Supplements as foods: when the food pathway applies

In short

• A powder, drink, bar or capsule can be sold as a food in Australia unless its presentation, or something else about it, makes it a medicine, or it is declared one.
• Beauty supplements are declared medicines, and so are sports supplements presented for a therapeutic use, such as gaining muscle, that come as a tablet, capsule or pill or contain certain substances.
• Protein powders, nutrition bars and energy drinks made only of food ingredients stay foods. A food must meet the Food Standards Code, and no food may claim to prevent, cure or alleviate a disease.
• Since 9 June 2026, a retail food can't contain caffeine unless the Code permits it, as it now does for sports foods: up to 200 mg a day.

How a product ends up a food or a medicine

The TGA says, "Generally a product that is swallowed will be either one form of therapeutic good (a medicine) or a food." Under the Therapeutic Goods Act 1989, it is a therapeutic good if it is represented as, or likely to be taken to be, for therapeutic use.

The Act leaves out goods covered by a food standard, and goods with a tradition of use as food in Australia or New Zealand in the form presented. The exception is goods declared under section 7, or determined under section 7AAA, to be therapeutic goods.

Declared medicines

Once declared under section 7, a product "cannot be a food", the TGA says, even if a food standard covers it. The Therapeutic Goods (Declared Goods) Order 2019 declares them. Some are declared by form alone, whatever their presentation; others by how they are presented.

Sports supplements. Products taken by mouth and represented as improving or maintaining performance in sport, exercise or recreational activity are declared when 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.

Beauty supplements. Goods labelled or promoted for cosmetic purposes, such as improving the appearance of skin, hair and nails, are declared when used, advertised or presented for oral consumption.

By form alone. Goods containing fibre, made as a tablet, capsule or pill. Goods that contain, or are promoted to contain, isolated HMB or its salts, made as a tablet, capsule, pill or powder. Goods containing shark cartilage, made as a tablet, capsule or pill, or as a powder that isn't a wholesale product for use as an ingredient in food.

What stays a food

The TGA 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 food standards that matter

Unless the Code expressly permits them, a food for sale must not contain added nutritive substances, such as vitamins and minerals. Nor, without such permission, can a retail food be or contain a novel food.

Since 9 June 2026, a retail food also can't contain caffeine from any source unless the Code expressly permits it, as Standard 2.9.4 now does for sports foods. Caffeine that comes naturally from added cocoa, chocolate, coffee or tea doesn't count, but caffeine from added guarana extract does, and caffeine itself and guarana extract can't be sold as a retail food. Until 9 June 2028, a product may follow the Code as it was or as amended.

Standard	Covers	What it allows or requires
2.9.4 Formulated supplementary sports foods	Products formulated to help sports people achieve nutritional or performance goals	Vitamins, minerals, amino acids and other substances listed in Schedule 29, within its limits; since 9 June 2026, up to 200 mg caffeine a day, below 5% of a powder or 1% of a liquid
2.9.3 Formulated meal replacements and formulated supplementary foods	Meal replacements, and foods formulated and sold as a supplement to a normal diet where energy and nutrient intakes may not be adequate	For a formulated supplementary food, at least 8 g protein, 550 kJ and 20% of the RDI of a listed vitamin or mineral in a serving (less for children aged 1 to 3)
1.3.2 Vitamins and minerals	Vitamins and minerals added to foods generally	Permitted forms, in the foods Schedule 17 lists, within its limits
1.5.1 Novel foods	Non-traditional foods that need a safety assessment	No retail sale unless listed in Schedule 25 and used within its conditions; listing follows a safety assessment by FSANZ
1.2.7 Nutrition, health and related claims	Nutrition content claims and health claims	Health claims from pre-approved relationships or, for general level claims, notified ones; no disease claims

What a food can and can't claim

Under Standard 1.2.7, no claim on a food may refer to "the prevention, diagnosis, cure or alleviation of a disease, disorder or condition". Health claims have two levels:

• High level claims refer to a serious disease or a biomarker of one. They must rest on one of the 13 pre-approved relationships currently in Schedule 4.
• General level claims are any other health claim, such as "calcium for healthy bones and teeth". They can rest on one of more than 200 pre-approved relationships, or on one established by systematic review and notified to FSANZ before use.

For a health claim, the food must also meet the Nutrient Profiling Scoring Criterion, unless it is a special purpose food, a group that includes formulated supplementary foods and sports foods.

FSANZ doesn't consider the merits of a notified relationship. The business making the claim certifies that a systematic review established the relationship, and must provide records if an enforcement authority asks.

Unless Division 3 of Standard 2.9.4 permits it, a sports food's label must not, expressly or by implication, relate the food "to enhanced athletic performance or beneficial physiological effects".

Labels

Where a retail food needs a label, Standard 1.2.1 lists what it must show, from the name and ingredients to date marking and nutrition information. Most food sold in Australia must also be labelled with its country of origin, under the Country of Origin Food Labelling Information Standard 2016, and the ACCC can investigate breaches. Non-priority foods, such as sports drinks, need only a text statement about where the food was grown, produced, made or packed.

A sports food's label must also carry the name "formulated supplementary sports food" and say it is not a sole source of nutrition. It must advise use with a nutritious diet and an appropriate training or exercise program. It must give directions, the recommended amount for one day and a nutrition information panel.

Its warning says it is not suitable for children under 15 or pregnant women, and should only be used under medical or dietetic supervision. Since 9 June 2026, if a sports food has caffeine from anything other than cocoa, chocolate, or decaffeinated coffee or tea within set caffeine limits, the warning adds breastfeeding women. The label must then say it contains caffeine, and the panel must give the average caffeine per serving and per unit quantity. Until 9 June 2028, a product may follow the Code as it was or as amended.

Who enforces the Code

FSANZ develops and administers the Code but "has no enforcement powers". In Australia, state or territory agencies and local councils enforce and interpret it. The Department of Agriculture, Fisheries and Forestry enforces it at the border.

The department refers imported food for sale for inspection and testing under its Imported Food Inspection Scheme, at rates set by risk, and every consignment it inspects gets a label check. Failed food can't be released: the importer must relabel it if labelling was the problem, or destroy or re-export it under supervision. Since 30 November 2023, inspected sports supplements in tablets, capsules or pills that fall within the new rules are referred to the TGA.

In FSANZ's words, "A food recall is action taken by a food business to remove unsafe food from distribution, sale and consumption." FSANZ coordinates recalls in Australia, and the states and territories can mandate one.

On the wrong side of the line

A product that is really a medicine must be on the ARTG before it is imported, supplied or advertised, unless exempt, excluded or otherwise authorised. The sponsor of a declared sports supplement can't release it for further supply until it complies. As a medicine, it needs ARTG entry as a listed or registered medicine and must meet the applicable requirements; as a food, it needs "different product claims, ingredients, and/or dosage forms".

A food making disease claims breaks Standard 1.2.7, which the states and territories enforce.

Where we come in

We settle the pathway at the brief, before the formula, and develop products as foods as well as listed medicines. A sports brand's performance powder went to market as a food beside four TGA-listed capsules, and our founder's own brand, Ora, spans TGA-listed medicines and premium functional foods. Book a call, or see how the pathway is decided.