Guidance on the quality and labelling requirements of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024.
The purpose of this guidance is to assist sponsors, manufacturers, patients and health care providers to understand the minimum safety and quality requirements for unapproved therapeutic vapes.
This information is provided for guidance only.
It should not be relied on to address every aspect of the relevant legislation (state, territory and federal). You should seek independent legal advice to ensure that all legal requirements are met.
This guidance does not include information on how to comply with Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110 (2021)), which can be found on our website.
In addition, this guidance does not contain clinical or dispensing guidelines for health care providers or make recommendations about prescribing of therapeutic vapes (for example, dosage regimes).
Doctors, pharmacists or nurse practitioners considering prescribing or dispensing therapeutic vapes should have regard to clinical guidelines relevant to their practice, such as the Royal Australian College of General Practitioner’s guide for health professionals on supporting smoking cessation and any relevant guidelines published by the Pharmaceutical Society of Australia and the Royal Australian and New Zealand College of Psychiatrists.
Practical guidance materials for health care providers is also available on the Vaping hub page of our website.
This guidance does not include information on the requirements that apply to unapproved therapeutic vaping devices and therapeutic vaping device accessories.
TGO 110 (2024) is a product standard made under section 10 of the Therapeutic Goods Act 1989 (Act). It sets out minimum safety and quality requirements for unapproved therapeutic vapes that are imported into, supplied in, or exported from Australia. TGO 110 (2024) applies to:
that are finished products and the only indications for the goods are use for smoking cessation or the management of nicotine dependence.
Unless otherwise specified, the vaping goods mentioned above are referred to as 'relevant goods' for the purpose of this guidance.
TGO 110 (2024) does not apply to:
The TGO 110 (2024) commenced on 1 October 2024.
However, implementation is subject to the following transitional provisions:
From 1 October 2024, TGO 110 (2024) includes new and enhanced requirements for appearance, ingredients, containers, labelling and packaging of relevant goods, such as:
Generally, all unapproved relevant goods imported, manufactured, or supplied in Australia must meet the relevant requirements of TGO 110 (2024).
However, Australian sponsors may lawfully import goods for supply in Australia with non-compliant packaging and labelling provided the product is repackaged and/or re-labelled to meet the TGO 110 (2024) requirements before the vape is supplied to the market, or if another exemption applies.
Note
An unapproved therapeutic vape that is subject to, and in compliance with, a Premarket Tobacco Product (PMTA) marketing order issued by the United States (US) Food and Drug Administration (FDA) is no longer taken to automatically comply with the TGO 110 (2024) requirements.
TGO 110 (2024) specifies requirements for unapproved therapeutic vapes (or ‘vapes’ for the purpose of this guidance) under 4 broad groups:
All relevant goods are finished product and are subjected to the requirements of TGO 110 (2024).
They must only be used for a therapeutic purpose that is, smoking cessation or management of nicotine dependence.
There is no other therapeutic indication allowed for vapes in Australia.
Finished products and final dosage form vapes.
TGA defines finished product as a therapeutic good that has completed all stages of production, including packaging in its final container and labelling. This is the product that is ready for supply to the consumers.
For vapes, a finished product may not be the final dosage form as some vape liquid may need extemporaneous compounding before supply to the patients and the compounded form then becomes the finished product and requires complying with provisions of TGO 110 (2024).
Therapeutic vaping packs are subjected to the provisions of TGO 110 (2024).
However, vaping devices and vaping device accessories that are included in the vaping packs are subjected to the provisions of the MDSO or Essential Principles.
The name of the relevant good is the name assigned to the relevant good by the sponsor and is the name with which that good is identified.
This name is mentioned on the label or pack of the product, and it can be:
To reduce the appeal of vapes for youth and recreational users, the TGO 110 (2024) includes restrictions to ensure appropriate naming of the relevant goods.
Section 7 of the TGO 110 (2024) describes the requirements for appropriate naming of the relevant goods. The following restrictions are applicable to all relevant goods, including names of vaping packs and vaping kits.
The name must not:
Part 3 of the TGO 110 (2024) sets out requirements for the ingredients in therapeutic vaping substances. These requirements are relevant for vaping substances supplied in a container or a pod/cartridge (therapeutic vaping substance accessories).
All ingredients used in the formulation, except for flavours that are not menthol, must meet the quality standards outlined in at least one of the following:
This ensures that the ingredients meet a recognised quality standard suitable for therapeutic use in humans.
Evidence of ingredient quality standard must be held by the sponsor and must be produced on request.
In a therapeutic good, the active ingredients are the therapeutically active components, that are responsible for its physiological or pharmacological action.
Nicotine (whether in base or salt form(s)) is the only active ingredient allowed in unapproved therapeutic vaping substances. It is not appropriate to add any other active ingredients to unapproved therapeutic vaping substances.
Therapeutic vaping substances, including substance in a therapeutic vaping substance accessory, must have no more than 50 mg/mL of nicotine or equivalent base form (see subsection 10(2)). You cannot import, manufacture or supply a therapeutic vaping substance that exceed this concentration.
Health practitioners need to consider whether the nicotine concentration and type of product is appropriate for a particular person’s smoking cessation needs.
This limit does not imply that 50 mg/mL products are safe or necessarily appropriate for use.
Ingestion of, or exposure to, vaping substance containing nicotine (including through the skin or eyes) can have toxic, and sometimes severe, effects. Child fatalities, including at least one in Australia, have occurred following ingestion of vaping substance containing nicotine. Vaping substances containing higher concentration of nicotine carry greater risks of poisoning having severe effects.
The actual nicotine base form, nicotine salt and/or equivalent base form concentration or content in a therapeutic vaping substance must be within 90-110% of the stated content. These limits are consistent with standard pharmaceutical quality practices for nicotine products.
The concentration or content of the actual nicotine base form, nicotine salt and/or equivalent base form (depending on what is stated) should be tested using appropriately validated test methods. Due to the wide variety of products available, guidance is not provided on the specific test methods that should be used for a particular product. The laboratory conducting the testing would be expected to research or develop an appropriate method for the product(s) and ensure that method had been validated for its intended purpose.
The TGO 110 (2024) amendment restricts the formulation of vaping substance to a specified list of ingredients. These ingredients are defined as ‘Permitted Ingredients’ in the TGO 110 (2024) and are included in Schedule 1 as:
No other ingredient must be added to the formulation.
Since 1 March 2024, unapproved therapeutic vaping substances and vaping substance accessories were only allowed to have menthol, mint, tobacco flavours. The TGO 110 (2024) includes further restrictions on flavouring agents as follows:
The sponsor must hold evidence to justify the role of individual flavouring agents.
How are flavours and flavouring agents defined:
For the purpose of vaping goods, a flavouring agent can be defined as an ingredient or component, or mixture of ingredients or components, added to a therapeutic vaping substance to provide flavour to the vaping good or stability to the flavour.
Only 3 flavours are permitted in unauthorised vaping substance, these are mint, tobacco and menthol, and must meet the following definitions:
Products must not have flavours that are a mix of different tastes. For example, flavour combinations such as cherry mint, chocolate mint or tobacco mint are not permitted.
Any therapeutic vaping substance or vaping substance accessory containing flavour other than the abovementioned flavours cannot be imported, manufactured or supplied in Australia.
The vaping substance formulation is limited to permitted ingredients. However, it is acknowledged that some chemical entities might still be present unintentionally. These entities may be contaminants, degradation products, residual solvents, or reaction products etc. TGO 110 (2024) provides a list of such ingredients under the title of ‘Restricted Substances’ in Schedule 2.
This list includes chemical compounds with known health risks when inhaled, heavy metals and tobacco-specific nitrosamines, and states the maximum permitted limit for each compound.
Sponsors must hold the evidence to prove that none of these restricted substances exceed the maximum permitted limit and must provide the evidence to TGA, if requested.
Containers for the purpose of relevant goods is the vessel or article that directly contains the vaping substance.
The containers can be bottles, vials, pods or cartridges.
Vaping substance container:
Generally, these are bottles or vessels that contain the vaping substance and used for refilling open system vapes.
An individual vaping substance container must not contain more than 60 mL of vaping substance, but multiple containers may be supplied as part of a kit or a pack.
The container and the closure system can only be a combination of black, white, grey or clear and feature not more than 4 other colours or shades, including the colour or shade of any text.
Vaping substance accessory:
A vaping substance accessory is an enclosed container for a closed system vapes, usually in the form of pods or cartridges.
The liquid inside the container is not accessible to the consumer.
An individual vaping substance accessory must not have more than 5 mL of vaping substance but multiple vaping substance accessories can be sold as part of a kit or a pack.
The following requirements apply to the container of a therapeutic vaping substance accessory:
Note
If a pod or cartridge is sold without the vaping substance, then it is not considered a vaping substance accessory and the requirements of the TGO 110 (2024) are not applicable to it.
However, it is considered a vaping device accessory and should comply with the requirements included in the MDSO or Essential Principles.
All labelling and packaging of unapproved therapeutic vapes must meet the specific requirements set out in Part 5 of TGO 110 (2024).
A label for unapproved therapeutic vape is any written, printed or graphic information that is printed on, attached to or supplied with (e.g., information sheet) the container or primary pack of the vape.
Clear and accurate product labels and information sheets are essential to conveying information about a product’s quality and safety, allowing health practitioners and individuals to make informed choices about treatment and use.
All containers, primary packs (including vaping kits and packs) and intermediate packaging must contain a label.
Note
Sample labels included in the appendices are intended for illustrative purposes only and may not meet all the requirements specified by the TGO 110 (2024).
For a comprehensive list of relevant requirements for your product, refer to the appropriate sections in the TGO.
Many containers, primary packs and intermediate packaging have more than one label or different panels on one container. To reduce unnecessary replication of information in these instances, TGO 110 (2024):
The ‘main label’ is the portion of the label where the name of the relevant good is more or most conspicuously shown. A relevant good can have more than one main label if there are two or more portions of the label where the product name is presented in equal size or prominence. In general, each layer of packaging also has a main label. Some specific container types do not require all main label information and formatting e.g., very small container. The mandatory main label information must all be oriented in the same direction.
The information on the labels must have following characteristics:
You must use a text size of not less than 1.5 millimetres for information that is required to be on labels of therapeutic vaping substances or therapeutic vaping substance accessories under the provisions of TGO 110 (2024), except for very small containers.
The following table provides text size requirements for different types of labels.
Table 1. Text size requirement for different label types
| Label type | Minimum text size |
|---|---|
| Primary pack | 3.0 millimetres for name and nicotine content 1.5 millimetres for other information |
| Intermediate packaging | 1.5 millimetres for all information |
| Container | 3.0 millimetres for name and nicotine content 1.5 millimetres for other information |
| Small container (<25 mL) | 2.0 millimetres for name and nicotine content 1.5 millimetres for other information |
| Very small container (<5 mL) | 1.0 millimetres for all information |
| Therapeutic vaping kit | 3.0 millimetres for name and nicotine content 1.5 millimetres for other information |
| Therapeutic vaping pack | 3.0 millimetres for name and nicotine content 1.5 millimetres for other information |
Part 5 of the TGO describes requirements for the appearance of labelling and packaging of unapproved therapeutic vapes.
The vapes must be packaged and labelled in a way that they are not appealing to youth or recreational users, while providing all necessary information required by TGO 110 (2024) for its safe and effective use.
All labels on vapes must be predominantly white and printed material on the label must not feature more than 4 colours or shades. This includes any printed text, logo, pictorial or graphic.
The primary pack, if not the container, must be predominantly white and all printed material on the primary pack must not feature more than 4 colours or shades.
Note that colour in printed material should only be used for identification of the product and differentiating flavour and strength in a product range. Colour of printed material must not increase attractiveness or appeal of the product.
Black colour used for warning text on the warning panel constitutes one of the 4 permitted colours for printed material.
Certain features are prohibited from use on any packaging of your product, and include:
The primary pack of your product must include a minimum space of 70 x 30 millimetres for the dispensing label, unless the size of the pack is too small to allow this.
The size exemption does not apply if:
If the full dispensing label space cannot fit on the label, it is expected that a smaller space will be included where possible.
All containers, and primary packs (including vaping kits and packs) unless restricted by size, must be labelled with a warning statement panel that is at least 30% of the total main label size. The warning should state:
“THIS PRODUCT CONTAINS NICOTINE, WHICH IS A HIGHLY ADDICTIVE SUBSTANCE.”.
The warning statement text must be:
The warning statement panel is not required for products that do not contain nicotine. However, you should check relevant sections in Part 5 to ensure labels for your products contain other required warning statements.
Accidental ingestion of, or exposure to, vaping substances (including through the skin or eyes) can have toxic, and sometimes severe, effects (SCHEER 2021). Child fatalities, including at least one in Australia, have occurred following ingestion of vaping substances (SCHEER 2021). CRP is important to minimise the risk of accidental exposure to and/or ingestion of vaping substances, particularly by children.
Patients should also be advised to seek urgent medical attention if they believe that they have, or anyone else has, been exposed to and/or ingested a vaping substance.
Section 21 of TGO 110 relevantly provides that therapeutic vaping substances and therapeutic vaping substances must meet CRP requirements set out in sections 8, 9 and 10 of Therapeutic Goods Order No. 95 – Child-resistant packaging requirements for medicines (TGO 95), unless the product has been packaged for supply in Canada, the EU, NZ, the UK and the US and meets all CRP requirements imposed in that country.
For further information on the requirements in TGO 95, refer to Guidance on TGO 95.
Certain information must be included on labels of unapproved therapeutic vapes. These are clearly outlined in Tables in sections 22 to 36 of TGO 110 (2024) so will not be replicated in this guidance, instead focusing on specific aspects.
Where applicable, the relevant goods must be labelled with an ingredient list setting out:
The use of an Australian Approved Names for ingredient names is encouraged. The Australian Approved Names List can be searched on the TGA Business Services website under the ‘Ingredients’ tab.
Where applicable, the relevant goods must be labelled with below warning statements regardless of their nicotine content:
These statements must be on or attached to the container, intermediate packaging (if any) and primary pack of the product.
Vapes are ordinarily to be sold as Schedule 4 medicine and be subjected to signal heading as per ‘The Poison Standard (the SUSMP)’ .
If the size of the container precludes adding a signal heading, then an additional warning ‘Keep out of reach of children’ must be added to the main label of the container except for a ‘very small container’.
State and territory poisons legislation ordinarily require unapproved products containing nicotine supplied in Australia to include warning statements on the primary pack and immediate container of the product, unless an exemption applies. Products supplied in Australia are required to meet the requirements of both TGO 110 (2024) and state and territory poison legislation. A product will ordinarily comply with the warning statement requirements in both TGO 110 (2024) and state and territory poisons legislation by including the statements outlined above on the container, intermediate packaging (if any) and primary pack of the product.
Clear unambiguous identification of unapproved therapeutic vapes is critical in assisting with their safe use. The nicotine content and the name of the product must be easily identifiable and legible on the labels.
To achieve this:
You must include nicotine content on the main labels of unapproved therapeutic vape.
Example
For product containing 15 mg/mL of nicotine lactate, equivalent to 10 mg/mL nicotine free base:
Nicotine (as lactate) 10 mg/mL
For product containing 5 mg/mL nicotine as benzoate salt, and 15 mg/mL nicotine lactate, equivalent to 12 mg/mL nicotine free base:
Nicotine (as benzoate and lactate) 12 mg/mL
The equivalent base form concentration of a nicotine salt product will depend on the salt form(s) of nicotine used in the product and can vary depending on how the product is prepared. A standard table for converting nicotine salt concentration to equivalent base form concentration has not therefore been provided.
Labelling requirements for therapeutic vapes vary depends on the type of label (main label or other label) and layer of packaging (primary pack, intermediate packaging, or container).
An overview of labelling requirements for different labels is provided in the tables below, and mock-up labels are provided in Appendix 1 to 6.
Note
If your relevant good has a single label, then information for both main and other label must be included on the same label.
| Relevant section of TGO 110 (2024) | Signal headings | Product name | Nicotine content | Flavour | Volume | Warning Panel | |
|---|---|---|---|---|---|---|---|
| Main label of primary pack | 22 | Yes | Yes | Yes | Yes | Yes | Yes |
| Intermediate packaging | 24 | Yes | Yes | ||||
| Main label of container | 25 | Yes | Yes | Yes | Yes | Yes | Yes |
| Main label of small container | 27 | Yes | Yes | Yes | Yes | Yes | Yes |
| Main label of very small container | 29 | Yes | Yes | Yes | |||
| Main label of therapeutic vaping kit | 32 | Yes | Yes | Yes | Yes | Yes | Yes |
| Main label of therapeutic vaping pack | 35 | Yes | Yes | Yes | Yes | Yes | Yes |
| Relevant section of TGO 110 (2024) | Name of ingredients | Batch number preceded by prefix | Expiry date preceded by prefix | Name and contact of sponsor | Storage conditions | Warning statements |
|---|---|---|---|---|---|---|---|
| Primary pack | 23 | Yes | Yes | Yes | Yes | Yes | Yes |
| Intermediate packaging[1] | 24 | Yes | Yes | Yes | Yes | ||
| Label of container | 26 | Yes | Yes | Yes | Yes | Yes | Yes |
| Label of small container | 28 | Yes | Yes | Yes[2] | Yes | Yes | |
| Label of very small container | 30 | Yes | Yes | ||||
| Therapeutic vaping kit | 33 | Yes | Yes | Yes | Yes | Yes | |
| Therapeutic vaping pack | 36 | Yes | Yes | Yes[3] | Yes | Yes[4] |
[1] Intermediate packaging generally has single label therefore in the TGO both main label and other label requirements are combined under ‘main label’ in section 24
[2] Only requires name of the sponsor, not the contact detail.
[3] Also requires name and contact details of the manufacturer.
[4] Also requires warning statements, “Risk of fire explosion. Replace only with same size and type battery” and “Warning: Contains button or coin battery. Hazardous if swallowed – see instructions” (if applicable).
The information leaflet contains critical information on the safe and effective use of an unapproved therapeutic vaping substance or therapeutic vaping substance accessory, especially when dispensed as a Schedule 3 medicine.
The information in the leaflet must be written in English, clearly legible and written in language that will easily be understood by patients. They can be enclosed within the packaging, printed on the packaging, attached to the packaging or available in an electronic form (in a PDF or HTML file).
Information leaflets include:
For further detail on requirements for the leaflet refer to Schedule 3 of the TGO. Some useful information on how ‘Consumer Medicine Information (CMI)’ requirements are implemented for other therapeutic goods can be found on our Improved Consumer Medicine Information template.
Unapproved therapeutic vapes are also automatically subject to the requirements under subsection 11(1) of the Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018, also known as TGO 100. These requirements also apply to vaping substances or vaping substance accessories that are listed in the ARTG as Export Only products.
The purpose of tamper-evident packaging is to alert patients to possible safety concerns before the supply or use of those goods. TGO 110 (2024) does not include any tamper-evident requirements for unapproved vapes.
The TGA instead publishes a non-mandatory Code of practice for tamper evident packaging of therapeutic goods. Compliance with the code improves the security of the therapeutic goods supplied in Australia and increases the likelihood that patients can identify when a product has been tampered with.
Suppliers of therapeutic vapes in Australia may wish to consider whether their products should comply with this code, but it is not mandatory.
A primary pack is the complete pack in which the vaping goods, or vaping goods and their containers are to be supplied to the customers.
Primary pack is the pack that is visible on the shelf and sold through retail.
Requirements for the primary pack label:
Label for Primary Pack
This image shows a comprehensive layout template for a nicotine product label, likely for e-cigarette or vaping liquid.
The template is divided into several sections, each serving a specific purpose in conveying product information and warnings.
The template consists of three main parts:
This template demonstrates the comprehensive information required on nicotine product labels, including safety warnings, product details, and regulatory compliance elements.
Intermediate packaging is the packaging that encloses one or more containers and obscures the labels of a container.
Intermediate packaging can be in form of blister pack or card pack or similar and it is enclosed inside a primary pack.
Label for Intermediate packaging
This image shows a label for a nicotine-containing product, likely for use in electronic cigarettes or vaping devices.
The label is predominantly white with black text and a yellow band across the middle.
The label is designed to clearly communicate important safety information, product details, and warnings about the addictive nature of nicotine. Its layout prioritizes readability and emphasizes key points through the use of different text sizes and a contrasting color band.
Container is the packaging of the vaping substance in direct contact with the product. A vaping substance container can be in form of bottle, vial, pod or cartridge.
Containers with capacity between 25 mL and 5 mL are classed as small containers and containers with less than 5 mL capacity are classed as very small containers.
Requirements for container label
Signal heading for prescription medicines and keep out of reach of children.
Detailed Description of Nicotine Product Label
This image shows a label for a nicotine-containing product, likely for use in electronic cigarettes or vaping devices.
The label is predominantly white with black text and a yellow band across the middle.
The label is designed to clearly communicate important safety information, product details, and warnings about the addictive nature of nicotine. Its layout prioritizes readability and emphasizes key points through the use of different text sizes and a contrasting color band.
Label for small container
This image shows a label for a nicotine-containing product, likely intended for use in electronic cigarettes or vaping devices.
The label is designed with a clean, structured layout to present important product information, warnings, and regulatory details.
The label is divided into three main sections arranged horizontally:
This label design effectively communicates crucial product information, safety warnings, and regulatory compliance details in a structured and easily readable format, suitable for a prescription nicotine product.
Label for very small container
This image shows a simplified label design for a nicotine-containing product, likely intended for use in electronic cigarettes or vaping devices.
The label is presented as part of a larger "Main label panel" as indicated by an arrow at the top of the image.
The label is divided into two main sections:
This section contains two lines of text:
This simplified label design effectively communicates key product information including the product name, nicotine strength, flavor, volume, batch number, and expiry date in a concise and easily readable format.
A therapeutic vaping kit and therapeutic vaping pack typically includes vaping devices, substances, and accessories that are used for medical purposes, such as smoking cessation or managing nicotine dependence.
Appendix 6: Labels for vaping kits and packs
A template for vaping product labels for vaping kits and packs showing 4 panels.
Panels 2 and 4 also contain a prominent black box warning that states in larger, bold text:
