28 September 2020 - Deborah Wilkes
Australia’s Therapeutic Goods Administration (TGA) has declared that certain sports supplements are therapeutic goods rather than foods.
The regulatory agency said it had made a legislative instrument under section 7 of the Therapeutic Goods Act 1989 to “help protect Australian consumers from the unsafe use of certain sports supplements”.
The declaration would ensure certain sports supplements were “appropriately regulated as medicines”, it added.
Ingredients and dosage form
The TGA said the declaration would only apply to products that make claims relating to performance in sport, exercise or recreational activity, and contain ingredients that are higher-risk or are in a medicinal dosage form of a tablet, capsule or pill.
Higher-risk ingredients, added the TGA, included substances in a schedule to the Poisons Standard or included in the World Anti-Doping Code's Prohibited List.
The TGA noted that common sports supplements – such as protein powders, nutrition bars and sports drinks – would not be affected if they did not contain high-risk substances
From 30 November 2020, said the TGA, 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,” added the regulatory agency.
“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 three years to comply with the requirements,” continued the TGA.
The declaration follows a consultation launched in October 2019 (click here to read the News story).
Announcing the consultation, the TGA said sports supplements “often carry explicit or implied claims relating to sport, fitness or recreational performance that mean they are likely to be consumed for therapeutic use, yet some of them may be considered to be food under law”.
“It is appropriate that those sports supplements that are taken to be for therapeutic use are subject to the same national system of controls that are established for other therapeutic goods,” added the TGA.