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Case study: Restricted representations
About the advertising
During April 2020, the TGA received multiple complaints about advertising for the BioCharger, a medical device that emitted light. The TGA considered this device to be a therapeutic good, which was not entered in the ARTG, nor was it exempt from the requirement to be entered in the ARTG.
On the company website, advertising included the following health benefit claims about the device:
- 'proven to restore strength, stamina, coordination and mental clarity'
- 'sharpening your mental clarity'
- 'recovery...[from] an injury, stress', and
- 'accelerate muscle recovery, and reduce stiffness in joints'.
Advertising via Facebook live video included claims that implied the BioCharger was capable of having an effect in relation to COVID-19, as it was 'programmed with about a thousand different recipes, there's a couple on there for Wuhan coronavirus'. In the current context, consumers would interpret 'coronavirus' as a reference to COVID-19.
Details of non-compliance
It was alleged that the company advertised a therapeutic good not included in the ARTG, breaching section 42DLB(9) of the Act.
Advertising for the BioCharger device included the term 'coronavirus', which as a reference to a serious form of a disease, condition, ailment or defect (COVID-19), is a restricted representation. As TGA approval to make this reference had not been sought or obtained, this is a breach of section 42DLB(4) of the Act.
The TGA issued the company with two infringement notices totalling $25,200. The company accepted and paid these infringement notices and the material that was the subject of the complaint removed.