EU EU: Commission released report on the Tobacco Products Directive consultation

[Tom09]

Last year, the EU had a public consultation on the revision of the Tobacco Products Directive. E-cig “control” is one of the many topics to be covered in this upcoming revision of the EU law.

Commission publishes report of a consultation (Commission’s press release)

Brussels, 27 July 2011 – Today the European Commission's Directorate-General for Health and Consumers publishes the results of the public consultation on the upcoming revision of the tobacco Products Directive. The public consultation generated an unprecedented 85 000 responses. The vast majority of contributions came from individual citizens, illustrating the great interest in EU tobacco control policy. Other respondents represented industry, non-governmental organisations, governments and public authorities.
[...]

Link to pdf: Report on the public consultation on the possible revision of the Tobacco Products Directive (2001/37/EC)

[...]
As regards the future regulation of 'electronic cigarettes’ in tobacco legislation, Member States seemed to be more divided, with some presenting arguments for regulating the product as a pharmaceutical or medical device, and others arguing for the inclusion of electronic cigarettes in the Tobacco Products Directive.
[...]
The majority of Member States were in favour of banning all types of smokeless tobacco products, which was also the position of the two EFTA countries responding to the consultation. The main arguments for this solution came from the concerns about the harmful health effects of these types of products. Those in support of banning smokeless tobacco argued that while some of these products present a reduced risk, all smokeless tobacco use entails health risks. Respondents also linked the use of snus to an increase in smoking rates, as snus users are more likely to switch to cigarettes or to consume both snus and cigarettes. They also argued that the commercial import and sale of smokeless tobacco products needs to be banned across the EU while these products still have relatively limited market shares and popularity among consumers.
[...]

Actual submissions to this public consultation will not be made public: “Given the large number of contributions received, it is not considered useful to release an online database of individual submissions.”

 

[Eddie.Willers]

Actual submissions to this public consultation will not be made public: “Given the large number of contributions received, it is not considered useful to release an online database of individual submissions.”

Typical Gubbmint "We Know What's Best For The Little People" attitude...

 

[Vocalek]

Respondents also linked the use of snus to an increase in smoking rates, as snus users are more likely to switch to cigarettes or to consume both snus and cigarettes.

They must have received the above information from Gregory Connolly, who appears to have a secret source of data that differs from the data examined by Lee, Foulds, Rodu, Fagerstrom, Ferberg, Ranstrom, Benowitz, et al, and comes to totally opposite conclusions.

See:
Casaa.org - Harm Reduction
Bibliography. (tobaccoharmreduction.org)

At the TPSAC meeting on dissolvables, Connolly claimed that the smoking rates in Sweden have not gone down and that tobacco use overall has gone up. He neglected to share the source of his pretty graphs.

So what's up with that? Does the EU just read cherry-picked submissions sent to them by the public, or do they bother to do a literature review themselves?

 

[rothenbj]

Tobacco control has been cherry picking for decades, why should they change now? Looks like they're hell bent on turning more of the population into criminals. Why should they worry about sources of data, if they don't have it now they'll just invent,,,,er,,,pay for another Cali type study.

I'm sure releasing results of the public consultation would be counter productive. The few that supported their stance were the most knowledgeable and besides, it takes time to spin results.

 

[emus]

What if ecigs advanced to the point of producing satisfying TH from pure heated H2O.
Would they still be banned in many countries?

I think so.

 

[NorthOfAtlanta]

What if ecigs advanced to the point of producing satisfying TH from pure heated H2O.
Would they still be banned in many countries?

I think so.

They would call it di-hydrogen monoxide and tell everyone how deadly it is when inhaled.

 

[rothenbj]

They would call it di-hydrogen monoxide and tell everyone how deadly it is when inhaled.

U joke, but if u inhale too much of dat chit mon u b dead! Dat's solid.

 

[rolygate]

What we are looking at here is a WHO and MHRA-type exercise where the results are already known before the 'consultation' takes place. Such consultations are simply window dressing to legitimise future action that has already been decided. Do you think they will publish the fact that 90% of the submissions were against any form of further regulation? Hardly.

We know exactly what they will end up doing, you only have to look at the Snus situation to work that out. The science is irrelevant, the facts are irrelevant, the lives are irrelevant. There are only two important factors: keep the pharma money flowing and keep those Tobacco Control jobs paying.

If the correct and logical steps of legitimising Snus and e-cigarettes were to be taken, NRT sales would fall through the floor; and as the smoking mortality rate would eventually fall by over 50%, the TC crowd would be out of a job. Where would that leave this band of brothers?

You know my opinion anyway: give all these comedians Chantix and a length of rope with a noose.

 

[Vocalek]

Great idea, Roly!

 

[sqirl1]

You know my opinion anyway: give all these comedians Chantix and a length of rope with a noose.

yeah! make them take all the horrible drugs they force down our throats! and you also missed the fact that if people knew how effective nicotine is at treating so many things, pharma sales would fall all around, including but not limited to:

1. ADD medications
2. anti-depressants
3. at least a few anti-psychotics
4. medication used to treat alzheimers and similar conditions

it would be a CRISIS for big pharma. they'll do anything they can to keep their strangle hold on the people of the world. they are the Darth Vaders of the world

 

[Franz]

Unfortunately, in Italy, at that time that was taken into account, was marketed an electronic cigarette of poor quality, it could buy in a pharmacy and you can still buy it in pharmacies, with bad results for users of electronic cigarette. Often non-functional, defective, and very high prices, they are 100 € for a manual kit with 2 batteries and 2 Atty, usb charger, mains adapter.
However, meanwhile, are doing important experiments 2.
One at the Institute of Oncology in Milan Professor Veronesi.
The other U.S. military base at Sigonella, which began some time, followed by Professor Polosa Riccardo, University of Catania. Currently, the only study performed in Europe is his.
The LIAF's Fund, the Italian League Smoke, announced claws "Electronic Cigarettes: are safe and can help you quit smoking."
The products actually working, type joyetech, were sold at prices much higher than the U.S. or the UK or France. Now with the arrival of even the Oval Office prices have increased.
It 'clear that the end user does not have the ability to access all services given by the online retailers, is safer to buy drugs rather than buy from sites at birth, where in almost all the kits sold, there are instructions in Italian, another forbidden thing, you can not market a product in Italy, without the instructions of use.
People formal notice from these products, why not give the right information kits that come from china, so the sample number surely talk about a product not effective.
To consider that Italy, the first European country to ban cigarettes in public places, this has greatly affected the absolute rejection of cigarettes that you can somehow do not think about going back either.
The mass does not care that nicotine is less severe than carbon monoxide, regardless rejects due to anti-smoking campaigns, and associations against smoking.
P.s. the tobacco multinationals in Europe and China have great power ...
I enclose Quach study in Italy.

 

[Vocalek]

I ran the last document through Google translator:

As per the request of 30 November 2009 communicate the results of analysis carried out on steam emitted from the use of electronic device called "air electronic cigarettes". were analyzed the vapors produced by four different refills called respectively: ARIA nicotine (A), AIR without nicotine (ANN), AIR LIGHT with nicotine (AL) and without AIR LIGHT Nicotine (ALnN). Each charge has a cylindrical shape (diameter 9mm, length. 40mm) and contains on average 0.5g of liquid impregnating a sponge. An additional charge of type "use and sheds "with built-in vaporizer (9mm diameter, length. 35mm) contains about 1 gram of liquid. the Analyses were performed using gas chromatography technique, except the determination moisture (water) was performed using gravimetric method. The results of the analysis are shown in the table below and are expressed as the quantity of substances contained in a cubic foot of steam produced by the device:

substances Ann ALnN AL
propylene glycol 1.64 1.65 1.66 1.65
glycerin 0.58 0.59 0.61 0.58
water 0,23 0,23 0,24 0,25

volatile organic compounds (VOCs) in Ann CAS TO ALnN
Nicotine 11/05/54 6.22 6.21 no no
1-hydroxy-2-propanone 116-09-6 0.52 0.52 0.26 0.26
methylpyrazine 109-08-0 0.49 0.51 0.54 0.54
5-metilfurfurale 620-02-0 0.27 0.27 0.27 0.27
3-dihydro-2-methyl furanone 3188-00-9 0.25 0.25 absent absent
23726-91-2 beta-damascone absent absent 0.25 0.25
2,3-dimethyl pyrazine 5910-89-4 0.24 0.23 0.29 0.30
etilciclopentenolone 21835-01-8 0.24 0.25 absent absent
2.5-methyl piraziona 123-32-0 0.24 0.24 0.24 0.24
2,3,5,6-tetramethyl pyrazine 1124-11-4 0.21 0.24 0.03 0.02
2-ethyl-1-hexanol 104-76-7 0.20 0.20 absent absent
3-methoxy-2-metilpyran-4-one 118-71-8 0.13 0.13 0.06 0.06
3-hydroxy-4 ,5-dimethyl-5H-furan-2-One 28664-35-9> 0.01> 0.01 absent absent

Technical note: the chemical analysis was performed on the collected vapors to a device that simulated 16 aspirations lasting 3 seconds with a range 0.166L/sec intervals between intake and another 8 seconds. the maximum temperature of the steam out of the device measured was 43 ° C.

Perugia, December 15, 2009

 

[rolygate]

I would like to see the amounts in these analyses converted to percentages of the total vapor mass. Previous analyses reported approximately 66% water, 3% PG, 1% VG, 1% nicotine, the remainder probably flavoring (but not confirmed). Since the flavorings were individually analysed here, the percentages of the total would be of interest.

Here we do at least have a detailed analysis of flavoring amounts present. There seems to be no DEG or diacetyl reported, however no specific statement is made that 'all detectable ingredients were reported at the 1ppm level', for example, or 'DEG and diacetyl were tested for' - so that their absence cannot be taken as fact.

The precise test conditions are not clear from this report, so that the data is not of a class suitable for reliable citation, though if presented in a different format might be of interest. The main use of this data would be for comparative purposes with other studies that reported data in the form of mg per cubic metre; for example nicotine @ 6.22 mg/m3 in e-cigarette vapor here, for possible comparison with that from a tobacco cigarette.

The text appears to describe analysis of vapor from four differently-marked cartridges, plus two types: cartridges or cartomizers, as four different labellings and two different cart or carto types are described. Differences are shown in the analyses of certain samples but we are not told if they were of the cartridge or cartomiser type or of different flavors.

Because no test apparatus description or photos are given, or the detection method whether to 1ppm for all ingredients or if only for specific ingredients; and because the type of cart or carto actually used in the tests is not specified, or the specific flavors, or the labelled nicotine strength, this study is of an ad hoc / ad lib type with no defined or repeatable protocols and thus is mainly of interest value rather than citable value.

 

[Franz]

Oops sorry, I have not translated the pdf file.
This is the statement:


In particular, the calculation is based on nicotine inhaled the fumes of the certificate of analysis for the electronic cigarette Air: The calculation was made using cartridges containing 2.3 mg of nicotine per ml and simulating, with a special device, 16 aspirations lasting 3 seconds with a flow rate of 0.166 L / sec with intervals between aspiration and the other 8 seconds. Based on these measurements show that a cubic foot of steam vacuumed contains 6.22 mg of nicotine. Then one liter contains 6.22 / 0.00622 = 1000 mg (in a cubic meter, there are a thousand liters) and then at a rate of 0.166 L / sec, a roll of 3 / 2 will 0.00622 * 0.166 * 3 = 0 , 0031mg nicotine, always using a cartridge as 2.3 mg in the test. And a liquid-loaded with 1 mg of nicotine, therefore, produces 0.0031 / ​​2.3 = 0.00135 mg of nicotine per shot. Assuming approximately 50 shots the average length of a cartridge, the number will be 0.0675 multiplied by the amount of nicotine in the cartridge itself (mg / ml) to calculate the nicotine cartridges that produce the same. Ex: 18mg cartridge: 1.215 mg per cartridge. 24mg cartridge: 1.62 mg per cartridge.
Obviously these calculations are approximate, as you just vary the length and number of shots to get different results.

This study was made by Prof. Roberto Polos.
Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD) - Full Text View - ClinicalTrials.gov

 

[malyden]

The outcome measures look promising

Primary Outcome Measures:

Sustained 50% reduction in the number of cigarettes smoked per day at week-12 from baseline [ Time Frame: week-12 ] [ Designated as safety issue: No ]
sustained self-reported 50% reduction in the number of cig/day compared to baseline for the 30 days period prior to week-12 study visit (eCO levels were measured to objectively verify smoking status and to document a reduction compared to baseline)


Secondary Outcome Measures:

Sustained 80% reduction in the number of cigarettes smoked per day at week-12 from baseline [ Time Frame: week-12 ] [ Designated as safety issue: No ]
sustained self-reported 80% reduction in the number of cig/day compared to baseline for the 30 days period prior to week-12 study visit (eCO levels were measured to objectively verify smoking status and to document a reduction compared to baseline)

Sustained smoking abstinence at week-12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
complete self-reported abstinence from tobacco smoking (not even a puff) for the 30 days period prior to week-12 study visit (eCO levels were measured to objectively verify smoking status with an eCO concentration of ≤10 ppm )

Oops sorry, I have not translated the pdf file.
This is the statement:


In particular, the calculation is based on nicotine inhaled the fumes of the certificate of analysis for the electronic cigarette Air: The calculation was made using cartridges containing 2.3 mg of nicotine per ml and simulating, with a special device, 16 aspirations lasting 3 seconds with a flow rate of 0.166 L / sec with intervals between aspiration and the other 8 seconds. Based on these measurements show that a cubic foot of steam vacuumed contains 6.22 mg of nicotine. Then one liter contains 6.22 / 0.00622 = 1000 mg (in a cubic meter, there are a thousand liters) and then at a rate of 0.166 L / sec, a roll of 3 / 2 will 0.00622 * 0.166 * 3 = 0 , 0031mg nicotine, always using a cartridge as 2.3 mg in the test. And a liquid-loaded with 1 mg of nicotine, therefore, produces 0.0031 / ​​2.3 = 0.00135 mg of nicotine per shot. Assuming approximately 50 shots the average length of a cartridge, the number will be 0.0675 multiplied by the amount of nicotine in the cartridge itself (mg / ml) to calculate the nicotine cartridges that produce the same. Ex: 18mg cartridge: 1.215 mg per cartridge. 24mg cartridge: 1.62 mg per cartridge.
Obviously these calculations are approximate, as you just vary the length and number of shots to get different results.

This study was made by Prof. Roberto Polos.
Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD) - Full Text View - ClinicalTrials.gov

 

[Vocalek]

Actually, the principal investigator's name is Dr. Riccardo Polosa.

 

[Franz]

Yes, Italy is currently conducting another study with volunteers of the Italian Air Force, led by Professor Riccardo Polosa.

Presented at the 41 ° Stormo of Sigonella the only clinical study on the European electronic cigarettes


The volunteers of the 41 ° Stormo Italian Air Force for one year will experience electronic cigarettes

Continue clinical study on e-cig done in collaboration with the University of Catania's Fund and Category LIAF ®, using the prestigious presence of the 41 ° Stormo A / S of the Italian Air Force Sigonella. The trial, which began last April, requires the participation of volunteers by 41 Wing for the study of electronic cigarettes.

The presentation of the project was held today at Sigonella, with the participation of the Vice Rector of the University of Catania, Maria Luisa Carnazza, Professor Richard Polosa, clinical medical director of the University Centre for the prevention and treatment of tobacco company Vittorio Emanuele Hospital and project leader, the Commander of 41 Wing, Colonel Luca Tonello, Lt. Col. Rocco Massimo Zaffarana Public Information Officer of the 41 ° Stormo, Chief Nursing Corps, Lieutenant Colonel Vincent Bellantone; Liaf the communications officer, Dr. ssa Gabriella Papale, the psychologist and researcher of CPCT, Caponnetto Pasquale, who follow patients during the trial, and Dr. Ersilia Belfiore, a member of Category ®.

"Participating in the trial of the electronic cigarette is a great opportunity - Luca Tonello said the Colonel, Commander of 41 Wing A / S in Sigonella - and we are proud to make our contribution to scientific research through the voluntary cooperation of our staff."

"Smoking is a chronic relapsing disease - said Prof. Riccardo Polosa - and the electronic cigarette can be a valuable tool to help smokers manage the addiction. The idea of ​​this project was born in 2007 thanks to the experience of a patient who has failed to stop after testing electronic cigarettes. So we decided to start a trial to evaluate the effects of this tool in the fight against tobacco. The pilot study has led to very encouraging results: in about 50% of cases, the electronic cigarettes have proven a useful tool to help the smoker to reduce the number of traditional ones, and in some cases even stop. I would also like to clarify that, contrary to rumors in the past, today there were no contraindications and side effects. Each volunteer - continued Prof. Polos - has supplied the electronic cigarette kit ® category and will be followed by a special counseling service for one year, the first three months with frequent meetings, then a visit to six and a final to 12 months.

The University of Catania - said Prof. Polosa - is at the forefront in the fight against smoking and is among the top research centers in the world to carry out this type of experiment, whose studies are already being viewed on the database International Medical ClinicalTrial.gov and within the prestigious medical journal will be published BMCMedicine pilot study already completed. "

"The University of Catania - said Provost Maria Luisa Carnazza - is proud to have led this project, which demonstrates once again how the research activities of our University is not an end in itself, but aims to influence and improve the living conditions of citizens. "

'Class is proud to support such a clinical study on advanced electronic cigarettes - said the representative dell'Arbigroup Dott.sa Ersilia Belfiore - and so can provide qualified information on the product and reassuring. "

"The electronic cigarette is a useful tool to help smokers reduce and manage risks linked to smoking nicotine addiction - says Dr. Gabriella Papale, director of communications of LIAF - that's why the Italian League is actively involved Smoke the clinical study at the University of Catania. "
23/01/2011

 

[Vocalek]

Thanks for posting this, Franz. This needs to be brought to the attention of U.S. military Surgeons General (each service branch has its own SG). Several, if not all, of the military SGs have issued proclamations denouncing e-cigarettes and directing that they can only be used where smokers are permitted to smoke. Italy is leading the way! Viva Italia!

 

[rothenbj]

Thanks for the info Franz, this is truly good news. I particularly liked the comment, "I would also like to clarify that, contrary to rumors in the past, today there were no contraindications and side effects."

That says a whole lot!

 

[Bill Godshall]

Here's an interesting analysis of the EU Consultation
Outcome of public consultation on the reform of EU Tobacco Products Directive - Alberto Alemanno - Risk Regulation - EU Law - WTO
that alleges abuses of the EU consultation process by Italian tobacconists, but remains silent on the abuses by tobacco prohibitionists of the EU consultation process and their intentional misrepresentations of facts about smokefree alternatives.