Black Salve has not been registered (on the ARTG- Australian Register of Therapeutic Goods) with the TGA and does not contain an AUST-L or AUST-R. Nor is it exempt from this register, neither has there been an attempt to register it. This means that the product has not had due diligence done on its safety or efficacy and as TGA certified practitioners, only TGA certified products are to be used. Anyone can access and obtain their own personal amount of Black Salve, however do so at their own risk. If a practitioner is recommending it or prescribing it, they are at great risk of liability and fines.
What if a therapeutic good is not on the ARTG? Therapeutic goods not on the ARTG have not been formally assessed to ensure that they meet the quality, safety and efficacy standards required under the legislation. Unlawful importation or supply of therapeutic goods that are not entered on the ARTG or do not meet applicable standards carries penalties of up to $5.5 million.
A safety alert was made by the TGA in 2012: https://www.tga.gov.au/alert/ black-and-red-salves-treating- cancer
Adverse events must be reported: This would mean for a practitioner (aside from being subject to penalties mentioned above), that they would shoulder full legal responsibility for these products under the Victorian code of conduct for unregistered healthcare professionals (likely to become national code of conduct).
Section 8.2: A practitioner that claims to be able to treat or alleviate symptoms of cancer or other terminal illness must be able to substantiate their treatments. There is currently no acceptable substantiation for black salve. As for another person selling it; if they are making claims it treats; or it can / should be used for skin cancers they are acting as an unregistered healthcare professional; If in Victoria, under section 4 of the Health complaints act 2016, you would be legally required to report them. If you are not from Victoria, you may still find that your state code requires you to do this. This may feel harsh, but depending on where you live, it could be what you are required to do legally.
Section 4 of Health complaints act 2016 Victoria: General health service providers to report concerns about the conduct of other health service providers A general health service provider who, in the course of providing treatment or care, forms the reasonable belief that another health service provider has placed or is placing clients at serious risk of harm must refer the matter to the Commissioner.
To see all requirements of the Victorian code of conduct – download the PDF below. https://hcc.vic.gov.au/sites/default/files/code_of_conduct_full_text_a3_poster.pdf We hope this article gives members a clearer understanding of the possible implications of claims and selling products that are not registered with the TGA, or have an exempt status.