Chapter 1Introduction

1.1The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (the bill) was introduced by the Hon. Mark Butler, the Minister for Health and Aged Care, into the House of Representatives on 21March2024.[1]

1.2On 27 March 2024, the Senate referred the provisions of the bill to the Community Affairs Legislation Committee (the committee) for inquiry and report by 8 May 2024.[2]

Structure of the report

1.3This report contains two chapters. This chapter sets out:

the purpose of the bill;

background information relating to vaping reforms in Australia;

general information outlining the conduct of the inquiry and other committees’ consideration of the bills; and

an overview of the key provisions of the bill.

1.4Chapter 2 outlines inquiry participants’ views on the bill and concludes with the committee’s view and recommendation.

Purpose of the bill

1.5As articulated by the Hon Mark Butler, Minister for Health and Aged Care (the Minister), the intention of the bill is to:

… take strong action to ban the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods, except in very limited circumstances.[3]

1.6The bill represents the second stage of the Australian Government’s vaping reforms. The bill would extend the national system of controls for therapeutic goods under the Therapeutic Goods Act to include the regulation of vaping goods.[4]

1.7As outlined in the Explanatory Memorandum, the bill:

… provides 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.[5]

1.8The bill would implement:

a new framework for the regulation of vapes, enabling state and territory officials to undertake enforcement action;

new offences and civil penalty provisions related to importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods; and

enhanced existing compliance and enforcement powers in the Therapeutic Goods Act.[6]

1.9As the Explanatory Memorandum highlights:

Bans on the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods are intended to arrest and reverse the increasing uptake of recreational vaping, especially amongst youth and young adults by banning the domestic supply of vaping goods outside the pharmaceutical supply chain.[7]

Conduct of the inquiry

1.10Details of the inquiry were made available on the committee’s website. The committee also contacted a number of organisations and individuals to invite written submissions by 12 April 2024.

1.11The committee received 281 submissions, as listed at Appendix 1.

1.12The committee held two public hearings in Canberra on 1 and 2 May 2024. A list of witnesses who gave evidence is included at Appendix 2.

1.13In accordance with the committee’s obligations under the World Health Organisation Framework Convention on Tobacco Control,[8] the committee did not accept confidentiality requests for submissions. Further, the committee required all witnesses to disclose any support they had received, whether financial or non-financial, direct or indirect, from any parties involved in the production, distribution or sale of tobacco, nicotine or vaping products.

Note on references

1.14References to Committee Hansard in this report are to proof transcripts. Page numbers may vary between proof and official transcripts.

Note on terminology

1.15Vaping products and devices have a range of different names; including but not limited to: e-cigarettes, mods, vapes, pod-mods and electronic nicotine delivery systems (ENDS). For the sake of consistency, this report will use the phrases vapes and vaping products.

Acknowledgements

1.16The committee thanks the organisations and individuals who contributed to the inquiry by making written submissions and giving evidence at the public hearings.

Background

1.17Australia has a long history of world-leading reforms in regards to tobacco control, including the first restrictions on tobacco advertising and more recent reforms such as plain packaging reforms for cigarettes.[9]

Addressing a public health concern

1.18In Australia, there has been a rapid rise in vaping among young people, contributing to a ‘whole new generation of persons with nicotine dependence in our schools and our broader community’.[10]

1.19The proliferation of vaping across the community represents a severe public health concern.[11] In particular, vaping has been associated with significant potential adverse effects, including on adolescent brain development, worsened pregnancy outcomes, cardiovascular disease, respiratory disease and cancer.[12] Vaping also carries other health risks such as severe burns, poisoning and seizures.[13]

1.20There is also a marked increase in young people using vapes since 2017, with the latest national data showing that one in six secondary school students aged 12 to 17 years report recent vaping in 2022–23[14]and trend data showing that people aged 14 years currently using a vape had increased from 2.5 per cent to 8.9 per cent between 2020 and 2023.[15]

1.21Further, many vapes are marketed as containing no nicotine or zero nicotine,[16] but the Therapeutic Goods Administration (TGA) has reported that approximately 90 per cent of tested vapes are found to contain nicotine, regardless of statements listed on the label.[17]

1.22There has also been an increased risk with the potential co-occurrence of vaping and uptake of cigarette smoking:

Indeed, there is strong and consistent evidence that youth and young adults who vape are more likely to take up smoking, compared to those who do not, and the long-term health risks of vaping are not yet known. The highly addictive nature of nicotine, and the fact that vapes are inhaled into the lungs, mean the population-wide health risks of these products can be severe.[18]

Vaping and tobacco reforms in Australia

1.23Australia’s National Tobacco Strategy 2023–2030 (the Strategy) establishes a framework for the Commonwealth, state and territory governments to coordinate work to reduce the prevalence of tobacco use.[19] The Strategy also includes a specific priority area related to enhanced regulation on e-cigarettes and emerging products.[20]

1.24This bill is designed as the second phase to the Australian Government’s vaping specific reform measures.[21] The first phase of vaping reforms involved amending a series of regulations within the remit of the TGA.[22]

1.25With these regulation amendments, the importation of single-use vapes was banned on 1 January 2024, subject to very limited exceptions and the importation of all other vapes was banned on 1 March 2024, unless certain requirements were met in relation to those vapes under the Therapeutic Goods Act1989 (Therapeutic Goods Act).[23] The Minister described these reforms as ‘turning off the tap at the border as a necessary first step to combat supply’.[24]

1.26The Australian Government is also implementing a range of actions to reduce use of tobacco and nicotine products through the National Tobacco Strategy2023–2030.[25] The Public Health (Tobacco and Other Products) Act 2023 commenced on 1 April 2024 and streamlines and modernises existing Commonwealth tobacco control laws, as well as extending advertising regulations to cover vaping goods.[26]

1.27In May 2023, new tobacco excise measures were announced to reduce the affordability of tobacco products.[27] The government is also providing additional funding to services to encourage vaping and smoking cessation:

$29.5 million over four years for services that support quitting;

$63.4 million for public health information campaigns to discourage Australians from taking up vaping or smoking and encourage quitting; and

$141.2 million to extend the Tackling Indigenous Smoking program.[28]

Vapes as a therapeutic good

1.28The Minister explained the original introduction of vapes to the Australian market were designed for therapeutic use:

E-cigarettes and vapes were sold to governments and communities around the world as a therapeutic good—a product that could help hardened smokers, usually people in their 40s or 50s and beyond, to quit smoking and kick the habit.[29]

1.29In seeking to recognise the purpose of these goods as therapeutic goods, the Minister commented that:

If vapes are therapeutic goods then it is entirely appropriate that Australia should regulate them as therapeutic goods, instead of allowing them to be sold alongside candy bars in convenience stores, often down the road from schools.[30]

1.30Further, in recognition of the potential use of vapes as a therapeutic device, the Minister highlighted that:

Allowing patient access to therapeutic vapes strikes an appropriate balance between the health concerns posed by vaping and the need to provide legitimate patient access to support Australians to quit smoking or manage nicotine dependence.[31]

Consultation on the proposed reforms

1.31The Department of Health and Aged Care (the Department) specified that the reforms were developed through a series of consultations since November 2022.[32]

1.32Firstly, between 30 November 2022 and 16 January 2023, the TGA conducted a public consultation on proposed reforms to the quality standard for nicotine vaping products, with close to 4000 submissions received.[33]

1.33Following this consultation and two Tobacco Control Roundtables, the TGA engaged with states and territories via the Health Ministers’ Meeting and its subordinate National E-Cigarette Working Group, which culminated in a Health Ministers’ Meeting Communique, outlining a collective commitment to enhancing regulation of vapes.[34]

1.34In September 2023, the TGA undertook a second, targeted consultation on proposed reforms to the regulation of vapes developed in consultation with states and territories, as well as holding a series of webinars and stakeholder meetings.[35]

Financial impact statement

1.35The financial impact statement for the bill specifies that $82.0 million will be provided over four years from 2023–24 to ‘support the vaping reforms, awareness raising and enforcement activities’.[36] This funding includes:

$56.9 million over two years from 2023–24 to the Therapeutic Goods Administration 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.[37]

1.36The financial impact statement further outlines that this bill would build on the Vaping Regulation Reform and Smoking Cessation Package measure from the 2023–24 Budget, which included allocation of $511.1 million over four years from 2023–24. There was also $101.1 million ongoing for activities including a national lung cancer screening program, nicotine vaping product regulation and reform, and cessation support activities for tobacco and vaping use.[38]

Compatibility with human rights

1.37The Statement of Compatibility with Human Rights (the statement) notes that the bill promotes and supports the following rights and international obligations:

the right to health;

the right to life;

the obligation to ensure the survival and development of children; and

the obligation to protect children from illicit use of narcotic drugs and psychotropic substances.[39]

1.38The statement also highlights that the bill engages the following rights:

the right to privacy;

the right to freedom of expression;

the right to a fair hearing;

the right to the presumption of innocence;

the right to be free from self-incrimination; and

the right to not be tried or punished again for an offence for which a person has already been finally convicted or acquitted.[40]

1.39The statement specifies that the bill is compatible with human rights because it supports and promotes a number of rights.[41] Furthermore, in regards to the limitations of certain rights that could occur as a result of the bill, the statement highlights:

…to the extent that the Bill limits any of these rights the limitations are reasonable, necessary and proportionate to achieving the aim of protecting public health by limiting access to harmful vaping goods.[42]

Consideration by other committees

1.40The Parliamentary Joint Committee on Human Rights made no comment on the bill in its Report 3 of 2024.[43]

1.41The Senate Standing Committee for the Scrutiny of Bills (Scrutiny Committee) in its Scrutiny Digest No 5 of 2024 provided initial scrutiny of the bill, outlining concerns including:

the significant matters to be included in delegated legislation;

the strict liability offences; and

the reversal of the evidential burden of proof.[44]

Definitions of commercial quantities and the evidential burden of proof

1.42Firstly, the Scrutiny Committee emphasised that the proposed offences within the legislation are contingent on the definition of a unit and a commercial quantity of vaping goods, but these definitions are to be set out in regulations rather than the primary legislation.[45]

1.43The Scrutiny Committee noted that the:

…definition of the commercial quantity is a central component to the offence provisions, with different penalties applying depending on the amount of the units above the commercial quantity in contravention.[46]

1.44In emphasising its concern about this issue, the Scrutiny Committee made the following recommendation to the Minister:

The committee requests the minister’s advice as to why it is necessary and appropriate for the definition of a ‘unit’ of vaping goods (in item 10 of Schedule 1) or the quantity of a kind of vaping goods that would amount to a commercial quantity (item 6 of Schedule 1) to be left to delegated legislation, noting the importance of these definitions to the offence provisions proposed to be inserted by the bill.[47]

1.45Secondly, the Scrutiny Committee assessed the proposed inclusion of new offences within the Therapeutic Goods Act, noting that ‘most if not all the new offences are being introduced alongside offence-specific defences which reverse the evidential burden of proof’.[48]

1.46Of particular concern to the Scrutiny Committee was the issue of offences with strict liability elements which:

…removes the requirement for the prosecution to prove the defendant’s fault. In such cases, an offence will be made out if it can be proven that the defendant engaged in certain conduct, without the prosecution having to prove that the defendant had the intention to engage in the relevant conduct or was reckless or negligent while doing so.[49]

1.47The Scrutiny Committee emphasised the importance of clarification in regard to these issues by highlighting:

…while the statement of compatibility on human rights outlines the general circumstances relating to the imposition of strict liability on the offences generally, the committee’s expectation is that the imposition of strict liability should be explained contextually against each of the relevant offences. This is especially the case in relation to offences where more than 60 penalty units are being imposed, which is the case with many of the offences in the bill.[50]

1.48The Scrutiny Committee further highlighted that the proposed new offences are accompanied by offence-specific defences which reverse the evidential burden of proof, interfering with common law rights.[51] The Scrutiny Committee noted the inclusion of explanation of each of the reverse burden defences in the Explanatory Memorandum. However, the Scrutiny Committee still maintained concerns that most of the cases mentioned may not be justified as an offence-specific defence, given they may not necessarily exist as knowledge only available to the defendant.[52]

1.49In relation to these issues, the Scrutiny Committee drew the attention of senators to its scrutiny concerns.[53]

Broad discretionary powers

1.50The bill proposes to empower the Secretary of the Department of Health and Aged Care (the Secretary) to give consent to applications to manufacture, supply or possess vaping goods and to grant an application subject to conditions.[54]

1.51The Scrutiny Committee highlighted concerns in relation to these powers, noting:

…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. These concerns are heightened noting the relevant of consent granted under proposed subsection 41RC(1) to the offence provisions of the bill.[55]

1.52As a result of these concerns, the Scrutiny Committee requested the advice of the Minister to the necessity and appropriateness of these broad ranging powers and what criteria might be considered by the Secretary in making decisions under proposed subsection 41RC(1).[56]

1.53In further regard to the discretionary powers to be granted to the Secretary, the Scrutiny Committee raised concerns with the proposed section 42YT of the Therapeutic Goods Act which would ‘enable the secretary to issue enforceable directions under the TG Act [Therapeutic Goods Act] or an instrument made under the TG Act’.[57]

1.54Of these proposed powers, the Scrutiny Committee was concerned that these:

…are significant measures for which there is no explanation or justification provided in the explanatory memorandum. The committee is particularly concerned that notices may be issued as the result of the secretary’s ‘reasonable belief’ without any further guidance provided on the face of the bill or the explanatory memorandum as to the factors that may lead the secretary to form such a belief.[58]

1.55The Scrutiny Committee requested the Minister’s explanation for the criteria to be considered by the Secretary where there is a belief on reasonable grounds that a person is not complying with the Therapeutic Goods Act or its instruments, as well as whether independent merits review is available for directions issued under proposed subsection 42YT(2) of the bill and clear justification as to the reasoning if this is not available.[59]

Seizure of assets

1.56In regard to the proposed powers for the seizure of assets contained within the bill, the Scrutiny Committee sought clarification as to the power that specifies that the Secretary keep seized goods for the purposes of proceedings where the goods may form evidence.[60]

1.57Particularly, the Scrutiny Committee highlighted the Guide to Framing Commonwealth Offences that outlines that seized material:

… should only be retained for as long as necessary, and that consideration should be afforded to whether use and derivative use immunity applies in relation to incidentally seized materials.[61]

1.58The Scrutiny Committee sought the advice of the Minister as to ‘whether it is intended that use and derivative use immunities apply to materials incidentally seized and retained under proposed section 52AAA of the bill’.[62]

Delegation of powers

1.59The Scrutiny Committee noted the inclusion of delegated authority for issues of enforcement, forfeiture of things seized under search warrant and return or retention of things declared not be forfeited to representatives of state or territory departments and authorities.[63]

1.60The Scrutiny Committee sought clarification as to the level of delegation intended by the legislation, noting discrepancies between the text of the bill and the Explanatory Memorandum.[64] Specifically the committee:

… requests the minister’s advice as to the intended formulation of the delegation in proposed subsection 57(1A) of the Therapeutic Goods Act 1989. The committee’s preference is for the delegation to be limited to the head of the relevant departments and administrative units.[65]

1.61The ministerial response to the issues raised by the Scrutiny Committee was received by the Scrutiny Committee on 9 April 2024.[66] The response is due to be tabled in the Senate after the publication of this report. As such, it was not possible to outline the detail of the ministerial response in this report.

Key provisions of the bill

1.62The bill contains three schedules, which seek to amend legislation as follows:

Schedule 1 – Amendment of the Therapeutic Goods Act 1989 (Therapeutic Goods Act);

Schedule 2 – Amendment of the Customs Act 1901 (Customs Act); and

Schedule 3 – Amendments of the Industrial Chemicals Act 2019 (Industrial Chemicals Act) and the Public Health (Tobacco and Other Products) Act 2023 (Tobacco and Other Products Act).[67]

1.63The most significant amendments contained within the bill are those intended to be made to the Therapeutic Goods Act. Accordingly, Schedule 1 specifies the following proposed changes:

Part 1 – Definitions and objects of Act;

Part 2 – Regulation of vaping goods;

Part 3 – Advertising relating to vaping goods;

Part 4 – Enforceable directions and forfeiture;

Part 5 – Entry, searches and warrants;

Part 6 – Delegation and authorised persons;

Part 7 – Release of information;

Part 8 – Laboratory testing;

Part 9 – Approvals for certain part 3–2 exempt goods;

Part 10 – Offences and civil penalty provisions for breach of condition of certain exemptions or approvals; and

Part 11 – Other amendments.[68]

Amendments to the Therapeutic Goods Act

1.64The amendments contained within Schedule 1 of the bill are designed to expand the scope of the Therapeutic Goods Act to regulate all vaping goods, not just those that are designated as therapeutic goods.[69]

Part 1 – Definitions and objects of the Act

1.65The bill proposes to update the objects of the Therapeutic Goods Act to specifically include a national regulatory framework related to vaping, defined as follows:

(d) provide for the establishment and maintenance of a national system of controls relating to the regulation of vaping goods that are:

(i) imported into Australia; or

(ii) manufactured in Australia; or

(iii) supplied in Australia, whether manufactured in

Australia or elsewhere; or

(iv) exported from Australia.[70]

1.66The Minister may, by legislative instrument, determine that goods are therapeutic goods for the purposes of the Act.[71]

1.67In considering whether to determine if goods are therapeutic goods for the purposes of the Act, the Minister must give regard to particular issues, including:

the likelihood of the specified goods causing public health harm;

the appropriateness of applying the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods under the Act to regulate the specified goods; and

whether the risks from the specified goods might be more appropriately dealt with under another regulatory scheme.[72]

1.68The Minister may also have regard to any other relevant matter before making a determination under new subsection 7AAA(1).[73]

1.69Of the proposed definitions, the Explanatory Memorandum explains:

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.[74]

1.70Further, subsection 57(1) of the Therapeutic Goods Act allows the Minister to delegate this power to a broad range of delegates, which ‘ensures that those with the most relevant expertise in regulating new and emerging therapeutic goods can participate in the decision-making process’.[75]

1.71Under the Therapeutic Goods Act, the Secretary of the Department can request information from individuals who have imported into Australia, or supplied in Australia, goods under the Act.[76] The bill would also expand the scope of the classes of person from whom the Secretary of the Department may request information from, to include the specification of goods that are therapeutic goods under the new section 7AAA(1), namely goods related to vaping.[77]

Part 2 – Regulation of vaping goods

Defining and identifying vaping goods

1.72The bill would insert two definitions into the Therapeutic Goods Act: the definition of a ‘commercial quantity’ and the definition of ‘evidential burden’.[78] The insertion of ‘commercial quantity’ into the Act references that a commercial quantity of a kind of vaping goods would be defined in regulations under the Act.[79] The insertion of the definition of evidential burden reflects the definition in section 13.3 of the Commonwealth Criminal Code.[80]

1.73The bill seeks to amend the Therapeutic Goods Act to provide updated definitions for manufacture within the Act to include reference to vaping goods,[81] specific definitions for medical practitioner, nurse practitioner and pharmacist[82] and updated definitions of supply to include vaping goods.[83]

1.74Another element related to definitions within the Therapeutic Goods Act is the proposed inclusion of a new definition of a ‘unit’ of vaping goods, which is to be prescribed by regulations under the Act.[84]

1.75Further, the bill would insert new definitions for ‘vaping accessory’, ‘vaping device’, vaping goods’ and ‘vaping substance’ into the text of the Therapeutic Goods Act.[85] The Explanatory Memorandum notes that these definitions broadly mirror the definitions inserted into the Customs (Prohibited Imports) Regulations 1956 (CPI Regulations) by the Customs Legislation Amendment (Vaping Goods) Regulations 2023.[86]

1.76While the definitions of vaping accessory, device, goods and substance are specified within the bill, there is a proposed inclusion that expands the meaning of vaping goods where there is an ‘implied or express representation’ that the goods are intended to be utilised as vaping substances, accessories or devices.[87] This includes the presentation of the goods, such as name,[88] labelling and packaging,[89] and/or any advertising or informational material related to the use or supply of the goods.[90] The purpose of this inclusion in the bill is clarified in the Explanatory Memorandum as ensuring that:

… there is no requirement for testing or identification by an expert to determine whether a good is a vaping good. Goods can be vaping goods solely on the basis of express or implied representations made through the presentation of the goods, including the name, labelling, packaging and any advertising or informational material associated with the goods.[91]

1.77Further, the goods are taken to be presented as vaping goods even if the presentation is misleading or confusing as to the content, proper use or identification of the goods; or there is the suggestion that the goods have ingredients, components or characteristics that they do not have.[92] As the Explanatory Memorandum expands:

In practice, subsection 41P(2) will enable the offences in the new Chapter 4A to operate even if goods have inaccurate claims or are the subject of misleading marketing. Subsection 41P(2) is intended to prevent persons from evading the regulatory controls in Chapter 4A by:

• modifying the components or ingredients of vaping goods; or

• designing the vaping goods to make them difficult to identify or detect; or

• describing the goods in a way that conceals their purpose to an uninformed observer but signals the intended use to the user.[93]

1.78The bill would establish the power for the Minister to determine via legislative instrument that goods are or are not, or when used, advertised or presented for use in a particular way, are or are not to be specified as vaping goods.[94] As the Explanatory Memorandum further elaborates:

The subsection 41P(3) is intended to allow the Minister to determine that goods are vaping goods despite those goods not otherwise meeting the definition of vaping goods provided in 41P(1). Such a power is crucial if the Government is to maintain parity with an ever-evolving market.[95]

1.79The Explanatory Memorandum further specifies that the powers specified in proposed subsection 41P(3) can also be delegated to:

the Secretary;

an SES employee, who holds or performs the duties of, an SES Band 3 position in the Department; or

a person who is registered, in a state or internal territory, as a medical practitioner and who holds or performs the duties of, a position that is equivalent to or higher than, an SES Band 2 position in the Department.[96]

1.80The delegation of this power is designed to ensure the instruments are responsive to a ‘rapidly evolving market that has repeatedly sought to evade regulation’.[97] Given the time critical nature of this responsiveness, the Explanatory Memorandum specifies that ‘it is important to have a sufficient number of delegates, at a senior level available to make such an instrument’.[98]

Offences and civil penalty provisions

1.81The bill specifies offences and civil penalty provisions for the following activities:

importing vaping goods into Australia;[99]

manufacturing or carrying out a step in manufacturing vaping goods in Australia;[100]

supplying vaping goods in Australia;[101]

possessing at least commercial quantity but less than 100 times the commercial quantity;[102] and

possessing a quantity of a kind of vaping goods in Australia where the quantity is less than the commercial quantity of that kind of vaping goods.[103]

1.82The Explanatory Memorandum specified the policy intent, noting ‘the bans are intended to apply to all persons in the supply chain and ensure that supply is through the legitimate pathways’.[104] Further, the Explanatory Memorandum commented 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.[105]

1.83The offences and civil penalty provisions are designed in line with the remainder of the Therapeutic Goods Act, notably the Act:

… includes a tiered penalty regime for most offences, with two fault-based offences (one with an aggravated factor) and a strict liability offence. There is also usually a corresponding section which makes the relevant physical conduct a contravention of a civil penalty provision.[106]

1.84The operation of offence provisions such as these ‘gives regulators a choice of responses in respect of the same physical conduct and a range of enforcement options’.[107] Further:

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.[108]

1.85Further explaining the intention behind the varying tiers of offences contained within the bill, the Explanatory Memorandum elaborated that:

… the TGA would generally elect to deal with breaches by way of a criminal prosecution where there is an element of culpability. This is particularly so where there is an organised crime element to the offending. Where culpability and criminality of the conduct are not apparent but there is a need to address breaches of the Act and deter future non-compliance, it would be appropriate for the TGA to opt for a civil penalty fine, or other enforcement mechanism such as the giving of an infringement notice, accepting an enforceable undertaking or issuing a forfeiture direction.[109]

1.86A summary of each of the offences and civil penalty provisions, including the maximum penalties, is outlined below.

Source: Explanatory Memorandum, pp. 47–48.

1.87In discussing the significance of the penalties within the proposed bill related to vaping, the Explanatory Memorandum emphasises the proposed offences are similar to comparable existing offences within the Therapeutic Goods Act.[110]

1.88Related to the civil penalties, the Explanatory Memorandum discusses the employment of fines and civil penalties as an appropriate alternative to criminal sanctions in some instances:

… civil penalties are appropriate in regulating commercial activities involving the importation, manufacture, supply and possession of a commercial quantity of vaping goods. This is particularly so where the relevant activities are undertaken by incorporated bodies, including subsidiaries of multinational companies engaged in commercial operations in Australia. The financial disincentive that a civil penalty regime provides to address and deter breaches of the TG Act is likely to be more effect than criminal sanctions in appropriate circumstances.[111]

1.89Moreover:

It is anticipated that the level of civil penalties will act as an effective financial disincentive against non-compliance with regulatory requirements, especially for corporations for whom imprisonment is not available.[112]

Commonalities across the offence and civil penalty provisions

Separate contraventions for civil penalty provisions

1.90In relation to the civil penalty provisions for import, manufacture, supply and possession of vaping goods, each unit of vaping good would constitute a separate contravention.[113] The Explanatory Memorandum specified that defining a unit of vaping goods in the regulations is a deliberate measure to ensure ‘there is clarity in the proscribed conduct in these provisions and avoid ambiguity and unintended consequences’, such as treating singular amounts of vaping goods of vastly different volumes in the same manner.[114]

1.91The Explanatory Memorandum outlined the flexibility of powers afforded to the Secretary of the Department:

Framing the civil penalty contraventions in this way, on a per unit approach will also allow the Secretary to give a person an infringement notice(s) as an alternative to having the penalty determined by the court and provides greater flexibility for the Secretary to decide an appropriate penalty amount.[115]

Liability of CEOs and body corporates

1.92For each of the specified offences, there is also a note to section 54B. Section 54B is intended to apply to executive officers, such as managing directors or Chief Executive Officers who:

… are directly involved in or participate in the management of a company, and who should be made accountable for the actions of their company where such officers are in a position to influence the company and are aware of breaches by the company of the TG Act but fail to take reasonable action to prevent the breaches.[116]

1.93The Explanatory Memorandum specifies that this is a deliberate inclusion given the unique nature of vaping offences:

There is significant public harm from the importation of vaping goods into Australia caused by corporate offending and the liability of the corporation is not likely on its own to sufficiently promote compliance and have the desired deterrence effect.[117]

Strict liability offences

1.94As specified in the table above, the bill proposes a maximum penalty for strict liability offences for each of the identified unlawful behaviours related to vaping. In relation to the inclusion of strict liability offences, the Explanatory Memorandum explains:

A strict liability offence has been included to ensure that this conduct is criminalised to protect consumers from vaping goods even where fault is not established. The inclusion of an offence of strict liability will also provide the option for the giving of an infringement notice as an alternative to criminal prosecution.[118]

Exceptions for medicinal cannabis

1.95For each of the offences specified in the bill, the Explanatory Memorandum highlights that it would be likely that medicinal cannabis vapes would be subject to separate regulations. Particularly, it is noted that it is anticipated that the Minister would make a determination under proposed sections 41R and 41RA that would ‘determine indications appropriate for medicinal cannabis vapes’.[119]

Evidential burden of proof

1.96For all of the civil penalty provisions specified in this chapter of the bill, it is important to note that the burden of proof to provide evidence for reliance on an exception rests with the individual to prove. As the bill states:

If, in proceedings for a pecuniary penalty order against a person for a contravention of a civil penalty provision in this Chapter, the person wishes to rely on any exception, exemption, excuse, qualification or justification that applies in relation to the civil penalty provision, then the person bears an evidential burden in relation to that matter.[120]

Detail of the specified offences and applicable exceptions

1.97Each of the offences included within the bill are specified alongside circumstances in which there could be relevant exceptions and the types of evidence that might be provided by an individual seeking an exception.

Importation offences

1.98For the importation offences, exceptions to the application of these offences and civil penalty provisions would occur if the importation would not be prohibited under the Customs Act.[121] The person would bear an evidential burden in relation to the action not being prohibited under the Customs Act. As the Explanatory Memorandum clarified, this burden on the defendant is:

… evidential only, meaning that the defendant must adduce or point to evidence that suggests a reasonable possibility that the matter exists or does not exist. If that burden is discharged, the prosecution must disprove the matters in the exception beyond reasonable doubt, or in civil penalty proceedings on the balance of probabilities.[122]

1.99The Explanatory Memorandum outlined that:

A licence and permit would likely be the evidence a person would need to produce to avail themselves of the exception. Whether a person has an import licence and permit is a matter peculiarly within their knowledge.[123]

1.100The importation of vaping goods is subject to a requirement under the CPI Regulations requiring the importer to hold a licence and permit.[124] A permit to import each specific type of vaping good is required.[125] Before an import permit can be granted under a vaping good import licence, the vaping good must be entered on the Register or a sponsor notice must be given to the Secretary which complies with applicable requirements under the Therapeutic Goods Act.[126]

1.101A sponsor notice requires specification that a vaping good complies with applicable standards and is for smoking cessation or the management of nicotine dependence.[127] If a sponsor notice cannot be given as it does not meet these criteria, the importation and supply of the goods would be unlawful.[128]

1.102A sponsor notice is not required for a vaping good to which a licence and permit under the CPI Regulations has already been granted and the TGA specified its intention to publish a list of vaping goods in relation to which sponsor notices have been given that can be made available for lawful supply.[129]

1.103Under the CPI Regulations, a traveller’s exemption also exists whereby persons entering Australia are allowed to carry no more than two vapes, 20 vape accessories and 200mL of vaping substance in liquid form.[130] Per the Explanatory Memorandum, this exemption ‘gives effect to the intention not to criminalise possession of vaping goods for personal use’.[131]

Manufacturing offences

1.104Exceptions to the application of manufacturing offences and civil penalty provisions would be provided if the vaping goods are therapeutic goods[132] and one of the following applies:

the person holds a licence authorising the manufacture of the vaping goods at the site where the manufacture takes place;[133]

the person is the holder of a conformity assessment document that applies to the vaping goods;[134]

the Secretary has given consent under subsection 41RC(1) to manufacture the vaping goods and the manufacture is undertaken in accordance with consent.[135]

1.105The evidential burden would rest with individual manufacturers to prove the eligibility of their activities in line with the above exceptions.[136] The Explanatory Memorandum outlined:

Whether a manufacturer has a relevant licence, consent, exemption or certificate, and whether the vaping good is covered by the exception, is a matter within the person’s knowledge. That evidence will be able readily accessible to persons who can avail themselves of the exception.[137]

1.106The requirement for the individual to be able to provide this evidence is further explained as necessary in this instance due to the situation where:

The investigation and enforcement of these offences and civil penalty provisions will be undertaken by a combination of Commonwealth, state and territory agencies and may involve federal and state police. For this reason, the evidence to substantiate the lawful status of the goods, or the specified activity will not rest with any one agency and is very likely to be split across many.[138]

Supply offences – unlawful vaping goods

1.107There are a range of exceptions that are specified within the bill regarding supply offences.[139] These include exceptions if the supply is part of the wholesale supply chain for prescription medicines or the retail supply chain.[140]

1.108In instances of employing these exceptions for supply, the evidential burden rests with the supplier to provide sufficient documentation and evidence to demonstrate their involvement in supply of vapes is lawful.[141]

Wholesale supply chain exceptions

1.109The exceptions related to the wholesale supply chain specify that the vaping goods being supplied must be:

therapeutic goods that are included in the Register;[142] or

exempt under the Therapeutic Goods Act,[143] the sponsor has given a notice in compliance with the exemption[144] and the vaping goods are not subject of a determination by the Secretary ceasing the supply of the goods;[145] or

covered by a determination made by the Minister under the proposed section 41R of the Therapeutic Goods Act.[146]

1.110The type of evidence that could be provided to demonstrate these exceptions include:

a current certificate of registration of the vaping goods on the Register;

a sponsor notification provided to the Secretary;

evidence from the Department’s website that the vaping good is not the subject of a determination; or

a current determination applicable to the vaping goods made by the Minister.[147]

1.111The bill specifies the potential exceptions available to people involved in the supply of vaping goods. These exceptions include a person who:

is the holder of both a licence and a permission under regulations under the Customs Act or is otherwise approved under the regulations to import vaping goods;[148] or

is the holder of a licence that authorises a step in manufacturing of vaping goods;[149] or

is the holder of a conformity assessment document applying to vaping goods;[150] or

is an authorised wholesaler and the supply occurs in accordance with their licence or authority;[151] or

has received consent from the Secretary under proposed subsection 41RC(1) to supply the vaping goods and the supply occurs in accordance with the consent;[152] or

where the goods are covered by a determination made under proposed section 41R of the Therapeutic Goods Act.[153]

1.112The potential evidence that could be utilised in support of these exceptions are specified as the relevant licence, authority, consent or determination.[154]

1.113In regards to the supply of vaping goods to a person, the bill outlines the circumstances in which an exception could be applied to recipients of vaping supply where the person:

is a holder of a licence authorising a step in the manufacture of vaping goods;[155] or

is a wholesaler, pharmacist, medical practitioner or nurse who holds a licence or is authorised to supply the substances where they practice their business;[156] or

the Secretary has given to the recipient a consent under proposed subsection 41RC(1) to supply the vaping goods;[157] or

the recipient is specified in a determination, or is included in a class of persons specified in the determination, made under proposed section 41R in relation to the goods.[158]

1.114Again, the Explanatory Memorandum specifies that the type of evidence a person is likely to produce as a defence includes the relevant licence, permission, authority, consent or determination.[159]

Retail supply chain exceptions

1.115The bill further outlines the exceptions to the offences and civil penalty provisions for supply as part of a retail supply chain.[160]

1.116These exceptions are delineated depending on the specification of the vaping goods, the registration of the person supplying and the intention of the supply.[161]

1.117An exception applies for the person supplying vaping goods if:

the vaping goods are therapeutic goods entered on the Register;[162] or

the vaping goods are exempt under the regulations, the sponsor has given the Secretary a notice in compliance with the exemption and the vaping goods are not the subject of a determination by the Secretary otherwise limiting supply;[163] or

the vaping goods are covered by a determination made by the Minister.[164]

1.118If the person is a pharmacist, or a medical practitioner or nurse practitioner who is authorised to supply a vaping substance, they could apply for the exceptions.[165]

1.119Further, an exception is dictated where supply is provided by one person to another for use for smoking cessation or management of nicotine dependence, or to another person who is the carer for a third person for the use by that person for smoking cessation or management of nicotine dependence.[166] With this exception, the vaping goods must be in final dosage form, the supply must be in accordance with the Therapeutic Goods Act and be consistent with the person’s authority to supply the goods.[167]

1.120In regards to the final dosage form, the bill provides that this is to mean the vaping substance exists in a form that can be administered to a person without any change or modification.[168]

Banning the possession of at least a commercial quantity of vaping goods

1.121The bill would establish offences for the possession of commercial quantities of a kind of vaping goods, with exceptions in some circumstances.[169]

1.122A commercial quantity of vaping goods is to be prescribed within regulations under the legislation.[170] The penalties for this offence type are specified in accordance with the amount of the commercial quantity.[171] Specifically, different penalties would apply on the basis of whether the quantity possessed is:

at least a commercial quantity but less than 100 times the commercial quantity;[172]

at least 100 times the commercial quantity but less than 1000 times the commercial quantity;[173] or

1000 times the commercial quantity or more of the kind of vaping goods.[174]

1.123Of particular note in relation to these offences, the bill proposes to apply absolute liability to each of the offences.[175] As the Explanatory Memorandum outlines:

Applying absolute liability to the element of quantity will ensure the enforceability of these offences in circumstances where it may be difficult to establish a person’s state of mind with respect to the quantity of vaping goods possessed.[176]

1.124In continuation of the approach of the rest of the bill, there is the inclusion of a potential proposed offence of strict liability for each of the offences specified in relation to possessing at least a commercial quantity of a kind of vaping goods.[177]

1.125The bill also includes a civil penalty provision for offences where the quantity of a type of vaping good is at least the commercial quantity.[178] The Explanatory Memorandum further specifies that:

A person is only liable for a civil penalty contravention of subsection (10) if they are in possession of a kind of vaping goods of at least a commercial quantity and the exceptions do not apply to them. Each contravention also takes into consideration each kind of vaping good in the possession of a person which is at least of a commercial quantity.[179]

1.126For each unit of the quantity of vaping goods in a person’s possession, there is deemed to be a separate contravention.[180] The Explanatory Memorandum explains that it is:

… intended that the per unit is to apply to each individual unit of vaping goods in the person’s possession. For example, each vaping device, accessory or substance or combination thereof, would comprise of one unit for the purposes of calculating the number of contraventions.[181]

1.127The Explanatory Memorandum also provides a relevant example of how these provisions would operate in practice:

Another example is if a person is found in possession of a large shipment of vaping goods and the shipment contains 5,000 vaping devices, 5,000 vaping substances and 5,000 vaping accessories (each of which exceed the prescribed commercial quantity), there will be 15,000 contraventions of subsection (10) in relation to the shipment; 5,000 contraventions in respect of each kind of vaping good.

This approach to the civil penalty provision is justified to achieve consistency across the other civil penalty prohibitions for import, manufacture and supply of vaping goods.[182]

1.128Of the tiered penalties for criminal offences, the Explanatory Memorandum outlines:

Tiered penalties depending on the quantity of the vaping goods involved is appropriate in circumstances where there will be a wide spectrum of conduct captured under these offences. Tiered penalty structures also appear in other legislation such as Schedule 1 to the Taxation Administration Act1953 for possession of illicit tobacco and various offences under the Criminal Code.[183]

1.129The exceptions for these possession offences are available where the vaping goods are:

therapeutic goods on the Register;[184] or

therapeutic goods that are exempt under regulations, the sponsor has provided a notice and the vaping goods are not otherwise banned through determination by the Secretary;[185] or

covered by a determination made by the Minister.[186]

1.130For individuals in possession of vaping goods, the exceptions could apply where the person:

holds a licence or is approved under regulations to import vaping goods;[187] or

holds a licence or is approved to manufacture vaping goods;[188] or

holds a conformity assessment document;[189] or

is authorised to supply the substances in accordance with Schedule 4 to the current Poisons Standard;[190] or

has been granted consent by the Secretary to possess the vaping goods;[191] or

is specified or covered by a determination made by the Minister.[192]

Offences for possession of less than a commercial quantity of vaping goods

1.131The bill also seeks to establish tiered offences and civil penalty provisions for possession of less than a commercial quantity of vaping goods.[193] However, the Explanatory Memorandum to the bill explicitly states that this provision is not designed to target individual users, rather:

Section 41QD establishes offences and civil penalties for possessing a quantity of vaping goods less than the commercial quantity of that kind of vaping goods, with exceptions in certain circumstances including when the vaping goods are for personal use. The intention of these provisions is to deter persons possessing vaping goods less than a commercial quantity other than for personal use, including retailers or vendors who may be in possession of less than a commercial quantity of vaping goods in a retail setting not for personal use.[194]

1.132For this section, the bill follows the standard protocol of offences and exceptions. Of particular note however, is the specification that provides an exception if the vaping goods are for personal use[195] or are possessed by an individual on behalf of another person for whom the vaping goods have been lawfully supplied.[196]

1.133The Explanatory Memorandum dictates that this provision is deliberately included to give effect to ‘the intention not to criminalise possession of vaping goods less than a commercial quantity for personal use’.[197] Furthermore, the Explanatory Memorandum highlights:

The context and surrounding circumstances in which the vaping goods are possessed will likely be the primary factor which will determine whether this exception is available, such as whether the possession is in a retail setting. The type of evidence that a person is likely to produce to make out this subsection includes, but is not limited to, a prescription or written authority to possess the vaping goods. However, such evidence is not necessary.[198]

1.134Moreover, the Department further clarified:

Importantly, the controls in the Bill would not prohibit possession of vapes for personal use. The Bill would not penalise personal possession. Individuals will not be penalised for vaping. The Bill only seeks to prevent possession for the purposes of commercial supply.[199]

Determinations to be made by the Minister

1.135The bill would empower the Minister to determine specified vaping goods that may be supplied or possessed in Australia and the specific circumstances in which these goods would be exempt from the ban contained within the bill.[200] Such conditions the Minister may specify could include the value or amount of vaping goods or the manner in which the specified vaping goods could be supplied.[201]

1.136As the Explanatory Memorandum outlines, this power is intended to:

… provide a mechanism by which the Minister can authorise the possession or supply of specified vaping goods by certain people in circumstances where they may not be authorised under other relevant statutory provisions. The Minister does not need to receive an application to decide whether to make a determination, however, there is nothing preventing a person from requesting that the Minister consider exercising the power in a particular circumstance.[202]

1.137Further, the bill specifies that the Minister would be empowered to further classify via legislative instrument particular reasons (other than smoking cessation or management of nicotine dependence) for which vaping goods may be used.[203]

Consent of the Secretary

1.138If passed, the bill would empower the Secretary of the Department to provide consent for manufacture, supply or possession of vaping goods where an application is made.[204] This would occur through an application via a form approved by the Secretary and the Secretary may write to the applicant to seek further information concerning the application.[205]

1.139The Secretary would be empowered to grant consent unconditionally or subject to conditions for particular vaping goods or classes of vaping goods.[206]

1.140Where the Secretary does provide consent, the bill proposes that the details of the decision are to be made available on the Department’s website.[207] Where the Secretary refuses consent, written notice must be provided to the applicant within 28 days after making the decision with reasons outlining the decision taken.[208]

1.141The bill also specifies offences and civil penalty provisions for situations where there is a breach of the conditions of consent approved by the Secretary under proposed section 41RC of the Therapeutic Goods Act.[209]The offences include ‘a fault-based offence with an aggravating element’[210] where a person:

… commits an offence if the person does an act or omits to do an act and the act or omission breaches a condition of a consent given to the person under subsection 41RC(1) and the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.[211]

1.142There is also provision for tiered offences, including a fault based offence, an offence of strict liability and civil penalty provisions for breaching the conditions of a consent provided by the Secretary.[212]

1.143The bill seeks to make a range of amendments to the Therapeutic Goods Act to provide updated references to the offences and definitions specified.[213]

1.144The bill will also provide provision for evidence to be provided by the Secretary in relation to the civil penalty provisions, enabling:

… a certificate by the Secretary to the effect that the Secretary did not consent to the manufacture, supply or possession that is the subject of the proceedings, or consented to that manufacture, supply or possession subject to conditions specified in the certificate, is prima facie evidence of the matters specified in the certificate.[214]

1.145The Explanatory Memorandum further explains the operation of this power:

Although this power, in effect, reverses the onus of proof, this reversal is considered reasonable in the circumstances. The existence of a consent is a matter of fact, that, outside of the Secretary’s belief as expressed in a certificate, is peculiarly within the knowledge of the defendant. If the Secretary is of belief that the consent did, or did not exist, it is reasonable that only the defendant would be aware of the counter position. Adducing evidence to that effect would be most easily adduced by the defendant and would likely exist in the form of documentary evidence. The defendant need only meet an evidential burden of proof to rebut the certificate issued under 56A.[215]

Part 3 - Advertising restrictions related to vaping products

1.146The bill would seek to introduce a range of limitations on advertising related to vaping goods. As the Explanatory Memorandum outlines:

Advertising of vaping goods are absolutely prohibited in view of the health risks associated with vaping and the significant increase in the uptake of vaping in the last few years, in particular, by young people.[216]

1.147While the bill intends to apply restrictions on advertising of vaping goods as far as possible, it also frames the mechanisms through which certain activities and behaviours are excluded. There is an exclusion that would be applied to advertisements that are exclusively intended for health practitioners, practice managers or people who are engaged in wholesale vaping businesses.[217] For the purposes of these exemptions the Minister may, by legislative instrument, specify the types of aforementioned individuals as exempt from the advertising limitations.[218]

1.148The bill outlines that the advertising restrictions are also not applicable to health practitioners who are providing advice or information to their patient in the course of their treatment of that patient.[219] Moreover, the bill’s provisions related to advertising are designed to apply in Australia; where advertisements are solely for vaping goods intended exclusively for export and the advertisements are not available in Australia, the provisions do not apply.[220]

1.149The Explanatory Memorandum highlights that:

… there may legitimate reasons where advertising may in limited circumstances could be justified.For example, advertising for participants in a possible clinical trial, or advertising to discourage the use of vaping goods due to particular presence of an additive.[221]

1.150As such, the Secretary of the Department is empowered through the bill to authorise advertising, or a class of advertising, of specified vaping goods.[222] The Secretary may also authorise the use of specific representations on the packaging, label or material within the packaging of the vaping goods if satisfied that the representations are necessary for the appropriate use of the goods.[223] In the event the Secretary pursues this course of action, the information must be made available on the Department’s website specifying the authorisation given.[224]

Advertising offences

1.151The bill specifies these limited exemptions to the advertising ban, but then follows with clearly outlining the offences arising from engaging in unauthorised advertisement of vaping goods. Where a person advertises vaping goods that are not subject to an authorisation of the Secretary as specified above, the potential penalties include:

imprisonment for 7 years or 5000 penalty units or both (for an offence);[225] or

200 penalty units (for an offence of strict liability).[226]

1.152Further, where a person commits the above offences, for each day that they continue to advertise, it is considered a separate offence each day.[227] The maximum penalty for each day that an offence continues is 10% of the maximum pecuniary penalty.[228]

1.153The Explanatory Memorandum justifies these powers by highlighting:

As supply and access of vaping goods are significantly influenced by advertising (including online advertising) and prohibition of advertising is an effective way of curbing and stopping supply, the high penalties are justified…[229]

1.154Furthermore:

In assessing the level of penalties to be imposed it is considered that advertisements directed to minors (under 18’s), advertisements of vaping goods close to schools and facilities, and advertisements indicating safety of vaping goods would attract the maximum penalty.[230]

1.155The bill also specifies civil penalties where advertising of vaping goods occurs without authorisation or beyond the scope of the conditions of authorisation.[231]

Secretary’s powers to seek further information

1.156The Secretary would be empowered to seek further information or documentation by written notice where a person appears responsible for advertising[232] or providing generic information related to vaping goods.[233] The Explanatory Memorandum outlines this as an information gathering power, referred to as a ‘substantiation notice’.[234]

1.157Following the provision of such a notice by the Secretary, if a person does not comply with the notice or gives false or misleading information, they may commit an offence or be liable to a civil penalty.[235]

1.158The bill specifies the tiered scales of offences related to these notices, including a fault based offence and an offence of strict liability for failure to comply.[236] Where an individual deliberately gives false or misleading information there are stronger penalties specified within the bill, in comparison to those that are a result of a failure to comply with a notice.[237] There is also a civil penalty for individuals who provide false or misleading material that is produced under the auspices of complying with a notice.[238]

1.159The bill proposes amendments to the Therapeutic Goods Act that ‘abrogates the privilege against self-incrimination in relation to the giving of information or producing a document’[239] where the Secretary requests it via notice. Specifically, a person is not excused from giving information or producing a document on the grounds that the information or document may incriminate them.[240]

1.160The Explanatory Memorandum dictates the importance of this inclusion in the bill:

Without abrogating the privilege against self-incrimination, a person would withhold pertinent information that could seriously undermine the Secretary’s power to investigate possible contraventions of the TG Act or regulations and the ability to take timely regulatory action, criminal prosecutions or civil penalty proceedings in relation to such contraventions.[241]

1.161However, there are some exceptions that apply. In the case of an individual who provides information or a document; the information or document is not admissible in evidence against the individual except in relation to the more serious offences specified in the bill.[242]

1.162When satisfied that there has been a contravention of the Therapeutic Goods Act or its regulations, the Secretary would also be empowered to direct a person responsible for advertising or generic information about vaping goods to:

cease the advertisement or information;

make a retraction;

make a correction;

recover any advertisement or information in circulation;

destroy the advertisement or information;

cease making a particular claim or representation contained in the advertisement or generic information.[243]

1.163Where the Secretary gives a direction to a person under these powers, if the person does not follow the direction, the bill outlines a series of offences and civil penalties that can be enforced as a result.[244]

Public warning notices

1.164The Secretary can issue a public warning notice where there is a reasonable suspicion of a contravention of the Act in relation to advertising or generic information about vaping goods and the Secretary is satisfied it is in the public interest to issue the notice.[245]

1.165Further, where an individual has been served with a substantiation notice by the Secretary and fails to comply, the Secretary may also issue a public warning notice about the person who has failed to comply that specifies the matter to which the original notice related.[246]

1.166The bill would also seek to make a range of amendments across the text of the Therapeutic Goods Act for the purposes of consistency, reflecting the updated definition of advertise, as well as referencing the updated offence provisions specified in this section of the bill.[247] The bill would also include consistent references to the continuing contraventions specified above.[248]

Part 4 - Enforceable directions and forfeiture

1.167The bill proposes a range of additional powers to be established under the Therapeutic Goods Act, to specify new forfeiture provisions, enforceable directions in relation to unlawful vapes and therapeutic goods and amendments extending authority for the issuing of warrants.[249]

1.168Under the provisions of the bill, the Secretary would be empowered to give enforceable directions in relation to particular goods and in the event of a failure to comply with the direction, an individual may be liable for an offence or civil penalty.[250]

1.169Where the Secretary believes, ‘on reasonable grounds’ that a person is not complying with the Act or its instruments in relation to particular goods[251] and there is a risk to the health and safety of humans,[252] the Secretary may direct the person to do any of the following, at their own cost:

relabel or label the goods in compliance with the Act;

repackage the goods in compliance with the Act;

destroy or dispose of the goods;

deliver the goods to a specified person to have them destroyed or disposed of appropriately; or

any other thing prescribed by the regulations in relation to the goods.[253]

1.170Where a person is given a notice that they do not comply with, the bill specifies the applicable offences and civil penalty provisions.[254]

1.171The Explanatory Memorandum elaborates that these powers are intended to give the Secretary ‘a broad range of compliance and enforcement tools to manage unlawful vapes and therapeutic goods generally’.[255]

1.172In relation to the expanded forfeiture powers, the bill specifies that if items have been seized and the Secretary believes on reasonable grounds that the items have been imported, manufactured, supplied or possessed in contravention of the Act or its instruments, the item is forfeited to the Commonwealth.[256] The Explanatory Memorandum specifies the purpose of these powers:

These enhanced forfeiture powers 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.[257]

1.173Moreover, the Explanatory Memorandum elaborates that these powers:

… only apply where goods have been seized pursuant to a search warrant. The intention is that the Secretary would be empowered to initiate a process for the goods to be forfeited to the Commonwealth where there is a reasonable belief the goods have been unlawfully imported, manufactured, supplied or are otherwise non-compliant with the TG Act including in relation to possession.[258]

1.174The Secretary must give a written forfeiture notice to the owner or person most recently identified in possession or control of the item immediately before seizure,[259] outlining the specifics of the seizure that has occurred.[260]

1.175Where an individual was in possession of goods subject to a forfeiture notice, they are entitled to commence proceedings seeking to suspend the forfeiture from taking place.[261] These proceedings may commence prior to a forfeiture notice being issued, but may only be commenced before the end of two months from the day the forfeiture notice is given.[262]

1.176If such proceedings are not commenced or at the conclusion of proceedings a court has not made a declaration in regards to the item in question not being forfeited, it is automatically deemed to be forfeited to the Commonwealth.[263] The Secretary can then retain the item for purposes of the proceedings or cause for it to be disposed of as directed by the Secretary.[264]

1.177The bill outlines circumstances where a thing can be declared to be not forfeited to the Commonwealth.[265] In the event a court declares that an item should not have been forfeited to the Commonwealth, an authorised person must take ‘reasonable steps’ to return the thing to the person from whom it was seized within 120 days.[266]

1.178However, there are exceptions to this return of forfeited goods. The bill specifies situations where authorised persons may retain the items in question.[267] Further, the Secretary can specify terms and conditions of a return,[268] can make an application to an authorised person to retain the items for a further period[269] and can seek to retain the things for longer for the purpose of an investigation or as evidence for both civil penalties and offences.[270]

1.179If an issuing officer is satisfied it is necessary to retain the item for the purposes of an investigation or evidence, it can be kept for a period specified (not exceeding three years).[271]

Part 5 – Entry, searches and warrants

1.180The bill seeks to further extend the power to issue warrants and extension of time to retain seized goods to issuing officers.[272] Issuing officers are defined as a magistrate or registrar or other officer of a court of a state or territory who is authorised under law to issue search warrants.[273]

1.181The Explanatory Memorandum dictates the purpose of these expanded powers, arguing:

The TGA often experiences operational [issues] 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.[274]

1.182The bill proposes to make updated references throughout the Act, changing references from a ‘magistrate’ instead to an ‘issuing officer’.[275]

1.183An issuing officer has their power conferred in a personal capacity and not as a court, member or officer of a court.[276] The issuing officer does not have to accept the power conferred.[277] However, an issuing officer exercising a power conferred by this part of the bill has the same protection and immunity as if they were exercising the power as the court or as a member or officer of the court.[278]

Part 6 – Delegation and authorised persons

1.184The bill seeks to achieve a ‘nationally consistent approach for the regulation of vaping goods by relying on the federal cooperative scheme for therapeutic goods’.[279] The Explanatory Memorandum explains that all states and territories have enacted corresponding laws to adopt the Commonwealth Therapeutic Goods Act and these laws ‘fill the gap in the Commonwealth’s constitutional power to ensure appropriate coverage for the regulation of therapeutic goods’.[280]

1.185The bill seeks to make amendments to the Act to ‘empower state and territory officials to carry out enforcement powers under the new reforms’.[281] The bill would achieve this through the proposed powers of enforcement, forfeiture and retention of forfeited goods assigned to the Secretary[282] to be able to be further delegated to an officer of a state or territory authority.[283]

1.186The bill specifies that the Secretary may delegate these powers via written instrument to an officer of:

a Department of State of a State; or

a Department or administrative unit of the Public Service of a Territory; or

an authority of a State or of a Territory.

1.187The Explanatory Memorandum specifies that this ‘Department, unit or authority must have functions relating to therapeutic goods, health or law enforcement’.[284] Further, the Explanatory Memorandum clarifies that:

In practice, the Secretary only provides authorisation and delegation of powers to officers who have the relevant skills and experience in relation to enforcement powers such as entry to premises, execution of search, monitoring and investigation warrants, testing of things and samples, and the seizing of evidential materials. Current delegates and authorised officers range from APS 5 to SES officers. Although delegation and authorisation are given to APS officers, they are generally accompanied by high level APS officers, and depending on the risks associated with the search and seizure, will be accompanied by law enforcement officers.[285]

1.188A person exercising this authority must comply with any directions of the Secretary[286] and people to whom the power is further delegated must comply with any directions of the person who delegated the power.[287]

Part 7 – Release of information

1.189The existing section 61 of the Therapeutic Goods Act ‘principally provides for powers to release certain kinds of information to specified persons or the public, in certain circumstances’.[288] These powers are an ‘important mechanism’ that assists the Department to inform the public, health departments, law enforcement bodies and others of information, including safety and regulatory information within the remit of the Act.[289]

1.190If passed, the bill would create new powers to:

… release information relating to vaping goods which mirror existing information release powers relating to therapeutic goods, and make consequential amendments to expand the application of section 61 to vaping goods.[290]

1.191The Minister will be empowered via legislative instrument to authorise the release of vaping goods information to particular authorities or bodies, different types of authorities, different kinds of vaping goods information and for different purposes.[291] The Secretary will also be empowered to release particular vaping goods information following the establishment of such legislative instruments.[292]

1.192The Minister can also specify via legislative instrument the type of information related to vaping goods that can be released to the public by the Secretary.[293]

1.193The Explanatory Memorandum elaborates that these powers are intended to ‘provide flexibility for the release of a wide range of information relating to vaping goods’.[294] The types of information could include public safety alerts about particular vaping goods, notices for law enforcement and health authorities about vaping goods suspected to be in contravention of the Act and public information about enforcement of regulations in relation to vaping goods.[295]

1.194Under the Therapeutic Goods Act, therapeutic goods information provided to the Department in a manner may be used in consideration of another matter relating to therapeutic goods or given to a committee appointed to advise the Minister or Secretary on matters relating to therapeutic goods.[296] The bill seeks to expand this power to include information related to vaping goods.[297] The intention of this approach is to:

… ensure that information held by the Department in relation to a particular vaping-related matter (for example, intelligence about the kinds of prohibited vaping goods attempted to be illegally imported into Australia), may be used in relation to other functions, such as broader public health policy.[298]

Part 8 – Laboratory testing

1.195The bill seeks to expand ‘existing regulation-making powers concerning the testing of therapeutic goods to include the testing of vaping goods (or any kind of goods, to ascertain whether the goods are vaping goods or therapeutic goods)’.[299]

1.196Regulations exist which specify the procedures to be followed by the Department in the sampling and testing of therapeutic goods. The bill seeks to expand these testing powers to include vaping goods and any kind of goods for the purposes of ascertaining whether the goods are vaping goods or therapeutic goods.[300] The Explanatory Memorandum dictates that the phrase ‘any kind of goods’ has been especially included to ‘capture a broad array of things, including physical possessions and digital possessions (like software)’.[301] Furthermore:

This amendment is intended to expressly permit the making of procedures related to obtaining and testing samples of kinds of goods where, for example, it is not apparent that the goods are therapeutic goods or vaping goods until after they have been sampled and tested, or where sampling and testing would be preferable to confirm a suspicion that the goods are therapeutic goods or vaping goods.[302]

1.197Regulations made for the purposes of paragraph 63(2)(d) that are in force immediately before commencement will continue in force for the purposes of the paragraph as in force after its commencement.[303] This will maintain the existing regulations established prior to this bill.

1.198The bill also specifies that the existing regulation making power in relation to testing of therapeutic goods, inspection of manufacturing operations or evaluation of data concerning therapeutic goods are all to be amended to also include vaping goods.[304]

Part 9 – Approvals for certain Part 3-2 exempt goods

1.199Under the current operation of the Therapeutic Goods Act, the Secretary is able to grant approval for importing into Australia or exporting from Australia of specified therapeutic goods that are not registered, listed or exempt goods.[305] This relates to goods for use for either treatment or experimental purposes in humans.[306] The Act specifies that regulations may exempt specified therapeutic goods to enable ‘the regulations to specify therapeutic goods, or classes of therapeutic goods, that may be imported into, manufactured in, and supplied in Australia, despite the goods not being included in the Register’.[307]

1.200Currently, therapeutic vaping goods are only exempt goods if they are only for smoking cessation or the management of nicotine dependence and they are to be supplied to the ultimate consumer in accordance with approval or authority under section 19 of the Act, such as through the Authorised Prescriber Scheme.[308]

1.201In order to address this potential issue, the bill seeks to amend the Therapeutic Goods Act to remove the reference to ‘exempt goods’ to ensure that ‘the lawful supply of therapeutic vapes under the relevant exemption’[309] can operate in line with the existing powers of the Secretary to determine importation or export approvals for the purposes of clinical trials or treatment.[310]

1.202As the Explanatory Memorandum explains, the operation of these provisions:

… impacts the flexibility of the exemption for therapeutic vaping goods, as it establishes a barrier to legitimate patient access to such goods for smoking cessation, and the management of nicotine dependence, under appropriate clinical supervision.[311]

Part 10 – Offences and civil penalty provisions for breach of condition of certain exemptions or approvals

1.203Where an individual is operating with an exemption under the regulations specified throughout the Act and then acts or omits to act in a manner that results in a breach of a condition of their exemption, the bill seeks to establish offence and penalty provisions as a method for enforcement.[312]

1.204The bill also seeks to make a range of amendments across the Act to reflect the updated legislative enforcement mechanisms where individuals or corporations breach a condition of an exemption.[313]

Part 11 – Other amendments

1.205Under the existing powers of the Therapeutic Goods Act, the Secretary is able to issue export certification for goods for therapeutic use in humans.[314] A state or territory must not issue similar export certifications.[315] The bill seeks to add provisions to the Act that specify that these powers be applicable to vaping goods.[316]

1.206The Explanatory Memorandum further elaborates that fees may be prescribed for an application for such a certification or the inspection of a manufacturing site if necessary for the purposes of issuing such a certification.[317]

1.207The current operation of the Therapeutic Goods Act ‘provides the Commonwealth and protected persons with immunity from civil actions or proceedings in certain circumstances’.[318] Specifically, a protected person is protected from civil action where another person suffers loss, damage or injury, if the protected person is acting in the exercise of their powers under the Act or its regulations.[319]

1.208The Act specifies such ‘protected persons’, including the Minister, the Secretary and people who have had the power of Minister or Secretary delegated under the Therapeutic Goods Act.[320] However, the Explanatory Memorandum specifies that the list of protected persons ‘does not include all persons who may perform or exercise a function, duty or power under the TG Act or its regulations’.[321]

1.209As such, the bill intends to include a reference to ‘a person of a kind prescribed by the regulations’ within the list of protected persons.[322] The justification for this inclusion is to:

… ensure that, for example, any new category of persons empowered to perform functions under the regulations may be subject to the immunity (by disallowable regulation), without the need for a commensurate amendment to the TG Act.[323]

1.210Further amendments are subsequently proposed throughout the Act to substitute ‘an APS employee in the Department’ to be replaced by ‘a protected person’.[324] The Explanatory Memorandum elaborates that these inclusions are to:

… provide flexibility to, by regulation, broaden the range of persons that are protected from criminal responsibility when carrying out certain investigatory actions under the TG Act or its regulations.[325]

1.211It is further explained that this is intended to provide protection to officials of states and territories, in order to ensure effective enforcement of vaping reforms.[326] Particularly the Explanatory Memorandum provides the following example of the operation of these powers in practice:

For example, a state or territory official may seize or purchase vaping goods within their jurisdiction, and then arrange for the same to be conveyed to the TGA for testing. As section 62 of the TG Act does not currently apply in relation to such cases, the relevant official may be prohibited from doing so (particularly if the goods contain, or are, prescription medicines).

Consequently, it is necessary to extend the protection that is provided by section 62 so that it also applies to persons other than APS employees in the Department. The amendments made by these items give effect to this measure, by providing flexibility to, by disallowable regulation, prescribe kinds of persons as protected persons.[327]

Schedule 2 – Amendment of the Customs Act

1.212Through amendments to the CPI Regulations, vaping goods have already been specified as prohibited imports for the purposes of the Customs Act since 1 January 2024.[328] Further, prohibited imports fall in the definition of ‘special forfeited goods’, meaning they can be seized with or without a warrant in certain circumstances.[329] The definition has deliberately been included in disallowable regulations to enable flexibility of definitions to adapt to the shifts in the illicit vaping goods market.[330]

1.213Currently, under the Customs Act goods that are prohibited seized imports must be stored for a minimum of 30 days before they can be disposed of.[331] Further, a seizure notice must be served on the owner or person in possession of the goods who can subsequently make a claim for return of the seized goods within 30 days, otherwise they are taken to be forfeited to the Commonwealth.[332]

1.214However, under the existing provisions of the Customs Act, certain goods may be dealt with outside of this process. Particularly, where goods are seized under the Customs Act and the Comptroller-General of Customs is satisfied they are a prohibited psychoactive substance, tobacco products or a prohibited serious drug alternative, the Comptroller-General can deal with them in an appropriate manner – including destruction.[333]

1.215The bill proposes to include vaping goods in a similar list of specified seized goods able to be dealt with differently to the standard procedures for seized goods where the Comptroller-General is satisfied the goods are prohibited imports.[334] As the Explanatory Memorandum explains:

Applying this approach to seized vaping goods will significantly enhance the ability of Australian Border Force officials to effectively deal with imported vaping goods and would significantly reduce the operational burden of implementing the vaping goods reforms.[335]

1.216The bill also specifies provisions that following the goods in question having been dealt with or destroyed, no later than seven days after the Comptroller-General must publish a notice identifying the goods, the mechanism through which they were seized and how they have been dealt with.[336]

1.217Further, the bill proposes amendments to the Customs Act to articulate the mechanisms for recourse for vaping goods owners who wish to dispute the circumstances of their destruction.[337] As dictated in the Explanatory Memorandum:

The purpose of this clause is to permit the owners of ‘vaping goods’ destroyed under subsection 206(2B) the right to recover the market value of the goods, if they can establish that the circumstances required to trigger the destruction did not exist.[338]

Schedule 3 – Amendment of other Acts

1.218The bill will also make amendments to the Industrials Chemicals Actand the Tobacco and Other Products Act.

1.219For the Industrial Chemicals Act, the phrase ‘vaping goods’ will be inserted.[339] This is to ensure that ‘vaping goods are included in the exception of chemicals that are not industrial chemicals, such as chemicals for therapeutic purposes’.[340]

1.220Further, a new paragraph is inserted to specify that the definition of industrial use for the purposes of the Industrial Chemicals Act ‘means a use other than (or in addition to) use as a vaping good (within the meaning of the TG Act) or in the preparation of such a good’.[341]

1.221For the Tobacco and Other Products Act, amendments are proposed to include reference to the proposed new Part 5-1A of the Therapeutic Goods Act, which would regulate advertising and information related to vaping goods.[342]

1.222Further, the bill seeks to amend the Tobacco and Other Products Act to specify vaping goods to be included as therapeutic goods for the purposes of that Act.[343]

Footnotes

[1]House of Representatives Votes and Proceedings, No. 113, 21 March 2024, p. 1434.

[2]Journals of the Senate, No. 108, 27 March 2024, p. 3235; Senate Standing Committee for Selection of Bills, Report No. 4 of 2024, 27 March 2024, [p. 3].

[3]The Hon Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 2.

[4]Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, Explanatory Memorandum (Explanatory Memorandum), p. 7.

[5]Explanatory Memorandum, p. 1.

[6]Explanatory Memorandum, pp. 1–2.

[7]Explanatory Memorandum, p. 10.

[8]Department of Health and Aged Care, WHO Framework Convention on Tobacco Control, 14 December 2023, WHO Framework Convention on Tobacco Control | Australian Government Department of Health and Aged Care (accessed 4 April 2024). See also: Department of Health and Aged Care, Guidance for Public Health Officials on Interacting with the Tobacco Industry, November 2019,p.7.

[9]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 2.

[10]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[11]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[12]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[13]The Department of Health and Aged Care, Submission 1, p. 6.

[14]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[15]Explanatory Memorandum, p. 8.

[16]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[17]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[18]Explanatory Memorandum, p. 4.

[19]Department of Health and Aged Care, Submission 1, p. 2. See also: Department of Health and Aged Care, National Tobacco Strategy 2023–2030, 2 May 2023, National Tobacco Strategy 2023–2030 | Australian Government Department of Health and Aged Care (accessed 28 April 2024)

[20]Department of Health and Aged Care, Submission 1, p. 2.

[21]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[22]Explanatory Memorandum, pp. 1–2. See also: Jennifer Phillips and Leah Ferris, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, Bills Digest No. 61, 2023–24, Parliamentary Library, Canberra, 2024, pp. 3–4.

[23]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[24]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 3.

[25]Explanatory Memorandum, p. 5. See also: Department of Health and Aged Care, National Tobacco Strategy, 19 December 2023, National Tobacco Strategy | Australian Government Department of Health and Aged Care (accessed 9 April 2024).

[26]Explanatory Memorandum, p. 5.

[27]Explanatory Memorandum, p. 5. See also: The Hon. Mark Butler MP, Minister for Health and Aged Care, ‘Taking action on smoking and vaping’, Media Release, 2 May 2023.

[28]Explanatory Memorandum, p. 5.

[29]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 2.

[30]The Hon. Mark Butler, Minister for Health and Aged Care and Deputy Leader of the House, House of Representatives Hansard, 21 March 2024, p. 2.

[31]Explanatory Memorandum, p. 11.

[32]Therapeutic Goods Administration, Reforms to the regulation of vapes,Reforms to the regulation of vapes | Therapeutic Goods Administration (TGA) (accessed 8 April 2024).

[33]Explanatory Memorandum, p. 6. See also: Therapeutic Goods Administration, Proposed reforms to the regulation of nicotine vaping products, 23March2023, Proposed reforms to the regulation of nicotine vaping products - Therapeutic Goods Administration - Citizen Space (tga.gov.au) (accessed 8 April 2024).

[34]Explanatory Memorandum, p. 6. See also: Department of Health and Aged Care, Health Ministers Meeting (HMM): Communique 1st September 2023, 2023, [p. 2].

[35]Explanatory Memorandum, p. 6. See also: Therapeutic Goods Administration, Proposed reforms to the regulation of vapes, 14 December 2023, Proposed reforms to the regulation of vapes - Therapeutic Goods Administration - Citizen Space (tga.gov.au) (accessed 8 April 2024).

[36]Explanatory Memorandum, p. 7.

[37]Explanatory Memorandum, p. 7.

[38]Commonwealth of Australia, Budget Measures: Budget Paper No. 2 2023–24, p. 154.

[39]Explanatory Memorandum, p. 29.

[40]Explanatory Memorandum, p. 29.

[41]Explanatory Memorandum, p. 29.

[42]Explanatory Memorandum, p. 29.

[43]Parliamentary Joint Committee on Human Rights, Report 3 of 2024, 17 April 2024, p. 5.

[44]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 12.

[45]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 12.

[46]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, pp.12–13.

[47]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 15.

[48]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 13.

[49]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 13.

[50]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, pp.13–14.

[51]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, pp.13–14.

[52]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 14.

[53]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 15.

[54]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 15. Proposed section 41RC of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[55]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 15.

[56]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 15.

[57]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 16.

[58]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 16.

[59]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 16.

[60]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 17.

[61]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 17.

[62]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 17.

[63]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 18.

[64]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 18.

[65]Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 5 of 2024, 27 March 2024, p. 18.

[66]Senate Standing Committee for the Scrutiny of Bills, Ministerial Responses, Ministerial Responses – Parliament of Australia (aph.gov.au) (accessed 30 April 2024).

[67]Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, pp. i–ii.

[68]Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, pp. i–ii.

[69]Explanatory Memorandum, p. 31.

[70]Proposed amended subsection 4(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[71]Proposed subsection 7AAA(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[72]Proposed subsection 7AAA(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[73]New paragraph 7AAA(2)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, p. 34.

[74]Explanatory Memorandum, p. 34.

[75]Explanatory Memorandum, p. 34.

[76]Subsection 8(1) of the Therapeutic Goods Act.

[77]Proposed paragraph 8(1)(ba) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, p. 34.

[78]Proposed amended subsection 3(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[79]Explanatory Memorandum, p. 35.

[80]Explanatory Memorandum, p. 35.

[81]Proposed amended subsection 3(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[82]Proposed amended subsection 3(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[83]Proposed amended subsection 3(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[84]Proposed amended subsection 3(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[85]Proposed amended subsection 3(1) and proposed new section 41P of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[86]Explanatory Memorandum, p. 36.

[87]Proposed new subsection 41P(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[88]Proposed new subparagraph 41P(2)(a)(i) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[89]Proposed new subparagraph 41P(2)(a)(ii) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[90]Proposed new subparagraph 41P(2)(a)(iii) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[91]Explanatory Memorandum, p. 39.

[92]Proposed paragraph 41P(2)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[93]Explanatory Memorandum, p. 39.

[94]Proposed subsection 41P(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[95]Explanatory Memorandum, p. 40.

[96]Explanatory Memorandum, p. 75.

[97]Explanatory Memorandum, p. 75.

[98]Explanatory Memorandum, p. 75.

[99]Proposed section 41Q of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[100]Proposed section 41QA of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[101]Proposed section 41QB of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[102]Proposed section 41QC of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[103]Proposed section 41QD of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[104]Explanatory Memorandum, p. 41.

[105]Explanatory Memorandum, p. 41.

[106]Explanatory Memorandum, p. 41.

[107]Explanatory Memorandum, p. 41.

[108]Explanatory Memorandum, p. 41.

[109]Explanatory Memorandum, p. 42.

[110]Explanatory Memorandum, p. 43.

[111]Explanatory Memorandum, p. 44.

[112]Explanatory Memorandum, p. 45.

[113]Explanatory Memorandum, p. 45.

[114]Explanatory Memorandum, p. 45.

[115]Explanatory Memorandum, p. 45.

[116]Section 54B and 54BA of the Therapeutic Goods Act. See also: See also: Proposed sections 41Q, 41QA, 41QB, 41QC and 41QD of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 and Explanatory Memorandum, p. 49, p. 51 and 53, pp. 60–61.

[117]Explanatory Memorandum, p. 49. See also: Proposed sections 41Q, 41QA, 41QB, 41QC and 41QD of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 and Explanatory Memorandum, p. 51 and 53, pp. 60–61.

[118]Explanatory Memorandum, p. 49. See also: Proposed subsections 41Q(2), 41QA(2), 41QB(2), 41QC(3), 41QC(6), 41QC(9) and 41QD(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 and Explanatory Memorandum, p. 52, 54, 62, 67 and pp. 60–61.

[119]Explanatory Memorandum, pp. 55–56. See also: Explanatory Memorandum, p. 58, p. 59, p. 67, p. 69, p. 71 and pp. 64–65.

[120]Proposed section 41QE of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[121]Proposed subsection 41Q(5) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[122]Explanatory Memorandum, p. 50.

[123]Explanatory Memorandum, p. 50.

[124]Explanatory Memorandum, p. 50.

[125]Explanatory Memorandum, p. 50.

[126]Explanatory Memorandum, p. 50.

[127]Explanatory Memorandum, p. 51.

[128]Explanatory Memorandum, p. 51.

[129]Explanatory Memorandum, p. 51.

[130]Explanatory Memorandum, p. 51.

[131]Explanatory Memorandum, p. 51.

[132]Proposed subsection 41QA(5) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[133]Proposed subparagraph 41QA(5)(b)(i) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[134]Proposed subparagraph 41QA(5)(b)(ii) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[135]Proposed subparagraph 41QA(5)(b)(iii) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[136]Proposed subsection 41QA(5) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, p. 53.

[137]Explanatory Memorandum, p. 53.

[138]Explanatory Memorandum, p. 53.

[139]Proposed subsections 41QB(6), 41QB(7), 41QB(8), 41QB(9), 41QB(10) and 41QB(11) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[140]Proposed subsections 41QB(6), 41QB(7), 41QB(8), 41QB(9), 41QB(10) and 41QB(11) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[141]Explanatory Memorandum, pp. 54–50.

[142]Proposed paragraph 41QB(6)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[143]Proposed subparagraph 41QB(6)(b)(i) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, p. 55. To be exempt under the Therapeutic Goods Act, the goods would need to be exempt in accordance with subsection 18(1) or under regulations made for the purposes of subsection 41HA(1) of the Therapeutic Goods Act.

[144]Proposed subparagraph 41QB(6)(b)(i) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[145]Proposed subparagraph 41QB(6)(b)(ii) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[146]Proposed paragraph 41QB(6)(c) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[147]Explanatory Memorandum, p. 56.

[148]Proposed paragraph 41QB(7)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[149]Proposed paragraph 41QB(7)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[150]Proposed paragraph 41QB(7)(c) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[151]Proposed paragraph 41QB(7)(d) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[152]Proposed paragraph 41QB(7)(e) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[153]Proposed paragraph 41QB(7)(f) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[154]Explanatory Memorandum, p. 56.

[155]Proposed paragraph 41QB(8)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[156]Proposed paragraph 41QB(8)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[157]Proposed paragraph 41QB(8)(c) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[158]Proposed paragraph 41QB(8)(d) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[159]Explanatory Memorandum, p. 57.

[160]Explanatory Memorandum, p. 57.

[161]Proposed subsections 41QB(9), 41QB(10) and 41QB(11) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[162]Proposed paragraph 41QB(9)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[163]Proposed paragraph 41QB(9)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[164]Proposed paragraph 41QB(9)(c) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[165]Proposed subsection 41QB(10) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[166]Proposed paragraph 41QB(11)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[167]Proposed subsection 41QB(11) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[168]Proposed subsection 41QB(12) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[169]Proposed section 41QC of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[170]Explanatory Memorandum, p. 60. See also: proposed subsection 3(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[171]Explanatory Memorandum, p. 60.

[172]Proposed subsection 41QC(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[173]Proposed subsection 41QC(4) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[174]Proposed subsection 41QC(7) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[175]Proposed subsections 41QC(2), 41QC(5) and 41QC(8) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[176]Explanatory Memorandum, p. 60.

[177]Proposed subsections 41QC(3), 41QC(6) and 41QC(9) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[178]Proposed subsection 41QC(10) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[179]Explanatory Memorandum, p. 62.

[180]Proposed subsection 41QC(11) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[181]Explanatory Memorandum, pp. 62–63.

[182]Explanatory Memorandum, p. 63.

[183]Explanatory Memorandum, p. 63.

[184]Proposed paragraph 41QC(13)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[185]Proposed paragraph 41QC(13)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[186]Proposed paragraph 41QC(13)(c) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[187]Proposed paragraph 41QC(14)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[188]Proposed paragraph 41QC(14)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[189]Proposed paragraph 41QC(14)(c) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[190]Proposed paragraph 41QC(14)(d) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[191]Proposed paragraph 41QC(14)(e) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[192]Proposed paragraph 41QC(14)(f) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[193]Proposed section 41QD of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[194]Explanatory Memorandum, p. 66.

[195]Proposed paragraph 41QD(9)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[196]Proposed paragraph 41QD(9)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[197]Explanatory Memorandum, p. 70.

[198]Explanatory Memorandum, p. 70.

[199]Department of Health and Aged Care, Submission 1, p. 8.

[200]Proposed section 41R of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[201]Proposed section 41R of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, p. 71.

[202]Explanatory Memorandum, p. 71.

[203]Proposed section 41RA of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[204]Proposed section 41RB of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[205]Proposed subsections 41RB(2) and 41RB(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[206]Proposed subsection 41RC(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[207]Proposed subsection 41RC(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[208]Proposed subsection 41RC(4) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[209]Proposed section 41RD of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[210]Explanatory Memorandum, p. 72. See also: proposed subsection 41RD(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[211]Explanatory Memorandum, p. 72.

[212]Proposed section 41RD of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[213]Explanatory Memorandum, pp. 73–74.

[214]Explanatory Memorandum, p. 74. See also: proposed subsection 56A(4B) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[215]Explanatory Memorandum, p. 74.

[216]Explanatory Memorandum, p. 77.

[217]Proposed subsection 42DZ(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[218]Proposed subsection 42DZ(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[219]Proposed subsection 42DZ(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[220]Proposed section 42DZA of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[221]Explanatory Memorandum, p. 77.

[222]Proposed subsection 42DZC(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[223]Proposed subsection 42DZC(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[224]Proposed subsection 42DZC(6) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[225]Proposed subsection 42DZD(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[226]Proposed subsection 42DZD(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[227]Proposed subsection 42DZD(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[228]Proposed subsection 42DZD(4) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[229]Explanatory Memorandum, p. 79.

[230]Explanatory Memorandum, p. 79.

[231]Proposed section 42DZE of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[232]Proposed subsection 42DZF(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[233]Proposed subsection 42DZF(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[234]Explanatory Memorandum, p. 81.

[235]Proposed subsection 42DZF(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[236]Proposed subsections 42DZG(1) and 42DZG(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[237]Proposed subsections 42DZG(3) and 42DZG(4) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[238]Proposed section 42DZH of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[239]Explanatory Memorandum, p. 82.

[240]Proposed subsection 42DZJ(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[241]Explanatory Memorandum, p. 83.

[242]Proposed subsection 42DZJ(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[243]Proposed subsections 42DZK(1) and 42DZK(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[244]Proposed sections 42DZL and 42DZM of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[245]Proposed subsection 42DZN(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[246]Proposed subsection 42DZN(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[247]Explanatory Memorandum, pp. 88–90.

[248]Proposed subsections 42DLB(10A), 42DLB(10B), 42DMA(2A) and 42DMA(2B) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[249]Explanatory Memorandum, pp. 92–93.

[250]Proposed section 42YS of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[251]Proposed paragraph 42YT(1)(a) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[252]Proposed paragraph 42YT(1)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[253]Proposed subsection 42YT(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[254]Proposed subsections 42YT(4) and 42YT(5) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[255]Explanatory Memorandum, p. 92.

[256]Proposed subsection 52AAA(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[257]Explanatory Memorandum, p. 92.

[258]Explanatory Memorandum, p. 92.

[259]Proposed subsection 52AAA(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[260]Proposed subsection 52AAA(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[261]Proposed subsection 52AAA(4) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[262]Proposed subsection 52AAA(5) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[263]Proposed subsection 52AAA(6) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[264]Proposed subsection 52AAA(6) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[265]Proposed paragraph 52AAB(1)(b) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[266]Proposed subsection 52AAB(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[267]Proposed subsection 52AAB(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[268]Proposed subsection 52AAB(4) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[269]Proposed subsection 52AAB(5) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[270]Proposed subsection 52AAB(6) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[271]Proposed subsection 52AAB(6) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[272]Proposed amended subsection 3(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[273]Proposed amended subsection 3(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, p. 98.

[274]Explanatory Memorandum, p. 93.

[275]Explanatory Memorandum, pp. 98–100.

[276]Proposed subsection 51C(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[277]Proposed subsection 51C(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[278]Proposed subsection 51C(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[279]Explanatory Memorandum, p. 102.

[280]Explanatory Memorandum, p. 102.

[281]Explanatory Memorandum, p. 102.

[282]These powers refer to those to be codified under the proposed chapter 5A and sections 52AA and 52AAB of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[283]Proposed paragraph 57(1)(1A) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[284]Explanatory Memorandum, p. 102.

[285]Explanatory Memorandum, p. 102.

[286]Proposed subsection 7A(2) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[287]Proposed subsection 57(12) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[288]Explanatory Memorandum, p. 104.

[289]Explanatory Memorandum, p. 104.

[290]Explanatory Memorandum, p. 104.

[291]Proposed subsections 61(7A) and 61(7B) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[292]Proposed subsections 61(7A) and 61(7B) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[293]Proposed subsections 61(7C) and 61(7D) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[294]Explanatory Memorandum, p. 104.

[295]Explanatory Memorandum, p. 104.

[296]Subsection 61(8) of the Therapeutic Goods Act.

[297]Proposed amended subsection 61(8) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[298]Explanatory Memorandum, p. 106.

[299]Explanatory Memorandum, p. 108.

[300]Proposed amended paragraph 63(2)(d) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[301]Explanatory Memorandum, p. 108.

[302]Explanatory Memorandum, p. 108.

[303]Explanatory Memorandum, p. 109.

[304]Proposed amended paragraph 63(2)(g) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[305]Subsection 19(1) of the Therapeutic Goods Act.

[306]Subsubsection 19(1) of the Therapeutic Goods Act.

[307]Explanatory Memorandum, p. 110. See also: subsection 18(1) of the Therapeutic Goods Act.

[308]Explanatory Memorandum, p. 110.

[309]Explanatory Memorandum, p. 110.

[310]Proposed amended subsection 19(1) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[311]Explanatory Memorandum p. 110.

[312]Proposed subsection 22(6), amended subsection 22(7AA), amended section 22AA, amended subsection 41MN(9) and proposed subsection 41MNA(2A) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, pp. 111–114.

[313]Explanatory Memorandum, pp. 111–114.

[314]Subsection 58(1) of the Therapeutic Goods Act.

[315]Explanatory Memorandum, p. 115.

[316]Proposed subsections 58(2A) and 58(2B) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[317]Explanatory Memorandum, p. 115.

[318]Explanatory Memorandum, p. 115. See also: subsection 61A(1) of the Therapeutic Goods Act.

[319]Explanatory Memorandum, p. 115.

[320]Explanatory Memorandum, p. 115. See also: subsection 61A(4) of the Therapeutic Goods Act.

[321]Explanatory Memorandum, p. 115.

[322]Proposed paragraph 61A(4)(ga) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[323]Explanatory Memorandum, p. 116.

[324]Proposed amended subsections 62(1) and 62(2), proposed new subsection 62(3) of the Therapeutic Goods Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[325]Explanatory Memorandum, p. 116.

[326]Explanatory Memorandum, pp. 116–117.

[327]Explanatory Memorandum, pp. 116–117.

[328]Explanatory Memorandum, p. 118.

[329]Explanatory Memorandum, p. 118.

[330]Explanatory Memorandum, p. 120.

[331]Explanatory Memorandum, p. 118.

[332]Explanatory Memorandum, p. 118.

[333]Explanatory Memorandum, p. 118.

[334]Proposed subsection 206(2B) of the Customs Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[335]Explanatory Memorandum, p. 118.

[336]Proposed amended subsection 206(3) and proposed amended paragraph 206(5)(c) of the Customs Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[337]Proposed amended subsections 206(6) and 206(7) of the Customs Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[338]Explanatory Memorandum, p. 122.

[339]Proposed amended section 8 of the Industrial Chemicals Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[340]Explanatory Memorandum, p. 123.

[341]Explanatory Memorandum, p. 123. See also: proposed new paragraph 9(da) of Industrial Chemicals Act, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

[342]Proposed amended section 64 of the Public Health (Tobacco and Other Products) Act 2023, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, p. 123.

[343]Proposed amended section 64 of the Public Health (Tobacco and Other Products) Act 2023, Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024. See also: Explanatory Memorandum, p. 123.