The Therapeutic Goods Administration (TGA) has issued five infringement notices totalling $63,000 to Sydney-based company Chemforce Pty Ltd for alleged unlawful advertising in relation to COVID-19.
Chemforce allegedly advertised on its website a medicine known as RibaMin that is not included in the Australian 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 advertised to the general public in Australia.
The advertising allegedly claimed the medicine is an effective treatment for COVID-19. Under the Therapeutic Goods Act 1989 (the Act), any claims or references to treating COVID-19 (and related terms) are restricted representations. A restricted representation refers to a serious form of a disease, condition, ailment or defect. The use of restricted representations in advertisements for therapeutic goods is unlawful without an approval or permission from the TGA.
It is also alleged the advertising stated that the therapeutic good was safe and implied it had been endorsed or approved by the United States Food and Drug Administration (FDA). Advertisements for therapeutic goods must not state or imply that the goods are safe. Additionally, they must not make any statement that implies the goods have been recommended or approved by a government, except in very limited circumstances. This includes statements that therapeutic goods have been approved by the TGA or international regulators such as the FDA.
The advertising allegedly did not list the medicine ingredients and therefore did not meet the requirements of the Therapeutic Goods Advertising Code (No 2) 2018 (the Code) in relation to what must be included in advertisements for goods that are not available for physical examination before purchase.
The TGA has informed Chemforce that it must immediately remove all advertising in relation to COVID-19 from the company's website.
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 unlawful activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and 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.
