The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 (the Act) in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.
The individual allegedly promoted, on their website, a homoeopathic immunisation product that contained a representation that the product provided “a more competent immune response to the Covid-2 virus, and also to those who [are] presenting with post Covid symptoms”. The advertisement further stated that the product was made from “the SARS Covid-2”.
The alleged advertising was unlawful because it made representations in relation to COVID-19. Any claims or references about therapeutic goods concerning the prevention or treatment of a serious form of a disease, condition, ailment or defect are restricted representations.
Under the Act, the use of restricted representations in advertisements for therapeutic goods is unlawful without the prior authorisation of the TGA. In this case, no relevant authorisation had been granted for the advertised claims.
The TGA was also concerned that the advertisement may result in Australians delaying vaccination in reliance on an unapproved product.
The advertising of therapeutic goods to consumers must comply with all applicable requirements in the Act. This includes the obligation to comply with the Therapeutic Goods Advertising Code. In Australia, medicines containing homoeopathic preparations are considered to be low-risk medicines, and are usually regulated under the Act and entered in the Australian Register of Therapeutic Goods as complementary medicines.
Education and resources about Australia’s advertising rules for therapeutic goods and the Australian regulatory guidelines for complementary medicines can be found on the TGA website.
The TGA has provided the rules surrounding COVID-19 vaccine advertising and import compliance and guidance about communicating COVID-19 vaccines.
The TGA also published a warning to advertisers and consumers about illegal advertising relating to COVID-19.
The TGA takes action against breaches of the Act
The regulatory scheme is critical to the health and safety of Australian consumers and the TGA investigates suspected unlawful activity in relation to therapeutic goods.
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.
The TGA encourages the reporting of suspected non-compliant advertising.
The TGA website includes tips for consumers about how to spot a dodgy health product ad.