From 30 November 2020 the TGA will regulate sports supplements formulated to look like medicines with therapeutic claims.
This is a result of the prevalent use of sports supplements among athletes who are not always aware of the risk that comes with them of ingesting poisonous substances.
To protect these consumers, the Therapeutic Goods Administration (TGA) declaration 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 instrument declares certain sports supplements (those that include higher-risk ingredients or are in the form of a tablet, pill or capsule) to be therapeutic goods, ensuring they are appropriately regulated as medicines.
This means that sports supplements with therapeutic claims containing higher-risk ingredients must be included in the Australian Register of Therapeutic Goods (ARTG) as well as meet legislated requirements that ensure the safety, quality and efficacy for medicines, including advertising.
Sports supplements with therapeutic claims that are presented as tablets, capsules or pills and do not contain higher risk ingredients have three years (by 30 November 2023) to comply with the requirements.
Regulated as medicines means that sports supplements will also need to be manufactured in accordance with good manufacturing practice to ensure the quality of the product, with extra labelling, advertising and evidence requirements.
The declaration follows over 18 months of extensive consultation, including public and targeted stakeholder consultations held between October 2019 and February 2020.