The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Following an investigation by the Therapeutic Goods Administration (TGA), the Commonwealth Office of the Director of Public Prosecutions has laid 12 charges against an individual for alleged criminal offences under the Therapeutic Goods Act 1989 (the Act).
The alleged offences relate to the advertising and supply of black salve, bloodroot capsules and other unapproved therapeutic goods. It is alleged that the individual made claims about the products’ ability to treat serious health conditions, including anxiety and cancer.
The defendant faces a maximum penalty of 12 months’ imprisonment and/or a fine of up to $222,000 for each charge.
The TGA strongly advises consumers against purchasing or using black salve or bloodroot capsules. There is no credible scientific evidence to substantiate the benefits of these products for the management of serious conditions.
Black salve and bloodroot capsules are derived from Sanguinaria canadensis (bloodroot), which contains sanguinarine, a substance included in Schedule 10 to the Poisons Standard. Schedule 10 substances are considered so dangerous to health that they are prohibited from sale, supply and use in Australia.
Black salve is a corrosive topical paste which causes burns, destroying layers of skin and surrounding healthy tissue. This may result in pain, scarring, ulceration, swelling and infection. Bloodroot capsules may contain several of the same ingredients as black salve. For more information, check the safety alert on black and red salves.
Under the Act, therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be lawfully imported, exported, manufactured, supplied or advertised in Australia, unless a specific exemption or approval applies. In addition, advertising of therapeutic goods must not include restricted or prohibited representations unless an approval or permission has been given.
Businesses have a responsibility to understand their legal obligations under the Act before advertising or supplying therapeutic goods. Details about the legal framework for advertising, and guidance on how to advertise therapeutic goods.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices or suspected non-compliant advertising on the TGA website.
Contact for members of the media:
• Email: news@health.gov.au
• Phone: 02 6289 7400