There has been a recent surge in regulator activity around the promotion of therapeutic goods and health services in Australia. This coincides with the increased availability of telehealth, online prescribing and dispensing of therapeutic goods and the corresponding increase in direct-to-consumer advertising across multiple marketing channels, including social media. In late 2023, we provided an update on the Therapeutic Goods Administration's (TGA's) enforcement priorities. As predicted, we are now seeing increased compliance efforts, including by the TGA, in the healthcare sector.

This is a snapshot of recent action taken by regulators including the TGA, Australian Competition and Consumer Commission (ACCC) and Australian Health Practitioner Regulatory Authority (Ahpra) in the healthcare sector. It is a timely reminder for businesses to review their practices and advertising strategies to ensure compliance.

Advertising under scrutiny: Enforcement activity has ranged from infringement notices to Federal Court proceedings

TGA commences proceedings alleging unlawful advertising of medicinal cannabis.

In late June 2025, the TGA commenced proceedings in the Federal Court of Australia against AG Therapeutics Pty Ltd (trading as Atlus) and its sole director (Dr Shimal Jobanputra), Mamamia.com.au Pty Ltd (Mamamia), News Life Media Pty Ltd (News Life) and Straight Up PR Pty Ltd (Straight Up) for advertising medicinal cannabis in alleged contravention of the Therapeutic Goods Act 1989 (Cth) (TG Act) (TGA Media Release). The proceedings concern content published on the Atlus website, social media pages, and advertorials for Atlus published on the Mamamia and Body + Soul website as part of a public relations campaign by Atlus.

Advertising prohibitions under the Therapeutic Goods Act 1989 (Cth)

The promotion of therapeutic goods is strictly regulated by the TG Act.

At the outset, the promotion of prescription-only medicines (which includes medicinal cannabis) to the general public is generally prohibited (with some limited carve outs and exceptions), pursuant to sections 42DL(10) and 42DLA(7) of the TG Act. Similarly, the promotion of unregistered therapeutic goods is prohibited (see sections 42DL(12) and 42DLA(9) of the TG Act).

Further, advertising any therapeutic goods for the treatment of serious forms of disease or conditions (e.g. require diagnosis by a healthcare professional) is prohibited or restricted by the TG Act and its subordinate legislation. While approvals can be sought from the Minister to make representations relating to serious forms of diseases or conditions, it is an offence to make these representations where such permission has not been obtained.

It is also an offence under sections 42DM and 42DMA of the Act for a person or company to advertise therapeutic goods in a manner that does not comply with the Therapeutic Goods Advertising Code (TG Code). The TG Code includes a number of requirements (and prohibitions) when advertising to the general public.

Unlawful advertising of therapeutic goods can attract significant civil and criminal penalties. Where the conduct has resulted in, will result in or is likely to result in harm or injury to a person, a Court may impose a penalty of up to 5 years' imprisonment, or seek a financial penalty of up to 4,000 penalty units (which currently for an individual would be a fine of $1.32M or $6.6M for a body corporate). Separate penalties may be sought by the TGA in connection with each offence.

What allegations have been made by the TGA in relation to the Atlus proceedings?

The TGA has alleged that each of Atlus, Mamamia, and News Life engaged in unlawful advertising and promotion of medicinal cannabis by publishing materials across social media, the Atlus website, and articles on Body + Soul (News Life) and Mamamia that made both prohibited and restricted representations. These included claims about the use of medicinal cannabis for treatment of serious conditions such as chronic pain, endometriosis, arthritis, eczema, mental illness, and cancer. The Mamamia article also allegedly included a testimonial from a nurse and relative of a person involved in the marketing of medicinal cannabis at Atlus, and the Body + Soul article allegedly included endorsements from a doctor, both of which are prohibited by the TG Code.

The head of the TGA, Professor Anthony Lawler, has stated in media reports that Atlus, Mamamia, and News Life had been warned on multiple occasions in relation to the unlawful advertising of therapeutic goods, prior to the commencement of proceedings. In July 2024, the TGA issued infringement notices totalling $56,340 to News Life for alleged unlawful advertising of medicinal cannabis on Body + Soul.

This is a clear reminder to businesses to proactively respond to regulatory notices or warnings received from the TGA (or other regulatory bodies) to prevent escalation to formal proceedings, and to ensure that both future and historical content remains compliant or is otherwise removed.

It is noteworthy that the TGA has not only commenced proceedings against the entities responsible for publishing the advertisements but also against Straight Up, which is the PR firm that was engaged by Atlus and allegedly pitched the campaign to Mamamia and News Life, and Dr Jobanputra (the director of Atlus). This highlights how important it is that everyone responsible for content relating to therapeutic goods (including content in the health and wellbeing space) be aware of their obligations. It is clear that the TGA believes that responsibility falls to everyone involved in creating and publishing content, from the PR agent that pitches marketing ideas to the ultimate publisher of the content.

At the date of publication, none of the respondents have filed a defence in relation to these proceedings. The matter has been listed for case management on 8 September 2025, and we will be watching closely to see how it progresses.

ACCC targets misleading NDIS claims

The ACCC has issued infringement notices and penalties, and in one instance instituted proceedings, against several businesses for misleading representations made in relation to the National Disability Insurance Scheme (NDIS) in breach of the Australian Consumer Law.

Registered NDIS providers are permitted by the National Disability Insurance Agency (NDIA) under the NDIS Logo Guidelines to use the 'I heart NDIS' and 'I Support NDIS' logos, as well as the tagline 'Registered NDIS Provider', when advertising their products or services to the public, provided they comply with the conditions set out in the guidelines.

Providers must not, among other things, make statements:

• implying that they or their products or services have NDIS approval or endorsement; or
• that may be confusing or lead NDIS participants to incorrectly assume that the costs of a product or service will be covered under their NDIS plan when this may not be the case.

Providers who engage in such practices may contravene the misleading or deceptive conduct provisions under sections 18 and 29(g) and (h) of the Australian Consumer Law (Schedule 2 to the Competition and Consumer Act 2010 (Cth)).

Breaches of the Australian Consumer Law can attract significant civil and / or criminal penalties for individuals and businesses. The maximum penalty for a breach of the Australian Consumer Law is the greater of:

• $50,000,000
• if the Court can determine the value of the ‘reasonably attributable’ benefit obtained, three times that value; or
• if the Court cannot determine the value of the ‘reasonably attributable’ benefit, 30 per cent of the corporation's adjusted turnover during the breach turnover period for the contravention.

Recent enforcement action taken by the ACCC in this space includes:

• In December 2024, the ACCC instituted proceedings in the Federal Court against Ausnew Home Care Service Pty Ltd for alleged false or misleading representations relating to the sale of aged care and disability products, including the use of misleading pricing practices and statements that certain products were 'NDIS approved'.
• On 21 May 2025, Bedshed Franchising Pty Ltd paid $39,600 in penalties after it received two infringement notices for allegedly advertising on its website and Google Ads that some of its mattresses, furniture and bedding accessories were ‘NDIS approved’ and ‘NDIS permitted’.
• On 29 May 2025, Thermomix in Australia paid $79,200 in penalties after it received four infringement notices for allegedly making false or misleading representations to consumers online that two of its household appliances were endorsed through the NDIS by describing products as ‘NDIS approved’, ‘NDIS-registered product’, ‘NDIS-consumables’, ‘NDIS assistive technology’, and ‘NDIS equipment’.

We expect regulatory action in this space to continue, with the ACCC announcing it as one of their key compliance and enforcement priorities for 2025/26.

Ahpra takes action against Australian practitioners prescribing medicinal cannabis

In addition to regulatory action taken by the TGA against persons and businesses promoting therapeutic goods, Ahpra (the national regulator of healthcare professionals) has reportedly taken action against over 50 practitioners, pharmacists and nurses in respect of inappropriate medicinal cannabis prescribing and dispensing.

Ahpra has also released new guidance on medicinal cannabis prescribing, reminding practitioners of their responsibilities with respect to:

• professional conduct;
• obligations under the Health Practitioner Regulation National Law Act, which establishes requirements for advertising a regulated health service, in addition to regulating professional conduct; and
• advertising standards

In its guidance, Ahpra has indicated concerns that:

"Business models have emerged that appear to use aggressive and sometimes misleading advertising that targets vulnerable people" and that "some of these practices only offer the prescription and supply of a single product or class of drug and use online questionnaires that coach patients to say ‘the right thing’ to justify prescribing."

We have separately published an article summarising the key takeaways from the guidance.

Ahpra has said they are working with regulators including the TGA to investigate practitioners with high rates of prescribing medicinal cannabis. Information sharing between agencies is not uncommon and we expect that this may give rise to potential concurrent prosecution by multiple regulators, targeting different elements of the unlawful conduct including advertising, supply and prescription of therapeutic goods.

Non-compliant advertising of therapeutic goods and health services can be incredibly costly for businesses. Our dedicated Life Science and Health Regulatory team can support you in the assessment and management of compliance risks, including reviewing advertising strategies and your business' online presence.