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“Diacetyl has known serious inhalation risks, and this product should be withdrawn from sale.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 It should however be withdrawn from sale, and the flavour reformulated without diacetyl (or the related 2,3 pentanedione).”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).

Even if we assume that the limit is as much as 0.05%, the EU occupational exposure limit is 0.02ppm (parts per million) (based on an 8 hour workday average exposure), with a short term limit of 0.1ppm. Assuming each inhale from an ecig vapourises 10 microliters (or 0.01ml), which is then diluted into 70ml of air (during the draw), and then further diluted into 500ml (the general respiration volume of a person) the concentration inhaled is 0.07ppm, which falls between these values.

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.

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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:


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


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

free eliquid

eliquid supplied in packaging separate from 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.)


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:


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

  • 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 1


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


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.


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: “Store locked up and out of the reach of children and pets
    • Nicotine concentration in weight per volume (w/v) percentage and/or milligrams per millilitre (mg/ml) must be marked on the label
    • The text: “Only for use in electronic cigarettes
    • The text: “Seek medical advice if you feel unwell
    • 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 | 28 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


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.

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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:


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?


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


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.



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.



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]


“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.



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.)


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”.


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
[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
[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
[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
[7] ASH Briefing, June 2014, Electronic cigarettes (also known as vapourisers), www.ash.org.uk.
[8] Britton, J., and Bogdanovica, I., (May 2014), UK Centre for Tobacco and Alcohol Studies, Electronic cigarettes, Public Health England
[9] ASH Briefing, May 2014, Electronic cigarettes (also known as vapourisers), www.ash.org.uk.
[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.
[12] WalesOnline, (5 June 2014), ‘No evidence e-cigarettes lure young people into smoking’ claims expert, Wales Online
[13] Bates, C., (2014), Unable to take any more, I write to Dr Nathanson of the BMA (updated), The Counterfactual
[14] Sense About Science, (Dec 2013), What’s the evidence for banning electronic cigarettes?
[15] Liddle, R., (Sep 2013), The BMA’s bizarre jihad against e-cigarettes, The Spectator
[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
[18] ASH, (January 2014), Will you permit or prohibit e-cigarette use on your premises?, ASH
[19] Britton, J., and Bogdanovica, I., (May 2014), UK Centre for Tobacco and Alcohol Studies, Electronic cigarettes, Public Health England
[20] ASH Briefing, June 2014, Electronic cigarettes (also known as vapourisers), www.ash.org.uk
[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
[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
[25] Mayer, B, (2014), A Scientist’s view about nicotine & tobacco, Nicotine -  the basics, bernd-mayer.com
[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
[28] Newhouse, P., (2014), quoted in Tampa Bay Times, Study finds nicotine safe, helps in Alzheimer’s, Parkinson’s, Tampa Bay Times
[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
[34] McRobbie, H., (May 2014), National Centre for Smoking Cessation and Training (NCSCT), Electronic cigarettes, Public Health England
[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/
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
[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
[40] Bates, C., (2014), Regulation of e-cigarettes – general ideas, The Counterfactual




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


Tobacco Products Directive 2014/40/EU


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


Dangerous Substances Directive (as adapted) (2001)


Dangerous Preparations Directive (1999)






Low Voltage Directive (2006)


Electromagnetic Compatibility Directive (2004)


RoHS2 (2011)



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


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


Packaging and Packaging Waste Directive (1994)


as amended by

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


Electronic Commerce (EC Directive) Regulations (2002)


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


Comparative and Misleading Marketing Directive (2006)(MCAD)


UK Regulations

UK General Product Safety Regulations (2005)



The Poisons Act (1972)


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


UK Consumer Labelling & Packaging Regulations (2009)


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


UK Electrical Equipment (Safety) Regulations 1994


UK Plugs and Socket (Safety) Regulations (1994)


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


UK Producer Responsibility Obligations (Packaging Waste) Regulations 2007


UK Packaging (Essential Requirements) Regulations 2003


UK Packaging (Essential Requirements) (Amendment) Regulations 2013


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


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


UK Consumer Protection (Distance Selling) Regulations (2000)


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


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


UK Data Protection Act (1998)


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


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


UK Enterprise Act (2002)


UK Consumer Protection from Unfair Trading Regulations (2008)


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


Other EU Statutory Instruments

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


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


Commission Decision No. 2006/340/EC


Other UK Statutory Instruments

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


UK Advertising Standards Agency Code (CAP Codes)


International Standards

ISO 8317 – child-resistant closures

EN ISO 11683 – tactile warning labels

International Electrotechnical Commission standard IEC 884-1 (1987)


Original standard available from :


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


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


EU Guidance on FAQ (CE marking for RoHS)


Blue Guide on Technical Documentation for RoHS




The New Legislative Framework and the eco-management audit scheme




UK Guidances

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


NMO Guidance (CE marking for RoHS)


Packaging (Essential Requirements) Regulations, October 2013


Distance Selling Regulations Guidance Notes


Data Protection: The Guide


Security Measures


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


Health & Safety Executive: Report an Incident



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:


But there are also:

‘Pen-style’ electronic cigarettes

Div2Electronic cigars


Electronic pipes


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:



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:


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.



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 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.


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.


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.



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


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)


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.



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.



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:


Annex 3


Statement from specialists in nicotine science and public health policy

Dr Margaret Chan

Director General

World Health Organisation


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


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


“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


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


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


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


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


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


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


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


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


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.”


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


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


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


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


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.”


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


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.”



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:


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.”


“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

More of the same from Stanton Glantz – a specious arguement about vapour and smoke equivalence

By Tom Pruen

In a recent post, also submitted to the FDA, and used as ‘evidence’ that he is correct in his assertion that ultra-fine particles and ultra-fine droplets have equivalent effects (his comments are here), (despite this failing a test of simple logic, as detailed in my previous blog), as well as flying in the face of evidence, Stanton Glantz asserts that:

“This is an important finding because it shows, at least for this important biological measure of the effects of using e-cigarettes on lungs, they are no different than cigarettes and so, for this end point, do not pose less risk.”

What is the important measure? Exhaled Nitric Oxide. (Levels of exhaled Nitric Oxide are usually expressed as FeNO – Fraction of exhaled Nitric Oxide). Please go and read the wikipedia article, found here.

Done that? Good! You now know more about FeNO than the professor appears to. As I’m sure you will have noticed, FeNo is a measure of airway inflammation, and most commonly used in asthma diagnosis (a full and very informative reference can be found here, for anyone who is interested)

What FeNo doesn’t do, despite the quoted claim above, is provide a biomarker for ‘risk’. It indicates an increase in inflammation which, given that we know PG is a mild irritant, is hardly surprising. (In fact it may well be this mild irritation which allows PG to replicate so well the sensation of smoking). How this is supposed to create the same risk as inhaling smoke, with its known harmful chemicals and ultra-fine particles,  is unfortunately not explained by the good professor. Absent a credible reference, or even a suggested mechanism, I can only assume that he is unaware of how this is supposed to occur, and is just wildly speculating in line with his preconceived ideas.

In fact, given that there is a small study showing harm reversal in asthma sufferers using electronic cigarettes (available here), it looks increasingly as if the claim is nothing more than scaremongering.

Sadly, this is the calibre of ‘science’ we have come to expect from Prof Glantz

I would also strongly recommend reading Dr Farsalinos’s comments, (which I hadn’t seen until after I had written this blog) which have the added advantage of coming from a medical perspective. (Indeed Dr Farsalinos is a cardiac expert, Stanton Glantz’s own alleged area of expertise, which adds an extra twist to Dr F’s comments!)



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

Stanton Glantz – not just inflexibly dogmatic, but also dishonest

By Tom Pruen

53 experts in the field of tobacco control, addiction and related fields recently wrote a letter to the WHO, outlining the case for electronic cigarettes as a massive public health opportunity.

This letter clearly annoyed Professor Glantz, and he has written an extremely critical response. Unfortunately, there are a number of problems with his response. This blog addresses some of the more egregious issues, but is not intended as a full analysis.

Prof Glantz launches with an attack on the idea that nicotine is safe, citing the following:

The first link matches it reference, and is a discussion of the effects of second hand smoke:  Why this is relevant to discussion of nicotine without smoke, as found in electronic cigarettes, is unclear.

The second link is to the same discussion of the effects of second hand smoke, but the reference is to a paper published by that great self-referrer, S A Glantz. What, you might ask, does it contribute on the subject of fine particles?:

…it is not clear whether the ultrafine particles delivered by e-cigarettes have health effects and toxicity similar to the ambient fine particles generated by conventional cigarette smoke or secondhand smoke.

Following which, it turns to a discussion of the dangers of smoke. Not really a useful reference, and certainly not one that contributes to the point being ‘proven’.

Also open to debate is the effect of ultrafine droplets as distinct from ultrafine particles, which is why there are no health warnings on domestic showers, despite their proven generation of ultrafine droplets which are inhaled both actively and passively. (There is such a thing as ‘passive showering’.) It is the ability of ultra-fine solids to deliver toxins into cells, particularly the mitochondria, which gives them their enhanced toxicity. Solids are capable of adsorbing toxins (drawing them into the solid), and delivering them to the internal functioning parts of cells, which gives a targeted toxicity to chemicals that would otherwise have only relatively minor, or localised, effects. (In layman’s terms, they pierce the cell like a bullet.) By contrast, ultra-fine droplets, such as those delivered from electronic cigarette vapour, hit the moist surface of the cell, where they dissolve and are then absorbed by groups of cells. This is why ultrafine particles are increasingly being used as drug delivery methods. Aerosols are preferred to nanoparticle carriers as the latter have the potential to offer some of the same risks as ultrafine solid particles:

The toxicology of particulate matter differs from toxicology of substances as the composing chemical(s) may or may not be soluble in biological matrices, thus influencing greatly the potential exposure of various internal organs. [...] For nanoparticles the situation is different as their size opens the potential for crossing the various biological barriers within the body.

Next up is the carcinogenic nature of nicotine. (The link provided above is to an article):

This Opinion article discusses emerging evidence of direct contributions of nicotine to cancer onset and growth.

An opinion discussing emerging evidence? Interesting, and something to be aware of, but hardly proof of the statement made. Perhaps the reference (again to the work of a certain S A Glantz) does better?:

Exposure to second hand smoke (SHS) is believed to cause lung cancer.

These studies reveal that SHS promotes tumor angiogenesis and growth.

OK, so second hand smoke is a risk factor, but that doesn’t tell us anything about the nicotine. Not very helpful. Never-mind, moving on.

The next link and reference (helpfully) match. Oh, hang on though….

Prof Glantz says:

His reference says:

Summary and conclusions

The findings of this study demonstrate that nicotine causes acute endothelial dysfunction in long-term smokers and suggest that there may be other constituents of cigarette smoke that contribute to this adverse effect. However, the precise mechanisms responsible for this negative effect of nicotine on endothelial function remain unclear. We conclude that nicotine replacement therapy by nasal spray is less harmful for the endothelium than cigarette smoking but fails to preserve the integrity of endothelial function.

Now, correct me if I’m wrong here, but that reference says that the effect is smaller and less harmful, not “the same”. Did Prof Glantz actually read his references?

The next link (and reference) are to the US Surgeon General’s report, a weighty tome, and his referenced chapter is all about nicotine. It’s worth pointing out that no-one (as far as I’m aware) considers that nicotine use during pregnancy is a good idea, as it is known to cross the placenta and have detrimental effects; (if anyone is unaware, then the relevant section of the report is worth a read, and starts on page 11 of the linked PDF, or page 111 if you have the whole document).

That being said, it is also widely accepted that the use of nicotine alone is better than smoking during pregnancy with, for example, the UK’s medicines regulator, the MHRA, stating:

Overall, although the data currently available are limited, the use of NRT in pregnancy does not give undue concern and any harm caused by nicotine replacement must be compared with that caused by continued smoking – which is extremely harmful to both the woman and her child

So clearly, in an ideal world, nicotine use during pregnancy should be avoided. In our far from ideal one, however, it is more important to avoid smoke.

Also of note in chapter 5 of the Surgeon General’s report is a discussion of nicotine’s carcinogenic effects, which Prof Glantz inexplicably failed to mention:

Although in vitro data are suggestive of relevant bio-logical activity, this is not supported overall by the most recent experimental animal studies. In humans, there has been limited research and only one relatively short–term follow-up study on nicotine and cancer.

I wonder why he didn’t mention that?

Next Prof Glantz moves to “comments on the specific assertions in the Bates letter”. (Notice how suddenly it is all about one person, rather than the collected work of 53?)

(Quotes from the original letter are shown in bold, with Prof Glantz’s comments below.)

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.

To date there is no evidence that this “potential” to be part of the solution will be realized, particularly in the face of actual patterns of e-cigarette promotion and use, which show rapid penetration of the youth market, depressed cigarette cessation among all smokers, and high levels of dual use of cigarettes and e-cigarettes among both adults and adolescents.[8]

Would it surprise anyone to discover that the reference for this complete denial of any potential benefit to ecigs is a certain S A Glantz? It is, in fact, not even a new reference, but the same document as reference 3.

Nor are the conclusions of the paper, or the view given, particularly widely held and it is a trivial matter to find opposing evidence, and people and organisations who disagree, often strongly.

The next point deals with the question of whether or not the FCTC is a good way of providing regulation, which strikes me as frankly irrelevant, given that the US is not a signatory to it, and therefore not subject to any proposed regulation of ecigs through it.

There is one other comment which is, I think, worth looking at:

Of course  regulation as a therapeutic product would require the companies, including the tobacco companies who increasingly dominate the e-cigarette business, to submit data to the appropriate authorities demonstrating efficacy and safety, something that no company has yet done anywhere in the world.

Firstly, this is not as trivial, nor as easy, a task as Prof Glantz would like to suggest. ECITA’s analysis of the MHRA guidance, and on the cost of submitting an application to become a medicine being one example, and the other being Intellicig: “Intellicig had commenced a structured programme towards licensing as far back as November 2009″. To date, they still have not qualified for a license to sell their product as a medicine, and now, despite their “application for Marketing Authorisation expected in 2012″, appear to be making little mention of the idea.

It is the small number of Tobacco Industry entrants into the e-cigarette market who generally seem most keen to proceed with medicinal regulation of electronic cigarettes.  The large proportion of the Electronic Cigarette Industry, which is not owned by the Tobacco Industry, is unable to afford the huge cost burden of medicinal licensing. Therefore, compulsory medicinal regulation would only further the interests of the tobacco giants by reducing competition.

Then we move to the precautionary principle:

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.

This argument turns the precautionary principle on its head.  In particular,

The definition of the precautionary principle developed for the Rio Declaration of 1992 is often cited, and the 1998 Wingspread Statement contains similar language: “when an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.” The statement also lists 4 central components of the principle: (1) taking preventive action in the face of uncertainty, (2) shifting the burden of proof to the proponents of an activity, (3) exploring a wide range of alternatives to possibly harmful actions, and (4) increasing public participation in decision making.[9]  [references deleted]

The particular reference to the precautionary principle is well chosen – it advocates a hyper risk-adverse implementation that fits well with Glantz’s view, but is (perhaps not surprisingly) not widely shared. If we consider the UNESCO (United Nations Educational, Scientific and Cultural Organization) World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) working definition:

When human activities may lead to morally unacceptable harm that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish that harm.
Morally unacceptable harm refers to harm to humans or the environment that is threatening to human life or health, or serious and effectively irreversible, or inequitable to present or future generations, or imposed without adequate consideration of the human rights of those affected.
The judgement of plausibility should be grounded in scientific analysis. Analysis should be ongoing so that chosen actions are subject to review.
Uncertainty may apply to, but need not be limited to, causality or the bounds of the possible harm. Actions are interventions that are undertaken before harm occurs that seek to avoid or diminish the harm. Actions should be chosen that are proportional to the seriousness of the potential harm, with consideration of their positive and negative consequences, and with an assessment of the moral implications of both action and inaction. The choice of action should be the result of a participatory process.


THR is an action that is intended to reduce the harm caused by smoked tobacco (albeit after the effect exists). There is significant scientific plausibility to believe that it may work, (and also considerable evidence that previous interventions have plateaued in their effect), so does crushing a promising intervention on the basis that it still has some risk actually fulfil this definition? Um.. no. No it doesn’t. The users of electronic cigarettes would, I am sure, be extremely outspoken on item 4 of Prof Glantz’s chosen definition of the precautionary principle, as well as the last sentence of the quoted UNESCO definition, in that they should be involved in the process, rather than paternally dictated to.

Similarly, if there is no significant plausibility of risk (and no, Stan, the mere existence of small levels of toxicants does not demonstrate significant risk), is preventative intervention justified? (I should also point out that completely avoiding risk is not only implausible, but impossible. Carcinogens exist in bacon, as well as fish and dairy products, coffee, bananas, and indeed human breath, yet Prof Glantz seems to have no wish to apply the precautionary principle with such zealous abandon to these.) Again, I would consider that a response that is “proportional to the seriousness of the potential harm” would stop far short of the prohibition that seems to be Prof Glantz’s desired outcome.

He then goes on to turn the precautionary principle on its head himself, in no uncertain terms:

Presumably, in a few years there will be actual evidence about  the effects of e-cigarette use in England on youth uptake and overall population effects on cessation (as opposed to the effects on the much smaller group of motivated smokers who are using them as cessation aids).

Once WHO and others have that data, the precautionary principle can be applied properly and, if appropriate, restrictions on e-cigarettes relaxed.

So, once all the data is in, and we know everything we need to know, we can retroactively apply the precautionary principle to remove existing restrictions?! (This also ignores the fact that there is already sampled population data from the UK, in the Smoking Toolkit survey, which amazingly, also fails to agree with Prof Glantz’s paranoid hypotheses).

And then it’s back to nicotine…

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.

As noted above, the letter fails to present any evidence that these assertions are correct.  The evidence that has accumulated in the 23 years since Michael Russell first promoted this hypothesis has demonstrated that, at the very least, there are several direct adverse health consequences of nicotine.

As already indicated, there is divergent opinion on this, and the jury is still out. Additionally, for Prof Glantz to be consistent in his view, he would also have to advocate the prohibition of nicotine containing NRT products, something which he has not done, instead stating that:

NRT should be recommended in both clinical practice and public health practice.

Professor Glantz is perhaps alone in considering nicotine on its own to be inherently dangerous, with the UK medicines regulator, the MHRA, considering it to be:

 a very safe drug

And onward to THR as a concept:

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.

When and if the tobacco companies who are profiting from selling e-cigarettes submit evidence that these statements are true to competent authorities they should be permitted to market e-cigarettes for these purposes.

In the meantime England’s experience (as well as other countries where there are no meaningful controls on e-cigarette marketing and promotion, including the United States) will provide evidence on the actual effects of e-cigarette use on the population’s health.

Because, in Prof Glantz’s world, all the non tobacco companies that sell e-cigs, just don’t exist. The fact that big tobacco is a relatively new entrant to the e-cig market is not worthy of consideration. Also not worthy of consideration is the fact that, as long as there is a non-tobacco owned e-cig industry, it will force the market to be competitive, at the expense of tobacco sales. (It also doesn’t take account of the opportunity for the tobacco industry to move to selling safer products, but this is a view he is not alone in holding).

Hopefully, when data continues to support the use of e-cigs as a gateway out of, rather than into smoking, Prof Glantz will recognise this, but based on his performance to date, this seems unlikely.

Next is a discussion of advertising, that quite honestly, I cannot be bothered to pick apart. Suffice to say that Prof Glantz is opposed to advertising that is designed to appeal to any consumers, on the basis that it MAY also appeal to some consumers that it shouldn’t. This is an effect that isn’t just confined to e-cigs or tobacco, but also led to a giant surge in Viagra use (which is why everyone on the planet with internet access still gets Viagra spam). I should draw attention to yet another of Prof Glantz’s self references here, however:

because youth who experiment with cigarettes are much more likely to have become established cigarette smokers if they use of e-cigarettes than if they do not

Now, the clear implication of this is that youth who have used e-cigs are more likely to go on to smoke more heavily than if they haven’t, however his co-author said:

“The study doesn’t show a causal relationship. I can’t say e-cigarette use causes kids to smoke based on this finding. We need some more longitudinal data on this”.

So an equally valid (and more expected, at least to users of electronic cigarettes) interpretation would be that heavy smokers are more likely to seek safer alternatives. Sounds like a good thing to me.

Then we move to the prohibition of use on the basis of second hand vapour:

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.

This statement is incorrect on both counts.

The signatories of the letter seem not to have read Chapter 5 of the 2014 Surgeon Generals’ report, which concluded, based on a review of an extensive evidence base, thatThe evidence is sufficient to infer that nicotine adversely affects maternal and fetal health during pregnancy, contributing to multiple adverse outcomes such as preterm delivery and stillbirth.”[17]

Indeed, all the conclusions of Chapter 5 seem to have been ignored:

1. The evidence is sufficient to infer that at high-enough doses nicotine has acute toxicity.

2. The evidence is sufficient to infer that nicotine activates multiple biological pathways through which smoking increases risk for disease.

3. The evidence is sufficient to infer that nicotine exposure during fetal development, a critical window for brain development, has lasting adverse consequences for brain development.

4. The evidence is sufficient to infer that nicotine adversely affects maternal and fetal health during pregnancy, contributing to multiple adverse outcomes such as preterm delivery and stillbirth.

5. The evidence is suggestive that nicotine exposure during adolescence, a critical window for brain development, may have lasting adverse consequences for brain development.

6. The evidence is inadequate to infer the presence or absence of a causal relationship between exposure to nicotine and risk for cancer [but see the comments above about other effects on cancer].

Now, which of those 6 points do you think applies to the 1/10th of the already small amount of nicotine found in second hand smoke, that is found in exhaled vapour? I think it’s none of them at all. As another (and less dogmatic) Professor put it:

In order to inhale the equivalent amount of nicotine that would be inhaled by actively smoking one cigarette, a bystander would have to spend 12 days in a bar filled with e-cigarette vapor, at continuous exposure levels.

On the basis of which, perhaps Prof Glantz will be issuing a warning on the deadly dangers of the nicotine in tomato purée?

This is followed by quoting the hyper risk-averse warning on an ecig as evidence that it must do all it claims. (Given that it is a big tobacco product, this must be the first and only time that Prof Glantz has believed a tobacco company about anything).

Then we get:

While it is too soon to determine precise adverse long-term health effects of this involuntary exposure, there is no health justification for increasing involuntary exposure to ultrafine particles, nicotine, and other toxins.  (This is another example of how the Bates letter turns the precautionary principle on its head.)

An application of the precautionary principle on such narrow lines would ban the internal combustion engine, probably the biggest source of “involuntary exposure” to toxins and ultrafine particles, but I have yet to see Prof Glantz espouse the wonders of such a policy. In fact, given that Prof Glantz (like all people) is a source of involuntary exposure to formaldehyde, perhaps we should ban him under the precautionary principle?

And so onward… to the joys of punitive taxation

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.

This argument presumes that unrestricted promotion of e-cigarettes as a consumer product will result in net population health benefits, which, as noted above, have not been substantiated.

The alternative has also not been substantiated: the potential public health gains would be prevented if the appeal of these products to smokers (one of the driving forces behind people switching) was destroyed. Once again, this is an attempt to use the precautionary principle to prevent any chance of public health benefit from e-cigs. *sigh*

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.

While there are not yet longitudinal studies of e-cigarette use among youth that will provide a precise answer to what fraction of youth who smoke cigarettes began with e-cigarettes, as noted above we do know that (1) youth use of e-cigarettes is growing rapidly, (2) that there are high levels of dual use of cigarettes and e-cigarettes among youth, (3) that e-cigarette use is associated with progression from experimentation with cigarettes to established smoking, (4) that youth who use e-cigarettes are less likely to have stopped smoking cigarettes, and (5) that some youth who use e-cigarettes report never smoking a cigarettes, mean that some youth are initiating nicotine addiction with  e-cigarettes.

Note the complete lack of references in that section? If you make a statement that “we do know that”, it should be trivially easy to demonstrate that we do indeed know those things. Where then is the evidence? Apparently, even a self reference wouldn’t work to ‘prove’ it, so referencing is simply omitted.

There’s then a very non-representative sample set used (and abused):

The signatories of the letter also ignore longitudinal evidence from the United States that among a cohort of military trainees who experienced a period of forced nicotine abstinence during basic military training “smokers initiating smokeless tobacco use after basic military training, most demonstrated harm escalation (87%), which was 5.4 times more likely to occur than was harm reduction (e.g., smoking to smokeless tobacco use).”

Now, I’m proud to include some serving soldiers among my friends, and pretty much all of them smoke (especially when deployed). I can’t really comment on the US Air Force, but certainly in the UK, there is cultural expectation towards smoking, which is likely to impact smoking rates, as is stress. I don’t see any way in which this can be considered a guide to effects in the general population. Even leaving that aside (insofar as that is possible, given that it already renders the results meaningless) there is also this not-exactly-startling conclusion:

Smokeless tobacco users who agreed that illegal risk-taking was fun were more likely to escalate harm through smoking initiation

Risk takers are more prepared to take risks? Didn’t see that one coming! These, of course, are the risk takers of an already risk taking group, military service being rather less safe than, let’s say, mechanical engineering.

Then we move on to specific advice for the WHO:

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 TobReg Committee is already considering the issues surrounding e-cigarettes (and has for some time), including by commissioning a detailed summary of all the available evidence that was presented at its December meeting.[23]  TobReg continues to work on this issue and will be issuing a report on e-cigarettes later this year.

Rather than calling for a change to the membership of this committee, the signatories of this letter should allow TobReg to do its work.

Given that the ‘detailed summary’ was the work of none other than S A Glantz, and loaded with conclusions poorly supported by the evidence, I don’t imagine I’m alone in considering that this is part of the problem, rather than part of the solution! Indeed, if 53 experts in variously Public Health, Tobacco Control/Dependence, Addiction, Substance Abuse, and Oncology consider that the make up of the TobReg group is insufficiently expert, it is perhaps worth considering that they may have a point….

There follows a brief attack on Clive Bates, which I’ll treat with the contempt it deserves, before the closing section (which includes Glantz’s emphatic last paragraph):

In contrast, the reputations of the scientists who signed the letter are measured based on a different standard, notably their willingness to assess all the evidence (not just that which supports a particular decision or position) and whether the judgments that they make stand the test of time.

It is in that spirit that I urge the signatories of the Bates letter to consider the fact that they have put their reputations behind everything it says and recommends and carefully review the evidence cited in this comment (as well as the much larger literature cited in the papers and reports cited here) and consider whether they wish to remove their names from Bates’ letter. 

Given the number of self references that Prof Glantz uses, and his totally closed-minded position, it strikes me as entirely hypocritical for him to be giving others advice on reading the literature. It also requires stunning arrogance to assume that the 53 expert signatories are deficient in their reading because they disagree with one Stanton Glantz.

And there we have it…… reference abuse, ignoring evidence, inflating risk, and hypocrisy.

Sterling work – as ever – from Prof Glantz.



Posted in EU, FDA, MHRA, Safety, WHO | 8 Comments

Are abstentionist bias and fearmongering threatening to undermine Welsh Government consultation?

It appears that the Welsh Government position is not actually open to debate…..

by Tom Pruen

In an update today, Welsh Health Minister wrote an article that “clarifies the Welsh Government’s position on e-cigarettes”.

Considering that the Welsh Government has an open consultation that covers this very subject it should, one might suppose, be open minded about what the outcome of this will be. Sadly, Mark Drakeford has very clearly demonstrated that this is not the case.

“The Welsh Government has faced an onslaught of criticism for daring to consider the impact of e-cigarettes on the health of the nation and proposing new measures to protect people’s health from an emerging threat.”

So providing critical feedback on a public consultation is a bad thing? When did this startling change happen? Is a consultation not INTENDED to generate feedback? Do we live in a world where it is suddenly only appropriate to respond in support of a proposal?

Then there is the even more disturbing element: this statement is both prejudiced and prejudicial.

It does not even allow a hint of doubt that e-cigs are “an emerging threat”. All the people who (at their own expense) have switched from inhaling the smoke of burning tobacco, to a safer way of using nicotine? They apparently matter not a jot, this ‘emerging threat’ must be stopped! No consideration AT ALL is given to the potential for massive heath gains; the focus here is entirely on the potential for harm. It’s about as balanced as an elephant on a child’s see-saw.

Electronic cigarettes provide for the first time, (outside of Sweden, where a non-smoked tobacco product has slashed smoking rates to the lowest in Europe, with an accompanying low rate of lung cancer; a product that an abuse of the precautionary principle has banned across the rest of Europe), a method for smokers to stop inhaling smoke, while continuing to use nicotine in an enjoyable way. This gives them a massive appeal to smokers who are concerned by the health risks of smoking, but who are unable or unwilling to quit. It is this appeal that has led many long-term, hardened smokers to use e-cigs instead of smoking. Not only that, but because e-cig users are still using nicotine, it is very probable (in fact, almost certain) that relapse rates will be much, much lower than for methods that involve abstinence from nicotine. Does this sound like an emerging threat, or an emerging opportunity?

That isn’t to say that there are no concerns that need addressing; the potential for new nicotine addicts to be created must be carefully monitored and minimised. (That said, if new users, particularly youths, adopt e-cigs as a nicotine source INSTEAD of becoming smokers, this is still a massive benefit). More research is needed on the emissions to make the products even safer than they are already, (despite much hyperbole that e-cigs may not be safer than smoking, this a simply a lie; there is no known, plausible, or theoretical mechanism by which the harm caused by an e-cig can even begin to approach the risk of inhaling smoke), and to better measure nicotine delivery (some experts would even argue that the nicotine delivery needs to be increased to make e-cigs an even more effective alternative), but as a safer alternative to tobacco smoking, they are already more than safe enough.

Why, in the face of such a massive potential to prevent premature death, suffering and smoking related disease – particularly when smoking is more prevalent in already disadvantaged demographics,  is the Welsh Health Minister so certain that e-cigs are an emerging threat? Why is he happy to cherry pick research that supports his position (often from around the world, where smoking culture may be different) and ignore organisations who are local, relevant, and just as (or possibly even more) committed to reducing tobacco related suffering? Both ASH UK and ASH Cymru have produced research that suggests e-cigs have a minimal gateway effect into nicotine addiction (and provide a massive gateway out of smoking), and neither supports a public spaces ban. Yet Mark Drakeford apparently doesn’t consider any of this worthy of mention. Nor does he mention population-based data from the smoking toolkit survey that, concomitant with the rise in use of electronic cigarettes, intention to quit and success at quitting have both risen, while smoking prevalence has significantly dropped.

In the face of such evidence, is it reasonable for a Health Minister to baldly consider e-cigs an “emerging threat”?

I don’t think so.

E-cigs are an opportunity that needs to be carefully managed to maximise the health gains, and minimise the (already pretty small) risks.

It is important that the Welsh Government is not ‘proposing new measures to protect people’s health from an emerging opportunity’!


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Formaldehyde (and other carbonyls) in E-cig vapour

by Tom Pruen

Given that this relates to a news story initially published on the 3rd of May, and widely reported since, why has it taken this long for us to comment on it? Quite simply, the study that made the news has only just been released.

What is it?

It’s a study that looked at the emissions of a variety of e-liquids of different compositions from a single device type. (For practical reasons, it is impossible to test a multiple of samples through a single device). It also used control solutions representing different compositions of e-liquid at different voltages.

What did it find?

At the low end of standard e-cig voltages, the emissions of carbonyls are very low, at levels of less than 0.1 ppm (parts per million). Carbonyls are chemicals having a double-bonded oxygen functional group, often being more specifically ketones or aldehydes, of which some are known or suspected carcinogens. Almost all are extremely common in the environment with several occurring naturally in fruit.

At the top end of the voltage range, emissions rise dramatically and may exceed the levels found in cigarette smoke (for some of the few chemicals measured).

Are there any issues with it?

For some of the reported values, the variation between results is extremely large (expressed in the results table as standard variation from the mean), of the same size as or, in one notable case, larger than the mean result. The size of these variations suggest that there is some underlying flaw in the methodology. This could be due to a variation in the time the samples were allowed to stand, allowing the liquid to wick into the coil. Alternatively it could be that, despite using the same type of atomising device, there was significant variation between the atomisers. Given the quality of results from Goniewicz et al in the past, the latter seems a more likely explanation.

There is also a significant problem with raising concerns over the levels of carbonyls at high voltages. (I should point out that there is no real attempt to scaremonger about this in the research, but unfortunately, this isn’t reflected in the press coverage). The problem is that, quite simply, if the liquid is overheated, it becomes almost completely unpalatable. As every vaper knows, dry or burnt ‘hits’ are so unspeakably awful that no one would willingly inhale them.

A 2.4 Ohm coil running at 4.8V is using 9.6 Watts, far beyond the 6 to 8 Watts  (3.8 to 4.4V for a 2.4 Ohm coil) which most variable-wattage/variable-voltage vapers would recommend as the ideal range. It is by no means impossible to vape at higher power levels, but this almost always requires more advanced atomisers, and is most particularly found in rebuildable atomisers, where the users can build the coil and wicking material to suit the higher power levels, without overheating.

This was also flagged by Dr Farsalinos in his comments on the (then unpublished) research.

What does it actually tell us?

In combination with other research, it highlights that there is (still) no evidence of significant risk from e-cigs, although by the same token, absolute safety is not assured.

There are some interesting nuggets in the results, aside from the reported findings. One of particular interest is that more carbonyls were found in flavoured liquids than in the control solutions made from analytical grade ingredients, without flavourings. This may be an indication that the liquids tested contained some of these to start with. (On the face of it, this seems moderately unlikely if the ingredients were of good quality, but the liquids themselves were not analysed, so it is impossible to rule this out.) Alternatively, it may be an indication that flavourings increase the generation of carbonyls when heated.

Hopefully, further research will tell us more.

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It’s been a good week… Mainly…

By Tom Pruen

This week saw the publication of a number of very positive things, based on a good evidence base, and if perhaps more conservative in their conclusions than we would have liked, certainly far from some of the hysterical scaremongering we have seen in the past.

Our first featured item is a document on e-cigs from the National Centre for Smoking Cessation and Training (NCSCT).   I’d recommend actually reading it, but here are a few highlights from the executive summary:

  • Electronic cigarette use is increasing in smokers wanting to quit but particularly among smokers who want to reduce the health risks of smoking or to save money
  • Short-term exposure to electronic cigarettes appears to be associated with few serious risks. Mouth and throat irritation are the most commonly reported symptoms and these appear to subside over time. There are no high quality safety data regarding long-term electronic cigarette use but there is no a-priori reason to expect that such use may pose risks anywhere near the risks associated with smoking
  • Low levels of toxicants and carcinogens have been detected in electronic cigarette liquid and vapour although these are much lower than those found in conventional cigarette smoke and are not considered to pose any passive inhalation risk
  • There are currently no robust data to support the concern that the existence of electronic cigarettes might ‘normalise’ smoking and increase use of conventional cigarettes

The second featured publication is from the UK Centre for Tobacco and Alcohol Studies, for Public Health England (PHE) “Electronic cigarettes A report commissioned by Public Health England”

Again, I’d recommend that everyone reads the actual document, but here is the summary and conclusions:

“Smoking kills, and millions of smokers alive today will die prematurely from their smoking unless they quit. This burden falls predominantly on the most disadvantaged in society. Preventing this death and disability requires measures that help as many of today’s smokers to quit as possible. The option of switching to electronic cigarettes as an alternative and much safer source of nicotine, as a personal lifestyle choice rather than medical service, has enormous potential to reach smokers currently refractory to existing approaches. The emergence of electronic cigarettes and the likely arrival of more effective nicotine-containing devices currently in development provides a radical alternative to tobacco, and evidence to date suggests that smokers are willing to use these products in substantial numbers. Electronic cigarettes, and other nicotine devices, therefore offer vast potential health benefits, but maximising those benefits while minimising harms and risks to society requires appropriate regulation, careful monitoring, and risk management. However the opportunity to harness this potential into public health policy, complementing existing comprehensive tobacco control policies, should not be missed.”

There was also a very positive debate in the Welsh Assembly on the evidence base supporting the proposed ban on the use of e-cigs in public places, with politicians from (almost) all sides calling for more evidence to support such a move. You can watch the debate here.

But the news this week isn’t all good – reports from the PHE conference (unfortunately we were not there, so we don’t have any first-hand knowledge) suggest that the Chief Medical Officer (CMO), Dame Sally Davies, was not terribly interested in the evidence, as indicated in this exchange between Prof Robert West, Louise Ross (a smoking cessation Service manager) and an e-cig user, all of whom were at the the PHE conference



Not exactly a ringing endorsement of the CMO, and very disappointing.

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