Global Regulatory Approaches towards E-Cigarettes, Key Arguments, and Approaches Pursued

*Marissa Smith and Shona Hilton*

## **Abstract**

A range of regulatory approaches are being applied to e-cigarettes globally. This chapter examines the reasons for this and what this means for broader tobacco control efforts. The chapter starts with a discussion of tobacco control and how evidence has influenced the development of international tobacco control policies. The chapter then explores the development and emergence of e-cigarettes. It identifies and discusses the arguments and evidence used in the e-cigarette regulatory debates. The chapter concludes by suggesting that research in this domain could improve our understanding of what factors influence the regulatory environment, thus why different regulatory approaches as pursued.

**Keywords:** electronic cigarettes, e-cigarettes, regulation, harm reduction, precautionary

## **1. Introduction**

A key challenge for regulation of electronic cigarettes (e-cigarettes) has been keeping pace with the speed at which the e-cigarette market has emerged. But before examining regulation, it is worth considering the broader public health context in which e-cigarettes emerged and tobacco control efforts to reduce the morbidity and mortality associated with tobacco use. The health effects associated with smoking emerged in the 1950s and 1960s [1, 2]. By the 1990s, passive or environmental smoke was also found to have carcinogenic properties [3]. Since then, the tobacco control community (including public health experts, clinicians, and decision-makers) has worked together to reduce tobacco use and has been successful in supporting the implementation of various policies and frameworks such as the World Health Organisation (WHO) Framework Convention on Tobacco Control (FCTC). To address the global tobacco epidemic, the WHO developed the world's first public health treaty, the FCTC [4]. It was adopted by the World Health Assembly in 2003 and legally entered into force in 2005. The international treaty provides a comprehensive strategy for member Parties to address and combat the tobacco epidemic. It details a range of evidence-based measures to reduce tobacco demand (Articles 6–14) and supply (Articles 15–17) [4]. Between 2007 and 2014, it is estimated

that nearly 22million future premature smoking-attributable deaths were prevented as a result of the strong implementation of the FCTC [5]. Similarly, Dubray et al. [6] found that overall, countries with higher levels of implementation of the FCTC experienced greater decreases in current tobacco smoking between 2006 and 2009.

To assist parties to meet their commitment to the treaty and implement appropriate policies, in 2008, the WHO developed the MPOWER framework for tobacco control. This framework corresponds to WHO FCTC articles: Article 20 (Monitoring tobacco use and prevention policies); Article 8 (Protect people from tobacco smoke); Article 14 (Offer help to quit tobacco use); Articles 11 and 12 (Warn about the dangers of tobacco); Article 13 (Enforce bans on tobacco advertising, promotion, and sponsorship); and Article 6 (Raise taxes on tobacco) [4, 7].

Ngo et al. [8] reported a reduction in smoking prevalence and cigarette consumption during 2007–2014 as a result of the implementation of the MPOWER framework. The FCTC has served as a powerful tool to initiate, support, and advance national and global tobacco control policies. Evidence suggests that strong implementation of the FCTC and MPOWER framework can lead to significant reductions in tobacco use [6, 8, 9].

Unlike tobacco products, where most countries have coalesced around a series of regulatory approaches meant to shrink the market for the products over time, the development of alternative nicotine products, for example, e-cigarettes, has polarised the tobacco control debate. Their rapid proliferation, the limited evidence base on the long-term health effects, and their patterns of use among different population groups have led to controversial political and public health debates, with public health policymakers and researchers finding themselves with divergent views. As a result, a variety of regulatory approaches have been pursued. Before discussing the regulatory approaches pursued, it is pertinent to discuss the emergence of e-cigarettes.

## **2. The rapid emergence of e-cigarettes as a regulatory challenge**

Across the world, policy debates about tobacco control have been markedly altered by the rapid proliferation of e-cigarettes which have been readily available to global markets since 2004. This has meant that regulation has often lagged behind and been unable to keep pace with their increasing popularity, use, and availability. In addition to the rapid emergence of e-cigarettes, debates about them have led to a breakdown of old public health alliances, resulting in the polarisation of tobacco control arguments and debates about regulation.

Developing regulation has also been challenged by the speed at which a variety of models or 'generations' became available. First-generation e-cigarettes (sometimes referred to as 'cigalikes') were designed to mimic the look and feel of combustible cigarettes [10]. They are not rechargeable or refillable. Second-generation e-cigarettes are larger and are generally refillable using e-liquids [11]. E-liquids are nicotine-containing liquid solutions that are consumed in e-cigarettes. However, some solutions may contain no nicotine. Third-generation e-cigarettes (tanks or mods) are much larger than the previous generations and are refillable and rechargeable [10, 12]. They are modifiable devices ('mods'), meaning the user can customise the substances in the device [13]. The fourth generation of e-cigarettes is called 'Pod Mod'. They contain a prefilled or refillable 'pod' or pod cartridge with a modifiable 'mod' system ('Pod-Mod') [12]. Pod Mods are available in many shapes, sizes, and colours, and the most common brands worldwide include JUUL and Suroin. **Figure 1** illustrates the four generations of e-cigarette products available on the market.

*Global Regulatory Approaches towards E-Cigarettes, Key Arguments, and Approaches Pursued DOI: http://dx.doi.org/10.5772/intechopen.107343*

#### **Figure 1.**

*Illustration of the four generations of e-cigarette or vaping products. Texas department of state health services. 2020. What is Vaping? [Online]. Texas Department of State Health Services, Tobacco Prevention and Control Bureau. Available: https://www.dshs.state.tx.us/Vaping/WhatisVaping/ [Accessed 27 January 2021]., reproduced with permission from Texas Department of State Health Service.* 

This rapid emergence of e-cigarettes and the numerous generations and flavourings available has led to various concerns being raised including the risks, benefits and safety of these products. Policymakers find it hard to keep up with the rapid evolution of e-cigarettes, meaning regulations often have to be amended to include the next generation of e-cigarette. The next section will review some of the current arguments and evidence in e-cigarette debates, including the toxicology of e-cigarettes and the arguments about the use of e-cigarettes as a harm reduction tool, which have been used as evidence for pursuing a particular regulatory approach.

## **3. Arguments and evidence in the e-cigarette regulatory debate**

The development and population exposure to e-cigarettes have created a 'moral quandary' [14]. The tobacco control community remains divided on the evidence base and the appropriate approach for regulation. This section will examine some of the arguments and evidence used by different sides of the e-cigarette policy debate.

## **3.1 Should regulation take account of evidence on the health risks associated with e-cigarette use?**

Regulation could be warranted if there are health risks associated with e-cigarettes. Research on the health effects of e-cigarettes is increasing. The toxicology of e-cigarettes is an area that has been extensively studied by various scientific bodies. E-cigarette operation does not involve combustion, therefore no smoke or other harmful combustion products, such as tar and carbon monoxide, are formed [15, 16]. However, the content of e-cigarettes is a key concern for those considering whether further regulation is warranted. The variations in product design and e-liquid compositions among the variety of brands available affect the toxicants and chemicals released in the aerosol and delivered to the user [17]. E-liquids are

available in a variety of nicotine concentrations, with levels ranging from 0 mg/mL (i.e., no nicotine) to over 59 mg/mL [18, 19], and a single e-liquid cartridge for some devices can contain the same amount of nicotine that is in a pack of 20 cigarettes [20]. For general reference, combustible tobacco cigarette smokers absorb about 1 mg (range = 0.3–2 mg) of nicotine systemically from smoking, which represents about 80–90% of the amount of nicotine inhaled [13].

Research has identified a variety of chemical components in the cartridges, e-liquids and aerosols of e-cigarettes [21, 22]. Substances identified in e-liquids and aerosols include nicotine, tobacco-specific nitrosamines, aldehydes, metals, volatile organic compounds, phenolic compounds, polycyclic aromatic hydrocarbons, flavours, tobacco alkaloids and drugs (such as amino-tadalafil and rimonabant) [17, 18, 23–28]. Despite concerns regarding the contents of e-cigarettes, research has found the levels of these compounds to be lower than those found in traditional cigarettes [18, 24, 25, 28]. Additionally, research by Goniewicz et al. [24] showed that the carcinogenic compounds in e-cigarettes are 9–450 times lower than the levels found in traditional cigarettes and are comparable to the levels found in currently licenced nicotine-containing products. This could suggest that regulation does not need to mirror the regulation of tobacco cigarettes. However, there have also been concerns about the effects of flavoured substances administered by inhalation. For instance, there are some chemicals that, although approved for ingestion, have adverse health effects when inhaled including diacetyl, acetylpropionyl, acetoin, cinnamaldehydes and benzaldehyde [13]. There is also the issue of passive exposure although current research largely shows that second-hand vapour from e-cigarettes exposes bystanders to nicotine and other chemicals, is much less than from cigarette smoke [24, 29, 30].

Other health risks also muted in regulatory debates are about the risk of nicotine intoxication and fatal poisoning, particularly in young children if a high nicotinecontent solution is ingested [31, 32]. There have been incidents of children ingesting e-liquids used by parents/families to fill their e-cigarettes, leading to a large number of calls to poison centres and several cases of fatal nicotine ingestion [33]. Data from published case reports state that the ingestion of 4 mL of a 12 mg/mL nicotinecontaining solution would be lethal for an adult [34]. It is argued that the risk of accidental poisoning in children due to e-cigarettes is not different from household devices and chemicals [35].

Although existing research does not provide a definitive conclusion on the safety of e-cigarettes, research suggests that they are less harmful than tobacco products and are comparable in toxicity to approved nicotine replacement therapies (NRT) [15, 30]. Concerning the long-term health effects, the United Kingdom's (UK) National Centre for Smoking Cessation and Training stated that although they do not know the longterm risks, the "magnitude of any risks that may emerge from long-term e-cigarette use is likely to be small" [30, p.34]. However, some researchers and public health bodies and organisations argue that much is unknown about the long-term health effects of e-cigarette use, and we need focused research to study this [36–38].

## **3.2 Should regulation take account of evidence on whether e-cigarettes are associated with lung injury?**

In 2019, the United States of America (USA) reported a rise in people, particularly those under 30, being admitted to hospital suffering from pneumonia-like lung

#### *Global Regulatory Approaches towards E-Cigarettes, Key Arguments, and Approaches Pursued DOI: http://dx.doi.org/10.5772/intechopen.107343*

injuries; none were traceable to a microbial source, but all reported recently using e-cigarettes [39, 40]. The Centers for Disease Control and Prevention (CDC) referred to the outbreak of severe lung illness as e-cigarette or vaping product use-associated lung injury (EVALI). All individuals with EVALI reported using e-cigarette products, most of whom reported using their e-cigarette devices to ingest tetrahydrocannabinol (THC), the primary psychoactive compound in cannabis [41, 42]. Vitamin E acetate is strongly associated with EVALI, and it has been added to THC cartridges by cost-cutting manufacturers who would claim that their products contained more THC than they did, as Vitamin E acetate increased the viscosity of the THC [40]. It is important to note that not all EVALI cases have been associated with THCcontaining products and that in certain individuals, nicotine-containing or flavoured e-cigarettes may also cause acute lung inflammation and injury [40, 43, 44]. King et al. [40] argue that the use of e-cigarette products by youths is unsafe, regardless of whether they contain nicotine or THC, and the risks posed by these products are further heightened by the EVALI outbreak.

Other countries such as the UK, Australia, Canada and New Zealand were on alert for lung injuries caused by e-cigarette use after the outbreak in the USA. As of January 2020, in the UK there have been two potential cases of EVALI [45], occurring during a similar time period to the USA outbreak. UK public health experts argue that the EVALI outbreak could damage the reputation of e-cigarettes. In Australia, where there are no confirmed reports of EVALI, public health experts argued that the EVALI outbreak in the USA further entrenched the negative perception of e-cigarettes and therefore supported their regulatory approach [46]. In Canada, 20 EVALI cases were reported; eight were classified as confirmed and 12 as probable [47]. In New Zealand, where no cases were reported, public health experts and policymakers understood EVALI was not caused by nicotine-containing e-cigarettes and that precautionary policies towards that market were unlikely to solve that public problem.

#### **3.3 Should regulation consider that e-cigarettes are a useful harm reduction tool?**

Regulation needs to consider harm reduction as a strategy for reducing health risks. Harm reduction has been a pillar of public health practices, an example is the use of methadone and needle exchanges rather than eliminating intravenous drug use. However, harm reduction approaches are often controversial (including the example above) because it has been argued that they accommodate rather than eliminate risky behaviours [48]. Since the development of e-cigarettes, public health experts and tobacco control advocates have debated the role of e-cigarettes as a harm reduction tool. Several public health experts believe e-cigarettes can play a role in eliminating smoking-related diseases and consider them to be a breakthrough in harm reduction development [49–52]. Whereas other public health experts argue that caution should be taken when endorsing e-cigarette products until crucial evidence becomes available [53]. E-cigarettes are popular among smokers due to their ability to replicate the behavioural and physical aspects of smoking [54, 55]. E-cigarettes are often termed a short-term tobacco harm reduction tool, as they do not contain tobacco or tar, which are known to cause numerous smoking-related diseases, including cardiovascular disease. As there is no long-term evidence yet available, the debate about using them as a long-term tobacco harm reduction tool will continue, but this raises the question of what regulation should be in place until we have long-term evidence?

## **3.4 Is regulation needed to prevent e-cigarettes from becoming a gateway to youth smoking?**

One of the main concerns and important aspects in debates concerning the regulation of e-cigarettes is whether e-cigarettes increase tobacco smoking among youths, a gateway effect. Some in the tobacco control community argue that research has shown that youths who use e-cigarettes are more likely to start smoking compared with those who do not [56–61].

Another issue that has been raised relates to the increasing number of e-liquid flavours now available. In 2014, it was estimated there were 7764 unique flavours, with an average of 242 new flavours being added per month [62, 63]. The vast majority of flavours are related to confectionery (e.g., candyfloss, marshmallow, vanilla, cola, bubble-gum), and in 2020, it was estimated that there were over 15,000 different flavours available on the market [64, 65]. The question being asked is if this variety of e-liquid flavours is attracting youths to try e-cigarettes. Research has shown that the variety of available flavours is one of the top reasons for experimentation with e-cigarettes among youths, in addition to peer influence and curiosity [66–70]. Compared with adults, youths are more likely to use sweet e-liquid flavoured e-cigarettes, and their popularity among youths and the rates of prevalence have significantly increased in recent years [71, 72]. Research shows that youths perceived fruit and sweet flavoured e-cigarettes to be less harmful compared with tobacco flavour e-cigarettes [73–75]. Harrell et al. [72] argue that the elimination or restriction of flavoured e-liquids (particularly sweet and fruit flavours) could potentially aid youth and young adult prevention efforts. Already, Finland and several states in the USA (including Chicago and New York City) have brought in legislation to prohibit the sale of flavoured e-cigarettes [76, 77].

Several public health experts have disputed the gateway effect, arguing that the youths smoking prevalence continues to decline; therefore, e-cigarettes cannot be causing smoking among youths [78, 79]. It has also been argued that research has found that smoking more often preceded vaping rather than vice versa (i.e., most youths who had tried e-cigarettes are already smoking or have previously experimented with cigarette smoking) [80–82].

#### **3.5 Is regulation needed to prevent e-cigarettes renormalising smoking?**

Concerns over the renormalisation of smoking have been raised by numerous researchers and tobacco control advocates (including [83–85]). The renormalisation hypothesis suggests the growing prevalence and visibility of e-cigarette use could undo 'decades of work' in tobacco control regulation and shift social norms surrounding the extent to that smoking is once again seen as 'normal' behaviour [86–88].

Sæbø and Scheffels [87] and Hallingberg et al. [89] argue that the renormalisation hypothesis assumes cigarettes and e-cigarettes are viewed as similar to one another. E-cigarette products are evolving over time and as discussed previously, new models no longer resemble traditional cigarettes compared with earlier generations. Therefore, this needs to be considered when evaluating the renormalisation debate [87, 89] and considering the need for the regulation of e-cigarettes.

By contrast, some researchers argue that e-cigarettes may denormalise smoking through the social display of an alternative behaviour and cause some youth to not smoke who would otherwise have become smokers [89]. From this perspective, aligning e-cigarettes and tobacco regulation could result in the perception that the products are equal and potentially cause the renormalisation of smoking [89].

#### **3.6 Is regulation needed to reduce the risk of dual use?**

The issue of dual use relates to whether e-cigarette users will continue to use both tobacco cigarettes and e-cigarettes for an extended period of time [90]. Some researchers argue that from a population-level public health perspective, dual use could provide an opportunity to reduce the burden of tobacco use if it represents a temporary stage before smokers switch to solely e-cigarette use or quit tobacco products completely [90–92].

Nayak et al. [91] found that higher proportions of dual users have a stronger intention to quit compared with cigarette smokers. Similarly, research by Nabi-Burza et al. [93] showed that dual users may have higher rates of contemplating smoking cessation than individuals who only smoke cigarettes, suggesting that dual users may be using e-cigarettes for harm reduction or as a step towards cessation. However, it is possible that dual use could prolong nicotine addiction and consequently inhibit smoking cessation among smokers who might otherwise quit smoking [90, 94–96]. Concerns about the dual use of hazardous and reduced hazard products add another layer of complexity to the e-cigarette regulatory debate.

### **3.7 Do e-cigarettes lead to smoking cessation and if so, what does this mean for regulation?**

Since the development of e-cigarettes, there has been an increase in the number of smokers who use and enquire about e-cigarettes when attempting to quit smoking [97, 98]. Currently, available medications include NRT, Varenicline (Champix) and Bupropion (Zyban) [99]. There are severeal published randomised controlled trials (RCTs) evaluating whether nicotine-containing e-cigarettes increase smoking cessation compared with placebos, financial incentives and behavioural therapy or NRT (including [97, 100–106]).

A 2016 Cochrane review [102] found that data from research by Caponnetto et al. [100] and Bullen et al. [101] support an effect of nicotine e-cigarettes on cessation when compared with placebo e-cigarettes, but has low certainty in the evidence due to the small number of trials (n=2), low event rates and wide confidence intervals [102]. The study by Bullen et al. [101] compares e-cigarettes to standard NRT, which is the most relevant comparator for clinicians. Unfortunately, the trial design placed the NRT group at a disadvantage compared with the e-cigarette group, as the NRT group was given vouchers for purchasing patches while the e-cigarette group was provided with e-cigarettes [101]. The authors of the review [102] were unable to determine if e-cigarettes were better than a nicotine patch for smoking cessation due to the low number of participants in the study. Furthermore, the review indicated that none of the studies, included in the review, found that smokers who used e-cigarettes short- to mid-term (for 2 years or less) had an increased health risk compared with smokers who did not use e-cigarettes [102].

Since the 2016 Cochrane review, three RCTs have been completed [103–105]. Hajek et al. [103] conducted the largest RCT of e-cigarettes compared with NRT to date, finding that nearly twice as many participants quit smoking at 1 year in the vaping group (18.0%) compared with the NRT group (9.9%). Participants in the NRT groups were allowed to choose the NRT product they use, this included using

combination NRT (i.e., using two forms of NRT together, which is the most effective way to use NRT [107]) [103]. All three RCTs have found nicotine-containing e-cigarettes to be at least as effective as NRT, and some found that vaping was more effective [103–105].

The 2014 and 2016 Cochrane reviews both demonstrated low certainty in the evidence regarding the efficacy of e-cigarettes as a smoking cessation tool [97, 102]. A 2021 Cochrane review [106] found that nicotine e-cigarettes were superior to placebo e-cigarettes and at least as effective as NRT for smoking cessation, which is consistent with findings from other RCTs [103–105]. In addition, the review stated that there is moderate certainty in the evidence that nicotine-containing e-cigarettes increase the quit rate compared with NRT and non-nicotine-containing e-cigarettes [106]. As with the previous Cochrane reviews, there is imprecision due to the small number of trials, often with low event rates [97, 102, 106]. More evidence is required about the effects of e-cigarettes concerning smoking cessation, particularly due to the development of newer types of e-cigarette devices that have better nicotine delivery compared with older generations of e-cigarettes [108, 109].

This evidence is against a backdrop of the fact that e-cigarette use continues to increase globally despite uncertainty regarding their long-term health impacts and their effectiveness for tobacco smoking. This uncertainty creates unique challenges for governments and policymakers as they attempt to optimally regulate these products in a way that maximises the public's health. The next section will discuss current e-cigarette regulatory approaches and the variation across jurisdictions.

## **4. Regulation of e-cigarettes**

Current approaches to e-cigarette regulation appear to fall within a spectrum of options ranging from a singular focus on health protection, whereby policies intend to prevent the dangers of e-cigarettes, to a singular focus on using e-cigarettes for harm reduction, whereby policies intend to reduce the more harmful effects of smoking tobacco. Regulation options include prohibition, regulation as medicinal products, poisons, tobacco products, consumer products and/or unique products.

## **4.1 Regulatory spectrum**

A simplified view suggests that approaches to e-cigarette regulation fall within a spectrum of options. The spectrum ranges from a singular focus on a 'harm reduction' approach at one end to a singular focus on a 'precautionary' approach at the other end [110–113] (**Figure 2**). The main difference between the two ends of the spectrum is the population on which the recommendations are focused. The 'harm reduction' approach focused on the potentially positive health effects e-cigarettes pose to conventional smokers. In contrast, the 'precautionary' approach generally focuses on the health effects e-cigarettes pose to non-smokers, particularly youths and young people.

Both the 'harm reduction' and 'precautionary' approaches apply restrictions on e-cigarettes and tobacco products; however, in different ways. Adopting a 'harm reduction' approach does not require weak regulation of e-cigarette products; instead, it ensures that e-cigarette products are available as a smoking cessation tool for smokers who are unwilling or unable to quit smoking, meaning that the negative health effects caused by smoking can be reduced while minimising any exposure (resulting

*Global Regulatory Approaches towards E-Cigarettes, Key Arguments, and Approaches Pursued DOI: http://dx.doi.org/10.5772/intechopen.107343*

**Figure 2.**

*A representation of the regulatory spectrum towards e-cigarette regulation.*

in potentially positive health effects) among non-smokers and youths. While the 'precautionary approach' adopts stronger e-cigarette regulations to prevent initiation and use of e-cigarettes among non-smokers and youths.

#### *4.1.1 Harm reduction approach*

Harm reduction can be described as a way to reduce the negative health effects or health behaviours by making less harmful products available for use as a substitute for more harmful products [114]. The harm reduction approach acknowledges that cigarette users become addicted to nicotine and cannot easily stop smoking; it is, therefore, desirable to reduce the harms associated with the use of combustible cigarettes, by encouraging users to switch to a less harmful product (e.g., e-cigarettes) [115]. However, advocates of harm reduction do not always share the same views regarding the ultimate goals of e-cigarette use; some advocates argue that the goal should be to quit these harmful products entirely, whereas others believe risk minimisation is sufficient [116, 117].

#### *4.1.2 Precautionary approach*

Countries that are concerned about preventing the initiation of new users may choose to pursue prohibitive regulations that restrict the supply and demand (e.g., increasing taxes) of e-cigarette products. Numerous public health experts often argue that e-cigarettes are harmful, normalise smoking behaviour [83, 85] and serve as a gateway to nicotine addiction and even more harmful tobacco consumption for nonsmokers and youth [56, 60, 61]. Rather than aiding in smoking cessation, they may believe the sale of e-cigarettes will encourage continued use of conventional cigarettes resulting in the dual use of both products, consequently inhibiting complete cessation [90, 96, 118, 119].

## **4.2 Current regulatory approaches**

There is much variation in the current regulatory approaches adopted by countries, and this affects the availability and use of e-cigarettes and the perceived harms of e-cigarettes by the country's citizens. The perceived harmfulness of e-cigarettes among policymakers and citizens may affect the choice of regulatory framework adopted in a given country. The ways in which policymakers perceive and classify e-cigarettes will influence the regulatory approach pursued and will affect decisions about whether e-cigarettes should be included under existing legislation or whether new legislation is required [120].

**Table 1** provides an overview of the variation between countries showing what approach countries have adopted.


**Table 1.** *Countries' regulatory approaches towards e-cigarettes [121].* *Global Regulatory Approaches towards E-Cigarettes, Key Arguments, and Approaches Pursued DOI: http://dx.doi.org/10.5772/intechopen.107343*

#### *4.2.1 Prohibition*

Prohibiting all legal access to e-cigarettes is often motivated by the precautionary approach and the desire to avoid all possible risks, whether or not those risks are scientifically authenticated [122]. This approach typically prohibits the manufacture, import and export, sale and/or possession of e-cigarettes. Thirty countries around the world (including Argentina, Egypt, Lebanon and Singapore) have prohibited all legal access to e-cigarettes, regardless of nicotine concentration [121]. For example, Singapore's Tobacco Control Act prohibits the sale, possession, distribution and importation of e-cigarettes in the country [121, 123]. The prohibition of e-cigarettes falls within the precautionary approach end of the regulatory spectrum. Prohibiting legal access to e-cigarette products discourages e-cigarette initiation (particularly among non-smokers and youths), prevents the renormalisation of smoking [124] and prevents the health risks associated with dual use. However, several concerns have been raised. Firstly, by prioritising non-smokers and youths, the approach may prevent tobacco smokers from accessing a less harmful product [119, 122], as it removes e-cigarettes from the market. Secondly, prohibiting legal access to e-cigarettes may cause consumers to purchase e-cigarettes from illegal sources, and these products may not be quality-assured, thus more harmful [110]. Regulatory approaches need to consider these.

#### *4.2.2 Regulation as medicinal products*

Regulating e-cigarettes as medicinal products is motivated by a desire to strictly limit e-cigarettes to those who will use them as a smoking cessation tool [103]. This approach prohibits legal access to e-cigarettes except when used as a smoking cessation tool. Regulatory mechanisms under this classification include restricting sales to accredited pharmacies, applying strict regulation of internet sales in order to ensure pharmaceutical standards are being met and requiring a medical prescription for purchase [125]. Most countries that have pursued this regulatory approach also pursue other approaches in conjunction. For example, Norway regulates e-cigarettes as medicinal products, tobacco products and as unique products [121]. Pursuing a combined approach increases accessibility to e-cigarettes by creating an additional pathway for accessing these products.

Twenty countries around the world (including Austria, Iceland and the Philippines), regulate e-cigarettes as medicinal products [121]. For example, the Philippines classifies e-cigarettes as medicinal products and medical devices [121], meaning they must pass assurance checks (including all quality, efficacy and safety evaluations) conducted by the Food and Drug Authority of the Philippines before they can be sold [126].

This approach addresses several of the key health concerns at both ends of the regulatory spectrum. By preventing non-smokers from legally accessing e-cigarettes prevents initiation, while simultaneously allowing current smokers to access e-cigarettes and reduce the harms associated with conventional tobacco smoking and eventually quit smoking. Caponnetto et al. [125] state that there is a major advantage to this approach; most countries already have well-established regulations for medicinal products. In addition, Campus et al. [110] explains if e-cigarette products were regulated and prescribed as medicinal products, they could potentially be provided or reimbursed by health insurance plans. This coverage could serve as a

financial incentive for smokers to completely switch from conventional cigarettes to e-cigarettes, as it would ideally decrease or eliminate the cost of e-cigarettes for users of the product. While there are advantages, several limitations have also been raised. Lengthy pharmaceutical approval processes could create an interim black market for unregulated e-cigarette purchases [119]. Many e-cigarette manufacturers may lack the necessary expertise or resources to register their products or comply with stringent medicinal regulatory standards [125, 127]. Therefore, companies may choose to never go through the approval process and the black market may consequently become permanent [110, 119].

Applying medicinal regulations to e-cigarettes also creates unique challenges [125] regarding access to these products. Requiring a prescription to use e-cigarettes will limit accessibility and may encourage potential users to continue using conventional tobacco products.

#### *4.2.3 Regulation as poisons or hazardous substances*

Regulating e-cigarettes as a poison or hazardous substance is based upon the poisonous and potentially fatal nature of high nicotine concentrations [118]. With the focus on preventing nicotine overdose, possible regulatory mechanisms include banning nicotine-containing e-cigarettes or placing restrictions on nicotine concentrations in e-liquids [110]. Four countries have adopted this regulatory approach: Australia, Belgium, Malaysia and Brunei Darussalam [121]. In Australia, nicotine is classified as a dangerous poison; therefore, it is illegal to possess or use nicotine as a non-therapeutic good [128, 129]. However, there are currently two ways that Australians can legally purchase nicotine-contain e-cigarettes: through the personal importation scheme, or through a compounded pharmacy [129]. The personal import scheme enables Australians to ask a medical doctor to apply to the Therapeutics Goods Administration to allow the importation of up to a 3-month supply of nicotine for use in e-cigarettes for therapeutic purposes [119, 130]. Non-nicotine e-cigarettes are currently not regulated as a therapeutic good; therefore, they can be sold and used legally [130, 131]. In Brunei Darussalam, e-cigarette regulation focuses specifically on nicotine concentration. E-liquids with a nicotine concentration above 7.5% are classified as a poison, whereas those with a nicotine concentration under this amount are classified as tobacco products [121, 132]. Prohibiting nicotine-containing e-liquids would help address and potentially achieve the goal of preventing current nonsmokers from developing an addiction to nicotine. However, this approach does not pay attention to or address the potential risks associated with non-nicotine e-liquids [110] and may complicate and/or impede the achievement of smoking cessation goals [122]. Similar to the approach pursued by Brunei Darussalam, countries that wish this regulatory approach may consider limiting the nicotine concentration in e-liquids.

#### *4.2.4 Regulation as tobacco products*

Fifty-four countries regulate e-cigarettes as tobacco products (including Finland, the USA and Vietnam) [121]. For example, the United States (U.S.) Food and Drug Administration (FDA) has regulatory authority over all tobacco products, including e-cigarettes [133], except when e-cigarettes are marketed as drugs or combination products (i.e., to use as a smoking cessation tool) [121].

The U.S. FDA defines tobacco products as 'any product made or derived from tobacco that is intended for human consumption, including any component, part,

#### *Global Regulatory Approaches towards E-Cigarettes, Key Arguments, and Approaches Pursued DOI: http://dx.doi.org/10.5772/intechopen.107343*

or accessory of a tobacco product' [134]. Based on this definition, it has been argued that the classification of e-cigarettes as tobacco products is legally justified by the fact that nicotine is derived from tobacco [116, 127]. Many policymakers argue that e-cigarettes should be classified as tobacco products to include them in already wellestablished tobacco legislation [125, 130]. Under this approach, e-cigarettes would be legally available for purchase, similar to conventional tobacco products [123], and they would be subject to regulatory requirements, such as product labelling requirements, restrictions on advertising and minimum age requirements for purchase [116, 123, 125].

Tobacco control legislation is mostly well established, therefore classifying e-cigarettes as tobacco products would allow current legislation to apply to e-cigarette products. While this would be advantageous, it is worth considering the potential limitations of pursuing this approach. Campus et al. [110] argue that from a harm reduction perspective, regulating e-cigarettes solely as tobacco products may discourage people from switching completely to a less harmful alternative. Furthermore, e-cigarettes do not always contain nicotine, meaning they do not fit with the previous definition [122]. In terms of the precautionary approach, the same arguments motivating the strict regulation of tobacco products can be applied to e-cigarettes, in that the latter are also highly addictive products that cause harm and may serve as a gateway to even more harmful behaviours [79, 82, 119].

#### *4.2.5 Regulation as consumer products*

Similar to regulating e-cigarettes as tobacco products, countries can regulate e-cigarettes as consumer products, meaning they can be included in existing legislation relating to consumer protection [110]. If pursuing this regulatory approach, e-cigarettes would be subject to the same regulations as other consumer products and would be available to purchase in convenience shops, speciality shops (i.e., vape shops) and on the internet [122]. Countries that choose to pursue this regulatory approach could create quality control standards for e-cigarette products [125] such as child-resistant packaging, labelling regulations regarding nicotine concentrations [122], as well as post-market surveillance and product recall systems [110]. In doing so, this would help protect consumers from unsafe or faulty devices and e-liquids [125]. Campus et al. [110] highlight that it is important to consider that consumer protections vary substantially across countries; therefore, regulation as a consumer product will inevitably have different meanings in different countries.

Fifteen countries currently regulate e-cigarettes as consumer products [121]. In Hungary, e-cigarettes are regulated primarily as consumer products [121] and are subject to Article 20 of the European Union (EU) Tobacco Products Directive (TPD) [135]. The directive establishes safety and quality requirements for e-cigarettes, packaging and labelling rules, as well as monitoring and reporting requirements for manufacturers and importers [135]. By regulating the sale of e-cigarettes as consumer products, Hungary aims to achieve multiple competing goals. Firstly, introducing warning labels on e-cigarettes will warn non-smokers and non-users not to use the products. Secondly, prohibiting e-cigarette advertising will help prevent non-smokers and non-users, particularly youths, from pursuing smoking-related behaviours, while still allowing current smokers to access e-cigarette products to assist in their quit attempts.

Farsalinos and Le Houezec [122] argue that this regulatory approach fails to address the issues surrounding nicotine concentrations and may potentially give the impression that e-cigarettes are safe for anyone to use. Several countries (including Australia, France, Moldova and Switzerland) have opted to regulate non-nicotine e-cigarettes as consumer products while implementing stricter approaches for nicotine-containing e-cigarettes including prohibition or regulating them as poisons or hazardous substances [121].

#### *4.2.6 Regulation as unique products*

Policymakers may choose to classify e-cigarettes as a unique product, therefore creating new legislation that relates specifically to e-cigarette products. Sixty-eight countries currently regulate e-cigarettes as a unique product, including Canada, Denmark, Saudi Arabia and Uganda [121]. In Canada, e-cigarettes are regulated under several Acts [121]; Tobacco & Vaping Products Act (TVPA), the Canada Consumer Product Safety Act, the Food & Drugs Act and the Non-Smokers' Health Act [136]. The TVP aims to prevent youth from using tobacco and e-cigarettes (i.e., precautionary) while allowing adult smokers to access e-cigarettes as a less harmful smoking alternative (i.e., harm reduction) [137]. The TVPA prohibits the sale of e-cigarettes to those under 18, as well as the sale of e-cigarettes that may be appealing to youth in the way that they look or function (i.e., certain flavours) [136, 137]. In addition, Canada has banned lifestyle advertising, advertising that is appealing to youth and the use of testimonials and endorsements [121]. While Canada has taken a relatively moderate approach to regulating e-cigarettes, other countries have pursued more restrictive approaches, while still regulating e-cigarettes as a unique product. For example, Cambodia, which has also classified e-cigarettes as a unique product, prohibits the sale, importation and use of e-cigarettes in the country [138]. This example constitutes a precautionary approach.

Regulating e-cigarettes as a unique product acknowledges that no existing regulatory classification may be suitable. This approach enables policymakers to tailor and modify e-cigarette regulations to the unique goals of their country. Therefore, this regulatory approach can draw upon aspects from both ends of the regulatory spectrum. As mentioned previously, Canada is an example whereby regulating e-cigarettes as a unique product, and policymakers have been able to pursue both a precautionary and harm reduction approach. Whereas, if countries view e-cigarettes as entirely harmful, regulating them as a unique product allows the pursuit of a precautionary approach. However, pursuing this approach requires countries to develop and adopt new legislation and considerable resources must be dedicated to the process.

How countries choose to regulate e-cigarettes will also depend on contextual factors including, epidemiological features of smoking and/or vaping and the need to be consistent with previous tobacco control policies. Policymakers might want to consider developing policy approaches and solutions that facilitate harm reduction for certain population groups (e.g., smokers), while simultaneously protecting the health of other population groups (e.g., non-smoking adults and youths). Tailoring regulation of e-cigarette policies for each jurisdiction might allow for the achievement of certain policy goals and objectives. Policymakers would need to determine which goals and objectives to prioritise and which ones cannot be optimally achieved. While this is a difficult balance to achieve, the situation is further complicated by the fact that the long-term health impacts of e-cigarettes are currently unknown [134, 139–141]. Unfortunately, there is no one-size-fits-all solution, and it is not possible to achieve all competing objectives, meaning some competing objectives cannot be

*Global Regulatory Approaches towards E-Cigarettes, Key Arguments, and Approaches Pursued DOI: http://dx.doi.org/10.5772/intechopen.107343*

met. E-cigarettes are a relatively new product to the market and globally, countries are still in the process of determining the most effective policies. Policymakers should consider learning from other countries policies and from international organisations such as the WHO to facilitate cross-country learning related to e-cigarettes [110].

## **5. Conclusions**

E-cigarette regulation poses a real challenge for public health in determining which regulatory approach is most likely to improve population health and protect people from the damaging effects of tobacco smoking. This is evident from the variation of different approaches adopted across countries in taking a more 'harm reduction' or 'precautionary' approach. As the regulatory debate continues to evolve, it is likely a new 'middle ground' will emerge in the regulation of e-cigarettes as public health experts and tobacco control advocates alter their position on e-cigarette regulations in response to new evidence. In this chapter, we have summarised the global regulatory approaches towards e-cigarettes and debated some of the key arguments and approaches pursued by different countries. Despite various regulatory approaches being pursued, public health experts and tobacco control advocates are all focusing on the same goals—to reduce tobacco use and related harms.

## **Conflict of interest**

The authors declare no conflict of interest.

### **Author details**

Marissa Smith\* and Shona Hilton MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK

\*Address all correspondence to: marissa.smith@glasgow.ac.uk

© 2022 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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## **Chapter 15**
