The Therapeutic Goods Administration (TGA) have shifted decisively from education-based compliance to assertive TGA enforcement. With record-breaking penalties and increased litigation, the message to industry is clear: compliance is mandatory, and breaches will be prosecuted.
From Guidance to Litigation
Traditionally, the TGA promoted voluntary compliance through education and industry engagement. Today, it is actively pursuing Court proceedings against businesses and individuals who fail to meet their obligations under the Therapeutic Goods Act 1989 (Cth).
Recent enforcement actions have targeted:
- Unlawful advertising of medicinal cannabis and wellness products
- Supply of unapproved therapeutic goods
- Distribution of non-compliant medical devices
In just two years, the TGA has issued over 165 infringement notices, imposed more than $2.3 million in penalties, and initiated multiple civil penalty proceedings.
Record Penalties and Broader Enforcement
A recent Federal Court decision imposed a $22 million penalty—the largest ever under the Therapeutic Goods Act—on a supplier that failed to meet registration conditions. The court found that even without physical harm, the conduct undermined the integrity of the regulatory system.
This case reflects the TGA’s broader enforcement strategy, which now includes action against media outlets, lifestyle platforms, and digital advertisers.
Baybridge’s Role in TGA Defence
At Baybridge Lawyers, we have firsthand experience defending clients against TGA enforcement. Our team understands the complexities of therapeutic goods regulation—including the evolving rules around supply, importation, exportation, manufacturing, and advertising.
We’ve supported clients facing allegations of non-compliance, helping them navigate investigations, respond to infringement notices, and prepare for litigation. Our approach is strategic, informed, and focused on protecting your business interests.
Targeted Enforcement Priorities
The TGA’s current compliance strategy focuses on high-risk areas such as:
- Nicotine vaping products: Unlawful importation, advertising, and supply
- Medicinal cannabis, psilocybin, and MDMA: Misleading promotional activity
- Beauty and wellness products: Unapproved medicines and devices marketed for enhancement
- Substandard and falsified goods: Especially those containing harmful substances
- Alternative treatments: Products posing health risks under the guise of traditional medicine
The regulator also monitors social media and digital platforms, taking swift action against non-compliant advertising.
Government Investment in Oversight
The Australian Government has significantly increased funding to support the TGA’s enforcement efforts:
- $61 million over four years for long-term public health protection
- $55 million over two years for vaping regulation
- $150.4 million in the 2024–2025 Budget, with $92.6 million allocated to the TGA for expanded enforcement and infrastructure
These investments reflect a broader policy shift toward stronger regulatory oversight.
What This Means for Industry
The TGA’s evolving enforcement strategy sends a clear message: non-compliance carries real consequences. Whether you’re a small business advertising wellness product or a multinational distributing medical devices, you must ensure your goods are properly registered and compliant.
Failure to do so can result in infringement notices, court proceedings, and substantial financial penalties. In some cases, resolving enforcement action may require formal admission of contravention.
Baybridge Lawyers: Your Compliance Partner
Navigating the complex regulatory environment surrounding therapeutic goods requires expert legal guidance. Whether you’re facing enforcement action or seeking proactive compliance advice, Baybridge Lawyers is here to support your business and protect your interests.
