Australia has one of the more structured supplement regimes in the world — and it surprises a lot of brands, because most supplements aren't regulated as food there. They're regulated as medicines. If you're bringing a vitamin, mineral, herbal, or other complementary product into Australia, here's what actually governs you.
First: TGA or FSANZ?
Two regulators split the territory. FSANZ (Food Standards Australia New Zealand) handles foods. The TGA (Therapeutic Goods Administration) handles therapeutic goods — and most vitamins, minerals, herbal products, and complementary medicines fall under the TGA, not the food rules. Working out which side of the line your product sits on is the first decision, and it shapes everything after it.
The three TGA pathways
Assuming your product is a therapeutic good, there are three routes onto the Australian Register of Therapeutic Goods (ARTG):
- Listed medicines (AUST L) — the pathway for the majority of low-risk supplements. The sponsor self-certifies compliance; the TGA does not pre-evaluate the product for efficacy before sale. But this freedom comes with hard constraints (below).
- Assessed listed medicines (AUST L(A)) — like a listed medicine, but the TGA has assessed the evidence behind the indication, allowing a "TGA assessed" claim on the label.
- Registered medicines (AUST R) — the high-risk / higher-claim pathway, with full pre-market evaluation. This is what you need to make stronger therapeutic claims.
An ARTG number on a label is not a TGA stamp of proven effectiveness — for listed medicines it means the sponsor certified compliance, not that the TGA tested the product.
The two constraints that catch brands out
If you go the common AUST L route, two rules do most of the damage to unprepared brands:
1. Permitted ingredients only. A listed medicine can contain only ingredients on the TGA's Permissible Ingredients Determination — a curated list of substances assessed as low-risk, often at specified dose limits. If your ingredient isn't on that list, you can't use it in a listed medicine, full stop. This is where novel ingredients, higher doses, and trendy actives routinely fail.
2. Permitted indications only. You can't say whatever you like about the product. Listed medicines must select their indications (therapeutic uses) from the TGA's pre-approved Permissible Indications list — several hundred permitted indications — and you must hold evidence to support any you use. Claims to treat, cure, or prevent a disease aren't available on this pathway at all; those require registration.
Don't forget scheduling
Separately from all of the above, the Poisons Standard schedules substances by risk. If an ingredient is scheduled — Schedule 4 (prescription only), Schedule 8 (controlled), and so on — it can't sit in an over-the-counter listed medicine. This is exactly where ingredients like certain cannabinoids, some peptides, and various pharmacologically active compounds come unstuck: they may be perfectly real ingredients, but their scheduling puts them out of reach of the supplement pathway.
Advertising is regulated too
How you promote the product is governed by the Therapeutic Goods Advertising Code (the 2021 Instrument), under the Therapeutic Goods Act 1989. You can only advertise the indications in your ARTG entry, claims must be substantiated and not misleading, and prescription medicines can't be advertised to consumers at all. The TGA runs post-market compliance reviews and has cancelled and recalled non-compliant products — so the certify-it-yourself freedom of the listed pathway comes with real, enforced accountability.
The practical takeaway
Selling into Australia comes down to three questions, in order:
- Is every ingredient permitted (on the Permissible Ingredients list at your dose), and is none of them scheduled out of reach?
- Are your claims permitted indications you can actually substantiate?
- Does your advertising comply with the Advertising Code?
Get those wrong and the cost is cancellation, recall, or worse — after you've already shipped. Get them right before launch and Australia is a well-defined, navigable market. Regulave checks your ingredients against the Australian permitted/scheduled lists and your claims against what the framework allows, market by market, so you find the AUST L blockers before you commit to a formulation or a label.
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. Check your formulation and label against Australian rules with Regulave →