The TGA issued a safety alert for first aid creams containing bufexamac on 8 September 2020 advising of the risk of serious skin reactions (allergic contact dermatitis). The safety alert also advised that 12 topical first aid creams that contain the active ingredient bufexamac, under various brand names, will be cancelled from the Australian Register of Therapeutic Goods (ARTG), effective on 18 September 2020.
Cancelled therapeutic goods cannot be advertised to Australian consumers. Advertisements promoting the use or supply of cancelled goods will breach the Therapeutic Goods Act.
The TGA will take action against advertising breaches.
The regulatory scheme is critical to the safety of Australian consumers. The TGA has a range of compliance and enforcement tools available to detect, deter and address the illegal advertising of therapeutic goods not included in the ARTG. These tools may include criminal or civil court proceedings, which can result in substantial fines or imprisonment.
Any person, including businesses, advertising therapeutic goods to consumers must comply with the requirements for advertising.
