Prohibited and Restricted Representations

The sentence that keeps lawyers awake

Section 22 of the Therapeutic Goods Act 1989 (Cth) is not long. But I've watched it trip up companies that absolutely should have known better. The short version is this: certain representations about therapeutic goods are flatly prohibited in Australia, and cannabis products , whether listed, registered, or accessed via a pathway like the Special Access Scheme , are not exempt.

This matters more than most people realise. Because the regulatory architecture around medicinal cannabis has expanded quickly since 2016, there's a persistent misconception floating around that as long as a product has a legitimate TGA access pathway, the communications around it can be relatively loose. They cannot. If anything, the scheduling status of most cannabis products sharpens the obligations.

What "prohibited representations" actually means

The Therapeutic Goods (Prohibited Representations) Instrument 2021 (F2021L01572) sits under the Act and consolidates a list of representations that must not be made about therapeutic goods , with or without ministerial consent. These are representations that state or imply a product can be used to treat, cure, prevent, or alleviate serious diseases. The list is specific. It includes things like cancer, HIV/AIDS, serious forms of mental illness, and certain other conditions that the TGA has determined require protection from unsupported or misleading claims.

Prohibited representations are distinct from what the Act calls "restricted representations"; those that require the explicit written consent of the Secretary before they can be used. Both categories are separate again from the broader advertising framework, which prohibits prescription-only medicines from being advertised to the general public altogether. And most medicinal cannabis products sit at Schedule 4 or Schedule 8 in the Poisons Standard, which means the advertising prohibition applies automatically.

So: even if you avoid a prohibited representation, you still cannot advertise a Schedule 4 or Schedule 8 product to consumers. The frameworks stack.

How cannabis products fit into the picture

A medicinal cannabis product that contains cannabidiol at prescription strength, or any product containing tetrahydrocannabinol, is prescription-only at minimum. That restricts who can see promotional material about it, essentially to healthcare professionals, not lay consumers.

Where it gets genuinely complicated is with the lower-schedule CBD products. In 2020 the TGA down-scheduled certain low-dose CBD preparations to Schedule 3 (pharmacist-only), meaning limited consumer-facing communication became theoretically possible. But any such communication still cannot include a prohibited representation, and any claim about what the product does, not just what it contains; must be supported by evidence and approved through the relevant pathway. In practice this is a narrow corridor to walk.

I'll be honest: I've seen sponsors draft communications that are technically Schedule 3–compliant on the scheduling question but still fall foul of the representations rules because a copywriter somewhere decided to describe the mechanism in aspirational terms. Describing how CB1 receptors or CB2 receptors interact with a compound is mechanistic and educational. Describing that interaction in a way that implies clinical benefit to a named condition is a representation, and if that condition is on the prohibited list, you're in breach regardless of scheduling.

The ARTG listing and what representations can void it

Products on the Australian Register of Therapeutic Goods (ARTG) are entered on the basis of the indications a sponsor has submitted and the TGA has accepted. A sponsor is bound to those indications. If the approved entry says "to reduce the frequency of seizures in patients with [specific condition]", that's the indication, and any communication that stretches that framing, even slightly, into territory implying broader uses constitutes an unapproved representation.

This is not an abstract enforcement problem. The TGA's Advertising Compliance team actively monitors, and the consequences for a breach can include recall, suspension, or cancellation of the ARTG entry. For an Authorised Prescriber operating under TGA approval, inappropriate representations could implicate their approved prescriber status as well.

I spent a Saturday morning last winter; Trevor the sourdough starter fermenting quietly on the bench, going through a batch of TGA compliance notices from 2022–23. A notable chunk of them involved companies that had listed products correctly, then undermined themselves in their own press releases or website copy. It is a remarkably consistent pattern.

Restricted representations: the consent pathway

Some representations are not outright prohibited but are restricted, meaning they require the Secretary's written consent before being used. These tend to involve serious conditions that are not on the absolute prohibited list but still warrant oversight. The consent process involves demonstrating that the representation is accurate, that it is based on evidence the TGA considers adequate, and that it won't mislead consumers.

In theory, this provides a legitimate route to making more clinically specific claims. In practice, the evidence bar is high, the process takes time, and the consent is condition-specific. Getting consent to make a restricted representation for one indication doesn't generalise to others. Each one stands alone.

My measured view on this: the consent pathway exists for good reasons, and it's underused by sponsors who have genuinely strong evidence but are either unaware of it or find the process daunting. The TGA's published guidance on restricted representations (on tga.gov.au) is reasonably clear, and sponsors who have done the hard yards through proper clinical development should be engaging with it rather than defaulting to vague, representation-free language that provides no useful information to prescribers either.

What this means for educational content specifically

Educational or informational content; like this article, sits in a different category. Explaining that CBD interacts with the endocannabinoid system, or that research into cannabinoids covers a range of mechanisms, is not a therapeutic representation in the same sense. But the moment that framing is used by a product sponsor in connection with a specific product they supply, the regulatory character of that communication can shift. Context determines classification.

Journalists, researchers, and independent educators describing chemistry and scheduling frameworks are not making representations about a product on the ARTG. Sponsors distributing that same content in a way that connects it to their product might be. The TGA looks at purpose and likely effect, not just the literal words.

A note on the Poisons Standard and scheduling interplay

The Poisons Standard (formally, the Standard for the Uniform Scheduling of Medicines and Poisons) sets scheduling but doesn't by itself govern communications. What it does do is trigger the advertising restrictions in the Act: Schedule 4 and Schedule 8 goods cannot be advertised to the general public, full stop, regardless of whether the specific claim being made would otherwise be permissible. This is why understanding the relationship between the Poisons Standard and the representations framework, rather than treating them as separate silos; is so important.

Anyone working in this space should keep both documents open at the same time. The Standard tells you what the product is classified as. The Act and the Prohibited Representations Instrument tell you what you can say about it and to whom.

Sources

• Advertising therapeutic goods in Australia: regulatory framework overview, TGA
• Therapeutic Goods Act 1989, Federal Register of Legislation
• Therapeutic Goods Advertising Code; TGA
• Advertising medicinal cannabis, TGA

, Marcus Hale, Regulatory researcher, TGA & access law