In Australia, medicinal products containing ingredients like herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as 'complementary medicines' and are regulated as medicines under the Therapeutic Goods Act 1989 (the Act).
Food supplements, or nutritional supplements, are one category of complementary medicines.
· In terms of registration, Australia has a risk-based two-tier system for all medicines, including complementary medicines.
· That means, lower risk products can be listed in the Australian Register of Therapeutic Goods (ARTG), while higher risk products must be registered on the ARTG.Administrative data
· A complementary medicine is defined in the Therapeutic Goods Regulations 1990 as a therapeutic good consisting principally of one or more designated active ingredients mentioned in Schedule 14 of the Regulations, each of which has a clearly established identity and traditional use.
· Designated active ingredients are the following:
Herbal materials (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll
Microorganisms, whole or extracted, except a vaccine
Minerals including a mineral salt and a naturally occurring mineral
Materials of animal origin (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates
Lipids, including an essential fatty acid or phospholipid
Substances produced by or obtained from bees, including royal jelly, bee pollen and propolis
A sugar, polysaccharide or carbohydrate
Vitamins or provitamins
· As regards labelling, the following information is mandatory:
The product name
Name(s) of all active ingredients and their quantity
In some cases, excipient information
Relevant warning/advisory statements
Directions for use
In most cases the indications for which the product is used
· Information must be in the English language and in durable, legible lettering that is not less than 1.5 millimetres in height (except for the ARTG number which must be no less than 1 millimetre in height).
· Possible types of claims are nutrition content claims and health claims.
· These claims are regulated under the scope of Standard 1.2.7. of the Australia New Zealand Food Standards Code.
. Nutrition content claims and health claims are restricted for foods that contain more than 1,15% alcohol by volume: They may only refer to energy content, carbohydrate content or gluten content or salt or sodium content about a food that is not a beverage.
. Nutrition content claims and health claims are prohibited for kava and infant formulae.
Nutrition content claims
. Nutrition content claims refer to the content of certain nutrients or substances in a product, i.e. the presence or absence of any of the following:
A biologically active substance.
The components of any one of protein, carbohydrate or fat
Glycaemic index or glycaemic load
· Common examples are “low in fat” or “good source of calcium”.
. If there is a legal requirement to include certain information in a nutrition information panel, this does not constitute a nutrition content claim.
. Health claims refer to a relationship between a food and health rather than a statement of content.
. There are two types of health claims: General level health claims and high-level health claims.
. General level health claims relate to a nutrient or a substance in a food or to the food itself, and its effect on health. For example: “Calcium for healthy bones and teeth”.
. High level health claims refer to a nutrient or substance in a food and its relationship to a serious disease or to a biomarker of a serious disease.
. An example related to a serious disease would be: “Diets high in calcium may reduce the risk of osteoporosis in people 65 years and over.”
. An example related to a biomarker would be: “Phytosterols may reduce blood cholesterol.”
. General level health claims can be based on one of over 200 pre-approved food-health relationships or they can be self-substantiated and notified to Food Standards Australia New Zealand (FSANZ).
. High level health claims must be based on a food-health relationship pre-approved by FSANZ. There are currently 13 pre-approved food-health relationships for high level health claims.
. All health claims must be supported by scientific evidence.