The Therapeutic Goods Administration (TGA) has issued four infringement notices totalling $50,400 to Cairns based company Hydrogen Technologies Pty Ltd.
In April 2020, the company allegedly advertised on its website and social media page therapeutic goods, being hydrogen/oxygen generators and nanobubble infusion pumps, that are not entered in the Australia Register of Therapeutic Goods (ARTG). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered in the ARTG before they can be lawfully supplied or advertised in Australia.
It is also alleged that the company’s website made unlawful representations regarding the goods, including references to serious diseases and conditions such as COVID-19, diabetes and cancer. Under the Therapeutic Goods Act 1989 (the Act), representations relating to the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to neoplastic diseases (including all types of cancer) are prohibited representations. Representations concerning a serious form of a disease, condition, ailment or defect, such as COVID-19 and diabetes, are restricted representations under the Act. The use of prohibited or restricted representations in advertisements for therapeutic goods is unlawful without the express permission of the TGA.
Advertisements of this nature are of significant concern given the current pandemic. The TGA has published a warning to advertisers and consumers about illegal advertising relating to COVID-19.
The TGA takes action against advertising breaches
The regulatory scheme is important to the safety of Australian consumers, and the TGA investigates suspected illegal activity in relation to therapeutic goods. The TGA regulates all medicines, medical devices and biologicals used in Australia and has access to a range of tools to enforce compliance. Where necessary this may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
Any person, including businesses, must comply with the requirements for advertising. The TGA encourages online advertising complaints to prevent potentially serious consequences.
The TGA is also reminding consumers to be on the lookout for misleading ads in its how to spot a dodgy health product ad campaign.