Posted 18 August 2019
In May 2019, the Therapeutic Goods Administration (TGA – Australia) commenced work on a sector-wide compliance activity relating to the advertising of ‘bioresonance’ devices, which are sometimes mistakenly promoted as ‘biofeedback’ devices. This sector has been identified as having a high rate of advertising non-compliance, with widespread advertising. The advertising of bioresonance has been the subject of previous regulatory compliance actions.
(Editor: Beamer, Scio and Quantum SCIO-EPFX devices are included in this category)
Bioresonance is based on the belief that human beings emit electromagnetic waves, which can only be measured by bioresonance devices. Advertisers claim these devices can measure these waves to detect illness in the human body as well as sending ‘rehabilitated bad’ waves to the patient to alleviate illness.
The TGA is currently investigating the scientific credibility relating to the diagnostic and therapeutic use of these devices. The TGA is also working to address other concerns about the advertising of these devices by a large number of health practitioners promoting them for the detection and treatment of serious ailments, diseases and conditions. These claims are prohibited and restricted representations. Some non-compliant advertisements claim that this therapy can assist with or treat:
- Severe health conditions like cancers or diseases
- Joint pain / Osteoarthritis
- Clearing the body of heavy metals
- Disorders like chronic fatigue and insomnia
- Mental health conditions, including anxiety and ADHD
- Vitamin and mineral deficiencies
- Food allergies or intolerances
- Learning difficulties
- The side effects of Western Medicines, including chemotherapy and antibiotics.
What the TGA will do
We take non-compliance by advertisers seriously, particularly where there is the potential for consumers to rely on claims in advertising to seek treatment when those claims may be false or misleading.
As a result, the TGA is conducting a regulatory activity as a priority in this sector. This includes:
- working closely with our counterparts, including other federal regulators and state and territory government bodies and professional bodies to share the information on our activities on bioresonance device non-compliance issues
- writing to relevant practitioner peak bodies and sponsors of bioresonance devices to alert them to the advertising compliance issues faced by their sector and seek their assistance with disseminating information and rectifying these issues.
Two months following the completion of this activity, the TGA will conduct a round of random advertising reviews, gauging the level of compliance achieved. All non-compliant cases identified will be escalated to a higher level of non-compliance category for investigation, where appropriate compliance enforcement actions will be applied.
What you should do if you advertise bioresonance devices
If you have advertised, or intend to advertise these types of devices, you should:
- talk to your peak body or a regulatory affairs consultant
- check if the device is on the Australian Register of Therapeutic Goods (ARTG):
– If the device is not on the ARTG, don’t advertise the product.
– If the device is on the ARTG, make sure your advertising is compliant with the advertising requirements, and don’t refer to prohibited representations or restricted representations.
If you are considering seeking diagnosis or treatment of your health conditions using bioresonance, biofeedback and similar devices, please read Three questions to ask natural health practitioners about testing services.
For further information you can contact the TGA on 1800 020 653.