Guidance on mushroom products

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Aged Care and is responsible for administering the regulation of therapeutic goods.

This guidance relates to the advertising of mushroom products that are used for therapeutic purposes and are therapeutic goods. Commonly, these are products containing mushroom extracts that are advertised with therapeutic claims, including claims about the treatment or prevention of disease.

The advertising and supply of therapeutic goods must comply with the:

•         Therapeutic Goods Act 1989 (the Act)

•         Therapeutic Goods Regulations 1990 (the Regulations)

•         Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Advertising Code).

In Australia, there are differences in the way foods and therapeutic goods are regulated. Foods and therapeutic goods have separate standards and regulatory controls for safety, quality, efficacy, labelling, and claims made about the product.

This guidance explains when mushroom products used for therapeutic purposes are likely to be considered foods, and when they are likely to be considered therapeutic goods under the Act.

If therapeutic claims are made about a mushroom product, then it is likely to be a therapeutic good. Mushroom products that are therapeutic goods must be entered in the Australian Register of Therapeutic Goods (the ARTG) before they are advertised for use or supply in Australia. Restricted and prohibited representations cannot be made about therapeutic goods without prior approval or permission from the TGA.

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