Recent court prosecutions show that the Therapeutic Goods Administration (TGA) is undergoing transformation in its approach to regulatory enforcement. The TGA has swapped a focus on education for litigation, moving decisively from a model centred on industry guidance and warning letters to one that increasingly involves enforcement through infringement notices, penalties and direct court action. This evolution in strategy is evident across a range of recent TGA activities and is set to shape the regulatory landscape for therapeutic goods in Australia.
A new enforcement trajectory
By prioritising voluntary compliance and focusing on educating advertisers, importers, sponsors and health professionals under its obligations under Therapeutic Goods Act 1989 (Cth), the TGA historically relied on guidance, education and warning letters to address non-compliance. Court proceedings were typically the final weapon in the TGA's arsenal, but recent actions signal a clear shift. The TGA is now more willing to initiate Federal Court proceedings against companies and individuals who fail to comply with regulatory requirements.
This new direction is not limited to one sector or product type. The TGA’s recent enforcement actions have thrown a wide net, capturing a range of therapeutic goods. These enforcement actions have included unlawful advertising of cannabis products, supply of unapproved therapeutics and unlawful supply of medical devices that fail to meet Australian safety and performance requirements.
In the last two years, the TGA has commenced several civil penalty proceedings, issued more than 165 infringement notices and imposed penalties totaling over $2.3 million on organisations and individuals for unlawful advertising of medicinal cannabis. The TGA’s enforcement activities also extend beyond the recent growth of businesses involved in prescribing and distributing medicinal cannabis. For example, lifestyle websites and media companies have also been prosecuted for advertising breaches, indicating a broader interpretation and application of the advertising restrictions.
Strategic focus areas and public health priorities
The TGA’s 2023-2025 Import, Advertising and Supply Compliance Priorities sets out the Administration’s current enforcement priorities. Its continued focus on these areas aims to improve public safety, address serious breaches of the legislation and the high levels of non-compliance in these industry sectors.
The compliance priorities are to detect, deter and disrupt the unlawful:
Importation, advertising and supply of nicotine vaping products.
Advertising of medicinal cannabis, psilocybin and MDMA.
Supply and advertising of unapproved and high-risk medicines and medical devices used in the wellness and beauty industries including those intended to alter the body’s performance and appearance.
Importation and supply of substandard and falsified therapeutic goods with a particular focus on those products that declare or otherwise are suspected to contain higher risk substances that pose a risk to human health and/or safety.
Importation, advertising and supply of medicines and medical devices advertised as traditional or alternative treatments, particularly those that contain substances that pose a risk to human health and/or safety.
Within the TGA, a separate ‘compliance program’ is dedicated to each of these areas (as well as other areas), responsible for surveillance, information sharing, enforcement and education.
The TGA also keeps an eye on social media and digital platforms in monitoring advertisements of therapeutic goods. It may take compliance action on any non-compliance detected whether the matter falls within a compliance priority or not.
The TGA’s 2024-2025 Therapeutic Goods Advertising and Compliance Education Plan underscores its proactive approach. The plan sets out its approach to publish information on compliance and enforcement activities as a deterrent to non-compliance, publish communication materials regularly, maintain resources on the TGA website and engage stakeholders and other law enforcement and regulatory bodies.
Deterrence, transparency and community trust
The TGA’s move towards more frequent prosecutions is designed to serve as a deterrent to non-compliance and to highlight the importance of public health and safety.
By publishing information on compliance and enforcement actions, the TGA aims to promote transparency and build community trust in the regulatory system. The regulator’s enhanced legislative recall powers further strengthen its ability to act swiftly in the interests of public safety.
Government funding of the TGA’s enforcement
In the 2023-2024 Budget, the government provided $61 million over four years to the TGA for long-term activities aimed at protecting public health, including compliance and enforcement. In the same year, the government provided $55 million over two years to the Department of Health and Aged Care for the Measure - Enhanced Regulatory Model for Vaping Products, of which $23 million was allocated to the TGA in 2024-2025 for vaping activities.
In the 2024-2025 Budget, the government provided $150.4 million to the Department for the Vaping Regulatory Reform Package, including $92.6 million over two years from 2025-2026 to the TGA to extend its regulatory, compliance and enforcement activities on all vaping products, including for staffing costs and uplifting the TGA’s IT and digital infrastructure.
These large allocations, increasing year-on year, demonstrate the government’s willingness to fund TGA enforcement and deter non-compliance.
TGA’s mission
The TGA’s evolving enforcement strategy marks a significant departure from its previous reliance on guidance and warnings. While educational materials have helped businesses comply with the therapeutic goods framework, nothing conveys a message more clearly than seeing infringement notices and penalties being issued or debated before a judge.
By embracing a more assertive approach that includes direct prosecutions, the TGA is setting clear expectations for compliance and is sending a strong message to the industry: adherence to regulatory requirements is not optional and failure to comply will have serious consequences. This shift is central to the TGA’s mission to protect public health and maintain the integrity of Australia’s therapeutic goods regulatory framework.
How we can help
Given this shift, it is increasingly important for companies and individuals involved in the importation, advertising or supply of therapeutic goods to seek legal advice early in the process, particularly when responding to information requests from the TGA. Responses to the TGA at that early stage inevitably shape any subsequent formal enforcement processes. Protecting legal privilege and confidentiality is also essential, as the regulator adopts more assertive investigative and prosecutorial tactics.