Proposed reforms to the regulation of vapes

The Therapeutic Goods Administration (TGA) conducted targeted consultation in September 2023 on proposed reforms to the regulation of vapes. Stakeholders were given the opportunity to respond to an online survey and provide written comments, as well as participate in consultation meetings and webinars. The targeted consultation supplemented an earlier public consultation that was conducted by the TGA between 30 November 2022 and 16 January 2023 on proposed reforms to the regulation of nicotine vaping products.

The targeted consultation in September 2023 informed the finalisation of the relevant impact analysis and the Government’s consideration of the appropriate policy response to the vaping problem in Australia.

The consultation paper requested feedback on four main proposals:

• Proposal 1 – restrictions on importation, manufacture and supply of all vapes
• Proposal 2 – changes to market accessibility requirements for therapeutic vapes
• Proposal 3 – heightened quality and safety standards for therapeutic vapes
• Proposal 4 – strengthened domestic compliance and enforcement mechanisms.

The TGA received 291 responses (including 6 responses after the consultation closed). Responses were received from:

• retailers and retail associations
• importers, manufacturers, pharmaceutical wholesalers and distributors
• consumers, consumer groups and school related groups
• government agencies, including state and territory health departments
• health professional peak bodies
• public health associations
• researchers and public health experts.

1. Restrictions on importation, manufacture, and supply of all vapes (irrespective of nicotine content or therapeutic claims)

• Government agencies, health professional peak bodies, public health associations, university researchers, public health experts, pharmacy groups, and therapeutic vape importers and manufacturers supplying to the pharmacy market were nearly all supportive of the proposed ban on the importation, manufacture, and supply of disposable, single use and non-therapeutic, vapes. Vape manufacturers and importers not part of the pharmacy supply chain strongly opposed the ban, arguing that it would increase the black market. Consumer groups and retail associations did not generally support the proposal.
• Government agencies, health professional peak bodies and public health associations strongly supported the cessation of the personal importation scheme for therapeutic vapes. Approximately two-thirds of academic experts and vape manufactures and importers supplying to the pharmacy market expressed support, while those not part of the pharmacy supply chain, and consumer groups, were mostly unsupportive of the proposed change.
• Government agencies, health professional peak bodies, public health associations and academic experts expressed strong support for retaining the travellers’ exemption, although concerns were raised that the proposed quantity limits were too generous. More than half of vape retailers, manufacturers, and importers were opposed to retaining the travellers’ exemption. Numerous respondents from a diverse cross-section of stakeholders expressed concerns relating to specifying the precise evidence required for the travellers’ exemption to apply, noting that no other country requires the prescribing of therapeutic vapes.
• Most respondents across all stakeholder groups supported the proposed restrictions on the advertisement of vapes.

2. Changes to market accessibility requirements for therapeutic vapes

• Nearly all government agencies, health professional peak bodies, public health associations, and academic experts supported the proposed pre-market notification process. Vape manufacturers and importers supplying to the pharmacy market generally supported the proposal, while retailers and importers not part of the pharmacy supply chain strongly opposed the proposal.
• Government agencies, public health associations, and vape manufacturers were highly supportive of instituting the SAS C pathway to facilitate access to therapeutic vapes for smoking cessation and the treatment of nicotine dependence, arguing that it would reduce the burden on prescribers. Health professional peak bodies agreed that the SAS C pathway would reduce the burden on prescribers, but only marginally supported the proposal. Only 10% of vape retailers and importers were in favour of instituting the new pathway, compared to 100% of vape manufacturers.
• University researchers were also strongly in favour of the SAS C pathway but some raised concerns about the potential for abuse and the possibility for the regulation to be undermined (for example, by dedicated telehealth businesses prescribing vapes). Some feedback included a recommendation to include nurse practitioners as prescribers to reduce the burden on medical practitioners.
• Some stakeholders observed that the SAS C pathway would not improve legitimate patient access. Some medical practitioners are reluctant to prescribe vapes because there are no TGA approved vapes and there is limited evidence regarding the efficacy of therapeutic vapes for smoking cessation or the treatment of nicotine dependence.

3. Heightened quality and safety standards for therapeutic vapes

• All therapeutic vape manufacturers expressed familiarity with international guidance and standards (FDA, MHRA and EU) for devices and all but one meet relevant international standards for quality management systems. A few manufacturers have indicated interest in including devices in the Australian Register of Therapeutic Goods, but others felt the cost of inclusion was prohibitive and the rate of technological change was so fast that the benefit of inclusion would quickly become redundant. All but 2 manufacturers are seeking to include their device components in the Australian Register of Therapeutic Goods within the next 2 years. Some manufacturers and importers noted there was little detail in the consultation paper regarding the technical requirements for device components and time would be needed to adjust manufacturing processes to meet the enhanced technical requirements once settled.
• There was mixed support across all stakeholder groups for applying device requirements under TGO 110. Concerns were raised over the complexity of devices with different settings and batteries, and the lack of information available on the safety of vaping in terms of potentially toxic compounds migrating into the liquid from the device component or the packaging.
• Government agencies, health professional peak bodies and vape manufacturers supplying to the pharmacy market were very supportive of medicine and device components being regulated together where possible. Conversely, the proposal received mixed support amongst consumer groups and associations. Vape retailers and importers not part of the pharmacy supply chain strongly opposed the proposal. Most stakeholders agreed that more than 12 months would be needed to adjust to any requirement to supply medicine and device components together.
• Government agencies, public health organisations, health professional peak bodies and school related groups strongly supported limiting flavours in which vapes may be legitimately supplied. These groups submitted that a limited number of flavours would reduce the appeal of vapes to youth. University researchers were split, with some concerned over the definition of flavours not being specific enough, and some preferring no flavours at all. Support for this measure was low amongst vape manufacturers, vape retailers and consumer groups, citing the importance of flavours for smoking cessation, the low popularity of the proposed flavours, and the need for significant re-formulation to meet the flavour requirements.
• Stakeholders had mixed views in relation to nicotine concentration limits. Some argued that higher concentrations could be appropriate, while others supported a 20mg/mL concentration limit to align with international approaches based on the best evidence for smoking cessation that is currently available.
• Government agencies, public health associations and health professional peak bodies strongly supported the proposed upper limit on menthol. Health care professionals and public health organisations highlighted that menthol, and some isomers of menthol, are known for their pharmacological action causing lung injury, with some suggesting menthol should not be allowed at all. School related groups and university researchers showed mixed support. Consumer groups, vape retailers and manufacturers were largely opposed to the proposed limit on menthol, arguing the limit was too low.
• Government agencies, university researchers, public health associations, health professional peak bodies, and school related groups supported plain packaging requirements. There was less support amongst vape manufacturers, retailers, and consumer groups. Most vape retailers and manufacturers responded that it could take from 3 to more than 12 months to comply with any plain packaging requirement.
• Apart from vape users, vape retailers, importers and manufacturers, there was support for a permitted ingredient list across all other stakeholder groups.
• Government agencies, public health associations, university researchers g, health professional peak bodies and vape manufacturers strongly supported the same regulatory controls for zero-nicotine therapeutic vapes, as for nicotine therapeutic vapes. There was limited support amongst vape retailers and importers, and consumer groups.

4. Strengthened domestic compliance and enforcement mechanisms

• Government agencies, health professional peak bodies, public health associations and university researchers were supportive of uniform application of the therapeutic goods legislation across states and territories for the regulation of vapes, and the delegation of Secretarial powers to state and territory officials to support effective enforcement. Tougher regulations with penalty measures were also supported as a deterrent. It was further suggested that targeted educational and awareness programs would be required.
• Some other stakeholders, including vaping retailers and convenience store owners, expressed concerns about the capacity for effective compliance and enforcement activities, given the scope of the vaping problem. These respondents suggested that the reforms would be counter-productive and drive consumers to the illicit market.

On 28 November 2023, the Government announced new vaping controls to prohibit the importation, manufacture, and supply of disposable single use, and non-therapeutic, vapes: Next steps on vaping reforms | Health Portfolio Ministers | Australian Government Department of Health and Aged Care. Further information is available on the TGA’s website: Reforms to the regulation of vapes | Therapeutic Goods Administration (TGA)