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 is 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 the category your product sits in at home. It's how Australian regulators would classify it based on the ingredients and the claims on your label.

A protein powder with no therapeutic claims is a food under FSANZ. Put it in a medicine-style dose form or add a therapeutic claim, and it can cross into TGA territory. The regulator has formally pulled certain sports supplements into therapeutic-goods regulation for exactly this reason. A probiotic capsule is usually a therapeutic good. A probiotic yoghurt is usually a food. Form and claim together decide the pathway.

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

For products that are therapeutic goods, the TGA has three main entry pathways:

• AUST L (Listed) - Low-risk products built only from pre-approved permissible ingredients, carrying only pre-approved permissible indications. The sponsor self-certifies; the TGA does not assess the product before it lists, but holds the sponsor to having evidence and audits after market. Fastest route in.

• AUST L(A) (Assessed Listed) - Same low-risk ingredient rules as AUST L, but for products whose claims go above what a plain listing allows, beyond the "support / help / maintain" register of permissible indications and into stronger efficacy claims that can reference a specific condition. Because the claim is higher, the TGA reviews the supporting evidence before listing, which is why these products can display a "TGA assessed" mark. Slower and more expensive than AUST L.

• AUST R (Registered) - Higher-risk products that face full TGA evaluation for safety, quality, and efficacy before 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 claims. There's no pre-market approval for most standard foods, but non-compliance still carries real consequences: recalls, border rejections, retailer delisting.

Claims are the tightest part. Under Standard 1.2.7, nutrition content claims and health claims are only permitted when they meet specific conditions and approved wording. Two things catch brands out:

• Health claims are gated by the NPSC - Before a food can carry any health claim, it has to pass the Nutrient Profiling Scoring Criterion. A product high in saturated fat, sugar, or sodium fails the gate and can't make the claim at all, no matter how the claim is worded.

• Imported claims rarely translate - US or EU claim language frequently has no FSANZ equivalent, and dropping it straight onto an Australian label is one of the most common failures we see.

And FSANZ isn't the only enforcer: misleading claims on food are also actionable under Australian Consumer Law through the ACCC.

Where brands get the classification wrong

The decision isn't 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 listed quickly goes through AUST L(A) unnecessarily, adding months and cost. A product with prohibited ingredients reaches the border and can't enter.

The recurring errors: a therapeutic claim on a food product, a food-style claim on a therapeutic product, and an ingredient that's permitted in foods but not in listed medicines (or the reverse).

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 across both pathways, and validates your on-pack claims against FSANZ standards (including the NPSC gate) and TGA permitted indications. Book some time with us to see where your product stands.