Date of effect: 30 November 2023
Attention
Importers of sports supplements that make therapeutic claims and are in the form of a tablet, capsule or pill.
Purpose
To advise importers of regulatory changes for sports supplements that are in the form of tablets, capsules or pills.
Key points
From 30 November 2023, products for the improvement or maintenance of physical or mental performance in sport, exercise, or recreation activity and that are supplied in the dosage form of a tablet, capsule or pill, other than products that only contain glucose, will be required to be registered as a therapeutic good (medicine).
Therapeutic use includes (but is not limited to) the following functions;
- gaining muscle
- increasing mental focus
- increasing metabolism
- increasing stamina
- modifying hormone levels
- increasing testosterone levels
- reducing oestrogen levels
- injury repair
- losing weight or fat
- preparing for workout, or
- recovering from workout.
Manufacturers / importers may make a commercial decision to withdraw their sports supplements from the market or have the product reformulated to be considered as food, rather than be regulated as therapeutic goods.
From 30 November 2023, sports supplements in the form of a tablet, capsule or pill, that are referred for inspection under the Imported Food Inspection Scheme and are assessed as being within scope of the new requirements will be referred to the Therapeutic Goods Administration (TGA).
Sports supplements that meet the requirements of the Food Standard Code and are presented in a typical food form will not be affected by the changed requirements. This includes food products such as protein powders, nutrition bars and energy drinks.
Sport supplements that contain high risk or restricted ingredients captured in the Therapeutic Goods (Declared Goods) Order 2019 will continue to be regulated as therapeutic goods.
For sports supplements that are currently included on the Australian Register of Therapeutic Goods (ARTG) there will be no change to requirements.
The TGA has developed guidance material for importers, suppliers, distributors and retailers, which is available from the TGA website, including a fact sheet on sports supplements.
Further information
The TGA has also developed a tool (decision tree), available on the TGA website, to assist in determining if your imported products may need to be included on the ARTG.
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