On November 28, 2023, following a public consultation conducted by the Therapeutic Goods Administration (TGA), the Minister for Health and Aged Care, Mark Butler MP, announced a series of reforms to the regulation of vaping products, with the goal of reducing the harm of nicotine vaping products, particularly nicotine dependence in young Australians.

Legislation to implement Stage 1 of the reforms was passed in late 2023 and took effect in two steps. Unless amended, it will have the unintended effect of leaving medicinal cannabis users in the invidious position of being able to access the medicines they need for their treatment, but with severely impeded access to the devices and accessories that are essential to administer those medicines.

On 21 March 2024, the Albanese government announced Stage 2 of the reforms, introducing the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 to further strengthen the regulatory regime.

Stage 1a of the reforms: ban on single-use vapes, and access only on prescription

The first step in stage 1 of the reforms began on 1 January 2024, with a prohibition on the importation to Australia of all disposable single-use therapeutic vapes (with very limited exceptions) and the introduction of a pathway for individuals to access reusable nicotine vaping products on prescription when used for the therapeutic purposes of smoking cessation or treatment of nicotine dependence, through the TGA’s Special Access Scheme (SAS) or Authorised Prescriber Scheme (APS).  A new, more streamlined prescription pathway was made available under the “SAS C” regime.

There is a transitional period allowing disposable vapes imported before 1 January 2024 to still be supplied in Australia if:

• they do not contain nicotine and are not advertised for a therapeutic use (such as smoking cessation), subject to any separate restriction imposed at the state or territory level; or
• they contain nicotine and meet the TGA’s quality standards and are dispensed by a pharmacist on prescription.

Stage 1b of the reforms: customs ban on non-therapeutic vapes

The second step of the initial reforms, commencing on 1 March 2024, further restricts the importation, manufacture and supply of vapes (which includes components of vapes such as “batteries”), vaping substances (e.g. “e-liquid”) and accessories used in connection with vapes (such as pods/cartridges and mouthpieces). The intended means to achieve this is a requirement on importers of all vapes, vaping substances or vaping accessories (or any materials or items intended to be used to manufacture such vaping goods in Australia) to hold an import licence and permit from the Office of Drug Control (ODC).

Importers seeking ODC licences and permits will generally only be eligible if:

• their devices or substances have been evaluated by the TGA and included or registered in the Australian Register of Therapeutic Goods (ARTG); or
• they meet certain new notification requirements under the Therapeutic Goods Regulations 1990 (Cth) or the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth).

There are currently no vaping devices included in the ARTG for smoking cessation or nicotine dependence (there are a small number included exclusively for use with medicinal cannabis).  Any importer wishing to import any kind of finished vaping product that is not registered or included in the ARTG (i.e. is an “unapproved” product) must submit a notification declaring (among other things) compliance with:

• in the case of vaping substances and filled pods/cartridges, and vaping devices and accessories which contain or are combined with vaping substances and/or other vaping devices/accessories – Therapeutic Goods Order 110 (TGO 110); and
• in the case of vaping devices/accessories on their own – the 14 “essential principles” (EPs) applying to medical devices.

TGO 110 establishes minimum safety and quality requirements for nicotine vaping substances including limits on nicotine concentration, product labelling and restricting flavours to mint, menthol, and tobacco.  For the device elements of vaping products to which TGO 110 applies, it requires compliance of those elements with the essential principles.

For certain vaping devices for smoking cessation or nicotine dependence indications, there is a new standard (Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023(MDSO)) which provides an alternative and less stringent way for suppliers to establish compliance with the essential principles, for example by having certain forms of ISO certification.

Transition period

There is a transitional period for reusable vapes imported before 1 March 2024, which can still be supplied in Australia on almost the same conditions as those applying to previously-imported disposable vapes, namely that:

• they do not contain nicotine and are not advertised for a therapeutic use (such as smoking cessation), subject to any separate restriction imposed at the state or territory level; or
• if they contain nicotine, they meet the TGA’s quality standards and are dispensed by a pharmacist on prescription.

Unintended consequence: severe restriction on access to medicinal cannabis vaping devices, which jeopardises access to medicinal cannabis

The drafting of the stage 1b reforms has given rise to an unfortunate, and clearly unintended, consequence severely restricting access to  medicinal cannabis vaping devices and, therefore, medicinal cannabis itself. The stage 1b reforms attempt to differentiate vaping devices used for nicotine and medicinal cannabis, so as not to disrupt the medicinal cannabis regulatory regime. The MDSO permits supply of nicotine vaping devices which comply with significantly less stringent standards than those required by the 14 EPs in Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002.

By contrast, the MDSO does not permit supply of medicinal cannabis vaping devices complying with those less stringent standards. Because it is commercially unfeasible to supply medicinal cannabis vaping devices that comply with the EPs, access to medicinal cannabis vaping devices has been severely restricted. This is especially unfortunate as vaping is one of the most common and effective means of administering medicinal cannabis. The nearest alternative, smoking, is not a viable therapeutic option due to the lack of dosing specificity (compared to vaping), loss of terpene efficacy, and, most importantly, the risks to patients, including with respect to carcinogenic potential.

This has left medicinal cannabis users in the invidious position of being able to access the medicines they need for their treatment, but with severely impeded access to the devices and accessories that are essential to administer those medicines.

Stage 2 of the reforms: control of all vaping goods

On 21 March 2024, the Albanese government announced Stage 2 of the reforms, introducing the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 to further strengthen the regulatory regime, with the aim of eliminating altogether the importation, manufacture, supply, and commercial possession of all disposable single use vapes (with the exception of those containing medicinal cannabis) and all non-therapeutic / recreational vapes in Australia, including by creating specific offences for breaching the new restrictions.

The bill proposes to do this by introducing a new, broad category of “vaping goods” into the Therapeutic Goods Act 1989 (Cth), and regulating all such goods as though they were therapeutic goods (even those for non-therapeutic uses).  The bill, if implemented in its present form, will prohibit all dealings in all kinds of vaping goods except where they are supplied through the legitimate therapeutic pathways established in Stage 1 of the reforms, with the effect that, once implemented, the only vaping substances and vaping devices that will be lawful in Australia will be those that:

• are used exclusively for smoking cessation or the treatment of nicotine addiction; or
• comprise, contain or are used exclusively with medicinal cannabis.

The bill has been referred to the Senate Community Affairs Legislation Committee, which is due to issue its report on 8 May 2024.

Current status

Patients wishing to gain access to unapproved nicotine vapes for smoking cessation or nicotine dependence can seek to do so under the SAS, which permits certain health practitioners to seek approval from the TGA to prescribe unapproved vapes for therapeutic purposes, or from a TGA-approved Authorised Prescriber under the APS.   Such products can only be obtained from a pharmacist.

For suppliers, provided they hold an ODC licence and permit, and meet TGA notification and compliance requirements, they may import or manufacture unapproved vapes into Australia to meet anticipated patient demand under the SAS and APS pathways.

Ineffective 2021 reforms: vapes as therapeutic goods, and supply of vapes by pharmacies on prescription

These latest reforms build on regulatory changes introduced in October 2021 which brought nicotine vapes clearly within the therapeutic goods framework, and made it unlawful to supply or sell nicotine vapes outside of a pharmacy setting or to an individual without a prescription, although those changes still permitted patients to order vaping goods from overseas (but not Australian) online retailers and have them delivered in Australia under the personal importation scheme (provided the patient had a prescription).  These reforms applied to all purchases of nicotine vapes, including nicotine e-cigarettes, nicotine pods and liquid nicotine, with the effect of making it illegal for other Australian retailers, such as tobacconists, ‘vape’ shops, and convenience stores, to sell vapes containing nicotine to individuals, even if the individual held a prescription.

There has been widespread non-compliance with these earlier changes – it became apparent that vapes containing nicotine were readily available for purchase at many tobacconists and ‘vape’ shops, without the need for a prescription, including by children.  Overseas online retailers were also readily supplying Australian customers without requiring proof of a prescription.  Those earlier changes also did not restrict the supply of vapes and e-liquids that did not contain nicotine and were advertised for purely recreational use, which Health Minister Mark Butler highlighted in November 2023 was being exploited as a “loophole” by some in the vape industry, noting that: “Currently … it is legal to sell non-nicotine vapes. As we do the raids at the border … what we are finding [is] that all of those vapes that are labelled ‘no-nicotine’ or don’t contain a label at all, overwhelmingly … are found to contain nicotine.”

The Government has opted to ban, not regulate, supply for non-therapeutic / recreational use

The widespread flouting of previous restrictions highlights the most common concern raised in the TGA consultation on the proposed reforms – that a ban would only lead to the expansion of the ‘black market’ in vapes.  In particular, stakeholders expressed concern that unregulated black-market items are more dangerous than the items which are sold on a legitimate market and subject to a number of quality controls and safety standards; and that the black market will reach its target audiences regardless of the reforms.

Critics of banning access to vapes argue that the New Zealand model may be more suitable, where vape retailers must be licensed and can only supply particular vapes which satisfy certain quality and safety standards.

However, the legislative reforms make plain that the government has chosen to shut down access to all vapes with the exception of those for narrow therapeutic uses, based on its concerns about the prevalence of vaping amongst children and young adults when smoking rates in this age group had declined significantly over the past few decades.   It remains to be seen whether Stage 2 of the legislative reforms will pass in their present form and whether, combined with the Stage 1 reforms, they will have the desired effect.