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Selling supplements in Australia

Australia has no single supplement category. A product represented for therapeutic use is a therapeutic good regulated by the TGA, and is usually entered in the Australian Register of Therapeutic Goods before supply. A product that stays a food, such as a formulated supplementary sports food, follows the Food Standards Code. Ingredients, claims and dosage form decide which.

Updated · Each section links to the official source it comes from

Medicines route
Therapeutic Goods Act 1989, regulated by the TGA
Register
The Australian Register of Therapeutic Goods (ARTG)
Food route
Food Standards Code, including Standards 1.3.2 and 2.9.4
What decides
Ingredients, claims and form, such as tablet or powder
Listed medicines
Permitted ingredients and indications only, certified by the sponsor

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is the product represented for therapeutic use, or declared a therapeutic good? Read more
  2. 2If it is a medicine, who is the sponsor and is it on the ARTG? Read more
  3. 3Are the ingredients permissible and the indications on the permitted list? Read more
  4. 4If it is a food, are the vitamins and minerals permitted in that food and form? Read more
  5. 5Is it a sports food, and does its label carry the required statements? Read more
  6. 6Does it contain caffeine at a level banned from retail sale? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Food or therapeutic good

Where the line falls between the Food Standards Code and the Therapeutic Goods Act 1989.

  • Therapeutic goods are goods represented, or likely to be taken, to be for therapeutic use, which includes preventing or alleviating disease and influencing a physiological process in persons.
  • Goods for which there is a standard under the Food Standards Australia New Zealand Act 1991, and goods with a tradition of use as food in the form presented, are not therapeutic goods unless declared to be.
  • FSANZ says sports supplements can be regulated as either a food or a medicine, depending on ingredients, claims and form, and refers businesses to the TGA to decide.
  • The Declared Goods Order makes oral goods represented for performance in sport, exercise or recreation therapeutic goods if they contain certain substances, or, from 30 November 2023, come as a tablet, capsule or pill (other than glucose only).

How we help: Compliant Always sets your product's ingredients, form and label claims beside the definitions and declarations, so the route you have chosen is on record with the reasons. Ask about this

Listed medicines

The low-risk route on the ARTG used by most complementary medicines.

  • Each listed medicine gets an AUST L number, which must appear on the label.
  • Listing is done online through the TGA's eBusiness Services (the electronic listing facility), with a client ID obtained first. Medicines made solely for export must also be listed.
  • Indications are not evaluated at listing, but the sponsor holds evidence for them and gives it to the TGA on request; the TGA reviews new listings at random and by target.
  • Importing, manufacturing or supplying therapeutic goods for use in humans that are not registered or listed in relation to that person, and not exempt or authorised, is an offence (section 19B).
  • The sponsor is the person who imports the goods, or who manufactures them in Australia or arranges for that, for supply.
  • To list a medicine, the applicant certifies, among other things, that it is safe for its purpose, contains only ingredients the Minister has determined as permissible, and meets every applicable standard (section 26A).
  • Indications for listed medicines are drawn from the Therapeutic Goods (Permissible Indications) Determination.
  • Conditions of listing include keeping records to recall any batch and identify its manufacturer, keeping distribution records for five years, and telling the TGA of overseas recalls that may matter in Australia.

How we help: Compliant Always keeps the sponsor's records for each listed medicine with the batch: manufacturer, GMP agreements and distribution records, dated, with what is missing shown. Ask about this

Supplements sold as food

Vitamins, minerals and other substances added to food.

  • Vitamins and minerals can only be added to food where the Code permits it.
  • A vitamin or mineral may be used as a nutritive substance in a food if it is in a permitted form and listed for that type of food in Schedule 17, within any maximum amount (section 1.3.2—3).
  • Part 2.9 of the Code permits or requires vitamins and minerals in special purpose foods, including formulated meal replacements and formulated supplementary foods.
  • Added vitamins and minerals are listed in the ingredients; a claim about one puts its amount in the nutrition information panel.

How we help: Compliant Always reads your formula against the Schedule 17 permissions for the food it is, and keeps the supplier's certificates of analysis with each lot. Ask about this

Sports foods and caffeine

Formulated supplementary sports foods, and the caffeine limits that apply to them.

  • Formulated supplementary sports foods are regulated under Standard 2.9.4, which permits substances and higher levels of some vitamins and minerals not allowed in other foods.
  • The label states 'formulated supplementary sports food', that it is not a sole source of nutrition and goes with a nutritious diet and a training or exercise program, the recommended amount and daily intake, and a nutrition information panel (section 2.9.4—4).
  • Where section 2.9.4—4 requires it, the label carries the warning 'Not suitable for children under 15 years of age or pregnant women: Should only be used under medical or dietetic supervision'; caffeinated sports foods carry a caffeine statement and a longer warning.
  • Unless Division 3 gives permission, the label must not link the food to enhanced athletic performance or beneficial physiological effects (section 2.9.4—7).
  • Foods with 5% or more caffeine (solid or semi-solid) or 1% or more (liquid) are banned from retail sale, and are risk food at the border.

How we help: Compliant Always reads your sports food label for the required statements and your specification for caffeine content, and shows what does not match. Ask about this

Who answers for what

WhoWhat they answer forHow we help
SponsorListing the medicine on the ARTG, the certifications made, and the conditions of listing.The listing evidence and batch records kept together, dated.
BrandThe claims on the label and in advertising, which can decide whether it is a food or a medicine.Each claim set beside the indications or food rules it rests on.
ManufacturerMaking the product to the standard that applies, with GMP agreements where steps are contracted out.Certificates of analysis and GMP documents kept with each batch.
ImporterFood imports under the Imported Food Control Act, or acting as sponsor for imported medicines.Overseas suppliers' documents read and dated before the goods arrive.

States and territories

Food standards are developed by FSANZ and adopted without variation by the states and territories, whose agencies and local councils enforce the Food Standards Code. The Department of Agriculture, Fisheries and Forestry enforces it at the border.

The Australian Consumer Law is enforced by the ACCC for widespread issues and by state and territory consumer protection agencies, which handle individual complaints.

Questions businesses ask

Are supplements regulated as food or medicine in Australia?
Either. A product represented for therapeutic use is a therapeutic good under the Therapeutic Goods Act 1989, regulated by the TGA. A product that remains a food follows the Food Standards Code. Ingredients, claims and dosage form decide which.
Do I need to register my supplement with the TGA?
If it is a therapeutic good, it generally has to be registered or listed on the Australian Register of Therapeutic Goods before it is imported, manufactured or supplied, unless an exemption or authority applies (section 19B of the Act).
What is a listed medicine?
A medicine listed under section 26A of the Act. The applicant certifies that it is eligible, safe for its purposes, contains only permissible ingredients and meets applicable standards, and uses indications from the Permissible Indications Determination.
Who is the sponsor of a therapeutic good?
The person who imports the goods into Australia, or who manufactures them in Australia or arranges their manufacture, for supply. A person acting on behalf of someone resident or carrying on business in Australia is not the sponsor.
Can I make a health claim on a supplement sold as food?
Only within Standard 1.2.7: general level claims based on pre-approved or notified self-substantiated food-health relationships, and high level claims on pre-approved relationships only. Claims of therapeutic use can make the product a therapeutic good.
Are sports supplements in tablet or capsule form medicines in Australia?
Oral goods represented for sport, exercise or recreational performance are declared therapeutic goods if supplied as a tablet, capsule or pill on or after 30 November 2023 (other than glucose only), or if they contain certain listed substances.
What must a sports food label say in Australia?
'Formulated supplementary sports food', that it is not a sole source of nutrition and is used with a nutritious diet and training, directions for amount and frequency, the recommended daily consumption and a nutrition information panel. Some sports foods also carry a warning that they are not suitable for children under 15 or pregnant women.
Can I sell caffeine powder in Australia?
No. Foods with 5% or more caffeine as a solid or semi-solid, or 1% or more as a liquid, are banned from retail sale. They are also classed as risk food for imported food inspection.
Which records does a listed medicine sponsor keep?
Records needed to recall a batch and identify its manufacturer, GMP agreements for contracted Australian manufacturing steps, and distribution records for five years, provided to the TGA on request.
What is an AUST L number?
Each medicine listed on the Australian Register of Therapeutic Goods gets an AUST L number, which must appear on the label. Most supplements in Australia are listed complementary medicines.
Do supplements made only for export from Australia need to be listed?
Yes. The TGA says medicines made solely for export must also be listed on the Australian Register of Therapeutic Goods.
How does Compliant Always help with selling in Australia?
Our team reads the rules for the markets you sell in, including the Commonwealth, state and territory layers in Australia. Compliant Always shows which apply to your product and keeps the documents behind each one ready. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

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