH and a study in Oklahoma suggests strongly that when young people use electronic cigarettes they do so to quit, just like adults do.
If we are to take a precautionary approach to the risks of nicotine, will the Minister consider regulating aubergines as medicines? They also contain nicotine. If you eat 10 grams of aubergine, which you easily could with a plateful of moussaka, you will absorb the same amount of nicotine as if you shared a room with a cigarette smoker for three hours. It is not an insignificant quantity. That is data from the New England Journal of Medicine in 1993. If we are worried about unknown and small risks, can the Minister explain to me why, as Professor Hajek, put it, more dangerous chemicals, such as bleach, rely on packaging and common sense rather than on medicinal licensing?
There has been approximately an 8% reduction in the use of tobacco in Europe in the past year. The tobacco companies are worried. A big part of that reduction seems to be because of the rapid take-up of electronic cigarettes. They are facing their Kodak moment—the moment when their whole technology is replaced by a rival technology that, in this case, is 1,000 times safer. Does my noble friend think that there may be a connection between the rise of electronic cigarettes, the rapid decline in tobacco sales and the enthusiasm of tobacco companies for the medicinal regulation of electronic cigarettes?
It is not just big tobacco; big pharma has shown significant interest in the regulation of electronic cigarettes. That is not surprising because they are, again, a rival to patch products and other nicotine replacement therapies. Perhaps more surprising is that much of the medical establishment is in favour of medicinal regulation. I never thought I would live to see the BMA and the tobacco industry on the same side of an argument.
The BMA says that electronic cigarettes cannot be considered a lower-risk option, but this completely flies in the face of the evidence. As we have heard already, electronic cigarettes are 1,000 times safer. The BMA says that it is worried about passive vaping, the renormalising of smoking and the use of electronic cigarettes as a gateway to smoking. The excellent charity Sense About Science, to which I am proud to be an adviser, has asked the BMA for evidence to support those assertions. I must say that there is a strong suspicion that the only reason the medical establishment wants to see these things regulated as medicines is because it cannot bear to see the commercial sector achieving more in a year in terms of getting people off cigarettes than the public sector has achieved in 10. Instead of talking about regulating this product, should we not be talking about encouraging it, promoting it and letting people vape indoors if they want to—in pubs, on trains and in football grounds—specifically so that they are tempted to vape instead of smoke? That would be of enormous benefit to them and to the country as a whole.
I end by asking specifically in relation to the agreement that, as we heard from my noble friend Lord Borwick, was agreed last night, what its impact will be on what is happening, and in particular on advertising. As I understand it, under the agreement reached yesterday, it will be possible for the advertising of these things to be banned as if they were cigarettes. What is the justification for that, given the proportionality and the evidence that they will actually save lives rather than harm them?

Swedish Administrative Court rules e cigs are not medicinal!

A new ruling by the Swedish Administrative Court  this week stated that electronic cigarettes are  NOT  a medicine, and so do not need to be regulated as such.

That takes the total  to eight courts in Europe that have ruled e cigarettes are not medicinal.

Last spring the Swedish Heath Regulatory Agency/ Authority called the MPA stated that any electronic cigarettes that contained nicotine needed to be approved as a medicine and be licensed accordingly.

However, one company in Malmo decided to ignore this and sold e-cigs until the MPA threatened  them with a 700,000 SEK fine, and shutting down their business.

Not one to be outdone by proposed ridiculous laws made up by agencies , the e cig company in question appealed to the Administrative  Court.  The Court had a look at the facts, as the law must – and hey presto – The facts cleary show that  electronic cigarettes are not  a medicine, and therefore do not need to be approved as such.

Let’s hope that those in Trilogue at present within the EU, especially the Council and Commission and Lind McAvan the rapportuer, are aware of this new ruling, plus the other 7 court rulings that clearly state that e cigarettes are NOT a medicine. We hope this is at the forefront of their minds  while they negotiate the TPD and amendment 170.

Why this campaign? And what´s wrong with medical legislation?

Friends and families of Vapers have set up this campaign, because vaping affects us too.

We have seen the struggle first hand with our loved ones as they try to stop smoking, or carry on regardless of their health and ours. But e-cigarettes have made a difference, e-cigarettes are less harmful, they don´t smell, they don´t cost a fortune, and we all win.

So why not regulate them as a medicine, after all people do stop smoking with them don´t they?

The simple and honest answer is yes, many people stop smoking with them, but an e cigarette is not a medicine, it is an alternative to cigarettes, and should be regulated that way. Just because you stop smoking, does that automatically make it a therapy?

Making an e-cigarette into  a medicine will mean that it fundamentally it has to change. The technology will have to change to give exact, quantifiable doses each and every time, from battery start to battery finish; e cig technology doesn´t do this. Making it a medicine won´t allow for individuality of vaping style, there will be no tanks or mods, there will be virtually no flavours and the only devices that will be available will be ´cigalikes´, that won´t last all day, maybe two hours at the most.  And they certainly won´t be cheap.

We want electronic cigarettes to have sensible regulation. At present they are regulated by the EU, it just needs tightening up a bit; make it law that they can´t be sold to under 18´s, make sure that high grade ingredients are used and labelled correctly, other than that leave them alone. 7 million vapers can´t be wrong across the whole of Europe.

Please sign the letter, share it and let´s stop this EU madness that will send our loved ones back to smoking.