The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued four infringement notices totalling $10,656 to a Sydney-based individual, for alleged unlawful advertising of Cannabidiol Oil in breach of the Therapeutic Goods Act 1989 (the Act).
The TGA on a number of occasions raised concerns with the individual that they could not make reference to the substance Cannabidiol (CBD) in the advertising of CBD Oil or other medicinal cannabis products. This is because CBD (and goods containing CBD) is included in Schedule 3, 4 or 8 of the current Poisons Standard and cannot be advertised to the public unless the substance is also included in Appendix H of the Poisons Standard.
The Act prohibits consumer advertising of substances included in Schedule 3 (pharmacist only medicine) of the Poisons Standard unless the substance is also listed in Appendix H. Substances included in Schedule 4 (prescription only medicine) or Schedule 8 (controlled drug) of the Poisons Standard cannot be advertised to consumers.
It is also alleged that the CBD oil that was advertised was not entered, at the time of advertising, in the Australian Register of Therapeutic Goods (ARTG).
The Act prohibits consumer advertising of therapeutic goods that are not entered into the ARTG, unless a specific exemption, approval or authority applies (which had not occurred).
It is alleged that the individual referred to a prohibited representation in the website advertising of the CBD oil as a treatment for “cancerous tumours”. The Therapeutic Goods Advertising Code specifies that representations relating to the treatment, cure, prevention or diagnosis (including screening) of neoplastic diseases, including all types of cancer, are prohibited representations.
The alleged advertising, on the individual’s website, also included a restricted representation in relation to Alzheimer’s Disease. Any claims or references to treating a serious form of a disease, condition, ailment or defect are restricted representations.
Under the Act, the use of prohibited or restricted representations in advertising of therapeutic goods is unlawful without prior authorisation from the TGA. No relevant authorisations had been granted in relation to this matter.
The TGA has informed the individual that the alleged unlawful website and social media advertising must be removed immediately.
The TGA continues to undertake compliance activities in relation to the advertising, import and supply of medicinal cannabis products, particularly in relation to individuals and business who have previously received guidance or cease and desist letters concerning alleged non-compliance.
The TGA’s highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods.
Warning to consumers
The TGA has published a warning to consumers about potential harm from unlawfully supplied medicinal cannabis.
Talk to your doctor if you have any questions or concerns about medicinal cannabis products.
It is important to be careful if considering buying medicines, including medicinal cannabis, online. Products bought over the internet may be a serious risk to your health and may not provide the health outcomes that are advertised.
The TGA website includes tips for consumers about how to spot a dodgy health product ad.
The TGA takes action against breaches of the Act
The TGA reminds advertisers that sanctions and penalties can apply if they advertise therapeutic goods in a way that does not comply with Australia’s advertising laws. The range of compliance and enforcement tools available include substantial fines and criminal or civil court action.
Educational information and resources about Australia’s advertising rules for therapeutic goods can be found on the TGA website.
The TGA encourages the reporting of suspected non-compliant advertising.