TGA · AHPRA · FSANZ · ACCC

How do I know if my health product is regulated by TGA or FSANZ in Australia?

CompliGUARD reviews this compliance area against TGA · AHPRA · FSANZ · ACCC frameworks for Australian health brands — here's what the regulations say.

CompliGUARD helps brands determine whether a product sits under the TGA or FSANZ before marketing it. Whether your product is regulated by TGA or FSANZ depends on how it is presented to consumers — a product marketed for therapeutic use (preventing, treating, or modifying a physiological process) is likely a therapeutic good regulated by TGA; a product marketed as food or nutrition is regulated by FSANZ under the Australia New Zealand Food Standards Code.

The rule: Therapeutic Goods Act 1989 / Food Standards Australia New Zealand Act 1991, Therapeutic Goods Act 1989, s.3; TGA Food-Medicine Interface Guidance Tool

Under s.3 of the Therapeutic Goods Act 1989, a therapeutic good is any product represented to be for therapeutic use — including preventing, curing, or alleviating a disease; modifying a physiological process; or influencing the structure or function of the body. The critical word is 'represented': your marketing content can change your product's classification. A protein powder sold without therapeutic claims is a food regulated under FSANZ. The same protein powder marketed with claims about muscle repair or recovery may be a therapeutic good requiring ARTG listing. The TGA publishes a Food-Medicine Interface Guidance Tool to help determine which framework applies — but the tool is indicative, not definitive.

What this means in practice

Use the TGA's Food-Medicine Interface Guidance Tool as your first step for any borderline product — it assesses ingredients, concentration, dosage form, and intended purpose.
Review your marketing claims alongside the tool assessment — if your claims push a food product toward therapeutic territory, either obtain ARTG listing or revise the claims.
Document your classification decision: record the tool output, the claims you intend to make, and why you concluded the product sits in its assigned category.
Review classification whenever you reformulate, change dosage form, or update marketing positioning — any of these can shift the classification.
If classification is genuinely unclear, seek regulatory advice before launching advertising — the consequences of applying the wrong framework are more costly than the advice.

Common mistakes

Mistake

Assuming powder, gummy, or liquid formats are always foods

Problem

Dosage form alone does not determine classification. A gummy vitamin with ARTG-listed ingredients marketed for immune support is a Listed Medicine regardless of its form. Classification follows the ingredients, concentration, and claims — not the format.

Fix

Assess each product against the TGA Food-Medicine Interface Guidance Tool on its merits — do not assume classification based on form factor.

Mistake

Making therapeutic claims on a product registered as a food

Problem

A product with FSANZ food classification making therapeutic claims (treating, preventing, or modifying a health condition) may be operating as an unregistered therapeutic good — subject to TGA enforcement regardless of its FSANZ status.

Fix

Separate the classification question from the claims question. If you want to make therapeutic claims, the product needs ARTG listing. If the product is a food, claims must stay within FSANZ Standard 1.2.7.

Compliant vs non-compliant example

❌ NON-COMPLIANT

Assuming powder, gummy, or liquid formats are always foods

✅ COMPLIANT

Assess each product against the TGA Food-Medicine Interface Guidance Tool on its merits — do not assume classification based on form factor.

The enforcement context

The TGA can require products to be removed from sale if they are marketed as therapeutic goods without being listed or registered on the ARTG. In 2023–24, the TGA issued 4,806 removal requests — including products found to be operating as therapeutic goods without appropriate registration. FSANZ and state food authorities can also act against food businesses making health claims that exceed what the Food Standards Code permits.

Before you publish, check it.

CompliGUARD begins every review with product classification — routing content to the correct framework before assessing any claim.

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Regulatory references

Therapeutic Goods Act 1989 (Cth), s.3
Food Standards Australia New Zealand Act 1991 (Cth)
Australia New Zealand Food Standards Code, Standard 1.2.7
TGA Food-Medicine Interface Guidance Tool