Border controls
No legislative changes ought to be made to Australia’s current border controls for nicotine products.
The black market and mislabelling of nicotine e-liquids exists precisely because Nicotine Vaping Products (NVPs) are regulated as medicines and only available on prescription. Given the reluctance of many General Practitioners (GPs) to prescribe, the complicated policies and procedures involved, and the lack of awareness among smokers, it is not surprising that many turn to an easier illegal supply chain.
This of course, also means that NVPs may get into the hands of others who do not smoke, including young people. However, UK data shows that regular use by children and adolescents, particularly among those who do not smoke is very low (1.7%; ASH, 2022). In the US, vaping among young people has been on the decline since its peak in 2019 and this has been accompanied by a decline in smoking (Gentzke et al., 2021). This suggests that NVPs may be acting as a substitute for cigarette smoking and many of these young people might otherwise have smoked if NVPs were unavailable.
Harm from NVPs has been exaggerated in the media. Although risks to young people from vaping may become apparent, these are likely to be minor. Smoking, on the other hand, remains a real and known killer accounting for an estimated 20,500 deaths (13% of all deaths) in Australia in 2018 (AIHW, 2021). The benefits of NVPs for adult smokers are substantial and potentially lifesaving. Adopting a precautionary approach to reduced risk NVPs whilst deadly combustible cigarettes remain readily available, plays directly into the hands of the tobacco industry, and encourages smoking and smoking-related disease.
A better solution would be a regulated consumer model as adopted in the EU and UK, where NVPs are exempt from poisons standard, available from pharmacies, vape shops and other retail outlets, and underage access is restricted via age verification and penalties for illegal sales. This would resolve the issue of illegal imports.
Determining the quality of NVPs before they are available on the market
Quality and safety are important for NVPs but this can be achieved through a simple pre-market notification process rather than the assessment of every application prior to approval.
This approach has been implemented successfully in the UK (under the EU Tobacco Products Directive [TPD]) and in New Zealand. A pre-market authorisation process is not recommended and has not worked well in the US. It has been onerous, time-consuming and costly for the Food and Drug Administration (FDA) and for companies submitting applications.
Adding an assessment fee acts as a further barrier to market entry, discriminating against smaller companies and favouring those with the resources to submit an assessment, namely the tobacco industry. Moreover, no such pre-market assessment process exists for the deadly cigarette. A pre-market notification to the appropriate regulatory authority (in the UK, this is the Medicines and Healthcare Regulatory Agency [MHRA] and in New Zealand, this is the Ministry of Health’s Vaping Regulatory Authority’s Health Advisory and Regulatory Platform [HARP]) before marketing is permitted, in which companies provide product and labelling information, an ingredients list, emissions and toxicological data and a mechanism for safety reporting (e.g. the Yellow Card scheme in the UK) is a simpler, more cost-effective and streamlined approach.
Supplying efficacy data is not necessary given the strong certainty evidence from the recent Cochrane systematic review that NVPs are an effective cessation tool (Hartmann-Boyce et al., 2022).
Restricting access to:
Flavoured NVPs
Restricting or prohibiting flavours has often been proposed as a means of reducing youth uptake but flavoured NVPs appeal equally to adult smokers/vapers (Gendall & Hoek, 2020). Striking a balance is hard to achieve as any actions (such as restricting flavours) which make NVPs less appealing to smokers can increase harm by perpetuating smoking.
To promote appeal to smokers but reduce uptake by non-smokers, an alternative approach could be to focus on flavour descriptors and disallow ambiguous or potentially youth-appealing names such as ‘brain freeze’ ‘unicorn milk’ or ‘lava flow’ (though note, these names may also appeal to adults).
Specific ingredients
Any product that has been demonstrated to be harmful to human health via vaping should be restricted. It is however, important to note that the dose makes the poison; the mere presence of a potentially harmful chemical in e-liquid does not necessarily equal harm to the user. Restrictions should be updated on the basis of ongoing research findings. A good place to start is the list of banned chemicals published by the UK Medicines and Healthcare Regulatory Agency (2022).
Nicotine concentrations in NVPs to 20mg/mL (or base form equivalent concentration for nicotine salt products)?
Many of today’s smokers are highly dependent and may require higher nicotine levels to successfully switch completely from smoking to vaping. In addition, many lower-powered devices (e.g. disposables and simple all-in-one pen-like tank models) are less efficient at vaporising nicotine and necessitate the use of higher nicotine-concentration e-liquids. More importantly, there is a compelling body of research evidence suggesting that lower nicotine e-liquid concentrations result in more intensive puffing, greater consumption of e-liquid and exposure the user to higher levels of potentially harmful chemicals (Dawkins et al., 2018; Kosmider et al., 2018; Kosmider et al., 2020; Talih et al., 2020).
It is difficult to determine the upper nicotine concentration limit in the absence of research evidence but allowing concentrations up to 50mg/mL (5%) should be sufficient even for the most dependent smokers.
Plain packaging and health warnings on NVPs
As with flavour restrictions, plain packaging could be a way of reducing appeal to youth/non-smokers but equally reduces appeal to smokers who may benefit from switching to a reduced-risk product. Plain packaging is clearly justified for tobacco cigarettes given the considerable harms known to be caused by smoking. It is not recommended for NVPs and sends the wrong message that harms from NVPs are commensurate with smoking.
A reduced-risk health message that clearly explained that the use of NVPs is far less harmful than smoking would be a more appropriate response. The nicotine and tobacco research group at London South Bank University have developed and evaluated a number of reduced risk messages for NVPs (Cox et al., 2018; Kimber et al., 2019; Kimber at al, 2021).
These included:
Completely switching to e-cigarettes lowers your risk of smoking-related disease
E-Cigarettes are estimated to be 95% less harmful than smoking
Use of this product is much less harmful than smoking*
*In one study (Kimber et al., 2019) comparing the third message above to the standard EU nicotine addiction warning message in 2495 participants, harm perceptions, purchase intentions and use intentions increased after exposure to the reduced risk message in smokers but not in non-smokers. This suggests that such as message may potentially act as an effective harm reduction tool for smokers without resulting in increased uptake among non-smokers.
A pregnancy warning is not justified as Nicotine Replacement Therapy (NRT) has been shown to be safe in pregnancy and does not require such a warning. Recent findings from a Randomised Controlled Trial of NVPs vs. NRT in 1140 pregnant smokers found them to be safe and effective (Hajek et al., 2022).
A nicotine addiction warning is not necessary and can reduce the willingness to use among smokers (Cox et al., 2018). Moreover, an addiction message is misleading as nicotine addiction closely mirrors the speed of the delivery and is most addictive when inhaled in the form of smoked tobacco.
Limiting the maximum volume of liquid NVPs
Limiting the capacity of tanks and refill bottles creates more environmental waste and pollution. It is also less convenient for the user making vaping more expensive and complicated as more frequent refilling is required (Ward et al., 2020). Any restrictions that make vaping more complicated and less appealing will likely encourage smoking.
To reduce accidental ingestion, liquid refill containers should be unbreakable, clearly labelled and fitted with child-proof caps and anti-spillage mechanisms as standard as required for other household chemicals.
Preventing access to disposable NVPs
As with flavourings, disposable/single-use NVPs have been held as partly responsible for increased uptake among young people. However, disposable NVPs are also attractive for adult smokers as they are easy to use and do not require re-charging or replacing components. This is important for smokers who have found traditional NVPs hard to navigate including smokers with manual dexterity problems, visual difficulties, other physical health problems and mental health or learning disabilities.
Restricting underage access can be achieved through other means such as age verification, penalties for illegal sales, and potentially restricting bright attractive colours.
Irresponsible or uninformed disposal of single use NVPs has also been expressed as a reason for banning but this can be easily addressed through clear labelling and messaging around recycling and offering adequate and accessible recycling facilities.
Regulating NVPs that contain nicotine, but are not labelled as containing nicotine, under the therapeutic goods framework
Drug Science does not support this. Neither NVPs containing nicotine or without nicotine should be regulated under the therapeutic goods framework as NVPs are not medicinal products. Regulating NVPs as consumer products would alleviate the black-market and mislabelling issue and ensure the safety and quality of products.
Although the regulation of NVPs as medicines under the Therapeutic Goods Act was intended to ensure the availability of quality products for smokers, this has not been successful and tightening regulations will not address the issue.
GPs and other healthcare professionals are reluctant to prescribe/support NVP use in their patients and very few Australian GPs prescribe NVPs for their smoking patients or know how to. It is possible that if TGA-regulated quality products were available, confidence in prescribing may increase but this is unlikely given evidence that many GPs and other healthcare professionals erroneously believe that nicotine directly contributes to birth defects, CVD, cancer and COPD (Patel, Peiper & Rodu, 2013; Steinberg et al., 2021).
Regulation of NVPs should be commensurate with the risks which are substantially lower than for tobacco smoking (McNeil et al., 2021). As stated in the UK Royal College of Physicians (RCP) report (2016):
“A risk-averse, precautionary approach to e-cigarette regulation can be proposed as a means of minimising the risk of avoidable harm…. However, if this approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer friendly, pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking. Getting this balance right is difficult” – (p.187)
References
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