Food-Medicine Interface Guidance Tool (FMIGT)

The product may still be a therapeutic good if it is a biological or a medical device (see definitions at section 32A and section 41BD of the Therapeutic Goods Act respectively).

If it is neither of those, it may be food. A product can still be food even if it is not goods for which there is a Food Standard or goods that have a tradition of use as a food for humans in Australia or New Zealand.

A product will also be a therapeutic good under the definition of therapeutic goods in subsection 3(1) of the Therapeutic Goods Act if:

• it is represented in any way to be, or is, whether because of the way in which it is presented or for any other reason, likely to be taken to be for use as an ingredient of therapeutic goods, or
• included in a class of goods the sole or principal use of which is, or ordinarily is, a use as such an ingredient.

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:

1. preventing, diagnosing, curing or alleviating a disease, defect, ailment or injury; or
2. 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:

• 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.

Even if the class of products to which the product belongs has a therapeutic use, the product will only come within the paragraph if that use is the sole or principal use or ordinarily is that use.

Is the product any of the following:

• represented in any way to be for therapeutic use?
• likely to be taken to be for therapeutic use because of the way in which it is presented?
• likely to be taken to be for therapeutic use for any other reason?

This question 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:

1. what use does the product appear to be for?
2. is that use a 'therapeutic use'?

What use does the product appear to be for?

Is the product represented, in any way, to be for a particular use?

1. How is the product represented?

   Consider the claims being made explicitly, or by implication, about the intended use of the goods - are the claims making a representation that the product is intended to be used for a particular use? This may be in explicit claims on the label or in advertising about what the product does or is intended to do or even by a combination of name, perhaps combined with graphics or pictures on the label.

2. Is the product likely to be taken to be for therapeutic use because of the way in which it is presented?

   It is the overall impression gained by the combination of all or any of the following things that might suggest or imply to someone that a product has a particular use:

   • the name of the product (see above)
   • the style or manner of the presentation of the product (including shape, size, texture, colour, smell and flavour)
   • form of packaging
   • whether the product has dosage instructions
   • whether the product has instructions for use
   • whether the product is in a form that may imply it is meant for therapeutic use eg capsule, pill, tablet, powder
   • whether the product comes with device to measure controlled doses
   • whether the packaging of the product contain warnings or advisory statements
   • what is said in the advertising and other material associated with the product.
3. Is the product likely to be taken to be for therapeutic use for any other reason?
   Consider whether someone might come to the conclusion that the product is for a particular use due to other factors. These might include:
   • the context in which the product is marketed (e.g. location in the supermarket, kind of retailer dealing with them, including online)
   • matters outside the direct control of the manufacturer/sponsor/supplier, including what is known to the public about the potential use of the product or assumptions made about its use or effect, for example, products with well-known therapeutic use.

Is that use a therapeutic use?

The paragraphs of the definition of 'therapeutic use' in subsection 3(1) of the Therapeutic Goods Act most likely to be relevant to a product for oral use in humans are:

1. preventing, curing or alleviating a disease, defect, ailment or injury, or
2. influencing or modifying a physiological process in persons.

In coming to a view on whether a product has a therapeutic use in preventing or alleviating a disease, defect, ailment or injury, consideration is given to:

• identifying the disease, defect, ailment or injury, and
• determining whether the product is represented, presented or otherwise likely to be taken to prevent, cure or alleviate the disease, defect, ailment or injury.

In coming to a view on whether a product has a therapeutic use in influencing, inhibiting or modifying a physiological process, consideration is given to:

• identifying what the physiological process is, and
• determining whether the product is represented, presented or otherwise likely to be taken to influence, inhibit or modify that process.

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.

If it is considered that the product is a good that, in Australia or New Zealand, has a tradition of use as food for humans in the form in which it is presented, then the product is likely to be a food and thus regulated under state or territory legislation. The Administrative Appeals Tribunal (AAT) decided in 2012 that four products (two green coffee and two coffee, all in sachets) that had been listed in the ARTG through the Electronic Listing Facility (ELF) system were not therapeutic goods as they came within this exemption. They were in fact a 'premium' version of a widely consumed beverage (see Sumabe Pty Ltd and the Minister for Health and Ageing).

In the event that a tradition of use as food is identified, the sale of product would still need to comply with the relevant state and territory food or medicines and poisons legislation.

The fact that a product may contain an undisclosed scheduled substance (for instance, a substance in Schedule 4 of the Standard for the Uniform Scheduling of Poisons that requires a prescription) does not make it a therapeutic good if it is a good for which there is a tradition of use.

For instance, inclusion of sibutramine or sildenafil in tea or coffee in relation to which claims of therapeutic use are made is still a food as tea or coffee has a tradition of use in Australia and New Zealand - such a substance may make the food unsafe and its sale an offence under state or territory food and/or other legislation (such as poisons legislation).

The fact that claims of therapeutic use are made in relation to a product does not make it a therapeutic good if it is goods for which there is a tradition of use in Australia or New Zealand as food in the form in which it is presented (such claims may be subject to the requirements in Food Standard 1.2.7 (Nutrition, Health and Related Claims)).

However, the form in which it is presented may mean it does not come within the exception.

For instance, a herb may have a tradition of use as food in Australia and New Zealand in the form of fresh leaves or seeds. However if chemicals in the herb are extracted, concentrated and marketed in a capsule it may be a therapeutic good as the tradition of use as a food is not in encapsulated form. The cocoa and coffee in the Sumabe case were in sachets which the Administrative Appeals Tribunal found was a form in which those products had a tradition of use as food in Australia and New Zealand.

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':

1. a food standard relates to the product rather than its ingredients

   For instance, Food Standard 2.8.1 is about the composition of white sugar; Food Standard 2.10.2 is about the composition of salt- the presence of salt or sugar in a product does not mean that it is covered by one of these standards and does not make the product 'goods for which there is a standard' by that fact alone.

2. 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)

   For instance, the fact that nutrition or health claims are made about a product does not make it goods to which Food Standard 1.2.7 (Nutrition, Health and Related Claims) applies. This is because this food standard of the kind to which paragraph (e) refers is more likely to be about the composition of the goods rather than the labelling and packaging of the goods, the claims made in relation to the goods or the processes for manufacturing them.

3. 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

   For instance, if a product is covered by Food Standard 2.9.4 (Formulated supplementary sports food), the fact that it contains more of a particular substance than the standard allows is not relevant i.e. the product is still goods for which there is a standard (the sale of the product would have to comply with relevant state or territory food legislation).

4. the fact that goods for which there is a standard may contain an undisclosed scheduled substance does not mean the standard does not apply

   For instance, if it becomes apparent that a product contains a substance listed in Schedule 4 of the Standard for the Uniform Scheduling of Poisons that requires a prescription (such as tadalafil), it will not be a therapeutic good if it is goods for which there is a standard (eg Food Standard 2.9.4). Such a substance may make the product unsafe food and justify a recall and/or seizure, and its sale is an offence under state or territory food and/or other legislation (such as legislation regulating the supply of poisons) but will not make it a therapeutic good.

5. 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 food standard

   For instance, if a product is covered by Food Standard 2.9.4 (Formulated supplementary sports food), the fact that claims of therapeutic use are made will not make it a therapeutic good (see below).

Examples

The most common circumstance in which the issue of whether a product is goods for which there is a food standard is in relation to Food Standard 2.9.4 (Formulated supplementary sports food), Food Standard 2.6.2 (Non-alcoholic beverages and brewed soft drinks) and Food Standard 2.6.4 (Formulated Caffeinated Beverages).

It is not uncommon for products to include on a label a statement that it is a dietary supplement or that it is not intended to diagnose, treat, cure, or prevent any disease, or for warnings or 'directions for use' to be included on the label. None of those factors are determinative of whether or not it is a product for which there is a standard ie Food Standard 2.9.4 or a therapeutic good, nor is the inclusion of the words 'formulated supplementary sports food' on the label. That food standard applies to a product where it is possible to say that the product is:

• a food or a mixture of foods 'specifically formulated to assist sports people'
• to achieve 'specific nutritional or sports goals'.

Even if:

• there are therapeutic claims made about the product,
• it contains undisclosed Schedule 4 substances (such as sildenafil), or
• the product fails to comply with the requirements of the standard,

it will not be a therapeutic good if it is a good to which that standard applies. In such cases, the sale of that product may breach state or territory food laws and/or other legislation (such as poisons legislation) and be subject to seizure or recall under that legislation.

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

Issue 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

• 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.

The product is not food, so the issue of the food-medicine interface does not arise. The product may be a therapeutic good.

A product will be a therapeutic good if it is declared to be so under section 7 of the Therapeutic Goods Act.

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 under s3(1) of the Act can be disregarded (the operation of those paragraphs is described below).

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).