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The UKCTAS critique of the WHO paper on ‘ENDS’ isn’t just a specific critique; it is also a mythbuster for most of the fear based reporting and policy proposals.

28, Oct, 2016

The World Health Organisation has long demonstrated its utter hostility to Tobacco Harm Reduction (THR). This was most recently demonstrated in their report “Electronic Nicotine Delivery Systems and Electronic  Non-Nicotine Delivery Systems (ENDS/ENNDS)” (these products will be referred to as e-cigs or vaping products in the post, as ENDS is a term alien to the manufacturers and users of these products, being largely an invention of the WHO).

The level of cherry picking and bias in the report has led the UK Centre for Tobacco and Alcohol Studies (UKCTAS) to write a critical commentary.

The first point of the executive summary addresses the root of the problem very well:

"Positioning ENDS as a threat rather than opportunity.

Overall, the WHO report does not correctly position ENDS primarily as an alternative to smoking and instead focusses excessively on risks of ENDS use without adequately recognising the deep reductions in health risks when a smoker switches to ENDS. The FCTC itself recognises ‘harm reduction’ as a key strategy in tobacco control. But with minor exceptions, the WHO report discusses ENDS as a threat, whereas in fact they represent a major opportunity for public health."

It is not only excellent for the specific purpose for which it was written, but since the WHO report reflects such a negative view of the use of e-cigs and vaping products (and the state of science surrounding them), a detailed critique of it such as the one from UKCTAS, does not stop at being a critique of the WHO report, it is also a critique of the concepts that create it. As such, it is a very useful (and detailed) mythbuster of a lot of the ill-informed attitudes that generate fear-based reporting and policy proposals.

Some good examples of this are:

“But you’re still addicted”, and other such drivel that suggest that continuing use of nicotine is the same as continuing to smoke

“The report acknowledges that widespread switching to alternative sources of nicotine, and in due course quitting all nicotine, would be a significant contemporary public health achievement, but with the caveat that this applies only if recruitment of new nicotine users does not exceed that of smoking and eventually decreases to zero. In practice however, use of nicotine (as distinct from tobacco) by adults causes few if any health problems, so even a high prevalence of nicotine use would generate substantial benefits to public health if accompanied by appreciable reductions in smoking prevalence [14]. Similarly, the proviso that recruitment of new nicotine users should not exceed that of smoking is inappropriate since, whilst undesirable, becoming addicted to nicotine per se represents a health hazard of negligible proportion relative to that of tobacco smoking. If, theoretically, smoking was eradicated at the cost of 100% population addiction and use of medicinal grade nicotine, public health would still gain substantially as a result [14]. Levy et al estimate that 80% of otherwise non-smokers would be required to experiment seriously with products such as ENDS if ENDS are 5% as hazardous as tobacco cigarettes; and 30% of otherwise non-smokers would be required to experiment seriously with ENDS to generate overall public health harm if ENDS are 25% as harmful as tobacco [15]. So, depending on the hazard of ENDS relative to tobacco, substantial use among people who would never otherwise have used nicotine is still compatible with overall health gain. That is not intended as an endorsement of nicotine use, but to emphasise that the benefits of reductions in smoking matter for public health far more than detriments arising from increases in nicotine use.”

“These products are dangerous because they contain X”, where X is often formaldehyde, metals, nicotine, or the lazy journalists’ favourite, ‘anti-freeze’.

“5.1 This section places a strong emphasis on potential risks of ENDS use without balance or context from comparison with the health risks of tobacco smoke. Thus, whilst the text acknowledges that aerosol emissions from ENDS have much reduced levels and number of toxicants compared to cigarette smoke, disproportionate concern about their absolute harm is conveyed with little or no consideration for the notion of relative risk, either in relation to no use of ENDS, or in relation to smoking.

5.2 In paragraph 7, a list of substances detected in ENDS aerosol emissions is presented, with an assertion that many of these have known health effects and cause a range of significant pathological changes. A basic premise of toxicology is that risk is a function both of the hazardousness of the substance and the exposure to it. Simply listing substances detected in ENDS emissions is therefore only part of the process of assessing hazard. It is also essential to look at the levels of exposure generated, both in relation to occupational or other relevant exposure limits, and in relation to tobacco smoke, to give a sense of the magnitude of any risk to health from these exposures, and their hazard to smokers in relation to continued or future tobacco smoking.

5.2.1 Paragraph 7 highlights the presence of propylene glycol in the vapour. Propylene glycol is recognized as safe for human consumption by ingestion [23] and is widely used in foods, cosmetics and pharmaceuticals [23]. In animal studies, exposure to propylene glycol vapour has not been found to cause damage to lung tissues or to have other serious adverse effects [24, 25, 26, 27]. A study of the effects of exposure to aviation de-icing aerosol (composed mainly of non-pharmaceutical grade propylene glycol) on 27 healthy volunteers [28] did not show any reduction in lung function. Other findings from this study included self-reported sensations of sore and dry eyes, throat dryness, and irritative cough; and a decrease of tear film stability, which is likely to be related to the humectant effects of propylene glycol. Participants in this study were exposed for 1 minute to mean propylene glycol concentrations of 360 mg/m3, which is more than 3 orders of magnitude higher than the ambient level of propylene glycol (203.6) µg/m3 observed in a study in which 3 participants used ENDS ad lib for 1 hour in a small room [29]. Propylene glycol used in de-icing facilities is of industrial grade [30], and hence less pure than the pharmaceutical grade propylene glycol used in most ENDS. These irritant symptoms are transient and disappear spontaneously over a short period of time [31]. The question of whether such an acute irritation could translate into clinically meaningful lung disease remains unanswered, but there certainly is no evidence to suggest that this is an indication of clinically significant adverse lung effects. Inhaled propylene glycol is thus unlikely to represent a significant hazard to health.

5.2.2 In addition to propylene glycol, analysis of ENDS vapour has detected water, ethylene glycol or glycerine, nicotine and various other chemicals including low levels of formaldehyde, acetaldehyde, acrolein, volatile organic compounds (VOC) and tobacco specific nitrosamines [32]. However the levels of many of these substances are extremely low, ranging between 9 and 450 times lower than those in smoke from conventional cigarettes [32], indicating (though not necessarily guaranteeing) a much lower level of risk. ENDS vapour contains aldehydes (carbonyl compounds) generated through oxidation of e-liquids during heating and vapourisation, to an extent depending on the power levels (i.e. wattage) of the device and on the e-liquid used [33]. Yet as with other chemicals in vapour, their concentration is between 13 and 807 times lower than those found in tobacco smoke [34]. One study which demonstrated extremely high levels of formaldehyde in ENDS vapour [35] used voltage and heating levels which in practice generate what is known colloquially as a ‘dry puff’, which is aversive and hence avoided by ENDS users[36]. Although reported to contain a range of metals including cadmium, nickel and lead [32, 37], levels of these metals in ENDS vapour are substantially below permitted levels for daily occupational exposure, and below permissible daily exposure from inhalation medications, and are therefore unlikely to have significant adverse health effects [38]. The presence of potential toxins in ENDS at very low levels does not necessarily preclude safe use in humans: for example, medicinally licensed NRT products contain known carcinogens (TSNAs) [31], but at levels considered negligible to health. The presence of TSNAs in NRT is not used as justification to question their safety or role in public health, since trace levels of impurity are inevitable, but not necessarily hazardous.

5.2.3 These much lower levels of toxins in ENDS vapour become evident in studies of smokers who switch completely to ENDS use, and in whom significant reductions in exposure to volatile organic compounds, nitrosamines and carbon monoxide have been documents [sic] along with improved self-reported health [39]. Switching to ENDS while abstaining from smoking has also been shown to normalise lung function and improve respiratory symptoms [40], and to contribute to a reduction in blood pressure in smokers with elevated systolic blood pressure [41].

5.3 Paragraph 9 states that nicotine can have adverse effects on foetal development, may contribute to cardiovascular disease, and may function as a tumour promoter. However, it is important to acknowledge that the effects of nicotine alone are likely to be substantially less than those of continued tobacco smoking; it also remains far from certain that the reported adverse effects of nicotine do translate into significant morbidity or mortality.”

“Not safer than smoking”, fortunately only confined to a tiny minority of particularly hard-core fools (and alarmingly, the US FDA)

"5.6 Paragraph 11 acknowledges that ENDS are likely to be less hazardous than cigarettes, but argues that no quantitative estimate of this difference currently has scientific credibility. We agree that precise quantification is difficult, and highly dependent on product and e-liquid constituent characteristics, but disagree that the likely order of magnitude cannot be estimated. Given that nicotine itself accounts for little if any of the health effects of tobacco use, and that use of NRT has not been found to be associated with significant long term health harms, the hazards of ENDS use arise entirely from other constituents of vapour: and the range of constituents, and the concentrations of almost all of them, are far less than those generated by combustion of tobacco. Both Public Health England and the Royal College of Physicians have reviewed the evidence on the likely magnitude of the risk to health posed by ENDS and reached very similar conclusions: Public Health England estimated the risk at 5% of that of tobacco smoking, and the Royal College of Physicians that the risk was unlikely to exceed 5% [5, 59]. As ENDS quality standards are implemented, this relative risk may fall.

5.6.1 Whatever the true extent of the reduction in risk realised by smokers who switch to ENDS, it is important that public health messages are consistent in emphasising the reduced risk of ENDS relative to tobacco. In Britain, only 15% of adults correctly think that ENDS are a lot less harmful than smoking, while 25% believe they are as harmful or more harmful [13]. In the United States, only 5.3% of adults think, correctly, that ENDS are very much less harmful than smoking, while 37.5% think incorrectly that there is no difference in risk or that e-cigarettes are more harmful [60].

5.6.2 The danger of such misperceptions is that smokers will not appreciate the benefits of switching and so continue to smoke. If physicians or public health practitioners do not understand relative risks then there is a danger that they will give poor advice and do harm as a result. To address this problem of misperception of risk, the Royal College of Physicians proposes the following carefully worded statement that reflects a degree of uncertainty, but aims to align risk perceptions more closely to the current understanding of science:

"Although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure". (Section 5.5 page 87) We believe this remains the best most realistic formulation at present, and that it errs on the side of caution.

5.6.3 Paragraph 11 goes on to assert that modelling studies suggest that a relative hazard three times lower than that of tobacco is necessary to achieve a net population benefit. This is not true. Levy et al (cited in paragraph 11 as evidence supporting this statement) actually conclude that:

“a large proportion of VNP initiation leading directly to more cigarette smoking by otherwise never smokers or an increase in the magnitude of harms from VNPs relative to cigarettes (or both) would be required before a tipping point is reached where harms begin to exceed benefits at the population level” [15].

Professor Levy has expressed concern about his work being used by WHO in this way. He states:

"I am troubled by the WHO statement that my model indicates "for there to be a potential population-wide net health benefit from ENDS/ENNDS at present usage rates, these products would need to be at least three times “safer” than cigarettes." My model only looked at a single cohort at an age where individuals were likely to initiate smoking and did not consider smokers in later cohorts where e-cigarettes have the potential to increase cessation from cigarettes. Consequently, additional benefits may accrue when including e-cigarette use by later cohorts. Further, I did not consider e-cigarette risks at 1/3 the risk of cigarettes, because I do not consider that such a high level of risk is plausible given current evidence"

The Kalkhoran study [61] does model relative risks of ENDS relative to smoking of 0.25 and 0.5. However the estimates of costs to society in this study are highly dependent on numerous assumptions made about effects of ENDS on smoking, for which no supporting evidence is presented. The risk threshold of ‘at least three times safer’ in paragraph 11, therefore, has no validity and rests on misunderstandings of these modelling papers.

5.7 We agree with the statement in paragraph 12 that it is important to elucidate the risks of ENDS, and that comparisons only with tobacco smoke are insufficient. Comparisons with tobacco smoke elucidate the risk of ENDS relative to smoking; whilst comparisons with ambient air, and context from safe occupational exposure limits, elucidate risks relative to non-use. Both are necessary to the estimation of population harm from ENDS use, and demonstrate that while not free from hazard, ENDS are substantially less hazardous than tobacco cigarettes [62]."

“Second hand vapour is dangerous”, now spiced up by the possible harms of third hand vapour, by the particularly puritan or demented commentators.

"6.1 Paragaraphs 13 and 14 conclude that second-hand aerosol is a new source of air contamination with a range of particles and substances, including fine and ultrafine particles, 1,2-propanediol, some VOCs, some heavy metals, and nicotine. The systematic review cited in the WHO report [63] did not identify actual health risks because it referred primarily to the presence of, and not the level of exposure to, constituents of vapour. Any risk assessment analysis by definition requires the evaluation of exposure levels before determining any potential health effects.

6.2 Emission of fine and ultrafine particles has been cited as evidence of environmental contamination by ENDS. Compared to background levels in air, PM1.0 and PM2.5 in SHA are between 14 and 40 times, and between 6 and 86 times higher respectively [64]. However, more than 99.9% of this aerosol, if generated from glycerol-based liquids, is composed of glycerol and water, and 0.05% composed of nicotine [64]. This particulate matter is unlikely to represent a significant risk to health.

6.3 Levels of nicotine in ambient air in a room where ENDS vapour is being generated have been estimated at between 0.6 and 4.6 μg/m3 with a third generation ENDS device [65], and at 0.82 to 6.23μg/m3 when generated by a machine [66]; this latter study probably overestimates nicotine emissions since the absorption of nicotine when a person inhales is not taken into consideration. Average salivary cotinine levels in non-smokers exposed to ENDs at home for at least 2 hours per day have been recorded in one study to be extremely low, at 0.19 ng/ml, though higher than those (0.07 ng/ml) observed in unexposed control subjects [67]. This compares to levels of about 300 ng/mL in users of ENDS and in smokers [68].

6.4 Total carbonyls in exhaled air from ENDS have been shown to be similar to those in control exhaled breaths or room air blanks [64]. On the contrary, tobacco smoking led to a significant increase in exhaled carbonyl levels [64]. The presence of carbonyls is normal in exhaled breath and in room air, reflecting the pervasive nature of carbonyls in indoor environments [69, 70].

6.5 Metal emissions are expected to be generated by the heating process involved in creating ENDS vapour. However in a study assaying arsenic, barium, cadmium, chromium, cobalt, copper, lead, manganese, nickel, rubidium, strontium and zinc in the aerosol of 12 ENDS products [32] only three metals (cadmium, lead and nickel) were found at levels above the limit of quantification, and in all cases at very low levels [32]. These metals were also detected in blank samples and in emissions from a pharmaceutical nicotine inhaler, raising the possibility that environmental air was the source. Another study found detectable levels of aluminum, barium, chromium, copper, iron, lead, manganese, nickel, strontium, tin, titanium, zinc and zirconium in electronic cigarette aerosol from a first-generation ENDS product [37]. A risk assessment analysis of the findings of these two studies has estimated average daily exposure from the 13 electronic cigarette products analysed was 2.6- to 387-fold lower than US Permitted Daily Exposure (PDE) limits, 325-fold lower than Minimal Risk Levels (MRLs) and 514-fold lower than Recommended Exposure Limits (RELs) [38]. One of the 13 products was found, when used at the extreme of maximum daily use, to generate levels of cadmium exposure 10% higher than the PDE for cadmium [38]. These findings indicate that metal emissions are unlikely to represent serious health hazards.

6.6 Formaldehyde is an abundant chemical that is exhaled by healthy (non-smoking, non-vaping) humans [71]. In a study in which a smoker in an 8m3 space took six inhalations over 5 minutes from three ENDS at 15 minute intervals, a gradual increase in ambient formaldehyde levels that was not influenced by ENDS use was demonstrated [72]. Smoking a conventional cigarette in the same space then generated very high levels [72]. Estimated exposure to formaldehyde from active consumption of 600 puffs of electronic cigarette under realistic conditions is around 678 μg/day [36], around one third of the daily exposure sustained from breathing air containing formaldehyde at the WHO upper acceptable limit of 80 ppb (100 μg/m3) [73]. This results in a daily exposure of 2000 μg/day, assuming an average ventilation rate of 20 m3/day. Passive exposure of others to formaldehyde is thus expected to have negligible health effects. Similar findings apply for acetaldehyde, an endogenous metabolite detected in the exhaled breath of healthy volunteers at levels ranging from 0.2 to 0.6 nmol/l (i.e. 8.81-26.43 μg/m3) [74]. Acetaldehyde levels increase minimally relative to background levels (from 9.0 μg/m3 to 12.4 μg/m3) after ENDS use [29] and remaining well below the EU Indoor Air Quality guideline for acetaldehyde of 200 µg/m3 [75].

6.7 Paragraph 15 argues that it is ‘nevertheless reasonable to assume that the increased concentration of toxicants from SHA over background levels poses an increased risk for the health of all bystanders’. The quantitative evidence above indicates that if any health risk arising from exposure exists, it is likely to be negligible.”

Which leads to – “They should be banned where smoking is banned”

“Prohibiting by law the use of ENDS in indoor spaces or at least where smoking is not permitted: There is no justification for using the law to override the preferences of the owners or managers of indoor spaces unless a material risk to bystanders or workers has been identified, which it has not 121. As well as an unjustified imposition on property owners’ rights to determine their own vaping policy, there are at least two possible unintended consequences. First, that it will promote relapse to smoking. Second, that it reduces the appeal of vaping relative to smoking, and hence protect the cigarette trade.”

“Think of the children” “Gateway product”, and other emotive, legitimate, but often over-dramatized and fear-mongering concerns:

“8.2 There are many more than 27 studies of the use of ENDS amongst representative samples of young people. It is not clear why the WHO authors have chosen to select only those involving probability sampling, and wrong to exclude other valid studies from discussion in this section.

8.3 We agree that experimentation with ENDS among young people is rising in some countries, but the vast majority of surveys assess only ‘ever use’, which includes just one puff on an ENDS, ever; and ‘current use’, which is defined as use at least once in the past 30 days. The latter definition in particular categorises recent experimental users as current users: the reality is, however, that most use in adolescents is experimental and short-lived. Surveys therefore need to assess whether regular use is occurring, and examine this by smoking status. In studies that have done this, the findings are consistent: they show that experimentation (ever use) among young people in some countries is common, but that use at least weekly remains low overall and is concentrated in young people who already smoke. Regular use in never smokers remains very rare in any survey that has measured this. Professor Ken Warner, writing in the American Journal of Preventive Medicine, examines data from the Monitoring the Future survey of older teenagers in American High Schools [92]. Unlike some American surveys it is possible to establish the frequency of e-cigarette use (not just recent, i.e past 30 day use) from this survey. He identified that non- smoking high school students were extremely unlikely to ever use e-cigarettes, and amongst those that did, most had only ever used them on 1-2 of the past 30 days. Current smokers were far more likely to regularly use e-cigarettes. In addition, there is some evidence that many adolescents who use e-cigarettes use liquids that do not contain nicotine, i.e. ENDS [93].

8.4 The main area for concern is whether young people who have never smoked, and who in the absence of ENDS would not have become smokers, are becoming ENDS users; but here the evidence is very limited indeed. An analysis of UK surveys provides an illustrative example [94]. We reviewed four nationally representative cross-sectional surveys conducted in the same year, 2014, in each part of the United Kingdom [94]: a survey of youth across the UK [95], youth across Great Britain [96], young people in Scotland [97], and young people in Wales [98]. Although the age range between surveys differed slightly the findings were remarkably consistent. Around 12% of teenagers had ever tried an ENDS in that year, but a much smaller proportion (varying from 0.4% in Scotland to 2% in the UK wide survey) had used an ENDS more than monthly, and very few (1% UK, 0.7% in the Great Britain sample) more than weekly. Among teenagers who had never smoked tobacco, rates of ever trying an ENDS were also low, at between 2 and 5% [94] . Importantly, three of these surveys found no evidence at all of never smoking young people regularly using ENDS [95, 96, 97]. The fourth, a large survey in Wales of 9,055 11-16 year olds, identified just 54 never smoking young people who reported using ENDS at least monthly [98]. What these UK data show is the importance of assessing frequency of use, not just asking about experimentation at any time or experimentation recently. This is particularly important amongst never smokers. The WHO report does not acknowledge this, and does not cite the studies that include this important measurement.

8.5 Trend data on ENDS use (paragraph 19) also need to assess regular rather than experimental use, and to take into account trends in smoking as well. Data from across the US, for example, show that smoking rates are at an all-time low and that ENDS use among non-smoking youth is rare [92]. The Florida figures should be put in this overall context.

8.6 There are few longitudinal studies, but those available show an association between ever use of ENDS and smoking at follow up, though the numbers of young people in these surveys who used an ENDS but did not smoke at baseline, and who went on to become smokers, is extremely low. This association does not, however, provide evidence of a causal association between ENDS use and smoking, since the findings may arise from common liability to use of both products and the fact that the measures focus on experimentation and trial rather than regular use of either ENDS or tobacco. Existing longitudinal studies, therefore, do not provide evidence that ENDs use in young people leads to smoking. To illustrate, it is worth looking more closely at two of the four longitudinal studies cited in the WHO briefing [99, 100] (though similar points apply to the other two [101, 102]).

The first study [99] involved 2,530 14 year olds in California. None of the teenagers had tried any combustible tobacco product at baseline, but 222 had tried ENDs (with the measure being ever use). These teens were followed up one year later when one in four of the ever ENDS users had tried at least one puff of a tobacco cigarette, compared to just under one in 10 of the non-smokers who had not tried an ENDs at baseline. These numbers are very small, but more importantly the measures are very weak. Trying an ENDS once or twice, and then trying a tobacco cigarette (the measure was a puff in the last six months) does not demonstrate that young people will become regular users of either product, and provides no evidence that the cause of the subsequent smoking was the prior ENDS use. The second study had a smaller sample, 694 12-26 year olds. These were all non-smokers, and just 16 had tried an ENDS (again, ‘ever use’). One year later, just over one in three of those who had tried an ENDS had taken at least one puff of a tobacco cigarette compared with one in ten of those who had never tried ENDs. So more teenagers who had tried an ENDS than not had puffed on a real cigarette one year later. But this was still just six young people, and as in the first study, there was no measure of regular use. These studies thus provide no basis for concern about a ‘gateway effect’.

8.7 While experimentation with ENDS among young people has been rising, smoking rates in developed countries have been consistently falling [97, 103]. There is no evidence that use of ENDS is contributing to a stalling or reduction in the rate of decline in youth smoking, and in the US, the country from which many of the alarming headlines about ENDS use and smoking in youth emerge, rates of cigarette smoking in young people have dropped in recent years at a more rapid rate than in the past [104, 105, 106].

8.8 ENDS use may have benefits for young people who smoke if these devices help them quit, now or in the longer term. The analysis of youth data in the WHO report does not acknowledge this, and does not highlight that existing surveys can fail to examine ENDS use by smoking status, instead reporting overall prevalence. The WHO report also fails to acknowledge the possibility that by offering an alternative to the tobacco cigarettes favoured by older people, ENDS may be helping to denormalise smoking among the young.”

“Ban all advertising”

“Paragraph 21 summarises the diversity of ENDS promotion and highlights concerns that some promotions use deceptive health claims, or target young people, incite rebellion against smoke-free policies, and either intentionally or unintentionally promoting smoking.

9.2 However, inspection of the cited evidence indicates that the health claims made for these products include reduced harm relative to tobacco cigarettes [107, 108, 109], which is in fact true; that ENDS help smokers to quit [107, 108, 109], which is true; and that ENDS do not emit second-hand smoke [107], which is also true. The cited source of evidence of incitement to rebel against smoke-free policies is an analysis of news coverage that notes that people may vape where smoking is not permitted [110]. There is nothing in this paper to suggest that ENDS advertising encourages rebellious smokers to smoke where smoking is not permitted (i.e. a rebellion): and even any rebellion claim rests on untested speculations by the authors.

9.3 While we agree that advertising targeted at non-nicotine users, particularly children, is counterproductive to public health; and would oppose any advertising that intentionally or otherwise promoted smoking, we argue that advertising that promotes harm reduction and smoking cessation to smokers has the potential to be beneficial to public health. That ENDS companies are promoting their products as a means to quit or reduce harm is therefore probably a good thing; and as ENDS users are almost exclusively smokers, the paper should recognize that ENDS promotion could be a factor in reducing cigarette sales and converting smokers from smoking to vaping – which is beneficial to public health. Likewise, restraints on ENDS promotion could have the unintended effect of increasing smoking. There are examples of poor ENDS advertising, just as there are for every product. However, experience in the UK with a Code of Practice [111, 112] showed that complaints fell to very low levels once it was clear what the rules are.

9.4 We agree with the analysis of price elasticity and the market equilibrium between ENDS and tobacco cigarettes, which demonstrates the importance of maintaining a price advantage for ENDS, and particularly of not applying tobacco taxes to the ENDS/ENNDS category. This is one of the few sections of the WHO report that recognises that ENDS and cigarettes are substitutes and that their demand profiles therefore interact. That insight should be extended to the section on promotion – if there is a cross elasticity of demand for the product, then one would expect a cross elasticity in promotional expenditure – in other words, if the logic of the section on price is applied to the section on promotion, increased promotion of ENDS should lead to decreased demand for cigarettes.”

“Big Tobacco Ploy”, and other ‘arguments’ that seek to align the market for e-cigs with the historic actions of the large tobacco companies (and also deals very well with hyper-regulation):

“The WHO report misconstrues the ENDS market, the role of transnational tobacco companies (TTCs) in this market, and undervalues the potential effect of a disruptive technology such as ENDS to the commercial viability of the traditional cigarette business. The references cited in the report point out how regulations, such as those the WHO seeks, actually help the cigarette companies. Yet in its section on regulatory options, WHO appears entirely unaware of how its regulatory proposals may provide the tobacco industry with a twin advantage:

(1) slowing down the disruption of the cigarette market;

(2) shaping the e-cigarette market to suit the ENDS business model favoured by the TTCs.

10.2 We agree that the engagement of TTCs in the ENDS market is a cause for concern, for the reasons given in paragraph 26, and it is important that WHO policy prevents these outcomes. For this reason it is important that ENDS suppliers can promote their products as a complete substitute for, not a complement to, tobacco cigarettes; and can continue to innovate and improve the performance of ENDS and other novel nicotine devices to improve their competitiveness with cigarettes. Regulatory approaches that inhibit these processes therefore play to TTC interests. We agree that promotion of smoking should be prevented, and support measures to prevent advertising to children, or imagery that translates from ENDS to tobacco, as has been successfully achieved in the UK. TTC engagement with policy to undermine the FCTC can be prevented by applying the measures contained in FCTC Article 5.3 [5].

10.3 Unless aided by regulation that kills the open systems business, competition and market forces will prevent TTCs from controlling options for smokers. The commercial reality is that the cigarette trade faces an existential threat from ENDS, and some TTC are trying to compete in this market to avoid becoming yet another company that, like Kodak, were forced quickly from market domination to irrelevance by a new and disruptive technology. TTCs are now being forced to develop and promote reduced harm products to survive. It is vital that regulatory approaches sustain the disruptive competition that is forcing this change.

10.4 Paragraph 27 refers to commercial and other vested interests among researchers. All areas of medicine interact with commercial interests, and those working in the treatment of nicotine addiction necessarily have to interact with suppliers of nicotine and other smoking cessation therapies and substitutes. As with links with the pharmaceutical industry in other areas of medicine, prohibition of those links will retard much research and development. The key thing is that all such interests are openly and consistently declared, and managed appropriately [118].”

“They should come with health warnings”

“Health warnings: It is unclear what evidence-based health warnings could be placed on ENDS. It would be better to provide meaningful risk-communications to consumers encouraging ENDS use as an alternative to smoking. For example, “No nicotine product is completely safe, but this product presents substantially lower risks to health than cigarettes”. The option of presenting realistic risk communication has not been considered or proposed by WHO.”

Go and read the whole thing – it’s very good, quite detailed, and very, very sensible.

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