Sports supplements in Australia: food or medicine, and how to build one

Food or medicine: where the line sits

Most sports supplements fall on one side of a line the TGA drew in the Therapeutic Goods (Declared Goods) Order 2019. Products taken by mouth and represented as improving or maintaining performance in sport, exercise or recreational activity are declared medicines when they are used, advertised or presented for a therapeutic use, such as gaining muscle, increasing focus or stamina, losing fat, or preparing for or recovering from a workout, or in a way likely to be taken as one, if they:

• contain, or are said to contain, a Poisons Standard substance, an added substance on the 2023 World Anti-Doping Prohibited List, added dendrobium or methylliberine, or a substance with equivalent pharmacological action; or
• since 30 November 2023, are supplied as a tablet, capsule or pill, unless they contain glucose only.

Some goods are declared by form alone. A tablet, capsule, pill or powder that contains, or is promoted to contain, isolated HMB or its salts is a medicine, whatever its presentation.

Once declared, a product "cannot be a food", the TGA says, even if a food standard covers it. The TGA also says sports supplements "that only contain ingredients appropriate for food and are presented in a traditional food form" are not affected, "e.g. protein powders, nutrition bars and energy drinks". The full picture is in our guide to the food pathway.

Building a sports food

A protein, pre-workout, creatine or electrolyte powder made for sport is usually built as a food under Standard 2.9.4, formulated supplementary sports foods. That standard sets which vitamins, minerals, amino acids and other substances can be added, within its limits, and the statements the label carries. Since 9 June 2026 it also caps caffeine at 200 mg in the amount for one day, as directed on the label, and below 5% of a powder or 1% of a liquid. Until 9 June 2028, a product may follow the Code as it was or as amended.

A food's claims come from the Food Standards Code, not the TGA's list. Sports foods are special purpose foods, so a health claim on one doesn't have to meet the Nutrient Profiling Scoring Criterion that most foods must. How powders are made, packed and costed is in our powders and sachets guide.

Building a sports medicine

A capsule or tablet for recovery, stamina, joints or performance is a medicine, and usually a listed one. That means three things:

• Ingredients from the TGA's list. Every active and excipient must be permitted for listed medicines, with the conditions the Permissible Ingredients Determination sets (permissible ingredients).
• Claims from the TGA's list. Indications come from the Permissible Indications Determination, and the sponsor holds the evidence for each (permitted indications).
• A listing, a label and a stability program. The product goes on the ARTG with an AUST L number, is labelled to TGO 116 and is made under GMP (TGA approval).

A clinically studied branded ingredient can carry much of the evidence, if the studies match the product's dose and population (branded ingredients).

One brand, both pathways

A sports range often sits across both pathways. When we rebuilt a sports brand's core range, four products became TGA-listed capsules and a performance powder went to market as a food. Each pathway brought its own ingredients, claims, label and quality system, and we settled which product went where at the brief, before the formulas were written. Ora, our founder's own brand, also spans TGA-listed medicines and premium functional foods.

From our records

• ATP Science's core range: a private-equity-backed Australian sports and wellness brand, turning over A$24 million a year by 2019 and exporting to New Zealand, the UK and the UAE. Several of its best-known formulas had room to improve on ingredient quality, dose and permitted indications. We reformulated four TGA-listed capsules from scratch, one built on Testofen®, a clinically studied fenugreek extract, plus a food-pathway performance powder. We handled the listings, stability protocols and label review, and managed manufacturing for all five, working through a co-packer delay. Five products in production from late 2023, with reorders on three within a year.
• A joint formula for a sports nutrition brand: the formula, the claims evidence, the TGA listing, managed production and a later listing update to keep it current. Delivered in 2023.
• Ora: our founder's own brand, with TGA-listed medicines and premium functional foods in one range.