The Federal Court of Australia has ordered – external site CDA Clinics QLD Pty Ltd (CDA Clinics) to pay $6.5 million in civil penalties for the unlawful advertising of medicinal cannabis to the public in breach of the Therapeutic Goods Act 1989 (the Act).
The Court also ordered Dr Benjamin Jansen, the former director of CDA Clinics, to pay $450,000 in civil penalties for his role in aiding and abetting CDA Clinics’ conduct.
The Court found that CDA Clinics promoted the use of medicinal cannabis products, including unapproved and prescription-only medicines, that were not entered in the Australian Register of Therapeutic Goods, in breach of the Act.
The advertisements also unlawfully promoted the use of medicinal cannabis for the treatment of serious diseases, conditions and disorders, including but not limited to cancer, mental illnesses, autoimmune conditions, fibromyalgia, chronic pain, seizures, meningitis and autism. Such references are known as restricted representations or prohibited representations, and are not allowed to be included in advertising for therapeutic goods unless an approval or permission is given by the TGA.
In delivering her judgment, Justice Collier noted:
“The advertisements formed part of a deliberate commercial strategy. I accept the Secretary’s Submissions that the Website, Blog Posts and Facebook Posts worked together to encourage consumer engagement with CDA’s services and to facilitate access to CBD products. The advertisements were neither inadvertent nor isolated but rather formed part of the manner in which CDA conducted its business.”
“Clearly, Dr Jansen was not a passive director removed from the conduct of the business. Rather, he was the individual principally responsible for the development and operation of the CDA model and the Website during the Relevant Period.”
Her Honour also noted that, for prohibited and restricted representations, “the legislation clearly singles out such representations for particular regulation because of the significant risk that vulnerable consumers may be influenced by therapeutic claims concerning serious diseases.”
Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and Head of the TGA, said the outcome highlights the importance of complying with Australia’s therapeutic goods advertising laws.
“The advertising of prescription-only medicines to the public can lead to inappropriate demand and expose patients to avoidable risks. These can include unsuitable treatment and side effects that might have been avoided by a different treatment strategy. Treatment decisions should be made by patients in consultation with an appropriately qualified health practitioner, and not driven by advertising.
“The TGA will continue to take strong compliance and enforcement action against unlawful advertising where individuals, health practitioners and businesses do not meet their legal obligations,” Professor Lawler said.
Businesses, individuals and health practitioners must understand their legal obligations under the Act before advertising, manufacturing, importing or supplying therapeutic goods. Consequences of non-compliance may include infringement notices, direction or prevention notices, civil penalties or criminal prosecution.
This action reflects the TGA’s ongoing compliance and enforcement activities for therapeutic goods as outlined in the TGA’s Compliance Principles 2026 and 2027.
If you suspect non-compliance in relation to therapeutic goods, or their advertising, you can report it to the TGA at any time.
