TGA’s New Laws on Cosmetic Injectables

Sharon Givoni Consulting Copyright
Credit: Ina Garbe (Unsplash)

Transforming the Cosmetic Injectables Landscape – New TGA Regulations

The world of cosmetic injectables, including popular treatments like Botox and fillers, has been booming.

Clinics across Australia have been creatively navigating the thin line of legal advertising, employing generic terms such as “anti-wrinkle treatments” to market their services. Yet, recent shifts by the Therapeutic Goods Administration (TGA) regulations have sent ripples through the industry, prompting a re-evaluation of marketing strategies.

Understanding the TGA’s Role

The TGA’s mandate is to ensure that therapeutic goods available in Australia meet stringent standards of safety, efficacy, and quality.

Operating under the Department of Health, the TGA oversees the Therapeutic Goods Act 1989 (Cth), governing the import, export, manufacture, and supply of therapeutic goods.

In the realm of cosmetic injectables, this oversight is crucial, categorising products like botulinum toxin and dermal fillers as prescription medicines.

This classification demands that these products not only prove their safety and effectiveness but also be marketed in a way that accurately informs consumers without misleading them.

The Latest From the TGA: A New Advertising Paradigm

A pivotal announcement from the TGA has introduced tighter advertising guidelines for injectables. Terms familiar to both providers and consumers, such as ‘dermal filler’ and ‘anti-wrinkle injections,’ are now off-limits.

This significant adjustment challenges aesthetic practitioners to rethink how they discuss their services, encouraging a shift towards broader treatment categories.

The changes took effect on 18 December 2023.

Staying Compliant

For those navigating these changes, here are three tips to help you align with the new TGA regulations:

  1. Stay Informed and Proactive: The landscape for cosmetic injectables is rapidly evolving. Stay ahead by monitoring TGA updates and subscribing to legal advisories specialising in health law and cosmetic regulations. Anticipating changes can position you to adapt swiftly and efficiently.
  2. Consult with Legal Experts: The intricacies of TGA regulations necessitate expert interpretation. Seeking legal advice can demystify the complexities of the cosmetic injectables industry, ensuring your advertising remains effective and compliant.
  3. Use the Right Words in Your Advertising: Navigating TGA regulations requires a judicious choice of words. Focus on crafting content that meets regulatory standards without compromising your message’s effectiveness.

Looking Ahead

As legal professionals practicing in the cosmetics industry, we’re here to demystify these changes for you. Keeping up-to-date and consulting with experts is key to ensuring you remain compliant while still connecting with your audience effectively.

In recent years, the cosmetic injectables industry, encompassing treatments like Botox and fillers, has witnessed explosive growth. Clinics have creatively marketed their services, skirting the fine line of legal advertising by using generic terms such as “anti-wrinkle treatments.”

However, an unexpected pivot by the TGA has set the industry abuzz.

How does the TGA work?

It is first useful to consider how the Therapeutic Goods Administration (TGA) works.

It is responsible for ensuring that therapeutic goods available to Australian consumers meet acceptable standards of safety, efficacy, and quality. It operates under the Australian Government Department of Health and administers the Therapeutic Goods Act 1989 (the Act), which lays down the legal requirements for the import, export, manufacture, and supply of therapeutic goods in Australia.

When it comes to the cosmetic industry, the TGA plays a critical role. Cosmetic injectables, such as botulinum toxin (e.g., Botox) and dermal fillers, are considered prescription medicines and thus fall under the TGA’s purview.

The TGA’s involvement ensures that products are not only safe and effective but also that they are marketed and advertised in a manner that does not mislead consumers.

In a significant development from the Therapeutic Goods Administration (TGA), new restrictions have been announced that tighten the guidelines on advertising injectables. Kate Kaylock, Assistant Director of Advertising and Compliance Education and Policy Section at the TGA, outlined in a recent letter that terms such as ‘dermal filler’ and ‘anti-wrinkle injections’ are now prohibited in advertising clinic or practitioner services. This decision stems from these terms indirectly referencing prescription-only products, further tightening the already strict ban on the use of brand names or their variations in advertisements.

This change presents a notable challenge for aesthetic practitioners in marketing their injectable services, pushing them towards mentioning broader treatment categories like ‘consultations on reducing the appearance of wrinkles’ instead. Although these adjustments became effective on December 18, 2023, official guidance has yet to be published on the TGA’s website, expected by mid to late January.

Australia’s advertising regulations for schedule-4 drugs are now among the world’s strictest, marking a significant shift that cosmetic injectors will need to adapt to. Stay tuned for more updates and commentary from the TGA on this evolving situation.

For more insights and updates, SPA+CLINIC offers a variety of platforms, including a quarterly print magazine, a frequently updated website, a weekly newsletter, a digital magazine, and regular social media updates.

The TGA has now banned the use of terms such as ‘anti-wrinkle injections’ and ‘dermal fillers’ in advertising cosmetic injectables. The rationale behind this prohibition is that these terms allude to prescription-only products. Instead, the TGA suggests alternative phrases.

This has had immediate implications on the cosmetics industry and for those navigating this evolving landscape, compliance is paramount. We give straightforward advice in this area to ensure your business understands the new guidelines.

Tips – the Future of Cosmetic Injectables

  1. Stay Informed and Proactive: The legal landscape surrounding cosmetic injectables is evolving, and staying ahead means being informed. Consider setting up alerts for TGA updates or subscribing to legal advisories that focus on health law and cosmetic regulations. This proactive approach can help you anticipate changes rather than reacting to them when it might be too late.
  2. Consult with Legal Experts: Given the complexity and specificity of TGA regulations, seek legal advice so that you can understand the nuances of the cosmetic injectables industry to ensure that your advertising content is compliant while still effectively reaching your target audience.
  3. Use the right words in your advertising – Writing your advertising content within the confines of TGA regulations requires a careful selection of terms so as to align with regulatory requirements.

Please note the above article is general in nature and does not constitute legal advice.

Please email us if you need legal advice about your brand or another legal matter in this area generally.