Two Regulators, Not Three
Food Standards Australia New Zealand (FSANZ) develops the Food Standards Code and regulates products as food. The Therapeutic Goods Administration (TGA) regulates therapeutic goods, including listed and registered complementary medicines. There's no third "supplement" category sitting between them: a product that isn't classified as food is, by elimination, assessed against the therapeutic goods framework instead.
The TGA's Food-Medicine Interface Guidance Tool
The TGA publishes a decision tree, the Food-Medicine Interface Guidance Tool, that sets out the actual questions used to work out which framework applies. Two of the questions matter most for a product like a fibre supplement:
Is the product "goods for which there is a standard" in the Food Standards Code? Dietary fibre has a defined standard (Standard 1.2.8 and Schedule 11, covering the definition and measurement of dietary fibre). A product that is dietary fibre, meeting that standard, answers yes here, which points toward food rather than a therapeutic good.
Is the product represented, presented, or likely to be taken as being for therapeutic use? This is the claims and presentation test. A product that states or implies it treats, prevents or manages a disease or condition, or that's presented the way a medicine typically is, fails this test and is pushed toward therapeutic good status, regardless of what the ingredient itself is.
What This Means in Practice
A fibre ingredient that meets the Food Standards Code's dietary fibre definition, sold with claims limited to permitted nutrition content claims (like "excellent source of fibre") rather than therapeutic claims, is regulated as a food. The same ingredient, sold with a disease-treatment claim or presented in a dose form implying medicinal use, could cross into TGA territory even though nothing about the fibre itself changed. Form and claims, not the raw ingredient, decide which framework applies.
Listed vs Registered Medicines
Products that do fall under the TGA aren't all treated the same way either. Complementary medicines can be "listed," meaning the sponsor certifies the product meets requirements without a pre-market assessment of each specific claim, or "registered," which involves a more detailed evaluation, generally reserved for higher-risk products or stronger claims. Neither pathway applies to a product that's already been classified as food in the first place; the listed/registered distinction only becomes relevant once a product has crossed into TGA territory.
Where DULCI Sits
DULCI is a prebiotic fibre supplement, classified as a food. It's regulated under the Food Standards Code, not as a therapeutic good.
Why This Matters to a Shopper
The classification affects what a product is legally allowed to say about itself. A food-classified fibre product can make specific, defined nutrition content claims (an excellent source of fibre, for instance) but can't make therapeutic claims about treating or preventing a condition. A listed complementary medicine can make certain claims a food can't, but goes through a different compliance process to do so, and is held to different labelling and evidence requirements. Knowing which category a product sits in explains why its label reads the way it does.
Sources
- TGA, Food-Medicine Interface Guidance Tool diagram
- Australia New Zealand Food Standards Code, Standard 1.2.8, Nutrition Information Requirements
- Australia New Zealand Food Standards Code, Schedule 4, Nutrition, Health and Related Claims