The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $26,640 to Sydney-based company Obelisk Ventures Pty Ltd (trading as Markson Sparks) for the alleged unlawful advertising of a medical device in relation to COVID-19.
It is alleged Markson Sparks emailed its subscribers using the email marketing platform 'MailChimp' to promote the Bionic Air Plasma Medical Device, and claimed the device could prevent COVID-19. The advertising was allegedly in breach of the Therapeutic Goods Act 1989 (the Act) as claims in relation to preventing 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 prior approval or permission from the TGA.
Markson Sparks also allegedly claimed, in the email to subscribers, that the medical device is safe for the elderly.
It is a breach of the Therapeutic Goods Advertising Code (No. 2) 2018 to promote a therapeutic good as being safe, harmless or without side-effects.
"As the COVID-19 pandemic continues, the TGA is determined to stamp out advertising which makes unlawful claims about the cure or prevention of COVID-19," Adj. Professor John Skerritt, Deputy Secretary of the Department of Health said.
"Advertising targeting vulnerable groups, including seniors, is of particular concern to the TGA during these challenging times."
The TGA has informed Markson Sparks that the relevant advertising must be immediately removed.
The TGA is investigating other entities that have been the subject of complaints about alleged unlawful advertising in relation to COVID-19.
The TGA has published a warning to advertisers and consumers about illegal advertising relating to COVID-19.
The TGA has also provided a warning about products claiming to treat or prevent COVID-19.
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.
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.
Visit the TGA website for tips about how to spot a dodgy health product.
