We asked for feedback on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia. Feedback was sought on:

• changes to border controls for NVPs
• pre-market TGA assessment of NVPs against minimum quality and safety standards
• minimum quality and safety standards for NVPs
• clarifying the status of NVPs as ‘therapeutic goods’.

We received almost 4,000 submissions in response to the consultation. The respondents were:

• State and Territory Health and Education Departments
• health professional bodies
• public health associations
• university researchers
• pharmaceutical industry and peak bodies
• vaping manufacturers/importers
• vaping retailers, including convenience stores and petrol stations
• pro-vaping associations
• individual healthcare professionals
• the general public, including individual vapers, smokers and ex-smokers.

A large number of the submissions from the general public appeared to be campaign responses that advocated changing the current regulatory framework in which NVPs are regulated as prescription medicines (which was outside the scope of the consultation).

Changes to border controls

• TGA’s preferred option was to strengthen border controls by requiring importers to obtain an import permit and by closing off the personal importation scheme.
• All State and Territory governments supported tightening border controls for NVPs, with most also supporting closing the personal importation scheme and requiring import permits.
• Health professional bodies, public health associations, individual health professionals, university researchers and companies marketing prescription NVPs to Australian pharmacies overwhelmingly supported tightening border controls for NVPs.
• Many (but not all) of these groups also submitted that border controls should be placed on non-nicotine vaping products (which went further than the proposed option in the consultation paper).
• Individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations did not generally support any import controls.

Pre-market TGA Assessment of NVPs against a product standard

• TGA’s preferred option was to require pre-market TGA assessment of NVPs against a product standard specifying certain quality and safety requirements.
• Companies supplying to the prescription pharmacy market supported this approach, as did about half of State and Territory governments, half of health professional bodies and nearly half of individual health professionals.
• Nearly half of public health associations and health professional bodies proposed instead that all NVPs be registered in the Australian Register of Therapeutic Goods and opposed pre-market assessment as they were concerned it could be misinterpreted as TGA approval.
• A large number of individual vapers, vaping retailers, vaping manufacturers/importers and pro-vaping associations supported at least some regulation to ensure NVP quality and safety (but with NVPs regulated as consumer goods, instead of as prescription medicines).

Strengthening quality standards for NVPs

• There was strong support for TGA’s preferred option from State and Territory governments, health professional bodies, individual health professionals, public health associations and university researchers to strengthen Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 to introduce warning statements (although this was opposed by some), require pharmaceutical-like packaging, lower the maximum allowable nicotine concentrations, prohibit/restrict flavours and certain other ingredients and limit NVP volume and overall nicotine content.
• Many of these submissions also called for the imposition of similar controls on non-nicotine vaping products (this was outside the scope of the consultation).
• Many individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations proposed abandoning the prescription model and the TGO 110 (also outside the scope of the consultation), but nonetheless many in this category supported some regulation to ensure NVP quality and safety.
• There was significant support for banning disposable NVPs from all categories of submitters (including individual vapers), but some opposed this because of concerns a ban could affect accessibility for smoking cessation and because of the risks of using some alternative products.

Clarifying the status of NVPs as ‘therapeutic goods’

There was general support for the proposal to clarify that all vaping products containing nicotine are therapeutic goods from all categories of submitters except individual vapers, vaping retailers, vaping manufacturers/importers, and pro-vaping associations.

The TGA has considered the submissions and is now providing advice to Government on possible options for reform. The Government is actively considering the TGA consultation and advice.