New in your June Wise and Well- TGA news including updates on bioresonance devices, Andrographis warning and COVID-19 advertising.
As you may be aware, the activities of the ATMS are guided by its Strategic Plan, which all members, ATMS staff and Directors had the opportunity to contribute to in 2017, and will have again shortly as we once more ask for your guidance in shaping your Society’s direction. The 2017-2020 Strategic Plan has 4 overarching goals, one of which is to advocate on your behalf with government stakeholders. One of our largest stakeholders, and a regulator that has a significant impact on our capacity to use medicines and therapeutic devices, is the Therapeutic Goods Administration (TGA). The TGA, apart from other functions, regulates therapeutic goods and devices- what can be used as therapeutic goods and devices, how and where they’re manufactured and what advertisers can say about them. The ATMS has significant input into the various functions and actions of the TGA, through:
- Membership of consultative committees.
- Submission lodgement where legislative or regulatory changes are imminent.
- Lobbying relevant government ministers, their opposition shadows, or their staff.
Because of the potential impact that the TGA may have on the capacity of ATMS members to practice, the ATMS has taken great care to generate and maintain very good relations with the TGA. As such, we’re the only professional natural medicine association to maintain permanent delegate status on committees such as the Therapeutic Goods Advertising Consultative Committee (TGACC) and receive regular communication from the TGA regarding matters that may be of importance to you.
Four important matters have recently arisen that we’d like to share with you.
1. Bioresonance devices
The ATMS recently received notification from the TGA regarding increased surveillance of “bioresonance” devices, and the advertising of these devices. The TGA noted that, “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.”(https://www.tga.gov.au/bioresonance) To emphasise this, the TGA has provided advertising compliance enforcement examples in its 2018-2019 Annual Report (https://www.tga.gov.au/sites/default/files/therapeutic-goods-advertising-compliance-2018-19-annual-report.pdf) In this notification, the TGA went on to state that it is, “…currently investigating the scientific credibility relating to the diagnostic and therapeutic use of these devices.” (https://www.tga.gov.au/bioresonance) and is conducting random and targeted reviews of practitioners’ advertising of these devices. What will be of particular interest to the TGA are the following:
- Advertisements promoting devices for the detection and treatment of serious ailments, diseases and conditions.
- Claims for things such as:
- Severe health conditions like cancers or other serious 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.
The claims referred to above may constitute prohibited representations (https://www.tga.gov.au/book-page/part-4-restricted-representations-and-prohibited-representations#s30 ) or restricted representations (https://www.tga.gov.au/restricted-representations) and anyone making these claims in relation to bioresonance devices may be committing an offence and may be penalised for doing so.
The TGA also pointed out that anyone advertising these devices where that device is not registered or listed on the Australian Register of Therapeutic Goods (ARTG), will be committing an offence and may be penalised for doing so. If you use a bioresonance device and are wondering if it is on the ARTG, you can search for it at https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg
In relation to the above, Members are reminded of their obligation to comply with the ATMS Code of Conduct, in particular:
- Section 3.9 All medicines supplied to clients by Members must be supplied in accordance with the relevant therapeutic goods and consumer legislation and meet all other applicable regulatory requirements. All assessment and treatment devices must be properly maintained, must be fit for their intended purpose and meet all regulatory requirements.
- Section 6.1 Advertisements in print, electronic, or any other form of media, must not be false, misleading or deceptive and must be in accordance with applicable legislation.
- Section 6.3 Members must not make claims as to the merits or outcomes of any treatment that they provide that cannot be substantiated.
- Section 4 Members must not advertise, by any means, products or devices that do not comply with applicable legislation.
For further information on bioresonance devices you can contact the TGA on 1800 020 653.
2. Andrographis Warning
If you’re a prescriber of Andrographis paniculata (Andrographis) it may be useful for you to be aware of a growing number of reports that have been received by the TGA regarding its potential to change the sense of taste or cause a complete loss of taste in consumers, and the possible need to warn clients of this.
Based on the reports received by the TGA, it can take up to several weeks after a client stops using the product for taste to return to normal. In addition, at the time of reporting, not all individuals had regained a normal sense of taste. It should be remembered that a sudden onset of loss of taste or altered taste may be a symptom of a serious medical condition, including COVID-19. Anyone experiencing loss of taste should seek assessment by a health professional or call the National Coronavirus Helpline on 1800 020 080.
If you are treating a client who has presented complaining of reduced or altered taste or loss of taste functions of the tongue, you should consider whether a product containing Andrographis could be involved. Please report any suspected adverse reactions involving taste disorders and Andrographis containing products to the TGA via https://www.tga.gov.au/reporting-problems.
In relation to the above possible risks to clients from the use of Andrographis, Members are again reminded of their obligation to comply with the ATMS Code of Conduct, in particular:
- Section 1.3 Members must do no intentional harm to clients. Members must not knowingly undertake any action or treatment that might adversely affect the wellbeing of a client.
- Section 2.9 Members must advise clients of the possible risks and benefits of any treatment offered and encourage the client to make an informed choice about the treatment.
3. COVID-19 Advertising
Earlier this year, the TGA issued an infringement notice to Melbourne based company NutriPATH Pty Ltd for the alleged unlawful advertising of a COVID-19 Polymerase Chain Reaction (PCR) test collection kit in breach of the Therapeutic Goods Act 1989. The value of the infringement notice was $12,600. Members should exercise extreme caution whenever advertising disease claims to clients or potential clients and be aware that diseases such as COVID-19 infections are a restricted representation under the Therapeutic Goods Act. While the infringement notice referred to above was received by a commercial organisation marketing a sample collection kit, such advertisements made by ATMS members may also constitute a breach of the Therapeutic Goods Act. Penalties may apply if you’re detected breaching the Therapeutic Goods Act or the Therapeutic Goods Advertising Code and the TGA may conduct random or targeted surveillance activities designed to detect such breaches.
4. Therapeutic Goods Advertising Consultative Committee (TGACC) Meeting
On the 14th of May this year the Therapeutic Goods Advertising Consultative Committee (TGACC) met by teleconference to discuss various matters related to the advertising of therapeutic goods and devices. The TGACC guides the TGA in formulating advertising policy and is made up of senior TGA staff, TGA legal and scientific staff, delegates from professional medical associations, professional natural medicine associations (of which the ATMS is the only member), delegates from therapeutics goods and devices manufacturers, advertising consultants, the ACCC, private regulatory consultants and consumer associations. The items that were discussed that may be of interest to Members included:
- Reports of the large number of non-compliant COVID-19 therapeutic goods and devices being advertised and supplied, and details related to the detection and enforcement of the Therapeutic Goods Act or the Therapeutic Goods Advertising Code in relation to these matters. For example, since the beginning of the pandemic the TGA had received 513 COVID-19 advertising related complaints, of which, 49 related to complementary medicine products. Also mentioned were infringement notices related to COVID-19 advertising, including breaches noted for Pete Evans Chef Pty Ltd’s BioCharger (fined $25,200), Oxymed Australia Pty Ltd’s advertising of hyperbaric oxygen therapy chambers (fined $63,000), Genesis II Church of Health and Healing (fined $151,200) and various COVID-19 test kits. It should be noted that the TGA is currently taking COVID-19 product and device advertising very seriously.
- Statements made by Clive Palmer concerning the provision of hydroxychloroquine for the treatment of COVID-19 and the possible advertising of this product by Clive Palmer- ruled by the TGA not to constitute advertising, therefore, no action taken.