Medicine, food or cosmetic? How a product's pathway is decided

In short

• In Australia the same capsule or powder can be a listed medicine or a food, and the same cream a listed medicine or a cosmetic.
• Mostly, presentation decides: the claims, the name, the form, the dose, even where the product is sold.
• Declared goods, such as beauty supplements, are medicines whatever else applies. Excluded goods, such as an SPF 4 to 15 moisturiser that meets its conditions, are not.
• The pathway decides the ingredients you can use, the claims you can make, the label and who regulates you.

Three pathways, three sets of rules

	Listed medicine	Food	Cosmetic
The law	Therapeutic Goods Act 1989, run by the TGA	The Food Standards Code, written by FSANZ and enforced by the states, territories and local councils	Consumer law, with the ACCC as the main regulator of safety, ingredient labelling and claims; AICIS regulates the import and manufacture of cosmetic ingredients under the Industrial Chemicals Act 2019
Before you sell	Entry on the Australian Register of Therapeutic Goods (ARTG); the AUST L number goes on the label	The product must comply with the Code	A business that imports cosmetics or their ingredients, or makes the chemicals in them, registers with AICIS for each year it does, with exclusions such as small-batch soap
What you can claim	Therapeutic claims only from the TGA's permitted indications, with evidence held for every indication and claim	Health claims only on foods that meet the Code's nutrient profiling test (special purpose foods, such as sports foods, don't need to): high level claims from its pre-approved list, general level claims from that list or a relationship notified to FSANZ first, and never about preventing, diagnosing, curing or alleviating a disease	Appearance, cleansing, odour, protecting the skin and keeping it in good condition
Ingredients	Only those in the Permissible Ingredients Determination	As the Code allows: novel foods must be listed, vitamins and minerals added only as permitted	Each chemical introduction is categorised under AICIS rules
Examples from our work	Capsules, tablets, powders and a kava cream	A sports brand's performance powder; functional foods in Ora's range	Vitable's hair serum

How the line is drawn

The rules are applied in roughly this order:

1. Declared goods are medicines, whatever else applies. Some products are declared therapeutic goods by form alone: fibre in tablets, capsules or pills; isolated HMB or its salts (or a product promoted to contain them) in tablets, capsules, pills or powders; and shark cartilage in tablets, capsules or pills, or in a powder that isn't a wholesale product for use as a food ingredient. Others are declared by how they are presented: anything swallowed that is labelled or promoted for cosmetic purposes (beauty supplements), and sports supplements presented for a therapeutic use, such as gaining muscle, that contain certain substances or, since 30 November 2023, come as a tablet, capsule or pill.
2. Excluded goods are not. The Excluded Goods Determination takes some products out of the medicines rules if they meet every condition it sets, such as an SPF moisturiser of SPF 4 to 15 that meets its conditions, or an acne product presented as controlling acne only by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons.
3. Otherwise, presentation decides. A product is a therapeutic good if it is presented as, or likely to be taken to be, for therapeutic use: preventing, curing or alleviating a disease, or "influencing, inhibiting or modifying a physiological process". The TGA weighs the name, the claims, the form, dosage instructions, warnings, the advertising and even where it is sold.
4. Foods have two ways out. A swallowed product is a food if a food standard covers it, such as Standard 2.9.4 for formulated supplementary sports foods, or if it has a tradition of use as a food in Australia or New Zealand in the form presented. A disease claim, or a health claim the Code doesn't permit, doesn't turn such a product into a medicine; it makes it a food breaking Standard 1.2.7. More on the food pathway.
5. Form can move a product across. A herb eaten as fresh leaves is a food; extracted, concentrated and sold in a capsule, it may be a medicine.
6. On the skin, the claim decides. A cream, serum or lotion is a cosmetic while it only changes appearance, cleanses, perfumes, protects or keeps the skin in good condition. A claim to treat a condition, an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, or the way it is used can make it a therapeutic good. The skincare page has the claim examples and the sunscreen rules.

What people often get wrong

• "A health claim makes it a medicine." Not on its own. A food that a food standard covers stays a food. It can carry a health claim that meets Standard 1.2.7, but a claim to prevent, cure or alleviate a disease is not allowed on any food.
• "Capsules and powders are medicines." The TGA says the fact that a product "comes in capsules or powders, or is labelled as a 'dietary supplement'" doesn't decide it, though form is one of the factors it weighs.
• "Listed medicines have been evaluated by the TGA." They are not individually evaluated. The sponsor certifies that the product meets the rules, and the TGA can review any listing afterwards. Our TGA listing guide explains what that means.
• "FSANZ approves self-substantiated claims." It doesn't assess them, and publishing a notification is not approval. Nor can one business rely on another's notification.
• "AICIS registers products." It registers businesses, not products or ingredients, and it doesn't set or enforce labelling rules.

What happens on the wrong side

A product that is really a medicine must, unless it is exempt or otherwise authorised, be on the ARTG before it is imported, supplied or advertised. The TGA's own guidance lists civil and criminal penalties, with civil penalties for a company of up to 50,000 penalty units for a single contravention: $18.2 million at the $364 penalty unit that applies from 1 July 2026. A food making disease claims, or health claims the Code doesn't permit, breaks the Food Standards Code, which the states and territories enforce. Either way, finding out after launch means relabelling, reformulating or withdrawing stock.

How we settle it

At the brief, before anyone designs a formula, we test the product against these rules: its ingredients and doses, the claims the brand needs to make, the format and where it will be sold. Then we build for that pathway. A sports brand's four capsules went through as TGA-listed medicines and its performance powder as a food. Vitable's capsule is a listed medicine and its matching serum a cosmetic. A kava cream we developed is a listed medicine, not a cosmetic, because of what it is for.

To test a product of your own against these rules, ask your AI assistant: the same check runs in Claude, ChatGPT and other assistants, with each rule quoted from this page.