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What are 'therapeutic goods'?
Many of us use medicines or medical devices in our daily lives. When we:
- apply a bandage
- relieve a headache with items from the supermarket
- take vitamin tablets
- receive an injection
- undertake a prescribed course of treatment to manage a serious illness.
What makes goods therapeutic?
In relation to the evaluation, assessment and monitoring done by the TGA, therapeutic goods are broadly defined as products for use in humans in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
- influencing inhibiting or modifying a physiological process
- testing the susceptibility of persons to a disease or ailment
- influencing, controlling or preventing conception
- testing for pregnancy
This includes things that are:
- used as an ingredient or component in the manufacture of therapeutic goods
- used to replace or modify of parts of the anatomy
A more precise definition of 'therapeutic goods' can be found in Section 3 of the Therapeutic Goods Act 1989.
Is it a medicine or food?
Some products you consume make claims about the health effects they are intended to have on your body. This does not necessarily mean that they are therapeutic goods. They could be either foods or medicines (i.e. therapeutic goods).
For some of these products it may be unclear as to whether they are a medicine or food, and therefore how they are regulated. Such products are described as being at the Food Medicine Interface.
Medicines and other types of therapeutic goods are regulated under the Therapeutic Goods Act and foods are regulated by state and territory food regulatory bodies by reference to the Australia New Zealand Food Standards Code (Food Standards Code).
A product may be presented to consumers in a variety of ways - this may be important in determining whether it is a food or medicine but is only one of the factors relevant to that determination.
For example, minced or crushed garlic in a bottle is likely to be a food as there is a tradition of use of garlic as food in that form in Australia. However, if chemicals in the garlic are extracted, concentrated and marketed in a capsule with claims that it can be used to 'relieve cold and flu symptoms' it might be considered a medicine.
Manufacturers and importers of products need to know whether such products are regulated as medicines or as food because different regulatory requirements apply.
Consumers may also want to check if the products they are using or buying are medicines (and thus regulated by the TGA and subject to advertising and other requirements in the therapeutic goods legislation), or food and thus regulated by state and territory food regulatory bodies.
A Food-Medicine Interface Guidance Tool is available to help work out whether or not a product is a therapeutic good (and thus a medicine). The Guidance Tool is only for use in determining which regulatory regime applies to a product. It does not enable a determination to be made about whether a product would meet all the requirements of the relevant legislation. It is the responsibility of the manufacturer/importer/supplier to ensure that their products comply with all relevant requirements under the applicable regulatory scheme.
Is it a therapeutic good or a cosmetic?
One of the main factors in determining whether a product is a cosmetic or a medicine (or a medical device) is the claims made about the product. For example, moisturisers that contain a sunscreening agent as a secondary component and have a stated therapeutic purpose (e.g. 'helps protect skin from the damaging effects of UV radiation') are medicines.
Even if a product is intended for marketing as a cosmetic, it may be classified as a medicine. This depends on:
- its ingredients
- the route of administration
- if therapeutic claims are made on its label, or in advertising.