Know how food and medicine are regulated

A product that is taken orally can either be a food or medicine under the law. The classification depends on what’s in it, the health claims it makes, and how it’s labelled and advertised.

Sometimes it can be hard to tell the difference between medicines and foods as health claims can be made for some foods. If a product makes a health claim, it doesn’t necessarily mean it’s a medicine. Also, some products can look like medicines but are actually foods.

We call this overlap between foods and medicines the Food-Medicine Interface.

We use the definition of a therapeutic good in the Therapeutic Goods Act 1989 to determine if a product is or is not a therapeutic good (medicine).

Our Food-Medicine Interface Guidance Tool asks questions to help determine if your product is a therapeutic good or not.

It won’t tell you if your good is compliant with the requirements of the relevant regulatory framework. It is the responsibility of the manufacturer or importer to make sure their product is compliant.

Food Medicine Interface Tool

In Australia, food and medicines are regulated under separate legislative frameworks. There are different requirements for foods and medicines in relation to their manufacturing, labelling, advertising and evidence required to substantiate claims made for the products.

We regulate medicines and other therapeutic goods according to the Therapeutic Goods Act 1989.

Food Standards Australia New Zealand (FSANZ) sets Food Standards Code for safe food in Australia and New Zealand. State and territory governments enforce these standards through Food Regulatory Agencies.

The Department of Agriculture. Fisheries and Forestry (DAFF) regulates imported food under the Imported Food Control Act 1992.

If a product is a therapeutic good

A therapeutic good must be included in the Australian Register of Therapeutic Goods (ARTG) to be lawfully imported into, supplied in or exported from Australia.

If a product is a therapeutic good and not in the ARTG, we will usually contact the supplier first and provide information about relevant regulatory requirements. We may take action against the importer, exporter, manufacturer or supplier where appropriate.

If the product could be a health risk to the public, we can publish an alert and if necessary, order a recall of the product. This could happen if it contains substances that are only available when prescribed by a health professional.

If a product is not a therapeutic good

If a product is not a therapeutic good and is in the ARTG, we can take action to remove the product.

Sponsors will have the opportunity to write a response which we will consider. Sponsors can also seek a review by the Minister of Health and by the Administrative Appeals Tribunal (ART).

We need to work out if a product is a medicine (therapeutic good) when:

• Customs asks us if an imported product is a medicine or food
• someone reports that a product isn't in the ARTG, and they believe it should be
• we do a compliance review of a product that's listed in the ARTG as a complementary medicine and find that it is not a therapeutic good
• a product is supplied within Australia and a state or territory government agency asks us for advice on whether it is a therapeutic good.

We work with the following organisations when needed:

• Food Standards Australia New Zealand (FSANZ)
• Australian Border Force
• Department of Agriculture, Fisheries and Forestry (DAFF)
• Australian Federal Police
• state and territory agencies.

Find out about the use of nutrition content and health claims on food labels and advertisements in the Food Standard (Standard 1.2.7).