Short answer: if you sell a listed medicine (AUST L) in Australia, you can't write your own claims — you must pick the product's indications from the TGA's fixed Permitted Indications list and hold evidence for each one. Anything not on that list, and any claim to treat or cure a disease, isn't allowed on the listed pathway.
This one rule shapes nearly every Australian supplement label. Here's how it works and how to stay inside it. (It sits within the broader TGA framework for selling supplements into Australia.)
What is a "permitted indication"?
An indication is the claim about what a product is for — what it does or helps with. For listed medicines, the TGA publishes a closed list of permitted indications in a legislative instrument — currently the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025, which commenced 3 April 2025 (replacing the 2021 determination) — and a listed medicine may use only indications from that list. The list runs to several hundred low-level indications.
Why can't I just write my own claim?
Because the listed pathway trades pre-market evaluation for a fixed menu. The TGA doesn't review a listed product's efficacy before sale, so it constrains the language instead: pick from the approved list, and the claim is pre-vetted as appropriate for a low-risk self-certified product. Write your own, and you've stepped outside the listed-medicines framework — which is a compliance breach, not a creative choice.
What kinds of claims are on the list?
Permitted indications are low-level — health maintenance, support, and traditional-use style statements rather than disease claims. In practice that's why compliant Australian supplements say things like "supports", "helps maintain", "assists", or "maintains general health and wellbeing" rather than naming a condition. Traditional-use indications (e.g. for listed herbal medicines) generally must carry the required qualifying statement that the use is based on traditional evidence.
What evidence do I need to hold?
Self-certification isn't the same as no evidence. For every indication you use, you must hold evidence that supports it, and be able to produce it if the TGA asks — the agency runs post-market reviews and has cancelled products where the evidence wasn't there. The level of evidence depends on whether the indication is scientific or traditional.
What if the claim I want isn't on the list?
You have three realistic options:
- Reword to the closest permitted indication you can actually support.
- Go the assessed listed (AUST L(A)) route, where the TGA assesses your evidence for a stronger claim.
- Go the registered (AUST R) route for a higher-level or disease claim — see AUST L vs AUST R.
What you can't do is use the off-list claim on a listed product and hope it passes. Before you finalise wording, run your claim through our free checker to see how it reads against the rules — and note that the claims that get brands fined are almost always the ones that drift off the permitted list.
Last reviewed: June 2026. This article is general information, not legal or regulatory advice; the TGA framework is detailed and changes over time. Verify current requirements with the TGA or a qualified regulatory professional.