Supplements cover a range of products in Australia, including vitamins, minerals, sports nutrition products such as protein powders, and other goods that may improve nutrition and performance. Supplements may be regulated as either a food or a medicine in Australia, depending on whether it meets the requirements outlined in the Food Standards Code, or the Therapeutic Goods Act 1989. Determining whether a sports supplement is a food or a medicine can sometimes be complex.
Manufacturers and importers of products need to know whether the products are regulated as therapeutic goods or as food because different regulatory requirements apply. Consumers may also want to check if the products they are using are classified and regulated suitably.
TGA provides a food-medicine interface guidance tool to help in determining whether a product is a medicine or a food. Some of the considerations include:
- the form of the product (capsule, tablet, liquid)
- whether the product contains a scheduled substance
- how the product is represented, i.e. for human therapeutic use
- whether people are likely to perceive the product as being for therapeutic use due to the way it is presented
- the types of claims the product makes
Identifying products regulated by the TGA
Any product that is regulated by the TGA will have an 'AUST' number on the label. These products are regulated proportionate to their risk, approved for supply in Australia and included in the Australian Register of Therapeutic Goods (ARTG) as either registered medicines (AUST-R) or listed medicines (AUST-L).
All products that meet the criteria of a therapeutic good must be included in the ARTG before they can be legally supplied. Some sports supplements on the market may be therapeutic goods but have not been included in the ARTG by the manufacturer or importer prior to supply-we may target these as part of our compliance program based on complaints and other signals we receive.
