By Roy, founder Last updated 18/08/2026
Pick up two products off the same shelf. One has an AUST L number on the back. The other doesn't. Both promise better nights. Only one of them is allowed to tell you why. Most people have no idea which is which, or what that number actually buys you.
What's actually different about a listed medicine?
A listed medicine sits inside the Therapeutic Goods Administration's system. To carry an AUST L number, a product has to be entered on the Australian Register of Therapeutic Goods, formulated only from ingredients the TGA pre-approves for listed status, and manufactured to the medicines standard. In return, it's allowed to make a defined set of health claims, things like supporting a named body function, as long as the sponsor holds evidence for them on file.
That's the trade. Meet the therapeutic-goods bar, including the ingredient rules in the Poisons Standard, and you earn the right to say more.
What's a food-format supplement, then?
A food-format supplement, sometimes called a functional food, is regulated as food under the Food Standards Code, the same rulebook that governs everything from breakfast cereal to sports drinks. It's assessed by Food Standards Australia New Zealand, not the TGA, and it never carries an AUST L number because it was never entered as a therapeutic good.
The trade runs the other way. A food-format product can usually get to market faster and doesn't need TGA listing. But it picks up a hard limit most people never hear about: under Standard 1.2.7 of the Food Standards Code, a food generally can't make a health claim at all unless it clears a nutrient profiling test first, and plenty of otherwise-healthy foods don't clear it. So a food-format supplement can tell you exactly what's in it, in exactly what amount. It can't tell you what that amount does inside you.
Why can the same ingredient show up in both?
Because the ingredient isn't what decides the pathway, the product's legal category is. Magnesium, glycine, chamomile extract, all of these turn up in listed medicines and in ordinary food. What changes is what the label around them is allowed to claim, and what evidence has to sit behind that label.
A listed medicine built around magnesium can say what magnesium is being included to support, because it earned that right through TGA listing. A food-format drink with magnesium in it, even at a meaningful dose, is stuck stating the number and nothing else. Two products, same ingredient, completely different rulebook.
This is also why "clinically proven" and "TGA approved" mean something specific and can't be borrowed. A listed medicine has AUST L status behind those words. A food never does, no matter how well-run the ingredient sourcing is.
How do you tell which one you're holding?
Three places to look, in order.
The pack. An AUST L (or AUST R) number on the label means therapeutic goods. No number at all, and a nutrition information panel instead, means food.
What the front of pack claims. If it names a body function or an outcome directly, "supports calm", "promotes deep sleep", it's very likely leaning on listed-medicine status, or it shouldn't be making that claim. If it only states ingredients and amounts, with no outcome language, that's the signature of a food-format product staying inside its lane.
Where it's sold. Products that only ever appear in supermarkets and everyday grocery aisles are almost always food-format. Products that carry pharmacy-only or pharmacist-supervised claims are operating in therapeutic-goods territory.
None of this tells you which pathway is "better". It tells you which set of rules the product in front of you is playing by, and what it's therefore allowed to promise.
Where Settl sits
Settl is a food-format product. It's packed in Sydney in a facility that holds a TGA manufacturing licence, but that licence covers the facility, not this product, and it isn't a TGA approval. Settl holds no AUST L listing and none is being filed. That's why you'll see every ingredient and every amount printed on the tub, glycine, L-theanine, chamomile flower extract and the rest, but you won't see a claim about what any of it does once it's in you. It's a deliberate choice to stay inside the food pathway rather than borrow language that belongs to a different one. If you want to see what that looks like on a real label, the product page has the full ingredient list, and why we left melatonin out covers the same pathway question from a different angle.
The plain-English version
Listed medicine: pre-approved ingredients, TGA registration, allowed to claim an effect, has to hold evidence for it. Food-format supplement: broader ingredient flexibility, no TGA listing, generally can't claim an effect, has to earn trust through transparency instead. Neither pathway is a shortcut. Each one just trades a different freedom for a different constraint.
This is general information about how the two systems work, not legal or medical advice. If you're trying to classify a specific product for a specific purpose, the TGA's own guidance and the Food Standards Code are the primary sources, not a blog post.
For more on how to read an Australian supplement label properly, see the sleep supplement guide.
Cheers, Roy