The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued five infringement notices totalling $63,000 to Victoria-based company, SGC Products Pty Ltd for alleged unlawful advertising of products in relation to COVID-19.
The TGA alleges that SGC Products is responsible for the website www.doctorageless.com.au (the Website) and the Website unlawfully advertised Thymosin Alpha-1 and Thymosin Beta-4 peptides (the Products) as a "breakthrough preventative treatment for coronavirus (COVID-19)".
"The TGA has not registered any products as a preventative treatment for COVID-19 infection," Adj. Professor John Skerritt, Deputy Secretary of the Department of Health, said.
"We allege an advertisement that claims a particular medicine can prevent COVID-19 could put lives at risk and is likely to be illegal.
"Businesses are responsible for the content of their advertising - and just because they quote another source it does not remove this responsibility."
The TGA's highest priority is to protect the health and safety of the Australian public through its strict regulation of therapeutic goods - we will continue to pursue companies whose actions potentially risk people's health.
The infringement notices were issued for five separate alleged contraventions.
The TGA alleges that the Website advertised the Products as being effective against "cancerous cells". Under the Therapeutic Goods Act 1989 (the Act), representations relating to the treatment, cure, prevention, diagnosis, monitoring or susceptibility to cancer are prohibited representations.
Representations concerning serious diseases (including two allegedly made on the Website referring to COVID-19) are restricted representations.
The use of prohibited or restricted representations in advertisements for therapeutic goods is unlawful without prior approval or permission from the TGA.
SGC Products also allegedly advertised therapeutic goods (two peptide medicines) not included in the Australian Register of Therapeutic Goods (ARTG) and those goods were neither exempt nor excluded from the operation of the Act. 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 the Website promoted a prescription only medicine (containing the peptide Thymosin Beta-4). The Act prohibits advertising to the general public for a substance included in Schedule 4 (prescription only medicine) of the current Poisons Standard.
The TGA has informed SGC Products that the relevant advertising must be immediately removed from the Website. The TGA has published a warning to advertisers and consumers about illegal advertising relating to COVID-19. The TGA has also warned about products claiming to treat or prevent the novel coronavirus.
The TGA takes action against advertising breaches
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
In July 2019 the Federal Court of Australia ordered Peptide Clinics Australia to pay $10 million to the Commonwealth for breaches of the mandatory rules for advertising, which included advertising of prescription only peptides to the general public.
Any person, including businesses, advertising therapeutic goods to consumers must comply with the requirements for advertising. The TGA encourages people to report suspected non-compliant advertising via its advertising complaints form.
The TGA website includes tips for consumers about how to spot a dodgy health product.
