TGA injecting new life into renewed cosmetics guidance

The Australian market for cosmetic injectables in Australia is significant, with the marked size valued at USD 3.05 billion in 2024, and likely to continue growing. Aspects of those products are regulated at both a Federal and State level, and in recent times the relevant regulators have updated or published guidance notes for industry.

Broadly speaking, the advertising of these products is regulated at a Federal level by the Therapeutic Goods Administration (TGA). The approval, registration and supply of these products is also regulated by the TGA at a Federal level, however each State and Territory also separately regulates the supply and availability of medicines and poisons at a local level. There is no uniform guidance about the intersection between these regimes, making it a grey and complex area. It is not straightforward for manufacturers and suppliers to know how to comply when bringing their products to market in Australia.

Last year the TGA released updated guidance about the advertising of cosmetic injectables (TGA Guidance) which, among other things, provides that non-specific terms such as "wrinkle reducing injections" are no longer permitted in advertising. In April 2025, Queensland Health (the relevant regulator of the Medicines and Poisons Act 2019 (Qld) has updated its guidance about these products.

Following recent investigative journalism alleging potential widespread non-compliance among industry, public comments have also been made by the TGA this year which are consistent with increased scrutiny of the marketing and supply of cosmetic injectable products.

As a result, it is important for manufacturers and suppliers of cosmetic injectables to be aware of the legal risks of the advertisement of such products and the complex rules and regulations in the space generally.

The regulatory frameworks

Cosmetic injectables such as botulinum toxin and dermal fillers such as collagen and hyaluronic acid are classified as prescription-only medicines under the Poisons Standard (classified as Schedule 4 substances). Accordingly, the advertising and supply of these products is tightly controlled under the Therapeutic Goods Act 1989 (Cth).

The Therapeutic Goods Advertising Code prohibits the advertising of prescription medicines to the public, with such prohibition extending to social media advertising.

In conjunction with the TGA's March 2024 updated guidance, the TGA also released a FAQ and answers page. This guidance provided several notable takeaways:

1. It is the responsibility of each advertiser to ensure their advertisement does not promote therapeutic goods in a way that is not compliant with the legislative requirements, such as including non-specific terms.

2. Section 42DL(1) of the Act makes it unlawful to advertise therapeutic goods in a way that is misleading or deceptive, that suggests that the goods are effective for a condition or purpose that is not supported by evidence, that creates unreasonable expectations of the benefit, or that exploits fear or misunderstanding about health conditions. This legislation has not changed. Rather, the guidance has been updated to ensure the legislation is applied consistently across all industries.

3. The TGA expects the industry to take prompt steps to review their advertising – including historic social media posts – to ensure it complies with this guidance.

4. As per section 42AA of the Act, the advertising of prescription-only cosmetic injectables directed exclusively to health professionals (and other named groups) is not prohibited.

The April 2025 Queensland Health Guidance

Queensland Health also provided further guidance earlier this year, aimed at clarifying its interpretation of the Medicines and Poisons Act 2019. It says, for example:

1. Registered Nurses are not authorised to buy schedule 4 cosmetic injectable medicines.

2. Only a medical practitioner (doctor) or nurse practitioner can buy schedule 4 cosmetic injectable medicines to hold as stock for use at a clinic where they will exercise exclusive custody and control over the stock of schedule 4 medicines (or joint custody and control only with another doctor or nurse practitioner).

3. Doctors and nurse practitioners are not approved persons to supply a stock of cosmetic injectables for use at cosmetic injectables clinics where they will not have exclusive custody and control over the stock.

These are interesting propositions for the hundreds of nurse-led beauty clinics.

TGA activity: enforcement and consequences

The TGA has strict enforcement powers in the cosmetic injectables space and has been increasingly active in recent years, especially as the cosmetic industry grows and social media advertising becomes more prominent. The TGA expects the industry to take prompt steps to review their existing advertising and bring it in line with the updated guidance.

The TGA will act in line with their regulatory framework and, dependent on the nature and seriousness of the alleged non-compliance, punishments can range from warning letters to injunctions to criminal prosecutions. It has also signalled its willingness to pursue litigation for serious or repeated contraventions.

That being said, no prosecutions were undertaken by the TGA in 2024, although it has issued multiple infringement notices to clinics and practitioners for advertising prescription only cosmetic injectables on various social media platforms, which permit recipients to pay a fine for contravention of the Therapeutic Goods Act without admission. The infringement notice fines have reached up to $13,320 per contravention for individuals and $66,600 for corporate entities.