On November 10, 2023, Department of Agriculture, Fisheries and Forestry (DAFF) of Australia issued a notification of changes to the regulation of sports supplements, with effect from November 30, 2023.
From November 30, 2023, products for the improvement or maintenance of physical or mental performance in sport, exercise, or recreation activity, and are supplied in the form of tablet, capsule or pill, will be required to be registered as therapeutic goods (medicine) under the supervision of the Therapeutic Goods Administration (TGA). Products containing only glucose are exempted from such registration.
Sports supplements that meet the requirements of the Food Standard Code and are presented in the typical food form will not be affected by these changes. This includes food products such as protein powders, nutrition bars and energy drinks.
Manufacturers or importers have the option to make a commercial decision, either removing their sports supplements from the market or reformulating the product to fit the classification as food, thus avoiding regulation as therapeutic goods.
Overview of sports supplements regulation in Australia
The regulation of sports supplements in Australia can be classified into two categories: foods and therapeutic goods. Imported food intended for sale in Australia should be inspected and tested under the Imported Food Inspection Scheme (IFIS). Sports supplements are considered therapeutic goods if they contains restricted ingredients listed in the Poisons Standard, Declared Goods Order or WADA Prohibited List, or they are in the dosage form of tablet, capsule, or pill (excluding those containing only glucose), effective from November 30, 2023.
For a therapeutic good to be imported, manufactured, supplied, or advertised in Australia, it is mandatory to have it listed or registered in the Australian Register of Therapeutic Goods (ARTG). Lower risk medicines are listed while higher risk medicines are registered in the ARTG. The label of these products will display an ARTG listing or registration number, which can be accessed by the public on the ARTG website.
Additionally, sports supplements categorized as therapeutic goods should comply with the labeling requirements in the Therapeutic Goods Order No. 92. The information typically provided in the “nutritional panel” is often inadequate. Instead, the label should clearly declare all active ingredients (as well as certain excipient ingredients) in the product.
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