The TGA, has made a legislative instrument. The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020 (“the Amendment Order”) to help protect Australian consumers from the unsafe use of certain sports supplements.
From 30 November 2020, in order for sports supplements with therapeutic claims containing higher-risk ingredients to be advertised and supplied, they must be included in the Australian Register of Therapeutic Goods (ARTG). They must also meet legislated requirements that ensure the safety, quality and efficacy for medicines, including advertising.
Those sports supplements with therapeutic claims that are presented as tablets, capsules or pills will, as long as they do not contain higher risk ingredients, have 3 years (by 30 November 2023) to comply with the requirements.
The declaration follows over 18 months of extensive consultation, including public and targeted stakeholder consultations held between October 2019 and February 2020. A Regulation Impact Statement was also developed by the TGA to inform the decision.
Businesses producing products currently sold as foods that are affected by the declaration will need to change their products’ formulation to remain in the market as foods, or alternatively, transition their products to the therapeutic goods regulatory framework and be entered in the ARTG as medicines. As medicines, if they do not contain substances that are included in a schedule to the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard), they may continue to be sold from general retail stores including health food shops or supermarkets, similar to many other lower-risk medicines such as vitamins and dietary supplements. As with all other therapeutic goods in Australia, supplements containing substances included in a schedule to the Poisons Standard will be required to comply with the sale and access restrictions that it prescribes.
The declaration only affects some sport supplements. Common sports supplement foods such as protein powders, nutrition bars and sports drinks will not be affected where they do not contain high-risk substances
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 a schedule to 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.tablets, capsules and pills applies from 30 November 2023 onwards.
For more information , please refer to https://www.tga.gov.au/media-release/declaration-certain-sports-supplements-are-therapeutic-goods