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Proposed Changes to the Regulation of Dietary Supplements

9 Food Medicine Interface Considerations

In the majority of circumstances the appropriate regulatory coverage for products as complementary foods or complementary medicines will be readily apparent. There are a few products, however, that sit in the grey area or interface between food and medicine. For these products the appropriate regulatory pathway will need to be determined on a case-by-case basis. It is suggested that the following matters are taken into account in determining the likely regulatory coverage for a product:

• Is the product represented in any way that is likely to be taken for therapeutic use (whether because of the way it is presented or for any other reason)?

• How is the product represented or likely to be taken (from the perception of a ‘reasonable person’)?

- Is it in a pharmaceutical dosage form?

- Does it carry therapeutic claims (that is, claims relating to therapeutic use as per the definition¹⁰)?

- Does it have medicine dosage instructions?

(Note: If a product fulfils only one of these criteria, its appropriate regulatory status is usually under food legislation. If it fulfils more than one, the appropriate regulatory status is usually as a therapeutic product.)

• Does the product have an established use in Australia or New Zealand as a food or a medicine:

- In the form in which it is represented; or

- In the level in which the main ingredient is represented; or

- In another form of the product or level of the main ingredient?

(Note: If there is an established use under one or other set of legislation, it is likely to serve as a guide for the product’s future regulatory status.)

• What is the evaluated risk/benefit profile of the product as it is represented or likely to be taken?

- High risk/high benefit; or

- High risk/low benefit; or

- Low risk/high benefit; or

- Low risk/low benefit; or

- Unknown?

(Note: Higher risk products, particularly those with lower benefits, are usually more appropriately regulated as therapeutic products than as foods. In determining the answer to this question, considerable resources may be required for a proper evaluation. This would raise an issue under cost recovery regimes.)

• Is the product as it is represented or likely to be taken, within the scope of the Code? Is there a specific standard with which it complies, or should comply? If not, is the product or its main ingredient regulated elsewhere in the world specifically under food or therapeutics legislation? If this is the case, does this country have a similar approach to the scope of food and therapeutic legislation as Australia and New Zealand?

(Note: Where a product clearly sits within food legislation in Australia and New Zealand, its appropriate regulation is likely to be as a food. It is only appropriate to look to international legislation when the position of the food-medicines interface in that country, and its regulatory controls on each side of the interface, are the same as those applied in Australia and New Zealand.)

¹⁰ See http://www.anztpa.org/ (the Agreement) for definition of “therapeutic product” and “therapeutic use”.