Injecting Change: What you need to know about the revised TGA regulations in the cosmetic industry

KEY TAKE OUTS:

• In January 2024, the Therapeutic Goods Administration (TGA) implemented new regulations which no longer allow businesses to use terms like “wrinkle reducing injections” or “dermal fillers” in their advertisements.
• Non-compliance with the new regulations may result in warning letters, suspension of trade, infringement notices and criminal prosecution.

In this blog, we will explore how the recent changes in the TGA regulations impact you as a business owner and your clients, as these regulations can significantly alter the way you promote your services.

Many popular cosmetic injectables, such as ‘dermal fillers,’ ‘Botox,’ or ‘anti-wrinkle injections,’ contain substances classified under Schedule 4 of the Poisons Standards (prescription-only medication). Under the Therapeutic Goods Act 1989 (the Act), advertising these substances to the public is prohibited.

To ensure consistency in advertising regulations across all industries dealing with therapeutic goods, the Therapeutic Goods Administration (TGA) has revised its guidelines for businesses. This revision fundamentally alters how businesses can promote and provide information about their services and products containing these substances.

What Has Changed in TGA Regulations for Advertising Cosmetic Injectables?

The TGA now no longer allows businesses in the cosmetic injectable industry to directly or indirectly advertise or reference services containing prescription-only substances. This restriction includes:

• Usage of terms such as ‘dermal fillers’, ‘botox’ or ‘anti-wrinkle injections,’ as well as any acronyms, nicknames, abbreviations, and hashtags that might be interpreted by consumers as references to specific prescription-only medicines or substances;
• Posting before-and-after photos containing prescription-only substances or items used in delivering such services; and
• Advertising price lists for services, including in client booking systems.

This regulation does not apply to cosmetic injectables that do not contain any prescription-only substances.

Consequences of Non-Compliance with TGA Regulations for Cosmetic Injectables

Upon initial non-compliance, the TGA will offer educational guidance to the business on achieving compliance. However, regulatory actions may escalate if:

• The business repeatedly breaches compliance and shows unwillingness to comply, or
• The alleged breach is likely to impact the consumer’s safe and appropriate use of therapeutic goods.

If found in breach of the regulations, the TGA may issue the business:

1. Warning letters;
2. Directions notice, instructing the cessation, amendment, or removal of advertisements from circulation or specific claims made within the advertisements;
3. Infringement notices, with fines up to 5,000 penalty units for individuals and 50,000 penalty units for companies;
4. Enforcement undertaking wherein the TGA negotiates written agreements as an alternative to court action;
5. Applying for an injunction; or
6. Applying to the Court for criminal prosecution.

How Coutts Can Help with TGA Compliance for Cosmetic Injectables

At Coutts, we offer comprehensive legal services to address various needs your business may encounter. If you require assistance in ensuring compliance with the recent TGA changes to the advertising of cosmetic injectables or have been accused of non-compliance, our specialised Commercial team can help. We can review your procedures and structure to ensure they comply with the new regulations. Additionally, we can assist you in responding to non-compliance correspondences from the TGA.

Contact Coutts Lawyers & Conveyancers

Please note that the content of this blog is for general informational purposes only and does not constitute legal advice. If you need more detailed information or specific legal advice, our experts are here to help. Schedule an appointment or call our office at 1300 268 887 to speak with one of our experienced legal professionals.

Frequently asked questions

Should I revise old social media and website material mentioning cosmetic injectables? 

The TGA has emphasised that given the nature of social media, content remains readily accessible to consumers irrespective of its posting date. Hence, all social media posts and content, regardless of when they were originally published, must align with the updated advertising regulations.

Are there approved terms available for describing the cosmetic injection services I provide?

The TGA cannot provide advice on specific issues or to individual circumstances. Therefore, cannot provide a list of acceptable terms for businesses to refer to when describing the cosmetic injection services they provide.

How can I communicate treatment services with my patients?

According to the TGA, to determine whether the use of a prescription-only medication contained in service is appropriate for the patient, the practitioner should discuss the risk and contra-indications with the patient during a consultation. To ensure that the patient has the ability to make informed and accurate decisions about which cosmetic treatment is right for them.

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