Regulation Impact Statement – Therapeutic Goods Administration
On 18 September 2020, a delegate of the Secretary of the Department of Health made a declaration under section 7 of the Therapeutic Goods Act 1989, which clarifies that certain sports supplements are therapeutic goods.
The declaration is intended to ensure that these sports supplements are subject to regulatory controls commensurate with their level of risk, and that consumers are able to make more fully‑informed decisions. It also addresses existing legal ambiguity to enable more timely compliance and enforcement action by the relevant authorities when safety concerns are identified.
The Therapeutic Goods Administration prepared and certified a Regulation Impact Statement (RIS), which the Office of Best Practice Regulation assessed as meeting the Australian Government RIS requirements and consistent with good practice. The RIS estimated the average annual increase in regulatory costs at $0.22 million a year.