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Food-Medicine Interface Guidance Tool (FMIGT)
Manufacturers and importers of products need to know whether the products are regulated as therapeutic goods or as food because different regulatory requirements apply.
Consumers may also want to check if the products they are using are classified and regulated suitably.
Before using this tool, you are encouraged to familiarise yourself with the basics of food and medicine and regulation.
Underneath each question is more information to help you make your decision. For a full explanation of each question, including real-world examples where applicable, see the FMIGT questions - explanation and information.
Is the product a 'therapeutic good'?
This is an interactive interface that cannot be accessed with a keyboard. A keyboard-accessible version is also available.
Is the product for oral use for humans?AIssue of the food interface does not arise (may be a therapeutic good)
Under section 7 of the Act the Secretary of the Australian Government Department of Health (through the TGA) can declare that a product is a therapeutic good where satisfied that it is a therapeutic good. For this purpose, the fact that the product may come within paragraph (e) or paragraph (f) of the definition of therapeutic goods (see definition in subsection 3(1) of the Act) can be disregarded.
Thus if the TGA is of the view that a product which would otherwise come within either of those paragraphs is a therapeutic good (for instance, representations are made that the product has a therapeutic use) and believes it would be more appropriate for the product to be regulated as a therapeutic good, a declaration can be made. Declarations made under section 7 that products are therapeutic goods are on the website.
If a declaration has been made in relation to the product, it will be a therapeutic good and cannot be a food (even if it is goods for which there is a standard or it has a tradition of use as a food in Australia or New Zealand).AIssue of the food interface does not arise (may be a therapeutic good)
A product will not be a therapeutic good if it is covered by a declaration made under section 7AA of the Act (see paragraphs (g) and (h) of the definition of therapeutic goods in subsection 3(1) of the Act).
A declaration is a legislative instrument. There are currently no section 7AA declarations.
Section 7AA allows the Minister to exclude goods from the definition of 'therapeutic goods' having regard to the matters set out in subsection 7AA(3) which are
AThe product is not a 'therapeutic good'. It may be 'food' within state/territory food regulation legislation and/or regulated under other state/territory legislation
- whether it is likely that the goods might harm the health of members of the public if not regulated under the Act
- whether it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by this Act to regulate the goods
- whether the kinds of risks from the goods to which members of the public might be exposed could be more appropriately dealt with under another regulatory scheme, and
- any other matter the Minister considers relevant.
If the product falls into a category for which there is a food standard within the Food Standards Code (the Code), then the product is not a therapeutic good. It may be regulated under state or territory food legislation.
A number of matters are relevant in determining whether a product is 'goods for which there is a standard':
AThe product is not a 'therapeutic good'. It is likely to be 'food' within state/territory food regulation legislation and/or regulated under other state/territory legislation
- the food standard relates to the product rather than its ingredients
- a food standard of the kind referred to in paragraph (e) of the definition of therapeutic goods is likely to be located in Chapter 2 of the Code (Food Product Standards) rather than Chapter 1 of the Code (General Food Standards)
- if the product is goods for which there is a standard, the fact it does not comply with the standard does not mean the standard does not apply
- the fact that goods for which there is a standard may contain an undisclosed scheduled substance does not mean the standard does not apply
- the fact that claims of therapeutic use are made in relation to a product or that it is presented as if it is a therapeutic good does not make it a therapeutic good if it is a good for which there is a standard
Is the product goods which, in Australia or NZ, have a tradition of use as foods for humans in the form in which the thing is presented?
In determining whether a product is a good for which, in Australia or New Zealand, there is a tradition of use as food for humans in the form in which it is presented, consideration should be given to:
- what kind of good is the product (eg coffee or tea, a herb)?
- what is the form in which the product is presented (eg coffee in the form of granules, tea in a teabag, a herb in a fresh or dried form or encapsulated)?
- is there a use of the good as 'food for humans' in Australia or New Zealand in that form (ie granulated coffee as a food, tea in a teabag, herb in a dried form or encapsulated)?
- is there a 'tradition of use' of the product, by humans, in Australia or New Zealand, in that form?
'Tradition of use' is taken to be widespread and significant consumption of the product for use as a food over time. As a consequence of that use, there is presumed to be knowledge of the operation and effect of the particular product, and a sense of community acceptance of the product by later generations.A
The product is not a 'therapeutic good'. It is likely to be 'food' within state/territory food regulation legislation and/or regulated under other state/territory legislation
Is the product any of the following:
- represented in any way to be for therapeutic use?
- likely to be taken [by someone] to be for therapeutic use because of the way in which it is presented?
- likely to be taken [by someone] to be for therapeutic use for any other reason?
Question 6 relates to the apparent intended use of the product. Consideration now focuses on whether the product is represented/ presented as having a therapeutic use or appears to be for a therapeutic use.
The question is best considered in 2 parts:
AThe product is a 'therapeutic good', not food
- what use does the product appear to be for?
- is that use a 'therapeutic use'?
Is the product in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use?
This question relates to the actual use of the class of products to which the product belongs. The question is whether the sole or principal use of that class of products is, or ordinarily is, a therapeutic use in humans, for example, in:
- preventing, diagnosing, curing or alleviating a disease, defect, ailment or injury; or
- influencing or modifying a physiological process in humans.
In coming to a view on whether a product is in such a class of products, consideration will be given to:
- identifying the disease, defect, ailment or injury, and
- determining whether the product is in a class of products that is used in the prevention, diagnosis, cure or alleviation of that disease, ailment, defect or injury.
In coming to a view on whether a product is in a class of products the use of which is in influencing, inhibiting or modifying a physiological process, consideration will be given to:
AThe product is a 'therapeutic good', not foodAIf it is not a biological or medical device, the product is not a 'therapeutic good'. It may be 'food' within state/territory food regulation legislation
- identifying what the physiological process is, and
- determining whether the product is one in a class of products is that in fact influences, inhibits or modifies that process.