vaping-products

Therapeutic Vaping Products (Nicotine) – Changed Regulations in Australia

Public health concerns regarding vaping products

Every year, more than 8 million people die from smoking-related illnesses, including 1.3 million non-smokers exposed to second-hand smoke. (Source: WHO 2023.) With the evolution of vaping products, including pharmaceutical nicotine vapes, cannabis vapes, and non-therapeutic vapes, people are curious to know if nicotine addictions and smoking-related health harms and death rates will eventually diminish.

TGA view regarding vape safety: “The long-term health risks of nicotine vaping products, even those that comply with TGO 110, are still unclear and the evidence of their potential efficacy for smoking cessation is currently mixed.”

Why the need for updates to vape laws and import licencing?

The aims of regulatory reforms regarding vape devices and vape products (liquids, cartridges, etc.), including vape import licencing and distribution authorisations, include:

  • Mitigating the trend of non-medical ‘vaping’, particularly by:
  • Under 18s and other young adults
  • Former smokers unaware of the nicotine vape use addiction risks

Reduce public health risks related to

  • Poor quality/dangerous vape products (imported and sold illegally)
  • Vape liquids containing illicit and/or dangerous substances or irritants
  • Flavouring and toxic perfumes
  • Certain acetates
  • Lack of adequate product-use warnings
  • Lack of product traceability in supply chains
  • Distribution channels and product packaging designed to appeal to children & young adults while downplaying vaping health risks.

In a media statement dated 1st January 2024, The Hon Mark Butler MP, Minister for Health and Aged Care said:

These changes will protect Australians, particularly young people, from the harms of vaping and nicotine dependence, while ensuring those with a legitimate need to access therapeutic vapes can continue to do so, where clinically appropriate.

The Hon Mark Butler MP, Minister for Health and Aged Care

In January 2024, three key pieces of legislation that have significant impact to the nicotine vaping industry in Australia were commenced or amended:

Therapeutic Vaping Product Reforms – What does this mean to you?

A description of the staged approach to the implementation of these reforms is provided below.

Stage 1: Key Changes from 1 January 2024

Importation of disposable vapes (therapeutic and non-therapeutic) is banned (limited exceptions).

From the 1st of January 2024, all single-use disposable vapes (irrespective of whether they contain nicotine or not) are prohibited from being imported, supplied or manufactured in Australia, with very limited exceptions (e.g. scientific and medical research):

  • Personal importation: For example, online ordering of disposable single-use vapes to be delivered to your home is no longer legal, even with a prescription. This does not affect reusable vapes at this stage.
  • However, to facilitate legitimate patient access to therapeutic vapes the Therapeutic Goods Administration’s (TGA) Special Access Scheme C (SAS C) is available – speak to your healthcare professional for more information.

Further information for patients is also available on the TGA website: Vapes: information for patients | Therapeutic Goods Administration (TGA)

  • Importers & manufacturers:
    • Generally, disposable vapes imported prior to 1st January 2024 can continue to be sold within Australia until 1st March 2024, allowing businesses to run down existing stocks. The government has allowed this concession as they will not be providing businesses compensation for any remaining stock as part of these changes.
    • Therapeutic vape compliance with product standards: TGA must be informed (using the form in the TGA Business Portal ) about product compliance with the relevant product standards prior to importation into Australia, or release for supply of vapes manufactured domestically. Notices are required for goods imported or released for supply on or after 1 March 2024.

Stage 2 – Key Changes from 1 March 2024

Therapeutic-Vaping-Products

Importation of all vapes (disposable and reusable, therapeutic and non-therapeutic vapes) is banned*.

*Only businesses are eligible to apply for an import licence and permit under customs legislation. For traveller’s restrictions, see Vapes: information for patients | Therapeutic Goods Administration (TGA). New exemptions under the Therapeutic Goods Act 1989 will apply to unregistered vapes for smoking cessation or the management of nicotine dependence.

Supply to the ultimate customers must occur in pharmacy settings. Nicotine-containing vaping substances and accessories will still require a prescription.

Tighter restrictions for therapeutic vapes will also be implemented. Examples of these additional restrictions are provided below:

  • Ingredients: flavours will be limited to menthol, mint or tobacco only and certain ingredients will be prohibited.
  • Labelling: mandatory warning statements such as “KEEP OUT OF REACH OF CHILDREN” and the stated content of nicotine will be required on package artwork.
  • Packaging: implementation of child-resistant packaging (given under TGO 95).

Compliance requirements will be dependent on multiple factors such as:

  • what product(s) are being supplied: kit versus vaping device versus vaping substance.
  • country of import: there may be an existing regulatory approval that can be leveraged.

Demonstrating compliance can be by way of one or more of the following:

  1. Essential Principles
  2. ISO 9001 certification
  3. ISO 13485 certification
  4. Comparable regulatory approval or valid form of evidence from:
    a. the United States (US),
    b. European Union (EU) or
    c. United Kingdom (UK)

However, for these devices and their accessories, manufacturers and sponsors must provide notification to the TGA that they comply with the relevant product standards as required.

This list will be published on the TGA website from the 1st March 2024.

Future changes

TGA will be further strengthening the standards for therapeutic vapes in 2024, including the following:

  • Permissible nicotine concentration reduction
  • Plain pharmaceutical packaging
  • Enhanced regulatory requirements for vaping devices.

The TGA will seek to make further legislation changes in mid- to late-2024 which will require therapeutic vapes to be registered on the Australian Register of Therapeutic Goods (ARTG). If this occurs it is likely that these goods will be Class IIb.

How can PharmOut Help?

PharmOut can help you with Medical Device Registration with the TGA in Australia, providing regulatory compliance services for medical device product classification, preparation of technical files, and troubleshooting compliance problems.

Support services

Smoking cessation topics can be distressing to some people. If you or someone you know needs support, please contact any of the below crisis support helplines:

Adults

Youth

Terminology

There are six key terms to become familiar with which are provided in the table below. Please note that these terms and definitions exclude cannabis and their vaping devices/accessories.

TermDefinition4
Therapeutic vaping substanceMeans a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.
Therapeutic vaping substance accessoryMeans a therapeutic good that is a cartridge, capsule, pod or other vessel:
(a) that contains a therapeutic vaping substance (whether or not the vessel is designed or intended to be refilled); and
(b) that is designed or intended for use in or with a therapeutic vaping device.
Therapeutic vaping deviceMeans a therapeutic good that is a vaping device (within the meaning of the Therapeutic Goods Regulations 1990) other than:
(a) a disposable therapeutic vape (within the meaning of that instrument); or
(b) a therapeutic cannabis vaping device.
Therapeutic vaping device accessoryMeans a therapeutic good that is a cartridge, capsule, pod or other vessel:
(a) that contains a therapeutic vaping substance (whether or not the vessel is designed or intended to be refilled); and
(b) that is designed or intended for use in or with a therapeutic vaping device.
Therapeutic vaping kitMeans a kit, covered by subsection 7B(1) of the Act, that:
(a) contains one or more therapeutic vaping substances or therapeutic vaping substance accessories; and
(b) does not contain any other goods.
Therapeutic vaping packMeans a primary pack that:
(a) contains 2 or more therapeutic vaping goods, including at least one therapeutic vaping device or therapeutic vaping device accessory; and
(b) does not contain any other goods.
References

1 World Health Organization, Tobacco, 31 July 2023, https://www.who.int/news-room/fact-sheets/detail/tobacco, accessed 2nd February 2024.

2 Ministers Department of Health and Aged Care, Disposable vape imports now banned, https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/disposable-vape-imports-now-banned, Media event date: 1 January 2024; Date published: 2 January 2024; accessed 19th January 2024.

3 TGA, Guidance for Sponsor notice – Vaping goods (Notice to import or supply in Australia therapeutic vaping goods) form, Version 1.0, January 2024, https://www.tga.gov.au/resources/resource/guidance/guidance-sponsor-notice-vaping-goods-notice-import-or-supply-australia-therapeutic-vaping-goods-form, accessed 2nd February 2024.

4 Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023, Effective date 14 Dec 2023, https://www.legislation.gov.au/F2023L01667/asmade/details, accessed 2nd February 2024.