Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1697642113280.pdf (Australia)
Tobacco Harm ReductionSubmission 166 3 November 2020 Select Committee on Tobacco Harm Reduction Dear Senators, Thank you for the opportunity to make a submission to this important Inquiry.

Nicotine vaping is the most effective and most popular quitting aid globally.

There is overwhelming scientific agreement that vaping nicotine is far safer than smoking and the public health benefits are well recognised.
However, Australia remains the only western democracy to ban the sale and use of nicotine for vaping.

Countries like the UK and New Zealand treat nicotine liquid as a consumer product and promote vaping as a safer alternative to smoking.

No country in the world requires users to have a doctor’s prescription for accessing low concentrations of nicotine.
Nicotine vaping is a harm reduction strategy that will complement existing tobacco control and smoking cessation measures and accelerate the decline of smoking in Australia.
Australian medical professional associations are gradually acknowledging the benefits of legalised vaping as a public health measure, including the Royal Australian and New Zealand College of Psychiatrists, The Royal Australian College of General Practitioners and the Royal Australasian College of Physicians There is a compelling case to ease restrictions and implement carefully balanced regulations that protect consumers without compromising the considerable potential benefits.
Vaping has the potential to improve the lives of hundreds of thousands of Australians, especially disadvantaged and marginalised groups.

Board members Dr Joe Kosterich (Chairman) Dr Colin Mendelsohn Dr Alex Wodak AM Mr Ean Alexander What is ATHRA?

The Australian Tobacco Harm Reduction Association (ATHRA) is a registered health promotion charity established to help reduce the harm from tobacco smoking in Australia.
ATHRA’s aim is to provide smokers and health professionals with evidence- based information on safer alternatives to smoking.

ATHRA was established by medical practitioners with a special interest in tobacco, harm reduction and public health.

The Board Members have special expertise in this field and play an active role in evidence-based education of the public and health professionals and policy advice in Australia.

ATHRA is funded by public donations.


ATHRA does not accept donations from tobacco companies, their subsidiaries or the vape industry.

ATHRA accepted financial support from the small retail vape sector to help establish the charity in 2017 but has not accepted any industry funding since March 2019.

Board members do not receive any financial payments.

None have ever received funding or payments of any kind from the vaping or tobacco industry and have no commercial relationships with those industries.
11 Carlotta Rd, Double Bay NSW 2028 ATHRA is registered as a charity with the Australian Charities and Not-for-profits Commission ABN 72 6222 11223 2 Tobacco Harm ReductionSubmission 166 Contents What is ATHRA?
.................................................................................................................................................... 2 Executive Summary ............................................................................................................................................... 4 Recommendations ................................................................................................................................................ 6 Evidence ................................................................................................................................................................ 7 1 The treatment of nicotine vaping products (electronic cigarettes and smokeless tobacco) in developed countries similar to Australia ............................................................................................................................ 7 2 The impact nicotine vaping products have had on smoking rates in these countries, and the aggregate population health impacts of these changes in nicotine consumption .......................................................... 12 3 The established evidence on the effectiveness of e-cigarettes as a smoking cessation treatment ............ 14 4 The established evidence on the uptake of e-cigarettes amongst non-smokers and the potential gateway effect onto traditional tobacco products ........................................................................................................ 15 5 Evidence of the impact of legalising nicotine vaping products on youth smoking and vaping rates and measures that Australia could adopt to minimise youth smoking and vaping .............................................. 20 6 Access to e-cigarette products under Australia’s current regulatory framework ....................................... 21 7 Tobacco industry involvement in the selling and marketing of e-cigarettes ............................................... 22 8 Any other related matter ............................................................................................................................. 23 Tobacco harm reduction ............................................................................................................................ 23 Prescription model ..................................................................................................................................... 24 Opposition to vaping in Australia ............................................................................................................... 25 Priorities in tobacco control ....................................................................................................................... 27 The precautionary principle ....................................................................................................................... 27 Public vaping .............................................................................................................................................. 27 Flavours ...................................................................................................................................................... 28 Taxation ...................................................................................................................................................... 29 Social justice ............................................................................................................................................... 30 Human rights .............................................................................................................................................. 30 References .......................................................................................................................................................... 31 3 Tobacco Harm ReductionSubmission 166 Executive Summary 1 The treatment of nicotine vaping products (electronic cigarettes and smokeless tobacco) in developed countries similar to Australia Developed countries regulate nicotine vaping products as consumer products or tobacco products (USA only) and sales are restricted to adults.
Regulations aim to strike a balance between making safe and effective products available for adult smokers while restricting access to young people.

In general, there are mandatory product safety standards, labelling, health warnings and child-resistant containers and advertising is restricted or prohibited.

Rules on public vaping vary.

Pre-market notification systems and reporting and recall procedures are in place for consumer safety.
2 The impact nicotine vaping products have had on smoking rates in these countries, and the aggregate population health impacts of these changes in nicotine consumption The introduction of vaping has been associated with increased declines in population smoking rates.

In the UK and USA, the decline in smoking rates has accelerated since vaping became readily available.

Population studies have found that smokers who use vaping to quit have significantly higher quit rates than those who do not use vaping.
The population impact of nicotine vaping is amplified by its popularity with smokers.

Vaping devices are now the most popular quitting aids in western countries where they are readily available.

All modelling studies except one predict a substantial net public health benefit from vaping, in life-years saved and deaths averted, even after considering the potential risks such as harm from vaping and uptake by non-smokers.
3 The established evidence on the effectiveness of e-cigarettes as a smoking cessation treatment The scientific evidence that vaping is an effective quitting aid has been established by randomised controlled trials (RCTs), observational and population studies and accelerated declines in national smoking rates in countries where vaping is readily available.

Each type of study has benefits and limitations but combining and triangulating the results provides compelling evidence that vaping helps smokers quit.
4 The established evidence on the uptake of e-cigarettes amongst non-smokers and the potential gateway effect onto traditional tobacco products In adults, vaping is largely confined to smokers and ex-smokers.

International surveys have found that ‘current’ use by adult never-smokers is rare, generally <1%.

Daily vaping and use of nicotine are very rare in never-smokers.

There is no convincing evidence that vaping is a gateway to smoking for young people who would not otherwise have become smokers.
Young people who try vaping are more likely to also try other risky behaviours such as smoking, but there is very little if any evidence that vaping causes young people to take up regular smoking.

Most youth vaping is experimental, transient and infrequent.

Regular vaping is largely confined to smokers or ex-smokers and is rare in never-smokers (generally reported as ≤1% in international surveys).

Research suggests that vaping may be diverting some young people from taking up smoking.
Vaping is also used as a quit aid by some young smokers.

Most youths who try vaping are already cigarette smokers or have previously experimented with cigarette smoking.

Very few never-smokers who try vaping develop nicotine dependence.
4 Tobacco Harm ReductionSubmission 166 5 Evidence of the impact of legalising nicotine vaping products on youth smoking and vaping rates and measures that Australia could adopt to minimise youth smoking and vaping There is no evidence that legalising nicotine vaping products has increased youth smoking rates.

On the contrary, the international evidence suggests that vaping is accelerating the decline in youth smoking.
Youth vaping can be minimised by strict age verification and enforcement, restrictions on marketing which appeals to youth and public messaging that frames vaping as a harm reduction tool for adult smokers.

6 Access to e-cigarette products under Australia’s current regulatory frameworks Australia’s current de facto prohibition on vaping restricts access to vaping nicotine for adult smokers who wish to quit, especially disadvantaged smokers.
Vapers are criminalised under the current rules as most are unable to obtain a nicotine prescription.

Many smokers do not attempt to vape due to legal risks and continue to smoke.
The restricted access to legal vaping products has led to increasing black market sales which put users at risk from unsafe products, the sale of products to underage users, importation and manufacture of unregulated and dubious products and an increased risk of child poisoning due to importation of highly concentrated nicotine liquids.

7 Tobacco industry involvement in the selling and marketing of e-cigarettes Most vaping products are made and sold by small to medium independent companies.
Tobacco companies are estimated to have less than 20 per cent market share of the global vaping market.

No tobacco company vaping products are sold or marketed in Australia.

When nicotine liquids are legalised, sale and marketing will be subject to the same restrictions as for other companies.

However, the primary focus of vaping regulations should be on improving public health, not on who makes these safer alternative products.
8 Any other related matter Low concentrations of nicotine should be classified a consumer product and regulated by the Australian Competition and Consumer Commission (ACCC) which provide strong protection under consumer law.

No country in the world requires users to have a prescription for accessing nicotine liquid.

The government’s proposed prescription model is unworkable and will have many harmful consequences.

Nicotine vaping has the potential to improve health and financial inequalities.
Disadvantaged and marginalised Australians are disproportionally affected by tobacco use and are less responsive to traditional tobacco control strategies.

The right to health is a fundamental human right and is enshrined in international law and treaties.

Governments have a responsibility to make safer products available for adults who wish to use them to reduce the harm from smoking.
The Committee should be aware that vaping is opposed for reasons other than the scientific evidence, such as ideological, political, financial, moral reasons and vested interests.

Restricting flavours will have little effect on youth vaping but will reduce the appeal and effectiveness of vaping as a safer alternative for adult smokers.

Taxation of vaping products should be kept to a minimum to encourage smokers to switch to the safer alternative.
5 Tobacco Harm ReductionSubmission 166 Recommendations ▪ Endorse and support tobacco harm reduction as a legitimate strategy to reduce smoking-related deaths and disease as outlined in Australia’s National Tobacco Strategy and the WHO Framework Convention on Tobacco Control ▪ Exempt nicotine e-liquid in concentrations ≤ 5% for vaping from the Poisons Standard and regulate it as a consumer product by the Australian Competition and Consumer Commission.
▪ Allow the purchase of nicotine e-liquid in concentrations ≤ 5% without a doctor’s prescription and remove penalties for possession and use ▪ Develop regulations for e-liquids including minimum standards for manufacture and safety, restricted access for youth, mandatory standards for labelling, child-resistant containers and health warnings, clear guidelines about public vaping, a notification scheme for pre-market registration and a system for reporting harmful effects and recall of unsafe products ▪ Regulate nicotine vaping products in proportion to risk, for example with low taxation, allowing the use of a wide range of flavours, allowing some advertising to encourage switching and allowing vaping in public places subject to approval by local authorities ▪ Ensure that it is easier to access nicotine vaping products than deadly combustible tobacco products ▪ Recognise that excessive restriction on vaping to reduce uptake by young people may create net harm by reducing appeal and access for older smokers who are at imminent and far greater risk of harm from smoking ▪ Allow the manufacture of nicotine e-liquids in Australia and the importation of approved nicotine liquids from overseas ▪ Recognise vaping as the highest priority for tobacco harm reduction in Australia but when possible Swedish snus, heated tobacco products and nicotine pouches should all be made available ▪ Allow the use of tobacco harm reduction options in health facilities and prisons 6 Tobacco Harm ReductionSubmission 166 Evidence 1 The treatment of nicotine vaping products (electronic cigarettes and smokeless tobacco) in developed countries similar to Australia Australia is the only western democracy to ban the sale of nicotine vaping products.
Figure 1.

Legal status of vaping Reference [1] Australia is increasingly out-of-step with other all western countries which treat low concentrations of nicotine for vaping as consumer products (except the USA where they are classified as tobacco products).

Nicotine vaping products are widely available to adult smokers as a safer substitute for combustible tobacco.
Regulations generally aim to strike a balance between making safe and effective vaping products accessible for addicted adult smokers, while minimising use by non-smokers, especially youth.

Regulations vary between countries (and individual states and provinces eg in Canada and USA).

Regulation of vaping should be proportionate to the risk of the product (the principle of proportionality).

Vaping is at least 95% less harmful than smoking and should not be regulated like lethal tobacco products.
Regulations should make effective nicotine vaping products more accessible and affordable for adult smokers who are unable to quit with other methods.

Regulations on vaping should never be more restrictive than the deadly alternative, smoking tobacco.

The Australian Tobacco Harm Reduction Association has prepared a discussion paper on the regulation of nicotine e-liquids for vaping in Australia.
This is based on the best elements of the United Kingdom and New Zealand guidelines with input from toxicologists.

The document can be accessed here: Regulation of Nicotine e-Liquids for Vaping in Australia.

A Discussion Paper, ATHRA.

Sept 2020 It is important to note that many of the UK regulations are determined by article 20 of the European Tobacco Products Directive (TPD) regulatory framework which applies to all EU countries.
[link] Some of the restrictions on nicotine vaping are excessively restrictive and are not proportionate to the risk of the products.

For example, the arbitrary restrictions on bottle size (10ml) and nicotine limits (20mg/mL) are 7 Tobacco Harm ReductionSubmission 166 arbitrary and counterproductive.

Blanket bans on advertising prevent responsible, targeting advertising to adult smokers to educate them about these products.
A recent study found that In England, the “introduction of mandatory NVP [nicotine vapour product] warnings and leaflets in 2017” was associated with small increases in noticing them but not with changes in concerns about NVP use.” [2] Since Brexit, UK is no longer subject to EU law and there is growing pressure to lift some of the unhelpful restrictions, including: [3] 1.

Raising the limit on nicotine concentrations in vaping liquids 2.

Allowing restricted, responsible advertising 3.


Replacing excessive and inappropriate warnings on vaping products 4.

Reviewing the requirements for vaping information leaflets 5.

Remove wasteful restrictions on vaping product tank and e-liquid container size Table 1.

Summary of regulations in western countries Classification Consumer products in all countries except USA (tobacco products).
Some countries also have a medical pathway for products which make therapeutic claims Sale Adults only, generally 18+; 18-21+ in Canada; 21+ in USA Product safety Regulations for laboratory and safety standards, ingredients allowed in e-liquids, electrical safety, emissions testing Labelling and packaging Bottle and tank sizes Accurate labelling, health warnings, no health claims, child-resistant containers The UK and EU restrict bottle and tank sizes; other countries do not Nicotine limit The UK and EU limit nicotine to 20mg/ml; other countries do not set limits Advertising Partly restricted (UK, EU); prohibited (NZ); unrestricted (USA) Point of sale display Generally permitted Notification Most require pre-market notification (UK, EU, Canada) or approval before sale (USA) Public vaping Varying rules apply eg outdoor vaping permitted and individual businesses deciding policy (UK), prohibition in smoke-free areas and local authorities deciding on outdoor areas (NZ) Vaping in vape shops Reporting and recall Not restricted All have a system for reporting adverse effects and recalling faulty products Table 2.
Comparison of UK, NZ and US regulation of vaping and e-liquids 8 Tobacco Harm ReductionSubmission 166 Regulator ▪ Medicines and Healthcare products Regulatory Agency (MHRA) Classification Dual classification ▪ Consumer product, or ▪ Medical product if 1) higher nicotine concentration, or 2) making claims of safety or efficacy ▪ Ministry of Health ▪ Food and Drug Administration (FDA) (since 2016) Dual classification ▪ Tobacco product, or ▪ Therapeutic product Dual classification ▪ Consumer product, or ▪ Medical product if making claims about safety or efficacy Nicotine concentration ▪ Max 20mg/ml for consumer products ▪ No limits ▪ No limits ▪ >20mg/ml for therapeutic products Minimum age ▪ 18 years (same as ▪ 18 years (same as tobacco) tobacco) ▪ Individuals under 18 years not permitted entry to specialist vape shops Advertising ▪ Prohibited except for ▪ Prohibited outdoor, posters, cinema, side of bus, leaflets, direct hard copy mail, in trade press, blogs, tweets independently compiled ▪ 21 years (same as tobacco).
Both increased from 18 to 21 years in December 2019 ▪ Unrestricted.
Includes TV, radio, print, internet, billboards Point of sale display ▪ Permitted ▪ May communicate health ▪ Permitted information or warnings Public vaping ▪ Vaping permitted ▪ Prohibited in smoke-free outdoors and not subject to smoke-free legislation ▪ Local proprietors or organisations can decide policy on use in their premises areas ▪ Local authorities can make decisions on vaping in outdoor smoke-free areas ▪ Vaping in smoke-free areas regulated by individual states 9 Tobacco Harm ReductionSubmission 166 ▪ To be established after public consultation ▪ It is proposed that NZ will follow the UK model ▪ Must include: “WARNING: This product contains nicotine.
Nicotine is an addictive chemical” Labelling, packaging ▪ Products contain mandatory leaflet that includes information on: - use and storage - contraindications - possible adverse - effects addictiveness and toxicity - warnings for specific groups - batch number - contact details of manufacturer ▪ Health warnings must cover 30% of label’s surface area and must be placed on front and back Restrictions on hardware, bottle sizes ▪ Limit of 2ml for tanks or pods ▪ Nil ▪ Limit of 10ml for e-liquids ▪ Nil Child- resistant containers Product safety ▪ Nicotine-containing products or their packaging to be child- resistant and tamper evident ▪ To be established after public consultation ▪ No vitamins, colourings or prohibited additives (including caffeine and taurine) ▪ Using only ingredients of high purity ▪ Must not include ▪ Products will need to comply with any product safety requirements set out in regulations ▪ Requirements will prohibit certain ingredients ingredients (except for nicotine) which pose a risk to human health ▪ Exact requirements will be the subject of public consultation ▪ Deliver a dose of nicotine at consistent levels ▪ Mechanism for ensuring re-filling without leakage Reporting Side effects and safety concerns can be reported to Manufacturers and importers must advise the Director- ▪ Child-resistant packaging (Child Nicotine Poisoning Prevention Act 2015) ▪ Must comply with the requirements of PMTA Consumers and manufacturers report adverse effects to FDA 10 Tobacco Harm ReductionSubmission 166 Pre-market Notification MHRA through the Yellow Card reporting system General of any adverse reaction ▪ 6 months prior to ▪ Manufacturers and importers must notify products to the Ministry of Health before they can be sold in New Zealand ▪ A searchable database will be available marketing, producers must supply MHRA: - - A list of all ingredients in the product (liquid) and emissions from the product Toxicological data, including health and addictive effects - Nicotine dose and uptake when consumed - Components of the - product Production process details ▪ Manufacturers must submit a PMTA (Premarket Tobacco Application) before sale for all products.
Commenced 9 September 2020 - List of ingredients, additives - Toxicological and pharmacological data - Manufacturing details - Packaging and labelling details - Clinical studies Flavours ▪ No flavours prohibited ▪ Specialist vape shops: No flavours prohibited ▪ General retailers: Tobacco, mint and menthol only ▪ Federal - Prefilled pod or cartridge devices: only menthol and tobacco flavour - No restriction of flavours in open systems ▪ Some states have flavour restrictions Vaping in retail stores Legislation ▪ Not restricted ▪ Specialist vape shops: ▪ Not restricted Permitted ▪ General retailers: Prohibited The Tobacco and Related Products Regulations 2016 (Parts 6, 7 and 8) [link] Smokefree Environments and Regulated Products (Vaping) Amendment Bill 2020 [link] Family Smoking Prevention and Tobacco Control Act 2009 [link] 11 Tobacco Harm ReductionSubmission 166 Other references E-cigarettes: regulations for consumer products 2019 [link] E-cigarettes and vaping: policy, regulation and guidance 2020 [link] UK laws on the advertising of e-cigarettes 2016 [link] Licensing procedure for electronic cigarettes as medicines [link] Fact sheet: Smokefree Environments and Regulated Products (Vaping) Amendment Bill [link] The facts of Vaping (NZ Ministry of Health website) [link] FDA Deeming Rule 2016 [link] 2 The impact nicotine vaping products have had on smoking rates in these countries, and the aggregate population health impacts of these changes in nicotine consumption Smoking rates Decline in smoking rates The rate of decline in smoking in both the USA and UK has accelerated over the period that vaping has become widespread and quit rates have increased across the population [4, 5] These changes do not appear to be explained by other factors such as tax rises and public health marketing campaigns.
[6] Figure 2.

Adult smoking rates in England, US, Australia 2010-2019 The adult smoking rate in Australia has declined by 0.3% per year since 2013 compared to 1% per year in the US (2013-2018) and 0.8% per year in England (2013-2019).

12 Tobacco Harm ReductionSubmission 166 Figure 3.

Annual decline in smoking prevalence Population studies Population studies in the USA and the UK have found that smokers who use vaping to quit have significantly higher quit rates than those who do not.
[6-12] An English study of 19,000 smokers found that those who used vaping devices to quit in the last 12 months had significantly higher quit rates than those who bought over-the-counter NRT and those who used no treatment.

[9] A US study of nearly 23,000 smokers found that those who used a vaping device were 73% more likely to quit than non-users (8.2% vs. 4.8%) and were also more likely to make a quit attempt.
[6] Another study of 60,000 25-45-year-olds in the USA found that smokers who were vaping were 65% more likely to have quit smoking in the previous 12 months than smokers who were not.

[7] Daily vaping is more effective than less frequent vaping.

A study of 5,832 US smokers who initiated vaping daily were 8 times more likely to have quit 1 year later compared with those who did not vape.
[13] In another US study of 32,320 smokers, daily vapers were 2-4 times more likely to have quit after two years compared with those who didn’t vape.

[14] A simulation study estimated the impact of vaping on smoking rates in England from 2012-2019.

[12] A decline of 8% in the smoking rate was expected over that period based on previous patterns, however the actual decline was 28%.
The difference of 20% was attributed to vaping, which was estimated to have averted 165,660 smoking-attributable deaths by 2052.

These findings contrast with a review which concluded that vapers were less likely to stop smoking.

[15] This study has been widely criticised for its poor methodology.

[16, 17] Also see Science Media Centre; Cancer Research UK.

Popularity of vaping The population impact of nicotine vaping is amplified by its popularity with smokers.
Vaping devices are now the most popular quitting aid in the UK, [18] the USA [19], the European Union [20] and Australia [21].

The number of adults who vape continues to grow rapidly and was estimated to be at least 68 million globally in 2020.

[1] Aggregate population health impacts It is not possible to quantify the population health impact of vaping with the available data.

Some smoking- related diseases take decades to appear.
It is also hard to isolate the population impact of vaping from other causes, especially as vaping is taken up by only a small part of the population.

13 Tobacco Harm ReductionSubmission 166 However, modelling studies can estimate the future population health impact by calculating the benefits and risks of vaping under various assumptions.

[22] The main benefit is helping adult smokers quit; the main risks are the potential harm to health from vaping and the risk of uptake by non-smokers, including youth.
All modelling studies except one [23] indicate a substantial net public health benefit from vaping, such as life-years saved, and deaths averted, even after considering the potential harms such as harm from vaping and uptake by non-smokers.

[24-29] The most comprehensive study of the US population yielded positive estimates of 143,000 to 65 million life- years saved due to vaping by 2100.

[29] Most scenarios tested resulted in millions of individuals quitting smoking due to vaping.
Another study estimated the life-years saved or lost to the year 2070 in the US from vaping and projected population gains from 580,000 life years to 3.3 million life-years.

[24] A further study of the US population predicted that replacing most cigarette with vaping in the US over a 10- year period would yield between 1.6 and 6.6 million fewer premature deaths, with between 20.8 and 86.7 million fewer life years lost.
[25] Petrović-van der Deen modelled the health and cost impacts of liberalising vaping in New Zealand over the lifetime of the population alive in 2011.

They estimated a gain of 236,000 Quality Adjusted Life Years and a saving of NZ$3.4 billion (2017 $).

[26] The National Academies of Sciences, Engineering and Medicine (NASEM) report concluded that under likely scenarios, vaping will result in a net benefit in the US.

[30] The one study which found no benefit was based on implausible assumptions.
[23] It failed to account for potential health benefits of youth taking up vaping instead of tobacco smoking, and the potential small reductions in health harm among those who simultaneously vape and smoke tobacco (dual use).
3 The established evidence on the effectiveness of e-cigarettes as a smoking cessation treatment The scientific evidence that vaping is an effective quitting aid has been established by randomised controlled trials (RCTs), observational and population studies and accelerated declines in national smoking rates in countries where vaping is readily available.

Each type of study has benefits and limitations but combining and triangulating the results provides compelling evidence that vaping helps smokers quit.
Randomised controlled trials (RCTs) Randomised controlled trials show that vaping works in a controlled environment when compared to placebo or nicotine replacement therapy (NRT).

A trial of 886 smokers by Hajek found that smokers randomised to vaping nicotine with a modern device were nearly twice as likely to quit at the 1-year follow up as smokers who were given NRT.

[31] Abstinence rates at 12 months were 18% for the vaping group and 9.9% for NRT users.
In a trial by Walker of 1,124 smokers in New Zealand, those randomised to combined patch and nicotine vaping had triple the abstinence rates of the patch-only group at 6 months (7% vs. 2%).

[32] A more realistic estimate used by the authors gave success rates of 17% versus 10%.

Aggregating the results of the better quality RCTs into a meta-analysis provides greater statistical power and a higher quality of evidence.
Three recent meta-analyses of the best quality studies all found that the participants who vaped were 70% more likely be abstinent from smoking at follow up than those using NRT [33-35] It is also important to note that in these analyses “most data come from studies of cartridge devices which deliver relatively little nicotine in comparison to newer device models”.

[34] Other research shows that modern devices are significantly more effective than earlier versions.
[13] 14 Tobacco Harm ReductionSubmission 166 Observational and population studies Observational studies can help assess whether the effects found in RCTs are observed in the real world.

They cannot show ‘causality’ but add to the evidence that vaping is having a beneficial effect.

Many of the observational studies done so far are limited by poor methodology.

However, two comprehensive analyses of the more robust observational studies found that vaping facilitates quit attempts and increases cessation.
[36, 37] For example, an English study of 19,000 smokers compared the real-world effectiveness of quitting aids used in the previous 12 months.

[9] Smokers who used vaping devices had significantly higher quit rates than those who bought over-the-counter NRT and those who used no treatment.

In the NHS Stop Smoking Services in the UK, the highest quit rates over a number of years are consistently from those using e-cigarettes.
[38] Population studies in the USA and the UK have also found that smokers who use vaping to quit have significantly higher quit success rates than those who do not.

[6-11] A US study of nearly 23,000 smokers found that those who used a vaping device were 73% more likely to quit than non-users (8.2% vs. 4.8%) and were also more likely to make a quit attempt.
[6] Similar results were found in a study of 60,000 25-45-year- olds in the USA: smokers who were vaping were 65% more likely to have quit smoking in the previous 12 months than smokers who were not.

[7] Daily vaping is more effective than less frequent use.

In large studies in the USA, daily vapers were 3–8 times more likely to quit than smokers who did not vape.
[13, 14, 39] For example, Berry, found that smokers (n=5,832) who vaped daily were 7.9 times more likely to not smoke one year later compared with non-users of vaping.

[13] In a study of 32,320 subjects, Glasser reported that daily vapers were 2-4 times more likely to have quit compared with never-vapers at a 2-year follow up.

[14] These findings contrast with a review by Kalkhoran which concluded that vapers were less likely to stop smoking.
[15] This study has been widely criticised for its poor methodology.

[16, 17] Decline in national smoking rates It is not possible to conclusively prove that changes in population smoking can be attributed to any one intervention.
However, it is noteworthy that the rate of decline in smoking in both the USA and UK has accelerated over the period that vaping has become widespread and population quit rates have increased [6, 40] These changes do not appear to be explained by other factors such as tax rises and public health marketing campaigns.

[6] In comparison, smoking rates have declined much more slowly where vaping is less accessible.

See Figure 3 above.
See Figure 3 above.

4 The established evidence on the uptake of e-cigarettes amongst non-smokers and the potential gateway effect onto traditional tobacco products Uptake by non-smoking adults Vaping is largely confined to smokers and ex-smokers.

Vaping nicotine by adult non-smokers is rare.

In Australia, in 2019, 0.7% of never-smoking adults were current vapers (at least once in the previous 12 months) according to the National Drug Strategy Household Survey.
[21] Less than 0.3% were regular users (weekly or more).

By comparison, 9.7% of smokers and 3.2% of ex-smokers vaped.

Importantly, the vast majority of vaping by non-smokers is short term and does not progress to regular use.

In fact 93% of Australia never-smokers who try vaping are no longer current users.
[21] 15 Tobacco Harm ReductionSubmission 166 International surveys have found that current use by adult non-smokers is generally <1%, for example, England, 0.4% [40]; NZ, no regular use [41]; US, 0.3% [6]; EU, current daily use by never smokers, 0.08% [42]; Germany, 0.3% [43]; Iceland, 0.4% [link]; and Greece 0.2% [44].

Furthermore, daily vaping and use of nicotine are very rare in never-smokers.
For example, Farsalinos reported that only 0.04% of never-smoking adults vaped nicotine daily (one in 2,500 never smokers).

[45] There is no evidence of vaping acting as a gateway to tobacco products in adults that we are aware of.

Uptake by non-smoking youth Despite alarming headlines and a manufactured panic about youth vaping, current vaping rates by youth are low.

In Australia in 2019, 1.8% of 14-17 year olds had vaped at least once in the previous year.
[21] Headline statistics typically refer to lifetime or ‘ever-use’.

This is of little public health relevance as most use is transient and most use is by smokers.

The key concern for public health is regular vaping by never-smoking youth.
The evidence shows that ▪ Most youth vaping is experimental, infrequent and short-term ▪ Frequent vaping is concentrated in smokers or former smokers and is rare in non-smokers It is best if youth neither vape nor smoke but if they do choose to use nicotine, vaping is a much safer option.

Any risk to youth from vaping should be placed in context.

It is low risk compared to other risk behaviours like heavy drinking, illicit drugs and teenage pregnancy.
It is also far lower and less immediate than the substantial risks to middle-aged smokers.

It is also important to note that there is no evidence that vaping causes harmful effects on the human adolescent brain.

Nicotine has been linked to adolescent brain harm in animal studies, but these effects have not been demonstrated in humans.

Nicotine in NRT is approved for use from the age of 12 in Australia.

a.
a.

Prevalence of vaping by never-smokers Vaping is largely confined to smokers or ex-smokers and current use is rare in never-smokers (generally reported as ≤1% in international surveys).

For example, in 2019 in Australia, 9.6% of 14-17 year olds had used vaping products at least once in their lifetime.

This included 63.6% of smokers and 7.8% of non-smokers.

Furthermore, 17.5% of smokers and only <1.3% of non-smokers were current vapers, ie had vaped at least once in the last year.

See Figure 4.
See Figure 4.

16 Tobacco Harm ReductionSubmission 166 Figure 4 Vaping by 14-17 year olds by smoking status The frequency of vaping was not reported in 2019 National Drug Strategy Household Survey.

However, in 2017, only 0.3% of 12–17 year old never-smokers had vaped on 3 or more days in the last month, in the Australian Secondary Students’ use of Alcohol and Drug Survey.

[46] Overseas surveys have also found that regular vaping by never-smokers is rare.
For example, in the US 2018 National Youth Tobacco Survey, 3.9% were tobacco-naïve and had vaped in the last 30 days, but only 0.4% vaped regularly (defined as 20+ days in the last 30 days).

Seventy per cent of never-smoking youths did so on only 1-5 days in the last month.

[47] In the UK, in five large scale surveys from 2015-2017 of 60,000 11-16 year olds, regular use (at least weekly) among never-smokers was between 0.1% and 0.5%.
[48] In New Zealand, of 28,756 Year 10 students surveyed by Action on Smoking and Health in 2018, only 1.1% of never-smokers reported daily or weekly vaping.

[49] b. Gateway theory The gateway theory postulates that young people who would never have become smokers will try vaping and that as a result a substantial proportion will become nicotine dependent and progress to regular cigarette smoking.

The current evidence does not support this theory.


It is important to distinguish between causation and association.

Surveys of young people show a longitudinal association between vaping and cigarette smoking, ie that those who try vaping are more likely to later try cigarettes.

[50] However, these studies do not demonstrate that trying vaping causes young people to take up smoking if they would not otherwise have done so.
The most recent and comprehensive analysis of whether vaping causes smoking uptake was published in September by Australian authors from the University of Queensland.

[51] The study concluded that there was little evidence of a gateway effect.

If a gateway effect does exist, it is likely to be small.

A more plausible explanation for the association between youth vaping and smoking is ‘common liability’.
This posits that young people who experiment with risky behaviours such as vaping are simply more likely to also later try cigarette smoking because of shared risk factors (confounders) such as peer smoking, a family history of smoking, low socio-economic status and rebelliousness.

[52] Studies which adjust for these risk factors have found that most if not all the association is due to these other factors.
[53-55] A contrasting finding was made by the National Academies of Sciences, Engineering and Medicine in 2018.

[56] This conclusion is unconvincing because the analysis was not able to exclude residual, unadjusted confounding factors.

The report also did not provide evidence to support the claim that the association 17 Tobacco Harm ReductionSubmission 166 between youth vaping and smoking in the cross-sectional studies is causal.
The studies also referred to past 30-day smoking and there was no evidence that e-cigarette use led to regular smoking.

The plausibility of the gateway theory is weakened by the following additional evidence: c. Decline in smoking rates where vaping has become prevalent The rapid decline in adolescent smoking rates in the UK and US after the introduction of vaping is more consistent with the hypothesis that vaping is a gateway out of smoking.
The 2019 National Youth Tobacco Survey reported that smoking rates in high schoolers declined by an unprecedented 25% from 2018 levels.

[57] (Figure 5) Figure 5.

US youth smoking and vaping prevalence Levy analysed youth smoking rates in the USA from 2004-2018 and found that the decline in smoking accelerated two- to four-fold after 2014 when vaping became popular in young people.

[58] 18 Tobacco Harm ReductionSubmission 166 Figure 6.
Decline in youth vaping in the US Monitoring the Future survey, pre-vaping (2004–2013) and post-vaping (2014–2017) and last 30 days cigarette prevalence with linear trend for pre-vaping period.

Ref [58] In England, smoking rates in young people have also continued to decline rapidly since the introduction of vaping.

[59] d. Vaping as a diversion or quitting method Recent research suggests that vaping may have a protective effect in reducing the risk of an adolescent becoming a smoker.
[60-62] Some adolescents may try vaping as a less harmful alternative to smoking and not progress to smoking.

Friedman examined the impact of bans on the sale of vaping products to minors in the US.

The introduction of bans “counteracted 70 percent of the downward pre-trend in teen cigarette smoking in the states that implemented such bans” and was “consistent with e-cigarette access reducing smoking among minors”.
[63] In the 2014-2017 US National Youth Tobacco Survey, teens who used an e-cigarette first (before smoking) where significantly less likely to go on to become established smokers than: 1) those who smoked first and 2) matched teens who had not tried vaping.

[64] Other teens use vaping as a quit smoking method.

[65, 66] The 2019 NDSHS found that amongst 14-17 year old smokers, 44% vaped to quit, 33.8% vaped to cut down, 23% vaped to avoid relapse and 23% vaped to reduce harm from smoking.
[21] e. Smoking usually precedes vaping Smoking more often precedes vaping than vice versa, i.e.

most youths who try vaping are already cigarette smokers or have previously experimented with cigarette smoking.

In the 2017 Australian Secondary Students’ Alcohol and Drug Survey, two in three 12–17 year-olds who had ever vaped had first smoked.

[46] In studies in the US and UK, around 85% of young people report vaping before smoking.
[13, 59, 67] In the US National Youth Tobacco Survey in 2015 only 7.6% identified e-cigarettes as the first nicotine product they used.

[59] 19 Tobacco Harm ReductionSubmission 166 f. Use of nicotine and dependence Not all youth vapers use nicotine.

In the 2017 US Monitoring the Future survey, only two in three (66%) 12th grade students who had vaped in the previous 30 days used nicotine.

[68] The remainder vaped non-nicotine substances such as flavourings alone or cannabis.
In the UK in 2019, 31.7% of 11–18 year-old vapers said that they always used nicotine, 34.2% said they sometimes vaped nicotine, 19.6% had never used nicotine and 14.4% didn't know.

[69] Nicotine dependence is rare in young people who vape but have never previously smoked.

In the 2018 US National Youth Tobacco Survey only 3.8% of never-smokers who had vaped in the previous 30 days reported cravings and 3.1% wanted to vape within 30 min of waking.
[59] g. Experimental or regular smoking Even if vaping caused some young people to try smoking, most smoking is only experimental or occasional, does not cause nicotine dependence and of little importance to public health.

Approximately three in four youths who try smoking do not progress to daily use.

[70] Only long-term daily smoking is relevant to health risk because epidemiological research suggests that nearly all smoking-related disease can be avoided by stopping smoking by age 30.
[71] A French study of 40,000 17-year-olds found no evidence of an increased risk of transitioning to daily smoking amongst ever-smokers who also experimented with e-cigarettes.

[72] 5 Evidence of the impact of legalising nicotine vaping products on youth smoking and vaping rates and measures that Australia could adopt to minimise youth smoking and vaping The UK experience suggests that youth uptake of vaping can be minimised by appropriate regulations.
Youth vaping rates in the UK are low and smoking rates are continuing to fall.

[48] In 2019, 14-17 year olds in Australia obtained vaping products from the following sources From the Internet - Australian retailer From the Internet - Overseas retailers From the Internet - unsure of the origin of the retailer Friend or family member Tobacco retail outlet Other retail outlet *13.9 **6.0 **3.0 66.3 **4.3 **6.5 * Estimate has a relative standard error of 25% to 50% and should be used with caution.
** Estimate has a high level of sampling error (relative standard error of 51% to 90%), meaning that it is unsuitable for most uses.

Strict age verification and enforcement will reduce access to youth • Australian internet sales will decline.

Purchases from international websites are unlikely to change.

• Sales from tobacco and other retail outlets will be reduced.
Retail outlets that are licensed to sell vaping products will improve compliance if threatened with loss of licence and substantial fines for breaches.

• The most popular source of vaping products is friends of family members.

Some supplies from under- age friends would be sourced from the black market.

In a regulated system, the black market will diminish There are three main strategies to minimise youth access: 1.

Access control.
Access control.

Age limits and restrictions on where and how products can be purchased 20 Tobacco Harm ReductionSubmission 166 2.

Marketing control.

Restrictions on marketing, packaging and branding that is specifically targeted at young people 3.

Public information.
Public messaging that frames vaping as a harm reduction tool for adult smokers Recommended strategies Minimum age of sale laws ▪ 18+ nationally Age verification ▪ Clear requirements for retailers, with enforcement measures and harsh penalties including loss of retail licence, similar to tobacco and alcohol retailers Vape retailers ▪ Licensing of Australian vape retailers Brick and mortar vape shops ▪ No admission for individuals under 18 Online retailers ▪ Third-party age verification ▪ Signature and age verification on delivery Public education Marketing ▪ Education campaigns which frame vaping nicotine as a tool for smoking cessation or as a safer alternative for adult smokers ▪ Restrictions on branding and packaging that appeal to youth ▪ No advertising of vaping products The Australian Tobacco Harm Reduction Association has developed a comprehensive regulatory framework for nicotine e-liquids.
[link] 6 Access to e-cigarette products under Australia’s current regulatory framework Australia has imposed a de facto ban on nicotine liquid for vaping.

Criminalisation of vapers Vapers are required to get a nicotine prescription from a doctor and import nicotine liquid from overseas.

Possessing nicotine without a prescription is a criminal offence carrying penalties up to $45,000 and jail terms up to 2 years.
[link] However, only an estimated 1-2% of Australia’s 520,000 vapers have a nicotine prescription.

Very few doctors are willing to prescribe nicotine for vaping due to official disapproval of vaping and a lack of training.

Reduced access Many smokers do not have the technical skills, resources or a credit card to make online purchases, especially people with mental illness, drug and alcohol problems, Indigenous and homeless people who are most at risk from smoking.
Other smokers are unwilling to risk the criminal charges and penalties that may result from purchasing nicotine without a prescription.

21 Tobacco Harm ReductionSubmission 166 Black market products There is a black market for nicotine liquid in Australia which puts users at risk.

Back-yard suppliers sell unregulated products without quality or safety standards, child-resistant closures or accurate labelling and provide access for underage users.
[73] The US outbreak of EVALI, a serious lung injury due to vaping THC, was caused by black market products contaminated with Vitamin E Acetate.

Unregulated imports A lack of regulation also puts users at risk of unsafe imported products.

Most purchases by Australian vapers are made on the internet from a wide range of countries with varying regulatory or safety controls.
[74] A legal supply chain of regulated products will guarantee safer products with accurate labelling, health warnings and child-proof caps.

Child poisoning risk The current regulations increase the risk of nicotine poisoning by children.

Most experienced vapers import high concentrations of nicotine (100-200mg/ml and even 1000mg/ml) to mix with locally purchased flavours.

Highly concentrated nicotine does not come in childproof containers and requires home mixing with flavoured e-liquid.
In 2018, there was a tragic Australian case in which a toddler died from drinking concentrated nicotine (100mg/ml) while the mother was mixing.

[75] Making low concentrations of pre- mixed nicotine liquid available in Australia in child-resistant bottles will reduce the importation of highly concentrated nicotine preparations and reduce the risk of accidental or deliberate overdose.
In countries where nicotine liquid is legal, most users purchase low concentrations of pre-mixed nicotine liquid in a child-resistant bottle from a vape shop.

Initiation is difficult Initiation of vaping by smokers is more difficult under the current model.

The process of importing nicotine and home mixing is complex and risky and there is a steep learning curve.
A better model is for pre-mixed supplies to be available from a local vape shop where smokers can test different products under expert supervision.

Prohibition doesn’t work Numerous examples of prohibition show that it does not work.

A new supply chain for unregulated products is established by criminal gangs and serious harms are caused to society.

7 Tobacco industry involvement in the selling and marketing of e-cigarettes Most vaping products are made and sold by small to medium independent companies.
Tobacco companies are estimated to have less than 20 per cent market share of the global vaping market.

[1] No tobacco company vaping products are sold or marketed in Australia.

When nicotine liquids are legalised, sale and marketing will be subject to the same restrictions as for other companies.

The primary focus of vaping regulations should be on improving public health, not on who makes these products.

Safer alternatives to smoking will save lives, regardless of who makes them.
Campaigns against vaping perversely support the cigarette trade.

Furthermore, allowing reduced-risk options for nicotine may enable tobacco companies to escape from selling only the most dangerous options for delivering nicotine – combustible cigarettes.

It is important to note that vaping poses a huge and disruptive threat to the tobacco industry.

[76] Vaping is a consumer-led, bottom up industry.

The tobacco industry began investing in vaping in 2012 and has been trying to catch up ever since.
22 Tobacco Harm ReductionSubmission 166 The uptake of vaping has accelerated the decline in cigarette sales.

The FDA proposal in 2017 to encourage vaping led to an unprecedented decline in the value of tobacco stocks.

The combined value of the FT500 tobacco companies fell from US$700 billion to US$372 billion in September 2019.

Share prices fell by more than half from 2017-2020.
Reference: https://www.imperialbrandsplc.com/investors/share-price/lse/share-chart.html Highly restrictive regulatory barriers favour the tobacco industry.

For example, product registration by the Therapeutic Goods Administration is enormously costly and onerous.
The small independent companies that manufacture vaping products do not have the funds or experience in pharmaceutical regulation to conduct clinical trials or to complete the application process required to have their products registered as therapeutic goods.

This allows the tobacco industry with its enormous cash flow to eliminate most of the small to medium players and control the market.
8 Any other related matter Tobacco harm reduction The main purpose of tobacco harm reduction (THR) is to reduce (not necessarily eliminate) the harm from smoking.

The aim is not to stop nicotine as nicotine causes little harm.

Tobacco harm reduction involves encouraging smokers to switch from high-risk combustible (burnable) cigarettes to a lower-risk nicotine alternative such as vaping.

Complete cessation of all tobacco and nicotine consumption is always the ideal goal.
However, a large proportion of smokers are unable or unwilling to quit, therefore remaining at high risk of smoking-related death and illness.

THR aims to reduce the health risks in continuing smokers by switching from combustible tobacco to lower-risk smokeless nicotine alternatives.

Smokeless products are not risk-free but are much safer than smoking.
Reduced-risk products include vaping (using an e-cigarette), Swedish snus (small pouches of special tobacco placed under the upper lip) and heated tobacco products (which heat tobacco without burning it).

Burning tobacco causes almost all the harm from smoking.

It releases over 7,000 chemicals, tars, carbon monoxide, other toxic gases and solid particles.

Safer nicotine products can complement (not replace) traditional tobacco control strategies which target complete quitting.
23 Tobacco Harm ReductionSubmission 166 Harm reduction is a well established and effective concept in public health policy.

Tobacco harm reduction is no different to other harm reduction strategies such as methadone for heroin users, clean needle exchange programs and even car seat belts.

Tobacco harm reduction is one of the three pillars of Australia’s National Tobacco Strategy.

[77] One objective of the NTS is to “reduce harm associated with continuing use of tobacco and nicotine products” (p11).
Tobacco harm reduction is complementary, not an alternative, to current tobacco control policies which are based on supply and demand reduction.

Australia is legally obligated to support tobacco harm reduction as a signatory to the World Health Organisation Framework Convention on Tobacco Control.

The FCTC provides an obligation on governments to not only allow reduced-risk products but actively promote them as part of implementing their tobacco control policies.
Article 1(d) defines tobacco control as meaning “a range of supply, demand and harm reduction strategies that aim to improve the health of a population by eliminating or reducing their consumption of tobacco products and exposure to tobacco smoke.” Currently Australia is in breach of its international obligations as no harm reduction strategies are supported in practice.
Prescription model Low concentrations of nicotine for vaping is a consumer used almost exclusively as a less harmful substitute for another consumer product, tobacco cigarettes or as a short-term quitting aid.

No country in the world requires users to have a prescription for accessing nicotine liquid.

In Australia, nicotine liquid is inappropriately classified as a poison or a therapeutic good and is regulated by the medicine regulator, the Therapeutic Goods Administration.
The TGA is responsible for regulating medicines and medical devices which make therapeutic (medicinal) claims, such as 'this product can help you quit smoking'.

The TGA should not have a mandate over vaping products as they do not make therapeutic or medicinal claims.

Low concentrations of nicotine should be exempt from the Poisons Standard Consumer products are regulated by the Australian Competition and Consumer Commission (ACCC) which provide strong protection for consumers.
The ACCC ensures that products are safe, fit for purpose, of merchantable quality and comply with all legal requirements under the Competition and Consumer Act 2010.

Regulations on vaping should never be more restrictive than those for smoking.

[78] The requirement for a prescription makes it far harder and more costly to access a much less harmful product.

Furthermore, the prescription proposal is complex and unworkable.

▪ Vapers won’t do it.


The current laws require vapers to have a prescription to import nicotine.

ATHRA estimates that no more than 1-2% of vapers currently have a prescription.

▪ Doctors won’t do it.

There are less than a dozen GPs in Australia who are willing write nicotine prescriptions and 520,000 vapers.

Very few doctors understand vaping or know how to write a nicotine prescription.

▪ Pharmacists won’t do it.

Pharmacists are not trained in vaping and cannot give advice to new users.
The Pharmacy Guild does not support the sale of vaping products in pharmacies.

▪ Manufacturers won’t do it.

Most products are made by small to medium businesses which do not have the expertise, experience or budget to conduct clinical trials and go through the costly and onerous regulatory process for every single product.

The tobacco industry with its unlimited resources will take over the market.
Other harmful effects 24 Tobacco Harm ReductionSubmission 166 ▪ Providing prescriptions will add huge costs to Medicare.

If 25% of vapers get an annual prescription, the cost to Medicare will be $14.6 million each year.

If all current vapers comply, it will cost $60 million each year.

▪ The black market will thrive.

Illegal suppliers will fill the gap with unregulated and unsafe products, happily sold to young people.

▪ Vape shops will be decimated.


Vape shop staff have the experience and knowledge to help smokers make the transition to vaping nicotine.

Vape shops survive on the sale of vaping liquids.

▪ Costs to vapers will increase from the costs of regulatory compliance, doctor fees and pharmacy mark-up.

▪ Product choices and flavours will be drastically restricted.

Prefilled pods for popular pod models will most likely not be available.
Opposition to vaping in Australia The Committee will receive submissions from respected government departments, medical associations and health charities that come to totally different conclusions to ours.

How can two different groups of experts reach completely opposing conclusions based on the same body of science?

We believe that these organisations are influenced by many factors other than the evidence.

We ask the Committee to take these considerations into account.
Biases, emotions, ideology, moral judgements, self- interest etc should be identified and conclusions based on the best scientific evidence.

1 A long-standing commitment to an abstinence-only approach A tobacco and nicotine-free agenda is seen by some as the only acceptable goal.

They cannot accept that anything that looks like a cigarette, is used like a cigarette or delivers nicotine could possibly be a good thing.
Opposition to vaping is influenced by an ideological, deeply held abstinence-only conviction.

Harm reduction is not part of the traditional tobacco control paradigm.

In contrast, the pragmatic goal of harm reduction supporters is to reduce the rates of death and disease by whatever method works.

Traditional tobacco control has been fighting to destroy evil tobacco companies and there is an unwillingness to allow the industry any advantage, even if it will ultimately save lives.
This takes precedence over public health.

2 Moral psychology Some opponents have strong moral and puritanical views about smoking and see using an ‘addictive’ substance as wrong.

They see harm reduction as a tacit endorsement of unacceptable behaviour.

[79] There is a reluctance to accept that vapers should be allowed to enjoy vaping and addictive drug.
3 Vested interests Some public health organisations have built a business model around tobacco and nicotine abstinence and funding is needed to support their ongoing research, wages and campaigns.

The interests of funders need to be protected (Big Pharma opposes vaping which competes with their products).

A powerful orthodoxy is threatened by solutions it did not invent, cannot control and which may reduce its relevance.
Some individuals in tobacco control see new technologies as a threat to their legacy.

Harm reduction is a new paradigm which undermines the salience of the approach they have dedicated their professional lives to.

They defend an entrenched status quo that has provided them full time careers, a sense of purpose and prestige.

4 Financial issues 25 Tobacco Harm ReductionSubmission 166 Cigarette taxes generate over $17 billion per year in Australia.

Many believe that taxes are a hidden influence on policy.
5 Groupthink The Australian health establishment is locked in groupthink.

Members of anti-vaping organisations support the status quo and typically justify their position based on the similar views of other groups.

Contradictory views are discouraged in an echo chamber, and critical evaluation is suppressed.

Belonging to a tribe takes priority.

6 Political risk Government strategies have so far been based on minimising political risk by taking no action.
[80] Since e- cigarettes are consumed by a small fraction of citizens, and since public awareness of the product is still in its initial stages, there are few political rewards to be gained to merit the risk involved in proactive regulation.

However as the number of vapers is growing, this is changing.
7 Fear of innovation and new technology New technologies often generate fear and are resisted because of unknown risks, even when there are substantial benefits 8 Competing values Some of the debate is driven by different values.

For example, some believe that any risk to young people is not justified.

Therefore, they oppose vaping even if there are huge potential benefits to adults.

Some are more risk averse than others and refuse to consider anything that may entail more than a trivial risk.
9 Wrong model Some opponents of vaping believe it should fall under the medical model and that vaping should be restricted like a medicine rather than a consumer product.

This leads to inappropriate restrictions, standards and regulations.

Strategies to undermine tobacco harm reduction Organisations with a predetermined view create rationalisations to defend that position.

This often involves fabricating arguments based on misinterpreting, misrepresenting or cherrypicking the evidence.
They focus on and exaggerate the risks, with little attention to the benefits.

Emotional arguments are often used to win traction, such as the effect on children.
Some of the common tactics used to undermine vaping include: • Selective use of the evidence, for example relying on selected, isolated studies and ignoring the positive studies or the overall body of evidence • Exaggerating the significance of small or theoretical risks or minor physiological effects that have little or no significance to human disease • Exaggerating concerns about trace amounts of toxins which are of no clinical importance • Conflating association with causation • Failing to consider relative risk, ie not comparing the small risks of vaping to the huge risks of smoking • Making claims based on laboratory or animal studies which may not translate to humans • Minimising benefits of vaping and positive findings • • Relying on bad, junk science which has been discredited • Falsehoods and untruths, such as popcorn lung, EVALI (a lung injury due to contaminated cannabis Ignoring inconvenient evidence oils) • Discrediting the source eg by ad hominem attacks, false claims about funding • Confirmation bias then maintains the belief system 26 Tobacco Harm ReductionSubmission 166 Priorities in tobacco control Policy on vaping should be guided by how to achieve the greatest net improvement in population health.
Finding the right balance is vital to achieve the best outcomes.

A vaping policy that restricts vaping excessively to avoid a small and potential risk of youth vaping will result in a net public health harm to the extent that it reduces access to vaping nicotine for adult smokers.

Most of the decline in Australian smoking rates in recent years has been achieved by a reduced uptake of smoking by young people.
The 2019 National Drug Strategy Household Survey found that there was no decline in smoking rates for Australians over the age of 40 years.

[21] While continuing to reduce youth uptake of vaping is important, the more immediate and much greater public health concern is to assist adult smokers to quit.
The precautionary principle Many Australian health and medical organisations justify a delay in the introduction of nicotine for vaping by invoking the precautionary principle, [81] citing uncertainties about future harm.

However the precautionary principle is misused when applied to vaping in this way.

[82] When correctly applied, the precautionary principle requires a full assessment of both the potential risks and benefits of both adopting and rejecting a new product.
In the case of vaping nicotine, the risks of NOT adopting vaping are much greater because cigarettes are substantially more harmful.

Banning nicotine vaping denies smokers the opportunity to quit or switch to a much less harmful product.

This requirement for long-term evidence is not applied to other products.

If we applied this standard in other areas, no new medicines would be introduced until we had safety data from 20-30 years of use.
Over the past 15 years there has not been a single confirmed death from nicotine vaping anywhere in the world and serious adverse effects are extremely rare.

The alternative behaviour, tobacco smoking, kills 8 million people world-wide per year.
Beaglehole states that invoking “the precautionary principle to prevent the use of smoke-free products is unjustified in the face of the massive burden of smoked tobacco products, which are ubiquitously available.” [83] The Royal Australian and New Zealand College of Psychiatrists states in its 2018 Position Statement on vaping: [84] “Further research is required to ascertain the effectiveness of e-cigarettes and vaporisers as tools for smoking cessation and whether they may provide a novel route into smoking initiation.
This does not justify withholding what is, on the current evidence, a lower-risk product from existing smokers while such data is collected.” This principle is supported by the leading British epidemiologist Sir Austin Bradford Hill: “All scientific work is incomplete - whether it be observational or experimental.

All scientific work is liable to be upset or modified by advancing knowledge.
That does not confer upon us a freedom to ignore the knowledge we already have, to postpone action that it appears to demand at a given time”.

[85] Public vaping There is no reasonable justification for banning public vaping on health grounds.

Unlike second-hand smoke, the risk to bystanders from passive vaping appears to be minimal.

Secondhand vapour is an issue of public nuisance, like loud conversations on mobile phones or strong perfumes.
27 Tobacco Harm ReductionSubmission 166 According to Public Health England’s review in 2018, “to date there have been no identified health risks of passive vaping to bystanders”.

[86] The report of the Royal College of Physicians in 2016 stated “There is, so far, no direct evidence that such passive exposure is likely to cause significant harm.” [87] This is because the vaper absorbs most of the inhaled aerosol.

Less than 10% of the chemicals are exhaled and they are at very low levels in the air.
[88] There is also no ‘side-stream’ vapour, while side-stream smoke accounts for at least 80% of second-hand smoke from a cigarette.

Furthermore, the liquid aerosol droplets from vapour evaporate and disperse in seconds, much more quickly than the solid particles in smoke, reducing risk further.

[89] Based on the carcinogens in second-hand vapour and the estimated doses, the cancer risk for passive smokers is estimated to be five orders of magnitude (50,000x) greater than for passive vapers.
[90] Exposure can be reduced by educating vapers about vaping etiquette and to be considerate of the people around them.

Vapers should not blow large clouds in crowded areas or vape around children.

Authorities can erect signs requesting that vapers only blow small clouds and be considerate of others.
Regulators should consider the harm principle, which is that “The only purpose for which power can be rightfully exercised over any member of a civilised community, against his will, is to prevent harm to others.” However, restrictions are appropriate in some circumstances, such as at schools and hospitals.

Public Health England recommends that vapour policy be set by owners, employers and managers for local premises according to their circumstances, rather than a blanket ban.
[91] A blanket ban on all public vaping sends the misleading message that vaping is just as harmful as smoking.

This could deter smokers from switching to vaping.

The opportunity to vape in places where smoking is prohibited is an incentive to switch to the healthier behaviour.

Vapers may be more likely to relapse if they are forced to vape in smoking areas with smokers.

Flavours Flavours are an integral part of vaping and make it more appealing as an alternative for adult smokers.
[92] Flavours facilitate initiation of vaping for current smokers, reduce the likelihood of relapse [92] and increase quit rates compared to non-flavoured or tobacco flavoured e-liquids.

[14] Flavours are used in nicotine replacement products for this reason.

Nicorette gum is available in Australia in fruit, mint, spearmint and icy mint flavours and research shows that flavoured nicotine gum enhances appeal and improves compliance.
[93] Flavours are not the primary reason for youth experimentation with vaping in Australia [21] or the US.

[57] For example, in the US in 2019 they were the third reason given for trying vaping after curiosity and because of use by a friend or family member.

28 Tobacco Harm ReductionSubmission 166 Non-tobacco flavours preferred by young people are very similar to those preferred by adults.

[94] The most popular flavours used by adults are fruit, dessert, and other sweet flavours.
Restricting flavours will have little effect on youth vaping or smoking.

One large study found that young people who started vaping with non-tobacco flavours were no more likely to go onto smoking than those who started with tobacco flavours.

[95] Another study found that when US e-cigarette maker JUUL removed its fruit flavoured producet due to concerns about youth uptake, users simply switched to other flavours, notably mint, menthol and tobacco flavours, with no sustained reduction in use.
[96] Importantly, restricting flavours may reduce the appeal of vaping to adult smokers and increase smoking prevalence.

[97] It would also lead to increased black-market supplies and home mixing.

According to Public Health England, “To date, there is no clear evidence that specific flavourings pose health risks but there are suggestions that inhalation of some could be a source of preventable risks”.

[86] These flavourings include diacetyl, cinnamaldehyde and benzaldehyde and should be avoided.
Taxation Taxation of vaping products should be kept to a minimum to encourage smokers to switch to the safer alternative.

There is a good case for high tobacco taxes on cigarettes to discourage their use and reduce smoking rates.

However, vapes are a less harmful substitute for smoking and there is no justification for high taxes on health grounds.

Low taxes on vaping will incentive smokers to switch and will improve public health.
Vaping nicotine should be taxed according to risk in a similar way to nicotine replacement products.

Vaping is at least 95% less harmful than smoking and is a lifesaving substitute behaviour.

[86] Furthermore, smoking is increasingly concentrated in low-income and disadvantaged groups.

A significant price advantage for vaping will incentivise low-income smokers to make the switch to the much less harmful alternative.

A significant tax differential between vaping and smoking should be maintained.
[98] One modelling study found that e-cigarette use is very responsive to price changes.

Every 10% increase in e- cigarette prices was associated with a drop in e-cigarettes use by up to 11.5%.

High taxes on nicotine e-liquid were introduced in Italy in 2015 leading to the closure of 3 in 4 vape shops, the return of many vapers to smoking and growth in the black market.

In 2018, the tax was cut by 80-90% and vaping started to increase.
[99] Similar changes were found in Minnesota after tax rises on vaping were introduced.

[100] Because the benefit to society is so high, regulators should look to other sources of income to replace tobacco taxes.

Raising vape taxes to replace tobacco excise is as illogical as saying that someone who 29 Tobacco Harm ReductionSubmission 166 switches from driving a car to riding a bicycle should expect new taxes on biking to replace the lost petrol taxes.
Social justice There is a strong social gradient in smoking rates.

Decreasing socio-economic status is associated with higher smoking prevalence, higher nicotine dependence and lower quit rates.

[101] As a result, smoking is a leading cause of health and financial inequalities for those on low incomes, people living with mental illness or alcohol and drug problems, homeless people, Indigenous groups and prisoners.
[102] Traditional tobacco control interventions have had less impact in these populations and so health disparities have increased over time.

[103] Vaping nicotine has the potential to reduce smoking rates in these priority populations and reduce health inequalities.

[104] Disadvantaged populations “have many stressors, few resources and a paucity of other rewards in their lives, thus making the transitory ‘pleasures’ of smoking and the challenges of nicotine withdrawal more salient.
For those for whom the ‘loss of smoking’ is too great, tobacco harm reduction approaches, such as switching to non-smoked nicotine products, should be considered”.

[101] There is growing evidence that uptake of vaping may be higher in disadvantaged groups, which would help to reduce inequalities.
[105-108] A recent study by Brose of a large UK population concluded that “E-cigarettes were associated with increased success and they were used similarly across those with and without mental health problems, indicating that improved uptake of e-cigarettes for smoking cessation among smokers with mental health problems could help address inequalities”.

[10] The high cost of tobacco is causing considerable financial stress in low income groups and is contributing to financial inequalities.
[109] Australia has the highest cigarette prices in the world.

[110] A pack a day smoker spends approximately $12,775 per year on smoking (Pack of Marlboro 20, $35).

Vaping is 85-90% cheaper than smoking and switching to vaping would result in substantial financial savings to the household budget.

Human rights The right to health is a fundamental human right and is enshrined in international law and treaties including 1.

Constitution of the World Health Organisation 2006, preamble [link] 2.
The Universal Declaration of Human Rights, UN 1948 [link] 3. International Covenant on Economic, Social and Cultural Rights.

UN 1966 [link] 4. International Covenant on Civil and Political Rights UN 1966 [link] 5. International Convention on the Elimination of All Forms of Racial Discrimination.
UN 1969 [link] For example, The WHO Constitution states: “The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.” [link] Governments have a responsibility to make safer products available for adults who wish to use them to reduce the harm from smoking.
To deny smokers access to these safer products is paternalistic, deprives them of an opportunity to reduce their health risks and breaches international law and human rights.

A switch from smoking to vaping also protects the rights of bystanders to cleaner air with minimal adverse health risks.

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