Food vs medicine in Australia: when FSANZ ends and TGA begins (2026)

The food-medicine boundary is one of the most commercially significant — and most misunderstood — compliance questions for Australian supplement and health food brands. A magnesium tablet marketed for "muscle recovery" may be a Listed Medicine. A magnesium-fortified smoothie powder marketed for the same purpose may be a food. The same active ingredient, two different regulatory frameworks, two different sets of rules for what you can say on the label and in your advertising.

Getting this classification wrong is not a technicality. The TGA can require removal of products from sale if they are marketed as therapeutic goods without being listed or registered on the ARTG. FSANZ can take action against food businesses making health claims that exceed what the Food Standards Code permits. And the ACCC can act against both food and therapeutic goods businesses for misleading claims — regardless of which primary framework applies.

Under s.3 of the Therapeutic Goods Act 1989, a therapeutic good is a good that is represented to be, or is likely to be taken to be, for therapeutic use — including preventing, diagnosing, curing, or alleviating a disease, ailment, defect, or injury; influencing, inhibiting, or modifying a physiological process; or testing the susceptibility of persons to a disease or ailment.

The critical phrase is "represented to be." A product's classification is determined not only by its formulation, but by how it is presented to consumers. A protein powder that is sold with no health claims and positioned purely as a food ingredient may be classified as a food. The same protein powder marketed with claims that it "supports muscle repair after injury" may be classified as a therapeutic good — because the marketing has positioned it for therapeutic use.

This means that your marketing content can change your product's classification. A formulation decision made in product development can be undone by a single health claim in your Instagram caption.

The TGA publishes a Food-Medicine Interface Guidance Tool to help manufacturers, importers, and sponsors determine whether a product is likely to be a therapeutic good or a food for the purposes of Australian regulation. The tool assesses products based on: the ingredients and their concentrations; the dosage form (tablet, capsule, powder, liquid); the intended purpose as represented in marketing; and the likely consumer perception.

The TGA is explicit that the guidance tool does not determine compliance, and that responsibility for ensuring a product meets regulatory requirements remains with the manufacturer or importer. The tool provides an indication, not a ruling.

For borderline products — particularly powders, drinks, gummies, and concentrated herbal extracts — the guidance tool is the correct starting point. The output will indicate whether a product is more likely to be assessed as a food or a therapeutic good, and therefore which framework's marketing rules apply.

Products that sit clearly on the food side of the boundary are regulated by FSANZ. Products that sit clearly on the therapeutic goods side are regulated by the TGA. Products in the middle — the most common situation for functional food and supplement brands — require a deliberate classification decision, ideally supported by regulatory advice.

For products classified as foods, the Australia New Zealand Food Standards Code (specifically Standard 1.2.7 and Standard 2.9) governs what health and nutrition claims can be made.

The Code distinguishes between three categories of claims:

Nutrition content claims describe the presence or absence of a nutrient or energy — "high in protein," "low in sodium," "source of calcium." These are permitted where the product meets the prescribed thresholds set out in the Code.

General level health claims link a food or nutrient to a health effect that is not a disease — "calcium is good for healthy bones," "dietary fibre helps maintain digestive health." These claims must be based on a systematic review of the scientific evidence and must be on the FSANZ list of pre-approved general level health claims, or have been the subject of a self-substantiated claim assessment.

High level health claims link a food or nutrient to the reduction of risk of a disease — "diets high in calcium may reduce the risk of osteoporosis in people 65 years and over." High level health claims are only permitted from the pre-approved list in Schedule 2 of Standard 1.2.7.

The key constraint for supplement brands: FSANZ health claims are tied to specific nutrients at specific thresholds, assessed against the scientific evidence base that existed at the time the claim was approved. You cannot make a health claim about an ingredient just because you believe the evidence supports it — the claim must be on the approved list, or you must have completed the FSANZ self-substantiation process.

The practical implication of the food-medicine boundary for marketing teams is straightforward: you cannot determine whether your content is compliant without first knowing which framework applies. Applying TGA permitted indications rules to a FSANZ-regulated food product is not just unnecessary — it may create a false sense of compliance while the actual issue (an unpermitted FSANZ health claim) goes unreviewed. And vice versa.

The classification question should be answered once, documented, and reviewed whenever the product formulation, dosage form, or marketing position changes. It is not a set-and-forget decision.

The Therapeutic Goods Advertising Code is currently under formal review by the TGA (2025–26). This guide reflects the current Code. This content does not constitute legal advice. For binding classifications, consult the TGA or a qualified regulatory professional.

• Publishing without checking the complete advertisement’s overall impression.
• Treating one regulator’s checklist as coverage for every applicable framework.
• Failing to retain evidence showing what was reviewed and approved before publication.

CompliGUARD reviews the complete advertisement against TGA · AHPRA · FSANZ · ACCC requirements, identifies clause-level risks, proposes compliant wording, and retains the result in an audit trail before publication.