Food for special medical purposes is used to manage the diets of people with certain diseases, disorders or medical conditions. These special foods are intended for people whose nutritional requirements cannot be met by normal foods.
Food for special medical purposes can include formulated dietary products intended for use as the only source of nutrition, and also some formulated products that can supplement a person's food intake. Some of these products can be taken orally, whereas others need to be taken through a feeding tube (e.g. a naso-gastric tube). They are to be used under the supervision of a medical practitioner and other appropriate health professionals.
Standard 2.9.5 of the Food Standards Code regulates the composition, labelling and sale of food for special medical purposes. As most of these products are manufactured overseas and imported into Australia and New Zealand, the standard aligns with the relevant regulations of the European Union and the United States of America, as much as possible.
Under this standard:
- The label on a food for special medical purposes must indicate that the food is to be used under medical supervision, and state the medical purpose of the food. Other mandatory statements are also required on the label, for instance, a statement indicating whether or not the food is suitable as a sole source of nutrition.
- The label must provide certain information which is required on most packaged foods, for example, an ingredient list, date marking, and the mandatory declaration of allergens. Flexibility in some of the labelling requirements is permitted to align with overseas regulations, for example, the words 'expiry date' or similar may be used instead of 'use by' for the date mark.
- For those products that are to be used as a sole source of nutrition, the standard lists the essential nutrients, with amounts, that must be provided in the product. However, manufacturers may vary the amounts to meet the particular nutritional needs of some specific medical conditions. The variation must be stated on the label.
Foods for special medical purposes can only be sold from or by a medical practitioner or dietitian; a medical practice, pharmacy or certain other institutions; or appropriate distributors. This is to help manage the possible risk of inappropriate use and to help consumers seek professional health advice. See Standard 2.9.5 for further details about their sale.
Food for special medical purposes does not include infant formula products, total parenteral nutrition products that are given intravenously, or products formulated and represented as being for the dietary management of obesity or overweight.
Also, food for special medical purposes is different to therapeutic goods which are used to treat or cure a medical condition. The Therapeutic Goods Administration in Australia and the Medicine and Medical Devices Safety Authority (Medsafe) in New Zealand are responsible for regulating therapeutic products.