All State and Federal Health Department submissions supported the existing restrictions on the sale of e-cigarettes and non-government health bodies overwhelmingly opposed any relaxation of the restrictions (Erku et al., 2019). These included: the Australian Cancer Council, the Australian Medical Association, the National Heart Foundation, the Royal Australasian College of Physicians, the Thoracic Society of Australia and New Zealand, and the Australia and New Zealand Public Health Association. The only peak health body that supported greater access to e-cigarettes was the Royal Australian and New Zealand College of Psychiatrists.

The most common argument used to justify the sales ban on nicotine e-cigarettes was the claim that there was no evidence that e-cigarettes are safe or effective in helping smokers to quit (House of Representatives Standing Committee on Health, 2018). Peak health bodies and government health departments argued that there was insufficient evidence on the long-term safety of e-cigarettes so the precautionary principle required a ban on their sale (Morphett et al., 2021). The Commonwealth Department of Health defined the precautionary approach as warranting:

…action to prevent harm when there is scientific uncertainty and until a body of evidence establishes the requirement for alternative regulation. This includes the lack of conclusive evidence around the safety risks posed to users by the unknown inhalation toxicity of nicotine and other chemicals used with e-cigarettes, passive exposure to e-cigarette vapour, risks associated with child poisoning, and issues around quality control and efficacy. The precautionary approach also takes into account the broader risks that e-cigarettes may pose to population health, namely their potential to disrupt the decline in tobacco use in Australia. (Australian Government Department of Health, 2018)

The Commonwealth Department of Health suggested that "conclusive evidence" about safety was required to justify a shift in policy, but it did not specify what sort of evidence would comprise "conclusive evidence."

The majority report of the House of Representative inquiry accepted this framing of the evidence:

As the E-cigarette is a device that has only recently come into widespread use, there is limited, and often conflicting research available in relation to the impact of E-cigarettes on smoking rates and the health implications of long term E-cigarette use. (House of Representatives Standing Committee on Health, 2018)

The majority report also represented the precautionary principle and a harm reduction approach as being in opposition to each other:

Participants advocating for a continuation of current policy towards E-cigarettes tended to emphasise the precautionary principle, while participants advocating for greater availability of E-cigarettes tended to emphasise harm reduction principles. (House of Representatives Standing Committee on Health, 2018)

Peak health bodies and government health departments argued that because there was insufficient evidence on the long-term safety of ecigarettes, the precautionary principle required a ban on their sale (Morphett et al., 2021). The Thoracic Society of Australia and New Zealand (TSANZ) and the Lung Foundation Australia defined the precautionary principle as follows:

If there is a suspected risk of harm and the scientific information is lacking, such that there is an absence of scientific consensus, then the burden of proof that it is not harmful falls on those wanting to progress the issue. (Thoracic Society of Australia and New Zealand and Lung Foundation Australia, 2017)

In 2018, the Committee's majority report supported a continuation of the e-cigarette sales ban (House of Representatives Standing Committee on Health, 2018). It recommended that the National Health and Medical Research Council (NHMRC) conduct a review of evidence on the safety and efficacy of e-cigarettes. It also recommended that the Department of Health develop a national approach to regulation, including "if necessary, restricting colourings and flavourings used in electronic cigarettes" (House of Representatives Standing Committee on Health, 2018).

A dissenting minority report by three members of the Liberal Party recommended that nicotine in e-cigarettes be made exempt from Schedule 7 of the Poisons Standard so that they could be regulated as consumer products like in the European Union and include restrictions on e-cigarette colourings and flavourings (House of Representatives Standing Committee on Health, 2018). The dissenting report downplayed the claims about the health risks of nicotine and argued that the primary concern was with the health effects of additives, colourings and flavourings (House of Representatives Standing Committee on Health, 2018). They also shared the concern of the NHMRC (National Health and Medical Research Council, 2017) that flavourings and colourings could appeal to young people and be toxic when inhaled. These were also among the reasons used by the committee majority to justify sales restrictions on e-cigarettes (House of Representatives Standing Committee on Health, 2018).

### *2.3 A 2021 Proposal to Tighten E-cigarette Regulation*

In June 2020, the Federal Health Minister, Greg Hunt, announced that he would ban the personal importation of nicotine and only allow ecigarettes with nicotine to be obtained on prescription. Nicotine would only be able to be imported with an authorisation from the Office of Drug Control (Sutton, 2020). The proposal was prompted by several developments that had alarmed the Australian public health community.

The first was a very large increase in the use of e-cigarettes by adolescents and young adults in the US between 2015 and 2019 (National Institute on Drug Abuse, 2020). The second was an outbreak in 2019 of 2558 serious lung injuries (including 60 deaths as on 7 January 2020) (Werner et al., 2020). These injuries were given the name Ecigarette and Vaping-associated Lung Injury (EVALI) because most of the cases reported using e-cigarettes (Hall et al., 2021). Australian State and Federal Chief Health Officers were quick to invoke the EVALI outbreak in the US to justify Australia's precautionary prohibition on the sale of nicotine e-cigarettes (Gartner et al., 2020a; Hall et al., 2021). A leading Australian tobacco control advocate described EVALI as a "canary in the coalmine" for nicotine e-cigarettes (Knott, 2019). Because most EVALI cases reported using e-cigarettes, CDC investigators initially focused on nicotine e-cigarettes as the cause of the outbreak (Hall et al., 2021). Investigations indicated that cannabis oils adulterated with vitamin E were the most likely cause of the outbreak (Centers for Disease Control and Prevention, 2020). Despite the CDC and FDA conclusions on the cause, a 2022 statement by the Chief Executive Officer of the NHMRC still identifies e-cigarettes as cause of EVALI.

The third factor that contributed to the Minister's decision was that e-cigarette use had increased among Australian adolescents and young adults around the same time as the US "youth e-cigarette epidemic" (King et al., 2020) and EVALI outbreak. A 2019 national household survey found a substantial increase in e-cigarettes use between 2016 and 2019 among young adults (Australian Institute of Health and Welfare, 2020). The fact that the largest increase occurred among young adults who were already cigarette smokers was overshadowed by claims that ecigarette use had greatly increased among the minority of adolescents who had not previously smoked cigarettes.

### *2.4 Senate Inquiry into Tobacco Harm Reduction 2020*

Because of objections from backbench coalition members of parliament, the implementation of the Minister's proposed new regulations was delayed until after the report of a Senate Select Committee on Tobacco Harm Reduction in October 2020 (that had been established in to examine criticisms of the proposed policy). The Select Committee received over 900 public and name withheld submissions, over 30 confidential submissions and 8324 form letters. The contents of the submissions largely reprised the evidence that had been presented to the 2018 House of Representatives Inquiry. The majority of medical and public health groups strongly supported Australia's "precautionary approach," arguing that: there was an absence of evidence that e-cigarettes were safe and effective, and that allowing Australian smokers to have ready access to e-cigarettes would promote uptake among Australian youth and expose smokers to the unknown long-term harms of e-cigarette use. In another echo of the House of Representatives inquiry, the Chair and a committee member (both from the centre-right governing party) dissented from the majority report because they claimed that its findings did not accurately reflect the evidence that had been presented.

The majority report accepted the findings of evidence reviews on the effectiveness of e-cigarettes for cessation and gateway effects commissioned by the Health Minister (Banks, 2020). The TGA spokesperson defended the proposal to tighten rules on importation of nicotine e-cigarettes by increasing penalties for importing nicotine without a prescription up to \$222,000. The Committee's findings were framed as if the policy choice was between having no regulation of e-cigarettes and adopting a precautionary approach. The committee majority unsurprisingly supported continuing policies that restricted access to e-cigarettes.

## 3 The 2021 Rescheduling of Nicotine

At the Health Minister's request, the Commonwealth Department of Health developed a streamlined process to allow smokers to access nicotine e-cigarettes using the TGA's Special Access Scheme (SAS) or Authorised Prescribers (AP) programme. These programmes are intended to allow patients to have access to unapproved therapeutic goods on prescription. In the case of e-cigarettes, the programmes allow medical practitioners to apply for approval from the TGA to prescribe and arrange the supply of NVPs to Australian smokers who want to quit smoking and who have unsuccessfully used an approved cessation medicine (Therapeutic Goods Administration, 2021a). A prescription can be written by any medical practitioner for a named patient and, in the case of prescribers approved by the TGA, to a broad class of patients (e.g. tobacco smokers who want to quit and have failed to do so using approved methods) (Gartner et al., 2020b).

The regulation allows nicotine-containing e-cigarettes to be sold in Australian pharmacies, if they meet a product standard (TGO 110) that sets minimum quality, and packaging and labelling requirements, and imposes some restrictions on the content of these products (maximum nicotine content, prohibited ingredients) (Therapeutic Goods Administration, 2021b). Heat not burn and smokeless tobacco products were excluded from the TGO 110 standard after the TGA rejected an application from Philip Morris to allow the sale of a heat not burn tobacco product in August 2020 (Therapeutic Goods Administration, 2020). If they are purchasing an e-cigarette in Australia, patients with a prescription can only obtain the specific product listed on the prescription from a pharmacist. E-cigarettes can also be imported for personal use if the individual importing the nicotine product holds a prescription from any Australian medical practitioner. Some TGO 110 requirements, such as ingredient requirements, also apply to imported products. The TGA recommends that the imported product is shipped with a copy of the prescription enclosed so that customs can confirm the item has been legally imported.

In principle, the proposed TGA processes will increase Australian smokers' access to nicotine e-cigarettes. In practice, their impact may be more limited because medical and public health spokespersons discourage patients from using them and doctors from prescribing them. The Australian Medical Association (AMA), for example, supports GPs prescribing "nicotine solutions to patients where appropriate" (Australian Medical Association, 2020), but a prominent former AMA president has said that he would never prescribe nicotine e-cigarettes for his patients because they "actually get young people into smoking, rather than helping them get off it" and the current president has argued that doctors should focus on getting smokers "off nicotine completely" (McCauley, 2020). Pharmacy professional bodies' support for dispensing unapproved nicotine e-cigarettes is unclear (Haggan, 2020; Pharmaceutical Society of Australia, 2020; Retail Pharmacy, 2020). It is also uncertain how many manufacturers or importers will supply nicotine e-cigarettes that can be dispensed and it remains to be seen how many Australian vapers will use this pathway to access them.

The TGA has cautiously supported the use of nicotine e-cigarettes for patients who have unsuccessfully tried to cease smoking using approved cessation aids such as NRT and pharmaceutical drugs. Its website now encourages medical practitioners, pharmacists and consumers to use the approved pathways and provides advice on how to do so. It also provides a list of medical practitioners who are authorised to prescribe nicotine e-cigarettes, who have consented to being publicly listed and who are prepared to prescribe via telehealth consultations.

### 4 Explaining How Australia's E-cigarette Policy Came About

As noted above, Australia's policy was initially formulated by federal and state health regulators acting on the advice of tobacco control and public health advocates who favoured policies to reduce demand for tobacco, such as increased tobacco taxes, and who were opposed to tobacco harm reduction approaches. This was in large part because of the past failure of "light" and "low-tar" cigarettes to reduce harm, while convincing smokers that they were smoking less harmful products (King et al., 2003). The failure of "low-tar" cigarettes produced an understandable mistrust of tobacco harm reduction as Simon Chapman, a leading tobacco control advocate in Australia, has written:

… most in the public health community have bitter memories of being hoodwinked by the industry. We were kept in the dark about its internal knowledge of compensatory smoking that made a mockery of machinemeasured yields …. This has engendered immense mistrust of any next generation harm reduction claims. (Chapman, 2007)

### *4.1 Key Public Health Policy Advisors*

After the election of a federal Labour government in 2007, the new Health Minister, the Hon. Nicola Roxon, established a National Preventative Health Taskforce in April 2008. Tobacco policy was given priority and she explained that she was determined to toughen up tobacco control policy motivated by her father dying from a smoking-related oesophageal cancer. She appointed a Tobacco Working Group chaired by Mike Daube, former director of Action on Smoking and Health (ASH) in the UK, a former Director General of the Health Department in Western Australia, a past president of the Public Health Association of Australia and Professor of Health Policy at Curtin University. The working group's report (National Preventative Health Taskforce, 2009) recommended that e-cigarettes should only be marketed as smoking cessation aids, and then only if they were listed on the Australian Register of Therapeutic Goods (National Preventative Health Taskforce, 2009):

If e-cigarettes are marketed as an aid in withdrawal from smoking they will be considered a therapeutic good, and would have to be listed on the Australian Register of Therapeutic Goods before they could be imported and retailed in Australia. It seems unlikely that they would meet standards for safety and efficacy. If, on the other hand, e-cigarettes are marketed exclusively as recreational devices, they may not meet the definition of therapeutic use. The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) currently categorises all nicotine products that are not tobacco products or are used for NRT as falling under Schedule 7, which covers Dangerous Poisons. Therefore, at present, such products (not being clearly a tobacco product or NRT) would probably not satisfy the stated exceptions, and could not be retailed under state and territory legislation. (National Preventative Health Taskforce, 2009)

Nicola Roxon supported this approach, describing e-cigarettes as an "insidious, manipulative attempt to hook people on smoking" (Cauchi, 2009). In 2011, Nicola Roxon announced a campaign to introduce tobacco plain packaging in Australia, describing this "as the next great step we could take in limiting the glamour and appeal of tobacco" (Australian Council on Smoking and Health, 2017). Plain packaging legislation came into force on 12 December 2011.

### *4.2 Tobacco Harm Reduction: Advocates and Opponents*

Advocates of policies that would increase smokers' access to e-cigarettes justified it as a harm reduction approach to tobacco. They included researchers (such as two authors, Coral Gartner and Wayne Hall), ecigarette advocacy groups and clinicians. A general practitioner and founder of the Australian Tobacco Harm Reduction Association, Dr. Colin Mendelsohn, argued that e-cigarettes were "an ideal tobacco harm reduction product," because they provided nicotine without most of the harmful constituents of tobacco smoke and involved the hand-to-mouth action that smokers are accustomed to (Mendelsohn, 2017). The Royal Australian and New Zealand College of Psychiatrists also emphasised the value of e-cigarettes in tobacco harm reduction for persons with serious mental illness (Royal Australian and New Zealand College of Psychiatrists, 2017).

Nigel Gray, an Australian tobacco control pioneer, had earlier advocated for the regulation of cigarettes to reduce harm to smokers. He proposed a comprehensive nicotine policy that would combine the progressive reduction in the nicotine content of combustible cigarettes with increasing smokers' access to clean forms of nicotine, such as pharmaceutical preparations (Gray et al., 2005). After e-cigarettes were introduced and taken up by smokers in the US, he recognised their potential value as cleaner nicotine products (Gray, 2014). Professor Ron Borland, a leading tobacco control researcher at Cancer Council Victoria from 1986 to 2019, has also been a proponent of tobacco harm reduction policies within a comprehensive tobacco control strategy (Borland, 2016).

The overwhelming majority of Australian healthcare and public health organisations, however, have opposed tobacco harm reduction policies. Michael Moore, CEO of the Public Health Association of Australia, argued that Australia had very successfully reduced the prevalence of smoking so there was no need for tobacco harm reduction (Public Hearing of the Parliamentary Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia, 5 October 2017). Opponents of e-cigarettes also argued that their introduction would reverse the gains Australia had made in tobacco control over the last few decades and increase the population harms arising from the use of nicotine (Studdert, 2017).

Increasing hostility to the concept of tobacco harm reduction was reflected in changes made in successive Australian National Tobacco Strategies. These form sub-strategies of the National Drug Strategy (NDS) that adopts a harm minimisation approach to alcohol, tobacco and illicit drugs in which the "three pillars" of demand reduction, supply reduction and harm reduction are "equally important" and "applied together in a balanced way" (Ministerial Council on Drug Strategy, 2010).

Tobacco harm reduction was a prominent part of the National Tobacco Strategy of 2004–2009. Among its four primary objectives was "where feasible, to reduce harm associated with continuing use of, and dependence on, tobacco and nicotine" (Ministerial Council on Drug Strategy, 2004). An associated outcome indicator was "a reduction in the exposure of remaining users of tobacco (or tobacco substitutes) to dangerous smoke constituents" … "by replacing some or all tobacco products with medicinal nicotine or other nicotine products" (Ministerial Council on Drug Strategy, 2004). The strategy noted the lack of a comprehensive plan to regulate nicotine products with the statement that "we have no mechanism at all for regulating some classes of products" (Ministerial Council on Drug Strategy, 2004).

The strategy noted that "The absence of measures that reduce harm from continuing smoking results in greatest harm among socially disadvantaged smokers" (Ministerial Council on Drug Strategy, 2004). A document was developed: "More efficiently regulating tobacco: Ideas and resources" by an unnamed consultant "with advice from the former National Expert Advisory Committee on Tobacco and support by the Intergovernmental Committee on Drugs" (Unknown Author, 2004). It provided options to regulate tobacco and nicotine products to "reduce overall population harm." These included:

These suggestions were not implemented and a proposed report commissioned by the Victorian Department of Health to investigate nicotine and tobacco product regulation (Ministerial Council on Drug Strategy, 2004) was never released.

In the 2010–2015 National Drug Strategy, by contrast, the only tobacco harm reduction strategy mentioned was smoke-free policies to reduce harms to non-smokers in workplaces and public spaces. The National Tobacco Strategy 2012–2018 contained no strategies to reduce harm to smokers other than cessation. E-cigarettes were only mentioned in recommendation 6.7 to: "Consider further regulation of the contents, product disclosure and supply of tobacco products and alternative nicotine delivery systems" (Intergovernmental Committee on Drugs, 2012) in order to "determine whether there is a need to increase restrictions on their availability and use" (Intergovernmental Committee on Drugs, 2012).

### *4.3 Selective Citation of Evidence on the Risks and Benefits of E-cigarettes*

Critics argue that policy makers and supporters of Australia's ban on the sale of e-cigarettes as consumer products used have justified it by selectively using the evidence on the effectiveness and safety of e-cigarettes. These appraisals have discounted evidence from clinical trials that ecigarettes assist smokers to quit and dismissed observational evidence that smoking has declined as e-cigarettes use has increased. They have also amplified equivocal evidence that e-cigarettes cause harm to smokers and exaggerated the strength of the observational evidence that e-cigarettes served as a gateway to cigarette smoking in adolescents.

### *4.4 Protecting Young People from the Gateway Effect*

A major justification for an e-cigarette sales ban has been that e-cigarettes could addict a new generation of young people to nicotine and serve as a gateway to cigarette smoking (National Heart Foundation, 2017). The review commissioned by the Department of Health concluded that there was "strong" evidence for a gateway effect in longitudinal studies (Banks, 2021), and the TGA cited this conclusion to justify its classification of ecigarettes. Advocates of e-cigarettes argued that these studies failed to take account of the shared liability to addiction and pointed to the UK and the US where rates of smoking had declined among young people as the use of e-cigarettes increased (House of Representatives Standing Committee on Health, 2018). Some of those who invoked the gateway effect to support Australia's sales ban implied that policy makers had to choose between (1) banning the sale of e-cigarettes and (2) allowing e-cigarettes to be sold without regulations or restrictions on supply, advertising or age of purchase.

There are plenty of drugs that we know do harm. I take one, but it's medically administered. That's okay in that group of people, but to sell it to children who are unable to give consent and are unable to understand the issues at hand, that's just unconscionable. (Professor Thompson, Thoracic Society of Australia and New Zealand, Public Hearing for the 2018 Parliamentary Inquiry)

Alternative policy options were neglected, such as restrictions on where e-cigarettes were sold and used, were overlooked, as was the inconsistency in imposing lesser restrictions on the sale of cigarettes than those proposed for e-cigarettes.

### *4.5 The Adverse Health Effects of Nicotine*

Nicotine replacement therapy has long been considered safe when used for smoking cessation or as long-term substitute for smoking by organisations that have strongly opposed the use of e-cigarettes (e.g. Quit Victoria, 2018). However, Australian governments and health organisations have increasingly emphasised the potential harms of nicotine, arguing that it causes acute toxicity and poisoning in children, for example, (Queensland Government, 2018), that it is an "addictive and potentially toxic substance" (Cancer Council Australia, 2016) and may be a cancer promoter (Chapman, 2016). The Commonwealth Department of Health has argued that nicotine was addictive, posed "significant health risks including adverse cardiovascular, respiratory, and reproductive effects" and was "associated with DNA damage and other pathways of carcinogenesis" (Commonwealth Government Department of Health, 2017). In its 2017 decision on rescheduling, the TGA also claimed that nicotine adversely affects the brain development of young people and foetuses, potentially causing learning and anxiety disorders (Therapeutic Goods Association, 2017).

### *4.6 The Role of the Tobacco Industry*

The decisive fact for many in the Australian tobacco control community is that the tobacco industry has invested in e-cigarette companies and campaigned for a relaxation of the e-cigarette sales ban. They argued that the tobacco industry would use e-cigarettes to reduce quitting among smokers and promote youth smoking. The industry was also accused of using tobacco harm reduction to re-engage with public health authorities and ensure that tobacco policies better served their interests. For example, Maurice Swanson from the Australian Council on Smoking and Health stated of the tobacco industry that:

Their objective…is to provide a range of nicotine delivery devices, from traditional cigarettes to e-cigarettes through to heated tobacco products, and their reason for doing so is that they know that in many Western countries the prevalence of smoking is falling and they need to maintain profitability. If they can dress up their alternative nicotine delivery products as being safer—that's what they're promoting—then they can maintain both their share value and their profitability. (Select Senate Committee on Tobacco Harm Reduction, 2020)

Advocates for tobacco harm reduction were sometimes depicted as witting or unwitting allies of the tobacco industry (Slessor, 2018). Media articles also reported on advocates' receipt of funding from commercial sources, particularly e-cigarette retailers (Chenoweth, 2021; Han, 2018; Workman & Hutcheon, 2021).

Witnesses who gave evidence to the Senate Committee inquiry in favour of more liberal e-cigarette policies were required to make multiple sworn statements that they had not received any funding directly or indirectly from the tobacco or e-cigarette industries.

### *4.7 The Misuse of the Precautionary Principle*

The most popular arguments advanced against allowing Australian smokers to have greater access to nicotine e-cigarettes were that there was insufficient evidence that e-cigarettes are safe or effective in helping smokers to quit, and that they posed an unacceptable risk to youth (House of Representatives Standing Committee on Health, 2018). Peak health bodies and government health departments also argued that given the lack of evidence on the long-term safety of e-cigarettes, the precautionary principle required a ban on their sale until evidence showed that they were safe (Morphett et al., 2021). The Commonwealth Department of Health defined the precautionary approach as warranting:

…action to prevent harm when there is scientific uncertainty and until a body of evidence establishes the requirement for alternative regulation. This includes the lack of conclusive evidence around the safety risks posed to users by the unknown inhalation toxicity of nicotine and other chemicals used with e-cigarettes, passive exposure to e-cigarette vapour, risks associated with child poisoning, and issues around quality control and efficacy. The precautionary approach also takes into account the broader risks that e-cigarettes may pose to population health, namely their potential to disrupt the decline in tobacco use in Australia. (Australian Government Department of Health, 2018)

The Commonwealth Department of Health indicated that "conclusive evidence" of safety would justify a shift in policy, but it did not specify what would comprise "conclusive evidence" of safety.

The Australian Medical Association implied that evidence of zero risk would be required:

**CHAIR:** What would be the threshold? … The claims around less harm have ranged up to 95 per cent less harm. What is the threshold that becomes an acceptable point? If 95 per cent was accurate, would you say, 'That's a good basis, then, for legalising it'?

**CHAIR:** So You Would Have to Be Convinced that It Did no Harm at All?

**Dr Bartone:** I'm not Going to Be Tied to a Number Other Than 100 Per Cent Because—

**Dr Bartone:** Yes, before I would personally look at that. (Public Hearing of the Parliamentary Inquiry into the Use and Marketing of Electronic Cigarettes and Personal Vaporisers in Australia, 5 October 2017)

Most guidelines on the use of the precautionary principle reject the strong form that requires a product to be 100% safe because zero risk is impossible to achieve (Commission of the European Communities, 2000; Morphett et al., 2021; Weir et al., 2010). These guidelines usually recommend that regulations should be proportional to the risk the product poses (Commission of the European Communities, 2000; Weir et al., 2010). Two of the authors of this chapter (Wayne Hall and Coral Gartner) have argued that zero risk is not appropriate in a regulatory context when consumers are freely able to use a widely-available product that is an established cause of very serious health harms (House of Representatives Standing Committee on Health, 2018).

## 5 Conclusion

Drugs and poisons regulations in Australia have made it difficult to access nicotine-containing e-cigarettes since 2012. Moves to increase smokers' access to e-cigarettes have been resisted by regulatory authorities and the public health field. This has been despite the relaxation of similar restrictions in Canada and New Zealand and evidence that using e-cigarettes is less harmful than smoking tobacco (Byrne et al., 2018; Health, 2017; McNeill et al., 2018; U.S. National Academies of Sciences Engineering and Medicine, 2018). Influential public health organisations in Australia, and all relevant government agencies, maintain that nicotine-containing e-cigarettes should only be available on prescription.

Australian e-cigarette policy comprises a complex and confusing array of state and federal laws that have been difficult for smokers to navigate (Saw et al., 2019). The regulatory challenges raised by novel nicotine products have been acknowledged in parliamentary reports and the National Tobacco Strategy 2004–2009 (Ministerial Council on Drug Strategy, 2004), but over the past decade recommendations to develop a comprehensive regulatory regime for all tobacco and nicotine products have been ignored.

The main reasons for the strong resistance to changes in e-cigarette policy in Australia are as follows:

Firstly, public officials and politicians believe that tobacco harm reduction approaches are unnecessary because demand reduction strategies (e.g. taxation, smoke-free polices and media campaigns) have successfully reduced smoking prevalence to date. They also believe that tougher demand reduction policies will further reduce smoking prevalence.

Secondly, harm reduction strategies have been framed as presenting an unacceptable risk in comparison with "tried and true" demand reduction strategies, namely because e-cigarettes may allegedly deter smokers from quitting and recruit non-smokers to nicotine dependence and cigarette smoking.

Thirdly, there is also a lack of enthusiasm for nicotine replacement in smoking cessation because of the belief among leading public health advocates that cold turkey is the best way for smokers to quit. The result is that the majority of Australian tobacco control advocates support the sales ban on nicotine-containing e-cigarettes because they believe that Australian policy should give priority to preventing smoking uptake among young people over any benefits to adults who smoke.

The history of tobacco control in Australia has been strongly influenced by key individuals and professional networks. Tobacco control has been dominated by public health professionals whose successful advocacy for demand reduction policies has substantially reduced overall smoking prevalence. These policies have been less successful in reducing social disparities in smoking prevalence (Intergovernmental Committee on Drugs, 2012), and health inequalities have not been featured strongly in policy documents or discussions about e-cigarettes.

Major health organisations and government health departments at Commonwealth and state level have justified the rejection of e-cigarettes as a harm reduction strategy by invoking a strong interpretation of a precautionary approach. According to this approach, e-cigarettes should be shown to be completely safe before they can be legally sold to consumers. This use of the principle does not compare the safety of ecigarettes with that of smoked tobacco but instead compares their safety to that of not using nicotine. This approach is inconsistent with guidelines on the use of the precautionary principle in public policy (Morphett et al., 2021).

The fact that the tobacco industry is now involved in the e-cigarette market has been a major reason that many in the tobacco control community oppose the sale of e-cigarettes in Australia. As one reporter observed, "The shadow of Big Tobacco has darkened the e-cigarette landscape" (Powell, 2018). Concern about tobacco industry motives is understandable, given their history of manipulation and their continued interest in selling dangerous and addictive tobacco products to consumers. Nonetheless, suspicion of the tobacco industry has produced a policy that perversely protects cigarettes by restricting smokers' access to lower risk e-cigarettes and low nitrosamine smokeless tobacco products while cigarettes remain freely accessible as consumer products in supermarkets and convenience stores.

### References

Gruszczynski (Ed.), *The regulation of e-cigarettes: International, European and National Challenges*. Elgar Online.

*personal vaporisers in Australia*. http://parlinfo.aph.gov.au/parlInfo/dow nload/committees/reportrep/024115/toc\_pdf/ReportontheInquiryintoth eUseandMarketingofElectronicCigarettesandPersonalVaporisersinAustralia. pdf;fileType=application%2Fpdf

**Open Access** This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/ by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.

The images or other third party material in this chapter are included in the chapter's Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.

## E-Cigarettes and the Burdens of History: Children, Bystanders and the American War on Nicotine

*Ronald Bayer and Amy L. Fairchild*

**Abstract** Although e-cigarettes arrived on the American market in 2006, they remained unregulated at the federal level until 2022, when the Food and Drug Administration issued an order that JUUL, which once commanded some 75 per cent of the vaping market be removed from the American market. The period between introduction of e-cigarettes and FDA regulation was marked by fierce debate as states and cities sought to fill the regulatory void. Proponents of e-cigarettes embraced a harm

A. L. Fairchild (B)

© The Author(s) 2023 V. Berridge et al. (eds.), *E-Cigarettes and the Comparative Politics of Harm Reduction*, https://doi.org/10.1007/978-3-031-23658-7\_4

R. Bayer

Center for the History and Ethics of Public Health, Mailman School of Public Health, New York, NY, USA e-mail<EMAIL_ADDRESS>
College of Public Health, The Ohio State University, Columbus, OH, USA e-mail<EMAIL_ADDRESS>
reduction perspective, seeing in the new products a safer albeit not safe alternative to combustible cigarettes. Yet virtually the entire American public health establishment asserted that e-cigarettes threatened the 40 year effort to bring smoking to an end. In the battles over evidence and ethics, adolescents and non-vaping bystanders, as opposed to smokers, emerged as focus of concern.

**Keywords** Harm reduction · Precaution · Prohibition · Evidence · Adolescents · Bystanders · Addiction

On 23 June 2022, the US Food and Drug Administration (FDA) announced that after a thorough review of the application by JUUL—the most widely used vaping product from November 2017 to April 2022—it had determined to issue a Marketing Denial Order (MDO). The company was ordered to stop selling its products in the US market, and retailers had to stop selling them. In announcing its decision, the FDA declared that JUUL's application "Lacked sufficient evidence regarding the toxicological profile (of its) products to demonstrate (the sale and use) of its products would be appropriate for the protection of the public health" (FDA news release, FDA Denies Authorisation to Market JUUL Products, June 23, 2022).

The ruling made clear that JUUL bore the burden of proof for establishing the safety of its products. Tthe comments of FDA Commissioner Robert M. Califf underscored the degree to which youth vaping defined the US policy debate over e-cigarettes. JUUL was one of the products that, he noted, accounted "for most of the U.S. market" and "played a disproportionate role in the rise in youth vaping." At the same time, the agency underscored that "To date the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUUL pods." In a clear reflection of the impact of the precautionary principle, the FDA made clear that the absence of evidence regarding harm was not sufficient to overcome the concerns raised in its review. Against the backdrop of public furore about allegations of JUUL having blatantly marketing to youth, the FDA came to rest on the position that despite the massive evidence that JUUL had submitted, it had provided "insufficient evidence to assess the potential toxicological risks" from using those products (FDA news release, FDA Denies Authorisation To Market JUUL Products, 23 June 2022).

For those who had pressed for years for a ban on e-cigarettes, the FDA ruling represented a triumphal moment for public health. Matt Myers, President of the prominent Campaign for Tobacco-Free Kids declared, "This would be the most significant action the FDA has taken to date to end the youth e-cigarette epidemic and stop tobacco companies from using these nicotine-loaded products to addict another generation of kids" (FDA Orders JUUL e-cigarettes Off the Market, *Politico*).

To those whose commercial interests were imperilled, the FDA determination was disastrous. The product was popular not only among youth—the product has had disproportionately higher youth rates compared to other brands—but also adult smokers (Wang et al., 2020). The president of the American Vapour Manufacturers Association denounced the decision as the "latest sorry example of the agency's campaign of regulatory arson against nicotine vaping products that millions of Americans rely on as an alternative to cigarettes" (FDA Orders JUUL e-cigarettes Off the Market, *Politico*). But there were others, not driven by narrow economic interests, who were also profoundly distressed. There had been for years a cadre of public health researchers who saw in e-cigarettes an opportunity for harm reduction, an opportunity to dramatically limit the toll exacted by tobacco cigarette smoking. Kenneth Warner, the former Dean of the University of Michigan School of Public Health and founding member and former President of the Society for Research on Nicotine and Tobacco (SRNT), who for years had sought to underscore the need for careful analysis that balanced the risks and potential benefits of e-cigarettes, saw the future as bleak unless there was a reversal of the FDA's June 23 determination. E-cigarettes would begin to disappear, "a black market for such products would emerge, fewer people would vape, more would smoke, more would die" (Kenneth Warner, interview 20 July 2022).

Yet within, a month both advocates and proponents were thrown into confusion.

On 24 June, the day after the FDA denial, the D.C. Circuit Court issued and administrative stay of the order in response to an emergency motion from JUUL. This stopped the MDO from going into effect until JUUL could file an emergency brief, which the court would consider along with the FDA response (Scribner, 2020). In their emergency brief filed 27 June, JUUL Labs, Inc. (JLI) claimed that the FDA review of their evidence had been insufficiently thorough and that the agency had capitulated to "unprecedented, inappropriate" "political pressure" from congressional representatives that "tainted the entire agency process." Although the FDA had approved other e-cigarettes, JUUL was the 1000-pound gorilla in the room when it came to share of the US e-cigarette market. The FDA denial was, in the eyes of the company, "manifestly erroneous." JLI argued, "As it has with other PMTAs, FDA should have evaluated the totality of JLI's evidence, which conclusively established that the public-health benefits of JUUL products significantly outweigh any potential risks" (JUUL Labs, Inc., v U.S, Food and Drug Administration, 27 July 2022).

On 5 July 2022, the FDA announced a temporary stay of its own MDO, explaining, "There are scientific issues unique to the JUUL application that warrant additional review." Although the agency stressed that the stay should not be misinterpreted as FDA authorisation, under the deeming rule all e-cigarette products were technically on the market illegally until they received formal marketing authorisation. Until the matter is resolved, then, business as usual will continue for JUUL (FDA news release, FDA Denies Authorisation to Market JUUL Products, 23 June 2022, 5 July 2022 update note).

Yet for JUUL, business as usual would have to be very different. On 6 September 2022, the company tentatively settled a suit brought by some three dozen states over its sales and marketing practices, which relied on launch events, social media campaigns that had a sizeable proportion of followers 17 or younger, youthful spokespersons, and what the Attorney General of Connecticut described as "porous" age verification processes (Jewett, 2022). Without conceding fault, the company was poised to pay a \$438.5 million settlement. Nonetheless, the company had already begun to emphasise that its target market was adult smokers and had curtailed its advertising and removed key flavoured products (Beachum & McGinley, 2022).

With hundreds more cases against the company awaiting conclusion or pending (Larson et al., 2022), the FDA review reopened, and rates of youth vaping dramatically down among both high school and middle school students from a zenith in 2019 (CDC, 2022), the 15-year controversy involving science, politics, and the ethics of public health continues to hang in the balance.

## 1 First Encounters

E-cigarettes arrived on the American market in 2006. Two years later, in October 2008, the FDA detained a number of shipments of electronic cigarettes at the Los Angeles International Airport, claiming that they were in violation of the Food, Drug, and Cosmetic Act. The FDA believed the products were intended to be used as drugs—defined as something that affects the structure or function of the body—since they contained nicotine and could treat or mitigate addiction to combustible tobacco.

Importers and manufacturers, predictably, had a different view. By strategically avoiding claims about the therapeutic effects of e-cigarettes as a treatment for nicotine withdrawal during smoking cessation, for example—they argued that their products could not be regulated by the FDA as combination drugs/delivery devices but should instead be regulated as tobacco products. Two e-cigarette manufacturers sued the FDA to end the detention of their products. Both a District Court and the US Court of Appeals, District of Columbia Circuit, in *Sottera, Inc. v. FDA,* sided with the e-cigarette manufacturers and importers (Sottera, 2010). The FDA could not regulate tobacco products as drugs or drug delivery devices unless the products were marketed with claims about their therapeutic effects.

In April 2011, in the aftermath of the D.C. Circuit's opinion in *Sottera*, the FDA released a letter to stakeholders stating that "the government has decided not to seek further review of this decision, and the FDA will comply" (Letter to Stakeholders, 2011). Three years later, with U.S. sales of e-cigarettes rising meteorically, reaching \$1.5 billion, the FDA continued to contemplate its options (Wahba, 2014). The agency's inaction raised several questions, including what the FDA had the authority to do (the Family Smoking Prevention and Tobacco Control Act of 2009 had given the agency authority to regulate tobacco, but the act was not updated to extend authority to e-cigarettes until 2016), what it *should* do, and when it would act. They were operating in a grey area when it came to e-cigarettes.

In October 2013, the FDA submitted a draft Notice of Proposed Rulemaking to the Office of Management and Budget's Office of Information and Regulatory Affairs in the White House. The FDA announced its intention to bring e-cigarettes and a variety of other products under its regulatory authority by "deeming" them tobacco products under the Tobacco Control Act (Husten & Deyton, 2013). The content of the proposed rules, including product manufacturing standards such as appropriate ingredients, provisions for testing, and limits on advertising, sales, and distribution, had yet to be determined. The absence of adequate data on the possible harms of e-cigarettes to users and to bystanders exposed to the vapour they emitted, as well as on the question of whether ecigarettes were more likely to create new combustible tobacco smokers or ease current smokers away from their habit, made it extremely difficult for the FDA to base its regulations on epidemiological or medical evidence (the deeming rule would not go into effect until August 2016).

In the face of uncertainty, US anti-tobacco advocates took a precautionary stance, arguing that accepting lesser harms was akin to being wilfully duped by the industry and serving as little more than "naïve" pawns in a grand scheme to take back lost ground in the long battle over smoking (Chapman & Wakefield, 2013). Given the long history of tobacco industry deception regarding what it knew about the harms of smoking, such advocates asserted there was no room for compromise when it came to a product in which Big Tobacco had any financial interest. As the FDA moved cautiously, municipalities in the US were responding to the new challenge from e-cigarettes.

In 2011, Boston, Massachusetts health officials voted to treat ecigarettes like tobacco products, banning their use in the workplace and restricting their sale to adults (BPHC, 2011). Boston would go on to ban all combustible cigarette smoking, including the use of ecigarettes, in outdoor parks, squares, and cemeteries (Rousseau, 2014). New York City was the second major city to ban e-cigarettes in all of the places tobacco smoking was banned, including parks and beaches (Gay et al., 2013; Robertson, 2013). While the measure was not passed unanimously, it passed without significant controversy. Los Angeles unanimously passed an e-cigarette ban in March 2014 (Whitcomb & Gorman, 2014; Zahniser, 2014). Like New York, Los Angeles also banned smoking and vaping in parks and certain beaches.

Chicago, Illinois also banned e-cigarette vaping in public, but with some degree of controversy. On a first attempt in November 2013, the proposed ban received a chilly reception from city aldermen, who said their constituents were using e-cigarettes to wean themselves off of combustible tobacco products (Yellen, 2014). A second attempt in January 2014, aided by the advocacy of Mayor Rahm Emanuel, succeeded in prohibiting the use of e-cigarettes in bars, restaurants, and most other *indoor* public places in the city (AP, 2014; Byrne, 2014). In 2018, San Francisco passed a new ban on sales of menthol cigarettes and flavoured e-cigarette liquids, which was deemed to be the strictest municipal restriction on e-cigarettes sales in the nation (Hoffman, 2018b). By 2018, 12 states, including California, Massachusetts, New Jersey and New York, and the District of Columbia had laws prohibiting the use of e-cigarettes in otherwise smoke-free settings.

### 2 Harm Reduction Confronts Precautionary Thinking

In the context of tobacco, harm reduction—if not always by that name surfaced in the mid-1990s. In 1996, the FDA approved Nicorette gum, which was nicotine-based, for sale over-the-counter. The next year it approved two forms of the nicotine patch, which delivered nicotine through the skin (Hughes et al., 1999). Over-the-counter availability of nicotine replacement therapies (NRTs) forced the medical, public health, and research communities to investigate the likelihood and consequences of long-term nicotine use (Fairchild & Colgrove, 2004).

In 2000, a Public Health Service panel, drawing on widely respected researchers across an impressive array of leading schools, institutions, and agencies, dramatically reframed tobacco dependence as "a chronic condition that warrants repeated treatment until long-term or permanent abstinence is achieved" (TCPGT Tobacco, 2000). The panel equated tobacco dependence with "high blood pressure, high cholesterol or diabetes." Drawing an analogy to psychiatric patients, its chair explained that good practice sometimes requires "keeping them on medication for the rest of their lives because I know it saves their lives. We have the exact same circumstances here" (Barker, 2000). In framing the guidelines in this fashion, the panel offered long-term treatment using nicotine replacement as a companion to cessation (*Clinical practice guideline*, 2008; Fiore et al., 2000). This did not amount to a formal endorsement of tobacco harm reduction. It did, however, solidify the acceptance of NRT and established a treatment mindset with cigarette smoking abstinence as the goal.

One year later, the Institute of Medicine (IOM), a private, nonprofit institution renowned for its scientific advice, released a report opening the door for endorsement of such products as a feasible component of a harm reduction strategy (Bondurant et al., 2001). The FDA, concerned about the safety and efficacy of emerging nicotine-laced and tobaccobased products, had commissioned the report from the IOM, which had on more than one occasion endorsed the concept of harm reduction in the case of needle exchange to prevent HIV transmission (Normand et al., 1995; Trussell et al., 2001). The 2001 IOM committee on smoking and harm reduction released its report after a year-long process of reviewing evidence on tobacco control and harm reduction. Key to the panel's conclusion that harm reduction was "feasible and justifiable" was the observation that "approximately 10–15 per cent of the adults in the United States are expected to be regular users of tobacco in 2010, and they will continue to suffer the increased incidence of harmful and lethal consequences. Among this group are many who cannot or will not stop using tobacco, and it is to this group that effective programs and products of harm reduction should be directed" (Bondurant et al., 2001). This perspective was inevitably met by challenges that ranged from scepticism to utter rejection, in important ways recapitulating the history of responses to the evidence of the efficacy of needle exchange.

Underscoring the persistence of profound disagreement over tobacco harm reduction, on the heels of the IOM report the National Cancer Institute (NCI) issued its own analysis: *Risks Associated With Smoking Cigarettes With Low Machine-Measured Yields of Tar and Nicotine* (NCI, 2001). It fuelled enthusiasm for a cessation-only approach. The NCI was decidedly hostile to less harmful tobacco products like smokeless tobacco (e-cigarettes were not yet on the scene) and raised provocative questions about the place of harm reduction within tobacco control. The NCI described its monograph as a complement to the IOM report, but its emphasis fell more heavily on discrediting low-tar cigarettes, once touted as safer, and underscoring the duplicity of the tobacco industry (Burns & Benowitz, 2001). The NCI report thus confirmed for many that the only reasonable objective remained total cessation: "If you are concerned about your health, quitting is your only choice" (American Lung Association, 2001; Davis, 2001).

## 3 E-Cigarettes Take the Stage

In 2009, the World Health Organization warned that e-cigarettes threatened bans on public smoking, which were key to tobacco control. In the US, long-time anti-tobacco champion Stanton Glantz, a prominent tobacco researcher at the University of California, and his colleagues raised similar concerns: "Given the substantial research demonstrating the effect of viewing smoking in the movies on adolescent smoking initiation, the addictive nature of nicotine and the lack of regulatory assurance of their quality or safety, it is important to keep Electronic Nicotine-Delivery Systems (ENDS), and other similar products, from being sensationalized through the use of celebrity promotion or product placement in movies or other entertainment media" (Fairchild & Bayer, 2016a, 2016b).

Glantz and others—a geographically dispersed group of researchers, many of whom had studied with him or looked to him for leadership were alarmed by a flood of e-cigarette advertisements (Fairchild & Bayer, 2016a, 2016b). "Smelling like an ashtray is not the ideal aphrodisiac," scolded talk-show host Jenny McCarthy, as she enjoyed her BlueCig. Actor Stephen Dorff, another Blu spokesperson and former smoker, added, "I'm tired of feeling guilty every time I want to light up." He implied that public health messages were paternalistic: "We're all adults here. It's time to take our freedom back. Come on guys, rise from the ashes." On Super Bowl Sunday 2013, an NJOY e-cigarette ad seen by 10 million viewers declared, "Finally, smokers have a real alternative. Cigarettes, you've met your match" (Fairchild et al., 2014). That the e-cigarette promotions also sought to stigmatise combustible cigarettes was of little consequence to those who saw in them a grim assault to the television promotion ban on tobacco advertising established nearly five decades earlier.

Although youth use of tobacco, understood as underaged use and typically meant to mean use in middle or high school but also inclusive of use by even younger children, continued its steady decline, dread was compounded by data from the Centres for Disease Control and Prevention: twice as many young people experimented with e-cigarettes in 2012 as in 2011 (Fairchild et al., 2014). The driving concern, at that time, was that e-cigarettes would prove to be a "gateway" or "bridge" product, leading to an increase in underage smoking. Invoking images of terrorism, two tobacco-control advocates claimed, "smoking bans and clean air advocacy are being hijacked" (Fairchild et al., 2014). Seeing in e-cigarettes a Trojan horse that would unleash a new epidemic of tobacco consumption, in September 2013, 40 US attorneys general, the chief legal officials in the states, called on the FDA to act swiftly to regulate e-cigarettes as tobacco products.

This group of alarmed scientists struck a decidedly precautionary stance, echoing the sentiments of the Wingspread Statement of 1998, one of the foundational documents in the history of precautionary thinking focused on preventing environmental threats. "When an activity raises threats of harm to human health or the environment," the Wingspread environmentalists agreed, "precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically" (*Visionary Science*, n.d.).

By 2015, it appeared clear that a precautionary perspective informed the outlook of the Centres for Disease Control and Prevention (CDC). In October of that year the CDC hosted a public health grand rounds expert panel on e-cigarettes, during which speakers discussed background information and strategies for addressing the emergence of these devices. All five of the speakers, including CDC director Tom Frieden and Campaign for Tobacco-Free Kids president Matthew Meyers, focused on the health concerns associated with e-cigarette use. The Campaign for Tobacco-Free Kids, an advocacy organisation that was among the most vocal proponents of ever-more restrictive tobacco policy, was critically important because while other non-governmental organizations (NGOs) had emerged as sharply opposed to e-cigarettes (such as Action on Smoking & Health, known as ASH), Meyers's organisation was the most influential and focused exclusively on youth. None acknowledged the potential role of e-cigarettes in reducing the tobacco burden on marginalised populations or in reducing health disparities (*E-cigarettes*, 2015). Overwhelming concern for the threat to youth and non-smokers set the parameters for the precautionary approach for US policymakers.

Challenging those whose precautionary perspective suggested a need for strict regulation, if not explicit outright prohibition, were vaping organisations, e-cigarette industry retailers, and a small but vocal group of academic experts on tobacco policy, whose disciplines included economics, epidemiology, psychology, and medicine. Most important at this juncture was the American Legacy Foundation.

## 4 The Contours of Opposition

The American Legacy Foundation, which in time would be renamed Legacy and then Truth Initiative, was a non-profit public health organization created by funds made available by the Master Tobacco Settlement, a civil litigation settlement with major tobacco companies. Organisationally, it would provide an ongoing commitment to policies that would counter the still powerful tobacco industry. The position that it would take on the emerging debate over e-cigarettes was signalled in a keynote address by its founding chief executive officer, Cheryl Healton. In 2008, she sought to locate that controversy in the context of public health challenges other than those posed by tobacco. "I think we really need to consider making that product more accessible to individuals so that they may choose to use that product in lieu of smoking" (Healton, 2008). Healton's Board of Director's included individuals who would emerge as strong proponents of harm reduction. Among them were Thomas Miller, the Iowa Attorney General who had led the effort to secure creation of the foundation as part of the Master Settlement Agreement, and Kenneth Warner, a Professor of Economics and former Dean of the School of Public Health at the University of Michigan, who had initially expressed scepticism over e-cigarettes. Healton also created an autonomous but affiliated research group, the Schroeder Institute, staffed by social scientists who would become among the most prominent proponents for making e-cigarettes available to those who smoked combustible tobacco cigarettes.

But the deck was hardly stacked in favour of e-cigarettes. Initially, the Schroeder Institute was hostile to the prospect of e-cigarettes as harm reduction. In a 2010 editorial in *AJPH*, Schroeder Director David Abrams wrote, "ENDS should be removed from the market and permitted back only if and when it has been demonstrated that they are safe, that their benefits outweigh their harms to overall public health, and that a comprehensive regulatory structure has been established under the appropriate FDA division. … Until then, health and safety claims based on assumptions are unacceptable" (Cobb et al., 2010).

As the evidence evolved, the institute cautiously opened itself to the harm reduction potential of e-cigarettes. By 2014, Abrams called the products "a disruptive technology that might give-cigarettes a run for their money" (Abrams, 2014a). A year later Abrams expounded on this perspective in *JAMA*. "Applying overly burdensome, expensive regulatory hurdles to e-cigarettes could stifle innovations and favor the market domination of tobacco companies." For Abrams the central question was whether e-cigarettes should be aggressively supported by tobacco control advocates. He described this as "an extraordinary opportunity to end the-cigarette century well before the 100th anniversary of the Surgeon General's report on smoking and health in 2064" (Abrams, 2014b).

But it was a moment in which political controversy was mounting. Those who advocated for tobacco harm reduction found themselves under enormous political pressure. Over the years in the course of our formal research, the individuals we interviewed in both academic and government positions reported experiencing a variety of tactics that had become part of the anti-tobacco playbook to silence them or bring them around to the emerging public health anti-e-cigarette consensus (Pertschuk, 2001). Some were accused of taking funds from big tobacco. Pressure was put on supervisors to "muzzle," fire, or deny tenure to individuals. Others did not need a direct threat, but it was clear to them that their jobs depended on aligning with anti-vaping messages coming from major NGOs and the CDC (Fairchild & Bayer, 2016a, 2016b).

At the centre of the heated controversy that had begun to inform the debate over e-cigarettes, Abrams wrote, "Policy making relies on science not dogma…It is not nicotine per se that kills people.... If nicotine can be decoupled from deadly tobacco smoke, adults and youth can be saved—The public health standard need not be weighed to favor youth prevention" (Abrams, 2014a).

It was thus no surprise, in 2015, that the foundation, now renamed the Truth Initiative, published an extensive review of the literature that made clear the grounds for the role of e-cigarettes in harm reduction. The "Truth About: Electronic Nicotine Delivery Systems" sought to debunk what it deemed as unfounded assertions about the risks posed by e-cigarettes. A striking feature of the analysis was the extent to which it relied on the work of Public Health England, which had published the evidence base for UK e-cigarette policy. Truth's report concluded, "If prudently regulated we believe ENDS hold promise as one means to move smokers to a less harmful product and reduce the devastating death and disease burden caused by combustible tobacco products" (*The Truth about*, 2015).

Cheryl Healton left the Truth Initiative in 2014. But her impact lingered for some time. In a 2015 letter to the acting commissioner of the FDA, the Truth Initiative reiterated its belief that "the overarching goal of …regulation must be to protect the public health. By maximizing ENDS benefits and minimizing ENDS potential harms…" (Udall et al., 2015).

In time, however, new leadership at the Truth Initiative did a dramatic about-face on e-cigarettes. A determination to focus exclusively on the potential risks to children was central to the radical shift. Reflecting the new orientation, the organization took all earlier public facing messages that embraced the role of e-cigarettes for harm reduction from its website. Asked to explain the new stance CEO Robin Koval stated, "We have an epidemic of young people vaping. We know from an emerging body of science that these products are far from harmless" (Gunther, 2021). By 2018, the Schroeder Institute was absorbed into the Truth Initiative, losing its quasi-independent status. It is two most prominent scientists, who had been strong proponents of the role e-cigarettes in confronting the toll of smoking combustible-cigarettes, resigned.

With the radical turn on the part of Truth Initiative, there remained no strong institutional voice on e-cigarette policy that was firmly grounded in a commitment to harm reduction for current adult cigarette smokers. That voice was to be filled by what amounted to an ad hoc group periodically called together by Thomas Miller. Of note, a number of those who joined the group were formerly leaders in the no longer independent Schroeder Institute at the Truth Initiative.

Miller's position as an advocate for the role of e-cigarette in combatting the toll of tobacco cigarettes was well-known. A public address he delivered in 2016 was titled, "E-cigarettes—A Harm Reduction Tool to Save Millions of Lives." As he laid out his case, he underscored how poorly understood the evidence-based was. "What troubles me and bothers me a lot," he concluded, "is that the American public does not realize that ecigarettes are dramatically less harmful. The misconceptions are amazing and extremely troublesome. …  It was that commitment to sharing unvarnished evidence that was to inform Miller's ongoing efforts to address the public health challenge of e-cigarettes.

The FDA officially deemed c-cigarettes tobacco products on 8 August 2016 (FDA, n.d.). On 14 June 2017, in a letter addressed to recently appointed FDA commissioner Scott Gottlieb, Miller brought together a group of co-signers who laid out what was essential to a policy approach that would be committed, in deed as well as word, to harm reduction. Children had to be protected from nicotine addiction while adult smokers had to have access to e-cigarettes that protected them from the harms of combustible tobacco cigarettes. Further, the group urged, "It was necessary to have in place a regulatory framework for less harmful products." While acknowledging that Gottlieb had spoken favourably about harm reduction, the letter asserted, "At this time we do not believe that the current regulatory framework for the low-risk nicotine products such as e-cigarettes and smokeless tobacco is appropriate or will deliver the substantial public health benefits we hope and expect FDAs oversight will bring" (Miller et al., 2017). The letter went on to lay out a broad set of policy proposals that would be familiar to those who had followed the arguments that had made clear by the early American Legacy Foundation stance and the publications of the research scientists at the Schroeder Institute.

## 5 Protecting Children: Harm Reduction Under Fire

Two weeks after the FDA's deeming rule, on 28 June 2017, Scott Gottlieb announced a "new comprehensive plan for tobacco and nicotine regulation" under the Tobacco Control Act (TCA) (Gottlieb, 2017). Companies that hoped to market new e-cigarettes were required to submit to the FDA a pre-market tobacco product application, known as a PMTA. E-cigarettes that were already on the market when they were deemed tobacco products in 2016 also had to meet this requirement. To allow for both scientific deliberation and product innovation, the FDA initially set a deadline of August 2018 for those products to submit a PMTA (Lindbloom, 2020). In 2019, it extended that deadline to August 2022. At the heart of the change was what the agency described as "a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible-cigarettes" (FDA, 2017). Combusted tobacco was the most dangerous, followed by regular smokeless tobacco, low-nitrosamine smokeless tobacco, e-cigarettes, and, finally, nicotine replacement therapy. The FDA's statement, followed by a strong rationale in the *New England Journal of Medicine* in September, 2017, recognised harm reduction as an appropriate public health strategy for curbing the tremendous morbidity and mortality toll of combustible tobacco (Gottlieb & Zeller, 2017).

Just months after its potentially game-changing summer statements, the FDA published a blog that suggested to many that it might, after all, hew to a more restrictive definition of harm reduction, harking back to its original position in which it tried but failed to treat them as therapeutic devices. On 29 November 2017, the agency announced the creation of a Nicotine Steering Committee charged with "re-evaluating and modernizing FDA's approach to development and regulation of nicotine replacement therapy products that help smokers quit." Alarming to some e-cigarette advocates was a new medical orientation: "FDA also sees compelling opportunities to explore additional opportunities for the development of new and improved products that could be sold as new drugs, typically as over-the-counter pharmaceuticals" (Gottlieb, 2017). For advocates of harm reduction, there had to be non-medical (e.g., recreational) alternatives for smokers who either wanted to quit or who wanted to enjoy nicotine without the terrible risks of combustible tobacco smoking.

The FDA's more cautious course would come to rest on an evidence review that it commissioned from the prestigious National Academies of Science, Engineering and Medicine (NASEM, 2018). NASEM's official charge was to analyse the research literature, identify the need for research to fill evidentiary gaps, and make judgments about the short- and longterm health effects of e-cigarettes.

The NASEM report affirmed the mounting evidence that e-cigarettes were substantially safer than combustible products: "There is conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users' exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes" (NASEM, 2018). But the report sounded an alarm when it came to the risks to children and bystanders, two of the weight-bearing pillars of the US approach to tobacco control.

NASEM concluded that since e-cigarettes contained and emitted potentially toxic substances, "using e-cigarettes in indoor environment may involuntarily expose non-users to nicotine and particulates, but at lower levels compared with exposure to secondhand smoke from combustible tobacco cigarettes." On the heels of the NASEM report, the CDC stated in information for consumers, "E-cigarette aerosol is not harmless. It can contain harmful and potentially harmful substances, including nicotine, heavy metals like lead, volatile organic compounds, and cancer-causing agents" (NASEM, 2018).

When it came to children, the report advised, "There is substantial evidence that e-cigarette use increases the risk of ever using combustible tobacco cigarettes among youth and young adults." While the report did note contradictory data, it determined that observational or ecological evidence could not provide a conclusive refutation of the risk to children. Only randomised clinical trials could meet that bar. And conclusive proof, for NASEM, was the standard when it came to vulnerable populations like children (NASEM, 2018).

Most important was how the head of FDA's Tobacco Division, Mitch Zeller, read the evidence in light of the NASEM Report. "For kids who initiate on e-cigarettes, there is a great chance of intensive use of cigarettes. As the regulator," he said, "we've got to factor that in" (Kaplan, 2018). How that evidence should be factored in was clear to Shannon Lea Watkins, a member of Stanton Glantz's research team, which had long warned of threats posed by e-cigarettes. "It comes down to this tradeoff between definitely hurting kids and maybe helping some adults," she said. "To me the tradeoff sounds quite clear" (Anapol, 2018).

How different the "trade off" might be understood was made clear by an analysis conducted by Kenneth Warner and his colleague Lynn Kozlowski. Citing evidence from large, cross-national studies, they argued that adoption of e-cigarettes as a harm reduction tactic "might come at the cost of additional new smokers among the younger generation. While unpleasant to contemplate, this cost must be compared to the far more immediate benefit in terms of health consequences that would be realized by adults quitting smoking" (Kozlowski & Warner, 2017).

With children at the centre of debate, harm reduction became a politically unpalatable approach. Said FDA Commissioner Gottlieb, "Innovations that could present an alternative to smoking—particularly as it relates to e-cigarettes—cannot, and will not, come at the expense of addicting a generation of children to nicotine through these same delivery devices" (Gottlieb, 2018).

In September 2018, the FDA launched a \$60 million campaign targeted at adolescents who had used or might be tempted to use ecigarettes. Employing graphic imagery, the campaign depicted hideous worm-like creatures crawling under the skin and into the lungs and brains of otherwise blemish-free teenagers. The ads sounded an urgent warning: "There is an epidemic spreading" and "vaping can put dangerous chemicals into your lungs." The Agency's "Don't Get Hacked" campaign suggested that nicotine triggered a kind of wild-eyed mania or personality hacking, in which nicotine transforms teens into emotionless robots that lack the autonomy or charm of a chatbot. The imagery and language evoked the 1920s and 1930s, when narcotic crusaders framed drugs as "parasites" and addicts as little more that "The Living Dead" (Speaker, 2001).

Beyond the risk that e-cigarettes posed as a gateway to tobacco cigarettes, another danger informed the FDA's posture. Increasingly, the argument became that nicotine, in and of itself, posed a threat to the developing brain of adolescents. This was all the more remarkable since decades of research on tobacco had never suggested such a threat. Indeed, the Surgeon General's 1988 Report on Nicotine centred on the harms of addiction and the potential nature of the impact of nicotine on organ systems without mentioning the brain (Kandel, et al., 1994). But the 1988 Joe Camel controversy, centered on R.J. Reynold's adoption of a cartoon character in its marketing, had sparked interest in nicotine's impact on the brain (Fairchild & Colgrove, 2004). Both the Surgeon General and the director the CDC came to express alarm about the threat of nicotine exposure to the adolescent brain.

It is against this backdrop that JUUL—an inexpensive, trim, high tech device that looked like a long, elegant thumb drive—entered the market in 2015 without the legacy of having previously manufactured combustible products. Sales of JUUL kits increased 680 per cent and sales of refills increased 710 per cent between 2017 and 2018, according to RBC Capital Markets. JUUL quickly took command of the e-cigarette market. On 6 October 2018, Wells Fargo Securities attributed 74.5 per cent of e-cigarette market unit shares to JUUL (Craver, 2018).

JUUL, which in the US had a much higher nicotine content than in the UK, improved nicotine delivery to users, meaning that they got more nicotine, faster, than with other vaping products. Most products on the market used propylene glycol and glycerine as the solvents that allow the delivery of nicotine (*Public Health Statement*, 1997). Distinguishing JUUL was its use of nicotine salts, a mix of a nicotine base combined with a weak organic acid (NASEM, 2018). Nicotine salts allowed for absorption of nicotine in a fashion similar to combustible products. One 2018 study suggested that the nicotine hit from JUUL was also less harsh on the throat, which might produce a more pleasant experience for both seasoned cigarette smokers and people who had never smoked or vaped (Nguyen, 2018).

All of the features that made it appealing to adults also made "JUULing" a youth phenomenon. It was, in addition, easy to hide because it was small and produced little vapour. A Truth Initiative study found that, in a national sample of 1012 people aged 15–17, seven per cent reported ever having used a JUUL. Twenty-one per cent of this age group also recognised a photograph of a JUUL. Recognition (34 per cent) and past 30-day use (11 per cent) were higher among those in the sample who were more affluent. Adolescents who were just experimenting might not realise that JUUL delivered nicotine as efficiently as a combustible product, potentially increasing their risk of addiction (Willet et al., 2018).

In May 2018, the former chair of the American Academy of Pediatrics Tobacco Consortium weighed in on the side of peril. Dr. Jonathan Winickoff described JUUL in *The New Yorker*, a culturally sophisticated and politically liberal weekly with a generally affluent readership, as nothing short of "bioterrorism." He declared JUUL "a massive publichealth disaster" (Tolentino, 2018). Once again resisting the tide, Iowa Attorney GeneralTom Miller, continued to see promise in JUUL and other products that delivered nicotine electronically. Miller continued to argue that public health had an obligation to inform the public that ecigarettes were substantially safer than combustible products. While Miller said that JUUL gave "cause for concern" when it came to kids, "it had not reached panic or epidemic stages" (Miller, 2018a).

## 6 The Pressure for Regulation Mounts

Deep concern about the malevolent intentions of e-cigarette proponents was fuelled when JUUL established an important financial relationship with Altria, the makers of Marlboro. "The union," the *New York Times* reported, "would create an alliance between one of public health's greatest villains and the start-up that would upend it. Particularly, alarming was Altria's plan to invest "\$12.8 billion for a 35 percent stake in JUUL, at a \$38 billion valuation" (Richtel & Kaplan, 2018).

A review of newspaper articles, op-eds, and editorials from the *New York Time*s, and *Los Angeles Times* makes clear that from 2010 onward, pessimistic pieces on e-cigarettes had come to over-shadow descriptive new accounts. Optimistic stances were all but eclipsed.

Nothing more tellingly underscored the prevailing tone of profound hostility to e-cigarettes, than the decision on the part of the *New York Times* to publish on its front page an investigative report detailing the horrific experience of an adolescent who quickly became addicted to nicotine through e-cigarettes, and his subsequent struggle to break free of the overpowering drive of his dependence. In what may have been an act of balancing, the *Times* published a less emotionally compelling account of a person who had successfully used e-cigarettes to free herself from tobacco. In mid-December 2018, the day that US Surgeon General Jerome Adams tweeted that he was "officially declaring e-cigarette use among youth an epidemic." The *Times* returned to the theme of e-cigarettes use as a crisis, again in a front-page story (Vurthy, 2018). "Addicted to Nicotine, Teenagers Have No Clear Path to Quitting" was an account of parents, teachers and clinicians all paralysed as they observed teenagers falling prey to a brain and health threatening drug (Hoffman, 2018a).

Not just in the popular media were e-cigarettes characterised as a grave threat. In January 2019, the *New England Journal of Medicine* published the results of a major randomised clinical trial on efficacy of e-cigarettes. It concluded that e-cigarettes were more effective for smoking cessation than nicotine replacement therapy (NRT). After one year, 18.0 per cent of the e-cigarette group was "tobacco abstinent" compared to only 9.9 per cent of the nicotine replacement group (Hajek et al., 2019a). For e-cigarette users who were not tobacco abstinent, the problem of dual use remained. The journal's senior editors published a formal commentary alongside the results of the clinical trial. They repeated the grim NASEM conclusions without ambiguity, "There is substantial evidence that e-cigarette used by youth increases the risk of smoking combustible tobacco cigarettes" (Hoffman, 2019).

Under these circumstances, the FDA history of delaying the PMTA process struck the mainstream public health community as inexcusable, leading many to conclude that it was necessary to challenge the agency in federal court. On 27 March 2018, after the PMTA deadline had been extended to 2022, major US NGOs including the American Cancer Society, Cancer Action Network, the American Heart Association, the America Lung Association, The Campaign for Tobacco-Free Kids, and the Truth Initiative filed a lawsuit in the Maryland Federal District Court claiming that the FDA had, in effect, violated its legal responsibility. "The FDA had effectively arrogated to itself…statutory forbearance that Congress had nowhere derogated to the agency" (*Complaint*, 2018). If it was following the law, in other words, the agency had no right to keep delaying.

One year later, on 15 May 2019, the court handed down a stinging decision. "Instead of addressing public health concerns associated with tobacco the August 2017 Guidance exacerbates the situation by stating in essence, that manufacturers can continue to advertise and sell products that are addictive and that target a youth market." The Guidance "was clearly contrary to the Tobacco Control Act's purpose" (*Memorandum Opinion*, 2019). The FDA, the court concluded, had "exceeded the authority granted to it by Congress" (*Memorandum of Opinion and Order*, 2019).

Two months later in a Memorandum of Opinion the Court imposed a 10-month deadline for PMTA submission and a one-year deadline for FDA approval. The 2022 deadline was unacceptable to the court. Yet, the onset of the COVID-19 epidemic set the stage for yet another move to extend the court's deadline. On 30 March 2020, the FDA filed a request for a 120-day extension, a request the court agreed to. Hence, the new deadline was 9 September 2021.

In the midst of these legal manoeuvres, the FDA took a modest step. In November 2018, it declared that many flavoured e-cigarettes could be sold only in shops that had age-restricted entry or that set aside products in areas that were not accessible to those under age 18. Flavours like "gummy bear" or "bubble gum" had long drawn caustic critique from those who had fought so hard to combat efforts to make vaping appealing to youth. The FDA had thus not, as many had initially hoped, banned all flavours and all advertising. Rather, it took the approach of requiring exacting age verification controls on all sales, both in stores and online.

In a forceful op-ed in the *Washington Post* in response to the new FDA regulations, Tom Miller again weighed in. Sceptical of numbers that suggested plague-like youth uptake and hyperbolic concerns that nicotine could be injurious to adolescents he wrote, "To overreact and limit access to harm reducing tools means that adults die…. The FDA should be the last institution to strip the harm reduction potential of these products. The FDA should never act in a way to cause tens of thousands of Americans, perhaps hundreds of thousands, to die" (Miller, 2018b).

These events occurred against the backdrop of dramatic amplification of the already heated controversy. In August 2019, the CDC reported the emergence of a striking number of cases of life-threatening vapingrelated pulmonary illnesses. A growing concern about the rising number of young vapers—15 per cent of cases were younger than age 18, and 37 per cent were ages 18 to 24—exposed to the risks of nicotine addiction had taken a dramatic turn with hospitalisations and fatalities from this condition (CDC, 2020). Confounding policy makers' response to the new threat was uncertainty about what had caused the sudden outbreak of acute lung injuries.

News reports captured the emerging sense of alarm. On August 15, the *New York Times* published an update with the headline, "Dozens of Young People Hospitalized for Breathing and Lung Problems After Vaping" (Kaplan, 2019). Two weeks later, against the backdrop of 193 cases nationwide, the *Times* announced, "First Death in a Spate of Vaping Sicknesses Reported by Health Officials" (Richtel & Kaplan, 2019).

Over time, public health messages became ever starker. Following a death in Los Angeles, the county's public health director stated, "Today we are issuing a warning to all residents 'Stop vaping now'" (Christodoulou, 2019). In so doing, he echoed the position of the American Medical Association, which called vaping an "urgent public health epidemic" (Berg, 2018). To spur the adoption of local and state restrictions on flavoured vaping products, Bloomberg Philanthropies announced the funding of \$160 million campaign over the next three years. Matt Myers stated that his organisation had mobilised to "transform what is going on" in "the battle over e-cigarettes" (McGinley, 2019).

Primed by long-standing fears that flavours attractive to adolescents were responsible for the steep acceleration in youth vaping, the new outbreak set the stage for more restrictive policy proposals. Indeed, total bans on e-cigarettes were being considered. In early September, Michigan's governor announced an immediate ban on the sale of e-cigarettes. In California, the governor made clear while announcing a \$20 million vaping awareness campaign that if he had the necessary legislation he would ban e-cigarettes. On September 24, Massachusetts declared a public health emergency and imposed a four-month ban on e-cigarettes.

By December 2019, four months after the initial CDC reports, both the CDC and the FDA confirmed that vitamin E acetate, a tetrahydrocannabinol (THC) product additive, was the likely cause of the US outbreak of lung injuries. Strikingly, although neither nicotine or flavoured vaping liquids were implicated and both CDC and FDA warnings focused on THC and products purchased off the streets, that new information did not reduce confusion about the source of the injuries in a context in which the youth vaping rate was increasing. Massachusetts, San Francisco, Ohio, and New York made immediate moves to ban either vaping products or flavours. The American Medical Association (AMA) called for a total ban on all vaping products. By 14 January 2020, there had been 2,668 cases and 60 deaths (CDC, 16 January 2020).

Political controversy continued unabated in 2020 as the FDA's efforts were characterised as half-measures that failed to address the threat of ecigarettes. In January, the FDA made its most substantial move against the sales of flavoured e-cigarettes. Although no e-cigarettes had yet received FDA authorisation through the PMTA process, the agency retained enforcement discretion and opted to "prioritizing enforcement" against flavoured products. Only tobacco-or menthol-flavoured e-cigarettes could continue to be sold. Further, it targeted manufacturers that targeted minors or failed to prevent access by minors to its products. In its press release, the agency stressed, "By not prioritizing enforcement against other flavoured ENDS products (e.g., tobacco and menthol flavours) in the same way as flavoured cartridge-based ENDS products, the FDA has attempted to balance the public health concerns related to youth use of ENDS products with consideration regarding addicted adult cigarette smokers who may try to use ENDS products to transition away from combustible tobacco products." In other words, although it did not shut the door on flavours other than menthol or tobacco, it drew a line in the sand when it came to kids: flavours like mint and fruit could no longer be marked without agency authorisation. It also determined to target enforcement against e-cigarettes, regardless of flavour, that had not submitted a premarket application (*FDA finalizes*, 2020).

This move drew sharp rebukes from those who believed the agency had retreated from what many took as a pledge by President Donald Trump to "sweep the market" of all flavours except tobacco (McGinley, 2020). Harold Wimmer, President and Chief Executive of the American Lung Association said the plan could "only compromise the health of our nation's children" (Dasey, 2020). For Robin Koval of the Truth Initiative, this was nothing more than a Band-Aid when major surgery was called for (Dasey, 2020). Significantly, the ongoing hostility to e-cigarettes by Democratic law makers became ever more present. Patty Murray, the ranking member of the Health Education, Labor and Pensions Committee of the US Senate, attacked the FDA Commissioner as "having placed politics ahead of science, data and public health." She like other Democrats saw this retreat on the part of the FDA as emblematic of the politics of the Trump Administration. After all, she said the President had said that vaping was a big industry and "we want to protect the industry" (Dasey, 2020).

Thirty Democratic Senators, in a letter to the Commissioner to the FDA, wrote that the "Newly announced e-cigarette flavour policy represent[ed] an alarming reversal from what the administration promised." The policy, they said, was "weak and unlikely to have a meaningful impact on e-cigarettes use by youth" (Weixel, 2020). A month later Democrats in the House of Representatives passed a bill that would forbid the sale of flavoured cigarettes and e-cigarette liquids (Sheryl, 2020). The vote was 213 for banning and 195 against, and largely along party lines. "All but 5 Republicans voted against the bill. For them the measure represented overreach by a big government, liberal elites, telling adults what they can do." A striking feature of this vote was the fact that some African American Democrats viewed the bill and its ban on menthol as "a targeted attack" rather than as a "value neutral health car policy decision" (DeBonis, 2020).

At the same time, the FDA's effort was attacked by the vaping industry as a grave threat (DeBonis, 2020). Evidence suggested that vaping flavours with or without nicotine might appeal to youth, but flavours also appealed to adult smokers and might help them switch. Some evidence suggested that the vast majority of smokers who successfully switched completely from smoking combustible products to vaping did so—often after weeks, months, or even years of dual use—by transitioning from tobacco-flavoured or menthol-flavoured liquids, to other flavours and often to lower nicotine concentrations, or even to no nicotine in order to reduce the triggers that reminded them of their prior combustible smoking product (Abrams et al., 2018; Hajek et al., 2019b; McNeill et al., 2018; Russell et al., 2018).

In the next months, prior to the court-imposed deadline of 2021, the FDA followed through with its targeted approach. In April 2020, the FDA issued 10 warning letters to those who sold and produced or imported unauthorised nicotine delivery systems that were targeted to or were likely to promote use by youths. The director of the FDA's Centre for Tobacco Products said of these warnings, "the public should really be outraged by these products." He went on to say, "If you're marketing or selling these products to youth, the FDA will not tolerate it" (*FDA Warns*, 2020). In July, the FDA again issued warning letters notifying 10 companies to remove their flavoured products from the market since they lacked premarket authorisation (*FDA Warns*, 2020).

The COVID-19 epidemic provided yet another occasion for pressure to mount for more aggressive regulation. A study published in the *Journal of Adolescent Health* suggested a dramatic increase in the risk of disease among those who vaped. The study leader stated, "In young people many believe their age protects them but the data shows that this isn't true" (Digitale, 2020). This provoked a Democratic controlled subcommittee of the House of Representatives to send a letter to the FDA calling upon the agency to "temporarily clear the market of all e-cigarettes for the duration of the coronavirus crisis" (Howard, 2020).

The long-anticipated 9 September 2021 FDA regulations that would confront the challenges posed by larger companies involved in the production and sale of e-cigarettes was, as we have noted, met with an announcement that there would be yet another delay. While it had rejected the applications of 940,000 flavoured e-cigarette products, one careful observer noted, "they hadn't made any of the tough decisions…I expected a little bit more" (Richtel, 2021). The American Heart Association, which had long called upon the FDA to reject the application of JUUL, expressed its disappointment noting that large companies involved in the vaping industry "had targeted our nation's teens for years and contributed to the epidemic of tobacco use among youth" (Phend, 2021).

In August 2021, the depths of the division over policy was thrown into bold relief. The *American Journal of Public Health* published yet another appeal to consider the potential contribution that e-cigarettes could make to the goal of reducing morbidity and mortality associated with smoking tobacco cigarettes. "Balancing Consideration of the Risks and Benefits of E-Cigarettes" was co-authored by 15 past presidents of the SRNT, an international organisation with approximately 1000 members. Of the past presidents since the organisation's founding in 1994, only seven had chosen not to join the effort that had commenced several months before the article's publication (Balfour et al., 2021).

There was little that was new given the long-standing effort of harm reduction proponents to press for a careful understanding of the evidence. What mattered most was an appeal to reason: "our objective is to encourage more balanced consideration of vaping within public health and in the media and policy circles." Given the conclusion that e-cigarettes could contribute to smoking cessation it was essential that smokers "should be well informed about the relative risks of vaping and smoking and vaping's potential to help quit smoking." Acknowledging the need to carefully monitor the challenge of youth vaping, the authors lamented that "as public health groups, the media, policy makers and the general public focus[ed] on youth vaping, vaping's potential to help adults quit smoking too often gets lost. That may come at a significant public health cost." A final element of this appeal centred on the fact that a disproportionate number of African Americans, those with lower education, individuals with mental illness, and LGBTQ individuals smoked cigarettes. It was they who became ill in greater numbers; it was they who died from tobacco-related illness at higher rates. In short, this was a challenge to social justice (Balfour et al., 2021).

A contemporaneous statement by the Truth Initiative could not have been more different. Most strikingly in their September 2021 statement was the determination to embrace a very narrow interpretation of what harm reduction truly necessitated. Truth acknowledged the contribution of needle exchange to preventing the spread of HIV infection among drug users. But it went on to state, "We forcefully reject…the notion that [harm reduction] requires the further development of a huge commercial market in addictive nicotine products focused on youth and young adults. Instead, we argue that a genuine harm reduction approach requires a measured and careful deployment of nicotine alternatives that are tightly focused on helping smokers who otherwise would not quit smoking cigarettes…[We] reject the notion that unregulated or lightly regulated commercial markets in nicotine alternatives are equivalent to harm reduction" (*Truth Initiative Statement*, 2021). It was against this background that the FDA appeared, surprisingly, to side with those who had argued that e-cigarettes could indeed make an important contribution to the public health effort to reduce the toll exacted by smoking tobacco. On 12 October 2021, the FDA issued a long-awaited decision on e-cigarettes, permitting the sale of two nicotine flavoured cartridges manufactured by R.J. Reynolds corporation. In making the announcement, the FDA stated that the "potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth provided that [the company] follows post marketing requirements aimed at reducing youth exposure and access to [these] products." In taking these steps, the agency noted that it had ordered the removal of more than 1,000,000 products "that lacked sufficient evidence that the benefit to adult smokers who used the flavored products would overcome the public health concern posed by the well documented and considerable appeal of the products to youth" (*FDA Permits*, 2021).

Left to a future moment was the question of menthol. On 29 April 2021, the FDA had made clear its intention to ban menthol in combustible cigarettes (*FDA Commits*, 2021). Menthol has long been the single most dangerous tobacco chemical flavour when it comes to both adult and youth smoking. Despite two FDA-derived reports that recommended a ban on menthol in combustible products, one internal and one externally commissioned, there has been policy paralysis in the face of appalling evidence: 52 per cent of all adolescents initiate smoking with menthol. But among African American youth, that figure is over 90 per cent (Villanti et al., 2017). The menthol burden on African American communities reflects a history of deliberate marketing. After the 1950s, as the evidence on the harms of smoking began to mount, industry shifted from marketing menthol away from women to Black Americans. Industry engaged in what historian Keith Wailoo calls "corporate race work" to target the urban market in Black communities. For marketers, "human crises (drug use, economic distress, fears of cancer, poverty) were opportunities" (Wailoo, 2021, p. 12). Although smoking rates dropped for all racial groups in the US, targeted marketing created disparities in consumption (and, as a result, death and disease) that have narrowed since the middle of the last century but not yet closed for Black men. In a context in which behaviours like smoking were increasingly viewed not as having structural causes but as being the result of bad choices, such disparities had consequences for stigma and discrimination in social and economic life as well as in access to care (MMWR, 2011).

Even though there is currently a renewed push to ban menthol in combustible products, it continues to remain unclear whether the FDA would extend such a ban to e-cigarettes. But in approving only tobaccoflavoured e-cigarette products in October 2021, it seemed more certain that e-cigarette flavours would be a thing of the past, shaped in large measure by the historical contours of debate over tobacco and youth in this US.

The decision on the part of the FDA was remarkable in that it had determined that the evidence supported a harm reduction approach to the human toll of smoking combustible tobacco products. In so doing, it hewed to a position that put it at odds with a well-financed campaign on the part of virtually the entire public health establishment in the US. At the same time, the agency rejected the claims on the part of e-cigarette proponents that a range of flavours other than tobacco could enhance the appeal of e-cigarettes to adult smokers.

It was not surprising that the FDA drew the ire of long-time antagonists to e-cigarettes who saw in them yet another ploy on the part of the tobacco industry. The national assistant vice president for advocacy of the American Lung Association stated bluntly "This throws young people under the bus. The industry has been waiting for the next big thing and they found it with e-cigarettes" (Richtel & Kaplan, 2021). A Democratic Congressional representative echoed the position that had characterised the party's deep hostility to the tobacco industry e-cigarettes, stating, "The FDA has turned its back on the public health by approving high nicotine e-cigarettes" (Washington Post 10/2021), and accusing the agency of "ignoring the data" (Pietsch, 2021).

The decision was also castigated by e-cigarette proponents, who had asserted that a range of flavours made e-cigarettes more appealing to smokers seeking options that helped them transition away from combustible cigarettes.

It thus came as a surprise to many that, not ten months later, the FDA issued is Denial of Marketing Order to JUUL, noted at the start of this chapter.

## 7 Conclusion

On 23 June 2022, the FDA issued its ruling against the marketing of JUUL vaping products. For proponents of harm reduction, this seemed nothing short of a defeat, despite the willingness of the FDA to approve some e-cigarettes. It is thus important at this juncture to acknowledge the issues at hand have not finally been put to rest.

A huge, and apparently unbridgeable, gulf continues to separate the Truth Initiative, other major NGOs, and the core of the public health community from those who warned that overly restrictive measures would subvert the fundamental goals of public health by denying harm reduction as a viable approach for smokers. It would be naïve to imagine that evidence alone will resolve this debate with its deep historical roots. Fear of addiction, even benign addiction, remains a central concern for American policy makers. Youth, too, remain centre stage. Understanding and reckoning with these powerful frames will continue to shape the prospects for both those opposed and committed to tobacco harm reduction.

## Bibliography

FDA. https://www.fda.gov/news-events/press-announcements/fda-deniesmarketing-applications-about-55000-flavored-e-cigarette-products-failing-pro vide-evidence

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## Conclusion: Why Did the UK, US and Australia Have Different E-cigarette Policies?

*Virginia Berridge, Amy L. Fairchild, Kylie Morphett, Coral Gartner, Wayne Hall, and Ronald Bayer*

**Abstract** We sought to understand why three countries with similar political systems and similar anti-smoking policy histories developed such very different policies towards e-cigarettes. All appealed to a value-free concept of "evidence" in making use of precautionary and harm reduction principles to deal with the remaining uncertainties in the evidence. Yet policy processes were mediated by important contextual factors. These

e-mail<EMAIL_ADDRESS>
A. L. Fairchild

© The Author(s) 2023 V. Berridge et al. (eds.), *E-Cigarettes and the Comparative Politics of Harm Reduction*, https://doi.org/10.1007/978-3-031-23658-7\_5

V. Berridge (B)

Centre for History in Public Health, London School of Hygiene & Tropical Medicine, London, UK

College of Public Health, The Ohio State University, Columbus, OH, USA e-mail<EMAIL_ADDRESS>
included: the nature and role of the state in each country; the political parties in power at the time e-cigarettes were first introduced; the role played by existing regulatory institutions in dealing with e-cigarettes; longer-term changes in ways of thinking about tobacco smoking within public health; the specific pre-history of tobacco control policy, nicotine and smoking cessation services; the organisation of professional and activist networks that were in favour of and against e-cigarettes; the uses of fear to discourage e-cigarette use; and the influence (or lack thereof) of harm reduction ideas from drug or AIDS policy on tobacco control policy. The object of policy also differed between countries from protecting the smoker to protecting children and young people.

**Keywords** Evidence · Precautionary principle · E-cigarettes · Nicotine · Policy · Activism · Public health · Fear

The UK, Australia and the US are three nations that share a liberal democratic tradition and each of which adopted similar approaches to reducing the public health toll of cigarette smoking after 1962. By the twentyfirst century, all had achieved dramatic reductions in smoking prevalence among adults by introducing a range of tobacco control policies that included increased cigarette taxes, restrictions on tobacco promotion,

K. Morphett · C. Gartner

School of Public Health, Faculty of Medicine, University of Queensland, St Lucia, QLD, Australia e-mail<EMAIL_ADDRESS>
C. Gartner e-mail<EMAIL_ADDRESS>
W. Hall National Centre for Youth Substance Use Research, University of Queensland, St Lucia, QLD, Australia e-mail<EMAIL_ADDRESS>
R. Bayer Center for the History and Ethics of Public Health, Mailman School of Public Health, New York, NY, USA e-mail<EMAIL_ADDRESS>
smoke-free policies and public education campaigns to encourage smokers to quit and to discourage non-smokers from taking up smoking.

In the early 2000s, all confronted a new common challenge in deciding how to respond to the marketing of e-cigarettes in the first decades of the new century. Each country pursued a different path towards the regulation of these new products; all did so in the name of public health. In this final chapter, we synthesise our accounts as to why our three countries developed very different policies on e-cigarettes over the last decade. Discussion on the subject has often focused on seemingly valuefree concept of "the evidence" and the appeal to "the precautionary principle" and tobacco harm reduction. Our analyses emphasise how these concepts are rooted in and mediated by social and policy contexts.

Our conclusions reveal the important role played by country-specific factors. These include: the nature of the state and the "pre-history" of policies towards tobacco and nicotine in each country, as well as the broader political context. Against that backdrop, also key were leading ideas about tobacco control within regulatory institutions and the role of policy and activist networks in each country. Changes within public health, particularly after World War II, also helped to shape differences, as did the impact of ideas from the field of drugs and HIV. The approach to drugs and HIV heavily influenced the political viability of harm reduction approaches, which had implications for tobacco control and e-cigarettes. Also important were differences in the acceptability of fear-based campaigns and what counted as evidence and populations of concern. Who was the object of policy was also important—whether it was the smoker who had to be protected and encouraged to stop smoking or whether it was young people who had to be protected. Let us consider each of these factors in turn.

## 1 The Nature of the State

England is a highly centralised state in which relatively little power is delegated to local government. The centralisation of policy making in England means that when the central government decided on a policy towards e-cigarettes it became the policy of the whole country. There were initiatives at the local level, but in most cases these were pioneering uses of e-cigarettes in smoking cessation services before this policy was endorsed centrally.

Australia and the US, by contrast, are federal states in which policy making is divided between federal and state governments. States may have their own policies or adopt variations of federal policy. In Australia, federal and state governments agreed to ban the sale of e-cigarettes containing nicotine by using poisons regulations. Some state governments banned the sale of all e-cigarettes, including those that did not contain nicotine. A National Tobacco Strategy has attempted to harmonise state policies.

In the US, most public health policy is a matter of state and sometimes municipal decision making. In the absence of federal policy on e-cigarettes for more than a decade, some cities and states imposed stringent regulation involving limitations on where and to whom e-cigarettes might be sold. San Francisco, for example, was ahead of the federal government striking a precautionary posture when it came to regulating e-cigarettes. Within the federal government, there were disagreements in approach between key bureaucracies with responsibility for the regulating e-cigarettes, the CDC and the FDA. It was only in 2021 that the federal government assumed a leading role shaping policy that would provide a policy framework that would override state and local policies that might have been less restrictive. So the degree of centralisation of state power was a key factor in policy making.

## 2 The Political Context

Governments from the late 1990s in the UK, both Labour and Conservative/Liberal Democrat, generally welcomed the use of nicotine products and later e-cigarettes. The Labour government expanded stop smoking services to address social inequalities in smoking prevalence, and the use of NRT was a key feature of these services. The Conservative-Liberal Democrat coalition government continued this support. It also expanded the approach to include e-cigarettes in line with its preference for a light, "hands off" approach to regulation.

In the US, there was virtually no political support for making ecigarettes available as harm reduction devices. Indeed, at a federal level, the Democratic Party and, especially, its most liberal constituents saw ecigarettes as a threatening ploy by the tobacco industry to undermine tobacco control. In the period marked by federal restraint, restrictive measures were adopted by state and local governments where Democrats were in power. Only marginal libertarian voices with no political sway expressed an openness to e-cigarettes as part of the more generalised opposition to a "nanny" regulatory state.

In Australia, e-cigarette policy was formulated under a centre-left Labour government that was more sympathetic than its Liberal-National Party predecessor to tough tobacco control policies. Policy was made by a Health Minister who wanted to end tobacco smoking. She was advised by tobacco control advocates who had secured earlier bans on tobacco advertising and the sale of smokeless tobacco products. Smoking was increasingly concentrated in low-income groups, but reducing social inequality in smoking prevalence was much less of a policy focus in Australia apart from public subsidies for NRT and smoking cessation medicines. There was little history of the use of NRT for harm reduction in quit smoking services.

## 3 The Role of Regulatory Institutions

Regulatory institutions have played a key role in the three countries. In England, the MHRA as the licensing organisation was already heavily involved in the harm reduction agenda. NICE guidelines did not advocate the use of e-cigarettes immediately but later took on board the harm reduction case. Public Health England played a particular important role. As an "arm's length" government body, it was not part of the Department of Health or the "empire" of the Chief Medical Officer. Its tobacco function was free standing and in strong relationship to the drugs and alcohol field, for which the agency was given responsibility when founded in 2013. The new organisation facilitated linkages between policies across tobacco and other substances. In that sense, it mirrored the linkages within the Addiction Research Unit where Michael Russell had carried out his work.

The regional regulatory level was also important. The role of the European Union and Britain's membership was important, as was the consumer response to e-cigarettes in policy processes. This contrasted with the role of WHO's influence on policy. There was a long history of UK/WHO liaison and of policies flowing from national to international levels and vice versa. That did not happen in the case of e-cigarettes in the UK where the EU role was far more influential.

In the US, as noted, there was no unanimity of approach at the federal level. The FDA was more open to tobacco harm reduction than the CDC, which was set against harm reduction in the case of e-cigarettes. This was illustrated by the CDC's haste in identifying nicotine e-cigarettes as a cause of an outbreak of lung injuries—EVALI that its own investigations later showed were the result of contaminated illicit cannabis vaporisers. Yet there was also a long history of delay in formulating e-cigarette policy at the FDA, which allowed the precautionary position time to take hold and harden.

In Australia, the regulation of nicotine went down the poisons route under the leadership of the federal TGA agency that regulates poisons and medicines. State health departments agreed with this approach and used their own poisons regulations to enforce the policy. Regulators took a hostile stance towards e-cigarettes and used their poisons regulations to effectively ban the sales of e-cigarettes with nicotine unless they had been approved for medical use.

## 4 Changes Within Public Health Thinking

Our discussion has described changes in public health ideology and focus which have taken place since the nineteenth century. The most notable ones were the post-World War II emphasis on the role of lifestyle and risk in noncommunicable diseases symbolised by the smoking issue. This and the anti-industry/stop smoking "turn" of the 1970s dominated a whole generation of public health researchers and activism. This was the case in all three countries a notable area of similarity between them.

The UK and US pioneered in making anti-tobacco a key public health issue and their approach—restrictions on public smoking, limiting advertising and taxation—had become the standard one across many issues in that field. In the UK, however, by the second decade of the twentyfirst century, the anti-tobacco movement, although important as a public health cause, was no longer as dominant as it had been. Those who expressed mistrust of tobacco harm reduction were not specialists known for their tobacco work, but public health generalists, who commented on many public health issues. The nicotine researchers on the other hand were specialists in that field who had spent many years researching the topic. They had moved from the niche of "addiction scientists" into the public health arena. Public health as a practice was also changing in some areas in the UK, with medication and drugs as standard preventive tacticsstatins for heart disease, methadone for opioid addiction, nicotine for smoking cessation and harm reduction. It was notable how the mainstream public health approach was still institutionalised in the position of the Chief Medical Officer (CMO) within government. The CMO, for example, was opposed to the Nudge Unit's encouragement of e-cigarettes uptake under the coalition government. A subsequent CMO, Professor Sally Davies, expressed concerns about e-cigarettes in evidence to the Science and Technology committee of the House of Commons.

In the US, although the public health field had increasingly emphasised "personal responsibility" for health in the 1970s, smoking continued to be framed in terms of industry manipulation. Individuals could not be held accountable for smoking when the tobacco industry lied about the risks of smoking and the power of nicotine addiction. Indeed, the industry had deliberately manipulated nicotine content to better hook smokers. That framing along with the threat to "innocent" bystanders helped to justify strong government action to drive, first, smoking and, later, vaping, into the shadows.

Yet the personal responsibility framing was interpreted as "personal choice" in many parts of the nation, particularly those where Republicans dominated. In these states, there were areas where smoking in public places was not banned and high cigarette taxes had been pre-empted. In both liberal and conservative strongholds, for those who continued to smoke and wanted to quit, it was a clinical model and not a harm reduction approach that came to dominate. Treatment—lifelong, if necessary—was the path to cessation. And complete cessation was the only acceptable outcome.

In Australia, the public health advocate Simon Chapman had been an outsider for most of the 1980s and 1990s as a critic of government inaction and an advocate for tougher tobacco control policies. He became a policy insider by the middle 2000s and along with Michael Daube, shaped policies towards e-cigarettes under the new Federal Health Minister Roxon. Their advocacy of an e-cigarette sales ban was strongly supported by the cancer councils and receptive officials in the federal and state health bureaucracies. There was no countervailing, well-organised professional group that agitated for tobacco harm reduction. Those who were sympathetic to the use of e-cigarettes for cessation (including two of the authors Coral Gartner and Wayne Hall) found themselves with few allies in the tobacco control field. As was also true in the US, attempts were made to silence dissenters in the interests of the field presenting a "united front" to government.

So traditional public health, with its views formed in the 1970s, was strong and institutionalised in all three countries. But its influence in the UK was reduced for various reasons including the position occupied by researchers sympathetic to nicotine harm reduction.

## 5 The Pre-history of Nicotine Regulation for Cessation and Harm Reduction

There has been much discussion in the public health and anti-smoking fields about the "safer smoking" debacle of the 1970s. The tobacco industry introduced filtered and low-tar cigarettes to reassure smokers that the risks of smoking had been reduced. Initially, this was done with the support of governments, NGOs and public health bodies. The release of internal tobacco industry documents in the 1990s revealed that the companies were aware from their own research that low-tar and filtered cigarettes did not reduce smokers' tar exposure. Even before this in the UK, the issue of compensatory smoking had derailed the safer smoking agenda by the end of the 1970s.

The low-tar cigarette experience engendered strong hostility on the part of the public health field in Australia and the US, provoking scepticism about the feasibility of tobacco harm reduction. In the US, considerable interest in and support for safer cigarettes that dated from the mid-1960s crumbled in the early 1980s when several factors converged: evidence that tobacco companies were targeting children, lawsuits forcing the publication of internal tobacco industry documents that revealed the extent of industry deception, the conceptualisation of nicotine addiction as a disease that required treatment and acceptance and later widespread availability of nicotine replacement therapies.

In Australia, the search for safer cigarette was supported by government in the 1960s and 1970s with the aim of growing domestic tobacco production. Tobacco control advocates such as the Cancer Councils later followed the lead of peers in the UK and US as evidence on compensatory smoking emerged. The failure of safer cigarettes to reduce harm was used as justification for Australia's precautionary ban on the sale of e-cigarettes. The low-tar cigarette experience was also invoked in recent debates about e-cigarettes, with a sales ban often advocated as the best way of avoiding a replication of this earlier history. This was the case to some degree in all three countries.

In the UK, there was a more important harm reduction pre-history. This was the role assigned to nicotine as a therapy and substitute for smoking, long before e-cigarettes came on the scene. Here, there were distinct differences between the three countries. In the UK, there had been support for nicotine as a cessation tactic since the 1970s and this grew in importance during the 1980s and 1990s. Research on nicotine had expanded and, at the policy level, nicotine replacement therapy became embedded within NHS stop smoking services, which had expanded under the Labour government elected in 1997. In the first decade of the twenty-first century, the utility of nicotine therapies had expanded even further with a harm reduction objective. Nicotine was no longer seen as a short-term therapy for smoking cessation but as a potential long-term substance to replace cigarettes and thereby reduce tobacco-related harm. Allied to this was a very different attitude to nicotine addiction. It was seen as acceptable outcome in terms of the balance of risk in relation to tobacco smoking.

The US is a nation that has a long history of hostilities to public health policies perceived to be paternalistic. Youth, however, have always warranted special protections. Concern about the potential danger to youth has dominated US policy conversations about e-cigarettes. In this context, researchers began to suggest that nicotine posed a threat to the adolescent brain. Laboratory studies based on mice proved powerful and politically persuasive. The "brain disease" concept of addiction across the substances also had strong appeal in the US.

In Australia, leading tobacco control figures had long been sceptical of need for NRT, arguing that cold turkey was the most common and successful method of quitting. The policy emphasis was accordingly given to encouraging smokers to make quit attempts and providing behavioural counselling and support via telephone helplines. NRT was available for sale over the counter after the late 1990s, but there was no public subsidy for its use until 2006, when cancer councils persuaded the government to give it a public subsidy to address the social inequalities in smoking prevalence. The fear that NRT would produce an addiction was not a reason given for opposing NRT, but the fear that e-cigarettes would addict nonsmoking adolescents become a common justification for a sales ban on e-cigarettes in Australia. This was increasingly reinforced using claims originally made in the US that nicotine exposure damaged adolescents' brains.

So the role of nicotine and attitudes towards addiction showed considerable variation across the three countries even before e-cigarettes arrived. Neither the US nor Australia had the range of stop smoking services nor the health service support for nicotine as a therapy. This meant that the main focus of UK policy was the smoker, not so much the case in the two other countries.

## 6 Professional Networks in Favour and Against

Professional networks have played a key role in producing a positive response to e-cigarettes in the UK. These have a long history deriving from the network of researchers who first came into the field to work with Michael Russell at the Addiction Research Unit at the Institute of Psychiatry in the 1970s. This group was located in a psychiatric institution and favoured the use of nicotine for what later became called harm reduction. It was not part of the public health mainstream in the 1970s and 1980s. But it remained a cohesive group whose members moved into positions of influence in health institutions from the 1990s onward. Ann McNeill, for example, had worked with Russell and chaired the PHE evidence reviews of e-cigarettes. There were also allied networks, such as the Tobacco Advisory Group of the Royal College of Physicians with John Britton at the helm. This group had moved to support a harm reduction position for nicotine before e-cigarettes came on the scene. The prestige of the RCP and its stop smoking history dating back to the late 1950s gave the Tobacco Advisory Group's views particular weight.

In the US, by contrast, the most prominent networks were antie-cigarette and concerned about the adverse impact of nicotine on adolescent brains. At one juncture, the Legacy Foundation—a significant, well-funded organisation—was open to the promise of e-cigarettes, but a change in leadership produced a remarkable about-face. Renamed the Truth Initiative, it took on a leading vocal role in opposing e-cigarettes, which it portrayed as a special threat to adolescents and young adults. Those who took the contrarian pro-harm reduction view comprised a loose network of prominent researchers led by a state attorney general who had played a leadership role in the massive, successful state lawsuit against the tobacco industry. Networks of individuals, research centres and NGOs that opposed e-cigarettes all emerged as powerful evidence brokers. They took the stance that e-cigarettes were dangerous—harmful in and of themselves, even to smokers and especially so to youth. Other groups in the broader public health community accepted their evidence, partly through trust but partly because there were reputational consequences for dissenters.

The Australian network of tobacco control advocates and state cancer councils was unanimous in supporting Australia's e-cigarette sales ban. Their advocacy had successfully driven smoking prevalence down by persuading governments to adopt public health policies that reduced demand for cigarettes, viz. increased taxes; advertising bans; graphic health warnings; smoke-free policies; and a ban on the sale of smokeless tobacco. Their major policy preference when e-cigarettes appeared was to introduce plain cigarette packaging. They did not see any need for THR policies and were worried that allowing the sale of e-cigarettes would be used to promote smoking and reduce quitting. Given these policy preferences, an e-cigarette sales ban was seen as the best approach to avoid e-cigarettes entering the legal market in Australia.