Posted on October 28, 2016
With a greater recognition of the importance of nutritional support in medical therapy and improved technology, the “food for special medical purposes” (FSMP) market is currently surging. However, many questions arise, what is food for special medical purposes? Where can patients access them? Is it classified as therapeutic goods? Who is the regulator of such products?
As per Standard 2.9.5 – Food for special medical purposes under Food Standards Australia New Zealand Act 1991 (Cth), FSMP means food that is:
- Specially formulated for the dietary management of individuals:
- By way of exclusive or partial feeding, who have special medically determined nutrient requirements or whose capacity is limited or impaired to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients in ordinary food; and
- Whose dietary management cannot be completely achieved without the use of the food; and
- Intended to be used under medical supervision; and
- Represented as being:
- A food for special medical purposes; or
- For the dietary management of a disease, disorder or medical condition.
In Short, FSMP may be used to help people suffering certain diseases, medical conditions or disorders and cannot meet the nutritional requirements via normal diet.
Even though they are food, consumers, cannot purchase them from local supermarkets. FSMP can only be provided via health care professionals, such as a medical practitioner or dietitian or pharmacists.
However, they are not considered therapeutic goods. The line between a medicine and therapeutic food has become even greyer over the past few years. TGA has developed an online tool – Food-Medicine Interface Guidance Tool – and encourages customers to familiarise themselves with the basics of food and medicine and regulation. Manufacturers and sponsors can also use the Tool to work out which regulatory regime would apply to their products.
Unlike therapeutic goods regulated by the TGA, FSMP are regulated by Food Standards Australia New Zealand (FSANZ), who developed the Food Standards Code. Standard 2.9.5 of the Food Standards Code regulates the composition, labelling and sale of food for special medical purposes. It limits FSMP to make any therapeutic claims, for example, FSMP cannot make a claim in relation to the prevention of the disease.
Because FSMP is so similar to a medicine, it may cause undesired effects as well. However, which regulatory authority should we report to? Under the mandatory reporting obligations section of the Australian Competition and Consumer Commission (ACCC) guidelines: “Individual suppliers are responsible for reporting incidents where consumer goods have been associated with a death or serious injury or illness of any person.” The manufacturers of the FSMP may wish to be conservative and report such cases to ACCC.
This article was written by Wenna Zhang, from our Medical Services team.