Perceptions of a prescription model for accessing nicotine vaping products: an examination of submissions made by self-reported e-cigarette users to an Australian consultation

Abstract

In response to rapid and substantial increases in rates of e-cigarette use among young people, Australia’s Therapeutic Goods Administration (TGA) made changes to the regulations governing nicotine vaping products. As part of the regulatory change process, Australians were invited to comment on the proposed regulations, which featured the introduction of a prescription model for nicotine vaping products. To inform strategies to enhance compliance with the tightened regulations, this study examined submissions made by self-reported e-cigarette users to the TGA’s public consultation (n = 1405). A content analysis was conducted to identify and quantify key arguments. Claims about possible negative consequences associated with the regulations (e.g. people will return to smoking, inconvenience) featured in most submissions (84%). Around half (55%) of submissions mentioned perceived benefits of e-cigarettes, including favourable health outcomes (e.g. improved breathing) and enhanced tobacco cessation. Around half (52%) featured concerns about inconsistency in treatment and the argument that e-cigarettes should not be restricted when more harmful tobacco products are readily available. Alternative approaches to a prescription model were offered in nearly one-third (31%) of submissions. One-quarter (26%) included text provided by an industry-led astroturfing campaign. The arguments made in the analysed submissions suggest a lack of appreciation of (i) the negative health outcomes associated with e-cigarette use and (ii) evidence linking these devices to smoking relapse. Results highlight the need for targeted health campaigns that address (i) gaps in consumers’ knowledge and (ii) vaping-related misinformation being promulgated by the industry and its allies.

Contribution to Health Promotion.

• We identified arguments made by self-reported e-cigarette users in submissions to a consultation on e-cigarettes.

• A prescription model was described as having numerous negative consequences, and many submissions focussed on perceived benefits of e-cigarettes.

• Content from an industry-led astroturfing campaign was detected in a substantial minority of submissions.

• To increase compliance with regulations, health communications could inform users of the risks associated with vaping.

• To prevent public policy from being influenced by vested interests, health organizations must expose disingenuous, industry-backed ‘grassroots’ campaigns.

INTRODUCTION

Australia’s approach to regulating e-cigarettes is among the strictest in the world, with nicotine-containing products legally available only via medical prescription (Greenhalgh et al., 2022). E-cigarettes that do not contain nicotine are less restricted, and may be sold by retailers to those aged 18+ years in all states and territories except Western Australia (Greenhalgh et al., 2022). The regulations relating to nicotine e-cigarettes are consistent with a precautionary approach to public health (World Health Organization, 2004). Such an approach involves taking action to prevent the harms associated with e-cigarettes given ongoing uncertainty about the benefits and long-term risks associated with use of these products. Consistent with tobacco industry exploitation of tobacco control laws (Moodie et al., 2022; Watts et al., 2021), there is evidence to suggest that Australia’s regulations relating to e-cigarettes are being circumvented by commercial interests (Bara et al., 2023; McCausland et al., 2021; Scott et al., 2023).

Australia’s regulations in relation to e-cigarettes were developed following concerning increases in rates of use among young people. Use of the devices among adolescents increased from 4.3% in 2013 to 9.6% in 2019 (Australian Institute of Health and Welfare, 2020), prompting Australia’s Therapeutic Goods Administration (TGA) to make changes to the regulations governing nicotine vaping products to reduce their accessibility. This involved the TGA making it illegal to purchase nicotine e-liquid or e-cigarettes that contain nicotine e-liquid without a prescription from a medical practitioner, regardless of whether the intended use is for therapeutic purposes. In addition to the health consequences associated with use among youth, the TGA cited several other reasons for proposing these changes (Therapeutic Goods Administration, 2020). These included the (i) lack of evidence supporting e-cigarettes as a safer alternative to currently available smoking cessation aids, (ii) insufficient evidence linking e-cigarette use with successful smoking cessation, (iii) potential for nicotine addiction in new or continuing users and (iv) need to implement effective measures for preventing and reducing nicotine addiction (Therapeutic Goods Administration, 2020), as per the World Health Organization’s Framework Convention on Tobacco Control (World Health Organization., 2003).

As part of this regulatory change process, the TGA consulted Australians regarding its proposal (Therapeutic Goods Administration, 2020), allowing public health organizations, industry and industry front groups and the general public to comment on e-cigarettes and how they should be regulated. To provide a greater understanding of views on the Government’s attempts to restrict widespread availability of nicotine vaping products, the present study aimed to identify and quantify the arguments made by self-reported e-cigarette users in their submissions to the TGA’s consultation. Results have the potential to inform strategies to enhance compliance with the tightened regulations.

METHOD

This research was approved by a university Human Research Ethics Committee. Publicly available submissions to the TGA’s consultation on the introduction of a prescription only model for nicotine vaping products were downloaded (n = 2385). Of these, 1405 were submitted by those who (i) self-identified as users of e-cigarettes and (ii) provided their views on the TGA’s proposal. One researcher (M.J.) read all submissions in their entirety and used an inductive approach to identify coding categories, which were subsequently defined in a codebook. During this initial sweep of the data, the use of identical text across submissions was observed. Further exploration revealed this text to be from a template provided by an industry-led organization as part of an astroturfing campaign encouraging e-cigarette users to voice their opposition to the TGA’s proposal. Verbatim text from this campaign was added to the codebook to facilitate identification, along with a link to the campaign’s website.

Authors M.J. and A.R. independently coded 200 submissions according to the developed codebook, met to discuss instances of disagreement, and then independently coded the remaining submissions. Cohen’s Kappa at the conclusion of all coding was 0.97, with a third coder (A.H.) resolving any discrepancies and consulting the two original coders as required.

RESULTS

The arguments made in the assessed submissions were categorized into topics. All topics are presented in Table 1, but only those identified in at least 10% of submissions are discussed below.

Table 1:

Arguments made in self-reported e-cigarette users’ submissions to the TGA’s consultation on introducing a prescription model for nicotine vaping products in Australia (n = 1405)

Code	n	%
Perceptions of the potential negative consequences associated with the TGA’s decision	1178	84
People will go back to smoking	674	48
Decision infringes upon freedom of choice	332	24
Seeing a doctor for a prescription will be difficult/time consuming/inconvenient	303	22
Black market will emerge	276	20
Smokers will never quit/smokers who have quit will find it harder to stay quit	266	19
Seeing a doctor will burden the health system/cost taxpayers money	252	18
People will get sick and die	212	15
Will cost consumers more money	173	12
Youth will turn to cigarettes	131	9
Access to the variety of products needed to quit will be denied	66	5
Decision will increase appeal of use among youth because they want to rebel	42	3
Decision will burden the health system as people will go back to smoking	41	3
Destroy the vaping industry	24	2
Smoking rates will increase	21	2
Put pressure on justice system/enforcement	19	1
Claims made about the benefits of e-cigarettes/vaping	772	55
Vaping has beneficial health outcomes	601	43
E-cigarettes are an effective quitting aid	174	12
Vaping is cheaper/has financial benefits	129	9
How e-cigarettes make it easier to quit	95	7
95% factoida	80	6
Vaping is proven to be safer than smoking	80	6
Users have greater control of content	35	3
Vaping reduces burden on the health system	33	2
Vaping is not harmful to others	29	2
Vaping is better for the environment	16	1
Inconsistent treatment	736	52
E-cigarettes should not be restricted when more harmful tobacco products are readily available/e-cigarettes should be as accessible as nicotine replacement therapies	671	48
A script is not needed for tobacco cigarettes or nicotine replacement therapies	259	18
Alternative policy and practice approaches	436	31
E-cigarettes should be available in retail stores	267	19
Tobacco cigarettes should be harder to access	94	7
E-cigarettes should be taxed instead	50	4
Vape store staff are experts/preferred providers of information	45	3
Youth should be educated on the harms associated with vaping	36	3
Industry-led campaign	370	26
Motivation behind legislation	236	17
Revenue raising by government	197	14
Government is in the pocket of Big Tobacco/Pharma	60	4
Ploy by Big Tobacco	11	<1
Bandwagon fallacy: need to legalize e-cigarettes as per other countries	231	16
Denial of evidence	174	12
Youth uptake is not a problem	103	7
Nicotine is not harmful	50	4
Gateway hypothesis/normalization is a fallacy	36	3
Only certain vapes are the problem	13	<1
Healthcare professionals are unwilling to prescribe or dispense e-cigarettes and are not trained in how to do so	172	12
Harm reduction at the individual level prioritized over the population level	105	8
Benefits of legalizing e-cigarettes	90	6
Better for kids to vape than smoke	38	3
Create jobs/benefit economy	33	2
Rates of cigarette smoking will decrease	27	2
Government ignoring evidence	52	4

Note. Proportions within and between codes do not add to 100% as submitters could make multiple arguments.

^aRefers to the use of Public Health England’s claim that e-cigarettes are 95% less harmful than smoking (McNeill et al., 2015).

In most of the assessed submissions (84%), at least one potential negative consequence of the TGA’s decision to introduce a prescription model for nicotine vaping products was nominated. Smoking relapse was most frequently reported (48%), followed by infringement on freedom of choice and personal liberties (24%) and the perceived inconvenience associated with accessing a medical practitioner for a prescription (22%). In a substantial minority of submissions, it was claimed the TGA’s decision would result in the emergence of a black market (20%), make it harder for smokers to quit (19%) and/or burden the healthcare system (18%).

Around half (55%) of submissions featured claims about the benefits of e-cigarettes, specifically that (i) use has beneficial health outcomes (43%) and/or (ii) the devices are an effective quitting aid (12%). Around half (52%) mentioned inconsistent treatment, noting that e-cigarettes should not be restricted when more harmful tobacco products and other nicotine replacement therapies are readily available (48%).

One-third (31%) of submissions included suggestions for alternative approaches to policy and practice. For example, in 19% of submissions it was noted that e-cigarettes should not be restricted but rather made widely available in retail stores. Text from the industry campaign to legalize vaping was identified in one-quarter (26%) of submissions.

The motivation behind the TGA’s decision was questioned in some submissions (17%), with the suggestion made that it was an attempt by the government to raise revenue and that the government was acting on behalf of tobacco industry lobbyists. In some submissions (16%) it was noted that Australia should adopt the approaches of countries such as New Zealand and the UK and legalize e-cigarettes. Just over 1 in 10 (i) countered scientific evidence that e-cigarettes are problematic (e.g. some submitters claimed that there is no youth uptake of e-cigarettes) and/or (ii) reported that healthcare professionals are unwilling to prescribe or dispense e-cigarettes and are not trained in how to do so.

DISCUSSION

The present study sought to examine submissions made by self-reported e-cigarette users to a public consultation on the introduction of a prescription model for vaping products in Australia. No support for the model was expressed in the analysed submissions, which is consistent with research indicating that those whose behaviours would be restricted are less likely to be supportive of proposed interventions than others (Diepeveen et al., 2013).

The belief that a prescription model would have negative consequences, particularly smoking relapse, featured in most of the analyzed submissions. To counter this perception, it may be beneficial to inform the general public (and e-cigarette users in particular) that former smokers who use e-cigarettes have been found to be more than twice as likely to relapse than former smokers who do not use the devices (Baenziger et al., 2021) and that dual use of e-cigarettes and tobacco cigarettes is not associated with reduced overall quit rates (Jackson et al., 2020). It may also be useful to communicate research outcomes showing that a majority of those who use e-cigarettes to quit smoking continue to use the devices in the long term and that use of e-cigarettes for smoking cessation may lead to permanent nicotine dependence (Hanewinkel et al., 2022).

Claims about the benefits of e-cigarettes, including favourable health outcomes (e.g. improved breathing) and that e-cigarettes are an effective quitting aid, were evident in many submissions. While there is evidence to suggest e-cigarettes are less harmful than tobacco cigarettes (National Academies of Sciences, Engineering, and Medicine, 2018), the long-term health risks associated with e-cigarette use remain unknown. Informing users about this uncertainty may assist them to make informed decisions about ongoing use. Given 40% of smokers who use e-cigarettes to quit smoking become users of both e-cigarettes and tobacco cigarettes (Kaplan et al., 2021), ensuring users are aware that complete cessation of tobacco cigarette smoking is needed to optimize health benefits is also warranted (Stokes et al., 2021). Cutting down on the number of cigarettes smoked per day reduces the health risks of smoking by only a small amount (Chang et al., 2021), and those who smoke even one cigarette per day are at substantially increased risk of experiencing a heart attack and stroke (Hackshaw et al., 2018). Correcting misperceptions among dual users who may mistakenly believe they have markedly reduced their risk is warranted.

In many submissions, concerns were expressed about inconsistency between the regulatory treatment of e-cigarettes and tobacco products. In these submissions, attempts were made to discredit the TGA’s proposal by arguing that nicotine replacement therapies and more harmful tobacco cigarettes are widely available. In a substantial minority of submissions it was argued that e-cigarettes should be available in retail stores. Communications highlighting (i) the historical mistake of tobacco cigarettes being made consumer products, (ii) the urgent need to reduce the accessibility and availability of both tobacco and e-cigarettes rather than increase the accessibility and availability of e-cigarettes and (iii) that nicotine replacement therapies have been approved by the TGA and are thus subject to quality and safety standards (unlike e-cigarette products) may be useful. Ongoing messaging communicating that e-cigarettes have not been approved by the TGA and have therefore not undergone rigorous testing for effectiveness, quality and safety may assist with ensuring users are adequately informed of the risks associated with use. Informing users of the differences in risks associated with use of e-cigarettes and approved nicotine replacement therapies (e.g. mouth sprays and inhalators) has the potential to go some way towards alleviating concerns over the apparent contradictions in the current availability of these products.

The degree to which content from an industry-led astroturfing campaign promoting the legalization of e-cigarettes appeared in analyzed submissions is concerning and evidences the continued attempts of the tobacco and e-cigarette industries to sway public policy in a manner that protects their financial interests. By lobbying users to make submissions on their behalf, the tobacco and e-cigarette industries are bypassing conflict of interest declaration requirements. Exposing the disingenuous methods used by industry to promote their agenda may assist with ensuring public policy is not influenced by vested interests. Given in some submissions it was noted that the TGA's proposal was evidence the Australian Government was in the pocket of Big Tobacco, communications that expose Big Tobacco as being behind much of the push to legalize vaping may address this misperception.

It is concerning that some submissions featured content denying scientific evidence showing that e-cigarettes are problematic. This finding evidences the proliferation of vaping misinformation, especially claims that youth e-cigarette use is intentionally exaggerated and use is not addictive (Sidani et al., 2022). Strategies to address these claims, and misinformation generally, are urgently needed.

Finally, arguments that healthcare professionals are unwilling to prescribe or dispense e-cigarettes and are not trained in how to do so warrant further investigation. The effectiveness of the prescription model is dependent on general practitioners being open to prescribing e-cigarettes to smokers who wish to quit smoking but have been unable to do so with first-line treatments. The Royal Australian College of General Practitioners has developed resources to assist practitioners with providing evidence-based support to their patients. Ensuring practitioners are aware of these resources may assist in reducing any hesitancy to prescribe e-cigarettes for those who may benefit.

The present study had some limitations. First, the results cannot be considered to represent the beliefs of all e-cigarette users. Only a fraction of Australian vapers made a submission and it is probable that those who strongly opposed the TGA’s reform were more likely to make a submission than those who were neutral or supportive. Second, although we were able to identify at least 26% of submissions that were influenced by an industry-led astroturfing campaign, it is likely that more may have been influenced by this and related campaigns, but did not use text that could be readily identified. Third, e-cigarette user status was self-reported and could not be independently verified. It is possible that some submissions were made by industry under the guise of being consumers. Finally, it was not possible to assess whether arguments differed by sociodemographic characteristics because submitters were not required to provide this information.

CONCLUSION

The present study identified and quantified the arguments made by e-cigarettes users who submitted responses to a proposal to implement a prescription model for nicotine vaping products in Australia. Health communications could inform users of the risks associated with vaping, including the potential for smoking relapse, and advise that e-cigarettes have not been approved by a medical authority and have therefore not undergone rigorous testing for effectiveness and safety. These communications could also be used to address misinformation, especially claims downplaying the issue of youth uptake. Such an approach could assist in reducing potential barriers to compliance with e-cigarette regulatory policies, such as those recently announced by the Australian Government (Department of Health and Aged Care, 2023). Disseminating information in a manner that can be easily understood by the lay community is critical.

AUTHORS’ CONTRIBUTIONS

M.J. made a substantial contribution to the conception and design of the work, and the acquisition, analysis and interpretation of data. She also drafted the work. A.R. and A.H. made substantial contributions to the analysis of the data. A.R., A.H. and S.P. made substantial contributions to the interpretation of the data and the writing of the manuscript. All authors agree to be accountable for all aspects of the work.

FUNDING

This work was supported by a National Health and Medical Research Council Investigator Grant (APP1194713). The funding source had no involvement in study design; in the collection, analysis and interpretation of data; in the writing of the article and in the decision to submit the article for publication.

CONFLICT OF INTEREST

M.J. holds the position of Editorial Board Member for Health Promotion International. She was not involved in the review process for this manuscript nor the decision to accept this manuscript for publication.

ETHICAL APPROVAL

This research was approved by a university Human Research Ethics Committee (2022-22925-27027-3).