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Therapeutic goods advertising compliance, 2018-19 annual report
Emerging trends in compliance
Under the advertising risk-based activity model, the categorisation of the complaint as low is applied in the following circumstances:
- the alleged breach was the first time the advertiser had come to our attention,
- the alleged breach was not considered to be seriously misleading as to the proper identification or use of the goods, and
- there were no prohibited or restricted representations in the advertising.
Seriously misleading claims include falsely claiming that a device was TGA approved, or if the advertising was for a product not on the ARTG, nor exempt from inclusion on the ARTG.
Low level non-compliance is addressed in the following ways:
- through providing education and training as well as guidance material
- partnering up with sponsors, industry group and relevant sponsors, industry groups, relevant practitioner peak bodies and other regulatory agencies to assist in achieving compliance.
In reviewing the low level complaints that have been received to date, a number of sectors and common advertising issues have been identified which the TGA has flagged for future compliance efforts.
In May 2019, the TGA began work on a sector-wide compliance assurance priority relating to the advertising of 'bioresonance' devices (which are sometimes promoted as 'bio-energy' or (mistakenly) 'biofeedback' devices).
This sector has been identified as having a high rate of non-compliance and was the subject of previous regulatory compliance actions, including issuing individual advertisers with warning letters advising that their advertising was non-compliant.
Bioresonance devices are being promoted as being able to detect illness in the human body as well as to treat illness, including serious forms of illness. Through complaints, the TGA has been alerted to concerns about the scientific credibility of both the diagnostic and therapeutic use of these devices and is currently assessing this aspect of the complaints. Although this assessment is not yet complete, the TGA has cancelled five bioresonance, bio-energy and related devices from the ARTG. Reasons for cancellation include failing to respond to the TGA's requests to provide information or documents. Two sponsors also voluntarily cancelled their devices from the ARTG in advance of the TGA's assessment.
While the scientific basis for these devices remains under consideration, the TGA is, as a priority, working to address other concerns about the advertising of these devices by a large number of health practitioners, such as promoting them for the detection and treatment of serious ailments, diseases and conditions (which are restricted representations).
We are approaching this as a sector-wide compliance activity, which 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, and
- 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.
Multi-level marketing and direct selling
The TGA has received a number of complaints about advertising by multi-level marketers and direct sellers under both the new and previous regulatory frameworks.
The TGA considers that the nature of multi-level marketing and direct selling poses particular risks in relation to the advertising of therapeutic goods, largely because of the high degree of independence of the end seller from the 'parent' company and the often high number of 'end sellers'.
As highlighted in the encapsulated powdered fruit and/or vegetable products matter below, this independence presents particular challenges in:
- ensuring the sector is appropriately educated on the legislative requirements for the marketing of therapeutic goods,
- taking appropriate and equitable regulatory action against a large number of seller/advertisers all advertising the same products with same or similar claims, and
- ensuring our regulatory action is effective across the whole sector.
Encapsulated powdered fruit and/or vegetable products
From October 2018 to June 30 2019, the TGA received 28 complaints, from both consumers (93%) and medical practitioners (7%), about the advertising of a range of encapsulated powdered fruit and/or vegetable products being marketed with therapeutic claims and supplied only through multi-level marketing.
The complainants asserted the advertisers were making false and misleading claims in support of the product across various social media platforms and YouTube. The complainants took issue with the inclusion of both 'restricted' and 'prohibited' representations, false and misleading scientific claims, indications not included in the products' ARTG inclusions and the use of health professional endorsements in the advertising.
Initial investigations confirmed the individual sellers advertising the products were using prohibited representations including cancer, and restricted representations such as anxiety, autism, depression, diabetes, Crohn's disease and heart disease. Further investigations confirmed the involvement of medical practitioner endorsements and claims that the particular range of therapeutic goods was superior to dietary nutrients. Claims of 'scientifically proven,' 'most researched,' and '100% safe' were found to be used extensively in the advertising material.
When contacted by the TGA, the product advertisers advised they had all copied one another in relation to the therapeutic claims for the product. A small proportion of the advertisers conveyed that the training they received from the parent company was minimal or non-existent while others stated that they were regularly trained by those who recruited them.
Action taken by the TGA
- The TGA issued each seller/advertiser with a warning letter outlining the breaches identified in their advertising. They were given 14 days to correct or remove the advertising.
- The TGA will continue to monitor each seller/advertiser that was warned that further breaches will result in infringement notices being issued.
- Several medical practitioners advertising the product in a way which contravenes the Act and the Code have been referred to AHPRA.
Encapsulated powdered fruit and/or vegetable products are not the only area of concern in relation to advertising compliance in this sector. For example, a TGA Facebook post on 25 July 2019 about the dangers of ingesting essential oils generated a significant number of comments from stakeholders that expressed concerns about the inappropriate promotion of essential oils by multi-level marketers and other retailers.
The TGA is working to develop and disseminate educational material to both parent companies and their sellers/advertisers, including on the use of endorsements and testimonials in advertising therapeutic goods. The TGA will also release more detailed guidance for multi-level marketers and direct sellers on advertising of therapeutic goods generally.
In the year ended 30 June 2019, the TGA received 23 complaints regarding 10 different vendors of a Class 1 Medical Device. All complainants self-identified as consumers when submitting their complaints, yet scrutiny of the data revealed 48% of all complainants were vendors with competing products. The complainants all referenced the use of 'restricted representations' such as anxiety, autism, depression and post-traumatic stress disorder in their complaints.
Initial investigations revealed all vendors to be advertising the product using 'restricted representations'. Following initial contact by the TGA, warning letters were issued in respect of five vendors. This resulted in a number of those who received warning letters raising complaints against other vendors. Of these, all complaints referenced the three entities who are the leading sellers of the medical device. All 10 vendors stated they had seen other vendors using the same claims and restricted representations and had followed suit.
The TGA intends to undertake regulatory action against those entities who have demonstrated their awareness of their advertising obligations and have remained non-compliant.
|||See the database Medical devices and IVDs: Cancellations from the ARTG. Devices cancelled include Rayonex biofeedback system (ARTG 224787) and E-Lybra Bio-energy mapping system (ARTG 310955).|
|||See the database Cancellations requested by the sponsor - regulatory actions.|