TGA Advertising Compliance: What the Montu Case Signals for Regulated Health Services

There is a hard truth about operating in a regulated sector. Your marketing compliance is judged not only by what you publish, but by the record you create getting there.

A Federal Court action between the Therapeutic Goods Administration (TGA) and one of Australia’s larger digital health providers has put corporate advertising governance back under the spotlight.

In April 2024, the TGA commenced proceedings against Montu Group Pty Ltd, its subsidiary Alternaleaf Pty Ltd, and their common director, over alleged unlawful advertising of medicinal cannabis on websites and social media. The proceedings remain before the court.¹

For businesses operating in regulated health, is a clear signal to every healthcare business and every individual practitioner about advertising governance, document retention, and the potential risks of getting compliance wrong.

Why Your Internal Marketing Communications Are Legally Discoverable

When a regulated business runs a marketing campaign, the creative process leaves a digital trail. Brainstorming boards on Miro, compliance discussions on Slack or Microsoft Teams, email threads working through messaging. All of it is standard practice. Many brands assume these internal platforms are private workspaces. They are not.

Once an enforcement body commences formal court proceedings, internal collaboration tools sit squarely within the reach of civil discovery. Slack channels, Teams histories, and Miro boards relating to the conduct in question can be required to be produced under the Federal Court’s procedural rules.

If a marketing team or external agency is floating exaggerated benefits or unapproved messaging in a private channel, that conversation can later become part of the evidentiary record.

For a regulated business, document retention is a core governance obligation, not an IT housekeeping task. The more risk-aware posture is simple: treat internal strategy conversations with the same care you apply to a published advertisement, because either one can end up in front of a regulator.

How TGA Advertising Compliance Works in Australia

The TGA regulates the advertising of therapeutic goods in Australia. The framework rests on one idea: advertising of therapeutic goods must be accurate, balanced, and support safe, informed choices by consumers.

Therapeutic goods, which include medicines, medical devices, and biologicals, cannot be marketed like ordinary consumer products. Every claim has to hold up against the framework set by the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code.

The Truthful, Evidence-Based Standard

All advertising of therapeutic goods to the public must be truthful, balanced, and capable of substantiation. Hyperbole and speculative benefit claims do not meet that standard.

• ARTG alignment, not “TGA approval”: This is the point most often misunderstood. The TGA does not pre-approve advertising claims and there is no such thing as a “TGA-approved claim” for a listed medicine or device. The obligation runs the other way. The advertiser must self-certify that consumer-facing copy is consistent with, and not broader than, the indications or intended purposes recorded for that product on the Australian Register of Therapeutic Goods (ARTG).²
• Substantiation: Representations about safety and efficacy must be supported by evidence before they are made, not justified after the fact.
• Clarity for the consumer: Factual, intelligible information is the most reliable route to a compliant advertisement.

The Rules for Medical Devices

The position for physical medical technology is just as strict. Advertising for medical devices must comply in full with the current Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, which is the binding instrument in force. There is no room for creative workarounds. A device that has not been evaluated and included on the ARTG cannot be advertised to the public at all.³

The Social Media Position: Same Rules, Faster Mistakes

Social media now drives much of healthcare marketing, and its speed is exactly where compliance slips. The TGA applies the same advertising rules to social platforms as it does to any other medium. A post on Instagram, TikTok, or Facebook carries the same legal weight as a television spot or a billboard.

A few practical points your team should treat as fixed.

1. The advertisement must be identifiable as advertising. A consumer should recognise content as advertising without having to act to find out. Hiding the commercial nature of a post behind a “see more” expansion, a buried caption, or a click-through does not meet the standard.
2. Mandatory statements must be prominent. Where a product requires a safety declaration or warning, that statement must be prominently displayed or communicated. In practice that means legible at a normal viewing distance, or clearly audible, without the consumer having to scroll, expand, or hunt through a carousel to find it.⁴
3. Required product information must be present. Where the Code requires particulars such as the product name and directions for proper use, removing them to make a post look cleaner is a breach, not a design choice.
4. The influencer question: the brand carries the risk. Engaging an influencer does not transfer your compliance obligation to them. If a third-party creator makes a non-compliant claim while promoting your product or service, the business that engaged them carries the exposure. Both the TGA and AHPRA can hold the business responsible.

One overriding point sits above all of the above. For prescription-only medicines, and for unapproved products such as most medicinal cannabis, advertising to the public is prohibited outright. No amount of layout, labelling, or disclaimer makes a public consumer advertisement for those products compliant. This is the heart of the TGA’s concern in the Montu proceedings.⁵

Testimonials and Endorsements: The AHPRA and TGA Divide

Reviews, testimonials, and endorsements are where regulated businesses get caught most often, usually because they apply one set of rules to a situation governed by another.

The distinction that matters: there is a real legal difference between advertising a regulated health service (a dental clinic, a medical practice) and advertising a therapeutic good (a medicine or a device). They sit under different regimes, and the testimonial rules are not the same.

Testimonials for Regulated Health Services

A regulated health service falls under the Health Practitioner Regulation National Law and AHPRA’s advertising guidelines. The common shorthand, “you can’t use patient testimonials,” is close but not accurate, and the difference is commercially important.

The prohibition applies to testimonials that refer to the clinical aspects of a regulated health service. That covers symptoms, diagnoses, the treatment a patient received, and clinical outcomes. A patient review that says a treatment cured a condition or relieved a symptom cannot be used in advertising, even where the patient offered it freely.⁶

Reviews that are purely non-clinical are a different matter. Feedback about reception staff, ease of booking, wait times, parking, or billing does not engage the testimonial prohibition in the same way, because it says nothing about clinical care. A clinic can work with non-clinical feedback while staying clear of anything that touches symptoms, diagnoses, treatments, or results.

The line is narrow and easy to cross. A five-star review that starts as a comment on friendly staff and ends with “and my back pain is finally gone” has crossed into clinical territory and cannot be used.

Testimonials for Therapeutic Goods

The position for therapeutic goods under the 2021 Code is also restrictive, and for prescription or unapproved products it is effectively a closed door.

Where consumer testimonials are permitted at all, they cannot be given by anyone involved in the production, sale, supply, or marketing of the goods. That rules out testimonials from people who have received any benefit for giving them, including brand ambassadors and paid influencers. A testimonial also cannot carry a claim that goes beyond what the product’s ARTG entry supports.⁷

Put those constraints together for a prescription-only or unapproved product such as most medicinal cannabis, and there is no compliant path to a public consumer testimonial. The product cannot be advertised to the public in the first place, which settles the question before the testimonial rules are even reached.

No Suggestion of Government Endorsement

This holds whether you are promoting a service or a product. An advertisement must not state or imply endorsement by the TGA or any government body. Presenting a product as “TGA approved” as a marketing badge is not permitted. The only acceptable references are factual statements about a product’s registration or listing status on the ARTG, used in their proper context.⁸

The Red Lines in Regulated Marketing

Some boundaries are absolute. Cross them and the business moves from a growth position to a serious legal exposure in a single step.

1. No direct-to-consumer advertising of prescription medicines: Advertising prescription-only medicines to the public is prohibited. This is the engine behind the TGA’s scrutiny of medicinal cannabis and telehealth. Where a product requires a prescription, marketing has to stay on the right side of the line: factual education about a condition or a service, not promotion of the restricted product itself.⁹
2. Clinical trials cannot claim safety or efficacy: Advertising for a clinical trial must not represent that the treatment is safe or effective. The point of a trial is to test exactly that, so claiming the answer before the data exists is a clear breach.
3. No guaranteed or instant outcomes: Advertising must not promise guaranteed or instant results, or create unrealistic expectations. Vulnerable consumers are the people most exposed to bold promises, which is why this prohibition is enforced firmly. Any suggestion of a guaranteed cure or a flawless result is treated as misleading.

The Cost of Getting It Wrong

The consequences of non-compliant advertising run well past a warning letter. The framework is built to penalise breaches and to deter the rest of the sector from cutting corners. A breach of the advertising provisions can attract civil penalties and, in serious cases, criminal liability, and for an individual practitioner it can put professional registration at risk.

• Infringement notices: Penalties are set by reference to Commonwealth penalty units. At the current penalty unit value, an infringement notice for a body corporate can reach 60 penalty units (around $19,800), and the TGA can issue a separate notice for each breach. (Penalty unit values are indexed and adjusted periodically, so the dollar figure shifts over time.)¹⁰
• Court-imposed penalties: Matters that proceed to the Federal Court carry far larger civil penalties, into the millions of dollars per breach for a corporation, alongside injunctions and declarations of the kind the TGA is seeking in the Montu proceedings.
• Personal exposure: Individuals face their own infringement and civil penalty exposure, and directors can be pursued personally where they are alleged to have been involved in the conduct. The Montu proceedings, which name the companies’ director personally, are a live illustration.
• Audits and disruption: A non-compliant campaign can trigger an investigation that consumes management attention and legal cost long after the original post comes down.
• Reputation: Misleading health claims erode public trust, and that damage outlasts any fine.

Mitigating Regulatory Risk in Your Marketing

Operating at the intersection of strict government rules and modern digital marketing takes specialist oversight. Generic agency frameworks are built for unregulated sectors, and applying them to therapeutic goods or regulated health services is how businesses end up in the position Montu now occupies.

At ContentClicks we build risk-aware content strategies for healthcare, financial, and legal practices. We keep public messaging evidence-based and aligned to the relevant framework, and we help you maintain a clean, defensible audit trail behind it.

If you want to protect your practice or corporate entity against costly advertising breaches, explore our regulated-industry content services and build a compliant, high-performing marketing program that protects your reputation.

Bibliography

A  Legislation

• Crimes Act 1914 (Cth)
• Health Practitioner Regulation National Law
• Therapeutic Goods Act 1989 (Cth)
• Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cth)

B  Other

• Australian Health Practitioner Regulation Agency, ‘Guidelines for Advertising a Regulated Health Service’, Ahpra (Web Page, December 2020) <https://www.ahpra.gov.au/Publications/Advertising-hub/Guidelines-for-advertising-regulated-health-services.aspx>
• Therapeutic Goods Administration, ‘Court Proceedings Initiated against Montu Group Pty Ltd, Alternaleaf Pty Ltd, and an Individual for Alleged Unlawful Advertising of Medicinal Cannabis’, Therapeutic Goods Administration (Media Release, 18 April 2024) <https://www.tga.gov.au/news/media-releases/court-proceedings-initiated-against-montu-group-pty-ltd-alternaleaf-pty-ltd-and-individual-alleged-unlawful-advertising-medicinal-cannabis>
• Therapeutic Goods Administration, ‘Therapeutic Goods Advertising Code’, Therapeutic Goods Administration (Web Page) <https://www.tga.gov.au/how-we-regulate/advertising/therapeutic-goods-advertising-code>
• Therapeutic Goods Administration, ‘Medicinal Cannabis Hub’, Therapeutic Goods Administration (Web Page) <https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis-hub>