You have a product ready to sell in Australia: a capsule, a powder, a gummy, a drink. Before the label, before the launch, one question decides almost everything that follows. Is it a food, or is it a medicine?
The answer tells you which rules apply. A therapeutic good generally needs an entry on the Australian Register of Therapeutic Goods before it can be sold, and for a low-risk supplement that is usually an AUST L listing. A food is sold under the Food Standards Code instead, and it may never carry therapeutic claims. Getting this wrong in either direction costs time, money, and sometimes the product.
This article explains how the question is actually decided, in the order the law asks it. That is the same order Regulave's free Food or Medicine Checker follows when it checks your own product.
The four answers you can get
Every product lands on one of four outcomes. These are the checker's own words:
- It will likely need AUST L listing. A rule names products like yours as therapeutic goods.
- It can be sold as a food — no AUST L listing needed. A food standard covers it, and no medicine rule does.
- It sits outside the therapeutic goods rules — no AUST L listing needed. A rule takes products like yours out of the therapeutic goods framework. That does not by itself make it a food; other rules may still apply.
- It depends. The law turns on something only you know about your product, such as what it is made for or how you present it, and you are asked that question in the law's own words.
Notice the word likely in the first outcome. A check like this reads the law against what you tell it. It does not make the decision for the regulator, and it never pretends to.
How the question is decided, step by step
The checker walks the same path for every product, and each step names the law it checks:
- The Therapeutic Goods Act 1989, section 3. The Act's definition of a therapeutic good is where everything starts. The law decides what counts as a therapeutic good largely by how a product is presented, not only by what is in it.
- The Therapeutic Goods (Declared Goods) Order 2019, Schedules 1 and 2. Some classes of goods are named outright: declared to be therapeutic goods, or declared not to be.
- The Therapeutic Goods (Excluded Goods) Determination 2018, Schedules 1 and 2. Some goods are taken out of the medicines framework altogether.
- The Act's section 3, paragraph (e) — is there a food standard for your goods? A product is sold as a food under a food standard for its kind of goods. This is where the Food Standards Code enters.
- The Act's section 3, «therapeutic use». Your own wording is read for health claims, because a claim can move a product across the line.
- The Poisons Standard. Some substances face restrictions no matter how the product is sold, so every ingredient is checked against it.
Why capsules usually mean AUST L
The dosage form tells you a lot before any ingredient is read. This is the note the checker shows the moment you choose «capsule»:
A capsule is a unit dosage form — measured daily doses. Products in this format are usually medicines that need AUST L listing, not foods, unless a specific food standard covers them (sports foods, for example).
The reasoning comes back to presentation. A capsule delivering set daily doses of actives is the classic presentation of a listed medicine. That is why supplements in this format are listed on the ARTG rather than sold as food. The same is true of tablets, softgels, lozenges and gummies sold as measured daily doses.
"Usually" is doing honest work in that sentence. Where a food standard genuinely covers the product, the answer can differ, and the only way to know is to check the exact formulation.
A worked example: vitamin D, and the 25 µg line
Take an invented product, Harbourline D3 Capsules, with one active: vitamin D3 at 10 µg a day. Here is how the checker reads it.
The Poisons Standard draws a line. The Food Standards Code's Schedule 17 lists colecalciferol (vitamin D3) as a permitted form of vitamin D, so it is read against the Poisons Standard's entries for VITAMIN D. The Schedule 4 entry covers vitamin D for human internal therapeutic use, except, among other things, in preparations containing 25 micrograms or less of vitamin D per recommended daily dose. So there is one line, at 25 µg per recommended daily dose, and the Schedule 4 entry applies above it.
At or under the line, a second limit agrees. The Permissible Ingredients Determination sets the limit for listed medicines in its own words: "When for internal use, the maximum recommended daily dose must not be more than 25 micrograms of Vitamin D." Harbourline's 10 µg is at or under the line on both counts.
Two more entries exist, and the checker names them for what they are. A preparation dosed weekly is read against the Schedule 3 entry instead: 175 micrograms per recommended single weekly dose. There is also a Schedule 7 entry, and its own words limit it to use as a rodenticide, which a product for people is not.
And the overall answer? For Harbourline D3 Capsules the checker does not say "food". It finds three things:
- No food standard it holds covers this product. On the law it holds, the food pathway is not open to this formulation as it stands. It says plainly that the Food Standards Code has standards it does not hold yet, so this is a statement about what it holds, not a claim that no standard exists.
- A capsule with measured daily doses is presented like a medicine.
- The vitamin D3 dose is under the Poisons Standard's line.
That is a real answer, even where it cannot close every door. It tells you where the product stands, why, and what is left to settle. Everything is backed by the rule's own words, one click away.
What the Food Standards Code does — and does not — permit
A product is not a food just because it is not a medicine. It is sold as a food under a food standard for its kind of goods, and that standard comes with conditions.
- A standard covers a kind of food. Honey is sold under Standard 2.8.2 – Honey. An invented raw honey, Tallowmere Raw Honey, reads as a food under that standard. So does a breakfast cereal under Standard 2.1.1.
- Some standards turn on purpose. Standard 2.9.4 covers formulated supplementary sports foods: products "specifically formulated to assist sports people in achieving specific nutritional or performance goals". Whether your product is one is a fact about how you make and present it. So the checker asks you, in the standard's own words, rather than guessing. An invented whey powder, Stridewell Whey Sports Powder, reads as a food under Standard 2.9.4 when that answer is yes.
- Vitamins and minerals have permitted forms. The Code's Schedule 17 lists the permitted forms of vitamins and minerals, and the checker reads each ingredient against it.
- A standard sets its own limits. Each one carries composition limits and labelling requirements. Selling under it means staying inside them.
- A food never carries therapeutic claims. Keep your marketing free of health claims. A health claim can bring a product back under the medicines rules, and the checker reads your own wording for exactly that reason.
Check your own product
Reading about the rules is one thing; applying them to your exact formulation is another. The Food or Medicine Checker asks for your product's name, its form and what is in it, including the daily dose of each ingredient if you know it. It then walks the same path described above:
- it names each law it checked, in order;
- it gives its finding in plain words, with the reason for each point;
- it compares your doses with any line the Poisons Standard draws;
- and it keeps every rule it relied on in its own words, one click away.
It is free with a Regulave account, and you get a copy of your finding by email.
Check your product with the Food or Medicine Checker →
If your product will likely need AUST L listing, that is a well-trodden path, and preparing the submission is what Regulave does.
This article is general information built from the legal instruments Regulave holds, current when it was written. It is not legal advice. The products named in it are invented for illustration. Before you sell, confirm your own product's position against the current instruments, or with a regulatory professional.