TGA vs FSANZ: which pathway does your supplement actually need?

One of the most common questions we hear from brands entering Australia: do I go through the TGA or FSANZ? The short answer is that it depends on what your product does and what you claim it does. The longer answer is below.

The fundamental split

FSANZ governs food and beverages. The TGA governs therapeutic goods. The classification that matters is not what category your product fits into in your home market. It's how Australian regulators would classify it based on the ingredients and claims on your label.

A protein powder with no therapeutic claims is a food under FSANZ. The same protein powder with a claim like 'supports muscle recovery' could cross into TGA territory. A probiotic capsule is almost always a therapeutic good. A probiotic yoghurt is almost always a food. The form and the claim together determine the pathway.

The TGA pathways: AUST L, AUST L(A), and AUST R

For products that are therapeutic goods, the TGA has three main listing and registration categories:

AUST L (Listed): For low-risk products with permitted ingredients and indications. Self-assessed by the sponsor. Fastest route to market. The TGA does not review the dossier before listing, but audits after.

AUST L(A) (Listed with Assessed Evidence): For products where the sponsor wants to use an indication that requires assessed evidence. The TGA reviews a dossier. Takes longer and costs more than AUST L.

AUST R (Registered): For higher-risk products. Requires full TGA review and approval. Significantly longer timelines and higher cost. Most food and supplement brands don't end up here.

The FSANZ pathway

If your product is a food, it falls under the Australia New Zealand Food Standards Code. FSANZ sets the rules for permitted ingredients, additives, nutrition labelling, and health claims. There is no pre-market approval process for most standard food products, but non-compliance still carries significant risk: recalls, border rejections, retailer delisting.

Nutrient content claims and health claims are tightly regulated under Standard 1.2.7. Only claims that meet specific conditions, using approved wording, are permitted. The most common mistake is importing a product with US or EU claims that have no FSANZ equivalent.

Where brands get the classification wrong

The classification decision is not always obvious, and the cost of getting it wrong is real. A product that should be AUST L gets sold as a food, attracts TGA attention, and faces a forced withdrawal. A product that could have been listed quickly goes through AUST L(A) unnecessarily, adding months and cost. A product with prohibited ingredients gets to the border and can't enter.

The most common errors: using a therapeutic claim on a food product, using a food claim on a therapeutic product, and using an ingredient that is permitted in foods but not in listed medicines (or vice versa).

What Taama checks

Taama gives you a definitive classification verdict for Australia, tells you which TGA pathway applies if your product is therapeutic, flags prohibited or restricted ingredients for both pathways, and validates your on-pack claims against FSANZ standards and TGA permitted indications. Run a free assessment to see where your product stands.