The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued an infringement notice for $13,320 to Brisbane-based company PPE Direct Pty Ltd (PPE Direct), trading as Infinity Biotech. The infringement notice is for the alleged unlawful advertising of a COVID-19 Rapid Test kit under the Therapeutic Goods Act 1989 (the Act).
PPE Direct allegedly implied, on the Infinity Biotech website, that a COVID-19 Rapid Test kit has been endorsed by a government or government authority.
Advertisements for therapeutic goods must not make any statement that suggests or implies that goods have been recommended or approved by government (except in very limited circumstances). This includes statements that therapeutic goods have been endorsed or approved by the TGA, state government authorities or international regulators.
The unlawful advertising of therapeutic goods in relation to COVID-19, including the inappropriate use of government endorsement, is of significant concern to the TGA given the current pandemic. The TGA has published a warning to advertisers and consumers about illegal advertising relating to COVID-19.
The TGA's highest priority is to protect the health and safety of the Australian public through regulation of therapeutic goods.
The TGA takes action against breaches of the Act
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 reporting form.
The TGA website includes tips for consumers about how to spot a dodgy health product ad.
