Complementary Medicines
Guidance tool for assessing the appropriate regulatory coverage for products at the food-medicine interface
December 2007
This guidance tool is intended to be used to determine whether a product that falls within the 'grey-area' at the food-medicine interface would be regulated as a food or as a therapeutic product.
The objective in applying the tool is to determine whether a 'reasonable person', when faced with the product in its final presentation, would consider that the product was intended for therapeutic use. If the product would be considered to be for therapeutic use, it would be regulated as a medicine and would be subject to the controls under therapeutic product legislation. If the product would not be considered to be for therapeutic use, it would be regulated as a food and would be subject to the controls under food legislation.
The guidance tool is only for determining the appropriate regulatory coverage for the product. It does not enable a determination to be made about whether the product would meet all the requirements of the relevant legislation. Having determined which regulatory scheme (food or therapeutic product) would apply, it is the responsibility of the product sponsor to ensure that they comply with all the relevant requirements under that regulatory scheme.
Note: Decisions about the appropriate regulatory coverage for products are often made without access to the advertising material that may be associated with the product. Where the current or intended advertising material is available, this should also be taken into account.
How is the product represented or likely to be taken (from the perception of a 'reasonable person')?
Question 1: Is it in an oral medicinal dosage form?
Question 2: Does it have medicine dosage instructions (rather than a food serving suggestion)?
Question 3: Does it carry therapeutic claims (that is, claims relating to therapeutic use)?
'Therapeutic use' means use in or in connection with preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury; or influencing, inhibiting or modifying a physiological process.
Question 4: Does the product have a traditional or otherwise well-established therapeutic use (that is, it is primarily for therapeutic use)?
If the answer is 'Yes' to none or only one of questions 1, 2 and 3, the appropriate regulatory coverage for the product is usually under food legislation.
If the answer is 'Yes' to more than one of questions 1, 2 and 3, the appropriate regulatory coverage for the product is usually under therapeutic product legislation.
The exception would be where the answer to question 4 demonstrates that the product has a clearly established use within the Australian/New Zealand communities as a therapeutic product. In this situation the appropriate regulatory coverage for the product would be under therapeutic product legislation.