‘Schedule 4 Cosmetics’ top TGA advertising complaints
On 1 July 2018 the TGA became the single body for handling complaints about the ‘Advertising of therapeutic goods in Australia’ and on 25 October 2019 published its inaugural report on ‘Complaint Handling Activity’ – with ‘Schedule 4 Cosmetics’ topping the list.
The Therapeutic Goods Administration (TGA) is part of the Australian Government’s Department of Health and contributes to the ‘protection and promotion of public health through the regulation of therapeutic goods advertising’.
Because therapeutic goods are ‘intended to effect and influence the health and wellbeing of those who use them’, they are subject to special advertising requirements beyond those required for other consumer goods.
People who seek information about therapeutic goods are often facing health concerns (including serious diseases or conditions) and may be vulnerable to advertising claims. Hence the TGA emphasises that ‘it is vital consumers have accurate information’ about the products and treatments available ‘as misleading information could affect their health outcomes’.
The advertising requirements are specified in the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code.
As of 30 June 2019, there were 88,438 therapeutic goods included in the Australian Register of Therapeutic Goods (ARTG) by 4,126 sponsors. Of these, around 70,000 can be marketed directly to the public.
21% complaints for Schedule 4 cosmetics
During the 2018-19 financial year, the TGA received 1,468 complaints about advertising of therapeutic goods from various sources:
- Consumers: 42%
- Business: 20%
- Government/Statutory Body: 11%
- Academia: 10%
- Health Practitioner: 7%
- Consumer Organisaton/Body: 5%
- Regulatory/Legal Consultant: 4%
- Peak Healthcare Body/Organisation: 1%
- Peak Industry Body less than: 1%
- Publisher less than: 1%
The number of cases in the Top 10 complaints categories were:
- Schedule 4 cosmetic: 304
- Disease detection & screening: 186
- General health & wellbeing: 129
- Skincare/skin condition: 115
- Schedule 4 (therapeutic): 113
- Head lice: 99
- Pain/in inflammation relief device: 76
- Sun protection: 54
- Pain/inflammation relief medicine: 31
- Cold & Flu: 27
- Detox & Diuretics: 27
- Weight management: 27
The ‘Schedule 4 cosmetic’ category captures advertising to the public for prescription medicines used for cosmetic procedures (such as wrinkle reduction and filling).
The products concerned include botulinum toxins, hyaluronic acid, and polycaprolactone. With the exception of botulinum toxins, these products are generally regulated as medical devices.
The ‘Schedule 4 (therapeutic)’ category refers to advertisements to the public for prescription medicines that are not being promoted for cosmetic purposes.
‘Risk-based approach’ to deciding priorities
When a complaint is received, it is recorded as a ‘lead’. Each lead
is then assessed to determine the responsible parties involved and a ‘case’ is then created for each party.
The complaints received generated 2,436 cases. Of these, 1,601 cases were completed during the reporting period.
The TGA takes a ‘risk-based approach’ to complaints and case handling. This means:
- priority is given to cases where the ‘risk to consumers posed by a product, or the way in which a product is being advertised, is high’; and
- the regulatory response ‘is commensurate with the risk posed by the non-compliant advertising’.
In that process, each complaint is triaged and cases categorised as critical, high, medium or low ‘based on the risk to public health and safety’. The number of cases for each category in 2018-19 was:
LOW: 1,668 cases (one-o or isolated non-compliance; low risk of harm; advertiser has not previously come to TGA attention).
MEDIUM: 749 cases (advertiser has been made aware of obligations in the past; advertising breaches are ongoing; the advertising is not likely to lead to inappropriate or excessive use).
HIGH: 9 cases (continued non- compliance despite evidence advertiser is aware of obligations and the non-compliance is more serious in nature, such as use of prohibited or restricted representations; advertising is likely to lead to excessive use or impact on the ability to use the goods safely, in line with intended use).
CRITICAL: 10 cases (claim the goods treat serious or very serious conditions; target vulnerable or disadvantaged consumers with a risk that use may result in or is likely to result in harm or injury due to reliance on claims made or because of indications advertised; raise public health concerns, such as where use may result in harm or injury; undermine public health campaigns).
Bioresonance devices: concerns re ‘scientific credibility’
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)’.
The TGA noted: ‘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.’
Encapsulated powdered fruit & vegetable products
Between October 2018 and June 2019, the TGA also received 28 complaints (from both consumers and medical practitioners) 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.
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 who 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. AMP
Gumby Gumby Capsules
Gumby Gumby (Pittosporum angustifolium) has been traditionally used for therapeutic purposes by Aboriginal and Torres Strait Islander peoples.
The TGA received a complaint about Gumby Gumby capsules being advertised as a cure for various cancers and other serious conditions (including emphysema, autoimmune diseases and arthritis) across social media platforms including Facebook, YouTube and Vimeo.
This complaint was categorised as critical ‘due to the high risk of physical and clinical harm
posed to extremely vulnerable individuals’. As the advertising contained many claims about the product’s ability to treat cancer ‘without side effects’, the TGA was ‘particularly concerned
the advertising would entice consumers to delay conventional cancer treatments posing real risks to their health and lives’. Documented evidence of substantial sales of the product ‘prompted TGA to act quickly’.
A ‘direction notice’ was issued to the advertiser to permanently cease all advertising of Gumby Gumby capsules.
Sawyer Extractor Bite & Sting Kit
The Extractor Pump Kit was a product advertised by Backpacking Light, Survival Australia and Outdoor You. It claimed to remove poisons from snake bites, bee and wasp stings and more.
Claims the advertisers made about this product were ‘highly misleading and conflicted with contemporary first aid procedures for bite and sting treatment’. The likelihood of ‘harm, or even death, if these claims were believed by a consumer was high’.
The TGA demanded immediate action and the product advertising and supply was ceased.
Black salve, red salve and cansema are products containing an active ingredient called sanguinarine, which comes from Bloodroot (Sanguinaria canadensis). Sometimes zinc chloride is also present.
These products have been sold in Australia as an alternative treatment for cancer, including skin cancer. The TGA ‘is not aware of any credible, scientific evidence which shows that any black or red salve preparation is effective in treating cancer and has issued ‘alerts’ about the use of these products.
In May 2019, the TGA received a complaint about black salve being advertised as an ‘inexpensive, safe answer to cancer’. The advertiser also included instructions on how to make black salve and sold the ingredients needed to make it.
The complaint was categorised as ‘critical’ due to the ‘high risk of potential harm to extremely vulnerable individuals’.
As black salve is unproven for cancer treatment, ‘it may result in ineffective treatment of otherwise treatable cancers, to the extent that those patients are no longer treatable with conventional interventions’. As it is corrosive, people using black salve ‘may
be left with significant damage to their skin and tissue’.
In addition to cancer, the material indicated bloodroot could also treat bronchitis, bleeding lungs, cardiac conditions and other serious conditions.
The advertiser removed the identified non-compliant advertising from its website.
Seremind, a listed complementary medicine that contains lavender oil as an active ingredient, is indicated for relieving nervous tension, mile anxiety and sleeplessness in adults. An advertiser made references
to the product being ‘clinically tested’ for specific therapeutic
uses, ‘implying there were well- established, clinically certain health benefits associated with the product’.
The advertiser was issued with a warning letter and required to amend its website to remove reference to ‘clinically tested’.
PRP Stem Cell Therapy, Stem Cell Hair Technology Factors
Advanced Hair Studio of Australia advertised Stem Cell Hair Growth Factors to treat hair loss on its website.
The claims made about this product ‘were highly misleading, claiming clinically proven efficacy, video footage of endorsement by a ‘medical professional’, and images of people having benefited from using the product to improve hair growth’.
The TGA determined the advertising had breached 10 sections of the Code by advertising that was found to be ‘misleading and untruthful, making scientific claims that were not valid and easily disproved’.
Specifically, there had been no proper human trials of the product, the product claimed to contain stem cells but did not, and it used imagery unrelated to the product ‘to give the false impression that the product had produced good results for patients’.
The TGA sent a warning letter to the advertiser to remove non- compliant material from its website; the warning was complied with and the material.
Ease-A-Cold Cough, Cold & Flu
The Health365 website, operated by PharmaCare Laboratories Pty Ltd, promoted the Ease-A-Cold Cough, Cold & Flu Day & Night product as ‘clinically proven’ and ‘scientifically formulated’ to [help] shorten a cold.
TGA considers the use of the term ‘clinically proven’ in therapeutic goods advertising implies a level of certainty in the health benefit associated
with the advertised product, in that it has been tested in humans and proven to be effective. Such terms are not acceptable unless supported unequivocally by robustly designed, published peer-reviewed clinical trial(s) conducted on the actual medicine being advertised, or an identical formulation and dose (as a minimum).
Previous TGA assessment of the scientific evidence provided by the advertiser identified that it was not of sufficient quality to support strong claims, including ‘clinically proven’. The TGA therefore considered that the use of the terms ‘clinically proven’ and ‘scientifically formulated’ breached the Code.
The TGA required the advertiser to amend its website to remove references to ‘clinically proven’ and ‘scientifically trialled’, reminding them of the sanctions and penalties which may apply. The advertiser complied and removed the material.
Sensitive Imago Biofeedback Machine
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.
TGA found that the device was not included in the ARTG and advertisements contained unapproved prohibited representations (including references to assisting with anxiety and panic attacks) and restricted representations (including asthma, recurrent infections and thyroid conditions).
True Medicine was required to amend its website to remove any reference to treatments being ‘clinically proven’ and to remove reference to the unapproved device from its website.
Compounded Pea and Sublingual Hormone Spray
TGA received a complaint about a local pharmacy, Visionary Health Compounding Chemist, advertising palmitoylethanolamide (PEA) ‘for nerve pain’ as well as a ‘new diet spray’. The diet spray contained Human Chorionic Gonadotrophin, a Schedule 4 (prescription-only) substance.
The advertising occurred through the chemist’s website, and in the chemist’s premises itself.
The products were not included in the ARTG and were not the subject of an exemption. One product contained a substance that is not permitted to be advertised
or used without clinical authority. The advertisement contained claims that the products could assist with serious conditions such as Diabetic Neuropathy, Carpal Tunnel Syndrome, Multiple Sclerosis, Irritable Bowel Syndrome and stroke. No approval had
been granted by the TGA to make reference to restricted representations.
The advertiser removed all references to the product from its website.
Section 20 of the 2018 Code sets out that an advertisement must not contain an offer of a sample (with some exceptions for certain therapeutic goods).
In September 2018, Chemist Warehouse proposed providing sample bags (which included samples of therapeutic goods, in the form of seat cushions) at the 2018 AFL and NRL Grand Finals.
The TGA assessed that giving sample bags was a promotional activity which met the definition of ‘advertise’ in relation to therapeutic goods and the advertisement offered a sample which would have contravened the 2015 Code.
The TGA intervened and requested Chemist Warehouse not include therapeutic goods in the sample bags. Chemist Warehouse consequently did not include therapeutic goods in the sample bags, other than some approved sunscreen samples (which because of the inclusion of sunscreens in Schedule 3 of the 2018 Code, may be offered as a sample).
The TGA investigated Peptide Clinics Pty Ltd for breaches of the mandatory rules for advertising of medicines, including the ban on advertising prescription-only medicines to the public.
The Federal Court of Australia ordered a $10 million penalty against the company.