Proposed reforms to the regulation of nicotine vaping products

Closed 16 Jan 2023

Opened 30 Nov 2022

Feedback updated 23 Mar 2023

We asked

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’.

You said

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.

We did

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.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is seeking public comment on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia.

The potential reforms are aimed at preventing children and adolescents from accessing NVPs, while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription.

We are seeking public comment on whether you support potential reforms in 4 main areas:

  1. Changes to border controls for NVPs – to curb the unlawful supply of NVPs in Australia
  2. Pre-market TGA assessment of NVPs against a product standard – to create a regulated source of quality NVPs to encourage doctors to prescribe, pharmacies to supply and vaping consumers to purchase ‘safer’ products lawfully
  3. Strengthening the product standard regarding minimum quality and safety standards for NVPs – to make them less attractive to children and adolescents, for example by not permitting certain flavours or labelling
  4. Clarifying the status of NVPs as ‘therapeutic goods’ – to ensure that any vaping product containing nicotine is captured by the regulatory framework.

Consultation paper

Consultation paper - Proposed reforms to the regulation of nicotine vaping products.

Making a submission

To make a submission:

  1. Read the consultation paper about the proposed reforms to the regulation of NVPs in Australia (see link above).
  2. Go to the online consultation questions (see 'Give us your views' below), complete and submit your response.

This consultation will be open until COB 16 January 2023 and feedback can be provided via the 'Online Survey' link at the bottom of this page.

Note that if you make a submission, it will be published to comply with Australia’s obligations under Article 5.3 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), which requires Australia to protect its public health policies from all commercial and other vested interests of the tobacco industry. Those interests may be related to tobacco products and electronic nicotine delivery systems, including for example, NVPs. The Guidelines for implementation of Article 5.3 require that the Australian Government ensures that any interaction with the tobacco industry on matters related to tobacco control or public health is accountable and transparent. While names of individuals (including officers of an organisation or company) can be redacted by the TGA on express request, it is not possible to make "in confidence" submissions to this public consultation.

Support services

Some people may find issues relating to smoking cessation distressing. If you or someone you know needs additional support, please contact any of the below crisis support helplines:

Adult

  • Lifeline: 13 11 14
  • Suicide Call Back Service: 1300 659 467
  • Beyond Blue: 1800 512 348
  • MensLine Australia: 1300 789 978

Youth

  • Kids Helpline (5-25 years): 1800 551 800
  • Headspace: 1800 650 890
  • ReachOut

Why your views matter

Evidence is emerging that the reforms that commenced on 1 October 2021, which classified NVPs as prescription medicines under the Poisons Standard, are not adequately meeting the aim of preventing children and adolescents from accessing NVPs, while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription. Children are continuing to access NVPs in higher numbers, and many adults are accessing NVPs on the black market, rather than through lawful supply channels with a prescription from an Australian registered doctor. In addition, the lack of pre-market assessment of products against a quality and safety standard by the TGA has reduced prescriber and pharmacist confidence in these products as prescription medicines.

We are seeking your input on whether you support some or all of the proposed regulatory reforms in relation to NVPs and, whether you have additional or alternative proposals.

What happens next

This consultation has now closed. We will review all feedback received in response to this consultation.

 

Audiences

  • Aboriginal and Torres Strait Islander People
  • Seniors
  • Men
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