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.

 

 

Why Article 18 now needs to be removed from the TPD. An open letter to MEPs

Dear Member of the European Parliament,

 

E-cigarettes and Trilogue

 

On the 8th of October e-cigarette users (vapers) welcomed the vote in the European Parliament, believing it to have been a sensible compromise.  MEPs had listened to the genuine concerns of vapers throughout the EU and a cross party majority supported amendment 170.

 

Now the Tobacco Products Directive (TPD) is in trilogue and vapers are being kept in the dark.  Vapers do not know what is being discussed and what regulatory proposals are gaining support.  Many vapers feel frustrated and isolated.  They hear rumours and read about leaked proposals, yet they feel totally impotent.  They cannot influence proceedings even when they fear the wrong decisions may be being taken.

 

From the leaked documents we have seen, it is clear that the new proposals being put forward by the Council and Commission are more than simple amendments to aid the trilogue process; they amount to entirely new proposals for the regulation of e-cigarettes.  As the EU protocol on the Application of the Principles of Subsidiarity and Proportionality makes clear, new proposals like these need to be forwarded to national parliaments for comment, with eight weeks for the national parliament to respond.  The new proposals that we are aware of are also about as far removed from amendment 170 as is possible.

 

In a desire to conclude the TPD before Christmas, due process, legitimate concerns, and legal opinions are being ignored by many of those involved in the trilogue process.  This is not how good legislation is made.

 

If trilogue and/or Parliament cannot deliver a regulatory regime for e-cigarettes that protects flavours and refillable tanks, and allows for the continued use of effective strengths of nicotine, then reluctantly we would have to come to the conclusion that Article 18 should be removed from the TPD and that the Commission should instead bring forward a new legislative proposal for the regulation of e-cigarettes.  We believe that this will allow the TPD to be drawn to a rapid and satisfactory conclusion before Christmas.

 

In the interim the TPD should be used to send a strong signal to Member States that they should more forcefully apply and enforce existing regulations relating to e-cigarettes, as we believe that when correctly adhered to, they are robust and proportionate.

 

As a campaign representing vapers and their families, we endorse the Electronic Cigarette Industry Trade Association Industry of Excellence Audit Programme and commend it to the e-cigarette industry and to policy makers.  We would also like to see vendors doing more to keep their customers informed and up to date with proposed changes to the regulation surrounding e-cigarettes.

 

The Commission should use this interim period to consult with all those who have a genuine interest in the sale, manufacture, and, most importantly, use of e-cigarettes.  They will then be in a good position to bring forward new legislative proposals (informed by the European Parliament’s position) with proper evidence based justification, impact assessment, consultation, and scrutiny.

 

Finally, may we take this opportunity to wish you and your family a Merry Christmas and a Happy New Year.

 

Yours sincerely

 

Save E-cigs

www.saveecigs.com