Ethical imperatives assuming ENDS effectiveness and safety are fragile

Hall et al. 1 apply four core ethical principles to three broad regulatory positions regarding electronic nicotine delivery systems (ENDS): a ban, and what they call ‘levelling up’ and ‘levelling down’ options in allowing legal sales of ENDS. They conclude that the levelling down option, where sales, promotion and use of ENDS would be subject to the same kinds of restrictions that now, and could be applied further, to combustible products, is most likely to see pragmatic compromises between what are currently two broad camps, now well divided. Their analysis raises important issues and is refreshingly civil, coming after much often destructive rancour from others. ENDS advocates anchor their case to four core claims: that ENDS are far less dangerous than cigarettes; that any reduction in smoking is self-evidently harm-reducing; that they are radically more effective than other ways of quitting smoking; and that unlike nearly all other entrants in the train wreck history of tobacco harm reduction 2, ENDS have high appeal to smokers. On safety, Hall et al. acknowledge that the long-term safety profiles of ENDS are ‘unknown but are likely to be substantially less than those of daily cigarette smoking’. We agree, but emphasize that even should the long-term health risks of ENDS be subsequently confirmed at even 10% that of smoking, the burden of disease caused would still rank among the leading preventable causes of disease, should vaping proliferate. There are many reasons for serious concern at efforts to trivialize as largely inconsequential day-long, long-term dosing with unregulated levels of nicotine 3-6, which the International Agency for Research in Cancer has included as a priority for carcinogenic assessment 7. As the US Flavor and Extract Manufacturers Association has warned 7, the cornucopia of flavourants used in e-juice have not been safety tested for deep inhalation, let alone some 200 times a day 8. All longitudinal studies of vaping have found cessation rates lower in ENDS users than non-users 9. All have been criticized for including non-daily users in their analyses, but the most recent study which separated daily from non-daily users also found no statistically significantly differences between daily, less than daily and non-vaping smokers for smoking cessation 9. A sub-analysis found that daily ‘tank’ vapers were more likely to quit, although nearly three quarters of these were still dual using at 12 months and the proportions of smokers involved were small 10. So the new emperor's clothes of ENDS in smoking cessation are looking decidedly threadbare. Ethical imperatives which assume effectiveness and benign levels of risk are decidedly fragile. The same study 9 found daily ENDS users reduced daily smoking frequency significantly, but four cohort studies 11-13 have now reported that even 50% reductions do not confer either any or significant risk reductions compared to smoking cessation. Dual use, far more common in daily vapers than exclusive ENDS use, is not harm-reducing; so, again, high-minded ethical exhortations about reducing harm remain questionable. As Hall et al. wisely emphasize, consequentialist ethics must consider policy effects on all who are affected. ENDS policy must be not simply about putative benefits to current smokers, but critically about the probable impact on youth, and particularly those who would have been unlikely to take up any form of nicotine use. Here, only the naive could give credence to any business model for ENDS which claimed to seriously dissuade the young from interest in these products 14. Surprisingly, Hall et al. omit any consideration of the massive range of advertising and promotion for e-cigarettes in countries such as the United States and United Kingdom, much of it clearly targeting young people and promoting the smoking behaviour 15, 16. Similarly, they are silent on the way in which tobacco companies are using e-cigarettes as a means of both re-normalizing smoking and seeking access to governments, presenting themselves as genuinely concerned about health, when globally they are getting on with the business of promoting lethal products and opposing any policy that might reduce sales (British American Tobacco's Nicoventures section even describes a company with which it has a licensing agreement as ‘a consumer healthcare company’ 17). With more youth already vaping than smoking in the United States 18, and alarming data possibly suggestive of substantial gateway effects from ENDS to smoking evident in Poland 19, ‘levelling down’ regulation should be a responsible starting point. With record lows in youth smoking prevalence which have taken decades to achieve, and which are slowly starving the cigarette market in some nations, it is imperative that policies to maximize still putative harm reduction benefits should not unravel these achievements and that unconflicted, evidence-based efforts be increased to better inform the community about the developing picture on effectiveness and safety. None.