The Australian Therapeutic Goods Administration has declared that, as of 30 November 2020, certain sports supplements will be captured and regulated as 'therapeutic goods' under the Therapeutic Goods Act 1989 (Cth) (TGA) and existing Therapeutic Goods (Declared Goods) Order 2019 (Order). This announcement, and the updates to the therapeutic goods regulatory regime, comes after a 12 month public consultation focused on sports supplement safety and legal regulation in Australia.
Those in the business of manufacturing and supplying sports supplements will now need to be across the advertising, labelling and regulatory requirements which apply to 'medicines', regulated under the TGA and the Order, rather than 'sports foods', regulated by Food Standards Australia New Zealand (FSANZ) or risk large financial penalties. Critically, manufacturers and suppliers of the sports supplements outlined below will also need to ensure those products are registered on the Australian Register of Therapeutic Goods (ARTG).
The Therapeutic Goods Administration has also suggested that businesses producing sports supplements, currently sold as 'foods' but soon to be regulated as 'medicines' under the TGA, should consider altering product formulas in order to continue to supply them as foods or otherwise register their products on the ARTG.
Supplements covered by the TGA from 30 November 2020
Under the Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020, sports supplements administered orally and represented overtly or impliedly as being for the improvement or maintenance of physical or mental performance in sport, exercise and recreational activity and containing certain ingredients will be considered to be therapeutic goods (medicines) within the meaning of the TGA and Order from 30 November 2020.
The qualifying ingredients include:
- a substance captured by The Poison Standard (the Standard for the Uniform Scheduling of Medicines and Poisons or 'SUSMP');
- a substance expressly identified on the World Anti-Doping Code's Prohibited List that is added as an ingredient to the sports supplements;
- a relevant substance that is added as an ingredient to the sports supplements (currently these ingredients include dendrobium and methylliberine); or
- a substance with equivalent pharmacological action to a substance mentioned in the above ingredients, including those that may be characterised as an active principle, precursor, derivative, salt, ester, ether or stereoisomer.
Manufacturers and suppliers of any sports supplements containing the above ingredients should immediately register these products on the ARTG.
Supplements covered by the TGA from 30 November 2023 – tablets, capsules and pills
Sports supplements represented for improvement or maintenance of physical or mental performance in sport, exercise and recreational activity and in tablet, capsule or pill form must be registered on the ARTG by 30 November 2023.
If you are a manufacturer or supplier of sports supplements and are unsure about whether your products are captured by these TGA legislative amendments, or require advice around the TGA regulatory obligations which now apply to you, please contact a member of our life sciences team.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.