Keywords

In England, policy makers have embraced the possibility of e-cigarettes (ENDS) to reduce tobacco-related harm by encouraging smokers to use them to quit smoking or as a long-term substitute for cigarettes. Regulation has been in ways which facilitate access by smokers. How did this come about? This chapter will examine how the tobacco policy arena developed in the 1980s and 1990s and the changing role of nicotine within that constellation. The acceptability of nicotine as a harm reduction strategy predated the arrival of e-cigarettes and this was a key factor in their initial reception. UK regulatory agencies also changed stance and the role of the EU was of importance in placing e-cigarettes within consumer regulation rather than medicinal licensing, at least initially. ASH, important as an activist organisation, changed stance before their arrival, and was crucial in building a coalition of support among influential organisations. So pre-history, the context of what had gone before, was of great importance in the English sphere. E-Cigarettes fitted into a welcoming policy context.

1 Nicotine From the 1970s

One area of tobacco research had diverged from the public health norm over several decades: this was the use of nicotine for tobacco harm reduction. There had been some early work on nicotine funded by the tobacco industry that was presented to the Royal College of Physicians committee in 1969 and published in Nature. The psychiatrist Michael Russell, based at the Addiction Research Unit at the Institute of Psychiatry, undertook research on nicotine with Medical Research Council (MRC) funding. Russell was a member of the third Royal College of Physicians committee in the 1970s, but his views differed from those of the other members. Russell argued that it would be more practical to make a much safer cigarette rather than to try to stop people from smoking. The minutes of the committee recorded “…there was disagreement in the committee as to whether the primary aim should be to urge people to stop smoking or whether the emphasis should be laid on safer methods of smoking. It was agreed that this dilemma should be discussed in the report as the kind of problem that doctors have to face in giving advice” (Royal College of Physicians, 1975).

Russell was interested in using nicotine as a smoking cessation treatment. He developed a strong link with the Swedish pharmacologist Ove Ferno, whose research on nicotine chewing gum for use by submariners (who could not smoke on board) had been presented to the second world conference on smoking in 1971. Russell and Ferno developed a nicotine replacement therapy (later renamed Nicorette) that slowly made its way into medical practice. Until the late 1980s, nicotine gum was only available on private rather than NHS prescription.

Russell and the psychologists who worked with him were outside the public health mainstream at this time. They were addiction scientists not public health researchers. In “Nicotine Use after the Year 2000” published in the Lancet in 1991, Russell argued for a nicotine addiction harm reduction model:

What distinguishes nicotine from other widely abused drugs is that its effects are subtle and do not cause socially disruptive intoxication, provoke violence, or impair performance. Yet deaths due to tobacco far outnumber those caused by all other drugs. The central paradox is that, while people smoke for nicotine they die mainly from the tar and other unwanted components in the smoke. Why have governments persisted in allowing the manufacture, extensive advertising and promotion of such a lethally contaminated drug delivery system as the cigarette, while putting so little pressure on the tobacco industry to develop more purified forms of nicotine delivery? (Russell, 1991)

Russell’s work was not popular within the public health smoking field because of his emphasis on the role of nicotine in harm reduction. But he developed a cadre of researchers that included Martin Jarvis, Ann McNeill, and Peter Hajek, who later became leaders in UK research and policy on nicotine and e-cigarettes. Russell’s work was important also because of its location in a research setting, the Addiction Research Unit, which brought together researchers on drugs and alcohol as well as on tobacco.

Substantial research on nicotine took place in the UK from the 1980s onwards under the aegis of the Independent Scientific Committee on Smoking and Health (ISCSH), a Department of Health committee reporting directly to ministers. This was funded by the Tobacco Products Research Trust (TPRT) funded at arm’s length by the tobacco industry to do research on product modification. A major symposium organised by the CIBA Foundation the MRC and the TPRT in 1986 concluded that the toxicity of cigarettes would be reduced more if tar levels were reduced more than those of nicotine. Dependence or addiction to nicotine was recognised as a double edged concept. Nicotine levels in cigarettes could be maintained in order to reduce harm-or they could be lowered in order to wean smokers off the habit. This work marked the arrival of addiction as an important science/policy concept in the tobacco field (Berridge, 2005). It was of some use to the “stop all smoking” public health camp but also to those who favoured harm reduction, who clustered in a different scientific network. The recognition of a group of smokers who could not give up, who were generally among the poorer sections of the population, helped support the interest in strategies to combat this problem.

In the UK, the concept of nicotine addiction, and the use of nicotine for smoking cessation, benefitted from increased policy attention to social inequalities in health. By the mid-1990s, GPs could prescribe both Nicorette nasal spray and Nicotinell chewing gum on the NHS. Direct advertising of the gum was allowed in 1998, and gum of two strengths and transdermal patches were sold to the general public. In the Labour Government’s White Paper, Smoking Kills, published in 1998, NRT was given a central role in reducing social inequalities. It played a similar role in a Royal College of Physicians report on Nicotine Addiction in 2000 and a government inquiry into health inequalities chaired by Sir Donald Acheson, the former Chief Medical Officer. There were also calls to establish a nicotine regulatory authority. These events, and the response to nicotine, shaped the subsequent development of policies on e-cigarettes.

Initially however, harm reduction was not to the fore. This was demonstrated by the case of Skoal Bandits in the 1980s. In 1985, Alison Hillhouse, director of ASH Scotland, heard that US Tobacco, with financial support from the British government, was to open a factory in Scotland to manufacture Skoal Bandits, a type of oral snuff. This prompted a campaign which ended five years later with the British government’s announcement that it would ban oral snuff. Snus, a smokeless tobacco pouch popular in Sweden, was also banned by the EU in 1992 although Sweden was given an exemption for its use when it joined the EU in 1994 (Raw et al., 1990). ASH, the main activist organisation in the UK, resolutely anti-industry under the leadership of Mike Daube, its second Director in the 1970s, was in trouble in the early 1990s. There were internal problems and personality difficulties after David Simpson, who had been a campaigning director, left in 1990. ASH adhered to its oppositional stance of the 1970s, but with more focus on information rather than campaigning. Hence, it was hostile to the model of addiction, which it thought could undermine the focus of the anti-tobacco movement on giving up or quitting. ASH also supported and advocated for the EU ban on snus. Anti-tobacco was now an international movement and there were moves at the international level which eventuated in 2003 in the Framework Convention on Tobacco Control (Reubi & Berridge, 2016). This had a harm reduction component but the elimination of tobacco was to the fore as the major goal (Reynolds, 2012).

The policy mood began to change quite significantly in the late 1990s. The election of the Labour government in 1997 and a heightened focus on inequalities was a crucial watershed. Even before the political change, researchers had begun to focus on nicotine and its role in combatting inequality. The Health Education Authority, which had been a bastion of abstentionist sentiment, organised an international conference and published a report on regulating nicotine delivery systems. In a paper given at the London School of Hygiene and Tropical Medicine (LSHTM) in 1996, the smoking researcher Martin Jarvis, a leading member of Russell’s group, linked inequality, NRT and availability on NHS prescription.

Deprived smokers are the most dependent smokers…What are the implications for treatment? There has been much thrust towards a health education message. Get the poor to take smoking seriously. That kind of idea is not supported by the data. We need to find interventions which target dependence more effectively. Make the prescription for nicotine reimbursable. (Jarvis, 1996)

By the mid-1990s, both Nicorette nasal spray and Nicotinell chewing gum were prescribable on the NHS, but GPs had to justify the circumstances under which the prescriptions were written. Direct advertising of the gum came in 1998; and gum, along with transdermal patches were on sale to the general public.

There was interest in the highest levels of public health. One researcher remembered the then Chief Medical Officer, Sir Kenneth Calman, encouraging moves on NRT and NHS prescription.

Ken Calman, ….he challenged us because we were saying we’re not quite sure what to do about nicotine replacement therapy and we were discussing it and then he said well why don’t you ask for it to be on prescription and we said because we’ll never get that and he said well aim high. And so we then as our working group came up with that recommendation. And although Smoking Kills didn’t make it an NRT on prescription, it allowed for one week supplies for people who were getting behavioural support. It led the way I think, it paved the way to NRT being on prescription. There wasn’t this kind of row then. I mean there were some people who didn’t think treatment is important, who felt that population approaches were the way to go. But if you’re in front of an addicted smoker, even if they haven’t got a smoking related disease, or if they’ve got a smoking related disease, you want to throw the kitchen sink at them to get them to stop. (McNeill, 2018)

In the Labour government’s White Paper Smoking Kills, published in 1998, NRT was given a central role in the battle against smoking and inequality, which were linked together. NRT was to be free for a limited period to those on low incomes and there was the possibility of NRT in pregnancy for the heaviest smokers. The Royal College of Physicians issued a report on nicotine addiction in 2000 (Royal College of Physicians, 2000). The public health field also began seriously to consider harm reduction as a strategy. Innovations such as the smokeless cigarette and nicotine delivery devices led to calls for a nicotine regulatory authority which would consider all these varied modes under one regulatory umbrella.

Part of the change of position was a sea change in the stance and positioning of ASH. The resolute opposition of that organisation to smoking and its adoption of an absolutist stance had been a central part of the anti-tobacco coalition established in the 1970s. But this position began to change in the 1990s. Clive Bates became its director in 1997 and took the Michael Russell view of nicotine and harm reduction, making a powerful intellectual case for harm reduction. He was supported by some on the ASH Board, in particular John Britton, who chaired the Royal College of Physician’s Tobacco Advisory Group. But public health members of the Board such David Simpson, its former Director, and Jean King, of Cancer Research UK, were not comfortable with this stance. Bates left ASH and moved to the Policy Unit at Downing Street. He was succeeded in 2003 by Deborah Arnott, who came from the Financial Services Authority, where she had been head of Consumer Education. Her major focus initially was on achieving smoke free legislation, which occupied her attention between 2003 and 2007. But she also continued policy support for harm reduction with highly effective alliance building. The main activist organisation in the UK had therefore completely changed stance on harm reduction and nicotine prior to the advent of e-cigarettes. Its powerful advocacy skills and skilful networking was exercised on behalf of the idea of harm reduction.

2 Harm Reduction Expands for NRT 2000–2010 and for E-Cigarettes

In the first decade of the twenty-first century, there was an expansion of indications for NRT under the aegis of the Medicines and Healthcare Regulatory Authority (MHRA) the licensing body for UK medicines. In February 2010, the MHRA published a report, Nicotine Replacement therapy and harm reduction, which was the product of an expert working group established in 2005. It stated clearly at the outset

There is a new element to the indication of nicotine replacement therapy (NRT) of ‘harm reduction’ since it has become widely accepted that there are no circumstances in which it is safer to smoke than to use NRT. (MHRA, 2010)

The process by which the MHRA had moved to this position had been a gradual one. There had been moves to involve the agency before but without success. Deborah Arnott contacted Kent Woods, its new chief executive.

…from a strategic point of view he got it and …as a result of that an expert committee was set up to look at how NRT was licensed and the MHRA changed its position significantly…..the particular thing we were pushing for was if people aren’t using NRT they will go back to smoking….So you need to licence it in that context, not as you would a novel and potentially highly risky drug. (Arnott, 2018).

The expert working group was set up in 2005 to review the usage of NRT. Its membership included Ann McNeill, a member of Russell’s group and an experienced public health researcher. It recommended that restrictions on NRT use should be minimised for pregnant and breast feeding women; patients with heart disease; those with kidney and liver problems and with diabetes, and children aged 12–18 years. Then the indication for NRT was extended, such as by “cut down to quit,” and “temporary abstinence” introduced in 2005 and 2006. This was supported by data from clinical trials showing NRT as an effective intervention in achieving sustained smoking abstinence for smokers who had no intention to stop completely or who were unable to quit abruptly. With advice from the Commission on Human Medicines (CHM) in October 2009, MHRA approved an extension to the indication to include a harm reduction element for a particular product—the Nicorette Inhalator—either as a complete or partial substitute for smoking. This harm reduction approach was a significant plank in the wider strategy on tobacco launched by the Department of Health at the same time.

The MHRA recognised that the extension of the indication for NRT to include harm reduction marked a major shift in medicines regulation. It concluded.

NRT has to date not been licensed for harm reduction and the decision to do so raises the question of the regulation of other unlicensed nicotine containing products on the market such as electronic cigarettes, which have not been assessed for safety, quality and efficacy. (MHRA, 2010)

At the same time, as medicines regulation was moving to accommodate harm reduction for NRT, influential professional bodies were also moving in the same direction. In 2007, the Tobacco Advisory Group of the Royal College of Physicians (RCP) published its report, Harm reduction in nicotine addiction; helping people who can’t quit (Royal College of Physicians, 2007). It explicitly tied this new direction to the RCP’s pioneering work in the 1960s. The measures of the 1960s, however, did not address the problem of smokers who could not quit. The new report

demonstrates that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.

Harm reduction is a fundamental component of many aspects of medicine and indeed everyday life, yet for some reason effective harm reduction principles have not been applied to tobacco smoking.

The emergence of a coalition around the principle of harm reduction for nicotine was underlined by the composition of a UK delegation which went to Washington, DC in January 2010. There was US interest in e-cigarettes and the principle of harm reduction. The delegation contained representatives of the voluntary sector, academics and different branches of the government and regulatory institutions presenting a united front. It was hosted by Mitch Zeller of the FDA Tobacco Centre. Its members were Deborah Arnott, director of ASH, Martin Jarvis, long-term researcher with Michael Russell, June Raine, director of vigilance risk management of medicines for the MHRA and Oliver Smith, Deputy director of Tobacco, Health and Wellbeing Policy at the Department of Health. The delegation visited the FDA Centre for Tobacco Products; NIH; the Legacy Foundation; and the Department of Health and Human Services. June Raine presented the MHRA view.

Tight regulation of medicinal nicotine imposes strict restriction on new product development. This clear and unjustifiable regulatory imbalance works against public health. The regulation of nicotine products needs to be radically overhauled….UK regulatory controls on NRT products have evolved stepwise over the last decades, increasing choice and widening access….The radical new approach now being developed in the UK uses regulation to encourage use of less harmful products and reduce use of more harmful sources of nicotine. (Raine, 2010)

Although this demonstrated the strength of the UK policy coalition, there was little change in US policy as a result.

Deborah Arnott was busy engaging with relevant interests and organisations in the field. Together with John Britton, she went to see Sir Michael Rawlins, head of NICE (National Institute of Clinical and Healthcare Excellence) the non-departmental public body which reviews evidence and produces guidelines. Rawlins was a smoker, known during his period at NICE for going out of the room to have a quick smoke. He understood the issue. NICE then organised one of their citizens’ events discussing NRT and tobacco harm reduction and that led into guidance on tobacco harm reduction, published in 2013. Arnott also produced a paper for the Treasury in 2006 reviving the old issue of price differentials and VAT. These were revised so that NRT over the counter attracted only 5% VAT rather than 20%. In 2010, the organisation produced a report called Beyond Smoking Kills which marked the tenth anniversary of the Labour government’s smoking White Paper. It reviewed the field after the achievement of smoke free legislation and asked, what next? It examined alternatives to smoking and what the regulatory framework should be, whether it should be medicines regulation, light touch regulation by the Department of Health, food regulation, or retaining the existing situation which was no regulation. It came down on the side of medicines regulation (ASH, 2010).

By this time, the first e-cigarettes were starting to come on to the market in the UK. Deborah Arnott remembered.

I went to a lunch in a casino in central London and they were being imported by enthusiasts and people with an eye to the main chance, from China, they knew they couldn’t promote them as a way to help people quit, they had this sort of third rate nonentity celebrity, who kept saying this is great it’s helped me stop smoking. And they had to keep saying, no, you mustn’t say that, it’s an alternative to smoking otherwise it gets caught by the legislation. (Arnott, 2018)

ASH was also talking to the Department of Health about increasing the number of routes to quit and so it was in the official strategy document which consulted on the way forward for tobacco control. Jeremy Mead who worked for the MHRA and then became the tobacco lead in the Department of Health was important in embedding this approach. David Graham who worked for Johnson and Johnson was important in persuading them to put in an application for a long-term licence for NRT, which was agreed in 2010. This discussion was what brought e-cigarettes into the regulatory field. Previously, they had been seen as a “borderline product,” not of interest to the MHRA. But if long-term licensing was on the cards, then e-cigarettes would be caught up in the process. So MHRA consulted on whether e-cigarettes should be regulated or just taken off the market. They were seen than as “a bit of an oddity” costing £80 a device. They were big and clunky. ASH had asked about e-cigarette use in its regular annual YouGov survey about attitudes relating to smoking and nicotine in 2010. Usage was tiny, so the cigarettes were not mentioned in the 2011 survey. But after that matters started to change. MHRA consulted about the position on e-cigarettes and their potential regulation. Both ASH and the RCP stated that they should not be taken off the market but should be regulated. But there were also a large number of responses from e-cigarette users who were worried that they would no longer be able to use products which they had found useful. They were alarmed at the prospect of medicines regulation which would make these products less accessible.

Political support also came into the equation. The psychologist David Halpern who was leading the Behavioural Insights Team in Downing Street (the “Nudge unit”) under the coalition government, took up the issue. He was surprised to find people who might have been anti-tobacco—John Britton and ASH—in support of e-cigarettes. The unit’s new year document on health behaviour in 2011 was to include a section on the case for e-cigarettes but at the last minute this had to be taken out on the insistence of the Department of Health. Then a battle opened within government with most of the mainstream public health community, including the Chief Medical Officer, coming out against e-cigarettes. The Unit took the issue to the Prime Minister, David Cameron, who had been a smoker and had even tried an e-cigarette. Cameron supported their line and they decided to stick to the objective of light touch regulation to ensure the product was free of toxins but had enough nicotine to satisfy smokers’ cravings, and to legislate to ensure they were not sold to under 18s (Halpern, 2019).

So the first decade of the twenty-first century in England, even prior to the arrival of e-cigarettes on the scene, had seen significant advances in the role of nicotine and NRT as a harm reduction strategy in the tobacco control field. Key influences here were the changing attitudes of the leading activist organisation and the skills of its leadership; the growth of an coalition involving researchers, ASH, and government regulatory agencies such as MHRA and (to a lesser extent) NICE. E-Cigarettes fitted into this framework and political support helped. In June 2013, on advice from the MHRA the government proposed to regulate all non-tobacco nicotine products, including e-cigarettes, as medicines.

3 The Role of Europe

However, there was another aspect to regulation. This was Europe and the EU. Membership of the EU required the UK to comply with regulations mandated under the EU Tobacco Products Directives (TPD). These regulations also fitted with the preference of the Conservative government under David Cameron (on the advice of the Behavioural Insights team, the “nudge unit”) for the use of “light touch” regulation to encourage smokers to use e-cigarettes as cessation aids and long-term smoking substitutes (Halpern, 2015). It was during this process that a significant change to regulation occurred.

The European Commission had also intended to use medicinal licensing as the entry point, but this approach was voted down by the European Parliament on 8 October 2013. The Parliament decided that e-cigarettes would be regulated like tobacco. The policy change in the Parliament was brought about by an alliance of vaper activists, who made good use of social media, and obtained the support of MEPs, in particular, those from Italy and Germany. In 2014, passage of the European TPD (2014/40/EU) placed limits on the sale and merchandising of tobacco and tobacco-related products in the EU. In 2016, a revised TPD updated regulations on tobacco products and set new regulations. These required medicinal licensing if therapeutic claims were made for these products or if they contained more than 20 mg/ml of nicotine. They also placed limits on the sale and merchandising of tobacco and tobacco-related products in the EU. The European Parliament approved these regulations in February 2014. They prohibited the use of health or cessation claims when advertising these products and set limits on the maximum concentration of nicotine in products (20 mg) and the maximum volumes of liquid which could be sold. They also required child proof packaging of e liquids, specified purity of ingredients, devices that delivered constant doses of vapour and disclosure of ingredients and nicotine content. Regulators were empowered to act if these regulations were not met (European Union, 2014). The Tobacco Products Directive prohibited all forms of advertising capable of crossing borders. The English committee on advertising practice produced guidelines which balanced the protection of minors and the promotion of new low risk products to consumers. From 2015, restrictions on the age of sale (18 years) and advertising were introduced.

Clive Bates, observing what happened, commented.

…E cigarettes were taking off, not just in the UK, I mean France and other parts of Europe as well and e cigarette users were enormously alarmed, understandably, about the idea that they’d become a medicine and that would mean they wouldn’t be able to get hold of products they liked. There was a massive campaign…Linda McAvan (Labour MEP for Yorkshire and Humber)…was the lead on getting the TPD agreed and sorted, which is what led to a compromise position where e cigarettes could still be regulated as licensed medicines, if you put in an application, but if they’re not, then they are caught as consumer products and under the TPD there’s only limited advertising and limits on the size of tanks, and the size of refills, and they need to be child safe etc….It was all done very last minute so it was not the most carefully thought through legislation and it has some problems….it was a compromise, because member states really didn’t like e-cigarettes and that’s where the ad ban comes from….and then there was this enormous pressure from e cigarette users and other member states who wanted to make sure they stayed on the market. (Bates, 2018)

The role of vaper activists was an important new dynamic and this fed back into the research community focussed on harm reduction. An e-cigarette summit organised by a vaper, Amanda Strange, began to meet in 2013 and this brought together academics and vapers. Bates commented on the impact this and the TPD change of stance had.

They have got a much stronger connection to the people, who are the object of study and object of public health activity and they I think between them executed a very, this sort of graceful change of position back to, backed up by data, backed up by the statements that were coming out of the smoking toolkit, that the accumulation of studies, toxicology exposure studies and so on and also driven by their personal experience of meeting people. So the empathy and humility side of this played a really important role in my view, I don’t think it was they all sat down in a room and had a meeting and decided that they got the policy wrong. (Bates, 2018)

The harm reduction alliance/network recognised that medicinal licensing was not going to be an immediate way forward. A tobacco company had put in a product but this did not make it through to licensing before it became obsolete. Consumer regulation was the way forward for the foreseeable future. E-Cigarette harm reduction moved back into the British political and regulatory apparatus, where a new organisation became important.

4 Public Health England and the Evidence

The new organisation was Public Health England (PHE), set up in 2013. The origins of PHE were in the Lansley, Conservative Health minister, reforms of the health service, which had involved the devolution of public health out of the National Health Service and into local government. The national agency set up at this time brought together a number of quangos, (semi-public bodies funded by government) primarily the National Treatment Agency, which had dealt with drugs and alcohol and the Health Protection Agency, which had the brief of dealing with infectious disease, terrorist threats, chemical spills and so on. It had played a leading role during the swine flu outbreak of 2009–2010. The new agency brought together drugs, alcohol and tobacco; a single tobacco post was transferred from the Department of Health as there was no tobacco agency to amalgamate. A temporary post was advertised for tobacco control and Martin Dockrell, who had been policy officer at ASH, moved over into the new job.

Dockrell had a background in drugs harm reduction and also in sexual health/HIV/AIDS harm reduction and this had informed his work at ASH.

He commented.

I arrived, harm reduction was the coming thing in tobacco control and the fact that I had history not once, but twice, first in injecting drug use and then in sexual health with harm reduction, I think we discussed this in my interview and I said that one of the things I wanted to achieve in my time at ASH is to avoid the kind of fratricidal bloodletting that we saw in the other, you know deeply personalised arguments between colleagues that we saw in harm reduction for drug use and then even worse in harm reduction in sexual health. I thought we could do better this time, we know how bad it could be, so let’s plan to make it a lot less bad and that guided our thinking at ASH in the way we ran a whole string of consensus, I was going to say events, but more processes. (Dockrell, 2019)

He had been involved in the same sequence of events between 2000 and 2010 which had smoothed the path for nicotine and then for the regulation of e-cigarettes.

…when the Royal College of Physicians produced their harm reduction, I think it was 2007 report on tobacco harm reduction, again we organised some consensus building work around that. So I think that’s why, that’s partly, so we had this whole series of reports and meetings, most of them private, where we would try to avoid that kind of public acrimony. And certainly we did avoid that public acrimony among everybody who took part in those processes and it was only really people who weren’t part of those processes, who’ve, in the UK anyway, who’ve been, where the relationship has been a source of acrimony. So I think we probably avoided the worst of it, or at least when you look at the way the debate is conducted in the US and Australia, it’s much worse. (Dockrell, 2019)

His objective at PHE was to align the new agency’s position with what was described as the “English consensus” on harm reduction and nicotine.

I arranged high level meetings between PHE leaders and some of the kind of top leaders in tobacco control and that was how we got that position. I’ve got to say I was pushing at an open door. Before I arrived, everything was being commissioned by PHE, on e-cigarettes, one of them from John Britton and one from the team at Stirling, which had been led by Gerard Hastings, much less, much more cautious about e-cigarettes. But about that time Gerard retired and Linda Bauld took over and Linda is much more in that kind of, in the harm reduction tradition. So it turned out that both evidence reviews that were commissioned were pretty positive and not commissioned by me and then PHE was right from the top very supportive in driving the direction. (Dockrell, 2019)

Public Health England produced a series of reports and evidence updates beginning in 2014/2015 and continuing a regular basis after that. In the UK Tobacco Control Plan of 2017 it was charged with providing these evidence updates up to 2022. The evidence updates were produced by a team led by Ann McNeill and were clearly distinct from the US approach. US researchers noted a difference in emphasis in the UK. In the UK the focus was on current smokers and how to help them. In the US the evidence focus was on the “innocent victim,” children and bystanders. PHE was also crucially the catalyst for a coalition of supportive organisations in the UK. In 2015 its statement “E-cigarettes: an emerging public health consensus” was supported by a wide range of public health bodies: ASH; the Association of Directors of Public Health; British Lung Foundation; Cancer Research UK; Faculty of Public Health; Royal College of Physicians; Royal Society for Public Health; the UK Centre for Tobacco and Alcohol Studies; and the UK Health Forum (Public Health England, 2015). Early on it stated that vaping was 95% less harmful than smoking, and this statistic was often used against it in the following years. The figure came from a paper by a group of experts led by Dr. David Nutt, who had been chair of the government’s drug advisory body, the Advisory Council on the Misuse of Drugs (ACMD), but who had been forced to resign when he controversially compared the risks of horse riding (Equacy) with the risks of taking Ecstasy-the latter came out better. Nutt was forthright in his opposition to attacks by Professor Stan Glantz of the University of California San Francisco, an anti-tobacco veteran. Nutt was quoted by the Guardian health journalist Sarah Boseley,

Does he actually think that tobacco is not much more harmful than vaping or the likelihood of lung cancer? The paper ‘comes up with an answer he doesn’t want. That’s why he thinks its bad science’. (Boseley, 2020)

Ann McNeill, who led on the PHE evidence reviews, felt that they had been unfairly attacked for the 95% figure. A 5% risk of harm was not unsubstantial and the statement had been twisted as if PHE had said vaping was completely safe (Boseley, 2020).

The British Medical Association, which had earlier been unwilling to associate itself with harm reduction, came out in support in 2017 (BMA, 2017).

Further evidence review came in the same year, when the House of Commons Science and Technology committee examined the evidence again, including the evidence on these devices for smoking cessation, the suitability of regulations guiding their use and the financial implications of a growing market on business and the NHS. Its report supported e-cigarettes and other devices as a form of tobacco harm reduction. The committee concluded that

‘Some aspects of the regulatory system for e-cigarettes appear to be holding back their use as a stop smoking measure’ and recommended that regulations be liberalised (Science and Technology Committee, 2017).

5 Public Health Opposition

The publication of the PHE reports and official sanction for e-cigarettes brought some public health researchers into overt opposition. Martin McKee, Professor of European Public Health at LSHTM and Simon Capewell, Professor of Clinical Epidemiology at Liverpool University, were prominent among them. They attacked the 95% figure and the implication that e-cigarettes were safe in a series of articles, editorials and letters in the Lancet and the British Medical Journal (McKee & Capewell, 2015a, 2015b). They were joined by the President of the Faculty of Public Health, John Ashton (2014). A heated debate broke out online with vaper activists weighing in against these leading public health figures. In September 2014, John Ashton apologised for language he had used on line in the debate with vapers and took several months leave of absence from his office while the incident was investigated. The public health researchers highlighted the potential adverse effects of the chemicals in e-liquids and the risk that they might serve as a gateway to cigarette smoking in young people. They favoured limitation of access to e-cigarettes as approved medical devices.

These opponents framed their attack within the long standing public health position on tobacco, formed in the 1970s and discussed above. The aim was elimination and deep opposition to the tobacco industry. Anything which threatened that position was of great concern. A seminar held on the new approach elicited the following response, remembered by Arnott

the sort of attitude you get from traditional tobacco control people was summed up by someone…who had been in the area for a long time and said, when I hear John Britton speak it all makes sense, but it just doesn’t feel right. And that’s the issue you have is that it’s not about evidence, it’s about emotion. (Arnott, 2018)

This wariness about e-cigarettes was something which permeated the mainstream public health community. The Chief Medical Officer had come into conflict with the “nudge” unit about the issue; and in 2019 Dame Sally Davies, then CMO, expressed her continuing concerns to the Science and Technology Committee.

E-Cigarettes are clearly much safer than tobacco smoking, and they have become a much-liked way of stopping smoking. If they help people to stop, they are so much safer so I would like them to use them. I would encourage the NHS smoking cessation services to work with that.’ Nevertheless, she continued, “I have concerns because we do not know their long-term side-effects. Therefore, not only do I reserve my position on this, but I would like us to be careful. It took us 50 years, as I said earlier, to discover the harm of tobacco. Being much safer does not mean it is safe. I just don’t want us to set an example to children of them being smoked or used publicly…….. I don’t want that pollution and I don’t want it put over as a cool lifestyle, because it’s an addictive product. Why introduce and have openly available a new addictive product? (Science and Technology Committee, 2019)

This public health approach was in sharp contrast to the network supporting harm reduction. The Royal College of Physicians 2016 Report Nicotine without smoke: tobacco harm reduction gave its take on policy.

A risk averse, precautionary approach to e- cigarette regulation can be proposed as a means of minimising the risk of avoidable harm e.g. exposure to toxins in e-cigarette vapour, renormalisation, gateway progression to smoking, or other real or potential risks.

However, if this approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking. Getting this balance right is difficult (Royal College of Physicians, 2016).

So whereas in the 1970s anti-tobacco activism had been the main thread within the public health field, by the time e-cigarettes came on the scene, the role of nicotine in harm reduction had assumed greater importance. Whereas the researchers of the 1970s had been located in the addictions arena, far from the public health mainstream, by the turn of the century, their role and significance within public health and also within policy, had become more significant and central. Public health researchers had engaged little with nicotine products whereas addiction scientists had.

6 Getting the Balance

By 2018–2019, it seemed as though this balance had been reached. Data from the Office of National Statistics survey (ONS) showed that UK adult smoking prevalence had fallen from 20% in 2011 to 14.7% in 2018. There were 7.2 million smokers in that year. Meanwhile vaping prevalence reached 6.3% in 2018, a rise from 3.7% in 2014 and from very low levels in 2011. There were 3.2 million vapers in the UK in 2018.

Clive Bates commented,

Vaping has become a large scale phenomenon relative to smoking and appears to be having significant downward pressure on smoking rates. In England, we are witnessing tobacco harm reduction in action and starting to benefit from a public health win. (Bates, 2017)

However, events soon occurred which helped to undermine this optimistic assessment.

6.1 The EVALI Epidemic

In September 2019, an outbreak of serious lung disease in the US made headlines round the world. By October of that year, 1604 cases had been reported to the Centres for Disease Control (CDC) in the US, including 34 deaths. The group of people involved was very specific. This was an outbreak largely among young men: 70% of patients were male with an average age of 24. Almost half were under 21. Several US states banned the use of flavourings in e-cigarettes and called for urgent action. By December 2019, it had become increasingly clear that e-cigarettes based on THC and vitamin E acetate were the likely cause of the US outbreak of lung injuries. Vitamin E was used as a thickening agent for cannabis vaping and was toxic to the lung. Remarkably, however, that new information did not reduce confusion about the source of the injuries in a US context in which the youth vaping rate was increasing. The evidence that the acute lung injuries were related to contaminated THC products was lost in media reporting that lumped together very different types of products under the heading of e-cigarettes (vaping nicotine with flavours, vaping nicotine without flavours, and vaping THC and CBD cartridges), all of which were sold in some legal retail outlets and on the black market.

In the UK, the traditional public health attack on e-cigarettes intensified. A Lancet editorial “E cigarettes; time to realign our approach?” in October urged the linking of e-cigarettes and cigarettes in terms of harm.

As concerns mount about the safety of e-cigarettes, several countries and national bodies have tightened regulations. India plans to ban e-cigarettes. Several US states have moved to ban flavoured e-cigarettes. The European Respiratory Society has aligned its recommendations on e-cigarettes with those on cigarettes, both encapsulated in one word: don’t. They also announced that the same membership restrictions will apply for those with conflicts of interest related to e-cigarettes as for cigarettes. Public Health England, however continues to endorse e-cigarettes as safer than cigarettes. (Lancet, 2019)

This statement caused fury in the pro e-cigarette community and concern in PHE. It pointed out in a statement issued in October that the US epidemic was not linked to long-term use of regulated nicotine vaping products. If it was there would be a different demographic profile, more typical of long-term vapers. E-cigarettes in the UK were, crucially, more tightly regulated in the UK by the MHRA than they were in the US. The main chemicals under suspicion, THC and Vitamin E acetate, were not permitted in UK e-cigarettes. Across European countries covered by the European Tobacco Products Directive, the regulatory system was similar and no US style vaping cases had been reported to the EMCDDA (the European Monitoring Centre) by its early warning system network. Commentators in the UK pointed that the MHRA’s Yellow Card system by which health professionals and members of the public could report suspected adverse reactions to medicines, had received 73 individual adverse reaction reports between May 2016 and October 2019, with only 3 reports of lung infections, none of them fatal (PHE, 2019). As Professor Alan Boobis, chair of the government committee on Toxicity in Food, Consumer Products and the Environment, pointed out in December 2019, “the U.S experience was due to their regulatory and behavioural climate” (Boobis, 2019). It was also, as Tom Sheldon from the Science Media Centre pointed out in December 2020, the result of “lazy reporting” (Sheldon, 2020). Some UK newspapers continued to publish stories implying that nicotine based e-cigarettes were at fault. The Daily Mail for example reported, “Shocking scans show how vaping e-cigarettes left a 19 year old’s lungs filled with solidified oil that looked like hardened bacon grease and left him unable to breathe on his own” (Daily Mail, 2019). However, the damage was done in terms of public confidence in the UK if not in terms of policy. At the end of 2020, the ASH survey of smoking and e-cigarettes found there were 3.2 million vapers, a figure which had reduced by 12 and a half % since 2019. The survey found that perceptions of the harm of e-cigarettes were getting worse. One in three people surveyed thought e-cigarettes were more or as harmful as cigarettes (ASH, 2020). Vaping was plateauing in the UK but there was no youth epidemic. However, the loss of consumer confidence did bring a potential change in focus. Children became more important as a group in society to be protected.

The epidemic that never was in the UK presaged a more hostile external environment on the part of international agencies and also the revival of some long standing forms of regulation in the UK.

6.2 Changing Places 2019–2022

Review of the evidence on e-cigarettes in England continued to provide judicious but overall favourable conclusions, by comparison with the harms of cigarette smoking. In July 2020, a statement from the Committee on Toxicity in Food, Consumer Products and the Environment chaired by Professor Alan Boobis, summarised the conclusions of a review which had begun in February 2016. The committee concluded that e-cigarettes were not without risk but that the risk posed to users was substantially less than that posed by cigarettes. The committee could not quantify by how much. It pointed out that there were many data gaps, including long-term effects in users. Flavourings, which had been demonised in the US outbreak, were in fact widely used in food as well and had been for many years. The main difference from heating was the possibility of local effects in the lung (COT, 2020).

The external environment became more hostile. The attitude of the World Health Organisation (WHO) was an important factor. In October 2019, the WHO Study Group on Tobacco Product Regulation (TobReg) published its seventh report, on the scientific basis of tobacco product regulation. This concluded that states should consider a nicotine reduction policy coordinated with policies that allowed access to nicotine replacement therapies and other products, and as approved by relevant authorities and with appropriate safeguards. The report was intended to inform the work of the tobacco programme in the WHO Department for Prevention of Non-communicable Diseases, and also for the development of guidelines for the implementation of articles 9 and 10 of the WHO Framework Convention (FCTC), which deal with the testing and measuring of the contents of tobacco products and with the disclosure of the results to government and to the public. This report was not entirely hostile to harm reduction. But the attitude of the agency shifted to outright hostility. In a report published in July 2021, the head of WHO branded e-cigarettes as harmful and warned that their use should be better regulated to protect children and teenagers. Such products, the report said, were often marketed to young people using an array of different flavours which could “hook children on nicotine.” The report was greeted with incredulity by UK researchers, some of whom pointed to funding of some of the organisation’s work by the powerful Bloomberg Foundation, which had taken a leading anti-tobacco role in the US. But there was also concern that the WHO had failed to understand the difference between tobacco addiction, which killed millions each year and that to nicotine, which did not (Osborne, 2021). However, the profile of the concept of addiction overall was raised.

Britain’s departure from the EU at the end of 2019 also saw a situation in flux. The EU was in the process of reviewing its Tobacco Products Directive, a complex process which might produce an interim result by the end of 2022. Work within the Commission was informed by the SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) report published in 2020. The position of the Commission seemed to be anti-harm reduction. But the attitude of the Council and Parliament could be different. Commentators pointed out how the interventions of users, anti-vaping activists, had made a crucial difference in 2013–2014.

Brexit saw the TPD requirements initially enshrined in UK law and there was a review of the regulations. The use of e-cigarettes by young people grew during the COVID-19 lock down period. Young people were using disposable e-cigarettes often as an alternative to smoking tobacco. The debates shifted to how regulations could be tightened on youth use. The age of sale limit was 18 years, but with no restrictions on where sales were made. Deborah Arnott argued that better compliance was needed on sales-underage sales in specialist stores and also on promotion through online ads which were seen by young people, although illegal (Arnott, 2020). She argued that plain packaging was needed, which differentiated nicotine products from combustible cigarettes. There was also a regulatory gap for new products such as nicotine pouches. Regulation was needed to cover all products, not just e-cigarettes.

Medicines licensing also came back onto the agenda in the wake of Brexit. The MHRA had set up a working party on this some years previously. BAT had put in a product for licensing some years before but the process had taken six years, by which time the product was obsolete and never came to market. In October 2021, the MHRA produced a report which made headline news. It supported the medicinal licensing of e-cigarette products (MHRA, 2021). This development was reported as if it represented a major change. But as one expert pointed out, “This is very problematic still-there has to be consistency of giving a dose. But the dose is selected by the user and not supplied by the product. You could license JUUL but it’s not straightforward…NICE could issue recommendations and it could be prescribed on the NHS.” There was much to debate. No product had been submitted for such approval, although the MHRA was providing information for companies who were considering this step (MHRA, 2022). E-cigarettes had been successful as consumer products would being prescribable affect this image? Deborah Arnott pointed out in 2021 that e-cigarettes were suffering from a major image problem with potential new users, who often thought they were as, if not more, harmful than cigarettes. Licensing for cessation would add value. The products would be available in both locations—the consumer market and through the GP, although the licensed medicine and the consumer product would need to be differentiated. Advertising would expand to include TV and print, whereas under the EU TPD it had been limited to ads at the point of sale. She pointed to the big growth of the nicotine market which had taken place at the turn of the century when both types of nicotine products became available, over the counter, and prescription based (Arnott, 2021). E-cigarettes were already available in hospitals. Mary Yates, a nurse consultant at the South London and Maudsley Foundation Trust, greeted the news positively.

I’m a big fan of e-cigarettes and I’ve been supporting people to use e-cigarettes since 2012 here in South London and Maudsley. Since March 2020, we’ve been giving free starter packs to all our adult smokers and refills for the duration of their hospital stay. I would love to be able to extend that even further to all the smokers in community mental health services. So that’s my next plan, and if the rules around e-cigarettes change, then we will definitely be able to do that. (Yates, 2022)

The arrival of COVID-19 also brought further complexity. There was some debate about smoking, e-cigarettes and the impact on the severity of COVID-19 infection. Smokers, so it seemed suffered less from COVID-19 infection but were at greater risk of in hospital disease severity. The evidence on e-cigarettes was more indecisive-nicotine could have a role in damping down the hyper-immune response stimulated by the disease. This line of research was unresolved. More important was the policy impact of the pandemic on PHE. The agency’s role in combatting the epidemic was criticised and, as in previous health crises, the government sought to deflect criticism by organisational change. A widespread review of the public health system and its response saw PHE divided into two new agencies. The Health Security Agency was to focus on infectious disease while a new Office for Health Improvement and Disparities, which included tobacco control, was subsumed into the Department of Health and Social Care under the leadership of the Chief Medical Officer, Chris Whitty. COVID-19 had also brought the issue of disparities in health to the fore, with the clear evidence of how the disease had impacted more severely among poor people and racial minorities.

The e-cigarette issue was being presented in the context of overall tobacco control as part of “making smoking obsolete” (O’Connor, 2021). It was firmly tied into the issue of health inequalities. In February 2022, the Health Minister at that time, the Conservative Sajid Javid, called for a “vaping revolution.” In June 2022, a report commissioned by the government into smoking and carried out by Dr. Javed Khan, Making Smoking Obsolete, called for the promotion of e-cigarettes as a substitute for smoking with accurate information to health professionals (Khan Report, 2022). A final evidence review on e-cigarettes was published in the autumn of 2022. This looked at the relative risk of vaping versus smoking and also at perceptions of risk. Vaping, it concluded, provided only a small fraction of the risks of smoking. But it was not risk free, in particular for people who had never smoked. The way ahead was, according to Ann McNeill, one of the authors of the review, to achieve a balance between these two groups—expanding use to users through subsidised programmes and licensed e-cigarettes available through the NHS, but at the same time ensuring use did not expand among non-smokers in particular young people. Enforcement of the age of sale laws was a key strategy there (McNeill, 2022). A dizzy period of political change within the Conservative government saw four Health secretaries in post in 2021–2022, with briefings during the brief tenure of Therese Coffey in the post, that anti-smoking plans would be dropped. However, at the time of writing, policy had resumed a relatively even keel.

7 Conclusion: What Lay Behind the British Approach?

An editorial in Nature in 2019 predicted that “policies on e-cigarettes will be built on evidence and collaboration” (Nature, 2019). But the contemporary history of e-cigarette policy in the UK confirms that a reliance on the power of evidence is too narrow a focus. Far more important have been a number of wider contextual and specifically national factors in recent history through which the debate on evidence has been filtered. This final section will briefly survey them.

7.1 The pre-History of Nicotine and Stop Smoking Services

The pre-history of “safer smoking” from the 1950s to the 1970s has been cited by some commentators as a reason for doubting the value of e-cigarettes (Elias & Ling, 2018). In the US, this history has been weaponised by anti-tobacco forces as a means of discrediting the current British approach. The failure to establish safer cigarettes, doubt about their value and the role of the tobacco industry certainly formed the attitude of a generation of public health researchers and activists. But there was also a significant, and different, pre-history outlined above. This was the pre-history of the use of nicotine in cessation treatment and in a well-established network of stop smoking services. Specialised NHS smoking cessation services were established early on in the 1970s and 1980s and developed expertise in helping heavy smokers to quit. In 1999, comprehensive services were set up with major financial commitment as part of the Labour government’s tobacco control strategy. Those who worked in the services have in some cases played a major role in the e-cigarette debate and this has influenced the focus on helping the existing smoker either to quit or to adopt a less harmful habit. As discussed above, this focus on nicotine had developed well before the advent of e-cigarettes to encompass a harm reduction agenda, into which e-cigarettes fitted, albeit initially as a consumer product rather than a medical one. The concern in the UK has historically been for the smoker as the result of this extensive network.

7.2 The Role of Regulatory Agencies and Health Institutions

In this agenda, the role of regulatory agencies and institutions was of key importance. The MHRA had an existing role in nicotine regulation. PHE was a new agency at arm’s length from government, but crucially also brought together for the first time tobacco control with drugs and alcohol which had been within the National Treatment Agency. Its head, Kevin Fenton, was fully conversant with the substances across the board, in contrast to the public heath tobacco control field which tended to focus on that one issue. Tobacco, drugs and alcohol had not been natural bedmates previously. PHE’s distance from the traditional focus of public health tobacco was important. And Britain’s membership of the EU also led to significant change in regulation. By contrast with the US situation where there was either consumer availability or prohibition, and with few controls on advertising, Britain had a complex but effective system of regulatory agencies which had slowly but surely embraced the harm reduction utility of nicotine products prior to e-cigarettes arrival on the scene.

7.3 Networks

Networks of researchers have been of crucial importance. An influential tobacco policy network was established in London at the Institute of Psychiatry in the 1970s, which adopted a more positive view of tobacco harm reduction using nicotine. Led by Michael Russell, the psychologists he trained have been influential actors in UK policy—Ann McNeill, Robert West, Martin Jarvis and Peter Hajek. Their views later received support from the RCP and from a leading tobacco control expert, John Britton, a respiratory physician who influenced the policy advice given to David Cameron by the “nudge unit.” The RCP Tobacco Advisory Group publications were important and were reminiscent of the leading role of that body in the initial fight against smoking from the 1960s.

7.4 Activism and Networks

These networks have also been accompanied and supported by a crucial coalition of public health and medical organisations underpinned by the work of ASH led by Deborah Arnott. ASH’s change of position on nicotine, dating back to the 1990s, was a precursor to Arnott’s effective coalition building and deft sensitivity to the avenues forward on policy. One commentator spoke of Deborah “spinning 18 plates in the air.”

It helped too that Martin Dockrell in PHE had been policy officer at ASH prior to his transfer to PHE. The tobacco field was a relatively small one.

Activism was also important at the European level where vaper activists played an important role in developing the UK’s policy in Europe. Pro smoking groups in the past in the UK (such as FOREST) had been primarily tobacco industry funded but the vaping activists who formed the New Nicotine Alliance avoided affiliating with or receiving any funding from the tobacco industry. Their role was also to bring “users” into a relationship with researchers and policy makers much as had happened in the drugs field from the 1980s (Mold & Berridge, 2010). The role of industry in this field was different to that of smoking. Thirlway has shown how the size of the independent vape industry has been underestimated; the Totally Wicked company had a turnover of £50 million a year. The traditional tobacco industry had bought other companies and was developing its own products but with no consistent strategy. Their products dominated in the convenience sector but had limited sale in the independent sector (Thirlway, 2020).

7.5 Time Passes; Drugs Harm Reduction and Other Influences

This concluding section has emphasised the importance of the pre-history of issues and events and this was also effective in a number of other ways. Harm reduction in the drugs field and the cross-over of personnel influenced the tobacco and e-cigarette debate in the UK more than in other countries. The concept was “in the air” by the 1990s and the cross-over of personnel such as Dockrell to PHE and the amalgamations which formed that agency brought the concept into tobacco from another direction-from drugs and HIV/AIDS—in addition to the Russell nicotine connection.

Time was passing too for the 1970s public health position on tobacco. A generation of tobacco researcher/activists was passing. One researcher commented how the position of leading agencies changed as their leaders retired. Cancer Research UK had new leadership, as did the Tobacco Control Centre at Stirling where Linda Bauld took over from Gerald Hastings. Public health researchers were no longer so focussed on tobacco or their concern was about overseas use and the role of the industry rather than in the UK.

The UK had been presented as an “outlier” in e-cigarette policy and regulation. But those in that field discerned signs of movement in other countries which had been hostile. In the summer of 2021, fifteen past presidents of the Society for Research on Nicotine and Tobacco reviewed the evidence on e-cigarettes and smoking in the American Journal of Public Health. Their conclusion was that the exclusive focus on youth vaping in the US had detracted from the overall goal of smoking cessation (Dockrell & Newton, 2021). The UK was presented as a pioneer rather than an outlier. Whether that position would be maintained and recognised remains to be seen.