You have a supplement ready for the Australian market and one question before anything else: does it need AUST L listing? Here is the five-minute answer, in the order the law asks it. Each step below is a step Regulave's free Food or Medicine Checker walks for your own product, and each one names the law it reads.
Why the question matters
AUST L is the listing a low-risk medicine carries on the Australian Register of Therapeutic Goods. Selling without it when your product needs it is not a paperwork slip. The Therapeutic Goods Act 1989 makes it a civil penalty to supply therapeutic goods for use in humans in Australia unless an exception applies, and the first exception is that "the goods are registered goods or listed goods in relation to the person" (section 19D).
So the real question is not whether you need AUST L, but whether your product is a therapeutic good. If it is, and it is a low-risk medicine, AUST L listing is the usual path. If it is a food, it is sold under the Food Standards Code instead.
Minute one: is it presented as a therapeutic good?
Everything starts at section 3 of the Act, which defines a therapeutic good. The definition turns largely on how a product is presented and what it is for, not only on what is in it. Two products with the same ingredients can land on different sides of the line because of the words on the label.
That is why the checker reads your own wording. If your description uses words that engage the Act's idea of "therapeutic use", the checker tells you which ones, because a health claim can move a product across the line.
Minute two: does a rule name your kind of product?
Before any judgement about presentation, two instruments settle some products outright:
- The Therapeutic Goods (Declared Goods) Order 2019 names some classes of goods as therapeutic goods, and names others as not.
- The Therapeutic Goods (Excluded Goods) Determination 2018 takes some goods out of the medicines framework altogether.
If one of them names your product, that usually decides the question. The checker quotes the item that names it, in the instrument's own words.
Minute three: is it a food?
The Act's definition carves out goods that a food standard covers. This is where the Food Standards Code enters, and it works differently from what most people expect.
- A food does not need a standard of its own. The Code says "food for sale may consist of, or have as an ingredient, any food" (Standard 1.1.1—10(2)).
- What the Code controls is what you add. A vitamin or mineral may be added to a food only where the Code expressly permits it (Standard 1.1.1—10(6)(b)): for listed kinds of food in Standard 1.3.2 and Schedule 17, and for special purpose foods such as sports foods in their own standards and in Schedule 29.
- Some standards turn on purpose. Standard 2.9.4 covers a product "specifically formulated to assist sports people in achieving specific nutritional or performance goals". Whether that describes your product is a fact about how you make and sell it, so the checker asks you, in the standard's own words.
Minute four: what format is it?
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 same reasoning applies to tablets, softgels and lozenges sold as measured daily doses. "Usually" is doing honest work: where a food standard genuinely covers the product, the answer can differ.
Minute five: what do the doses say?
Some substances carry a line in the Poisons Standard no matter how the product is sold. The checker reads every ingredient against it, and where an entry draws a dose line, it compares your daily dose with that line in the entry's own words. For vitamin D, the Schedule 4 entry excepts preparations containing 25 micrograms or less per recommended daily dose, so a product under that line reads differently from one over it.
Three products, three answers
Here is what the checker says about three invented products, in its own words.
Harbourline D3 Capsules — vitamin D3, 10 µg a day, in a capsule. The checker says: your product will likely need AUST L listing to be sold in Australia. Vitamin D3 can't be added to a food like this as described, the capsule is presented like a medicine, and the dose sits under the Poisons Standard's line.
Tallowmere Raw Honey — honey, in a jar. The checker says it can be sold as a food — no AUST L listing needed, because Standard 2.8.2 – Honey covers it and no medicine rule names it.
Stridewell Whey Sports Powder — whey protein isolate with vitamin A and ascorbic acid, a powder for muscle growth. The checker asks one question first: is it specifically formulated to assist sports people in achieving specific nutritional or performance goals? Answer yes, and it reads food, under Standard 2.9.4, with Schedule 29's own table permitting both vitamins. Answer no, and it reads likely AUST L, because the vitamins then have no food permission as described. Same tin, same ingredients; your answer decides it. The companion guide on sports foods walks through that case row by row.
The four answers you can get
Every product lands on one of four outcomes:
- It will likely need AUST L listing. A rule names products like yours as therapeutic goods, or what you add has no food permission as described.
- It can be sold as a food — no AUST L listing needed.
- It sits outside the therapeutic goods rules — no AUST L listing needed. That does not by itself make it a food.
- It depends. The law turns on something only you know, and you are asked that question in the law's own words.
The word likely in the first outcome matters. 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.
If the answer is AUST L
AUST L is the normal route for most vitamin, mineral and probiotic supplements in Australia. It is a listing, not an evaluation: the application asks you to certify that your product meets the requirements, and to hold the evidence behind every claim you make. If you want the difference between AUST L and AUST R first, read AUST L vs AUST R. For what the submission itself involves, read What actually goes into an AUST L submission.
Check your own product
Five minutes of reading gives you the shape of the answer. Your exact formulation gives you the answer. The Food or Medicine Checker asks for your product's name, its form, its ingredients and, if you know them, the daily doses, then walks the steps above and tells you where your product lands, with every rule it relied on one click away. For the longer version of this guide, read Food or medicine? How to tell whether your supplement needs AUST L listing.
Check your product with the Food or Medicine Checker →
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.