How Are Supplements Regulated in Australia? TGA, FSANZ and AUST L Explained
Who regulates supplements in Australia? A plain-English guide to the TGA, FSANZ, sports foods vs listed medicines, AUST L and allowed claims.
Quick answer
In Australia, supplements fall under one of two systems. Most vitamins, minerals and herbal products are complementary medicines regulated by the TGA and carry an AUST L (listed), AUST L(A) (assessed listed) or AUST R (registered) number. Most protein powders and sports foods are regulated as foods under the Food Standards Code (FSANZ). Some sports supplements cross into the TGA's system depending on ingredients, dose form and claims.
Knowing how a product is regulated tells you a lot about what's been checked, what claims it can make, and what to look for on the label. Here's a plain-English guide.
The two regulators
The TGA (Therapeutic Goods Administration)
The TGA regulates therapeutic goods — medicines and medical devices — including complementary medicines such as vitamins, minerals, herbal products and many supplements in tablet or capsule form.
FSANZ (Food Standards Australia New Zealand)
FSANZ develops the Australia New Zealand Food Standards Code, which covers foods including formulated supplementary sports foods such as protein powders, sports drinks and energy gels. State and territory food authorities enforce it.
Medicine or food? Why it matters
| Listed medicine (TGA) | Sports food (Food Standards Code) | |
|---|---|---|
| Typical products | Multivitamins, magnesium, fish oil, herbal supplements | Protein powder, mass gainers, sports drinks, many pre-workouts in powder form |
| Label identifier | AUST L, AUST L(A) or AUST R number | Nutrition information panel, ingredient list |
| Manufacturing | Must be made under GMP (good manufacturing practice) licence | Food safety and labelling requirements |
| Claims | Must use TGA-permitted indications | Limited to permitted nutrition and health claims under the Food Standards Code |
AUST L, AUST L(A) and AUST R explained
- AUST L (listed): lower-risk medicines made from TGA-permitted ingredients, using pre-approved "permitted indications" (claims). The sponsor must hold evidence for the claims, but the TGA doesn't evaluate effectiveness before listing. The TGA does conduct compliance reviews after listing.
- AUST L(A) (assessed listed): listed medicines whose efficacy evidence for higher-level claims has been assessed by the TGA.
- AUST R (registered): higher-risk medicines, individually evaluated for quality, safety and effectiveness — includes most prescription medicines and some over-the-counter products.
Where sports supplements fit
Sports supplements sit on a line between food and medicine. In 2020 the TGA clarified when sports supplements are regulated as medicines rather than foods — broadly, products in medicine-like dose forms (tablets, capsules), products containing certain substances, or products making therapeutic claims. Many powdered products that fit the food rules continue to be sold as sports foods. If a product carries an AUST L number, it's being regulated as a medicine.
What claims are allowed?
Australian rules restrict what supplements can say. Listed medicines can only use permitted indications — typically general wording like "helps support…", "may assist…" or "maintains normal…". They can't claim to treat, cure or prevent serious disease. Foods can only make permitted nutrition content and health claims under the Food Standards Code.
That's why reputable retailers use cautious language. If you see a supplement promising dramatic, guaranteed or medical-sounding results, be sceptical — and you can report concerns to the TGA or your state food authority.
What regulation doesn't guarantee
- Effectiveness: AUST L products haven't had their effectiveness individually evaluated by the TGA.
- Banned-substance testing: neither system requires testing against the WADA prohibited list. Athletes in drug-tested sport should choose independently tested products — see HASTA certification explained and our HASTA-certified range.
- Overseas products: supplements bought directly from overseas websites may not meet Australian rules. Some ingredients sold overseas are prohibited here — see why DMHA is banned.
How to check a product
- Look for an AUST L/AUST R number on medicines and search it on the TGA's Australian Register of Therapeutic Goods (ARTG).
- Read the label carefully — doses, serving size, warnings. Our guide to reading a supplement label walks you through it.
- Check for third-party testing if you compete. See third-party testing explained.
- Be wary of proprietary blends that hide individual doses.
- Buy from Australian retailers that stock products intended for the Australian market.
Red flags on a supplement
- Claims to cure, treat or prevent a disease.
- Promises of rapid or guaranteed results.
- Pharmaceutical-sounding ingredients or "research chemicals" in a sports product.
- No Australian contact details, ingredient list or nutrition panel.
- Before-and-after photos as the main evidence.
If something sounds too good to be true, it usually is.
Why we write the way we do
You'll notice our product descriptions and articles say things like "may support" or "helps maintain" rather than making big promises. That's deliberate: it reflects Australian rules and what the evidence actually supports. We'd rather you understand what a product can realistically do.
Want a starting point you can trust? Our Goal Stacks are built from well-known products in our range — for example, Everyday Wellness Essentials for daily health. Browse health supplements or protein.
This article is a general overview and not legal or medical advice. Regulatory requirements can change — refer to the TGA and FSANZ for current rules. If you have a medical condition or take medication, speak with your healthcare professional before using supplements.
