New TGA Guidance on Advertising Prescription Medicines: What Clinics Must Change Now

What the TGA alleges, in plain terms

According to the TGA media release, the regulator has commenced proceedings in the Federal Court of Australia against Better Leaf, Better Life and their sole director, Mr Jack Weisberg, for the alleged unlawful advertising of medicinal cannabis. Cannabiz reports that 44 advertising breaches are alleged across the matter.

The TGA alleges the companies advertised medicinal cannabis using terms including "medical cannabis" and "plant medicine", and that the advertising allowed patients to purchase prescription-only medicines following an online consultation. The TGA further alleges the advertising promoted medicinal cannabis for the treatment of serious diseases, conditions and disorders, a category of claim known as restricted or prohibited representations, which are not permitted in advertising for therapeutic goods.

The TGA also alleges the advertising implied that medicinal cannabis had been approved or recommended on behalf of the TGA itself, and that it included endorsements from current or former health practitioners. According to the TGA media release, the alleged advertising appeared on the companies' website, on social media pages, and in physical pamphlets at the dispensary. The TGA is seeking declarations and pecuniary penalties.

Why this followed warnings, not just a single letter

The TGA media release makes clear that this Federal Court action did not come first. The regulator issued repeated warnings and multiple infringement notices to Better Leaf and Mr Weisberg for alleged unlawful advertisements before commencing proceedings. Those infringement notices were not paid.

That escalation sequence matters for every health advertiser. It tells you the TGA has a staged enforcement approach, and that continuing to publish content that has been flagged by the regulator accelerates movement through that sequence. The time between a first warning and court proceedings is not infinite, and the record of what was published and when is preserved.

The practical takeaway is not that the regulator is waiting to catch you. It is that the escalation pattern is predictable, and that the earliest point in that sequence, before anything is published, is where your workflow should be doing the work.

Five advertising patterns that recur across regulated health content

• Naming or describing a prescription-only product directly to a consumer audience, without the restrictions that apply to prescription product advertising.
• Using softer or more colloquial language, terms like 'plant medicine' or 'natural remedy', that may still constitute advertising for a therapeutic good and attract the same rules.
• Making therapeutic claims about serious diseases, conditions or disorders, even if those claims are framed as patient stories, statistics or general wellness information.
• Implying that a product or service has been endorsed, approved or recommended by a regulator such as the TGA, even by association or by quoting regulatory language out of context.
• Using endorsements from health practitioners, current or former, as social proof in consumer-facing advertising, which raises separate considerations under the Therapeutic Goods Advertising Code.

Every channel is advertising

One detail from the TGA media release that health advertisers should sit with: the alleged breaches covered the companies' website, their social media pages, and physical pamphlets in the dispensary. That is not unusual. For the purposes of the therapeutic goods advertising rules, your website, your Instagram, your Google Ads, your email newsletter, and the A4 sheet in your waiting room are all advertising. The format does not change whether the rules apply. If you treat your social posts as lower-stakes than your website copy, or your printed materials as outside the scope of digital advertising review, that is a gap worth closing.

What a compliance-first content workflow actually looks like

The documented review step

A compliance-first workflow does not mean slower content or endless legal rounds. It means your review happens before publication, not after a complaint arrives. The practical centre of it is a documented review step: every piece of content that makes a therapeutic claim, names a product, or targets a patient audience goes through a defined approval process before it goes live.

That process should produce a record. Who reviewed the content? What claims were checked? Who gave final approval? A written record does not guarantee a particular outcome, but it demonstrates that your business took the rules seriously and built a process around them. That is a different posture than content that went live because no-one stopped it.

Who owns the claims in your copy

Accountability in the approval chain

The TGA proceedings name both the companies and the sole director individually. That is consistent with how Australian consumer and therapeutic goods law treats responsibility for published advertising: the business and the individuals who authorise the content can both be in scope.

For a clinic owner or marketing manager, this means it is worth being clear about who in your organisation is accountable for the claims that go into your content. If your marketing team writes the copy, your receptionist posts to social, and no-one with a clear understanding of the advertising rules reviews it before it goes live, that chain has a gap. Closing that gap means identifying one person, or one external partner, whose job it is to know the rules and check the content against them before publication. At ContentClicks, that person is an admitted lawyer who works directly on client content before it goes anywhere.

Compliance is the starting point, not a review step at the end. If the copy is done before anyone checks whether it can legally be published, you are already behind.

— Ivan Lusica, ContentClicks co-founder

What to do with your existing content right now

If you have not reviewed your website, social media pages, email content, or printed materials against the Therapeutic Goods Advertising Code recently, this case is a prompt to do that. The questions to start with are straightforward: Does any of your content name or describe a prescription-only product to a consumer audience? Does it make claims about serious diseases or conditions? Does it imply regulator approval or use practitioner endorsements as social proof? Does it appear on any channel, including physical materials at your premises, that you have not treated as advertising for compliance purposes?

You do not need to answer those questions alone. A structured compliance review of your existing marketing content will surface the gaps and give you a clear list of what to fix. That is exactly what our compliance review is designed to do.

Frequently asked questions

Do the therapeutic goods advertising rules apply to social media posts, not just paid ads?

Yes. For the purposes of Australian therapeutic goods advertising rules, social media posts, website copy, email content, and physical materials such as waiting-room pamphlets are all treated as advertising if they promote a therapeutic good or health service to consumers. The TGA media release in this case specifically identifies the companies' website, social media pages, and physical pamphlets as channels where alleged breaches occurred.

What is a restricted representation under the Therapeutic Goods Advertising Code?

A restricted representation is a claim that refers to the treatment, cure or prevention of a serious disease, condition or disorder. The Therapeutic Goods Advertising Code restricts or prohibits these in consumer advertising for therapeutic goods. This is a technical area of law and the specifics depend on the product and the claim, so check with a qualified adviser about your own content.

Can a practitioner endorsement appear in health advertising?

Practitioner endorsements in consumer-facing therapeutic goods advertising raise specific considerations under the Therapeutic Goods Advertising Code. The TGA alleges that the advertising in this case included endorsements from current or former health practitioners. Whether an endorsement is permitted depends on how it is framed and what it is endorsing. Get advice from a qualified practitioner before using them.

What does the TGA's escalation process look like before it takes court action?

Based on the TGA media release for this matter, the regulator issued repeated warnings and multiple infringement notices before commencing Federal Court proceedings. That escalation sequence suggests the TGA expects businesses to respond to earlier notices. Continuing to publish content that has been flagged accelerates movement through that process.

Does this apply to my business if I do not sell medicinal cannabis?

The advertising rules that apply in this case cover therapeutic goods advertising broadly, not only medicinal cannabis. If your business advertises any therapeutic good, including medicines, medical devices, or health supplements, or makes therapeutic claims about health services, the Therapeutic Goods Advertising Code is relevant to your content. Speak with a qualified adviser about your specific situation.

What should a pre-publication compliance review actually involve?

At a minimum, a pre-publication review should check whether the content names or describes a prescription-only product to a consumer audience, makes claims about serious diseases or conditions, implies regulator endorsement, or uses practitioner endorsements as social proof. It should produce a written record of who reviewed the content, what was checked, and who approved it for publication. The review should be done by someone with a clear working knowledge of the Therapeutic Goods Advertising Code.

References

• Therapeutic Goods Administration. TGA commences Federal Court proceedings against Better Leaf Pty Ltd, Better Life Aussie Pty Ltd and their sole director. tga.gov.au
• Therapeutic Goods Administration. TGA commences Federal Court proceedings against AG Therapeutics (Atlus), Mamamia, News Life Media and Straight Up PR. tga.gov.au
• Therapeutic Goods Administration. TGA issues infringement notices to News Life Media for alleged unlawful advertising of medicinal cannabis. tga.gov.au
• Therapeutic Goods Administration. TGA issues infringement notice to Myers Pharmacy for alleged unlawful advertising of Ozempic. tga.gov.au
• Therapeutic Goods Administration. TGA commences Federal Court proceedings against Montu Group and Alternaleaf. tga.gov.au
• Therapeutic Goods Administration. Federal Court imposes largest ever penalty for contravention of the Therapeutic Goods Act — Medtronic Australasia. tga.gov.au
• Federal Register of Legislation. Therapeutic Goods Act 1989 (Cth). legislation.gov.au
• Federal Register of Legislation. Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021. legislation.gov.au
• Therapeutic Goods Administration. Advertising therapeutic goods in Australia — compliance and enforcement. tga.gov.au