The TGA has made a declaration under s 7 of the Therapeutic Goods Act 1989 (Cth) that certain sports supplements are now therapeutic goods.
The declaration will only apply to those products that make claims relating to performance in sport, exercise or recreational activity and:
- contain ingredients that are higher-risk, such as those containing substances in the Poisons Standard or included in the World Anti-Doping Code’s Prohibited List or
- are in a medicinal dosage form of a tablet, capsule or pill.
Products with higher risk ingredients must comply with the TGA’s regulations by 30 November 2020. This means that these products must be included in the Australian Register of Therapeutic Goods and must have evidence to support their safety, quality, and efficacy.
Sports supplements that are only therapeutic goods because of their dosage form must comply by 30 November 2023.
Of course, product manufacturers may choose to reformulate the products or change their presentation so that they continue to be sold as foods. For more information on how Avicenna Consulting can help you ensure that your sports supplements are compliant with the appropriate regulatory framework, please check out our information page on the regulation of sports supplements.
The TGA says that it has declared these sports supplements to be medicines to address safety risks associated with these products. The TGA wants to ensure that these products are regulated according to their risk.
Consumers will still be able to access these products once they become therapeutic goods. Those sports supplements which are considered to be listed medicines can be sold in retail stores, supermarkets, supplement stores etc. However; those containing ingredients included in the Poisons Standard may have restrictions on where they can be sold. For example, a product may be restricted to sale at a pharmacy.
If you have products that are affected by these changes and need assistance working out what you need to do, please contact us or check out our information page on the changes to the regulation of sports supplements in Australia.