New regulation of vapes starting January 2024

REVIEWS

The first stage of Australia’s vaping reforms was made by the Governor-General in Federal Executive Council this week, through amendments to therapeutic goods and customs regulations. These amendments will help to address the increasing health risks posed by vaping, while preserving legitimate patient access to therapeutic vapes for smoking cessation and the management of nicotine dependence, under health practitioner supervision.

From 1 January 2024, the importation of disposable vapes will be prohibited, subject to very limited exceptions. The ban will apply to disposable vapes irrespective of nicotine content or therapeutic claims. It means that it will be unlawful to import disposable vapes on or after 1 January 2024, even if those vapes were ordered before 1 January 2024 and have not yet arrived in Australia.

The ban also applies to individuals who have ordered disposable vapes from overseas for therapeutic use under the personal importation scheme. A limited exception will apply to international travellers arriving in Australia to carry a small quantity of vapes for their treatment or the treatment of someone travelling with them under their care.

Disposable vapes that have been imported into Australia before 1 January 2024 may continue to be lawfully supplied in Australia subject to the following requirements:

  • disposable vapes containing nicotine that meet TGA requirements may continue to be lawfully supplied in Australia in pharmacy settings to a patient with a prescription in accordance with state and territory laws for prescription medicines,
  • disposable vapes that do not contain nicotine, or any other medicine, and do not make therapeutic claims, may be supplied by retailers generally, including vape stores, subject to state or territory law.

This will allow legitimate retailers of disposable vapes to run down their stocks prior to the Government introducing legislation in early 2024 to prevent the domestic manufacture, advertisement, supply and commercial possession of disposable vapes, to ensure comprehensive controls across all levels of the supply chain.

Also, from 1 January 2024, doctors and nurse practitioners will be able to prescribe therapeutic vapes for smoking cessation or the management of nicotine dependence without applying to the TGA for pre-authority or approval through a new Special Access Scheme C pathway. This will reduce the administrative burden on prescribers while facilitating legitimate access to therapeutic vapes as part of a medically supervised smoking cessation strategy.

Existing Authorised Prescriber and Special Access Scheme B pathways may continue to be used by practitioners in addition to this new pathway.

From 1 March 2024, the importation of all non-therapeutic vapes will be prohibited. This means that it will be unlawful to import non-therapeutic vapes on or after 1 March 2024 even if those vapes were ordered before 1 March 2024 and have not yet arrived in Australia.

In addition, the importation of all vapes under the personal importation scheme will end on 1 March 2024. From this date, patients will no longer be able to order vapes directly from overseas, even if they have a prescription.

A limited exception will allow international travellers arriving in Australia to carry a small quantity of vapes for their treatment or the treatment of someone travelling with them under their care.

Subject to state or territory law, non-therapeutic vapes imported before 1 March 2024 may still be lawfully sold by retailers generally, including vape stores, provided the vape does not contain nicotine or any other medicine, and does not make therapeutic claims.

This will allow legitimate retailers of non-therapeutic vapes not containing nicotine to run down their stocks prior to the Government introducing legislation later in 2024 to prevent the domestic manufacture, advertisement, supply and commercial possession of non-therapeutic vapes to ensure comprehensive controls on vapes across all levels of the supply chain.

Also, from 1 March 2024, new pre-market requirements will apply to the importation and manufacture of all therapeutic vapes. Notification, licence and permit forms and instructions will be available prior to 1 March 2024, in order to give importers and manufacturers the opportunity to comply prior to the new requirements coming into effect.

Importers must obtain a customs licence and permit to import therapeutic vapes, and must notify the TGA that their products comply with new product standards.

These new standards:

  • apply to therapeutic vapes irrespective of nicotine content,
  • limit flavours to only mint, menthol or tobacco flavours, and
  • specify certain requirements for vaping devices that were previously excluded from the therapeutic goods framework.

The TGA will publish a list of therapeutic vapes that have been notified by importers or manufacturers to be indicated for the purposes of smoking cessation or the management of nicotine dependence, and compliant with the relevant product standards.

Therapeutic vapes imported or manufactured before 1 March 2024 may still be lawfully supplied by pharmacists, provided those vapes meet the relevant product standards that applied at the time of the importation or manufacture. This will allow the supply of therapeutic vapes by pharmacies to continue without any interruption. During 2024, product standards for therapeutic vapes will be further strengthened, including to reduce permissible nicotine concentrations and require pharmaceutical packaging.

Therapeutic vapes containing medicinal cannabis will continue to be regulated separately, and will not be covered by the enhanced quality requirements mentioned above. However, new notification requirements will be required under the customs legislation for unfilled therapeutic cannabis vaping devices. These devices must comply with the Essential Principles as is presently the case.

Background
The proposed reforms will not criminalise vapers in any way. Personal possession and use of vapes is not, and will not be, criminalised by the Australian Government.

The degree and scope of the reforms was determined through a process of evidence-based analysis and consultation with stakeholders as described in the Proposed reforms to the regulation of vapes: Impact analysis (OBPR23-03933, 2023).

Amendments to the Therapeutic Goods Regulations 1989, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Customs (Prohibited Imports) Regulations 1956 were published on the Federal Register of Legislation yesterday:
Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023.
Customs Legislation Amendment (Vaping Goods) Regulations 2023.

The reforms complement a wider set of actions being taken by the Government in line with the National Tobacco Strategy 2023-2030 to reduce rates of tobacco and vape use (see Taking action on smoking and vaping).

Further information is available on our Reforms to the regulation of vapes page.


https://www.canva.com/p/gettyimages/

- Advertisement -

More articles

- Advertisement -
3

BLOG