Stephanie McLean A targeted compliance campaign is now underway, with 50 individuals and entities to be contacted in the first wave and more enforcement action expected to follow.
Australia’s Therapeutic Goods Administration (TGA) has launched a significant compliance crackdown targeting the unlawful advertising of cosmetic injectables. In a letter sent to industry professionals on April 15th, 2025, the regulator announced the first wave of its targeted compliance initiative, with 50 individuals and entities about to be under direct scrutiny for potential breaches of advertising laws.
This marks the most proactive step yet in the TGA’s efforts to enforce compliance within the cosmetic injectables space, a sector that has come under increasing regulatory focus. The action stems from what the TGA describes as a “high volume of reports” alleging non-compliance across social media platforms, clinic websites, and other advertising channels.
What Is the Focus of the Crackdown?
The TGA has made it clear that the rules around advertising Schedule 4 prescription-only medicines are strict and have not changed. However, many practitioners remain unaware that even indirect references to brand names, procedure types, or benefits can place them in breach.
Examples of non-compliance include:
- Using brand names of prescription-only medicines in promotional content
- Making claims that create an unrealistic expectation of benefits
- Offering testimonials related to Schedule 4 treatments
- Using before-and-after imagery that suggests results from a particular product
- Promoting discounts, giveaways, or bundled injectable packages
The Role of the TGA’s Targeted Compliance Unit
The recently expanded Targeted Compliance Unit within the TGA has been tasked with identifying high-risk advertisers through both internal audits and public reporting. This unit is responsible for issuing formal warning letters and initiating further regulatory action if required.
The initial 50 letters serve as a warning shot, but the TGA has confirmed that more individuals and clinics will be contacted in future rounds. It is clear that this is only the beginning of a broader compliance push one that practitioners can’t afford to ignore.
What Should Clinics Do Now?
If you work with or advertise cosmetic injectables, now is the time to take action:
- Audit your digital presence. Review all website, email, and social media content to ensure it complies with TGA guidelines.
- Avoid referring to Schedule 4 medicines by name. Generic descriptions should be used instead, without implying benefits or outcomes.
- Remove testimonials and before/after images related to prescription-only treatments.
- Educate your team. Ensure your staff and any external marketing providers are fully aware of what’s permitted.
- Stay updated. The TGA has released a new “10 Tips for Complying with the TGA Advertising Rules” document, which is essential reading for all aesthetic professionals.
As the regulatory landscape continues to evolve, clinics that remain proactive and transparent in their compliance practices will not only avoid enforcement, they’ll also build trust with patients and the wider community.
For more information, visit the TGA website or review the latest guidance and enforcement updates.
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