Sunday, 22 December 2013

The catalogue of ERRORs behind Article 18

The European Commission have published their "justification" for Article 18 of the Tobacco Products Directive - The latest proposals to regulate electronic cigarettes.

You can read their justification of each part of Article 18 here :

http://ec.europa.eu/health/tobacco/docs/fs_ecigarettes_en.pdf     (PDF)


If this is the reasoning behind the proposals, then they are totally flawed. As each and every single reason contains an error, they can only have been written by (a) the mis-informed, (b) idiots, (c) or people who are deliberately lying.



For each part of Article 18, lets have a look at the REASON and the ERROR MADE




Current Regulation 

Reason - Currently there is no EU wide regulatory framework to guarantee the safety and quality of  e-cigarettes. The application of the General Product Safety Directive is not sufficient.

Justification - 14 notifications concerning (re fill) liquids for E-cigarettes via the RAPEX system have been reported. DG Health and Consumers. Rapid Alert System for non-food products posing a serious risk (RAPEX) Brussels: DG SANCO; 2012.    http://ec.europa.eu/consumers/safety/rapex/index_en.htm

ERROR  

-  Pure Cherry Picking. These notifications show that the system IS working. In actual fact there are far more rapex reports for "Toys" than for refill liquids, and I wonder if the Commission have actually read these rapex reports ? They are reports for incorrect labelling of liquid, not for any toxicity or health problem. The system works, incorrect labels are picked up and corrective action is taken. Evidence that the General Product Regulations work.



Concentration and Size

Reason - An e-cigarette with a concentration of 20mg/ml delivers approx. 1 mg of nicotine in 5 minutes (the time needed to smoke a traditional cigarette, which delivers 1mg of nicotine). 

ERROR  

-  Pure twisting of figures. The time to deliver is similar, however the concentration delivered is completely different (10 times different). For a full explanation of why nicotine delivery cannot be simply compared like this see my earlier post on this subject - why 20mg from ecigs is not the same as 20 cigarettes.  .

MEGA ERROR  

-  They quote some research by Dr Farsolinos, perhaps they haven't read it or perhaps they are being duplicitous - but Dr Farsolinos was identifying MINIMUM level of nicotine that is needed to work for a smoker and the Commission have now turned this into a MAXIMUM

They are aware of the work done my Dr Farsolinos, so it is a clear error of omission, or deliberate cherry picking, to leave out information like this - which completely undermines the Commission position

 ''In facts, vapers need to use such devices for approximately 30min in order to get plasma nicotine levels similar to those found after smoking 1 tobacco cigarette. In another study, smokers who were using the e-cigarette for the first time showed significantly lower nicotine absorption compared to experienced users. Therefore, we provide sufficient data indicating that the addictive potential of e-cigarettes (even the new generation devices) is much lower compared to smoking, while at the same time we proved that new-generation devices are much more efficient and probably more effective for smokers. Moreover, we have shown that there is no chance of overdose or intoxication from e-cigarette use in na├»ve users, even when a new generation device is used. Of note, an 18mg/ml e-liquid was used in both studies. I doubt if a nicotine-containing liquid with double concentration would deliver nicotine similar to a tobacco cigarette.''  - Dr Farsolinos   HERE


MEGA ERROR 

- They are happy to quote that a cigarette "delivers 1mg of nicotine", using figures from the side of a cigarette pack when it is now accepted that these figures are manipulated by the Tobacco companies and the real does can be up to twice as much whilst the amount of freebase nicotine is optimised in tobacco smoke to increase the addictive properties - making the delivery not comparable with electronic cigarettes impossible.


Reason -  The most commonly sold strength of e-cigarettes is 17-18 mg/ml and strengths of 20mg/ml and lower were shown to be effective for the majority of smokers in their cessation efforts

ERROR 

- ... and the other 40% that use higher strengths will just have to carry on smoking ! - this is pure nastiness, they know that there is a large group (40%) that need a higher strength for e-cigs to work but they will stop them from having access to this product (that is currently available) because 'the majority' will be okay - pure evil and malicious.


Cartridges and Refills

Reason - The market share for refillable cartridges and tanks varies across the EU. At this stage reliable independent studies on market shares are not available. A recent study of a stakeholder estimated the EU average of refillable e-cigarettes to slightly exceed 40%

ERROR

- Refillable e-cigarettes represent 82% of the market


From Dr Lynne Dawkins presentation to the ecig summit

Trying to pass off a known 82% as 40% to hoodwink MEPs into believing that the regulations will only affect the minority, whilst banning the overwhelming majority of devices.

Reason -  Refillable cartridges and refill bottles with liquid can be contaminated, expose users to toxic nicotine liquid and are a safety risk for children. These products also allow users to home blend higher nicotine strengths and flavour combinations.

ERROR

- Banning liquids above 20mg/ml will simply force many more people to home blend, an activity that has not caused a problem, that allows people to customise and select the blends that work best for them. That e-liquids are regulated as General Products mean that the bottles come with child resistant lids which prevents problems like THIS happening. 

Reason -  The majority of products on the market consists of disposable e-cigarettes and e-cigarettes with sealed cartridges.

ERROR

- Bollocks, see ERROR before last - same lie repeated

Flavours

Reason - Regulating flavours is important to ensure that products are not attractive to young people and non-smokers (risk of gateway into nicotine addiction et alia).

ERROR

- There is no evidence of a gateway into smoking for young people (source ASH UK) - it doesn't happen. There is plenty of evidence that the flavours make electronic cigarettes much larger incentive for smokers to switch.

Question for the Commission - Has this product, legally available from age 12 and in a completely non child resistant package, acted as a gateway ?




Reason - Flavours currently in use in nicotine replacement therapies include tobacco (approx. 50% of the e-cigarette market), mint, fruit, lemon, toffee and liquorice

ERROR

- There is no tobacco flavour NRT

I wonder if they even realise that tobacco is actually a flavour, and that unflavoured is just that - unflavoured.


With so many basic errors for every single proposal, it is easy to think that the EU want to regulate electronic cigarettes in such a way as to render them useless.

If it transpires that these people knew that electronic cigarettes were a useful tool to provide an alternative to tobacco smoking and deliberately acted to suppress this innovation - then there will come a time when these decision makers will end up in court.



. .

Friday, 20 December 2013

Nicotine equivalence - why 20mg in ecigs are NOT the same as 20 cigarettes



It can be very frustrating when I read that people in the EU, making laws about e-cigs, seem to be saying that liquid containing 20mg/ml of nicotine is equivalent to 20 cigarettes.

It isn't - as I will explain.

The problem comes from a lack of understanding of the subject.

People look at the side of a bottle of e-liquid and read that it contains (say) 20mg/ml of nicotine.
Then they look at the side of a packet of cigarettes and read that each cigarette contains about 1mg of nicotine

They therefore state that 1ml of liquid is equal to 20 cigs - right ?

WRONG.

Now then, it is quite normal for new e-cig users to occasionally make this easy mistake - if they ask about it on a vaping internet forum they will receive the answer very quickly.

It is, however, completely unacceptable, negligent and ignorant for someone involved in the EU policy making to make this mistake. It demonstrates, at best, a complete lack of research - at worst, false propaganda.

WHY ?

The measure of nicotine that is declared on a bottle of e-liquid IS the amount of nicotine in the liquid.
The measure of  nicotine that is declared on the side of a packet of cigarettes is NOT the amount of nicotine in that cigarette.

It is easy to find out how much nicotine is actually in tobacco - HERE - and it is at least 10 times higher than the figure on the packet.

The amount of nicotine on the side of a cigarette pack is the dose of nicotine delivered to the body.

So, to compare the cigarette figure with the e-cig figure is quite simply not comparing the same thing.

Tobacco companies and Pharmaceutical companies WILL know this, but have not taken the opportunity to educate the legislators. Any competent Public Health professional should know this as well - but have left the legislators in ignorance - either that, or the legislators have been deliberately misled.

Tobacco smoking is the fastest way of delivering nicotine. If you use 1 ml of 20mg/ml e-liquid (over several hours), then not all of the nicotine will be absorbed into the body, and also the rate of absorption will be much slower than smoking tobacco, and nicotine is relatively rapidly metabolised - so the quantity of nicotine used will not be equivalent to the levels of nicotine obtained from smoking.

The rate of delivery is important - and in fact, it is believed that the concentration of nicotine in e-liquid that is required to deliver nicotine at the same rate as smoking tobacco is, in fact, 45mg/ml

The choice of strengths is important, and for those that need a higher dose then 20mg/ml there is a very good reason why.

There is another reason why the nicotine contained in e-cigs cannot be compared with the nicotine dose delivered by a cigarette - the habit and usage pattern is different. Smoking delivers a short, sharp, fast dose of nicotine, whilst vaping delivers a lower dose over a longer time - it is different

When looking at dosages, there are 2 important units of measure, T-max and C-max. T-max is the time to deliver the dose and C-max is the concentration that is delivered. ( Cmax is a term used in pharmacokinetics refers to the maximum (or peak) ... the drug has been administrated and prior to the administration of a second dose.)

Lets have a look at T-max and C-max for nicotine delivered by smoking and by e-cig vaping





- ( source - from ecigarette-research.com)


As you can see, there is not much difference between the time taken to deliver a dose of nicotine.

BUT - there is a huge, tenfold, difference between the C-max - in this case a 16mg/ml e-cig was used.

So - to come back to my original point :

You cannot compare the dose delivered from a cigarette with the concentration of nicotine in e-liquid - and most certainly not just by doing a quick sum, in your head, based on 2 labels.

The two figures are a measure of two completely things and in any case, the pattern of usage is different again.

Anyone that knowingly tries to do a simple mathematical comparison with cigarettes and e-liquid is a liar and attempting to deliberately mislead.


.


Update

- Further recommended reading on this subject:
WHY 20mg/ml E-LIQUID IS USELESS FOR MANY
by Dave K.   -   aka 'The Happy Vaper'

Thursday, 19 December 2013

Hoodwinked ! Article 18 is medical regulation in disguise (guest post)

Guest Post by 'Evaporate' - UKV member

This is a guest post by Evaporate, a member of the UK Vapers Forum, who explains why Article 18 is the same as medical regulation of e-cigs - a defeat, as if amendment 170 never happened.


 Don't be fooled, article 18 of the Tobacco Products Directive, which can be read on Clive Bate's website is the same as medicinal regulation for electronic cigarettes.

Vendors must inform the competent authority within 6 months of marketing
  -  The competent authority is the MHRA.

The information required is toxicity, emissions on heating, inhaled health effects and inter alia (meaning amongst other things) addictive effects, Also required is nicotine dosing and uptake under foreseeable conditions. 
  -  This data can only be obtained from lab experiments and clinical trials.

This is effectively market authorisation data.

This data plus manufacturing process data, also required, is normally provided on a product dossier for each product.


If the MHRA find fault, they could say the data is inadequate and does not comply with the directive, stopping marketing or removing from sale.

Section 8 requires market surveillance data and adverse reaction reporting, this is called pharmacovigilance in medicinal regulations.
Section 9 gives (Medical) authorities power to ban a device
Section 5 limits free speech


Unless MEPs realise that these are medicinal regulation they will not see they are being fooled.


.


Saturday, 14 December 2013

Complain to the PCC about the Daily Mail

Following previous successful complaints to the PCC ( Press Complaints Commission)  about the Mail publishing false info about e-cigs, now is the time for another round of mass complaints about this article :

http://www.dailymail.co.uk/health/article-2523175/E-cigarette-smokers-inhale-MORE-nicotine-toxins-regular-smokers-Study-finds-users-unknowingly-inhaling-host-dangerous-chemicals.html

Entitled 'E-cigarette smokers inhale MORE nicotine and toxins than regular smokers'

The article is based on this research here:
http://medicalxpress.com/news/2013-12-dental-hidden-health-impact-electronic.html

It is worth including in the complaint that this research HAS NOT EVEN STARTED YET.
as it clearly says, in the last paragraph "...Saxena and Li will collect saliva and oral mucosa from College of Dentistry patients who are e-cig users to determine the relative abundance of oral bacteria ... "



It is very easy to do.

First go to this page here :
http://www.pcc.org.uk/complaints/form.html

Enter your Name, Address and email into the form.


Then fill in the following:


Newspaper/magazine - Daily Mail

Publication Date (DD/MM/YYYY) - 13/12/2013

Headline - 'E-cigarette smokers inhale MORE nicotine and toxins than regular smokers'


NEXT - tick the box to say where you saw the article.

IMPORTANT - you MUST include a link to the article, or the complaint will not be followed up


The next box is where you explain why you think the code of practice has been breached.

 - It is important to note in the complaint that the article is based on research that has not even started yet



The final box asks - Please add the clause(s) you believe to have been breached

Answer :
1.Accuracy: i) The Press must take care not to publish inaccurate, misleading or distorted information, including pictures.




IF YOU THINK THAT THE ARTICLE WAS INACCURATE OR MISLEADING, THEN YOU CAN MAKE A COMPLAINT TO THE PCC.

Do it. Takes 5 mins. The more the better, and ask that the Mail publish a full retraction of this article.

This dangerous, innacurate and misleading article could be quoted for years to come, if a retraction is not published.

Tuesday, 3 December 2013

Piss Poor Research from 'Smoke Free Manchester' - a rebuttal

Smoke Free Manchester have produced a leaflet about electronic cigarettes.

It is either the result of piss-poor research or deliberate disinformation.

The leaflet of incorrect information from Smoke Free Manchester is reproduced below.




EVERY SINGLE LINE CONTAINS AN ERROR !

So lets have a look at each line :

"Are Electronic cigarettes safe ? - We don't know"  -  Yes we do, there has been extensive research by highly qualified Doctors such as the people working at the Clearstream Project, to name just one of many.
We know that electronic cigarettes are about 1000 times less harmful than cigarettes and on a par with caffeine use.

"There is no proof they are safe" - as above. Also to note that they are used as an alternative to tobacco smoking and equally there is no proof that they are unsafe.

"The vapour may reduce the oxygen levels in your body" - completely evidence free statement, with the "may" caveat - pure propaganda.

"There is no proof that they can help people stop smoking" - False, there is plenty of proof that they provide a suitable alternative to smoking tobacco. If they didn't work then people would stop using them. In the real world the growth is exponential - what does that tell you ?

"They may irritate some conditions" - using the "may" word again. However if you do not suffer from asthma or COPD then there is no reason for a smoker not to try them.

"There is no proof that they are safe for use during pregnancy" - Same as NRT, if the alternative is smoking then it is a no-brainer (a term that appears to apply to the author of this leaflet)

"E-cigarettes are not regulated" - yes they are, there are over 15 EU regulations that apply to them and indeed it is simply not possible to launch a product in the EU without regulations applying. - Very poor research from the brain dead author.

"There is now way of knowing what you are breathing in" - Yes there is, see the Clearstream Project (above) that conducts tests on the vapour that is produced. Ask your vendor if their liquid is tested, it is not hard to find a supplier that can provide tested liquid.
Also to note that the primary ingredient, PG, is regarded as safe and has been for decades and is also the main propellant in asthma inhalers (that are used by the NHS).

ANY OTHER RISKS ?

"E-cigarettes and chargers have exploded" - as have mobile phones and laptops, indeed anything that contains a rechargeable battery carries this (small) risk - often caused by not using the correct charger or one that was not supplied with the kit. A simple search on google with the term 'mobile phone explodes' or 'mobile phone fire' will bring up many more examples than can be found for e-cigs - Is Smoke Free Manchester also calling for people to never use a mobile or a laptop ?

"Using an e-cigarette makes smoking seem okay to children" - another evidence free statement, and what research there is indicates that children are supportive of their parents using an alternative to smoking.

"Using e-cigarettes indoors undermines the smoke free message" - No it does not. It promotes alternatives to tobacco smoking for smokers.

ANYTHING ELSE ?

"Many e-cigarette manufacturers are owned by tobacco companies" - yet more feeble research. In the UK only 2 out of hundreds of suppliers are owned by tobacco companies. A tiny proportion, and one which bears no significance at all on the relative safety, or not, of e-cigs. Japan Tobacco International (JTI) which trades in the UK as 'Gallagher' have developed an HIV treatment that is already available in Japan and soon to be licenced in the USA and Europe. Would Smoke Free Manchester advise an HIV patient to refuse treatment because it was developed by a tobacco company ?


I will go on record as saying that the author of this leaflet by Smoke Free Manchester is a cretin, a fool, a dingbat - who has done little research on the subject before publication, and as a result is providing poor information to the public.