Snow plus is a term Australians may encounter when researching vaping products, but understanding the regulations governing this industry is equally important. The Therapeutic Goods Administration (TGA) plays a central role in regulating therapeutic vaping products in Australia, with requirements covering product standards, pharmacy supply, importing, manufacturing and advertising.

Australia’s vaping laws have changed significantly since 2024. These changes introduced a national framework designed to regulate the supply chain and establish clear requirements for businesses and consumers.

Whether you’re researching Australian vaping regulations, checking product information or trying to understand the responsibilities of manufacturers and importers, knowing how the TGA operates can help you find accurate information.

This guide explains the regulatory framework in straightforward language, highlights important requirements and identifies official resources for further information.

This article is for general educational purposes only and does not constitute legal or medical advice.

1. What Is the Therapeutic Goods Administration?

The Therapeutic Goods Administration, commonly called the TGA, is Australia’s national regulator for therapeutic goods.

It operates within the Australian Government’s health portfolio and administers legislation covering medicines, medical devices and other therapeutic products.

In relation to vaping products, the TGA oversees requirements that apply to therapeutic vaping goods intended for smoking cessation or the management of nicotine dependence.

Its responsibilities include:

• Establishing applicable product standards.
• Maintaining information about notified therapeutic vaping goods.
• Providing regulatory guidance to businesses and healthcare professionals.
• Monitoring compliance with relevant legislation.
• Taking enforcement action where necessary.

The TGA also provides guidance for consumers, pharmacists, manufacturers, importers and other participants in the supply chain.

Why is TGA regulation important?

Regulation establishes the legal requirements that apply to therapeutic vaping products and the businesses involved in their supply.

It helps clarify which products may be lawfully supplied through the Australian therapeutic framework and what obligations apply to different participants.

Understanding these requirements is important because a product appearing on an online store or website does not automatically mean it can legally be imported or supplied in Australia.

2. How Are Vaping Products Regulated in Australia?

Australia introduced significant vaping reforms through the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024.

The legislation commenced on 1 July 2024 and established a national framework covering the importation, domestic manufacture, supply, commercial possession and advertising of vaping goods.

The framework covers several types of goods, including:

• Vaping devices.
• Vaping substances.
• Vaping accessories.
• Therapeutic vaping kits.
• Products containing vaping substances and associated components.

Under this framework, vaping products are regulated as therapeutic goods and are only lawfully available for therapeutic purposes through pharmacies and pharmacy settings, subject to applicable requirements.

What does therapeutic use mean?

The Australian regulatory framework recognises therapeutic vaping products for smoking cessation and the management of nicotine dependence.

This does not mean every vaping product is automatically approved, registered or permitted for supply.

Products must meet the relevant legal requirements, and businesses must comply with applicable obligations before importing, manufacturing or supplying them.

+1

3. What Is the Difference Between TGA Notification and Approval?

One area that can cause confusion is the difference between a notified therapeutic vaping product and a registered therapeutic good.

The TGA maintains a notified vape list containing products that have been notified as complying with applicable standards for lawful supply under the relevant framework.

However, notification is not equivalent to full TGA assessment or registration.

The TGA states that therapeutic vaping goods are currently unapproved therapeutic goods and are not included in the Australian Register of Therapeutic Goods (ARTG). They have not been assessed by the TGA for quality, safety, performance or effectiveness.

Why does this distinction matter?

When reviewing product information, it is important to understand exactly what a regulatory statement means.

For example:

• Notification indicates that the relevant notification requirements have been completed.
• ARTG registration involves a separate regulatory process.
• Neither a product listing nor a marketing statement should be interpreted beyond what the official regulatory information establishes.

For accurate information, consult the TGA’s official notified vape list rather than relying exclusively on descriptions published by commercial websites.

4. What Product Standards Apply to Therapeutic Vaping Goods?

The TGA establishes standards covering relevant therapeutic vaping products.

These requirements address matters such as product composition, packaging, labelling and device-related safety requirements.

The applicable standard depends on the type of product.

Product composition and ingredients

The Therapeutic Goods Order No. 110, commonly referred to as TGO 110, establishes requirements for therapeutic vaping substances and related goods.

It addresses matters such as ingredients, composition, product quality and labelling.

When reviewing ingredient information, readers should distinguish between verified product details and general statements about vaping substances.

Packaging and labelling

Applicable requirements also cover product packaging and labelling.

Depending on the product category, these requirements may address:

• Product identification.
• Required warnings.
• Relevant usage information.
• Packaging presentation.
• Information supplied with the product.

The purpose of these requirements is to establish consistent regulatory expectations for goods supplied through the therapeutic framework.

Device requirements

Therapeutic vaping devices and accessories are subject to applicable technical requirements.

These may involve device design, electrical safety, construction and risk-management considerations.

Manufacturers and sponsors should refer to the relevant TGA standards to determine which requirements apply to their specific products.

5. Can Vaping Products Be Sold Through Any Australian Retailer?

No. Australian regulations restrict the supply of vaping products to lawful pharmacy channels.

The TGA confirms that vaping products cannot be supplied through non-pharmacy retail stores, including tobacconists, specialist vape shops and convenience stores.

How does pharmacy access work?

The requirements depend on age, nicotine concentration, clinical circumstances and applicable state or territory legislation.

For adults aged 18 and over, certain therapeutic vaping products containing no more than 20 mg/mL nicotine may be supplied without a prescription following pharmacist assessment, where the relevant conditions are met.

A prescription is required in other circumstances, including for products containing more than 20 mg/mL nicotine.

Additional requirements apply to people under 18, and pharmacists are not required to stock or supply therapeutic vaping products.

Anyone seeking information about access should consult a pharmacist and check the relevant local requirements.

6. What Are the Rules for Importing Vaping Products?

Importation is another important part of Australia’s regulatory framework.

The Office of Drug Control (ODC) regulates and provides advice concerning the importation of therapeutic vaping goods.

Businesses importing these products must comply with applicable licensing, permit, notification and customs requirements.

According to the TGA, importers generally need to:

1. Hold the required import licence.
2. Obtain the relevant import permit.
3. Notify the TGA of compliance with applicable product standards.
4. Meet Australian Border Force import-clearance requirements.
5. Comply with applicable state and territory requirements.

Specific requirements depend on the product and the circumstances of importation.

What should businesses check before importing?

Businesses should confirm the product’s regulatory status before arranging importation.

They should also verify that the required documentation is complete and that the proposed activity is permitted under Australian law.

For detailed guidance, consult the Office of Drug Control and the TGA before proceeding.

7. Are Vaping Products Allowed to Be Advertised Online?

Advertising vaping goods is generally prohibited in Australia unless specifically authorised by the TGA.

The restrictions apply to public-facing promotional activity across different media, including websites and social media.

Does educational content count as advertising?

Whether material constitutes advertising depends on its purpose, content, context and overall effect.

The TGA assesses content on a case-by-case basis, including whether it promotes the use or supply of therapeutic goods or vaping goods directly or indirectly.

This is particularly relevant for businesses publishing vaping-related content online.

Content requiring careful review may include:

• Brand-focused articles.
• Product descriptions.
• Promotional imagery.
• Customer testimonials.
• Product availability information.
• Calls to action.
• Social media communications.
• Commercial search-optimised pages.

Simply presenting material as educational does not automatically exempt it from advertising restrictions.

Businesses should seek Australian regulatory advice before publishing commercial vaping-related content.

8. How Can You Check the Latest TGA Requirements?

Regulations and official guidance can change, so it is important to check current information rather than relying on outdated articles.

The TGA maintains a dedicated Vaping Hub containing guidance for consumers, healthcare professionals and industry participants.

Useful resources include:

• The notified vape list.
• Product standards for therapeutic vaping goods.
• Pharmacy supply requirements.
• Importation guidance.
• Manufacturing requirements.
• Compliance and enforcement information.
• Advertising restrictions.

The TGA’s official resources provide information about the regulatory requirements applicable to different participants in the supply chain.

When reviewing information, check the publication date and confirm that the guidance applies to your circumstances.

Conclusion

The Therapeutic Goods Administration plays a central role in regulating therapeutic vaping products in Australia.

Its requirements cover product standards, labelling, pharmacy supply, importing, manufacturing and compliance. Understanding these rules helps consumers and businesses distinguish between general product information and the legal requirements governing therapeutic vaping goods.

For businesses, maintaining accurate records, reviewing regulatory updates and obtaining appropriate professional advice are important parts of responsible compliance.

For the most current information, visit the official

or consult the relevant Australian government authority.

Frequently Asked Questions

1. What does the TGA do for vaping products in Australia?

The Therapeutic Goods Administration regulates therapeutic vaping goods under Australian law. Its responsibilities include administering product standards, maintaining information about notified goods and monitoring compliance.

2. Are all vaping products approved by the TGA?

No. Therapeutic vaping goods may be notified for supply under the relevant framework without being registered on the Australian Register of Therapeutic Goods. The TGA states that these unapproved goods have not undergone its assessment for quality, safety, performance or effectiveness.

3. Can Australian retailers sell vaping products?

Vaping products cannot be supplied through non-pharmacy retail stores such as tobacconists, specialist vape shops or convenience stores. Lawful supply is restricted to pharmacies and pharmacy settings under applicable requirements.

4. What standards apply to therapeutic vaping products?

Applicable standards address areas such as product composition, ingredients, packaging, labelling and device requirements. The specific requirements depend on the type of therapeutic vaping good.

5. Where can I check the latest TGA vaping regulations?

The TGA’s official Vaping Hub provides information about product standards, notified goods, pharmacy supply, importing and compliance requirements.

6. Can vaping products be promoted through Australian websites?

Advertising vaping goods is generally prohibited unless specifically authorised. Online material should be reviewed for its purpose, content, context and overall effect before publication.

Publication note: This is an informational draft, not a legal compliance certification. Before publishing it on a commercial vaping website, have an Australian regulatory specialist review the complete page, including brand references, metadata, imagery, internal links and calls to action.