Battery venting and mod design 2

Results of preliminary testing

by Katherine Devlin and Tom Pruen

Following a news report of injuries sustained to a user of a ‘Mutant Clone’ device, ECITA (the Electronic Cigarette Industry Trade Association) commissioned a test of this product to see if this incident was representative of the failure of this device. We felt it would be helpful to make the details publicly available as to how the test was carried out, as well as the results and corrective actions identified.

The Test:

A model which, according to reports, is identical to the one in the reported incident was sourced from an online vendor.

1. Clone before

The device body has two vent holes, each of approximately 2mm diameter.

2. Vent holes

The device in question takes a 26650 li-ion battery, a cylindrical cell 26mm in diameter, and 65mm in length. The battery was a fairly typical 26650, taken from existing materials held by us. Given the nature of the testing, the failure of this battery does not reflect on its inherent safety, as heating of this type ensures that the battery will fail.

The assembled device was then placed in a safety enclosure, with a K-type thermocouple attached (T1, red on the readout below).

4. Safety enclosure

A second thermocouple was placed inside the safety enclosure to measure the ambient temperature within (T2, green on the readout below).

The enclosure was then placed in the temperature controlled oven.

5. Oven with safety enclosure

The oven was heated at 15ºC/min to 160ºC, held there until the oven and device temperature had equalised, before heating at 25ºC/min to 260ºC. The chemistry of the inserted battery is referred to as IMR (with manganese), and batteries of this type fail when heated to above 250ºC.

Note: Although a battery in the ‘real world’ suffering a short circuit, ‘dead short’, or other terminal event will not heat up in such a controlled way as that for this test, nonetheless, the failure of the battery will give a good indication of whether the device can ‘fail safe’, or will fail catastrophically. A short circuit causes internal heating of the battery until it reaches the temperature of thermal runaway and fails. This test applies external heat to reach the same point. Furthermore, the advantage of having a controlled testing environment is that tests can be repeated, and the results can be usefully and meaningfully compared.

6. Temp readout

Shortly after reaching a critical temperature, the battery went into thermal runaway, and failed. There was a loud bang.

The build-up of pressure within the device, which exceeded expectations, forcibly ejected the base cap of the device, despite its screw threads and with considerable force. This caused the safety enclosure to fail, and went on to cause damage to the oven interior.

7. Damaged oven

The damage to the safety enclosure was significant, despite its robust materials and design. Indeed, it did not just fail at the welded joints, but certain parts of the steel have actually been torn.

8. Damaged safety enclosure

Test conclusion:

The vent holes clearly did not provide adequate pressure relief to allow gases to vent safely in the event of a battery failure. This would appear to be a significant design failure, resulting in the product failing in a dangerous way. This testing does not necessarily reflect on the safety of the original Mutant Mod, as its design may be different and has not been tested.

Further research:

ECITA is now commissioning some specific metal tubes to be constructed, with a range of different vent holes in various positions. (Suffice to say, the safety enclosures are also being redesigned, and repairs carried out to the oven liner! Fortunately, the oven did not sustain critical or irreparable damage.) These tubes should enable us to be able to try a variety of tests, with a view to establishing what appropriately safe venting holes – and their position – look like. We hope that this research can usefully inform future mod design. It is essential that the designs for such mods include sufficient – tested and proven – venting, so that catastrophic failures will not result in grievous injuries to users.

 

Posted in EU, FDA, Safety | 1 Comment

Battery venting and mod design

By Tom Pruen

With an exploding mod in the news after causing some quite serious injuries, I decided to apply some of the things that I learned in the development of ECITA’s battery testing to mods. After discussions with a similarly technically-minded forum user (thanks Griz!) about venting, pressure release, and battery failure, it seemed time for a practical test.

This is preliminary testing, and more results will be published when available.

The mod:

It’s from my own ‘spares box’ and is a cheap mass-produced tube mod, of which I don’t recall the name.

mod1It has vent hole of approx 1mm, placed in the center of the base of the tube:

mod2

This was then fitted with a fairly typical ICR battery. (Important note: this test does NOT reflect on the safety of the battery, as the test method ensures that battery failure WILL occur.)

mod3

The tube of the mod is a very tight fit for an 18650 battery, leaving little room for venting, so there is little expectation for safe venting, despite the presence of a vent hole.

The assembled mod is then placed into a safety enclosure:

mod4And the battery placed into an oven for heating. Heating an ICR battery above 150 centigrade will cause it to go into thermal runaway, and fail (regardless of any protection circuits built into it).

mod5The oven was heated from ambient temperature to 160 degrees centigrade, at 15 degrees per minute.

Both the battery and the mod failed, in quite interesting ways:

mod6

Note that the tube itself is intact, as is the upper screw thread, (I wouldn’t have been surprised if this was the failure point, as metal tubes are pretty tough) and the end cap of the tube has been forced off.

The battery propelled itself out of the tube, probably due to the tight fit limiting the venting of gas past it, until it was wedged against the end of the enclosure.

At this point, the mod had to sit for quite a while to cool down to a safe handling temperature before it could be investigated more closely.

Some venting had occurred through the 510 fitting, displacing the center pin, and the fitting was now packed with powdered electrolyte. This was probably due to the tight fit of the tube limiting the vent of gases to go through the open end (and the enclosure preventing the battery being completely ejected)

mod9

The spring in the base is mashed flat and the center of the tube, where the vent is located, is surprisingly clean:

mod10This combined with the clean patches under the mod, and behind the end cap suggest that any movement happened early in the process, and the vent hole did not play a significant role in venting the gases generated by the battery failure.

mod11

The failure and venting were clearly very energetic, and happened rapidly.

The unvented end of the battery itself was now domed as a result of the pressure, rather than flat – potentially posing a problem for center-vented tubes, especially those without springs:

mod12

The battery, rather than having vent holes, appears to have vented through the whole of the top:

mod14This ejected a significant amount of the contents into the mod tube:

mod13

So, what does this tell us?

Battery failure is very energetic, and seemingly happens very rapidly.

If a vent is obstructed, the pressure will find an alternative route to escape.

Relying on batteries having flat bottoms is likely to be a bad idea, and the battery will expand before failure.

Having vents at the bottom is not the best idea, if batteries go in ‘nipple’ first – that’s the end that vents.

What doesn’t it tell us?

Given that the base cap of this tube was a separate component, it tells us nothing about tubes where this is not the case, but given the energy involved we can expect something to give – probably the threads.

How well vent holes work in more sturdy mods.

What happens when bigger (or smaller) batteries fail; the volume of gas generated will be a function of the battery volume (and state of charge), so 26650s will be much bigger in effect.

Bottom line:

Li-Ion batteries hold a lot of energy, and release it quickly when they fail. There’s a pretty reasonable chance that in quite a few mods, the vents are either not big enough, or in other ways are unlikely to work as intended. We would urge mod makers to ensure that adequate venting is provided and, if there is any doubt, to test mods to demonstrate this is the case.

The low frequency of dangerous mod failures shows that although this type of failure is possible, it is very unlikely, and in normal use e-cigs remain safe.

Using a good quality battery will help avoid the risk of this happening, as the battery should cut out in the event of a short, preventing a catastrophic failure of this type.

 

 

Posted in EU, Safety, Uncategorized | 2 Comments

CAP and BCAP publish new UK advertising rules for e-cigarettes

by Katherine Devlin

In a frankly astonishing and devastatingly impressive flourish of efficiency, the Committees of Advertising Practice have today published their new rules specifically for electronic cigarettes – despite the large number of detailed responses. These will be enforced by the Advertising Standards Authority from 10th November 2014.

Following the public consultation in April, ECITA is delighted to see that the Committees appear to have robustly examined all the evidence submitted, and have produced rules which are truly proportionate, appropriate, fair, and crucially, absolutely in harmony with its stated objective: that adverts must not mislead, harm, offend or otherwise be socially irresponsible.

The rules which are included are very useful, and provide enough scope for creative advertising for this vibrant and innovative sector, but perhaps more fascinating is the rules which were not included. The rationales behind all the decisions taken make for very interesting reading, and can be found in the full Regulatory Statement, available here.

In summary, the rules are as follows:

1. Marketing communications/advertising for e-cigarettes must be socially responsible.

2. Marketing communications/advertisements must contain nothing which promotes any design, imagery or logo style that might reasonably be associated in the audience’s mind with a tobacco brand.

3. Marketing communications/advertisements must contain nothing which promotes the use of a tobacco product or shows the use of a tobacco product in a positive light. This rule is not intended to prevent cigarette-like products being shown.

4. Marketing communications/advertisements must make clear that the product is an e-cigarette and not a tobacco product.

5. Marketing communications/advertisements must not contain health or medicinal claims unless the product is authorised for those purposes by the MHRA. E-cigarettes may be presented as an alternative to tobacco but marketers must do nothing to undermine the message that quitting tobacco use is the best option for health.

6. Marketers/advertisements must not use health professionals to endorse electronic cigarettes.

7. Marketing communications/advertisements must state clearly if the product contains nicotine. They may include factual information about other product ingredients.

8. Marketing communications/advertisements must not encourage non-smokers or non-nicotine-users to use e-cigarettes.

9. Marketing communications/advertisements must not be likely to appeal particularly to people under 18, especially by reflecting or being associated with youth culture. They should not feature or portray real or fictitious characters who are likely to appeal particularly to people under 18. People shown using e-cigarettes or playing a significant role should not be shown behaving in an adolescent or juvenile manner.

10. People shown using e-cigarettes or playing a significant role must neither be, nor seem to be, under 25. People under 25 may be shown in an incidental role but must be obviously not using e-cigarettes.

11. Marketing communications must not be directed at people under 18 through the selection of media or the context in which they appear. No medium should be used to advertise e-cigarettes if more than 25% of its audience is under 18 years of age.

12. Radio Central Copy Clearance – Radio broadcasters must ensure advertisements for e-cigarettes are centrally cleared.

We are particularly pleased to note that the rules make it so clear that e-cigarettes are not tobacco products, and that tobacco companies must not in any way use their control of a small number of electronic cigarette brands to promote their tobacco products.

The rules which were consulted on, but which are not being implemented are very interesting indeed:

a. Links with gambling, alcohol or illicit drugs.

The Committees consulted on a rule which would prohibit linking e-cigarettes with gambling, alcohol or illicit drugs, but expressed at that stage their doubts about whether or not such a rule was necessary. They have:

had to consider whether the depiction within an advertisement of co-locating e-cigarettes with the responsible depiction of alcohol or gambling is in every circumstance likely to be regarded as irresponsible.

B/CAP’s consideration is that such a restriction is disproportionate. While B/CAP do not and cannot pre-approve specific creative treatments, it is their view that there are likely to be ways in which advertisements may feature an e-cigarette in an environment in which alcohol is being consumed or gambling conducted without being harmful or irresponsible. This is particularly the case given that, as some respondents have noted, e-cigarettes have a particular appeal as an alternative to tobacco in such environments.

This is very much in line with ECITA’s proposals in our response to this consultation:

Agree in relation to illicit drugs. However, neither gambling nor the consumption of alcohol is an illicit activity. Consider it would be entirely appropriate and potentially useful to be able to link the use of ecigs with the sensible consumption of alcoholic drinks, particularly because the association for smokers is so intense. Useful for ads to demonstrate that smokers can derive the same (or better) benefits from using an ecig instead of smoking in those social contexts. This will help gain the maximum public health benefits from more smokers switching to the demonstrably safer alternative.

(Several of the other decisions are also broadly in line with ECITA’s suggestions.)

b. Use in “unwise” situations.

The Committees had proposed, “on a precautionary basis”, a rule stipulating certain circumstances in which e-cigarettes should not be depicted because it would be “unsafe or unwise”.

Following review of the consultation responses, the Committees:

do not consider that any of those specific suggestions (for example certain locations, in public vehicles) are so unambiguously harmful in all instances that they need to be precluded in the wording of the rule. Some of the suggestions would more appropriately be addressed under other Code rules e.g. rules which prevent anything that is ‘likely to condone or encourage an unsafe practice’ (CAP) or ‘prejudice health and safety’ (BCAP).

c. “18 and over” messages

The Committees consulted on a rule which would require all advertisements to state that products were “only suitable for those aged 18 years and over”.

In the consultation, the Committees “had cause to question the overall value of warning messages”. They concluded:

Many consultation respondents shared B/CAP’s scepticism. In light of that and the available evidence, B/CAP consider that the limited effect of warning messages, when weighed against their potential to create warning fatigue, to have a result that is opposite to the one intended and their potential cost to advertisers, make the implementation of an 18 and over message unnecessary. B/CAP consider that the rules provided serve to offer sufficient protection to under 18s.”

In section 7 of the Regulatory Statement (linked above), the key decisions taken are given their rationale. We highly recommend that our industry colleagues read this document in full. Of particular note, however, at 7.3, they say:

E-cigarettes are not a tobacco product and are not currently subject to the same legislative controls as tobacco; although B/CAP understands that restriction of sale to those aged 18 and over is imminent. E-cigarettes are also a product of legitimate interest for those looking to consume nicotine without tobacco.

Section 7.5 deals with ‘Glamorisation and other specific creative treatments’, and reads:

A number of respondents suggested that B/CAP prohibit glamorisation or other specific types of creative treatment. B/CAP wish to set proportionate rules which allow marketers to use varied and creative approaches so long as those approaches are not particularly likely to be attractive to non-smokers or under-18s, and are not harmful, offensive or otherwise irresponsible. Given that the natural function of advertising is to present products in their best light, B/CAP consider that prohibiting glamorisation is too broad a criterion to be instructive to advertisers seeking to make responsible advertisements, or to the ASA when enforcing the rules.

Some respondents suggested that the rules replicate provisions provided in the Alcohol and Gambling sections of the Codes. For example, by prohibiting links with sexual success, or limiting their depiction in social situation. However, the content restrictions provided for alcohol and gambling reflect specific concerns that exist for those sectors. E-cigarettes present only some of the same concerns as alcohol and gambling and crucially there are strong arguments for the public health benefits of e-cigarettes. B/CAP therefore do not currently consider that the same content restrictions currently need to apply.

Unfortunately, at section 7.6, the Committees have felt it necessary to:

set and communicate a broad prohibition on any claims that e-cigarettes are able to convey health benefits or that they are ‘safer’ or ‘healthier’ than smoking tobacco.” (Our emphasis.)

Whilst ECITA understands that there are some ‘cowboy’ operators out there in this market, we feel that responsible companies who are undertaking the necessary safety testing of their products should be able to convey accurate messages, including that their products are ‘safer’ and ‘less harmful’ than smoking, providing they have the robust evidence to support such claims. We are very hopeful that the Committees will agree with us on this, and look forward to providing them with such evidence and having that discussion with them.

It is interesting to note at section 7.8 that even if an e-cigarette is licensed as a medicinal product, these new rules will still apply, although with the permission to make the medicinal, health and safety claims as supported by the rules on medicines advertising. They state:

Although such products will, by their nature, have had to meet particular standards of quality and safety, B/CAP considers that their advertising presents many of the same concerns as that for consumer electronic cigarettes. Specifically, they can look like tobacco products, are used in the same way and contain nicotine. For those reasons the new rules will apply to these products also.

At section 7.9, the Committees confirm that the rules will apply equally to products which do not contain nicotine, as well as those that do, including to e-shisha and e-hookah products. We totally agree with this assessment and are very grateful to the Committees for taking this clear position.

The Committees evaluation of the consultation responses they received can be found here.

Guidance on how to interpret the rules will be coming soon, as soon as the Committees have casework to inform them. This will help the industry ensure that its advertising is in compliance with these mandatory and enforceable rules.

The purpose of advertising is to educate and inform consumers. Today’s advertising rules do a fantastic job at enabling that. Well done, CAP and BCAP!

 

 

Posted in EU, FDA, MHRA, WHO | Leave a comment

We need to talk about….. The e-cig industry

By Tom Pruen

If you read many of the publications about ecigs, you could easily assume that almost all e-cigs are sold by, or on behalf of, the tobacco industry[1][2][3][4][5][6].

As with all too much of the generally accepted wisdom, this is fundamentally incorrect. It is true that the big tobacco companies have entered the e-cig market, with the first acquisition in 2012[7]. The UK market, on the other hand started to take off in 2009. A significant number of the business in the sector are Small to Medium Enterprises (SMEs), and many of these were founded by early adopters of e-cigs, who felt obligated to share the discovery they made (and, of course, make some money as well). As the market grows, there will be more entrants who are purely in it for business reasons, but there continues to be significant involvement from passionate vapers, and indeed many of the companies with multiple retail outlets preferentially employ vapers as they already have a significant knowledge (as well as considerable enthusiasm) about the products, reducing training time and cost.

It is easy to see why the involvement of the tobacco industry, given the past history that they have, would be of concern to practitioners of Public Health (and Tobacco Control in particular). However, regardless of what the corporate desires of the multinational tobacco companies are, if there is a significant, innovative, independent e-cig industry, with no desire to sell tobacco products, competition must drive all companies selling e-cigs to compete for market share. Appropriate age limits and marketing regulation should force this competition to be for existing smokers (or to encourage existing vapers to change brand – one of the primary purposes of advertising, but one which is often ignored).

There is also a financial benefit from the number of small companies active in the sector – SMEs lack the structure and knowledge that reduces the tax paid by large multinationals, and so pay a higher proportion of tax[8][9]. Because of the duplication of posts across multiple small companies, they also employ more staff proportionate to turnover.

Bottom line: There a wide range of companies in the e-cig market, many are (comparatively) small, they are very heterogeneous, and this is a good thing!



[1] http://www.bbc.co.uk/news/health-28554456

[2] http://blogs.bmj.com/bmj/2014/03/20/simon-chapman-why-is-big-tobacco-investing-in-e-cigarettes/

[3] http://www.drugfree.org/join-together/tobacco-companies-move-into-e-cigarette-business/

[4] http://online.wsj.com/articles/coming-soon-to-theaters-near-you-e-cigarettes-1410748204

[5] http://www.theguardian.com/global-development-professionals-network/2014/sep/01/smoking-tobacco-ecigarettes-public-health

[6] http://www.nzdoctor.co.nz/news/2014/october-2014/07/e-cigarettes-put-smoke–free-nz-at-risk,-says–industry-whistleblower.aspx

[7] http://www.thetimes.co.uk/tto/business/industries/consumer/article3636390.ece

[8] http://www.taxresearch.org.uk/Blog/2011/03/02/its-true-small-business-really-does-pay-tax-at-higher-rates-than-big-business-in-the-uk/

[9] http://www.highlandperthshirenews.co.uk/general-business/big-firms-pay-less-tax-smes-pay-more

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We need to talk about…. Re-normalisation

By Tom Pruen

This will (hopefully) be the first of a series of blogs about often raised concerns about electronic cigarettes, in the hope that it will make people think about the issues in depth, rather than making unwarranted (and often lazy) assumptions.

Re-normalisation is an issue that, despite having been firmly grasped by many in Public Health and Tobacco Control, is a source of bafflement to many users of electronic cigarettes. The issue, as stated, is that the use of electronic cigarettes re-normalises the use of smoked tobacco, because of the similar appearance of vapour and smoke, and the occasional resemblance between e-cigs and tobacco ones.

It has been mentioned in many of the more alarmist and/or negative publications and news items about electronic cigarettes[1][2][3][4], including statements from the Welsh Health Minister[5], UK Chief Medical Officer[6] and publications by the WHO[7].

It is easy to see why increasing the acceptability of smoked tobacco would be a cause for concern. However, there are a number of reasons why this is implausible:

The behaviours of smoke and vapour are very different. Smoke stays suspended in still air for extensive periods of time, but vapour is much more transitory. Indeed in one test using an 8m3 chamber, propylene glycol, the main ingredient of the liquid used in e-cigs was not present in high enough levels to be quantified[8]. The same test had no difficulty in measuring components of cigarette smoke.

On a more long term basis, the complete absence of tar[9] from the vapour means that it does not cause the yellowing of fingers, teeth, and indeed walls, associated with tobacco smoke.

Vapour is also significantly different from smoke in its smell. Tobacco smoke is, not surprisingly, characterised by smelling of smoke. The exact smell of the smoke depends on the type of tobacco that has been smoked, with pipe and cigar smoke much more distinctive than that from cigarettes. Vapour, on the other hand, has a smell that is entirely dependent on the flavourings used in the liquid. Each flavour has a slightly different smell, but none smell like tobacco (or indeed any other kind of) smoke, due in no small part to the absence of almost all combustion by-products[10][11]. Because of the relative airborne durations of smoke and vapour, the smell of smoke travels further and lasts longer. It is as yet untested, but it is entirely plausible to suggest that even a person who has never been exposed to cigarette smoke indoors could easily identify it as being different from, and more unpleasant than, vapour.

There is also a considerable (and increasing) visual difference in the devices themselves. Cigarettes generate ash, and are consumed during the process of smoking, generating side-stream smoke while burning. E-cigs are increasingly not cigarette shaped or coloured[12], do not generate side-stream smoke, and are visually unchanged during usage.

Both of these aspects were identified in the Public Health England report on e-cigs as reasons why renormalisation of smoking is of comparatively low concern[13]. This report also highlights that appeal to smokers is an important factor in encouraging switching.

 

On this basis, it seems pretty clear that e-cigs CANNOT re-normalise smoking. In fact, the clear delineation between the relatively safe e-cig and the dangers of smoked tobacco acts to further highlight both the harmful nature of smoking, and the restrictions placed upon it. Every incentive that can help to encourage smokers to switch to a safer alternative – be it indoor use, flavours, visual appearance of an e-cig, or price – will have a positive impact on population health.



[1] http://metro.co.uk/2014/08/26/e-cigarettes-must-be-banned-indoors-or-smoking-could-become-renormalised-warns-who-4846209/

[2] http://www.nejm.org/doi/full/10.1056/NEJMp1313940

[3] http://www.dailymail.co.uk/health/article-2617644/E-cigarettes-banned-public-places-fears-renormalise-smoking.html

[4] http://www.rcpch.ac.uk/news/e-cigarettes-may-renormalise-smoking-doctors-tell-who

[5] http://www.bbc.co.uk/news/uk-wales-26008450

[6] http://www.thetimes.co.uk/tto/health/article4204723.ece

[7] http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_10-en.pdf

[8] http://onlinelibrary.wiley.com/doi/10.1111/j.1600-0668.2012.00792.x/abstract

[9] The revised TPD, Directive 2014/40/EU, gives the following definition of tar: “‘tar’ means the raw anhydrous nicotine-free condensate of smoke”. E-cigs do not generate smoke, and cannot generate tar in this definition. They are also free from the vast majority of the low volatility compounds that make tar both dangerous and visible.

[10] http://tobaccocontrol.bmj.com/content/early/2013/03/05/tobaccocontrol-2012-050859.abstract

[11] http://www.ncbi.nlm.nih.gov/pubmed/24336346

[12] http://www.ecita.org.uk/diversity%20of%20ecigs.pdf

[13] https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/311887/Ecigarettes_report.pdf

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Diacetyl Found in VIP Butterscotch Eliquid

Regulations are put in place to ensure that products reach a certain standard, depending on the sector. As far as the Electronic Cigarette Industry is concerned, as with any other product sector, regulation does not mean that problems will never happen, or that all products will always be perfect. Inevitably, from time to time, problems will occur and products will not be up to the required or desired standard. This is true of all types of products, as evidenced by the regular product recalls listed on the European RAPEX alert system, and the various occasions where manufacturers contact their customers – and sometimes the wider public – about problems which have been identified with their products.

What happened with VIP’s Butterscotch eliquid is a classic example of the self-regulation overseen by ECITA working precisely as intended: as part of VIP’s routine auditing, eliquid samples were submitted from VIP to ECITA for GC/MS testing, including the Butterscotch (without nicotine).

The sample was blinded by ECITA on 15th May 2014, then sent to the lab, who received it on 19th May 2014. The sample was tested by West Yorkshire Analytical Services (the public analyst’s lab) on 27th May 2014, and the results of that testing were received back by ECITA on 28th May 2014, late in the evening. In the accompanying email, the public analyst, Chris Hunt wrote:

“One of these contains some diacetyl. The amount is less than 0.1% but I have reported it present. Probably around 0.05% though I have not attempted a proper quantification. I have included scans from the sample and our in-house control for comparison.”

The testing report was prepared immediately by ECITA’s Chief Scientific Officer, Tom Pruen, and sent to VIP on 29th May 2014. The advice given was as follows:

“Diacetyl has known serious inhalation risks, and this product should be withdrawn from sale. Given that the levels of diacetyl present in this product will deliver lower levels to the user than cigarette smoking, a recall from consumers would not seem warranted. It should however be withdrawn from sale, and the flavour reformulated without diacetyl (or the related 2,3 pentanedione).”

VIP then began the product withdrawal process through their internal procedures. As far as ECITA was concerned at that stage, the problem had been identified and the appropriate remedial action was being taken.

On 18th June 2014, ECITA received a call from VIP, expressing concerns that a journalist for BBC’s Inside Out had purchased a bottle of the VIP Butterscotch eliquid on 12th June 2014 from the Metro Centre, Gateshead. VIP told us that the product withdrawal had gone ahead, but unfortunately, owing to a change of management personnel in the Gateshead retail outlet, the information concerning the product withdrawal had not resulted in the products being removed by this date. When the BBC attempted to place an online order for the Butterscotch eliquid on 18th June 2014, this order was not fulfilled.

ECITA gave VIP inital advice concerning their product withdrawal and recall procedures, and suggested improvements to the communication system to the outlying retail outlets, including that retail outlets should confirm in writing that products had been removed from sale and that these correspondences should be monitored and checked by staff at Head Office to ensure that none were missed.

On 1st July 2014, ECITA was contacted by email by one of the BBC’s Inside Out journalists. ECITA provided the following statement, on 1st July 2014:

The risk of diacetyl at the level found is low and significantly lower than the diacetyl found in tobacco smoking, but we still consider it to be unacceptable. Therefore, we insist that products which contain it are withdrawn. The product recall was enacted following VIP’s testing of this product through our auditing system. Unfortunately, there was a change of management in one particular store (from which you purchased the product after the date of the recall), and we have worked with VIP to ensure that their recall procedures are more robustly enforceable.

This case underlines the vital importance of product testing, as required by the Regulations. All ECITA members’ products are regularly tested, including specifically for the presence of diacetyl, and we shall be increasing our testing regime to include battery and charger testing, extending the methodology for eliquid testing, and developing emissions testing as part of our work with the British Standards Institute. Testing is the only way to ensure that products on the market are of sufficient quality and are safe for use, so all manufacturers must follow the law and ensure they are carrying out this testing.

It is important to remember that the routine testing of VIP’s product identified diacetyl at a very low level – a level which is not a cause of significant concern in terms of harm to users of the product. Furthermore, diacetyl is found in cigarette smoke at significant levels – 300–430 µg per cigarette – yet bronchiolitis obliterans (popcorn lung) is not associated with smoking (although plenty of other respiratory conditions are).

In conclusion, the system worked as intended, apart from a very minor miscommunication with one of the retail outlets – an issue which has also since been rectified. At no point was anyone at significant risk of harm from the diacetyl in VIP’s Butterscotch eliquid, since even the considerably higher levels of diacetyl found in tobacco smoke do not appear to cause bronchitis obliterans. (It appears that it requires high levels of exposure to diacetyl over a sustained period to develop bronchitis obliterans. Indeed, there has only been one documented case of bronchitis obliterans outside of occupational exposure, which was the case of a man who ate microwave popcorn twice daily for 10 years.)

Diacetyl has been identified as a substance which we do not want to see in ecigs because it has a known inhalation risk. However, the actual risk is likely to be very low, and certainly pales into insignificance compared to the known very serious risks of continuing to smoke tobacco. That said, we shall continue to ensure that diacetyl is kept out of the supply chain by testing for it routinely, and withdrawing products which are found to be below the very high standards we expect. In this case, VIP undertook the testing as required, the diacetyl was identified, and the appropriate remedial action was taken.

Posted in Safety | 5 Comments

Summary of British Standards Institute PAS 54115

PAS providing a guide for the importation and sale of electronic cigarettes and directly related products, with product safety testing methods

This summary document is provided to allow industry and other stakeholders, or parties of interest, to have a preview of the sort of provisions ECITA has put forward as the base document for the PAS to the British Standards Institute. We hope that this will enhance the robust public processes which the BSI will be engaging in as the PAS progresses towards publication. The PAS itself will change as the process moves ahead, but this summary is broadly representative of the base document we have submitted to BSI.

Please note that this summary only covers the main points from the PAS, and the numbering of this document is not the same as that for the PAS itself. Please also be aware that British Standards documents do not contain legal requirements; the assumption is made that any and all legal requirements will be complied with, as a matter of course, so this PAS – as with all other British Standards – is a ‘best practice’ model. That said, Trading Standards has indicated that they will seek to enforce the PAS recommendations, to ensure a high level of consumer protection.

1.    Scope:

The purpose of this PAS is to specify guidance for manufacture, importation and sale of electronic cigarettes and directly related products (“Vaping Products”, “VP”), and testing methodologies. It gives guidance on the manufacture and testing of these products.

The PAS addresses two audiences: It is applicable to manufacturers and distributors of VP in the UK, and gives guidance on best practice for commercial operations in this sector. The PAS is also intended for laboratories and testing houses engaged in, or planning to be engaged in, the testing of VP, and will define parameters for the test solution, for the test bed atomiser, for the method used to operate VP to gather emission samples, the method and materials for gathering such samples, and an outline for the analysis itself.

This PAS is not intended to cover VP which are licensed as medicinal products.

2.    Terms, Definitions & Abbreviations:

There is an extensive list of terms, definitions and abbreviations included in the PAS. Most of these will be obvious to anyone connected with this sector, but for clarity, the following terms have been defined as follows in the first draft:

diluent

base liquid used to dilute concentrations of nicotine

electronic cigarette (ecig)

device which utilises battery power to heat an atomiser to transform eliquid into an aerosol vapour for inhalation

excipient

base liquid used to create eliquid to which nicotine may or may not be added

free eliquid

eliquid supplied in packaging separate from hardware

hardware

devices for use with eliquid but which may be supplied without eliquid

pre-filled ecig

device for inhalation of eliquid aerosol where battery, atomiser and eliquid cartridge form a composite whole, or where pre-filled replacement cartridges are designed only for use with the original device (commonly referred to as ‘1st generation’ products)

refillable ecig

device for inhalation of eliquid aerosol which utilises a tank system for holding eliquid, and which tank can be refilled from provided and/or separately purchased eliquid (commonly referred to as ‘2nd and 3rd generation’ products)

small vendors

small manufacturing business with fewer than 3 employees, producing niche and/or artisanal vaping products for sale to the public and/or to resellers

substantial modification

changes to products which materially alter the consumer risk profile (CRP)

vaping products (VP)

term used to describe the wide range of products in the sector as a whole, and which includes both nicotine and non-nicotine containing products

(Please note that there are many more terms defined, but the ones not listed here would be relatively obvious to anyone involved in the sector. The same applies to the abbreviations.)

Abbreviations

TRA   Toxicological Risk Assessment

UBR   Unique Batch Reference

VP    Vaping Products

3   Vaping product safety and quality

The PAS recommendations cover:

Eliquid manufacturing facilities to ISO 9001, plus food hygiene standards as a minimum

  • Personal Protective Equipment
  • Traceability of all ingredients throughout the supply chain
  • Proper batch control, to reduce the negative impact of product recall procedures, should these become necessary
  • EP/USP grade diluents (PG/VG) and nicotine, with supporting documentation including Certificate(s) of Analysis and Certificate(s) of Conformity
  • Base liquid nicotine concentration verification before manufacturing finished eliquids, by titration, isotope dilution analysis, or other suitable method
  • Food grade for flavourings, whether natural or artificial, except naturally-extracted tobacco flavourings (including Tobacco Absolute). (NB: Excipients used for these products should be of EP/USP grade, with supporting documentation including Certificate(s) of Analysis and Certificate(s) of Conformity)
  • Natural extracts should be additionally subject to a TRA (see below), and removed from the manufacturing process if a problem is identified by the TRA. (Problem substances identified in this way may be added to the list of substances which should not be present in eliquid. See Figure 1 below.)
  • Product recall procedures to ensure that resellers all the way through the supply chain are informed immediately if a product recall is instigated
  • Lists the documentation manufacturers should have for each product (including hardware as separate from eliquids), such as information on ingredients, test reports, TRAs, etc., and outlines the requirements for Technical Dossiers (for each product)
  • Recommends a Toxicological Risk Assessment (TRA) for each chemical component of the ingredients and emissions (including from atomising hardware). (NB: It is not necessary to repeat TRAs for the same flavouring compound or other ingredient, so TRAs can be reused across a wide range of eliquid products which all use the same ingredients and/or flavouring compounds.)
  • Includes an exemption from emission testing for small mod-makers who make non-atomising hardware (i.e. mods that hold batteries)
  • Includes recommendations for substantial modifications to products (eliquids and/or hardware), to trigger a new Technical Dossier if the Consumer Risk Profile (CRP) is altered by the modification (unless for exempted mods)
  • Hardware manufacturing recommendations to ensure traceability for all components used in the manufacturing process, thus considerably reducing the negative impact of product recalls should these become necessary; also recommendations for cleaning of hardware prior to shipping/packaging to ensure that microbial contamination is minimised. (Exclusively hardware manufacturing facilities do not need to be to the same high standard as those for manufacturing eliquids.)
  • A TRA is required for each chemical component of the ingredients and emissions (including from atomising hardware)
  • Recommendations for testing frequency, dependent upon the type of product. These are designed to minimise the regulatory burden while ensuring a high level of consumer protection

4     Vaping product labelling, packaging and instructions

  • Draws attention to CLP requirements for concentrations over 2.5%
  • Advises the following for lower concentrations:

CAUTION:

Store locked up and out of the reach of children and pets

Only for use in electronic cigarettes*

Seek medical advice if you feel unwell

* Refer to device manufacturer for refilling instructions

  • Child-resistant and tamper-evident packaging
  • Marking/statement that sale is for over 18s only
  • Allergy warnings for nuts and PG (where appropriate)
  • Requires that device operating instructions including safety information for charging, safe storage and handling, and instructions on proper operation to facilitate effective use
  • Shelf-life should be indicated, and the product should remain within specification throughout the stated shelf-life
  • Bottles should be fitted with a delivery spout capable of accurately delivering refill liquid into the appropriate part of the atomising device without spillage
  • Recommendations about giving healthcare advice and/or warnings to consumers. If manufacturers wish to include these, this should be simply stated as: “If you have any concerns about your health when using this product, please consult your doctor or other healthcare professional.”

5       Vaping product claims

  • Provides guidance on not making medicinal or unprovable claims, and states that marketing must not be targeted at children or non-smokers
  • Provides guidelines on not making unsupported – and/or unsupportable – equivalence (to cigarette) claims
  • Provides guidance on hardware performance claims, to avoid confusion and disappointment for the consumer

6     Testing methodologies

  • Provides information on what should be tested for with quantification (exact measurement of levels present): nicotine, formaldehyde, acetaldehyde and acrolein, as well as diacetyl (and related ketones) and 2,3 pentanedione. Other constituents may be measured from peak area (considered to be semi-quantitative)
  • Levels of tin, silver, lead, mercury, cadmium, nickel and chromium should also be measured, as should silicon, as a proxy for the amount of wick particles. (If silicon levels are high, a more rigorous investigation of wick structure and durability should be carried out)
  • In order to avoid the problems of automatically activating the wide range of manual batteries, the output under load of a battery/atomiser combination should be measured, and this voltage replicated using a bench power supply. This may then be automated easily. (A suggested method for this is also provided)
  • For atomising hardware supplied without liquid, a test solution of 78% PG, 18% VG, 2% water, and 2% nicotine is suggested
  • Atomising devices should be tested at a range of power outputs
  • A solvent trap is suggested for collecting the emitted vapour
  • The use of control measurements is required to minimise environmental effects on measurements
  • A test bed atomiser is described in detail, for testing liquids supplied separate from atomising hardware (See CAD annexed hereafter)
  • It is recommended that pre-filled devices be tested as composite units for the emissions testing of the eliquid and hardware

A ‘blacklist’ of eliquid components is suggested:

black list image

  • Where atomising hardware is supplied without a battery, it is suggested that it is tested at a range of power levels to determine a safe operating range
  • Batteries and chargers should be tested in combination to ensure that appropriate charge voltage/current is applied, and that charging stops when the battery is fully charged

 

Annex 1 – Computer Animated Design for Test Bed Atomiser

 Please note: We are in the process of having a prototype test bed atomiser built, and it is likely that some of the measurements will change. As soon as we are able to update this CAD (should this be necessary), we shall publish the updated version.

Assembly image

Barrel image

Base image

Isolators image

Negative Pin image

Positive Pin image

Stand image

Render

Render 1

 

Annex 2 – Method for Coiling the Wick for the Test Bed Atomizer

Equipment

1.5mm diameter silica wicking material

0.2mm diameter 80/20 nichrome wire

1.2mm diameter stainless steel (316) coiling rod, at least 50mm in length, preferably 100mm

Test Bed Atomizer

A cross-headed screwdriver, to fit a pan head M1.6 screw

Care should be taken not to introduce contamination to the wick and/or coil during construction. Care should be taken not to pull the silica wicking material when situated in the coil, as this can cause damage to the wick.

Method

1. Cut silica wicking material to 100mm length.

2. Cut a 150mm length of nichrome wire.

3. Fold the silica wicking material in half and hold in line with the coiling rod.

4. With both the coiling rod and silica held firmly between thumb and index finger, place wire across the coiling rod and silica at a 90° angle, in the middle of the doubled up lengths of silica, leaving a minimum of 30mm over hanging. Slide the wire under thumb and hold firmly.

5. With an even tension, tightly wind the wire around both the coiling rod and silica to form a 4 turn coil. Making sure the ‘tails’ of the wire finish on the same side. (Make sure that the coil turns are evenly spaced and are not touching each other.)

6. Slide the coiling rod out from inside of the coil, leaving the silica wicking material inside the coil.

7. Unscrew the positive pin (center) a few turns and wrap one of the coil ‘tails’ tightly between the underneath of the screw head and the top of the positive pin, one full turn clockwise. Make sure that the coil is close to the pins. The centre coil turns around the wick should not be touching the pins.

8. Repeat step 7, using the loose ‘tail’ and one of the negative pins. (Make sure that the coil keeps its shape and that the coil on situated to the side of the 2 pins).

9. Gently tighten both screws so that the coil is secure. (Be careful not to over-tighten the screws, causing the coil to become misshaped).

10. Cut excess wire off the tails, so they do not protrude from the pin.

11. Check the resistance of the coil, using an appropriate multi-meter. The range should be 2.0Ω ±0.1. (If the resistance falls outside of this range, you will need to discard the wick and coil and start from step 1.)

12. Place the test bed atomizer on the stand. Gently cut the loop on the silica wicking material, creating two equal ends. Ensure all of the wicking material is inside the base well and is touching the base.

13. Using a 1 ml liquid sample, fully saturate the silica wicking material and then place the remainder of the sample into the well in the test bed atomizer.

14. Visually inspect the coil when heated during a 2 second activation, to ensure no sections of the coil glow orange/red. If this occurs a new wick and coil should be constructed.

15. Replace top cap, ensuring no wick is caught in the threads.

Begin test.

 

We trust that as many industry colleagues as possible will want to engage in this process, as well as any other affected stakeholders, including test houses. Do please contact us if you have any comments or suggestions relating to this standard.

 

Posted in EU, FDA, MHRA, Safety, WHO | 2 Comments

How Toxic Is E-Liquid?

EDITED: To update labelling advice

Expert report recommends reclassification of nicotine solutions under CLP (Regulation 1272/2008)

Summary: European officials have been wrongly labelling e-liquid as extremely toxic. This is the view of ECITA, based on a report by toxicology consultants which has been verified by Professors Riccardo Polosa and Bernd Mayer, and Dr Jacques Le Houezec. The civil servants had been misclassifying e-liquid as either a CLP category 2 product, alongside strychnine, or a category 3 product, alongside formaldehyde. The new report demonstrates that the acute oral and dermal toxic hazards of the strongest consumer e-liquids only merit being classed as category 4 – along with washing-up liquid – while the vast majority of e-liquid (which has nicotine concentrations below 25mg/ml or 2.5%) does not require any type of formal hazard warning. ECITA will still mandate its members to provide clearly labelled e-liquid in child-proof containers.

There has been a great deal of confusion about how nicotine solutions for use in electronic cigarettes should be classified under CLP. Not only has there been considerable variation between advice given by regulators in different EU member states, but also from other sources.

Our own view differed from much of the advice we had seen, so in order to get a scientifically valid answer, we consulted a specialist toxicological consultancy, bibra http://www.bibra-information.co.uk/company_overview.html.

The full document from bibra is available here, but to summarise, they calculated that, based on the data in the CLP regulation (as amended), the acute oral and dermal toxicity of nicotine solutions of less than 2.5% are not classified under CLP, and that solutions of 2.5 to 5% are classified as category 4 (the lowest).

This came as quite a surprise to us here at ECITA, as while we have long been aware that most of the media and regulatory attention surrounding the risks of nicotine solutions were hyperbole, and exaggerated the risks, we did not anticipate quite this scale of exaggeration.

bibra undertake in-house peer review in order to ensure their results are of good quality, but given the nature of this result, we felt that we needed to take wider consultation in order to ensure that the classification was appropriate. We approached three people, in three member states, with specific expertise in nicotine, but from different perspectives.

Professor Bernd Mayer, Professor & Chairman of the Department of Pharmacology and Toxicology at Karl-Franzens-University, Graz responded:

“In his report, Peter Watts discusses the LD50 values of nicotine reported for different species. For the calculation of ATE [Acute Toxicity Estimate] he uses the widely accepted oral LD50 for rats (50 mg/kg). Taking the rat LD50 is generally accepted even at courts and every toxicologist will follow this rule. So Peter Watts’ calculation is definitively correct.”

Professor Riccardo Polosa, Full Professor of Internal Medicine at the University of Catania responded:

“After careful cross-checking of the calculations and verification of the ensuing reclassification, it is clear that the approach, calculations and reclassifications given in the bibra Proposal are correct.”

Dr Jacques Le Houezec, an Independent Consultant in Public Health and Tobacco Dependence, and Honorary Lecturer at the UK Centre for Tobacco Control Studies, University of Nottingham responded:

“The bibra report presents the calculations based on different dilutions, including those used for e-liquids. It clearly shows that the current CPL regulation is not following the principles of EC Regulation 1272/2008.

The consequence is that all e-liquids with a concentration of less than 2.5% (25 mg/ml) should not be classified under the EC regulation [for acute oral or dermal toxicity], and that higher nicotine concentrations (up to 5% or 50 mg/ml for dermal classification, and even higher for oral classification) should be considered as CPL category 4”.

It seems fairly conclusive, therefore, that the generally assumed CLP (or CPL, for most non-English speaking countries) classification of nicotine is in fact, incorrect.

So, where do we go from here?

As consumer protection is a vital part of ECITA’s ethos and purpose, we asked Professor Mayer if ‘upgrading’ the classifications to a level higher than actually calculated would be a valid way of ensuring consumer protection. He disagreed with this suggestion, stating that:

“My opinion in this matter is both simple and clear. Classification should be according to the CLP regulation. Deviation in either direction would object this regulation and raise confusion. You have commissioned consultancy from a certified expert toxicologist, who correctly classified nicotine containing products according to CLP.”

We asked the same question of Mark Gardiner, Joint Lead Officer for Product Safety at the Trading Standards Institute. As an active government enforcement officer, we felt sure that he would be able to give us specific advice to help us ensure that the level of consumer protection remains sufficiently high – particularly for children – even without the CLP warnings appearing on product labelling. His advice concurred with Prof Mayer. He said:

“It would run the risk of confusing the purpose of the CLP legislation if it is applied to products which shouldn’t be classified in that way, which could undermine consumer protection.”

And having reflected on their responses, they are clearly correct. The objective of seeking classification guidance from appropriate experts was to reduce confusion, and ignoring their proposed classification can only achieve the opposite.

The problem

Given that nicotine has significant emetic effects, and ingestion – even when non-fatal – is unpleasant and potentially traumatic, clearly the risk of this should be minimised as far as possible. Nicotine also has potential dangers for small children (particularly toddlers) and small animals (and nicotine-free liquid still presents a toxic hazard to cats, which are unable to safely metabolise propylene glycol).

ECITA’s advice (the solution?)

In order to maximise the protection of consumers, their children and indeed their pets, we advise the following, regardless of nicotine level, and including for no nicotine products, except for concentrations where CLP does apply:

  • Child-resistant closures must be used on all e-liquid bottles.
  • E-liquid labelling must include, as a minimum:
    • the heading: “CAUTION:
    • the text: “Keep out of the reach of children and pets
    • The text: “Only for use in electronic cigarettes*
    • The text: “Seek medical advice if you feel unwell
    • The text: “*Refer to device manufacturer for refilling instructions
    • Nicotine concentration in weight per volume (w/v) percentage and/or milligrams per millilitre (mg/ml) must be marked on the label
    • Batch number
    • Best Before End date
    • Nominal quantity
    • Contact details must be displayed
    • All of these label elements must be visible, legible and indelible

Please note that these recommendations are as replacements for former CLP labelling, and are in addition to other requirements, such as age restriction, allergy warnings, etc.

We asked Mark Gardiner’s opinion on this advice, and he agreed:

“This would concur with the GPSR, which requires that the risk of harm should be minimised to a tolerable level. Any potential risk must be minimised in this way in order to comply with GPSR requirements. It’s mandatory.

Whatever regulatory framework you apply, products have still got to be safe, and they’ve still got to minimise the risk of harm. It doesn’t matter if it’s CLP, GPSR, TPD or whatever. It is entirely appropriate for the recognised industry body, ECITA, to recommend appropriate measures to ensure compliance, since they are the experts in this field.”

Posted in EU, FDA, MHRA, Safety, WHO | 29 Comments

If it ain’t broke… be cautious not to fix it until it breaks

The German language has a word we do not have in English: verschlimmbesserung, meaning a supposed improvement that makes things worse. When it comes to the thorny topic of electronic cigarette regulation, policy makers would be well advised to exercise caution, lest they inadvertently create a verschlimmbesserung.

It is essential to remember that electronic cigarettes are a disruptive technology, and that they are competing with a dangerous established incumbent: smoked tobacco cigarettes. Over-zealous regulation of the challenger product (ecigs) shows increasing signs of creating regulatory protection of the disrupted, dangerous product (tobacco cigarettes). Consumer protection should be paramount, of course, but clearly there is a balance to be struck.

Before any regulatory measures are contrived, policy-makers should have been asking themselves a vitally important first question: “What is the problem we are creating regulation to address?” In some instances, (ecigs quite probably being a case in point), it may be the most prudent thing for regulators to simply leave well alone. In any event, mechanisms exist to weight up the risks and benefits of regulatory interventions, and it is a great shame that these have not been properly employed during the process of many of the regulatory proposals and, indeed, measures which have been introduced into law. There are negatives as well as positives with regulation, so the precautionary principle needs to be considered fully – from both sides of the equation, i.e. if we do something, what will the impact be, and if we do nothing, what will the impact be? Unless policy-makers have clear evidence to support both of these, they will be more likely to make mistakes. Even seemingly erring on the side of caution may not actually allow enough caution to be applied (ironically).

Proponents of medicines regulation for electronic cigarettes (‘ecigs’) have suggested that ecigs need to be offered on prescription to help the poorest and most vulnerable in society. Indeed, the Stop Smoking Services (SSS) in the UK were deliberately designed to target those people affected by the inverse care law, i.e. the poorer you are, the worse the health care you can expect to receive. Unfortunately, however, this arguments falls down in two key areas: firstly, SSS are only accessed by a paltry 1-2% of smokers, and secondly because if the poorest in society can afford to smoke, they can afford to buy their own ecigs – as firmly demonstrated by the lack of social demographic difference in ecig users:

“None of the demographic variables entered demonstrated strong association with current e-cigarette use, though due to the imprecision of estimates we cannot exclude the possibility of moderate associations that this analysis failed to detect.”[i]

Clearly, it is not only the more affluent who are switching in their millions to ecigs; the poorer in society are choosing this route, too. As Dr Hayden McRobbie, an international expert on nicotine and tobacco, said recently:

We don’t need medicines regs to be able to advertise, and get to people who smoke. […] This has been an interesting field in which people are using these without us [tobacco control] even interfering, and so why not just let it be, and let that spread through the community? People talk to each other.[ii]

And what has this mass migration away from smoking and onto vaping led to? Approximately a 33% increase in successful quit attempts within the past year, with a drop in smoking prevalence to 18.7%, according to data from Professor Robert West’s Smoking Toolkit Study.

Graph for If it ain't broke article

This is an unprecedented improvement in population level public health outcomes, and one which is not to be sniffed at. Tobacco Control measures over the past 5 decades have not achieved such dramatic improvements in such a short space of time, and have actually plateaued in recent years. That stubborn core of hard-to-persuade smokers was resolutely stuck at around 20% of the population, but this is now coming down.

If policy-makers and regulators apply the precautionary principle only to the side of the equation relating to protecting consumers from potentially dangerous products, and ignore the growing body of evidence which supports that electronic cigarettes are a) not killing people; b) being used by millions of smokers and former smokers around the world; and c) dramatically improving smoking prevalence rates and successful quit rates, then surely they are missing out the very significant precautionary approach which ought to be applied to any regulatory intervention which might change any of these factors.

Setting the regulatory barrier too high will create a dangerous black market. This is simply a fact – and well-supported by regulatory enforcement officers who have to deal with the fall-out from such problems. Black market products will not necessarily have the appropriate safety and quality standards in place, so we could see consumers beginning to be killed by substandard products.

Many consumers are law-abiding citizens who would not buy from a black market, so the only alternative for these people might be to return to smoking. Indeed, we have seen a tragic example of this in Spain recently, where one ill-informed doctor spread some egregious lies about electronic cigarettes through the media, including suggesting that ecigs are as dangerous as continuing to smoke, and an alarming number of former smokers gave up their ecigs and went back to smoking tobacco cigarettes!

If regulation protects the dangerous product (tobacco cigarettes) from the disruptive new technology (ecigs), then smoking prevalence rates will go back up, successful quit attempts will fall, and we will be back to square one, with about 20% of the population continuing to smoke, with no hope of a ‘get-out-of-disease-free’ card.

What is broken here? What are we seeing that requires a draconian regulatory response? What will happen if regulators are over-zealous in trying to fix mythical problems at the expense of the documented population level public health gains we are currently enjoying without their interference? Verschlimmbesserung, that’s what.



[i] Dockerell, M., Morison, R., Bauld, L., and McNeill, A., (2013), E-Cigarettes: Prevalence and Attitudes in Great Britain, Oxford Journals, Nicotine & Tobacco Research, doi: 10.1093/ntr/ntt057

http://ntr.oxfordjournals.org/content/early/2013/05/21/ntr.ntt057

Posted in EU, FDA, MHRA, WHO | 1 Comment

ECITA response to Welsh Public Health White Paper

This is ECITA’s response to the Welsh Public Consultation, which we have submitted today. They asked for evidence, so it’s a long one… ;)

 

Dear Sir/Madam,

Re: Listening to you: Your health matters

Public Health White Paper – Consultation Responses

I am writing to provide ECITA’s response to the above Public Consultation. ECITA (EU) Ltd is the Electronic Cigarette Industry Trade Association. We were established in 2010, with the specific aim of codifying the regulations surrounding the sale and marketing of electronic cigarettes, as well as the liquid manufacturing. The existing regulations for electronic cigarettes are many and varied (please see Annex 1 hereafter), so we offer assistance to our members to help them ensure that they are compliant with everything the law requires of them, as well as going above and beyond the legal requirements to achieve our Industry Standard of Excellence (ISE). (A Public Edition of our ISE guidebook will be available on our new website in the next few weeks.) We also assist government enforcement officers by auditing our members bi-annually, to ensure they are – and remain – fully compliant with the law, as well as performing regular product testing, not only for our members, but also for the wider industry, using a Public Analyst’s laboratory.

Our membership includes 2 companies based in South Wales, and we ourselves have our head office here in Wales, too. We are aware of a significant number of non-member companies who are also based in Wales. The Welsh Electronic Cigarette Industry accounts for hundreds of jobs, and SME turnover in the tens of millions of pounds per year. Indeed, as the Electronic Cigarette Industry has grown, numerous independent specialist outlets have opened to meet demand. These employ local people in many of the most deprived areas of Wales, (e.g. Merthyr Tydfil, Gower, Swansea, etc.). The sales cycle in such a store can last up to 15 minutes and involve trying a number of different products in order to discover which is best for the customer. This process, which can be vital in switching completely from lit to electronic cigarettes, necessitates using electronic cigarettes in an indoor retail setting. These hundreds of stores would close almost overnight were the proposal to be adopted, with a significant negative impact on the number of smokers who successfully make the switch to electronic cigarettes instead.

It is important to recognise the distinction between the independent Electronic Cigarette Industry, which introduced, developed, innovated and grew this product sector, and the Tobacco Industry, which has recently been buying into the ‘cigalike’ part of this sector. (Please see Annex 2 for information on the diversity of electronic cigarette products.) The vast majority of our members are SMEs entirely separate from, and with no affiliation with or funding from, the Tobacco Industry. However, one of ECITA’s members was recently acquired by a tobacco company (Skycig/Blu).

Since our focus is specifically on electronic cigarettes, as distinct from tobacco products, we have restricted our responses to questions 6-11 inclusive. For ease of processing, we have incorporated the relevant sections from the Public Consultation responses document into this letter.

Data Protection imageDetails form image1Details form image2

Chapter 2: Tobacco and electronic cigarettes

The consultation questions appear to have been framed with an unfortunate bias, and the attendant press releases have shown a startling unwillingness to consider any possible benefit from the use of electronic cigarettes. We trust that the Welsh Assembly will seek to distinguish between hypothetical (and often hysterically over-exaggerated) risks, (all too often couched in scaremongering language backed up by junk science which has been rubbished by the international academic community at large), and the growing body of robust scientific evidence which supports the fact that electronic cigarettes are a vitally important tool in the battle against the diseases and premature deaths caused by smoking.

Furthermore, ‘tobacco’ and ‘electronic cigarettes’ are separate issues, and should/MUST be treated as such. Electronic cigarettes are a solution to the problem of increased morbidity and mortality caused by tobacco smoking; they should not be clubbed together as equally problematic, and should certainly not be subjected to the same restrictions and suppressive measures. This only serves to ‘muddy the waters’.

You state your “overall target of reducing smoking prevalence levels to 16% by 2020”, but appear to have failed to recognise that electronic cigarettes will be an essential tool, if that target is to be achieved. It could well be exceeded, providing electronic cigarettes remain widely available. Consider the evidence from the most recent Smoking Toolkit Study[1], produced by Professor Robert West:

RW1

As these data demonstrate, electronic cigarette use is far more common among heavy smokers and ex-smokers, and more recent ex-smokers report current use of electronic cigarettes as opposed to conventional Nicotine Replacement Therapy products (NRT).

And what has this led to?

RW2

Little wonder, therefore, that Professor West concluded:

“Evidence does not support the view that electronic cigarettes are undermining motivation to quit or reduction in smoking prevalence.”

 

Electronic Cigarettes

Q6

Although you say, in your summary, “this proposal is to ban the use of electronic cigarettes in enclosed and substantially enclosed public places (including places of work) in Wales”, none of the consultation questions discussing the proposed ban on electronic cigarette use in public spaces actually asks the question. It seems to imply that the Welsh government has already decided that there should be such a ban. Why is there no straightforward question, put – in this Public Consultation – to the people of Wales, asking them: “Do you consider that the Welsh government should introduce a ban on the use of electronic cigarettes in enclosed and substantially enclosed public places?” We believe it would perhaps have been better to have included this as a direct question, since it is one of the issues of substance.

You state, at 2.28, that:

“The intention of this policy is to reflect increasing concerns amongst public health practitioners that, as e-cigarettes become more popular, there is a risk that smoking behaviours could be normalised.”

However, these concerns, together with the other concerns mentioned throughout, are simply not supported by the evidence. While there is increasing concern from some sectors of Public Health about the use of ecigs, there is also increasing concern from other areas of Public Health that rash and ill-considered bans or restrictions on the use of electronic cigarettes could have profoundly negative public health consequences.

With respect, the Welsh government needs to understand the qualitative value (or lack thereof) in the evidence it is presented with. This is why it is so important to look at a range of sources, rather than relying on only one or two – particularly when they have been roundly discredited, as in the case of Stanton Glantz. On an issue such as this, which is of such vital importance to every Welsh citizen, such scrutiny is essential. A cursory search for evidence to support a particular view is simply not good enough, and further searching would have uncovered the criticisms of Glantz’s work[2], and alternatives to it, thus encouraging further digging to reveal better quality publications upon which to base policy decisions.

Indeed, so easy is it to examine the claims made by Stanton Glantz, and their allegedly supportive references, for misquoting and clear bias, that ECITA’s Chief Scientific Officer, Tom Pruen, was able (in a matter of hours) to comprehensively demolish a recent article published by Professor Glantz. Professor Glantz had published an extremely critical response to the letter to the WHO, signed by 53 assorted international experts in the field of tobacco control[3]. (Please see Annex 3, where the letter to the WHO is reproduced in full.) The fact that 53 experts from within varying aspects of Public Health felt compelled to write such a letter, for which they were criticised by Professor Glantz, would seem to be a clear indication that his view is a minority one.

Glantz asserted:

“A dose of nicotine via nasal spray has the same immediate adverse effect on arterial function as smoking a cigarette.[6]”

However, the paper he referred to said:

“We conclude that nicotine replacement therapy by nasal spray is less harmful for the endothelium than cigarette smoking”.

The tendency of Professor Glantz to cite his own works appears to reinforce his argument, but is actually an indication of his unwillingness to consider works from the wider scientific community. Although the Minister cited the review of electronic cigarettes by Stanton Glantz as a source of evidence in support of his position, it is not the only such review that has been conducted, and the others have significantly different conclusions:

“Current state of knowledge about chemistry of liquids and aerosols associated with electronic cigarettes indicates that there is no evidence that vaping produces inhalable exposures to contaminants of the aerosol that would warrant health concerns by the standards that are used to ensure safety of workplaces. However, the aerosol generated during vaping as a whole (contaminants plus declared ingredients) creates personal exposures that would justify surveillance of health among exposed persons in conjunction with investigation of means to keep any adverse health effects as low as reasonably achievable. Exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern.”[4]

“This systematic review appraises existing laboratory and clinical research on the potential risks from electronic cigarette use, compared with the well-established devastating effects of smoking tobacco cigarettes. Currently available evidence indicates that electronic cigarettes are by far a less harmful alternative to smoking and significant health benefits are expected in smokers who switch from tobacco to electronic cigarettes.”[5]

When considering any and all evidence, we would urge the Minister, and all policy-makers, to beware of researchers using the word ‘may’, as in ‘this may result in’, ‘this could lead to’, etc. ‘May’ is an entirely appropriate word to use, in the context of suggestions for further research, for example, but must never be allowed to be misappropriated by policy-makers as a justification for specific policy interventions, particularly when largely disproven by other robust research findings. (This is where the precautionary principle must be very carefully considered, from all angles, to ensure that policies do not inadvertently cause more harm than good – as so clearly evidenced by the EU’s TPD.)

Professor Ann McNeill, and others, make this view very clear in their recent publication in Addiction, Electronic cigarettes: time for an accurate and evidence-based debate[6], stating:

“There is ongoing debate within the nicotine and tobacco research community concerning whether electronic cigarettes will offer a way out of the smoking epidemic or a way of perpetuating it. Robustly designed, implemented and accurately reported scientific evidence will be the best tool we have to help us predict and shape which of these realities transpires.

Evidence is urgently needed to inform the debate regarding the impact of electronic cigarettes on public health as national and international legislation moves forward. Current research and commentaries on electronic cigarettes/electronic nicotine delivery devices (referred to here as e-cigarettes) vary widely in quality, accuracy and objectivity. While these issues are not limited to the research community, we believe that researchers need to demonstrate better scholarship in this area. We illustrate our concerns with three examples below.

E-cigarettes do not contain tobacco

Many publications and statements by researchers, non-governmental and governmental agencies and the wider mass media mistakenly refer to e-cigarettes as tobacco products. For example, e-cigarettes were referred to as tobacco products in approximately one in four abstracts about e-cigarettes at the 2014 Annual Meeting of the Society for Research on Nicotine and Tobacco in Seattle [1]. The same error can also be found in the peer-reviewed literature and in writing by influential agencies. For example, the US Center for Disease Control and Prevention website states that ‘emerging tobacco products such as e-cigarettes and hookahs are quickly gaining popularity’ [2].

While it is true that the vast majority of e-cigarettes use a nicotine containing solution that is extracted from the tobacco plant, this is similar to nicotine replacement therapies (NRT) and, unlike ordinary tobacco cigarettes, the current e-cigarettes on the market operate with ‘no tobacco, smoke, or combustion’ [3]. Furthermore, although traces of tobacco-specific nitrosamines (TSNAs) have been found in some e-cigarettes, similar traces of TSNAs are present in licensed NRTs [4-7]. This mislabelling is exacerbated by national and international regulations including e-cigarettes in their tobacco regulations or proposing to do so. For example, e-cigarettes are regulated under proposed revisions to the European Union’s Tobacco Products Directive [8].

We do not believe that NRT products are referred to as tobacco products, so why are researchers inaccurately classifying e-cigarettes in this way? Whether this is due to lack of knowledge, carelessness or attempts to associate e-cigarettes with the immense harm caused by tobacco, classifying e-cigarettes as tobacco is inaccurate and unacceptable.

E-cigarettes are a heterogeneous category

Much of the research to date has treated e-cigarettes as if they were a single product. However, an enormous range of products is covered by the term ‘e-cigarettes’. E-cigarettes vary vastly in their function, content and appearance. For example, while the appearance of some e-cigarettes closely mimics that of tobacco cigarettes, others have no obvious similarity. Different types of e-cigarettes also vary in how much, if any, nicotine they deliver, and nicotine exposure may depend on the user [3, 9-11]. Also, different marketing and sales strategies are evolving. For example, in the United Kingdom, while many products are sold online, some products are only available in pharmacies, while others are being sold alongside tobacco in shops. Furthermore, there are now a variety of players in the e-cigarette market, including the tobacco industry. Some have questioned the motives of tobacco industry involvement in the e-cigarette market [12], and it is necessary to be cognisant of their involvement.

To move research and debate forward, it will be important to acknowledge the differences between e-cigarettes, the variability in how individuals use them, what limitations this poses on current research and any implications for regulations. Additionally, it will be important to pay attention to how nicotine delivery/exposure, marketing, the activity of industry stakeholders and regulation affect people’s use of different types of e-cigarettes and other nicotine products. E-cigarettes are not a homogeneous group of products and it is crucial to state clearly which product/s have been studied and avoid overgeneralizations from specific products onto the plethora of options available.

Are e-cigarettes a gateway to smoking ordinary cigarettes?

One of the main concerns about e-cigarettes is that they or the marketing concerning them could be attractive to children who will try e-cigarettes and then move from them to become dependent upon ordinary tobacco cigarettes (the ‘gateway’ hypothesis). This was also a concern about low nitrosamine smokeless tobacco products, but the evidence was highly contestable then [13] and is similarly contestable for e-cigarettes [14]. We think a useful research exercise would be to explore the ‘gateway’ hypothesis in more detail—what evidence would be needed before the ‘gateway’ hypothesis could be demonstrated to be accurate? Can we set a standard to which all academics would agree?

What needs to happen?

We believe that statements from the research community need to be evidence-based. While lively debates help to advance science and policy, adherence to good scientific practice is paramount. We need more rigour and oversight to ensure that interpretation of evidence is guided by data, not emotions, and that strong statements based on weak evidence are avoided. We need those reviewing grants and research papers, and also those publishing such papers, to be accountable. E-cigarettes may offer a way out of the smoking epidemic or a way of perpetuating it; robustly designed, implemented and accurately reported scientific evidence will be the best tool we have to help us predict and shape which of these realities transpires.”

Fortunately, the Public Consultation process protects both the Welsh government and the Welsh public, by ensuring that better evidence is provided for scrutiny.

Second-hand smoke is widely acknowledged as having adverse health implications. This is the justification for the internationally widespread adoption of smoke-free area policies. Such justifications are morally, ethically and legally required for any policy proposal which would affect the citizen’s right to indulge in any legal behaviour. If the smoking of tobacco had been demonstrated to have no effect whatsoever on bystanders, or those in close proximity, it would have been far harder to justify such a restrictive measure.

As far as e-cigarettes are concerned, there is no justification for such a ban. The use of an e-cigarette does not involve combustion, and therefore, no smoke is produced – either to the user, or to bystanders. Instead, an e-cigarette produces a vapour.

One of the most often stated opinions about electronic cigarettes is that ‘we do not know what is in them and are therefore unable to make an informed decision about permitting their use’. This is, however, not the case, and there is a large body of work detailing the emissions from electronic cigarettes (as detailed in Annex 4). Given the variable nature of combustion and natural products such as tobacco leaf, there is huge variation in composition of tobacco smoke. Despite having only been on the market for a relatively short time (8 years), we already know more about the composition of the vapour from electronic cigarettes than we know about the composition of tobacco smoke.

No study undertaken to date has been able to credibly demonstrate any harm caused, or likely to be caused, either to the user or to bystanders. Rather, the vapour has been shown to be orders of magnitude less harmful than the toxic cocktail of carcinogens and other toxins in tobacco smoke. Indeed, in Professor Polosa’s study (number 2 in Annex 3), the findings demonstrated harm reversal in asthmatic smokers.

ASH UK concurred, in their June 2014 Briefing[7]:

“In the UK smokefree legislation exists to protect the public from the demonstrable harms of secondhand smoke. ASH does not consider it appropriate for electronic cigarettes to be subject to this legislation, but that it should be for organisations to determine on a voluntary basis how these products should be used on their premises.”

As Professor West put it, on BBC Radio 4’s You and Yours recently:

“…you just have to remember that the reason why we brought in a ban on smoking cigarettes in indoor public areas was because of the health risk to non-smokers. That really doesn’t exist with vaping because the concentrations – if you’re standing next to a vaper – really are so small as to not really pose a risk.”

In the recent Public Health England report[8], Professor John Britton concurs:

“Electronic cigarettes do not produce smoke so the well-documented effects of passive exposure of others to cigarette smoke are clearly not relevant. Exposure of non-smokers to electronic cigarette vapour poses a concern, though laboratory work suggests that electronic cigarette use in an enclosed space exposes others to nicotine at levels about one tenth generated by a cigarette, but little else. The health risks of passive exposure to electronic cigarette vapour are therefore likely to be extremely low.”

You state, at 2.33:

“There have been reports that some businesses have introduced prohibitions on e-cigarettes on the basis that it is difficult and time consuming for staff to determine whether customers are smoking conventional cigarettes or are using e-cigarettes.”

The smoking ban in enclosed and substantially enclosed public places (including work places) has been in force in Wales since 2nd April 2007. There cannot be any Welsh (or other UK) citizen who is unaware of this law, and the restrictions imposed by it. Furthermore, for the avoidance of any doubt, there was the introduction of signage – required to be posted in every location where the smoking ban is in force – to inform the public of the requirements not to smoke in these areas.

Furthermore, ASH UK, in their recent briefing[9], stated:

“However, in the absence of evidence of significant harm to bystanders, ASH does not support the inclusion of electronic cigarettes in smokefree laws which would completely prohibit their use in enclosed public places”

and clarified:

“The fact that many electronic cigarettes look similar to conventional cigarettes has been said to risk confusion as to their use in enclosed public places, such as on public transport. However, given that the most distinctive feature of cigarette smoking is the smell of the smoke, which travels rapidly, and that this is absent from electronic cigarette use, it is not clear how any such confusion would be sustained.

Furthermore, the absence of risk from “secondhand” inhalation of vapour from electronic cigarettes has been described as an “often unconsidered advantage” of electronic cigarettes. As an alternative to smoking, electronic cigarettes are preferable in situations where secondhand smoke poses serious health risks to others, such as in vehicles or in the home.” [Emphasis added.]

We have published the table at Annex 5 herewith on our website (www.ecita.org.uk), and provide it to Trading Standards Enforcement Officers on a regular basis, to help them distinguish between illegal breaches of the smoking ban, and the legal use of electronic cigarettes.

It is vitally important to recognise that, if vapers (those who use electronic cigarettes) are forced out of enclosed public spaces in order to use their devices, this would expose them to the acknowledged harmful effects of second-hand smoke – which is what they are moving away from by vaping. This puts them back at risk, rather than allowing them to reduce the risk by moving right away from tobacco smoke to the demonstrably far safer electronic cigarette vapour.

Indeed, there is significant potential for unintended consequences with these proposals, which have the potential to actively harm the objective of the Welsh government to reduce smoking prevalence. This is both bad for public health, and bad for our industry, so we feel that our interests are in line with the broader objectives of the Welsh government. We are concerned that the proposals will be counter-productive because:

  • Forcing electronic cigarette users, who are former smokers, outside to stand with smokers, will encourage electronic cigarette users who have switched away from lit tobacco to relapse back to smoking;
  • Given the commitment to protect non-smokers from tobacco smoke, we believe that such a measure fails to take into account a reasonable expectation that electronic cigarette users will be afforded the same protection, rather than be forced to share smoking areas with users of lit tobacco;
  • The ability to use an electronic cigarette in areas where smoking is prohibited is an incentive for smokers who have not yet done so to switch from a dangerous and harmful behaviour (smoking) to a far less harmful alternative (electronic cigarettes). Removing that incentive would slow the population level change from smoking to electronic cigarettes which has been observed – and documented, in the Smoking Toolkit Study and elsewhere – over the last few years. This would be detrimental to public health because the rise in e-cigarette use comes at the expense of tobacco.

Since taste is largely subject to personal preference, when attempting to switch from smoking tobacco to using electronic cigarettes, choice of flavour is extremely important. For this reason, most – if not all – specialist retailers of electronic cigarettes (of which there are many in Wales), offer customers the opportunity to try products before purchasing them to ensure they purchase a flavour they will find enjoyable. A ban on the use of electronic cigarettes in public places including work places (such as shops) would effectively prohibit this. This has the potential to reduce the uptake of electronic cigarettes not only by this specific route, but also from ‘word-of-mouth’ referrals from strangers seen using electronic cigarettes rather than smoking. The exponential growth in the use of electronic cigarettes (with the demonstrated concomitant reduction in smoking prevalence) has been driven in almost equal parts by the advertising and marketing, and by these face-to-face interactions between smokers and vapers.

 

Q7

This is the position of the British Medical Association – the Trade Union for doctors – and it has done immense damage and caused significant harm with this unscientific approach (and counter-productive and aggressive political campaigning) on this issue. It is little wonder that the vast majority of the rest of the Public Health establishment has left the BMA isolated, preferring to focus on robust evidence.

Indeed, ECITA responded to the BMA’s Briefing on Electronic Cigarettes back in 2012[10]. Since then, their position has not changed; ours, however, has been supported by more and more evidence.

Consider, for example, ASH UK’s position, in their recent Briefing[11]:

“One of the risks highlighted by professionals is that electronic cigarettes could act as a ‘gateway’ to smoking tobacco among children. Current evidence suggests this phenomenon is not occurring. Among children, current electronic cigarette use is confined almost entirely to those who have already tried smoking. Figure 2 further shows that even having tried electronic cigarettes is rare among children, particularly those under the age of 15.”

ASH Fig 2

It is becoming ever clearer that the ‘gateway’ goes away from smoking and not into smoking behaviour. This is not at all surprising to vapers (users of electronic cigarettes), since once one has made the switch away from smoking tobacco and into using an electronic cigarette, the taste buds return to fully working order, one becomes accustomed to a new flavour – notably, without the smouldering-compost-heap taste associated with the burning of tobacco – and thus it is virtually impossible to relapse back to smoking. The notion that anyone would ‘progress’ from vaping to smoking is patently absurd. It would be like throwing out the colour TV in favour of black and white, or getting rid of your computer to return to paper and pen. It is simply incomprehensible.

This is further confirmed by Professor Peter Hajek, director of the Tobacco Dependence Research Unit at Queen Mary University of London, who said:

“The concern that e-cigarettes would lure young people to smoking has not been supported by evidence. About half of non-smokers who experiment with cigarettes progress to daily smoking. In a striking contrast to this alarming effect, among non-smokers experimenting with e-cigarettes, virtually nobody progresses to daily use.”[12]

Clive Bates, former Director of ASH UK, wrote to Dr Vivienne Nathanson at the BMA in February this year, providing evidence, and questioning the BMA’s publicly-stated (and oft repeated) position, describing it as “out of step with evidence, ethics and experience.” Clive also addresses the substance of their position, as follows:

“You drew on the idea of a gateway effect and ‘renormalisation’ of smoking, or that e-cigarette users would somehow progress from vaping to smoking. This argument was used to justify banning snus in 1992 in the EU (other than Sweden), but the effect never materialised and in fact in both Sweden and Norway, snus acts as an exit gateway from smoking, and diverts young people from smoking onset. I think everyone who comments on e-cigarettes needs to understand the snus story, and I recommend this letter to Jeremy Hunt from a dozen experts as a good starting point. This is important because harmful regulation (a ban) followed from irresponsible population-effect arguments and, as a result, many smokers have been denied access to these much-safer products. There was no scientific, ethical or legal basis for that, and there is a danger that restrictions on e-cigarettes will repeat this lethal error leading to thousands of unnecessary smoking related deaths. Your assertions about progression from vaping to smoking were quite rightly challenged on the programme: there is no evidence to suggest this pathway exists in reality or is any more than a theoretical construct created for campaigning purposes. If you know of any, please share it. Far more likely is that e-cigarettes will create beneficial pathways out of smoking for existing smokers or divert people who would otherwise have become smokers into vaping. When the BMA campaigns aggressively, but without evidence of a harmful gateway, it risks diminishing the health benefits that would arise from the beneficial gateways and thereby contributing to more death and disease. I have written about the gateway effect in some detail here: We need to talk about the children – the gateway effect examined. I would advise much greater care about protecting the health-positive pathways that introduction of a vastly reduced risk product creates.”[13]

Clive is not alone in recognising the BMA’s position as utterly untenable:

Sense About Science asked What’s the evidence for banning electronic cigarettes?[14] on 12th December 2013. (Please see Annex 6, where their letter is reproduced in full.) Also, in the Spectator, on 21st September 2013: The BMA’s bizarre jihad against e-cigarettes[15], Rod Liddle took an even dimmer view of the BMA.

Fundamentally, the trap into which the Minister appears to have fallen – along with so many ill-informed businesses, (many of which are cited in this consultation) – is to believe that if one body (in this case the BMA) repeats something often enough, even if what they repeat is demonstrably incorrect – or at best, entirely hypothetical – and not supported by the evidence, and then several bodies (in this case a range of Universities, football clubs, pubs and rail service providers) decide to introduce policies based on the oft-repeated inaccuracy, then this makes it logical for the fallacy to be deemed true. Patently, this is not the case.

It would be an utter travesty if the Welsh government were to force through such an ill-conceived policy, directly affecting the health and well-being of every Welsh citizen, due to following the advice of an (increasingly) isolated organisation, which has simply been repeating an inaccuracy with frequency and volume.

Indeed, we wrote to Scotrail recently, and published it as an open letter to all UK Rail Service Providers[16]. (Please see Annex 7, where the letter is reproduced in full.) We have yet to receive a response.

In a press release, the Minister said:

“In the world of politics it is often said that actions speak louder than words. That’s why the voluntary introduction of restrictions on the use of e-cigarettes by companies and organisations as varied as Wetherspoons; Arriva Trains; Ryanair; Glyndwr, Aberystwyth and Cardiff universities; some health boards; Caerphilly Council; the Welsh Rugby Union, Swansea’s Liberty Stadium and a growing list of others is so important. They have moved to bring e-cigarettes into line with conventional cigarettes because, in the practical business of enforcing the ban on smoking in enclosed public spaces, the use of e-cigarettes makes that more difficult.”[17]

While there may be circumstances, such as for example, crowded terraces at a football stadium, in which it is impossible to differentiate between the use of an electronic cigarette and a smoked one, these are few and far between. It is therefore appropriate for businesses to be able to decide for themselves whether or not they need to introduce such a policy, as is the case now. ASH provided guidance on this, in Will you permit or prohibit e-cigarette use on your premises?[18]:

“Tips on formulating your policy on NCPs

  • Be clear about what you are trying to achieve, especially on how you are intending to make the situation better.

  • Be clear about precisely what you are prohibiting – nicotine containing products, things that could be confused with cigarettes, or both.

  • Make sure your policy is good for health, by helping and not hindering smokers to reduce the harm caused by smoking.

  • Consider the part that your policy can play in ‘renormalising’ or ‘denormalising’ the smokefree environment and promoting the right role models to children.” [Emphasis added.]

The report from the UK Centre for Tobacco and Alcohol Studies for Public Health England[19] discusses this issue, suggesting:

“Therefore, use of electronic cigarettes in smoke free places is more likely to lead to normalisation of nicotine devices than to smoking”.

Unfortunately, the vast majority of the organisations which have introduced a ban appear to have blindly – and with absolute ignorance – follow the ill-conceived advice of the BMA, or taken a position that is ideological rather than evidence-based, and simply oppose the use of nicotine through any means. The devastating consequence of this is that, in all those locations, vapers have been forced through a gateway back into smoking. This is what the Minister, the Welsh government, and all policy-makers need to understand, (as a vaper put it so eloquently recently):

If e-cigarettes are banned then the ban itself is a gateway to smoking.

 

Q8PPC

In the recent ASH Briefing[20], they point out:

“The goal of tobacco control is to diminish the harm caused by tobacco products. While the ideal remains that people should stop using tobacco completely and permanently, consensus currently supports a properly regulated harm reduction approach for those unable to do so. This is a framework by which the harmful effects of smoking are reduced without requiring the elimination of a behaviour that is not necessarily condoned. Such strategies have proved successful in the past, for example within the contexts of needle exchange programmes for illicit drug use and the promotion of safer sex to prevent HIV infection.

In 1976 Professor Michael Russell wrote: “People smoke for nicotine but they die from the tar.”[1] Indeed, the harm from smoking is caused primarily through the toxins produced by the burning of tobacco. By contrast, non-tobacco, non-smoked nicotine products, although addictive, are considerably less harmful. Electronic cigarettes consequently represent a safer alternative to cigarettes for smokers who are unable or unwilling to stop using nicotine.”

[1] Russell M. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. British Medical Journal 1976;1:1430-1433

 

The safety profile of low-dose nicotine products, such as electronic cigarettes – which contain no more than 4.5% nicotine, at the highest strength anyone would actually consume – has received considerable attention recently, with a variety of experts confirming that there is little cause for concern:

Professor Robert West: “…nicotine, which is not carcinogenic, despite what some people think, and the main risk from nicotine is that it will keep you addicted to nicotine”;[22]

Professor John Britton: “Nicotine itself is not a particularly hazardous drug. It’s something on a par with the effects you get from caffeine.”[23]

And

“If all the smokers in Britain stopped smoking cigarettes and started smoking e-cigarettes we would save 5 million deaths in people who are alive today. It’s a massive potential public health prize.”

Professor Bernd Mayer: “Nicotine is a toxic compound that should be handled with care, but the frequent warnings of potential fatalities caused by ingestion of small amounts of tobacco products or diluted nicotine-containing solutions are unjustified and need to be revised in light of overwhelming data indicating that more than 0.5g of oral nicotine is required to kill an adult.”[24]

Indeed, Professor Mayer’s study demonstrated that the lethal dose has been overestimated by somewhere between 6 and 13 times:

Thus, a careful estimate suggests that the lower limit causing fatal outcomes is 0.5–1 g of ingested nicotine, corresponding to an oral LD50 of 6.5–13 mg/kg. This dose agrees well with nicotine toxicity in dogs, which exhibit responses to nicotine similar to humans (Matsushima et al. 1995).

Professor Mayer clarified the position further on his blog[25]:

“In normal use nicotine containing products are not toxic. Slight overdosing is readily recognized as dizziness, nausea and headache, prompting users to stop or reduce nicotine intake. Continued consumption of high nicotine doses would result in poisoning evident as severe diarrhea and vomiting, effects which significantly decrease the amount of systemically available nicotine. Therefore, fatal cases of nicotine poisoning are extremely rare and will not occur upon inhalation of – or dermal contact with – nicotine containing products.”

Other experts agree:

Dr Karl Fägerström: “If one believes that tobacco/nicotine is here to stay, and nicotine is not a big health problem by the way, how can one not want the least harmful forms to be used”?[26]

Dr Paul Newhouse: “There was no withdrawal syndrome and no subjects continued to use nicotine products. Thus, in this nonsmoking population, there was no evidence for abuse liability of transdermal nicotine”.[27]

According to our Chief Scientific Officer, Tom Pruen, since former smokers formed a part of Dr Newhouse’s study, and none of the test subjects continued to use nicotine, clearly none were returned to smoking status.

Dr Newhouse was also quoted recently: “It seems very safe even in nonsmokers. In our studies we find it actually reduces blood pressure chronically. And there were no addiction or withdrawal problems, and nobody started smoking cigarettes. The risk of addiction to nicotine alone is virtually nil.”[28]

It is the smoke, not the nicotine, which kills so many millions of smokers, so while quitting smoking is a noble aim, quitting nicotine is far, far less important – particularly if the aim is to improve public health outcomes, especially for those in the deprived social demographics.

Presumably, this is why Professor Jonathan Foulds said:

“In light of all the available evidence, the banning or exaggerated opposition to snus and e-cigs in cigarette-rife environments is not sound public-health policy.”[29]

Professor Peter Hajek expresses similar concerns:

“E-cigarettes are not fully competitive with conventional cigarettes yet, but they are likely to develop into a real alternative relatively quickly. The promise of this development is that smokers will switch from conventional cigarettes to much safer alternatives on a population scale. This may actually end the tobacco epidemic within the next few years.

Attempts to stop this process are in effect helping to maintain the market monopoly of the deadly conventional cigarettes. If it is true that you are poised to ban or restrict this development, this would have massive detrimental effects on public health. It is hard to imagine an argument for this. Various potential dangers of the alternative nicotine delivery devices have been proposed, but these are negligible compared to the potential benefits.”[30]

As does Dr Jacques le Houezec :

“The ultimate goal for a smoker is to stop using combustible products, the most deadly. Smokers should not be denied access to much safer alternatives, including long term use of pure nicotine. This would save many lives!”[31]

Perhaps it is best summed up by Professor Martin Jarvis:

“If low risk smokeless products and products such as e-cigarettes are simply banned, the cigarette’s position is entrenched. Given that the problem with tobacco is not the drug, but the delivery system, that would be a tragic nonsense.”[32]

Public Health England recently commissioned a report into Electronic cigarettes[33], which addressed the issues of a potential ‘gateway’ and the risk of ‘renormalising’ smoking:

“There have been some suggestions that among non-smokers, electronic cigarettes might be used as a gateway to smoking and promote smoking uptake and nicotine addiction, particularly among children and young people. However, to date there is no data supporting this claim. Experimentation with electronic cigarettes among non-smoking children in the UK is currently rare, and only about 1% of 16 to 18-year-old never smokers have experimented to electronic cigarettes and few if any progress to sustained use.[47] Furthermore, experimentation with electronic cigarettes should be considered in the context of current levels of experimentation with tobacco cigarettes, which in Great Britain currently generates a prevalence of smoking of 15% among 16 to 19-year olds, and 29% in 20 to 24-year olds.[79] Experimentation with electronic cigarettes is most likely to occur predominantly in the same group that currently experiment with tobacco, as indeed is suggested by recent US data.[40] It is therefore relatively unlikely that availability and use of electronic cigarettes causes or will cause significant additional numbers of young people to become smokers than do at present. It has been suggested that there is a risk of sustained dual use among smokers who might otherwise have quit smoking completely, representing missed opportunities to achieve complete cessation. This concern clearly applies equally to NRT, which is licensed for what is in effect dual use and recommended on the grounds that dual use is likely to increase quit attempts. The concern is therefore inconsistent; if dual use is good as a pathway to quitting, that surely applies to dual use involving either NRT or electronic cigarettes.

Some argue that use of electronic cigarettes, which to a degree resembles cigarette smoking, in places where smoking is currently prohibited might re-normalize smoking and undermine tobacco control efforts.[80] However, although similar in appearance, even cigalike products are easily distinguishable, both in appearance and smell, from tobacco cigarettes. Therefore, use of electronic cigarettes in smoke free places is more likely to lead to normalisation of nicotine devices than to smoking, and hence potential benefit as a support to existing well smoke-free policies.”

The National Centre for Smoking Cessation and Training (NCSCT) also considered these issues in partnership with Public Health England, in its report, Electronic cigarettes[34], also published in May 2014:

“There is a concern that electronic cigarette use may act as a gateway to tobacco use,15 16 but to date there is no evidence to support this. However it is reported that adolescents who smoke who had tried electronic cigarettes are more likely to intend to quit smoking.17

It is abundantly clear that the ‘gateway hypothesis’ simply does not bear scrutiny, and should be abandoned forthwith as any kind of justification for restricting electronic cigarette use.

 

Q9

As indicated above, it is patently absurd to suggest that any smoker could be unaware of the ban on smoking in public places. The existing Smoke-Free requirements already have the force of law, and are well enforced. The “message that smoking is no longer the norm” has been forced upon all smokers with such vehemence and for so long that they are all perfectly well aware that they are viewed as society’s pariahs.

However, since the use of electronic cigarettes is already a ‘smoke-free’ behaviour, there is no need to pass legislation attempting to include it in the ban on smoking in public places. More importantly, it would be unethical, immoral and illegal to attempt to do so, in the stark absence of any credible justification.

You refer, at 2.12 and 2.29, to the UK Government’s tabled amendment to the Children and Families Bill, which would prohibit the sale of nicotine products to persons under the age of 18, and to make proxy purchase of nicotine products an offence.

ECITA has been calling for a mandated age restriction for electronic cigarette products – with and without nicotine – since our inception 5 years ago. However, while your understanding of this is stated as: “These new offences will bring NPs more into line with tobacco products and work to reduce underage consumption of nicotine products”, there are a number of inherent problems:

  • If you were only to restrict products based on their nicotine content, this would not address the issue of non-nicotine electronic cigarette products, which ECITA also believes should not be sold to minors;
  • Also, presumably, both the UK and Welsh governments would recognise that ‘nicotine-containing products’ (NCPs) or ‘nicotine products’ (NPs) would necessarily include the licensed medicinal Nicotine Replacement Therapy products (NRTs), which are currently regularly provided to children as young as 12 in schools, without the knowledge of parents or teachers[35]. Whilst ECITA believes that this would be a sensible and necessary move, we fear it may be an unintended consequence of this action, which the UK and Welsh governments may have overlooked;
  • Finally, although ECITA supports the restriction of all electronic cigarette products to adults only, ASH Wales[36] recently urged caution:

“The use of e-cigarettes as smoking cessation or harm reduction devices by young people who are already smokers needs to be explored further. This is essential if the sale of e-cigarettes to under-18s is to be banned, as is currently planned in the UK as there would be adverse consequences to banning a product that young people may actually be using to stop smoking.” (Emphasis added.)

Q10

This is not strictly a ‘yes/no’ question, since it has many inherent assumptions which have been dealt with above. Setting that aside, in the Minister’s foreword, Mr Drakeford says:

“It is nothing short of a tragedy that the lives of so many of our fellow citizens are shortened or blighted by illnesses which were so clearly avoidable. Government has the responsibility to create the conditions in which such harm can be avoided – and that is what this White Paper is all about. Thereafter there is a responsibility which rests with individuals to act in ways which protect and promote their own well-being.”

It is nothing short of a tragedy that the Minister has failed to recognise that the many millions of smokers around the world who have already made the switch to vaping, and the many hundreds of thousands of smokers who are doing so today – including a substantial number of Welsh smokers and (crucially) ex-smokers – are taking responsibility to “protect and promote their own well-being”, because the “conditions in which such harm can be avoided” exist today, with electronic cigarettes widely available. If the Welsh government – or any other policy-making body – were to introduce restrictions on the sale and use of electronic cigarettes to adult smokers, all they will achieve is to misappropriate the individual’s responsibility for protecting and promoting their own well-being and put them directly in harm’s way by sending them back to smoking. Surely, this cannot be the action of any right-thinking policy-making body.

It is important to note also that, if electronic cigarette use were banned in enclosed public spaces, this would have the effect of forcing electronic cigarette users outside to where the smokers now regularly gather, thus exposing them to the acknowledged harm of second-hand smoke, as well as the temptation to relapse to smoking. Clearly, this would be exceptionally counter-productive.

At 1.13, you state:

“We acknowledge that there can be a fundamental tension between a government intervening to address major challenges to public health, and an individual’s freedom to ultimately live their life in the way he or she chooses. There is also a debate to be held, however, about the extent to which people who choose to engage in all kinds of unhealthy behaviours which are known to be risky to their own health and wellbeing should also expect to bear the consequences of such decisions. In an age of austerity, that debate cannot avoid encompassing the fact that treating avoidable illness arising from smoking, [...] draws disproportionately on the pool of resources available to provide health services for all. Compelling Welsh evidence indicates that even modest increases in uptake of healthy behaviours could considerably reduce the population burden of vascular disease, dementia and death from heart disease.”

Is it any wonder that the ‘vaping community’, which has a particularly strong presence in Wales, is feeling that “fundamental tension”, (and indeed, communicating this to the Minister), when this proposed government intervention would actively ‘challenge’ a current public health revolution, which is gaining momentum at no cost to the taxpayer. To remove the “individual’s freedom” to choose to reduce their own harm, at no cost to the taxpayer, and with the significant likelihood of reducing the avoidable illness arising from smoking, and therefore, the costs of treating same, seems entirely to contradict the stated desire for “uptake of healthy behaviours”.

Q11PPC

At 1.8, you state:

“These types of measures are wholly consistent with principles of prudent health care2, as they seek to intervene at the point where there is maximum return for investment.The example of the tobacco control measures outlined above provides a clear illustration of how legal intervention can contribute to a long term positive impact in terms of health gain. Such actions are considered to be both proportionate and preventative in terms of protecting public health, as they help avoid far larger damage to the health of individuals in the future, together with the greater costs involved. They also have a powerful impact on health inequality, because we know that many of the dangers which can be addressed through public health legislation fall disproportionately on the most disadvantaged individuals, families and communities.”

Furthermore, in the attendant press release, cited as reference 2, the Minister is quoted as saying:

“We need to work to a principle of what is often called minimum appropriate intervention. Who actually in practice would wish to undergo a greater level of treatment than that necessary for addressing their condition?”[37]

Well, who indeed?

The “types of measures” proposed for electronic cigarettes are in direct opposition to all the points made by the Welsh government above. It is neither “prudent”, nor a “minimum” (or “appropriate”) intervention to interfere with adult smokers’ right to choose for themselves – at no cost to the taxpayer, or anyone other than themselves – to reduce the harm they cause to themselves and others by switching to products which are widely acknowledged as being orders of magnitude safer than continuing to smoke.

As Professor West said:

“Imagine a world in which the 1 billion people currently smoking cigarettes were ‘vaping’ electronic cigarettes instead. The death toll would be cut from more than 5 million to perhaps a few tens of thousands at most. E-cigarettes allow vapers to get their nicotine fix in a much purer form without all the carcinogens and poisons in tobacco smoke. Smokers and vapers typically inhale about 20mg of nicotine per day and at that dose it is probably no more harmful than a few cups of coffee. We know this because milions of lifelong users of the smokeless tobacco product ‘snus’ in Sweden get similar doses of nicotine with nothing like the harm that smokers experience. [...]

I think this is too good an opportunity to miss. Of course regulation should ensure minimum manufacturing and labelling standards, but it should also be used to nurture their development as an alternative to smoking and an opportunity to legislate cigarettes out of existence.”[38]

At 1.14, you “accept that any intervention has to be in keeping with prudent health care; justifiable, appropriate and proportionate”, and recognise the need to assess other factors, “such as the associated costs, and whether the intervention needs to be supported by an enforcement regime.” At 1.42, you undertake to “continue to utilise a full range of approaches”, including “behavioural change programmes”, and yet the proposals relating to electronic cigarettes in this White Paper are in direct opposition to all these excellent principles.

In one of the attendant press releases[39], the Minister said:

The evidence in support of a precautionary approach comes from organisations such as Public Health Wales, the World Health Organisation, all four chief pharmaceutical officers, Cancer Research UK and the British Medical Association.

However, better informed bodies, including ASH Wales, said:

We should be cautious of taking steps that could undermine those who are using e-cigarettes to help them to stop or cut down on smoking. ASH Wales recommends that premises should continue to be allowed to make decisions for themselves on the use of e-cigarettes, although we recognise that there may be environments where the use of these devices is inappropriate.

ASH Wales would like to see more evidence on the long term effects of e-cigarettes before we support a ban on using e-cigarettes in public places.”

ASH Wales have clearly understood the precautionary principle, and know how it should be properly applied.

Clive Bates provides a useful explanation of the precautionary principle[40]:

The Precautionary Principle – misunderstood and abused

I increasingly think that the precautionary principle, a worthwhile idea, has become the last refuge for scoundrels with a regulatory mission but no evidence to support it. The European Commission published useful guidance on the precautionary principle in 2000. It sets out six guidelines:

Clive 6

For our purposes the key guideline is the 4th in the list above: the requirement to apply a symmetric assessment of risks and benefits arising from both regulation intervention and non-intervention. In other words, if a regulator wants to come down heavily on a product like e-cigarettes because of hypothetical dangers, it has to take into account the lost benefits that might arise if it bans, restricts or otherwise reduces the positive potential of the product. For e-cigs this is particularly salient as the benefits are to health, not just economic. This symmetry is almost always overlooked when activists make arguments using the precautionary principle.

Clive goes on to talk about ‘Finding the public health optimum’, saying:

“The regulatory objective is not to create the safest cleanest possible products, with the most risk averse advertising and most restrictive commercial practices. The perfectly safe product that no-one wants to use is of no value in public health terms. For the optimum public health outcome, the benefits to smokers who switch to e-cigarette must be weighed alongside the risks to people who use e-cigarettes. If regulation designed to reduce the risk of e-cigarette also makes them less attractive or reduces the choice offered to smokers the overall impact of ‘tougher’ regulation may actually increase harm to health.

The key is to retain the appeal to smokers and to balance risks associated with the e-cig products with risks of continuing but avoidable smoking if smokers are deterred from switching. In other words, the opportunity to have smokers switch should play a large part in the regulatory optimisation and therefore sustaining and encouraging the appeal of these products to smokers matters a great deal.”

In closing, we would like to urge the Welsh government to apply the precautionary principle fully, fairly, and in the way it is intended to be used. We are sure the Minister – as he said in one of his press releases – does not “want future generations to look back and shake their heads at our inability to see where the evidence was leading” because he failed to apply the precautionary principle properly, and led the Welsh government to introduce legislation which a precautionary approach did not support, and consequently caused deaths and disease from smoking to increase, rather than decrease.

 


[1] West, R., and Brown, J., (April 2014), Electronic cigarettes in England – latest trends (ref: STS140122). http://www.smokinginengland.info/latest-statistics/
[2] Dr K Farsalinos: http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/2014/165-ecig-harm
Professor M Siegel : www.tobaccoanalysis.blogspot.co.uk/2014/05/glantz-review-article-is-little-more.html
Clive Bates: http://www.clivebates.com/?p=2073
Tom Pruen: http://www.ecita.org.uk/blog/index.php/stanton-glantz-not-just-inflexibly-dogmatic-but-also-dishonest/
[3] Nicotine Science and Policy, (26 May 2014), Statement from specialists in nicotine science and public health policy, Letter to Dr Margaret Chan, DG, WHO
http://nicotinepolicy.net/documents/letters/MargaretChan.pdf
[4] Burstyn, I., (2014), Published in BioMed Central, Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks, doi: 10.1186/1471-2458-14-18
http://www.biomedcentral.com/1471-2458/14/18/abstract
[5] Farsalinos, K.E., and Polosa, R., (2014), Published in Therapeutic Advances in Drug Safety, Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review, Therapeutic Advances in Drug Safety
http://taw.sagepub.com/content/early/2014/02/12/2042098614524430.abstract
[6] Hitchman, S.C., McNeill, A., and Brose, L.S., (5 May 2014), Published in Addiction, Electronic cigarettes: time for an accurate and evidence-based debate, Wiley Online Library
http://onlinelibrary.wiley.com/doi/10.1111/add.12550/full
[7] ASH Briefing, June 2014, Electronic cigarettes (also known as vapourisers), www.ash.org.uk.
http://www.ash.org.uk/files/documents/ASH_715.pdf
[8] Britton, J., and Bogdanovica, I., (May 2014), UK Centre for Tobacco and Alcohol Studies, Electronic cigarettes, Public Health England
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/311887/Ecigarettes_report.pdf
[9] ASH Briefing, May 2014, Electronic cigarettes (also known as vapourisers), www.ash.org.uk.
http://www.ash.org.uk/files/documents/ASH_715.pdf
[10] ECITA blog, (2012), www.ecita.org.uk, Response to BMA Briefing, ECITA (EU) Ltd  http://www.ecita.org.uk/blog/index.php/response-to-bma-briefing/
[11] ASH Briefing, June 2014, Electronic cigarettes (also known as vapourisers), www.ash.org.uk.
http://www.ash.org.uk/files/documents/ASH_715.pdf
[12] WalesOnline, (5 June 2014), ‘No evidence e-cigarettes lure young people into smoking’ claims expert, Wales Online
http://www.walesonline.co.uk/news/wales-news/no-evidence-e-cigarettes-lure-young-7218460#.U5Arxf0jKiI.twitter
[13] Bates, C., (2014), Unable to take any more, I write to Dr Nathanson of the BMA (updated), The Counterfactual
http://www.clivebates.com/?p=2013
[14] Sense About Science, (Dec 2013), What’s the evidence for banning electronic cigarettes?
http://www.senseaboutscience.org/news.php/364/whats-the-evidence-for-banning-electronic-cigarettes
[15] Liddle, R., (Sep 2013), The BMA’s bizarre jihad against e-cigarettes, The Spectator
http://www.spectator.co.uk/columnists/rod-liddle/9026811/the-bmas-bizarre-jihad-against-e-cigarettes/
[16] http://www.ecita.org.uk/blog/index.php/open-letter-to-uk-rail-service-providers/
[17] Drakeford, M., (June 2014), Questions need to be asked about e-cigarettes, ClickonWales
http://www.clickonwales.org/2014/06/questions-need-to-be-asked-about-e-cigarettes/
[18] ASH, (January 2014), Will you permit or prohibit e-cigarette use on your premises?, ASH
http://www.ash.org.uk/files/documents/ASH_900.pdf
[19] Britton, J., and Bogdanovica, I., (May 2014), UK Centre for Tobacco and Alcohol Studies, Electronic cigarettes, Public Health England
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/311887/Ecigarettes_report.pdf
[20] ASH Briefing, June 2014, Electronic cigarettes (also known as vapourisers), www.ash.org.uk
http://www.ash.org.uk/files/documents/ASH_715.pdf
[21] Russell M. Low-tar medium-nicotine cigarettes: a new approach to safer smoking. British Medical Journal 1976;1:1430-1433
[22] West, R., May 2014, BBC Radio 4, You and Yours
[23] Britton, J., BBC interview, Electronic cigarettes – miracle or menace?, BBC News UK
http://www.bbc.co.uk/news/uk-21406540
[24] Mayer, B., (2014), Archives of Toxicology, How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century, NCBI PMC
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880486/
[25] Mayer, B, (2014), A Scientist’s view about nicotine & tobacco, Nicotine -  the basics, bernd-mayer.com
http://www.bernd-mayer.com/nicotine-the-basics/
[26] http://www.ecita.org.uk/appendix%201.pdf
[27] Newhouse, P., Kellar, K., Aisen, P, et al, (2012), Neurology, Nicotine treatment of mild cognitive impairment: A 6-month double-blind pilot clinical trial, doi: 10.1212/WNL.0b013e31823efcbb
http://www.gwern.net/docs/nicotine/2012-newhouse.pdf
[28] Newhouse, P., (2014), quoted in Tampa Bay Times, Study finds nicotine safe, helps in Alzheimer’s, Parkinson’s, Tampa Bay Times
http://www.tampabay.com/news/health/study-finds-nicotine-safe-helps-in-alzheimers-parkinsons/2175396
[29] http://www.clivebates.com/?p=674
[30] http://www.clivebates.com/?p=697
[31] http://www.ecita.org.uk/appendix%201.pdf
[32] http://www.clivebates.com/?p=674
[33] Britton, J., and Bogdanovica, I., (May 2014), UK Centre for Tobacco and Alcohol Studies, Electronic cigarettes, Public Health England
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/311887/Ecigarettes_report.pdf
[34] McRobbie, H., (May 2014), National Centre for Smoking Cessation and Training (NCSCT), Electronic cigarettes, Public Health England
http://www.ncsct.co.uk/usr/pub/e-cigarette_briefing.pdf
[35] United Press International, (2009), Boy, 14, overdoses on nicotine gum http://www.upi.com/Top_News/2009/07/20/Boy-14-overdoses-on-nicotine-gum/UPI-79591248131144/ and
The Mirror (UK), (2009), Boy, 14, overdoses on nicotine gum given out at school http://www.mirror.co.uk/news/2009/07/21/boy-14-overdoses-on-nicotine-gum-given-out-at-school-115875-21536385/
and
The Telegraph (UK), (2013), Children as young as 12 given nicotine patches on the NHS http://www.telegraph.co.uk/health/healthnews/9823681/Children-as-young-as-12-given-nicotine-patches-on-the-NHS.html
Also, please see: http://www.ecita.org.uk/blog/index.php/why-nrt-could-never-make-the-grade-as-a-consumer-product/
[36] Palmer, R., and Hallingberg, B, (March 2014), Young People and the Use of E-cigarettes in Wales, ASH Wales
http://www.ashwales.org.uk/creo_files/upload/downloads/young_people_and_e-cigarettes_in_wales_final_march_2014.pdf
[37] http://www.walesonline.co.uk/news/wales-news/nhs-cannot-turn-back-challenges-6520109
[38] West, R., (20 January 2013), Electronic cigarettes: carpe diem or caveat emptor, Robert West Blog http://www.rjwest.co.uk/blog.php
[39] WalesOnline, (5 June 2014), ‘No evidence e-cigarettes lure young people into smoking’ claims expert, Wales Online
http://www.walesonline.co.uk/news/wales-news/no-evidence-e-cigarettes-lure-young-7218460#.U5Arxf0jKiI.twitter
[40] Bates, C., (2014), Regulation of e-cigarettes – general ideas, The Counterfactual
http://www.clivebates.com/?p=2100#pp

 

Sigs

 

Annex 1

 

Legislation covering the sale and marketing of electronic cigarette products

There are many and various statutory instruments from both the EU and those which are specific to the UK. Rather than scatter these throughout the document, we have summarised them here, together with links to the original documents, for ease of reference.

EU Directives

Medicinal Products Directive 2001/83/EC

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF

Tobacco Products Directive 2014/40/EU

http://ec.europa.eu/health/tobacco/docs/dir_201440_en.pdf

General Product Safety Directive (2001) (as amended in 2004)

http://eur-lex.europa.eu/legal-content/EN/ALL/;jsessionid=pGhwTZQW6kJ9cBCTQF95p0yklmRXYRTTdpjxZyCVN182dcVb2vmK!-2062459230?uri=CELEX:32001L0095

Dangerous Substances Directive (as adapted) (2001)

https://osha.europa.eu/en/legislation/directives/exposure-to-chemical-agents-and-chemical-safety/osh-related-aspects/58

Dangerous Preparations Directive (1999)

http://ec.europa.eu/enterprise/sectors/chemicals/documents/classification/archives/dangerous-preparations/directive_en.htm

CLP

http://ec.europa.eu/enterprise/sectors/chemicals/documents/classification/index_en.htm#h2-1

REACH

http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/index_en.htm

Low Voltage Directive (2006)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:374:0010:0019:en:PDF

Electromagnetic Compatibility Directive (2004)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:390:0024:0037:en:PDF

RoHS2 (2011)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:en:PDF

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32011L0065&from=EN

Weights & Measures: Directive 2007/45/EC laying down rules on nominal quantities for prepacked products (2007)

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007L0045&from=EN

Waste Electronic and Electrical Equipment (WEEE) Directive (2012)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:197:0038:0071:en:PDF

Packaging and Packaging Waste Directive (1994)

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31994L0062&from=EN

as amended by

Commission Directive 2013/2/EU, amending Annex I to Directive 94/62/EC

http://www.ekokom.cz/uploads/attachments/English/Directive_2013_2_EC.pdf

Electronic Commerce (EC Directive) Regulations (2002)

http://www.legislation.gov.uk/uksi/2002/2013/contents/made

Directive 97/7/EC on the protection of consumers in respect of distance contracts (1997)(Distance Selling Directive (1997) (as amended))

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31997L0007&from=en

Comparative and Misleading Marketing Directive (2006)(MCAD)

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006L0114&from=EN

UK Regulations

UK General Product Safety Regulations (2005)

http://www.legislation.gov.uk/uksi/2005/1803/pdfs/uksi_20051803_en.pdf

http://www.opsi.gov.uk/si/si2005/20051803.htm

The Poisons Act (1972)

http://www.legislation.gov.uk/ukpga/1972/66/pdfs/ukpga_19720066_en.pdf

UK Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP4) (2009)

http://faolex.fao.org/cgi-bin/faolex.exe?rec_id=070275&database=faolex&search_type=link&table=result&lang=eng&format_name=@ERALL

UK Consumer Labelling & Packaging Regulations (2009)

http://www.legislation.gov.uk/uksi/2009/716/made

UK Weights & Measures (Packaged Goods) Regulations (2006)

http://www.legislation.gov.uk/uksi/2006/659/contents/made

UK Electrical Equipment (Safety) Regulations 1994

http://www.legislation.gov.uk/uksi/1994/3260/contents/made

UK Plugs and Socket (Safety) Regulations (1994)

http://www.legislation.gov.uk/uksi/1994/1768/contents/made

UK Batteries and Accumulators (Placing on the Market) Regulations (2008) (BMR)

http://www.legislation.gov.uk/uksi/2008/2164/pdfs/uksi_20082164_en.pdf

UK Producer Responsibility Obligations (Packaging Waste) Regulations 2007

http://www.legislation.gov.uk/uksi/2007/871/pdfs/uksi_20070871_en.pdf

UK Packaging (Essential Requirements) Regulations 2003

http://www.legislation.gov.uk/uksi/2003/1941/pdfs/uksi_20031941_en.pdf

UK Packaging (Essential Requirements) (Amendment) Regulations 2013

http://www.legislation.gov.uk/uksi/2013/2212/pdfs/uksi_20132212_en.pdf

UK Waste Batteries and Accumulators Regulations (2009) (WBR)

http://www.bbma.co.uk/pdf/uksi_20090890_en.pdf

UK Waste Electronic and Electrical Equipment Regulations (2006) (WEEE)

http://www.legislation.gov.uk/uksi/2006/3289/contents/made

UK Consumer Protection (Distance Selling) Regulations (2000)

http://www.legislation.gov.uk/uksi/2000/2334/contents/made

UK Consumer Contracts (Information, Cancellation and Additional Charges) Regulations (2013)

http://www.legislation.gov.uk/uksi/2013/3134/made

UK Electronic Commerce (EC Directive) Regulations (2002).

http://www.legislation.gov.uk/uksi/2002/2013/contents/made

UK Data Protection Act (1998)

http://www.legislation.gov.uk/ukpga/1998/29/contents

UK Control of Misleading Advertising (Amendment) Regulations (2000) (CMARs)

http://www.legislation.gov.uk/uksi/2000/914/contents/made

UK Business Protection from Misleading Marketing Regulations (2008) (BPRs)

http://www.legislation.gov.uk/uksi/2008/1276/pdfs/uksi_20081276_en.pdf

UK Enterprise Act (2002)

http://www.legislation.gov.uk/ukpga/2002/40/contents

UK Consumer Protection from Unfair Trading Regulations (2008)

http://www.legislation.gov.uk/uksi/2008/1277/contents/made

UK Health and Safety at Work Act (1974)(as amended)

http://www.legislation.gov.uk/ukpga/1974/37

Other EU Statutory Instruments

Regulation (EC) No 765/2008 Accreditation and Market Surveillance relating to the Marketing of Products (2008)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF

Decision No. 768/2008/EC on a common framework for the marketing of products

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:en:PDF

Commission Decision No. 2006/340/EC

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32006D0340&from=EN

Other UK Statutory Instruments

Statutory Instrument 2012 No: 3032 (appointing NMO as market surveillance authority responsible for RoHS regulations)

http://www.legislation.gov.uk/uksi/2012/3032/pdfs/uksi_20123032_en.pdf

UK Advertising Standards Agency Code (CAP Codes)

http://www.cap.org.uk/The-Codes/CAP-Code.aspx

International Standards

ISO 8317 – child-resistant closures

EN ISO 11683 – tactile warning labels

International Electrotechnical Commission standard IEC 884-1 (1987)

http://www.legislation.gov.uk/uksi/1994/1768/note/made

Original standard available from :

http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030083921

European Standards

BS EN 28317 – child-resistant closures

EN 862 – child-resistant packaging

EN ISO 11683 – tactile warning labels

EN13427:2004 – Packaging Waste

British Standards

BS 1363 – mains plugs

BS EN 28317 – child-resistant closures

EU Guidances

EU Guidelines for the Notification of Dangerous Consumer Products to the Competent Authorities of the Member States by Producers and Distributors in Accordance with Article 5(3) of Directive 2001/95/EC

www.ec.europa.eu/consumers/cons_safe/prod_safe/gpsd/notification_dang_en.pdf

EU Guide Product Safety in Europe: A Guide to corrective action including recalls – helping businesses to protect consumers from unsafe products

http://ec.europa.eu/consumers/cons_safe/action_guide_en.pdf

EU Guidance on FAQ (CE marking for RoHS)

http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf

Blue Guide on Technical Documentation for RoHS

http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=0CD4QFjAC&url=http%3A%2F%2Fec.europa.eu%2FDocsRoom%2Fdocuments%2F4942%2Fattachments%2F1%2Ftranslations%2Fen%2Frenditions%2Fpdf&ei=A-aBU47zJYKJOL3pgNgL&usg=AFQjCNFsTISCsssWGXn1wjcTpyNHFxVuVA&sig2=SysZ4UeNHhYx8NOSDZHY-Q&bvm=bv.67720277,d.ZWU&cad=rja

CENELEC FAQs

http://www.cenelec.eu/faq/faq_entry.htm.bak

The New Legislative Framework and the eco-management audit scheme

http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/new-legislative-framework-and-emas/index_en.htm

RoHS 2 FAQ

http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf

UK Guidances

UK DTI GPSR 2005 Guidance for businesses, consumers and enforcement authorities Guidance Notes

www.berr.gov.uk/files/file22713.pdf

NMO Guidance (CE marking for RoHS)

http://www.bis.gov.uk/assets/nmo/docs/rohs/support-literature/nmo_technicalbrochure_acc4.pdf

Packaging (Essential Requirements) Regulations, October 2013

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/244694/13-1155-packaging-regulations-government-guidance.pdf

Distance Selling Regulations Guidance Notes

http://www.oft.gov.uk/shared_oft/business_leaflets/general/oft698.pdf

Data Protection: The Guide

http://ico.org.uk/for_organisations/data_protection/the_guide/the_principles

Security Measures

http://www.ico.gov.uk/for_organisations/data_protection/security_measures.aspx

Office of Fair Trade (OFT): A quick guide to competition and consumer protection laws that affect your business.

(NB: The OFT has since been incorporated into the Trading Standards Institute (TSI).)

http://www.oft.gov.uk/shared_oft/business_leaflets/general/oft911.pdf; jsessionid=ABA5CB13D0F823D842BDC441284AB99A

Health & Safety Executive online assistance for risk assessments

http://www.hse.gov.uk/risk/assessment.htm

Health & Safety Executive: Report an Incident

http://www.hse.gov.uk/riddor/index.htm

 

Annex 2

 

Information about the Diversity of Electronic Cigarette Products

Electronic cigarettes

 Diversity: from the mass-produced to artisan, hand-crafted designs

What does an electronic cigarette look like?

Most people have now heard of electronic cigarettes, and many have seen them. However, many believe that electronic cigarettes look like tobacco cigarettes and are unaware that there is a vast range of electronic cigarette products on the market today which bear little to no resemblance to traditional tobacco cigarettes at all.

There are those that look like tobacco cigarettes, although even these come in quite a few variations:

Div1

But there are also:

‘Pen-style’ electronic cigarettes

Div2Electronic cigars

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Electronic pipes

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It is clear from the above images that electronic cigarettes, cigars and pipes come in a considerable variety of ‘ready-assembled’ kits, as well as some interesting artisanal variations on the theme. However, this is to barely scratch the surface of what the millions of ‘vapers’ all over the world are actually using on a daily basis. In reality, the choices of each of the various components are almost limitless, as we can see from the following.

Drip Tips

‘Drip tips’ can be used with most types of atomiser, cartomiser, clearomiser or tank system to replace the section which goes into the mouth. As clearly demonstrated below, these can be mass produced in interesting varieties, or crafted into works of art, allowing the consumer to tailor their electronic cigarette to suit their own personal taste:

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Atomisers:

The basic atomiser is quite out-dated now, since the technology has moved on in leaps and bounds. A cartridge, comprising some kind of fibrous material filled with nicotine eliquid, would be pressed onto the atomiser which, when heated, would produce the vapour. However, as part of this technological advance, we have seen the introduction of rebuildable atomisers, which have a small but dedicated following in the market:

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In reality, rebuildable atomisers are simply too ‘geeky’ to appeal to most smokers – at least to begin with. Initially, smokers are usually looking for a replacement product which is as much like a tobacco cigarette as possible. Fortunately, with the introduction of cartomisers in 2010, most of the ‘cig-a-like’ products switched from atomisers to cartomisers, dramatically improving their performance in most cases. With a cartomiser, the cartridge of eliquid is combined with the atomiser. The vast majority of these can be refilled with eliquid, minimising the environmental impact, as well as keeping costs down for consumers.

Cartomisers

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There are still considerable drawbacks with cartomisers, however, once the smoker has completely switched to vaping full time. Simply put, the amount of eliquid held in each cartomiser is not enough to last all day (if you are a heavy user), and the constant ‘topping up’, even with a drip tip (see above), becomes quite annoying. After a while, most vapers will want to move onwards and upwards. Some smokers who make the switch, however, are entirely happy with continuing to use cartomisers, and sticking with a ‘cig-a-like’ device, replacing the cartridges as they run dry. It’s all about personal choice: what works for some will not necessarily work for others.

Clearomisers

Clearomisers were introduced in late 2010, but really became popular in 2011 onwards. The performance is considerably better than with a cartomiser, plus the tank capacity allows for more eliquid to be carried in the device for use over more hours before requiring a top-up.

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Tank atomisers

In early 2012, we saw the introduction of tank atomisers – again, tackling that problem of having to top-up irritatingly frequently. Early models were not particularly sophisticated, but it was a further improvement in performance, compared with the earlier cartomiser models. Of course, as time has gone on, more and more different designs have been produced, so that today, we have a dazzling array of ‘off-the-shelf’ and ‘bespoke’ tank atomisers to choose from. The vast majority of these are of standard fittings, so will either fit directly onto the chosen battery, or can be made to do so by use of an adaptor sleeve.

Div9

Of course, as the atomiser/cartomiser technology has advanced, so too, we have seen considerable advances in the battery technology. This is another area where there is a huge amount of design innovation, alongside ever better performance.

Batteries

Div10Div11

Nearly all the electronic cigarette batteries are rechargeable, and thanks to good batteries regulations, there need be no undue concerns about battery safety, providing the regulations are complied with. Rechargeable batteries are obviously preferable to disposable ones, to minimise the impact on the environment. Naturally, since there are so many different types of batteries, there is also quite a range of battery chargers, including 12v ‘in car’ chargers. It is hugely important that consumers use the charger supplied with the battery, to avoid malfunction and the possibility of injury.

Battery Chargers

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There are also personal charging cases (PCCs). These were introduced in 2010 for the basic cig-a-like models, and allowed the vaper to charge an ecig battery while out and about. By 2011, we had bigger PCCs, which allowed vapers to charge the larger batteries ‘on the move’.

Personal charging cases (PCCs)

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Of course, over the years, many innovative craftsmen and artists have taken the basic principles, and allowed their imagination to run riot. Today, it seems that pretty much anything is possible, with new, intriguing designs coming onto the market regularly. Most of the ‘mods’ (modified electronic cigarette) can be used with a wide range of the available atomisers, cartomisers, clearomisers and/or tank systems, customised to suit the consumer’s taste by choice of drip tip, and many are engraved or designed specifically to order. Many of the ‘artisan’ products are hand-crafted, rather than being mass produced.

Mods

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But, of course, the most important component for smokers and vapers alike is the eliquid – the flavoured solution used to top up the electronic cigarette. Eliquids are available with and without nicotine, in a huge range of flavours, strengths, and with a variety of different base excipients. The ‘cig-a-like’ products tend to be supplied pre-filled with liquid (although these can be refilled), but the tank systems and more advanced systems are filled by the consumer from eliquid bottles. There are robust regulations in place concerning the packaging and labelling of eliquid, as well as requirements for testing to ensure that stated nicotine contents are correct, and that there is no contamination.

E-liquids

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There is also a growing market in DIY eliquid mixing, with kits being supplied to consumers, together with instructions on how to develop the perfect blend of flavours for their taste. It is important to note that the nicotine solution for DIY mixing is only supplied at the concentration allowed by the regulations. Currently this varies from country to country. In the UK, retail sales are allowed up to 7.5% concentration. Providing the packaging and labelling are as they should be, this need not be a cause for concern, and affords consumers wishing to dabble in DIY the opportunity to experiment with various levels of diluents (PG and VG) and flavourings. The online calculators and mixing guides can help people to create their own blends, at a fraction of the cost of ready-made eliquid. There is also a great deal of advice and help available from the various online forums, including mixology threads on each one. Most reputable vendors will supply DIY mixing products with advice on Personal Protective Equipment (PPE) required, such as gloves.

DIY Mixing Supplies:

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Annex 3

 

Statement from specialists in nicotine science and public health policy

Dr Margaret Chan

Director General

World Health Organisation

Geneva

CC: FCTC Secretariat, Parties to the FCTC, WHO Regional Offices

26 May 2014

Dear Dr Chan

Reducing the toll of death and disease from tobacco – tobacco harm reduction and the Framework Convention on Tobacco Control (FCTC)

We are writing in advance of important negotiations on tobacco policy later in the year at the FCTC Sixth Conference of the Parties. The work of WHO and the FCTC remains vital in reducing the intolerable toll of cancer, cardiovascular disease and respiratory illnesses caused by tobacco use. As WHO has stated, up to one billion preventable tobacco-related premature deaths are possible in the 21st Century. Such a toll of death, disease and misery demands that we are relentless in our search for all possible practical, ethical and lawful ways to reduce this burden.

It is with concern therefore that a critical strategy appears to have been overlooked or even purposefully marginalised in preparations for FCTC COP-6. We refer to ‘tobacco harm reduction’ – the idea that the 1.3 billion people who currently smoke could do much less harm to thier health if they consumed nicotine in low-risk, non-combustible form.

We have known for years that people ‘smoke for the nicotine, but die from the smoke’: the vast majority of the death and disease attributable to tobacco arises from inhalation of tar particles and toxic gases drawn into the lungs. There are now rapid developments in nicotine-based products that can effectively substitute for cigarettes but with very low risks. These include for example, e-cigarettes and other vapour products, low-nitrosamine smokeless tobacco such as snus, and other low-risk non-combustible nicotine or tobacco products that may become viable alternatives to smoking in the future. Taken together, these tobacco harm reduction products could play a significant role in meeting the 2025 UN non-communicable disease (NCD) objectives by driving down smoking prevalence and cigarette consumption. Indeed, it is hard to imagine major reductions in tobacc-related NCDs without the contribution of tobacco harm reduction. Even though most of us would prefer people to quit smoking and using nicotine altogether, experience suggests that many smokers cannot or choose not to give up nicotine and will continue to smoke if there is no safer alternative available that is acceptable to them.

We respectfully suggest that the following principles should underpin the public health approach to tobacco harm reduction, with global leadership from WHO:

1. Tobacco harm reduction is part of the solution, not part of the problem. It could make a significant contribution to reducing the global burden of non-communicable diseases caused by smoking, and do so much faster than conventional strategies. If regulators treat low-risk nicotine products as traditional tobacco products and seek to reduce their use without recognising their potential as low-risk alternatives to smoking, they are improperly defining them as part of the problem.

2. Tobacco harm reduction policies should be evidence-based and proportionate to risk, and give due weight to the significant reductions in risk that are achieved when a smoker switches to a low risk nicotine product. Regulation should be proportionate and balanced to exploit the considerable health opportunities, while managing residual risks. The architecture of the FCTC is not currently well suited to this purpose.

3. On a precautionary basis, regulators should avoid support for measures that could have the perverse effect of prolonging cigarette consumption. Policies that are excessively restrictive or burdensome on lower risk products can have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives, and cause harm as a result. Every policy related to low risk, non-combustible nicotine products should be assessed for this risk.

4. Targets and indicators for reduction of tobacco consumption should be aligned with the ultimate goal of reducing disease and premature death, not nicotine use per se, and therefore focus primarily on reducing smoking. In designing targets for the non-communicable disease (NCD) framework or emerging Sustainable Development Goals it would be counterproductive and potentially harmful to include reduction of low-risk nicotine products, such as e-cigarettes, within these targets: instead these products should have an important role in meeting the targets.

5. Tobacco harm reduction is strongly consistent with good public health policy and practice and it would be unethical and harmful to inhibit the option to switch to tobacco harm reduction products. As the WHO’s Ottawa Charter states: “Health promotion is the process of enabling people to increase control over, and to improve, their health”.  Tobacco harm reduction allows people to control the risk associated with taking nicotine and to reduce it down to very low or negligible levels.

6. It is counterproductive to ban the advertising of e-cigarettes and other low risk alternatives to smoking.  The case for banning tobacco advertising rests on the great harm that smoking causes, but no such argument applies to e-cigarettes, for example, which are far more likely to reduce harm by reducing smoking.  Controls on advertising to non-smokers, and particularly to young people are certainly justified, but a total ban would have many negative effects, including protection of the cigarette market and implicit support for tobacco companies. It is possible to target advertising at existing smokers where the benefits are potentially huge and the risks minimal. It is inappropriate to apply Article 13 of the FCTC (Tobacco advertising, promotion and sponsorship) to these products.

7. It is inappropriate to apply legislation designed to protect bystanders or workers from tobacco smoke to vapour products.  There is no evidence at present of material risk to health from vapour emitted from e-cigarettes. Decisions on whether it is permitted or banned in a particular space should rest with the owners or operators of public spaces, who can take a wide range of factors into account. Article 8 of the FCTC (Protection from exposure to tobacco smoke) should not be applied to these products at this time.

8. The tax regime for nicotine products should reflect risk and be organised to create incentives for users to switch from smoking to low risk harm reduction products. Excessive taxation of low risk products relative to combustible tobacco deters smokers from switching and will cause more smoking and harm than there otherwise would be.

9. WHO and national governments should take a dispassionate view of scientific arguments, and not accept or promote flawed media or activist misinterpretations of data. For example, much has been made of ‘gateway effects’, in which use of low-risk products would, it is claimed, lead to use of high-risk smoked products.  We are unaware of any credible evidence that supports this conjecture. Indeed, similar arguments have been made about the use of smokeless tobacco in Scandinavia but the evidence is now clear that this product has made a significant contribution to reducing both smoking rates and tobacco-related disease, particularly among males.

10. WHO and parties to the FCTC need credible objective scientific and policy assessments with an international perspective. The WHO Study Group on Tobacco Product Regulation (TobReg) produced a series of high quality expert reports between 2005 and 2010. This committee should be constituted with world-class experts and tasked to provide further high-grade independent advice to the WHO and Parties on the issues raised above.

The potential for tobacco harm reduction products to reduce the burden of smoking related disease is very large, and these products could be among the most significant health innovations of the 21st Century – perhaps saving hundreds of millions of lives.  The urge to control and suppress them as tobacco products should be resisted and instead regulation that is fit for purpose and designed to realise the potential should be championed by WHO. We are deeply concerned that the classification of these products as tobacco and their inclusion in the FCTC will do more harm than good, and obstruct efforts to meet the targets to reduce non-communicable disease we are all committed to.  We hope that under your leadership, the WHO and FCTC will be in the vanguard of science-based, effective and ethical tobacco policy, embracing tobacco harm reduction.

We would be grateful for your considered reaction to these proposals, and we would like to request a meeting with you and relevant staff and a small delegation of signatories to this letter. This statement and any related information will be available on the Nicotine Science and Policy web site (http://nicotinepolicy.net) from 29 May 2014.

Yours sincerely,


 

Signatories to this statement at 26 May 2014:

Professor David Abrams, Professor of Health Behavior and Society. The Johns Hopkins Bloomberg School of Public Health. Maryland. USA.  Professor of Oncology (adjunct). Georgetown University Medical Center, Lombardi Comprehensive Cancer Center. Washington DC. United States of America

Professor Tony Axéll, Emeritus Professor Geriatric Dentistry, Consultant in Oral Medicine, Sweden

Professor Pierre Bartsch, Respiratory physician, Faculty of Medicine, University of Liège, Belgium

Professor Linda Bauld, Professor of Health Policy, Director of the Institute for Social Marketing, Deputy Director, UK Centre for Tobacco and Alcohol Studies, University of Stirling, United Kingdom

Professor Ron Borland, Nigel Gray Distinguished Fellow in Cancer Prevention at Cancer Council Victoria, Professorial Fellow School of Population Health and Department of Information Systems, University of Melbourne, Australia

Professor John Britton, Professor of Epidemiology; Director, UK Centre for Tobacco & Alcohol Studies, Faculty of Medicine & Health Sciences, University of Nottingham, United Kingdom

Associate Professor Chris Bullen, Director, National Institute for Health Innovation, School of Population Health, University of Auckland, New Zealand

Professor Emeritus André Castonguay, Faculty of Pharmacy, Université Laval, Quebec

Dr Lynne Dawkins, Senior Lecturer in Psychology, Co-ordinator: Drugs and Addictive Behaviours Research Group, School of Psychology, University of East London, United Kingdom

Professor Ernest Drucker, Professor Emeritus, Department of Family and Social Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, Mailman School of Public Health, Columbia University, United States of America

Professor Jean François Etter, Associate Professor, Institut de santé globale, Faculté de médecine, Université de Genève, Switzerland

Dr Karl Fagerström, President, Fagerström Consulting AB, Vaxholm, Sweden

Dr Konstantinos Farsalinos, Researcher, Onassis Cardiac Surgery Center, Athens, Greece, Researcher, University Hospital Gathuisberg, Leuven, Belgium

Professor Antoine Flahault, Directeur de l’Institut de Santé Globale, Faculté de Médecine, Université de Genève, Suisse/ Institute of Global Health, University of Geneva, Switzerland, Professor of Public Health at the Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, France

Dr Coral Gartner, Senior Research Fellow, University of Queensland Centre for Clinical Research, The University of Queensland, Australia

Dr Guillermo González, Psychiatrist, Comisión de Rehabilitación en Enfermedad Mental Grave, Clínica San Miguel, Madrid, Spain

Dr Nigel Gray, Member of Special Advisory Committee on Tobacco Regulation of the World Health Organization, Honorary Senior Associate, Cancer Council Victoria, Australia

Professor Peter Hajek, Professor of Clinical Psychology and Director, Health and Lifestyle Research Unit, UK Centre for Tobacco and Alcohol Studies, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry Queen Mary University of London, United Kingdom

Professor Wayne Hall, Director and Inaugural Chair, Centre for Youth Substance, Abuse Research, University of Queensland, Australia

Professor John Hughes, Professor of Psychology, Psychiatry and Family Practice, University of Vermont, United States of America

Professor Martin Jarvis, Emeritus Professor of Health Psychology, Department of Epidemiology & Public Health, University College London, United Kingdom

Professor Didier Jayle, Professeur d’addictologie, Conservatoire National des Arts et Métiers, Paris, France

Dr Martin Juneau, Directeur, Direction de la Prévention, Institut de Cardiologie de Montréal, Professeur Titulaire de Clinique, Faculté de Médecine, Université de Montréal, Canada

Dr Michel Kazatchkine, Member of the Global Commission on Drug Policy, Senior fellow, Global Health Program, Graduate institute, Geneva, Switzerland

Professor Demetrios Kouretas, School of Health Sciences and Vice Rector, University of Thessaly, Greece

Professor Lynn Kozlowski, Dean, School of Public Health and Health Professions, Professor of Community Health and Health Behavior, University at Buffalo, State University of New York, United States of America

Professor Eva Králíková, Institute of Hygiene and Epidemiology, Centre for Tobacco-Dependence, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Czech Republic

Professor Michael Kunze, Head of the Institute for Social Medicine, Medical University of Vienna, Austria

Dr Murray Laugesen, Director, Health New Zealand, Lyttelton, Christchurch, New Zealand

Dr Jacques Le Houezec, Consultant in Public Health, Tobacco dependence, Rennes, France, Honorary Lecturer, UK Centre for Tobacco Control Studies, University of Nottingham, United Kingdom

Dr Kgosi Letlape, President of the Africa Medical Association, Former President of the World Medical Association, Former Chairman of Council of the South African Medical Association, South Africa

Dr Karl Erik Lund, Research director, Norwegian Institute for Alcohol and Drug Research, Oslo, Norway

Dr Gérard Mathern, Président de l’Institut Rhône-Alpes de Tabacologie, Saint-Chamond, France

Professor Richard Mattick, NHMRC Principal Research Fellow, Immediate Past Director NDARC (2001-2009), National Drug and Alcohol Research Centre (NDARC), Faculty of Medicine, The University of New South Wales, Australia

Professor Ann McNeill, Professor of Tobacco Addiction, Deputy Director, UK Centre for Tobacco and Alcohol Studies, National Addiction Centre, Institute of Psychiatry, King’s College London, United Kingdom

Dr Hayden McRobbie, Reader in Public Health Interventions, Wolfson Institute of Preventive Medicine, Queen Mary University of London, United Kingdom

Dr Anders Milton, Former President of the Swedish Red Cross, Former President and Secretary of the Swedish Medical Association, Former Chairman of the World Medical Association, Owner & Principal Milton Consulting, Sweden

Professor Marcus Munafò, Professor of Biological Psychology, MRC Integrative Epidemiology Unit at the University of Bristol, UK Centre for Tobacco and Alcohol Studies, School of Experimental Psychology, University of Bristol, United Kingdom

Professor David Nutt, Chair of the Independent Scientific Committee on Drugs (UK)

Edmund J Safra, Professor of Neuropsychopharmacology, Head of the Department of Neuropsychopharmacology and Molecular Imaging, Imperial College London, United Kingdom

Dr Gaston Ostiguy, Professeur agrégé, Directeur de la Clinique de cessation tabagique, Centre universitaire de santé McGill (CUSM), Institut thoracique de Montréal, Canada

Professor Riccardo Polosa, Director of the Institute for Internal Medicine and Clinical Immunology, University of Catania, Italy.

Dr Lars Ramström, Director, Institute for Tobacco Studies, Täby, Sweden

Dr Martin Raw, Special Lecturer, UK Centre for Tobacco and Alcohol Studies, Division of Epidemiology and Public Health, University of Nottingham, United Kingdom

Professor Andrzej Sobczak, Department of General and Inorganic Chemistry, Faculty of Pharmacy and Laboratory Medicine, Medical University of Silesia, Katowice, Poland, Institute of Occupational Medicine and Environmental Health, Sosnowiec, Poland

Professor Gerry Stimson, Emeritus Professor, Imperial College London; Visiting Professor, London School of Hygiene and Tropical Medicine, United Kingdom

Professor Tim Stockwell, Director, Centre for Addictions Research of BC, Professor, Department of Psychology, University of Victoria, British Columbia, Canada

Professor David Sweanor, Adjunct Professor, Faculty of Law, University of Ottawa Special Lecturer, Division of Epidemiology and Public Health, University of Nottingham, United Kingdom

Professor Umberto Tirelli, Director Department of Medical Oncology, National Cancer Institute of Aviano, Italy

Professor Umberto Veronesi, Scientific Director, IEO Istituto Europeo di Oncologia, Former Minister of Health, Italy

Professor Kenneth Warner, Avedis Donabedian Distinguished University Professor of Public Health, Professor, Health Management & Policy, School of Public Health, University of Michigan, United States of America

Professor Robert West, Professor of Health Psychology and Director of Tobacco Studies, Health Behaviour Research Centre, Department of Epidemiology & Public Health, University College London, United Kingdom

Professor Dan Xiao, Director of Department Epidemiology, WHO Collaborating Center for Tobacco or Health, Beijing Institute of Respiratory Medicine, Beijing Chao-Yang Hospital, China

Dr Derek Yach, Former Executive Director, Non-Communicable Diseases, Former Head of Tobacco Free Initiative, World Health Organisation (1995-2004), Senior Vice President Vitality Group plc, Director, Vitality Institute for Health Promotion, United States of America

 

 

Annex 4

 Electronic Cigarette Vapour Studies

1. Kosmider, L., Sobczak, A., Fik, M., Knysak, J., Zaciera, M., Kurek J., and Goniewicz, M.L., Published in Nicotine and Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco, (2014), Carbonyl Compounds in Electronic Cigarette Vapors – Effects of Nicotine Solvent and Battery Output Voltage, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/24832759

ECITA’s Chief Scientific Officer, a qualified analytical chemist, commented on this study here: http://www.ecita.org.uk/blog/index.php/formaldehyde-and-other-carbonyls-in-e-cig-vapour/ and

Dr Konstantinos Farsalinos also commented on this study, here: http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/2014/162-nyt-formald

2. Polosa, R., Morjaria, J., Caponnetto, P., Caruso, M., Strano, S., Battaglia, E., and Russo, C., Published in the International Journal of Environmental Research and Public Health, (2014), Effect of smoking abstinence and reduction in asthmatic smokers switching to electronic cigarettes: evidence for harm reversal, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/24814944

“Reduction in exacerbation rates was reported, but was not significant. No severe adverse events were noted. This small retrospective study indicates that regular use of e-cigs to substitute smoking is associated with objective and subjective improvements in asthma outcomes.”

3. Ruprecht, A.A., De Marco, C., Pozzi, P., Munarini, E., Mazza, R., Angellotti, G., Turla, F., and Boffi, R., Published in Tumori, (2014), Comparison between particulate matter and ultrafine particle emission by electronic and normal cigarettes in real-life conditions, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/24675506

The authors concluded:

“E-cigarettes appear to generate less indoor pollution than normal cigarettes and may therefore be safer. Further studies are required to investigate the long-term health-related effects of secondhand e-cigarette exposure.”

4. Burstyn, I., (2014), Published in Bio Med Central Public Health, Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/24406205

The author concluded:

“Current state of knowledge about chemistry of liquids and aerosols associated with electronic cigarettes indicates that there is no evidence that vaping produces inhalable exposures to contaminants of the aerosol that would warrant health concerns by the standards that are used to ensure safety of workplaces. However, the aerosol generated during vaping as a whole (contaminants plus declared ingredients) creates personal exposures that would justify surveillance of health among exposed persons in conjunction with investigation of means to keep any adverse health effects as low as reasonably achievable. Exposures of bystanders are likely to be orders of magnitude less, and thus pose no apparent concern.(Emphasis added.)

5. Goniewicz, M.L., Hajek, P., and McRobbie, H., (2014) Published in Addiction, Nicotine content of electronic cigarettes, its release in vapour and its consistency across batches: regulatory implications, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/24345184

The authors concluded:

“There is very little risk of nicotine toxicity from major electronic cigarette (EC) brands in the United Kingdom. Variation in nicotine concentration in the vapour from a given brand is low. Nicotine concentration in e-liquid is not well related to nicotine in vapour. Other EC brands may be of lower quality and consumer protection regulation needs to be implemented, but in terms of accuracy of labelling of nicotine content and risks of nicotine overdose, regulation over and above such safeguards seems unnecessary.”

6. Cantrell, F.L., (2014), Published in the Journal of Community Health, Adverse effects of e-cigarette exposures, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/24338077

The author’s abstract reads:

“In 2007, a new source of nicotine exposure was introduced to the United States market, the electronic cigarette (ECIG) or “e-cigarette”. Since then, the USA ECIG market has been doubling annually. Despite their widespread popularity, there is a paucity of existing data regarding ECIG toxicity. We report the experience of a statewide poison system. The database of a statewide poison system was queried for human ECIG exposures from 2010 (when Poisindex code first generated) through 2012. Year, age, manner and route of exposure, estimate exposure amount, product concentration, if evaluated at healthcare facility and symptoms were recorded. A total of 35 cases were identified – 4 in 2010, 12 in 2011, 19 in 2012. Age range 8 months-60 years. Reported symptoms were mild and transient. Five patients were evaluated in an emergency department and none were admitted. Product concentrations ranged from 4 to 30mg of nicotine per ml. Poison centers are likely to see an increase in exposures to ECIG given their growing popularity. Our modest results suggest that adverse effects and accidental exposures to ECIG cartridges are unlikely to result in serious toxicity.” (Emphasis added.)

7. Czogala, J., Goniewicz, M.L., Fidelus, B., Zielinska-Danch, W., Travers, M.J., and Sobczak, A., (2014), Published in Nicotine and Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco, Secondhand exposure to vapors from electronic cigarettes, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/24336346

The authors concluded:

“Using an e-cigarette in indoor environments may involuntarily expose nonusers to nicotine but not to toxic tobacco-specific combustion products. More research is needed to evaluate health consequences of secondhand exposure to nicotine, especially among vulnerable populations, including children, pregnant women, and people with cardiovascular conditions.”

8. Uchiyama, S., Ohta, K., Inaba, Y., and Kunugita, N., (2013), Published in Analytical sciences: the international journal of the Japan Society for Analytical Chemistry, Determination of carbonyl compounds generated from the E-cigarette using coupled silica cartridges impregnated with hydroquinone and 2,4-dinitrophyenylhydrazine, followed by high-performance liquid chromatography, Japan Society for Analytical Chemistry

https://www.jstage.jst.go.jp/article/analsci/29/12/29_1219/_pdf

This study is similar to study 1 above concerned with Carbonyl Compounds. Unfortunately, both these studies (1 and 8) suffer from similar flaws, which make their findings largely irrelevant, and certainly not robust enough to rely on.

9. Bertholon, J.F., Becquemin, M.H., Roy, M., Roy, F., Ledur, D., Annesi Maesano, I., and Dautzenberg, B., (2013), Published in Revue des Maladies Respiratoires, [Comparison of the aerosol produced by electronic cigarettes with conventional cigarettes and the shisha], (article in French), NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/24267765

The authors concluded:

“Contrary to tobacco smoke, which has a half-life in air of 19 to 20 minutes, the risk of passive “smoking” exposure from e-cigarettes is modest.”

10. Romagna, G., Allifranchini, E., Bocchietto, E., Todeschi, S., Esposito, M., and Farsalinos, K.E., (2013), Published in Inhalation Toxicology, Cytotoxicity evaluation of electronic cigarette vapor extract on cultured mammalian fibroblasts (ClearStream-LIFE): comparison with tobacco cigarette smoke extract, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/23742112

The authors concluded:

“This study indicates that EC vapor is significantly less cytotoxic compared tobacco CS.”

11. Williams, M., Villarreal, A., Bozhilov, K., Lin, S., and Talbot, P., (2013), Published in PloS One, Metal and silicate particles including nanoparticles are present in electronic cigarette cartomizer fluid and aerosol, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/23526962

The authors found:

“The concentrations of nine of eleven elements in EC aerosol were higher than or equal to the corresponding concentrations in conventional cigarette smoke. Many of the elements identified in EC aerosol are known to cause respiratory distress and disease.”

This study’s title, wording and reporting (by the authors and others) were distinctly unscientific. Indeed, this ‘evidence’ was widely criticised, including by Dr Farsalinos, who said:

“The researchers at first dissected some cartomizers and performed centrifugation to detect which metals could be present in the various components of the particular cartomizer. Although useful, this information has no clinical significance. Even the process of “dissecting” the cartomizer could lead to production of small particles that otherwise would not be present in vapor.”

And perhaps more importantly:

“According to the 2013 revision (concerning inhalation exposure), the levels were 5 micrograms/day for lead, 1.5 micrograms/day for nickel, 100 micrograms/day for cooper and 25 micrograms/day for chromium. According to our calculations (measurements in experienced vapers), 13 puffs in 5 minutes lead to consumption of 60mg of e-liquid, thus 1gram (approximately 1ml) is consumed by 216 puffs. Taking into account a mean consumption of 4ml e-liquid, vapers take approximately 880 puffs per day. According to the study measurements, they would get 1.5 micrograms/day lead (5 is the safety limit), 0.44 micrograms/day nickel (1.5 is the safety limit), 17 micrograms/day copper (100 is the safe limit) and 0.6 micrograms/day chromium (25 is the limit). All levels are significantly lower compared to safety limits, even for a daily consumption of more than 10ml of e-liquid.

Finally, it should be mentioned that in another study which evaluated cadmium, nickel and lead presence in e-cigarettes, they found levels similar to what is present in pharmaceutical nicotine inhaler.”

http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/2013/89-metals-and-nanoparticles-in-e-cigarettes-commentary

12. Goniewicz, M.L., Knysak, J., Gawron, M., Kosmider, L., Sobczak, A., Kurek, J., Prokopowicz, A., Jablonska-Czapla, M., Rosik-Dulewska, C., Havel, C., Jacob, P. 3rd, and Benowitz, N., (2014), Published in Tobacco Control, Levels of selected carcinogens and toxicants in vapour from electronic cigarettes, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/23467656

The authors concluded:

“Our findings are consistent with the idea that substituting tobacco cigarettes with e-cigarettes may substantially reduce exposure to selected tobacco-specific toxicants. E-cigarettes as a harm reduction strategy among smokers unwilling to quit, warrants further study.”

13. McAuley, T.R., Hopke, P.K., Zhao, J., and Babaian, S., (2012), Published in Inhalation Toxicology, Comparison of the effects of e-cigarette vapor and cigarette smoke on indoor air quality, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/23033998

The authors concluded:

“For all byproducts measured, electronic cigarettes produce very small exposures relative to tobacco cigarettes. The study indicates no apparent risk to human health from e-cigarette emissions based on the compounds analyzed.”

14. Pellegrino, R.M., Tinghino, B., Mangiaracina, G., Marani, A., Vitali, M., Protano, C., Osborn, J.F., and Cattaruzza, M.S., (2012), Published in Annali di igiene: medicina preventiva e di comunità, Electronic cigarettes: an evaluation of exposure to chemicals and fine particulate matter (PM), NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/22913171

The authors concluded:

“Fine and ultrafine PM emissions were higher for the conventional versus the e-cigarette (e.g.: PM10=922 vs 52 microg/m3; PM1=80 vs 14 microg/m3). The e-cigarette seems to give some advantages when used instead of the conventional cigarette, but studies are still scanty: it could help smokers to cope with some of the rituals associated with smoking gestures and to reduce or eliminate tobacco consumption avoiding passive smoking. However, the e-cigarette causes exposure to different chemicals compared with conventional cigarettes and thus there is a need for risk evaluation for both e-cigarettes and passive steam exposure in smokers and non smokers.”

15. Schripp, T., Markewitz, D., Uhde, E., and Salthammer, T., (2013), Published in Indoor Air, Does e-cigarette consumption cause passive vaping?, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/22672560

A number of flaws were identified in this study, including by ECITA’s Chief Scientific Officer:

“Worthy of note is that the initial tests in an 8m3 chamber did not show any of the expected chemicals from vapour, suggesting that the vapour is not sustained in the air, and is dispersed and settles out quickly, limiting exposure. They also detected formaldehyde, but stated:

‘This might be caused by the person in the chamber itself, because people are known to exhale formaldehyde in low amounts and the increase was already observed during the conditioning phase, furthermore the release of formaldehyde was below the limit of detection in the small scale [10 litre] experiments’.

The level observed during cigarette smoking stands in stark contrast to this, as indicated in this graph:

Forma graph

Given that formaldehyde is a ubiquitous airborne chemical, it suggests that emission of formaldehyde from the use of an electronic cigarette was not of a level to cause additional risk. Indeed, the results from the 8m3 show very few chemicals at detectable levels, and all of those chemicals have no risks associated with them at low concentrations, with the possible exception of isoprene (which is also generated in breath; in fact, it the most significant hydrocarbon in exhaled breath). Isoprene levels were 8 µg/m3 for the participant blank, and fell to below that for the first two e-cigarette tests, before rising to 10 µg/m3 for the third test.

No estimate of error margin was given, but these results are not suggestive of isoprene generation by e-cigarettes at significant levels. The value for cigarettes smoke was 135 µg/m3. Given the lack of results in a standard size room (8m3), the claim that “’passive vaping’ must be expected from the consumption of e-cigarettes” does not seem to be well supported by the results. Indeed, the data would seem to demonstrate exactly the opposite.

Results from a much smaller 10 litre chamber did show more results (again, mainly harmless) and this is not a volume representative of passive vaping since even the smallest conceivable shared space is necessarily larger than this. (People do not cohabit saucepans.) Unfortunately, they did not run the smoke tests in the 10 litre chamber, so direct comparisons on this extremely small volume cannot be made.”

http://www.ecita.org.uk/safety.htm

16. Vardavas, Cl., Anagnostopoulos, N., Kougias, M., Evangelopoulou, V., Connolly, G.N., and Behrakis, P.K., (2012), Published in Chest, Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide, NCBI PubMed

http://www.ncbi.nlm.nih.gov/pubmed/22194587

This ‘study’ was widely criticised, including by Professor Mike Siegel:

“It is first interesting to note that although the study’s declared purpose was to ‘assess whether using an e-cigarette for five minutes has an impact on pulmonary function tests and exhaled nitric oxide,’ the study’s abstract only reported the observed reduction in exhaled nitric oxide, not the lack of any effect on pulmonary function tests.

Moreover, the study failed to compare the acute respiratory effects of electronic cigarette exposure with those of active smoking, which is the most important comparison that needs to be made.

In contrast to what some are reporting, the study found no effect of e-cigarettes on lung function, as measured by spirometry. This is in contrast to tobacco smoking, which does have effects on lung function that can be measured using spirometric testing.

While previous research indicates that active smoking and even secondhand smoke exposure can affect acute lung function as measured by spirometry, the study demonstrated that electronic cigarette use led to no impairment of lung function detectable via spirometric testing.

What the study did show was subclinical evidence of impaired lung function, meaning that the observed (measurable) lung function was unchanged, but that there was evidence of physiologic effects consistent with some bronchial inflammation. What is not known is whether this acute bronchial inflammation has any significance in the long-term. The presence of bronchial inflammation may be a result of propylene glycol having a respiratory irritant effect. But this does not necessarily mean that long-term exposure would lead to any adverse effect on lung function. More research is necessary to clarify that point.”

http://tobaccoanalysis.blogspot.co.uk/2012/01/new-study-shows-that-in-contrast-to.html

 

Annex 5

Checklist for the differentiation between illegal breaches of the smoking ban and the legal use of electronic cigarettes

The most obvious indicator of an illegal breach of the smoking ban – particularly in light of the fact that most areas covered by smoking bans are relatively enclosed spaces – is the acrid lingering odour of tobacco smoke. Electronic cigarettes do not involve combustion, and therefore the vapour which is emitted carries no lingering odour at all. If you can smell smoke, this will most likely mean that a breach of the smoking ban has occurred. However, officers will need to provide more robust evidence than a statement regarding smell. There are many other sources of evidence which may help officers to distinguish between tobacco smoking and the use of electronic cigarettes:

Table1Table2

Despite the best efforts of government in introducing smoking bans in public places, smoking is still an immediately recognisable activity. The use of electronic cigarettes – while similar in appearance – is notably different, as indicated above. If a smoker’s behaviour looks ‘odd’ or ‘different’ from what you would expect to see, they may well be using an electronic cigarette.

We hope that the table above will assist enforcement officers in being able to pinpoint the evidence necessary to distinguish between the two, so that illegal breaches of the smoking ban can be dealt with appropriately, and users of electronic cigarettes can be allowed to enjoy them in peace.

 

Annex 6

 Sense About Science, letter to BMA, 12th December 2013

 What’s the evidence for banning electronic cigarettes?

 “We sent this letter to the BMA on November 15th asking for the evidence behind their claims about ‘re-normalising smoking’ and ‘passive vaping.’ Despite a number of reminders, we have not yet received a response.

‘For the attention of Co-Chairs of the BMA Public Health Medicine Committee, c/o Will Frost

Dear Will,

Football clubs have been receiving letters from the BMA asking them to stop people using electronic cigarettes in stadiums, something that train companies have already done, citing the Association’s advice. As you may know, Sense About Science helps civic organisations to ask for and negotiate evidence and we also respond to their enquiries about whether claims are evidence based. I have had a look at everything I can find on this issue and I am a bit surprised about the strength of your advocacy in light of the evidence.

From your briefing note (pdf), I would appreciate an explanation of the following points:

  • The briefing says that there isn’t enough evidence about the safety and efficacy of e-cigarettes, but cites studies that conclude that e-cigarettes “are a safer alternative to tobacco cigarettes” and that “e-cigarette use has substituted for use of licensed nicotine products rather than growing the market.” Professor Peter Hajek writes in Lancet Respiratory, “more dangerous chemicals such as bleach rely on packaging and common sense rather than on medicinal licensing.” Your conclusion that they should be banned in public and regulated as medicines appears to be in opposition to this. Why?
  • Since your briefing was published, an RCT by Bullen et al concluded that “E-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar achievement of abstinence as with nicotine patches, and few adverse events.” There’s also a Cochrane review imminent. Are you planning to consider and revise your campaign in light of these?
  • The claim about ‘passive vaping’ needs clarifying as the potentially dangerous compounds found in e-cigarettes are present in concentrations orders of magnitude lower than in conventional tobacco, so much so that there is “no apparent risk to human health from e-cigarette emissions based on the compounds analyzed” according to McAuley et al.

I couldn’t find any evidence to back up your claims about “reinforcing the normalcy of smoking behaviour,” or e-cigarettes being attractive to children or being a gateway to conventional smoking. Is this a hunch?”

 

Annex 7

ECITA: Open letter to Rail Service Providers, 7th May 2014

We have today written to Scotrail, following passenger complaints about their prohibiting the use of electronic cigarettes on their rail services.

In the absence of any “legal requirement” in national law or in the Railway Byelaws, we felt we had to write to Scotrail to point this out. This would, of course, equally apply to any and all other rail operators who may be under the illusion that there is some “legal requirement” to oppress their vaping customers by suggesting that they cannot use the products on the railways. As you will see in our letter, this in itself violates one of the Railway Byelaws, so it will be interesting to see what response – if any – we receive. Since Scotrail are part of the growing trend of rail operators to take this draconian step, we hope that others will read and rethink their policies on this issue.

 

Dear Sir/Madam,

It has been brought to our attention that an announcement was made on a rail service to the effect that the use of ecigs was banned on the train as a “legal requirement”. Furthermore, in response to an email of complaint from a Scotrail customer, published in part on the Rail UK Forum, Scotrail stated:

We have taken legal advice on this matter and believe we are within our rights to exclude e-cigarettes under the existing railway bylaw that refers to a “lighted item”. The bylaw does not require the nature of the lighting to be an actual flame. In addition, the definition of “cigarette” in the bylaw is not restricted to a classic tobacco cigarette but covers any cigarette. There is no reference in fact to tobacco in the bylaw itself.[1]

We do not believe that this is the case, since the Railway Byelaws clearly state:

“No person shall smoke or carry a lighted pipe, cigar, cigarette, match, lighter or other lighted item on any part of the railway on or near which there is a notice indicating that smoking is not allowed.”[2]

We would suggest that there is a clear inference that “lighted” in this context is a direct reference to the past tense of the verb ‘to ignite or cause to ignite’, rather than to the verb ‘to illuminate or cause to illuminate’. Electronic cigarettes involve no combustion, so are never ‘lit’ or ‘lighted’ within this definition. In addition, there is no definition of either “cigarette” or “tobacco” in the Railway Byelaws, and the intention of the cited paragraph is very clear in referring to any item which is alight, i.e. burning. There is a clear and obvious link between “lighted pipe, cigar, cigarette, match, lighter…” in that they all involve combustion, and the Byelaw makes it very clear that this is linked to areas where “smoking is not allowed”. This simply cannot be deemed to include an electronic cigarette, which does not involve combustion and therefore cannot produce smoke when used.

This is confirmed in Electronic cigarettes: time for an accurate and evidence-based debate, a paper published in the journal Addiction on 5th May 2014, the authors state:

unlike ordinary tobacco cigarettes, the current e-cigarettes on the market operate with ‘no tobacco, smoke, or combustion’.[3]

However, if any rail operator wishes to apply the alternative definition, i.e. anything that emits light is prohibited, we would hope that it would be applied in a consistent manner, and that consequently, all light-emitting products would also be prohibited, including laptop computers and mobile phones.

If a person using an electronic cigarette is not discommoding other passengers, it could indeed be argued that demanding that they cease to use their electronic cigarette, in the absence of any legal justification, directly contradicts article (8) of section 6 of the byelaws:

“6. Unacceptable behaviour

[...]

(8) No person shall molest or wilfully interfere with the comfort or convenience of any person on the railway.”

Of course, any rail operator has the right to decide what their policies shall and shall not include. However, in the context of the Railway Byelaws, which are prescribed standards that railway staff and passengers can reasonably expect to be upheld, unless such byelaws are over-ridden by national laws, it would seem that rail operators are not entitled to “wilfully interfere with the comfort or convenience of any person on the railway” by requiring them to desist from using their electronic cigarette if they so wish. Since no national law has been passed banning the use of electronic cigarettes in public places, then not only is it demonstrably not the case that the banning of electronic cigarettes on rail services is a legal requirement, it is in direct contravention of the existing Railway Byelaws.

We hope that you will want to reconsider any such policy in any event, particularly in light of a recent briefing from ASH (Action on Smoking and Health), who said:

“ASH supports regulation to ensure the safety and reliability of e-cigarettes but, in the absence of harm to bystanders, does not consider it appropriate to include e-cigarettes under smokefree regulations.”

and

“The fact that electronic cigarettes look similar to conventional cigarettes has been said to risk confusion as to their use in public places, such as on public transport. However, given that the most distinctive feature of cigarette smoking is the smell of the smoke, which travels rapidly, and that this is absent from electronic cigarette use, it is not clear how any such confusion would be sustained.”[4]

We would be very happy to provide any further information you might need, and hope that you will reconsider and look into this issue further. We remain confident that you will want to offer the best balance of comfort and convenience for all your passengers.

Posted in EU, MHRA, Safety, WHO | 2 Comments