This Bills Digest replaces a preliminary Digest published on 25 March 2024 to assist in early consideration of the Bill.

Purpose of the Bill

The purpose of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (the Bill) is to amend the Therapeutic Goods Act 1989 and other Commonwealth Acts to prohibit the importation, domestic manufacture, supply, commercial possession and advertisement of non-therapeutic and disposable vaping goods.

The Bill proposes to create ‘a single consistent framework that applies nationally to regulate the importation, domestic manufacture, supply, commercial possession and advertisement of all vapes, irrespective of nicotine content or therapeutic claims’.[1] Under this framework, vapes will be regulated as therapeutic goods and will only be supplied by registered pharmacists, medical practitioners or nurse practitioners authorised to do so under state or territory law.

The Bill also introduces criminal and civil penalty provisions relating to the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods. This includes an exception for personal use relating to the possession of less than a ‘commercial quantity’ of vaping goods (with ‘commercial quantity’ to be prescribed in the regulations).

The measures introduced in the Bill are intended to reduce the prevalence of smoking and vaping in the community, as well as prevent the uptake of vaping among people who have never smoked, in line with the objectives, priorities and targets outlined in the National Tobacco Strategy 2023–2030. The Bill does not prohibit vaping. Access to therapeutic vapes for smoking cessation purposes under medical supervision will be maintained.

Background

What are vapes?

The Department of Health and Aged Care (DHAC) defines electronic cigarettes (e-cigarettes) as battery‑operated devices that deliver an aerosol by heating a solution that users of the e-cigarette then breathe in.[2] As the aerosol is commonly referred to as ‘vapour’, using e-cigarettes is often referred to as ‘vaping’ and e-cigarettes are more commonly referred to as vapes.

Vapes come in two main configurations:

• a disposable single use (closed system) vape that is pre-filled with an e-liquid, cannot be refilled and is disposed of once the vaping substance runs out
• a refillable/reusable vape that may be refilled or reused multiple times, with various e-liquids pods, cartridges or solutions sold separately to the device; these vapes are intended to be recharged and reused.[3]

DHAC notes that the liquids contained in vapes may contain a range of chemicals, including nicotine.[4] The ways in which e-cigarettes are currently regulated in Australia depends on whether they contain nicotine; however, due to incorrect and incomplete labelling, the ingredients of e‑cigarettes are not always easily identifiable which can make regulation difficult.

Use of vapes

Vapes first began to be used in Australia in the mid-2000s and in recent years the number of people using vapes has rapidly increased. The National Drug Strategy Household Survey (NDSHS) and the Australian Secondary Students’ Alcohol and Drug Survey (ASSAD) are key sources of data on the use of vapes and vaping products in Australia. The most recent NDSHS and ASSAD data are for 2022–23.

According to the NDSHS, in 2022–23, 7% (1.5 million people) of Australians aged 14 and older were currently using vapes. This represents a three-fold increase on the figure for 2019 (2.5%).

While vaping increased in all age groups, the increase was particularly pronounced among younger Australians. Current use of vapes quadrupled between 2019 and 2022–23 among people aged 18–24 (from 5.3% to 21%) and increased more than five-fold—albeit from a lower base—among people aged 14–17 (from 1.8% to 9.7%). The most common reason people gave for first using a vape was ‘out of curiosity’, while one-in-five people who had ever used vapes reported doing so to help them quit smoking.

Despite it now being illegal to obtain vapes containing nicotine without a prescription, in 2022–23 around three-quarters of people currently using vapes reported that the last one they used contained nicotine. Most people who had used vapes with nicotine (87%) reported that they had obtained them without a prescription.

In keeping with latest NDSHS findings, ASSAD data for 2022–23 show that the number of 14–17 year-olds using vapes has increased significantly in recent years.

In 2022–23 just under one-third (30%) of Australian secondary school students had ever vaped. This represents an increase on equivalent figures for 2014 and 2017 (13% and 14% respectively). Similarly, past month vaping was significantly higher in 2022–23 (16%) when compared to 2014 and 2017 (3% and 4% respectively).[5] Of students who had ever vaped, more than two‑thirds (69%) reported never having smoked a tobacco cigarette before their first vape.[6]

While smoking has generally decreased among Australian secondary school students over time, ASSAD researchers expressed concerns that there was an increase in susceptibility to smoking among Australian secondary school students who have never smoked between 2017 and 2022–23.[7] One-in-five students (20%) who had never smoked prior to trying an e-cigarette reported subsequent smoking (that is, at least a few puffs) of tobacco cigarettes.^[8]

In addition to capturing data on the use of vapes, the NDSHS surveyed participants on their support for a range of policy measures to address vaping. There was significant support (over 60%) in all age groups for:

• banning additives in e‑cigarettes, to make them less attractive to young people (78%)
• restricting the use of e‑cigarettes in public places: 80% (an increase from 69% in 2019)
• prohibiting the sale of e‑cigarettes, including those without nicotine, to people under 18 years of age: 86% (an increase from 79% in 2019)
• strengthening restrictions on the advertising and promotion of e‑cigarettes: 82% (an increase from 67% in 2019).

Support for these policy measures was highest among people aged 60 and over, and lowest among people aged 14–29.

Health impacts of vaping

While vaping is generally reported to be less harmful than smoking, it should not be considered safe, particularly for non-smokers and young people. Vaping is associated with a range of adverse health outcomes, such as poisoning, nicotine toxicity, burns, throat and mouth irritation, cough, headache, nausea, and dizziness. Vapes that contain nicotine can cause dependence or addiction in non-smokers and may lead to smoking uptake.[9] A recently published systematic review of health outcomes associated with e-cigarettes, funded by the Department of Health and Aged Care and the National Health and Medical Council, found the following:

Evidence regarding the health effects of e-cigarettes is very limited. The risks of several adverse health outcomes are higher in e-cigarette users. There is conclusive evidence that nicotine e-cigarettes can cause poisoning and immediate inhalation toxicity (including seizures), particularly in children and adolescents, and that malfunctioning devices can cause injuries and burns; there is substantial evidence that nicotine e-cigarettes can cause dependence or addiction in non-smokers

… 

There is moderate evidence that nicotine e-cigarettes can cause less serious adverse events, such as headache, cough, throat irritation, dizziness, and nausea.

The study concluded:

E-cigarettes can be harmful to health, particularly for non-smokers and children, adolescents, and young adults. Their effects on many important health outcomes are uncertain. E-cigarettes may be beneficial for smokers who use them to completely and promptly quit smoking, but they are not currently approved smoking cessation aids. Better quality evidence is needed regarding the health impact of e‑cigarette use, their safety and efficacy for smoking cessation, and effective regulation.[10]

Tobacco in Australia also provides a summary of the evidence on the relationship between e‑cigarette use and a range of health issues such as pregnancy outcomes, brain development, cardiovascular disease risk, cancer risk and oral health. The authors state the following regarding vaping and health:

Due to their relatively recent introduction onto the market, most of the known health effects of e‑cigarettes have arisen from short term use. As e-cigarettes contain some of the same toxic chemicals present in cigarette smoke, there is concern that health effects will manifest in the future as a result of long-term use, in a similar manner to those caused by tobacco products. These may include cancer, cardiovascular disease, chronic obstructive pulmonary disease and periodontitis, as discussed in this section.[11]

Research on vaping and health continues to be published on a regular basis. Currently the long‑term health impact of vaping remains unknown.

Regulation of vapes prior to the recent reforms

Nicotine vapes

In Australia, responsibility for the regulation of medicines, poisons and therapeutic goods is shared between state, territory and Commonwealth governments. Currently Commonwealth law prevents the importation, and state and territory laws prevent the domestic supply, of nicotine vapes without a prescription.

Medicines are classified into Schedules which determine how freely they will be available to the public according to risk (for example, where you can purchase them from and whether you need a prescription).[12] The Schedules are published in the Poisons Standard made under the Therapeutic Goods Act and are given legal effect through state and territory legislation.

The Secretary of the DHAC makes decisions on the scheduling of medicines (and chemicals), and other changes to the Poisons Standard. On 21 December 2020, a delegate of the Secretary of DHAC made a final decision to list the regulation of nicotine as a Schedule 4 medicine except where it occurs:

• in tobacco prepared and packed for smoking or
• in preparations for oromucosal or transdermal administration (such as nicotine patches, gum, mouth spray, lozenges and inhalators) that are used as an aid in withdrawal from tobacco smoking.[13]

This decision took effect on 1 October 2021. The scheduling of nicotine vaping products as a Schedule 4 medicine meant that a prescription from a medical practitioner was required to access nicotine vaping products (including when they were being imported) and they could only be lawfully dispensed in Australia by pharmacists under state/territory legislation. These reforms also make it unlawful to import vapes containing nicotine without a valid prescription from a medical practitioner.[14]

Outside of these products, the Poisons Standard lists nicotine for human use as a Schedule 7 poison. Schedule 7 poisons are substances not for general sale by retail and under state/territory legislation it is an offence to manufacture, sell or supply nicotine as a Schedule 7 poison without a licence or specific authorisation. Schedule 7 nicotine does not include tobacco when prepared and packed for smoking or e-cigarette products that are included in Schedule 4 and available on a prescription.

State and territory laws vary when it comes to unauthorised possession of prescription medicines. In most jurisdictions, the possession of a prescription only substance without a valid prescription amounts to an offence:

It follows that in most jurisdictions, the possession of nicotine vaping products without a prescription is technically an offence (under the relevant state or territory drugs and poisons legislation). These offences are not new, and the penalties they impose relate to the possession/use of any prescription-only substance (and not specifically to nicotine vaping products).[15]

For example, in New South Wales, section 16 of the Poisons and Therapeutic Goods Act 1966 (NSW) provides that it is an offence to possess a restricted substance unless authorised or where it is has been lawfully prescribed (which includes nicotine as a Schedule 4 product), with a maximum penalty of a fine of 20 penalty units[16] ($2,200) or 6 months imprisonment or both (paragraph 16(1)(b)). Section 9 of the Poisons and Therapeutic Goods Act 1966 (NSW) provides that is an offence to supply a restricted substance for therapeutic use except in accordance with the relevant wholesaler’s license or authority with a maximum penalty of a fine of 15 penalty units ($1,650) or 6 months imprisonment or both (paragraph 9(1)(b)). NSW Health reports on the number of prosecutions for the illegal sale of nicotine containing e-cigarettes and other nicotine products, with there being 6 successful prosecutions in 2023.

Normally, prescription medicines can only be supplied in Australia if they have been approved by the Therapeutic Goods Administration (TGA), following an assessment of their safety, quality and efficacy, and they have been included in the Australian Register of Therapeutic Goods (ARTG), or a lawful exception to registration applies. Criminal offences and civil penalties are set out in the Therapeutic Goods Act for importing, exporting, supplying and manufacturing therapeutic goods and medical devices not included in the Register (these are summarised at pages 43–44 of the Explanatory Memorandum to the Bill).

As there are currently no nicotine vapes registered on the ARTG, nicotine vapes have been supplied to patients with a prescription as ‘unapproved therapeutic goods’ via the following pathways:

• Personal Importation Scheme: This scheme allows a person with a prescription from an Australian medical practitioner to directly import up to 3 months’ supply of nicotine vaping products (NVPs) per order for their own personal use. A person can also import NVPs for immediate family members who have a prescription.
• Authorised Prescriber Scheme (AP scheme): Under this scheme, a medical practitioner can apply to the TGA for approval to supply NVPs to their patients as an aid to stop smoking.
• Special Access Scheme B (SAS B): Under this scheme, a medical practitioner can apply to the TGA to supply NVPs to a single patient on a case-by-case basis.[17]

The TGA also introduced the TGO 110 Standard for Nicotine Vaping Products (as made) supplied domestically within Australia to align the 2021 scheduling change which sets out the minimum safety and product requirements with respect to NVPs.

Vapes that do not contain nicotine

Prior to the recent reforms, vapes which did not contain nicotine were not regulated under the Therapeutic Goods Act, unless represented to be for therapeutic use. As stated by the TGA, vaping devices were also excluded from the operation of the Act ‘unless they are intended exclusively for the vaporisation and administration by inhalation of a medicine’.[18] There was therefore no product standard that applied to these vapes.

Currently all states and territories restrict the supply of vapes that do not contain nicotine, through tobacco control laws and/or public health laws, though regulation ‘is limited and inconsistent’:

All ban the supply of vapes to minors and the use of vapes in smokefree areas. All regulate the advertising, display and marketing of vapes. Most states and territories (except Victoria and Queensland) require either a licence or a retailer identification number for retail sale. The controls in Western Australia are more extensive than other jurisdictions. The Tobacco Products Control Act [2006] (WA) makes it an offence to sell any food, toy or other product that is designed to resemble a tobacco product or package or is in packaging that is designed to resemble a tobacco product or package, regardless of whether it contains nicotine. Western Australia also permits registered pharmacists to supply nicotine vapes as part of a medically supervised smoking cessation program.[19]

Vaping reforms

In November 2022, the Minister for Health and Aged Care Mark Butler announced a public consultation process on the regulation of nicotine vaping products to be run from 30 November 2022 to 16 January 2023 by the TGA.[20] The public consultation process was instigated largely in response to evidence of an increase in e-cigarette use by children.

Following the TGA consultation process, Mr Butler announced in May 2023 that the Government, subject to consultation with states and territories, would be proposing stronger regulation and enforcement of all vaping products, ‘including new controls on their importation, contents and packaging’.

On 1 September 2023, Commonwealth and state/territory Health Ministers ‘agreed to extend the operation of the Therapeutic Goods Act to restrict the importation, manufacture, and supply of all vapes’.[21] Further details about these reforms were announced on 28 November 2023.[22]

In December 2023, the Government made amendments to three regulations and nine new or revised legislative instruments under the Therapeutic Goods Act and the Customs (Prohibited Imports) Regulations 1956 to give effect to the first stage of these reforms:

From 1 January 2024:

the importation of all disposable vapes is banned, with very limited exceptions

• the Special Access Scheme C (SAS C) pathway, is available to facilitate legitimate patient access to therapeutic vapes, for smoking cessation and the management of nicotine dependence
• a form for importers and manufacturers of therapeutic vapes is available to notify the TGA about compliance with the relevant product standards prior to importation into Australia, or release for supply of vapes manufactured domestically (notices are required for goods imported or released for supply on or after 1 March 2024)
• an application form for therapeutic vape importers is available to apply for licences and permits for importing therapeutic vapes (licences and permits are required for goods imported on or after 1 March 2024).

From 1 March 2024: 

• the importation of all vapes is banned unless importers have an import licence and permit from the Office of Drug Control
• therapeutic vape importers and manufacturers are required to notify the TGA about compliance with the relevant product standards before importation to Australia or release for supply in Australia
• the Personal Importation Scheme for vapes is closed
• travellers may bring a small quantity of vapes into Australia
• some changes to the quality requirements for therapeutic vapes for smoking cessation and the management of nicotine dependence, including restrictions on flavours to mint, menthol and tobacco
• a new medical device standard applies to therapeutic vaping devices that were previously excluded from the therapeutic goods framework.

Further information about these reforms is set out in detail in the Impact Analysis prepared by the TGA published in October 2023.

Prescribing pathways since 1 January 2024

As noted above, nicotine vapes have previously been supplied to patients with a prescription as ‘unapproved therapeutic goods’ via the Personal Importation Scheme (which closed on 1 March 2024 for vaping products), the Authorised Prescriber Scheme and the Special Access Scheme B (SAS B).

Since 1 January 2024, prescribers have also been able to prescribe therapeutic vapes to patients for smoking cessation or the management of nicotine dependence via Special Access Scheme C (SAS C). Products that can be supplied via the SAS C pathway are those that are deemed to have an ‘established history of use’. Under SAS C, prescribers can access an unapproved product immediately, without applying to the TGA for pre-authority or approval. Notification that a product has been prescribed under SAS C needs to be provided to the TGA within 28 days of use.

If the Bill is passed, prescribers will still be able to use the Authorised Prescriber Scheme, SAS B and SAS C to prescribe vaping products to patients (see Figure 1). In an overview of the regulatory changes under the proposed reforms presented by the TGA, it was noted that the SAS C pathway is intended to help reduce the administrative burden on doctors and nurse practitioners prescribing therapeutic vapes:

Doctors and nurse practitioners can prescribe therapeutic vapes for smoking cessation or the management of nicotine dependence through Special Access Scheme C (SAS C).

To reduce the administrative burden on prescribers:

• Doctors and nurse practitioners will be able to prescribe vapes through the SAS C pathway without applying to the TGA for pre-authority or approval.
• The SAS C notification process has been streamlined to help prescribers manage increased demand for prescriptions.

Doctors may also prescribe through the Authorise Prescriber (AP) Scheme

The SAS B may also be used.[23]

When prescribing and dispensing therapeutic vapes, prescribers and pharmacists must do so in accordance with relevant state of territory legislation.

To assist prescribers in determining when to prescribe therapeutic vapes, the Royal Australian College of General Practitioners (RACGP) are currently updating their guidelines for supporting smoking cessation (first published in 2011), to include new guidance on prescribing vapes. Provisional guidance, Supporting smoking cessation: A guide for health professionals, Guidance updates on smoking and vaping cessation support related to Australia’s vaping regulation, was published in December 2023.

Figure 1 – Pathways to prescribe therapeutic vapes

FIG 1

Source: TGA, Royal Australian College of General Practitioners and Quit Centre, Prescribing Therapeutic Vapes: Overview of Regulatory Changes, Webinar, accessed 6 May 2024, slide 13.

International regulation of vapes

Regulation of e-cigarettes and vaping products varies internationally. Tobacco in Australia has published an overview of regulation in other jurisdictions (updated September 2022), which includes information on the sale of vapes to minors, the regulation of e-liquid ingredients (including nicotine), restrictions on advertising and promotion, and taxes on vapes.[24]

The Global State of Tobacco Harm Reduction (GSTHR) provides a country-by country summary on the use, availability and regulations applying to vaping products, oral tobacco and heated tobacco products.

According to the UK House of Commons Library ‘some countries, including Brazil and Singapore, have adopted neither a medicine nor consumer product approach to regulation, instead issuing an outright ban on the sale, distribution and importation of e-cigarettes’.[25]

The World Health Organization reported in 2022 that ‘121 countries have adopted measures addressing ENDS [electronic nicotine delivery systems]’, with 34 countries currently banning the sale of ENDS and 87 countries allowing the sale of ENDS though have adopted one or more measures either fully or partially to regulate them:

ENDS are regulated in: Albania, Algeria, Andorra, Armenia, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belarus, Belgium, Benin, Bolivia (Plurinational State of), Bulgaria, Cameroon, Canada, Chile, China, Congo, Costa Rica, Côte d’Ivoire, Croatia, Cyprus, Czechia, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hungary, Iceland, Ireland, Israel, Italy, Jamaica, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Luxembourg, Malta, Monaco, Montenegro, Nepal, Netherlands (Kingdom of the), New Zealand, Niue, North Macedonia, Palau, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Republic of Moldova, Romania, Russian Federation, Saint Lucia, Samoa, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Tajikistan, Togo, Tuvalu, Ukraine, United Arab Emirates, United Kingdom, the United States, Uzbekistan

ENDS is banned in: Argentina, Brazil, Brunei Darussalam, Cabo Verde, Cambodia, Democratic People’s Republic of Korea, Ethiopia, Gambia, India, Iran (Islamic Republic of), Iraq, Jordan, Lao People’s Democratic Republic, Malaysia, Mauritius, Mexico, Nicaragua, Norway, occupied Palestinian territory, Oman, Panama, Qatar, Singapore, Sri Lanka, Suriname, Syrian Arab Republic, Thailand, Timor-Leste, Türkiye, Turkmenistan, Uganda, Uruguay, Vanuatu, and Venezuela (Bolivarian Republic of).[26]

Canada

In Canada, the ownership and possession of vapes is not prohibited and they are available for sale as a consumer product to adults. The relevant federal legislation, the Tobacco and Vaping Products Act (S.C. 1997, c. 13) and related regulations, provides a broad regulatory framework for the manufacture, sale, labelling and promotion of vaping products. As such, regulation of vapes is predominantly the responsibility of the Provinces and Territories which have each enacted their own Acts and Regulations. These prescribe minimum legal ages for sale and may also contain provisions regarding the display, advertisement, promotion, place of sale, premises where vapes may be used and prohibitions on flavours of vapes.

New Zealand

In New Zealand, vapes are available as a consumer product to adults. The sale, advertising, and use of e-cigarettes and nicotine liquids (vaping products) is largely regulated under the Smokefree Environments and Regulated Products Act 1990 (NZ) and associated regulations. The regulation of vaping products falls to the Ministry of Health’s Vaping Regulatory Authority and all vapes must be notified to the Authority before they can be sold. New requirements for vaping products, including restrictions on flavours, requirements for specialist vape retailers and nicotine limits, came into effect on 21 March 2024 and the New Zealand Government recently announced it would ban disposable vapes.

United Kingdom

The Tobacco Products Directive 2014/14/EU (TPD) was passed by the European Parliament and became law in April 2014. The requirements for e-cigarettes set out in Article 20 of the TPD cover product standards and nicotine strength; safety; labelling and packaging, notification and vigilance; advertising and annual reporting. Member States had until May 2016 to transpose the new rules into national law (including establishing relevant offences under their national law).

In the UK, vapes are regulated as both consumer and therapeutic products, but all supply is currently through the consumer market. The Tobacco and Related Products Regulations 2016 (which implemented the TPD into law) impose product standards for nicotine vapes. These include restrictions on maximum nicotine strength, refill bottle and tank size limits, and prohibit in certain media the advertising of nicotine-containing e-cigarettes and e-liquids sold as consumer goods. The Regulations do not apply to vapes that do not contain nicotine. These are covered by the General Products Safety Regulations 2005 which sets out general product safety standards. Currently under 18s may purchase non-nicotine vapes, although the UK Government is considering changing this and has recently announced a ban on disposable vapes, along with other measures to prevent youth vaping.[27]

Committee consideration

On 7 March 2024, the Senate referred the provisions of the Bill to the Senate Community Affairs Legislation Committee for inquiry and report by 8 May 2024. Public hearings for the inquiry were held on 1 May 2024 and 2 May 2024. Further information about the inquiry is available on the Committee’s homepage.

As of 3 May 2024, over 200 submissions had been received and published by the Committee. Submissions from health organisations and public health researchers are strongly supportive of the Bill, while submissions from retail organisations and individual retailers are broadly in support of a regulatory, rather than prescription only model. A number of submissions received from individuals who are current vape users also supported a regulatory model, with some expressing concerns about continued access to vaping products if the Bill is passed. Further information can be found in the ‘Position of major interest groups’ section below.

On 9 May 2024, the Committee tabled its report recommending that the Bill be passed.[28] Coalition Senators who participated in the inquiry and the Australian Greens both provided additional comments on the Bill, while National Party Senators provided a dissenting report (see the policy position of non-government parties/independents below).

Senate Standing Committee for the Scrutiny of Bills

The Senate Standing Committee for the Scrutiny of Bills raised a number of issues with respect to the Bill, including:

• the inclusion of significant matters in delegated legislation
• the imposition of strict liability on offences with higher than 60 penalty units
• the use of offence-specific excuses which reverse the evidential burden of proof
• the provision of a broad discretionary power to allow the Secretary of DHAC to consent to the manufacture, supply or possession of vaping goods, or to refuse such an application, or grant it subject to conditions
• whether independent merits review is available for directions issued under proposed subsection 42YT(2) of the Bill
• the new power to seize assets and whether use and derivative use immunity applies in relation to incidentally seized materials
• the appropriate delegation of administrative powers and functions.[29]

Some of these issues are discussed further in the ‘Key provisions and issues’ section of this Bills Digest.

The Minister provided a response to the Committee on 9 April 2024, however at the time of writing it has not been published.

Policy position of non-government parties/independents

Liberal Party of Australia

The Liberal Party is yet to formally announce its position on the Bill.

When the Bill was introduced, the Deputy Leader of the Opposition, Sussan Ley stated that the Coalition supported scrutiny of the Bill by a Senate Committee and expressed concerns about regulation of the illicit tobacco and e-cigarette market if the Bill were to be passed.[30] Prior to the Bill’s introduction, the Shadow Minister for Health and Aged Care, Anne Ruston commented that ‘the Coalition is still working through the details of the legislation’ and expressed concerns that the current model ‘will not prevent children from having access to vaping products and will further drive the sale of these products to the black market’.[31] She has previously indicated that the Opposition is open to ‘all sensible and workable options that will prevent children from getting access and becoming addicted to vaping’.[32] More recent media reports suggest that the Liberal Party is leaning towards supporting a regulatory model, in which vaping products are taxed and regulated in a similar manner to tobacco products. In a radio interview the Opposition Leader Peter Dutton, stated that his instinct is to ‘treat it [vapes] the same as tobacco’.[33]

In their additional comments to the Senate Committee’s report into the Bill, Coalition Senators stated that they ‘note the recommendations of the majority report and reserve our final position while this policy makes its way through our internal processes’.[34] While supportive of the policy intent of the Bill to combat youth vaping, Coalition Senators argued that the current, and proposed prescription model in the Bill, ‘has failed to address the exponential growth in underage vaping’ and raised concerns that the Bill would contribute to black market activity regarding the sale of both illicit tobacco and illicit e-cigarettes.[35]

The Nationals

The Nationals do not support the Bill, instead favouring a regulatory approach. In October 2023, the leader of the National Party, David Littleproud, called on the Government to ‘urgently regulate and tax e-cigarettes’ to address increasing vaping rates. In the same media release, the Leader of the Nationals stated:

‘... [t]he prescription-only model is not working and it’s time to stamp out the illegal black market and move in a constructive way towards regulation to protect children.

…

Licencing retailers for e-cigarettes, selling only to age 18 and above, removing flavours that are deemed attractive to children, while also ensuring harsh penalties for those illegally selling products, should be trialled, because prohibition isn’t working’.[36]

The preference for a regulatory approach was reiterated when the Bill was introduced, with the member for Cowper, Pat Conaghan stating:

We [The Nationals] believe that vaping needs to be viewed in the full context of law enforcement and harm reduction, by reducing the impacts and cost burden of traditional cigarettes and smoking on our health system, stopping the funding of organised crime organisations, stopping the availability of unregulated and unsafe products to the community, implementing plain packaging, regulating flavours, enforcing market bans and issuing stronger enforceable penalties for those caught conducting businesses outside those parameters.[37]

This preference was also reflected in the National Party Senators’ dissenting report on the Bill, which recommended that the Bill not be passed and instead argued that vaping products should be regulated in the same way as tobacco.[38]

The Nationals have previously stated that under their proposal any revenue generated through taxes on vapes would be directed towards regional healthcare and this suggestion was again raised by the member for Mallee, Dr Anne Webster during her response to the second reading speech.[39]

Australian Greens

The Greens are yet to formally confirm their position on the Bill.

Previously the New South Wales Greens have proposed regulating vaping by undertaking such measures as: legalising nicotine vapes to reduce harms and provide a pathway to quitting smoking; placing limits on nicotine levels; requiring health warnings on all vaping products and making nicotine vapes available to over 18s only. Recent reporting suggests that the Greens are not in favour of a prohibition model, with Greens leader, Adam Bandt stating, ‘we take a harm minimisation approach to issues concerning drugs … When it comes to other drugs, the Greens don’t support a prohibition model. We think history has suggested that prohibition models tend not to work’.

The Greens supported the inquiry into the legislation, stating concerns about penalties for individuals and access to general practitioners (GPs) to receive a prescription. In their additional comments to the Senate Committee’s report into the Bill, the Greens raised concerns with aspects of the Bill and stated that they ‘do not support the prohibition of vapes for adults and instead will work towards a carefully regulated scheme that focuses on public health outcomes, reducing harm and minimising the use of vaping products’. They also flagged that they would move amendments to the Bill.[40]

Other parties

At this stage neither One Nation nor the Jacqui Lambie Network appear to have commented on the Bill. Both One Nation and the Jacqui Lambie Network previously voted against a motion to regulate e-cigarette liquids.

Independents

The member for Kooyong, Dr Monique Ryan expressed support for the legislation when it was introduced and in a published opinion piece, noting that ‘[t]he government’s vaping legislation is important. It’s possibly too late – and it’s going to be tough to enforce – but I congratulate Mark Butler for having the courage to take on this scourge of an industry’.[41] The Member for Warringah, Zali Steggall and the member for Indi, Helen Haines also spoke in support of the Bill.[42]

Dr Sophie Scamps, member for Mackellar, does not appear to have commented on the Bill, but has previously called for stronger government action in relation to vaping.[43] Kate Chaney, member for Curtin, Allegra Spender, member for Wentworth and Kylea Tink, member for North Sydney have all previously spoken about strengthening regulations in relation to vaping.[44]

Position of major interest groups

All Australian Health Ministers support the proposed Bill, as stated in a Special Communique on Vaping released on 19 April 2024:

All Australian Health Ministers have come together to declare their support for coordinated action on vaping to protect young Australians.

…

Before the Federal Parliament there is currently world leading legislation to ban the sale, supply, manufacture and commercial possession of non-therapeutic vapes.

…

All Health Ministers have today urged the Australian Parliament to pass the Albanese Government legislation, to ensure consistency and coordinated action to protect the future generations of Australians.

When the Bill was introduced, a number of public health organisations, including the Australian Medical Association (AMA), the Royal Australian College of General Practitioners (RACGP), the Cancer Council, the Lung Foundation Australia and the Heart Foundation announced that they strongly supported the legislation and called on MPs to support it. This support was reiterated in submissions received to the Senate inquiry.

The Australian Medical Association stated:

The AMA strongly supports the Vaping Reforms Bill 2024. A single consistent framework that applies nationally to reduce rates of vaping and prevent long term adverse effects on population health is urgently required. The Bill will reduce widespread availability of vapes by controlling all levels of the supply chain … Importantly, the Government’s reforms will support people to cease smoking and/or vaping by retaining access to prescription vapes and making these more accessible to patients where clinically appropriate through any GP. GPs are highly trained and experienced in managing addiction with their patients and are experts in smoking cessation. With new clinical guidelines, GPs are ready to continue helping patients to quit.[45]

Cancer Council Australia supported reform in relation to vaping:

Use of vaping products is rising exponentially among young people. We have a rapidly closing window of opportunity to prevent a new generation of Australians from becoming addicted to nicotine. With a Bill currently before it that would enact strong measures to dramatically reduce supply of vaping products within a matter of weeks, the Australian Parliament now has one final chance to act before that window permanently slams shut.[46]

Support was also noted in submissions from the Australian Council of State School Organisations, the Society of Hospital Pharmacists of Australia and various public health researchers.

The Lung Foundation of Australia strongly supported the Bill, but noted in its submission to the inquiry that it could be strengthened by clarifying ‘personal possession versus commercial possession’:

Lung Foundation Australia does not want to see the criminalisation of individuals for personal possession of e-cigarettes, particularly for young people who have been targeted with these products.

…

Personal possession versus commercial possession should be clearly defined so that law enforcement can focus efforts on those who sell e-cigarettes outside of the regulated pathway.[47]

Concerns about legal protections for individuals found to be in possession of vaping devices and vaping accessories for personal use were also raised by the Australian Alcohol and Other Drugs Council in its submission. It argued ‘the limited personal use exemptions and significant criminal and civil penalties for possession of vaping goods currently contained within the draft Bill risk a range of unintended adverse consequences for people who use e-cigarettes who consequently become engaged with law enforcement and justice systems’.[48]

The CEO of the Australian Association of Convenience Stores (AACS), Theo Foukkare, has expressed concern that the prescription model in the Bill may lead to an increase in the black market supply of vaping products. In their submission to the Senate Inquiry, the AACS reiterated concerns about illegal vapes and recommended a regulatory based approach in which vapes are sold in the same way as alcohol and tobacco.[49] Concerns about the effect of the legislation on the black market have also been raised in some media reports.[50]

A number of submissions to the inquiry were received from individual vape retailers and individual vapers. Vape retailers generally support a regulatory approach, expressing concern about losing their businesses and an increase in illicit vapes under the proposed Bill. Individual vapers expressed concerns about continued access to vaping products if the Bill is passed, with a number noting that vaping had helped them quit, or substantially reduce, cigarette smoking.

Financial implications

According to the Explanatory Memorandum, ‘the Government will provide $82.0 million over four years from 2023–24 to support the vaping reforms, awareness raising and enforcement activities’.[51] This funding will include:

• $56.9 million over two years from 2023–24 to the TGA to support regulatory development activities and
• $25.0 million over two years from 2023–24 to support the Australian Border Force’s regulatory and enforcement activities.

This measure builds on the 2023–24 Budget measure titled Vaping Regulation Reform and Smoking Cessation Package (see the Parliamentary Library Budget Review which discusses these measures).[52]

Statement of Compatibility with Human Rights

As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act. The Government considers that the Bill is compatible.[53]

Parliamentary Joint Committee on Human Rights

The Parliamentary Joint Committee on Human Rights had no comment on the Bill.[54]

Key provisions and issues

Changes to the definition of a ‘therapeutic good’

The Therapeutic Goods Act provides for standardised controls on the manufacture, import, export, supply and use of therapeutic goods in Australia. ‘Therapeutic good’ is defined broadly in section 3 of the Therapeutic Goods Act as products for use in humans in connection with:

• preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
• influencing, inhibiting or modifying a physiological process
• testing the susceptibility of persons to a disease or ailment
• influencing, controlling or preventing conception
• testing for pregnancy.

This includes products that are used as an ingredient or component in the manufacture of therapeutic goods or used to replace or modify parts of the anatomy.

The Secretary of DHAC may also make a declaration defining a good to be a therapeutic good where they are satisfied that the good meets the definition of a therapeutic good.

Items 1 and 2 of the Bill will amend the definition of therapeutic good to include a determination made under proposed subsection 7AAA(1) which establishes a broad power for the Minister (in practice their delegate) to declare goods to be therapeutic goods.

Before making such a determination the Minister must have regard to whether:

• it is likely that the specified goods, if not regulated under the Therapeutic Goods Act, might harm the health of members of the public
• it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by the Therapeutic Goods Act to regulate the specified goods and
• the kinds of risks from the specified goods to which members of the public might be exposed could be more appropriately dealt with under another regulatory scheme.

Item 5 of the Bill makes a consequential amendment to allow the Secretary to request information from a person who has imported into Australia, or supplied in Australia, goods in relation to which the Minister is considering making a determination under proposed subsection 7AAA(1) which can then be provided to the Minister.

As noted by the Explanatory Memorandum, these amendments are not specifically related to the vaping reforms but rather allow for a broader category of goods to fall within the TGA’s remit:

Allowing the definition of therapeutic goods to be broadened in delegated legislation will enable rapid amendments to cater for novel and unanticipated products that it is desired should be regulated as therapeutic goods. Despite the broad definition of therapeutic goods, the importation, manufacture, supply, export and advertising of goods in novel and unanticipated forms that should be regulated as ‘therapeutic goods’ may not readily fit within the current definition is still a possibility and may pose a risk to public health. This is intended to be a broad power for the Minister to specify any good to be a therapeutic good.[55] [emphasis added]

The Scrutiny of Bills Committee’s general view is that ‘significant matters should be included in primary legislation unless a sound justification for the use of delegated legislation is provided’.[56] Given the existing definition of ‘therapeutic good’ is already broadly defined, it is unclear why this broad power is required given the Parliament continues to have the power to amend the Act to include goods which would not meet the definition of a therapeutic good so that they fall within the regulatory remit of the TGA.

Regulation of vaping goods

Key provisions

New definitions for ‘vaping goods’ and related terms

Part 2 of Schedule 1 inserts new Chapter 4A into the Therapeutic Goods Act which provides for ‘the establishment and maintenance of a national system of controls relating to the regulation of vaping goods that are imported, manufactured, supplied in Australia or exported from Australia’. The objects of the Act will also be amended to reflect this additional purpose (see item 3).

The Bill will provide for new definitions for ‘vaping goods’ and related terms (proposed section 41P). ‘Vaping goods’ includes ‘vaping substances’, ‘vaping accessories’, ‘vaping devices’, and goods determined by the Minister to be vaping goods. The Minister will also have the broad power to determine that goods are or are not vaping goods, including when they are used, advertised or presented for use or supply in a particular way.

According to the Explanatory Memorandum, these definitions would broadly mirror the definitions inserted into the Customs (Prohibited Imports) Regulations 1956 by the Customs Legislation Amendment (Vaping Goods) Regulations 2023 (CPI Regulations).[57] However, some differences exist due to the ‘differing purposes’ of the Therapeutic Goods Act and the CPI Regulations.[58]

New offences and civil penalty provisions relating to the importation, manufacturing, supply and possession vaping goods

The Bill introduces offences and civil penalty provisions that prohibit the importation, manufacturing, supply and possession of vaping goods, subject to exceptions.[59] According to the Explanatory Memorandum, the policy intent for introducing these new provisions:

… is to ensure that vaping goods are only supplied through the same supply chains that apply to goods containing substances included in Schedule 4 to the Poisons Standard (prescription medicines). This will give effect to the policy intention of ensuring that nicotine vapes are only supplied to consumers under medical supervision with a prescription at a pharmacy, subject to very limited exceptions.[60]

These new provisions have been drafted to include a tiered penalty regime, with a new criminal fault-based offence, an additional offence of strict liability, and a new civil offence.[61] This is ‘an example of dual track regulation where the legislation gives regulators a choice of responses in respect of the same physical conduct and a range of enforcement options’:

[Other] [e]xamples include sections 19B and 19D of the TG Act. Providing these options will enable the utilisation of a range of regulatory tools, including the issuing of an infringement notice, commencing civil penalty proceedings or criminal prosecution with a view to specifically and generally deterring the proscribed conduct.[62]

The Explanatory Memorandum provides guidance on where a criminal penalty would be pursued by the Commonwealth versus a civil penalty:

A criminal prosecution is considered to be a more appropriate sanction where a contravention is deliberate, where fraud may be involved, where the conduct demonstrates recklessness, where there is a serious pattern of continuous intentional contraventions, or where conduct has endangered lives or has caused death or serious injury.[63]

Table 1 – New provisions in the Bill, along with the relevant penalties.

Provision	Offence	Maximum penalty (fault-based offence)	Maximum penalty (strict liability offence)	Maximum penalty (civil penalty)
41Q	Importation of vaping goods	For an individual—imprisonment for 7 years and/or 5,000 penalty units. For a body corporate—25,000 penalty units.	For an individual—200 penalty units. For a body corporate—1,000 penalty units.	For an individual—7,000 penalty units. For a body corporate—70,000 penalty units.
41QA	Manufacture of vaping goods	For an individual—imprisonment for 7 years and/or 5,000 penalty units. For a body corporate—25,000 penalty units.	For an individual—200 penalty units. For a body corporate—1,000 penalty units.	For an individual—7,000 penalty units. For a body corporate—70,000 penalty units.
41QB	Supply of vaping goods	For an individual—imprisonment for 7 years and/or 5,000 penalty units. For a body corporate—25,000 penalty units.	For an individual—200 penalty units. For a body corporate—1,000 penalty units.	For an individual—7,000 penalty units. For a body corporate—70,000 penalty units.
41QC	Possession of commercial quantity of vaping goods	For an individual— At least the commercial quantity – 2 years imprisonment/1,000 penalty units. At least 100 times the commercial quantity – 4 years imprisonment/3,000 penalty units. At least 1,000 times the commercial quantity – 7 years imprisonment/5,000 penalty units. For a body corporate— At least the commercial quantity – 5,000 penalty units. At least 100 times the commercial quantity – 15,000 penalty units.  At least 1000 times the commercial quantity – 25,000 penalty units.	For an individual— At least the commercial quantity – 120 penalty units. At least 100 times the commercial quantity – 240 penalty units. At least 1,000 times the commercial quantity – 420 penalty units. For a body corporate — At least the commercial quantity – 600 penalty units. At least 100 times the commercial quantity – 1,200 penalty units. At least 1,000 times the commercial quantity – 2,100 penalty units.	For an individual—7,000 penalty units. For a body corporate—70,000 penalty units.
41QD	Possession of less than commercial quantity of vaping goods	For an individual—Imprisonment for 12 months and/or 500 penalty units. For a body corporate—2,500 penalty units.	For an individual—60 penalty units. For a body corporate—300 penalty units.	For an individual—1,000 penalty units. For a body corporate—10,000 penalty units.

Source: Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, Explanatory Memorandum, 47–48. The current value of a penalty unit is $313: Crimes (Amount of Penalty Unit) Instrument 2023.[64]

Each of these new offences are accompanied by relevant exceptions which require the defendant to disprove, or raise evidence to disprove, one or more elements of an offence. The Scrutiny of Bills Committee has indicated that provisions imposing the burden of proof on the defendant should be kept to a minimum, take into account the principles in the Commonwealth Guide to Framing Offences, and that the Explanatory Memorandum should describe the reason for placing the burden of proof on the defendant.[65] With respect to this Bill, the Committee stated that while it:

… welcomes the inclusion of an explanation against each of the reverse burden defences in the bill’s explanatory memorandum. However, the committee’s view is that in most of these cases it is not apparent that the matters are matters peculiarly within the defendant’s knowledge, or that it would be significantly more difficult or costly for the prosecution to establish the matters than for the defendant to establish them.[66]

For example, proposed subsection 41Q(5) provides that it is an exception to the importation offences if the defendant can provide that the importation of the vaping goods was not prohibited under the Customs Act 1901. In considering the justification for the reversal of the evidential burden of proof provided by the Government, the Committee stated:

… that whether a person has been issued a permit or licence by a government body administering the Customs Act 1901 is surely to be knowledge retained, recorded and available to the prosecution by way of the government body who retains these records. While it may be easier for a defendant to produce this evidence than for the prosecution to disprove the existence of such an approval, this does not equate, in the committee’s view, to these matters being peculiarly within the knowledge of the defendant.[67]

Proposed section 41R provides that the Minister may, by legislative instrument, determine that specified vaping goods, or a specified class of vaping goods, may be supplied or possessed in Australia:

• by a specified person, or a specified class of persons
• in the circumstances (if any) specified in the determination
• subject to the conditions (if any) specified in the determination.

The note to proposed section 41R provides that conditions may, for example, relate to the value or amount of specified vaping goods or the manner in which specified vaping goods may be supplied. The Minister will also have the power under proposed section 41RA to determine other indications (the specific therapeutic uses of the good) for which vaping goods may be used which would allow them to be lawfully supplied for this purpose. The Explanatory Memorandum states that ‘It is anticipated that a determination would be made by the Minister under section 41RA that would determine indications appropriate for medicinal cannabis vapes’.[68]

The Bill also introduces a consent scheme under proposed section 41RC to allow persons who do not have a licence or authority under the Therapeutic Goods Act or state and territory laws to lawfully manufacture, possess or supply vaping goods. A person who has been granted a consent under proposed section 41RC by the Secretary of DHAC will be able to lawfully use the consent as a defence to the manufacturing, supply and possession offences or civil penalty contraventions discussed above.

According to the Explanatory Memorandum, persons that can be granted consent may include:

• persons transporting vaping goods within a state or from one state to another
• persons storing vaping goods for supply to a wholesaler or a pharmacist and
• pharmacists compounding or manufacturing different vaping goods.[69]

However, as noted by the Scrutiny of Bills Committee, ‘there is no guidance on the face or the bill, nor in the explanatory memorandum, as to what criteria may be considered by the secretary when deciding whether to grant or refuse such an application, or in deciding which conditions to impose, if any’.[70] The Committee has sought the Minister’s advice on the need for this broad power and what criteria may be considered by the Secretary in making such a decision.[71]

New restrictions on the advertising of vaping goods

The Bill also contains prohibitions on the advertising of vaping goods in new Part 5-1A, which prohibit the direct and indirect promotion of vaping goods subject to very limited exceptions, including patient consultations, and authorisations given by the Secretary under proposed section 42DZC.

The term ‘advertise’ is already defined in section 3 of the Therapeutic Goods Act and includes, with respect to therapeutic goods, any statement, pictorial representation, or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods. While the Explanatory Memorandum states that ‘that the term advertise has a limited meaning and does not cover all communications in relation to vapes’,[72] according to the TGA, 'any promotional activity for a therapeutic good is likely to fall under the definition of an advertisement’.

As noted in the Explanatory Memorandum, this prohibition would apply to ‘a broad range of media platforms, extending to social media and other forms of advertising, promotion and sponsorship’.[73]

Proposed section 42DZF also introduces a broad information gathering power which will allow the Secretary to request information from a person responsible for the advertising of vaping goods. This includes a broad power to require a person to provide ‘generic information’ relating to vaping goods where that person may be responsible for disseminating, or for causing the disseminating of, the information. The term generic information in relation to vaping goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of the vaping goods, but does not include:

• an advertisement about the goods
• generic information included in an advertisement about the goods or
• bona fide news.[74]

The Explanatory Memorandum does not provide any clarity on what types of information would be considered ‘generic information’ and why this power is required. Failure to comply with a request of the Secretary to provide information is an offence, with a maximum penalty of 500 penalty units for a fault-based liability offence and 100 penalty units for a strict liability offence (proposed subsections 42DZG(1) and (2)). It is also an offence to give false or misleading information in response to a request, with a maximum penalty of 12 months imprisonment or 1,000 penalty units, or both, for a fault-based liability offence and 100 penalty units for a strict liability offence (proposed subsections 42DZG(3) and (4))

The Secretary will also be given the power to make directions to the person responsible for the advertising of vaping goods or the person apparently responsible for the dissemination of information, including to cease or destroy the advertisement/generic information, make a retraction or a correction, or recover any advertisement/generic information still in circulation (proposed section 42DZK). Criminal and civil penalties will apply where a person fails to comply with such a direction (proposed sections 42DZL and 42DZM).

Key issues

Lack of clarity regarding what constitutes a ‘unit’ or a ‘commercial quantity’

The Bill amends the definitions in subsection 3(1) of the Therapeutic Goods Act to provide that the quantity of a kind of vaping goods that will be a ‘unit’, or a ‘commercial quantity’ will be the amount set out in regulations.

These definitions are significant as they relate to directly to whether a person has committed an offence (for example, proposed sections 41QC (possessing at least the commercial quantity of vaping goods)). As explained by the Scrutiny of Bills Committee, different penalties also apply depending on the amount of the units above the commercial quantity in contravention of an offence:

As an example, item 11 would insert proposed section 41Q into the [Therapeutic Goods Act] which would create a new criminal offence, an additional offence of strict liability, and a new civil offence, in relation to the importation of vaping goods into Australia.

Proposed subsection 41Q(4) would provide that a person who contravenes the civil offence provision in proposed subsection 41Q(3) would commit a separate contravention in respect of each unit of vaping goods imported by the person into Australia. While the committee generally only comments in relation to criminal penalties, it is concerning that a significant component of a civil offence will be left to delegated legislation.

In addition, proposed section 41QC provides for a range of offences of possession where the person possesses differing amounts exceeding the commercial quantity of vaping products, with higher penalties for the larger amounts. As noted above, the prescription of the quantity of a kind of vaping goods that would amount to a ‘commercial quantity’ will be left to regulations, meaning that a significant component of the offences will be left to delegated legislation.[75]

The Scrutiny of Bills Committee sought the Minister’s advice on ‘why it is necessary and appropriate’ for these definitions to be left to delegated legislation, noting the importance of these definitions to the offence provisions proposed to be inserted by the Bill.[76]

Appropriateness of proposed penalties

As a general point, the Commonwealth Guide to Framing Offences provides that ‘[a] penalty should be consistent with penalties for existing offences of a similar kind or of a similar seriousness. This should include a consideration of existing offences within the legislative scheme and other comparable offences in Commonwealth legislation such as the Criminal Code’.[77]

The Explanatory Memorandum to the Bill provides examples with respect to the maximum penalties for comparable offences in the Therapeutic Goods Act and other Commonwealth Acts, as set out in Table 2 below.

Table 2 – Maximum penalties for comparable Commonwealth offences relating to therapeutic goods and illicit tobacco

Offence	Description	Maximum penalty – imprisonment	Maximum penalty – financial
s 19B(1) of the TG Act (aggravated offence)	unlawful importation, exportation, manufacture, supply of therapeutic goods by the sponsor of the goods	5 years	4,000 penalty units (or both)
s 19B(2) of the TG Act (fault-based offence)	unlawful importation, exportation, manufacture, supply of therapeutic goods by the sponsor of the goods	12 months	1,000 penalty units (or both)
s 19B(3) of the TG Act (strict liability)	unlawful importation, exportation, manufacture or supply of therapeutic goods by the sponsor of the goods	Nil	100 penalty units
s 42DL(1) of the TG Act (aggravated offence)	unlawful advertisement of therapeutic goods	5 years	4,000 penalty units (or both)
s 42DL(1) of the TG Act (fault-based offence)	unlawful advertisement of therapeutic goods	12 months	1,000 penalty units (or both)
s 42DL(1) of the TG Act (strict liability)	unlawful advertisement of therapeutic goods	Nil	100 penalty units
s 42E of the TG Act (fault-based offence)	importation, exportation, manufacture or supply of counterfeit therapeutic goods	7 years	2,000 penalty units (or both)
s 308-10 of Schedule 1 to the Taxation Administration Act 1953	possession of tobacco (500 kilograms or above)—reasonable suspicion offence	5 years	1,000 penalty units or both 5 years and the greater of 1,000 penalty units or 5 times the excise duty
s 308-15 of Schedule 1 to the Taxation Administration Act 1953	possession of tobacco (100 kilograms or above)—reasonable suspicion offence	2 years	500 penalty units or both 2 years and the greater of 5 times the excise duty
s 308-20 of Schedule 1 to the Taxation Administration Act 1953	possession of tobacco (5 kg or above)—reasonable suspicion offence	Nil	200 penalty units or the greater of 5 times the excise duty
s 320.2 of the Criminal Code	importation of psychoactive substances	5 years	300 penalty units (or both)

The Explanatory Memorandum states that in the context of the offences set out in the table above:

… the maximum penalties for offences relating to the importation, manufacture and supply of vaping goods are considered appropriate, being 7 years imprisonment for fault-based offences and 200 penalty units for strict liability offences. Equally, the sliding scale maximum penalties for offences relating to the possession of vaping goods are also appropriate. Depending on the quantity of vaping goods possessed, a maximum penalty of 7 years, 5 years, 2 years or 12 months will apply for fault-based offences and 420 penalty units, 240 penalty units, 120 penalty units or 60 penalty units will apply for strict liability offences.[78]

However, the only offence listed in the table above that provides for a term of 7 years imprisonment for a fault-based offence is section 42E of the Therapeutic Goods Act, with the criminal penalty being 2,000 penalty units (or both). Section 42E makes it an offence to import, export, manufacture or supply counterfeit therapeutic goods, which can include over-the-counter products (like paracetamol and ibuprofen) to life-saving medicines (such as AIDS, cancer and heart medicines). As noted by the TGA, 'using counterfeit medicines or medical devices carries a high risk of unexpected or potentially serious reactions’ and is considered to be a ‘serious threat to public health’.[79] The maximum criminal penalties for offences relating to the importation, manufacture and supply of vaping goods are 7 years imprisonment and/or 5,000 penalty units which is a higher financial penalty than what is set out in section 42E. The inclusion of terms of imprisonment for the maximum penalty for fault-based vaping offences seems disproportionate to the existing penalties in the Public Health (Tobacco and Other Products) Act 2023 for dealing with and possessing permanently banned tobacco products (sections 127 and 128).

With respect to the proposed possession offences,[80] it is difficult to compare these to existing possession offences in Commonwealth legislation given the lack of detail regarding what will constitute a ‘unit’ or a ‘commercial quantity’.

Ability for individuals to be prosecuted for possession of vapes

The Government has stated that in relation to possession, ‘the intent is not to criminalise or otherwise prohibit the personal possession of vaping goods. It is only commercial possession that is intended to be prohibited or possession other than for personal use’.[81] This is somewhat reflected in the inclusion of proposed subsection 41QD(9) which provides an exception for personal use or possession on behalf of another person where a person has committed the offence of possessing less than the commercial quantity of vaping goods. The Explanatory Memorandum states that this exception:

… has been included to protect persons who may be possessing vaping goods on behalf of someone who requires the vaping goods in connection with treatment for smoking cessation or the management of nicotine dependence, including carers and nurses in a hospital or nursing home setting.[82]

However, the person bears the evidential burden of proving that the vapes were for personal use/possession on behalf of another person. Proposed section 41QC (where the person is in possession of a commercial quantity of vaping goods) does not include a similar exception.

Ability for children to be prosecuted for vaping offences

Under section 4M of the Crimes Act 1914, the minimum age of criminal responsibility for Commonwealth offences is 10 years of age. Subsection 4N(1) provides that a child aged 10 years or more but under 14 years old can only be liable for an offence against a law of the Commonwealth if the child knows that his or her conduct is wrong, and subsection 4N(2) specifies that ‘whether a child knows that his or her conduct is wrong is one of fact’. The burden of proving that the child has sufficient capacity to know that the act/omission was one they ought not to do or make is on the prosecution, using evidence such as medical records, school reports, any police interviews with the child et cetera.[83]

The most relevant offences with respect to children in the Bill are proposed sections 41QC (possessing at least the commercial quantity of vaping goods) and 41QD (possessing less than the commercial quantity of vaping goods).

New enforcement powers for therapeutic goods

The Bill will also expand the existing enforcement powers applying to the regulation of therapeutic goods which are currently set out in Chapter 5A of the Therapeutic Goods Act, as well as allowing the Secretary to delegate their functions under Chapter 5A, proposed section 52AAA (forfeiture of things seized under search warrant) or proposed section 52AAB (return of retention of thing declared not to be forfeited) to a relevant state/territory officer (proposed subsection 57(1A)).

New power to issue enforceable directions

The Bill will insert new Part 5A-5 into Chapter 5A which provides for the broad power of the Secretary to give enforceable directions.

Proposed section 42YT permits the Secretary to make written directions to a person requiring the person to do specified things in relation to particular goods if the Secretary believes, on reasonable grounds:

• a person is not complying with the Therapeutic Goods Act in relation to particular goods and
• it is necessary to exercise this power to protect the health and safety of humans.

This power allows directions to be made requiring one or more of the following:

• to relabel or label goods in compliance with the requirements under the Therapeutic Goods Act
• to repackage goods in compliance with the requirements under the Therapeutic Goods Act or
• to destroy or dispose of goods at their own cost, including by delivering the goods to specific service providers who will dispose of the goods responsibly.

In complying with these directions, the person will bear the expense and criminal and civil penalties will apply where a person fails to comply with the directions. According to the Explanatory Memorandum, these powers are required ‘to manage waste issues associated with enforcement of vaping laws, but also to give the Secretary a broad range of compliance and enforcement tools to manage unlawful vapes and therapeutic goods generally’.[84]

Forfeiture and destruction of goods

The Bill will also insert new Part 6-2A into the Therapeutic Goods Act which provides for the forfeiture of things seized under search warrants in certain circumstances.

Currently under section 54 of the Therapeutic Goods Act forfeiture orders can only be obtained following a criminal conviction, an order under section 19B of the Crimes Act 1914, or a finding by a court that the person has contravened a civil penalty provision.[85] Under section 48H of the Therapeutic Goods Act, seized goods may be required to be returned to the owner if they are no longer needed for evidentiary purposes, regardless of whether it is lawful for the owner to possess or deal with the goods.[86]

Proposed subsection 52AAA(1) provides that where a thing has been seized under a warrant issued under section 50 of the Therapeutic Goods Act and the Secretary believes on reasonable grounds:

•  that the thing has been imported, manufactured or supplied or been in the possession, custody or control of a person, in contravention of the Therapeutic Goods Act or
• an instrument made or requirement under the Therapeutic Goods Act has not been complied with

then the thing is forfeited to the Commonwealth. Upon the thing being condemned as forfeited to the Commonwealth, the Secretary may retain the thing for the purposes of proceedings in respect of which the thing may afford evidence or dispose of the thing in a manner in which the Secretary directs.

The owner of the thing, or person who had possession, custody or control of the thing, may commence proceedings for a declaration that the thing is not forfeited to the Commonwealth (proposed subsection 52AAA(4)). Proposed section 52AAB provides for the return or retention of a thing that is declared not to be forfeited to the Commonwealth and allows the Secretary to impose terms and conditions on the return of things as the Secretary sees fit.

According to the Explanatory Memorandum, these amendments ‘will enable the TGA to disrupt the trafficking of unlawful goods more efficiently, as well as address potential storage and destruction issues where large quantities of unlawful vapes are seized’.[87] However, they will not be limited to the seizure and destruction of vaping products.

Expanded power to issue warrants

Currently sections 49 and 50 of the Therapeutic Goods Act require warrants to be issued by a magistrate. Item 58 of the Bill will amend the definition of ‘issuing officer’ in subsection 3(1) of the Act to allow court registrars and other legislative officers of a court of a state or territory to also issue warrants.

According to the Explanatory Memorandum:

The TGA often experiences operational [delays] when seeking timely access to magistrates to issue warrants. This is problematic when there is urgency in the obtaining and execution of a warrant. Consequently, these amendments extend the authority to issue monitoring, offence and civil penalty related warrants in relation to premises to court registrars and other legislative officers of a court of a state or territory.[88]

Access to vapes for smoking cessation purposes

Effects of vapes as smoking cessation aids

The most efficient means of finding quality scientific research on healthcare interventions is through meta-analyses or systematic reviews of articles published in peer-reviewed journals. Of these, the Cochrane Reviews of the evidence on healthcare interventions and summaries of the findings are generally recognised to be the gold standard.

Several Cochrane Reviews of vapes as a smoking cessation tool have been conducted, the most recent of which incorporates evidence published up to the 1st of July 2023.[89]

This review prioritised randomised controlled trials but also included studies in which all participants received vape treatment and had their health monitored, to evaluate the health impacts of vapes. The review was primarily concerned with the question of how many people using vapes as smoking cessation devices stopped smoking for at least 6 months and how many trial participants had unwanted effects. Vapes were compared with a range of other methods of quitting smoking.

Based on an analysis of 88 studies, which included 27,235 adults who smoked, the review found that people were more likely to stop smoking for at least 6 months using nicotine vapes than using nicotine replacement therapy or vapes without nicotine. The review also found that nicotine vapes may work better than no support, or behavioural support alone, and that they may not be associated with serious unwanted effects.

These findings are qualified by the review’s authors. They note that the results are based on a few studies for most outcomes and that for some outcomes the data varied widely. They also stress that more studies are needed to confirm whether nicotine vapes are more effective than non-nicotine vapes, and that most results for unwanted effects ‘could change when more evidence becomes available’.

In light of the still limited population-level evidence regarding the effectiveness of vapes as smoking cessation aids, the products are used as a second-line treatment in Australia. As such, they may be recommended by general practitioners (GPs) when smoking cessation with first-line therapy (behavioural support combined with TGA-approved pharmacotherapy) has failed.

Numbers using vapes to quit smoking

Judging by NDSHS data for 2022–23, 21.5% of vape users aged 14 and older are using the products to help them quit smoking. This proportion is less than that in the 2019 survey (32.5%). Other reasons for the use of vapes include people thinking they are less harmful than regular cigarettes (15.8%), to try to cut down on the number of cigarettes smoked (15.6%), and to try to stop going back to smoking regular cigarettes (13.9%).[90]

Under existing laws, a valid medical prescription is required to access nicotine-containing vapes or nicotine containing vapes. However, based on figures cited by the TGA in its impact assessment of options to address the public health problem posed by vapes, relatively few vapers are procuring them by means of a prescription. Several recent surveys suggest that between 3% and 12% of all vapers had a prescription.[91] Similarly, based on numbers of authorised providers and data on prescriptions, the TGA has observed that only a very small proportion of vape users seek prescriptions.[92] NDSHS data for 2022–23 indicate that only 0.3% of current vapers obtained their vapes from a pharmacy or chemist.[93]

As the TGA sees it this is less than ideal as it leaves people using directly sourced vapes as a means to quit smoking without the support of a medical practitioner:

Ensuring that vapes are only accessed with medical supervision provides an opportunity for consumers to receive appropriate advice from a health professional on the risks associated with their use and the benefits of smoking cessation. Medical supervision also enables close monitoring of emerging and ongoing health harms that may be associated with vaping.[94]

That people are currently bypassing official channels to source vapes for smoking cessation purposes is perhaps unsurprising for a number of reasons.

Availability and cost of illicit nicotine vapes

Despite it being an offence in all states/territories to supply nicotine vapes to consumers without a prescription, nicotine containing vapes are readily available. Illicit nicotine containing vapes are also typically cheaper than those purchased through a pharmacist. According to the TGA, ‘[t]he ease of access to, and low cost of, illegal supply can make this a preferred option, even if an adult has obtained a legitimate prescription’.[95]

Until such time as vapes are registered as a prescription medicine on the Australian Therapeutic Register of Therapeutic Goods (ARTG) and listed on the Pharmaceutical Benefits Scheme (PBS)—and perhaps even then—they will remain more expensive than those purchased through other means.

The TGA has noted that ‘the cost of vapes sourced solely through a pharmacy may be significantly higher than those sourced through most current means’.[96] There is a risk this situation could worsen under the changed arrangements, with additional costs associated with enhanced manufacturing standards being passed on to consumers, and pharmacies possibly exploiting a monopoly on supply.[97] The costs associated with obtaining a prescription are also likely to increase the expense of therapeutic vapes.

The cost of obtaining a prescription was noted in the Impact Analysis which found that the average cost per year for consumers (including GP and pharmacy visits) and the system costs over ten years, would be $52.1 million per year.[98]

Other factors that limit the supply of vapes for therapeutic purposes could also translate into higher prices for these products.[99] The cost of therapeutic vapes and pharmaceutical grade vape fluid could be expected to decrease over time if the market for the products were to increase. However, the TGA anticipates that this will not be the case, with the number of consumers declining over time ‘as consumers respond to public health messaging and advice from medical practitioners regarding the danger of vaping’.[100]

The generally higher cost of therapeutic vapes could result in an increase in black market sales, and, more alarmingly, an increase in cigarette smoking.

The TGA has acknowledged the potential for changes to regulatory settings to further increase black market activity. It has also noted that ‘if access to nicotine-containing vapes were to be significantly restricted there is a risk that Australians addicted to nicotine may seek alternative products to meet cravings, such as tobacco’.[101]

The TGA has outlined a range of measures calculated to manage these potential risks. In the case of a possible increase in tobacco use due to consumers being unable to source therapeutic vapes, the TGA has observed that alternative smoking cessation aids are available. It has also suggested that the risk can be reduced ‘by ensuring ease of supply for legitimate use and access ... [and] ‘implementing preventive public health campaigns focused on vaping and smoking cessation and increasing and improving vaping and smoking cessation support’.[102] Recently introduced measures that tighten tobacco plain packaging requirements should also help to reduce the possibility of a shift to cigarette smoking.[103]

Access to authorised prescribers

Another impediment to the greater use of therapeutic vapes is the limited number of authorised prescribers. Currently, many GPs are likely to be reluctant to prescribe vapes because, as noted above, these products have yet to be evaluated by the TGA and registered on the ARTG as smoking cessation devices. In the absence of such approval, and with outstanding concerns regarding evidence of vapes’ safety and efficacy as smoking cessation devices, GPs may simply be erring on the side of caution and recommending the use of first-line smoking cessation therapies which have an established safety and efficacy profile.

Enabling nurse practitioners as well as medical practitioners to supply therapeutic vapes and vaping goods may or may not improve consumer access.

Based on its modelling the TGA estimates that following the shift to a prescription only model 450,000 vapers will move from illegal to legal channels.[104] Once the regulatory changes are in place the TGA estimates that the number of authorised providers will increase by 10% in the first year and 2% per year thereafter. The initial boost in numbers is anticipated to be a result of ‘more confidence by prescribers in the new regulatory regime and pressure from patients’.[105] If the move to a prescription model that the Bill would enable proves unsuccessful, with people shifting to the illicit market or smoking, Wayne Hall, an Emeritus Professor at the National Centre for Youth Substance Abuse, has suggested an alternative approach of allowing the sale of approved vapes to adult smokers through licensed retailers under tighter regulations than apply to cigarettes.[106] This ‘pragmatic consumer model’ would retain most of the restrictions proposed in the Bill and already implemented but would not require a prescription for vapes or restrict dispensing to pharmacies.[107]

Smoking cessation support for under 18s

One of the main purposes of the Bill is to reduce vaping prevalence in the community, particularly among young people. The Explanatory Memorandum to the Bill states that ‘[i]n parallel to the introduction of the Bill, cessation services in Australia will be enhanced to ensure support for people who seek assistance to stop vaping’.[108]

As noted in the NDSHS, between 2019 and 2022–23 vaping increased among people aged 14–17 from 1.8% to 9.7%; however, it is unclear what assistance will be provided to young people who may be addicted to vaping, or those seeking to quit or taper down. The DHAC submission to the Senate inquiry outlines a number of cessation support programs announced in the 2023–24 Budget including funding for ‘a national campaign to target young people, their parents, carers and communities, as well as a stream of activities dedicated to reaching teachers and the education sector’,[109] but this does not directly address how under 18s who are already vaping will be supported.

Provisional guidance from the RACGP on prescribing vapes for smoking cessation, provisional guidelines (noted above), states the following regarding persons under 18:

[Nicotine vaping products] NVPs are not currently recommended as a smoking cessation aid for people under 18 years of age as to date there have been no studies of effectiveness and safety in this age group. For further information about smoking cessation in this group, refer to Adolescents and other young people. For advice on assisting adolescents who are already vaping see the section on vaping cessation.[110]

However, in a webinar held in conjunction with the TGA, the RACGP noted that there was uncertainty around how to best treat young people who are vaping due to a lack of evidence:

The prevalence of young people who vape (and may have never previously smoked) is rising however there is a currently a lack of evidence on the effectiveness and safety of medicines for smoking cessation in this group.

Young people who are nicotine dependent through vaping may benefit by using a therapeutic vape to manage nicotine dependence for a limited period with the intention to stop vaping, but again there is a lack of research on effectiveness and safety.

There are differences across jurisdictions about the legality of supplying a young person with a therapeutic vape even if it is on prescription. Currently information on this is not easily available and is likely to change over time.[111]