Educating advertisers about compliance with the new advertising code and procedures
Changes to the Code governing the advertising of therapeutic goods have meant a period of transition for the TGA and our industry partners.
Our aim has been to streamline and simplify the complaints process, whilst making information about advertising requirements and protocols clear and accessible, for both consumers and suppliers of therapeutic goods and treatments.
We want to be clear about the regulations, about how to comply and about our decisions and actions when non-compliance occurs.
The TGA is very committed to transparency and access to clear advice in relation to therapeutic goods advertising and how we interpret and apply the legislation.
Our advertising hub is designed to be an important source of information, including publishing:
- complaint outcomes
- performance statistics for managing alleged non-compliant advertising cases
- guidance and educational events
- regulatory decisions and announcements.
To supplement these valuable sources of information, we have selected the following case studies from the archive of advertising complaint cases completed to date. They are designed to guide advertisers on how the TGA applies the Act and Code, as well as how cases are categorised, from low to critical.
As a guidance tool, these case studies are best used in conjunction with other resources such as guidance and fact sheets, seminars and the advertising hub.
The majority of cases where advertisers have disputed the alleged breaches or concern allegations of misleading claims remain under consideration and a more comprehensive analysis will be available in the next Annual Report.
Cases categorised as Critical
Case study 1: Sawyer Extractor Bite and Sting Kit
'The most powerful suction available for the safe extraction of venoms and poisons'
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.
About the complaint and advertisement
A complaint against the advertising of this product was made on 30 July 2018, and was categorised as critical. The 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.
Summary of breaches
The product had not been included in the ARTG, and did not have an exemption from being included. Products not included in the ARTG cannot be advertised to the public.
Full details of the breaches for each advertiser can be found in the Advertising Complaints and Investigations Portal, by searching for "Sawyer".
Actions taken
The TGA contacted the sponsor demanding immediate action and the product advertising and supply was ceased. The case was completed on 27 August 2018.
Case study 2: Gumby Gumby Capsules
"Treat all kinds of cancer"
'Gumby Gumby' (Pittosporum angustifolium) has been traditionally used for therapeutic purposes by Aboriginal and Torres Strait Islander peoples.
However, it is not included in the ARTG, and has not been approved for therapeutic supply in Australia.
About the complaint and advertisement
On 3 August 2018, 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 Ken Murray's personal social media platforms, including Facebook, YouTube and Vimeo.
This complaint was categorised as critical due to the high risk of physical and clinical harm that was 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 that 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.
Summary of breaches
At least eight serious breaches of the Act and Advertising Code were identified, including that many claims made by the advertiser were misleading and false. These included references to cancer (prohibited representations) and other serious conditions, diseases ailments or defects (restricted representations), as well as advertising products that had not been included in the ARTG, and did not have an exemption from being included.
Full details of the breaches can be found in the Advertising Complaints and Investigations Information, reference number AC-BULV1O9Q/2018.
Actions taken
The TGA advised that immediate action was required to cease advertising of this product. When this did not occur, a direction notice was issued to the advertiser, to permanently cease all advertising of Gumby Gumby capsules. The advertiser then agreed and the case was completed on 17 September 2019.
Case study 3: Black salve
"Inexpensive, safe answer to cancer"
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.
About the complaint and advertisement
On 20 May 2019, the TGA received a complaint about black salve being advertised as an 'inexpensive, safe answer to cancer'. The advertiser, Plant Essentials, 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 material did include some balancing information concerning the limited evidence to support the claims made in relation to cancer and the advertising was mainly limited to a single website rather than being spread across multiple platforms.
Summary of breaches
The TGA reviewed the material provided by the complainant and the advertiser and confirmed that the advertised products including Black Salve were being promoted for therapeutic use. These therapeutic goods were not included in the ARTG and were not exempt from the requirement to be included in the ARTG.
The advertising included references to the treatment of 'cancer', which is considered a prohibited representation, as well as other serious conditions, diseases, defects or ailments (restricted representations). Prohibited and restricted representations require approval from the TGA prior to their actual use in advertising - the advertiser did not have these permissions.
Full details of the alleged breaches can be found in the Advertising Complaints and Investigations Information, reference number AC-QMUBSLLI/2019.
Actions taken
The TGA required the advertiser to amend their website to remove the representations about black salve and other therapeutic goods not included in the ARTG and to cease using prohibited and restricted representations without permission or approval.
The advertiser removed the identified non-compliant advertising from their website. The majority of the material related to Black Salve was removed shortly after contact by the TGA. The other issues such as the advertising of numerous unapproved therapeutic goods were resolved by the Advertiser following further contact by the TGA. The case was completed 20 May 2019.
Misleading claims
In the absence of legislative definitions, the meaning of a word is taken both from the context in which the word is used and from The Macquarie Dictionary. The Macquarie Dictionary defines 'misleading' as:
- to lead or guide wrongly; lead astray.
- to lead into error of conduct, thought, or judgement.
In the context of advertising therapeutic goods, any claim that is likely to lead a consumer into an error of conduct, thought or judgement and therefore compromise the consumer's otherwise rational judgement and informed decisions about the use of therapeutic goods could be misleading.
A claim can mislead in various ways including:
- the omission of important information
- the inappropriate use of statistics and by using claims which are ambiguous and open to different interpretations
Accurate claims can also be found to be misleading, depending on the context in which the claims are made. The following case studies highlight a number of complaints in which the TGA considered allegations of misleading claims.
Case study 4: Seremind
"Clinically tested"
About the complaint and advertisement
On 16 October 2018, the TGA received a complaint about Seremind, a listed complementary medicine that contains lavender oil as an active ingredient. It is indicated for relieving nervous tension, mild anxiety and sleeplessness in adults. The complaint was categorised as medium, as the advertiser, A Menarini Australia Pty Ltd, 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.Summary of breaches
The breaches occurred through:
- the references cited in the advertisement for the therapeutic claims, and
- the use of the claims about the 'clinically tested' effects of the product.
When used in advertising to the public, the term 'clinically tested' is considered to be an implied citation to clinical or scientific literature, as are related terms like 'clinically trialled' and 'clinically proven'. When used in conjunction with claims of therapeutic benefits, such terms become a clinical representation, implying a proven and significant impact on the health of consumers. There are additional requirements in the Code for both implied literature citations and clinical representations, over and above the general requirements for claims to be accurate, substantiated and not misleading.
The therapeutic claims in the advertisement, combined with the 'clinically tested' term, are clinical representations with implied citations of scientific literature. The references apparently included:
- 1. a consumer leaflet for Seremind, and
- 2. a published study in mice.
Following contact by the TGA, the advertiser also provided a randomized, double-blind, multicentre trial testing the possible anxiolytic effects of Silexan (80mg/day) in 221 adults 18-65 years old suffering from anxiety disorders.
Consumer leaflet
The leaflet provided general information about the medicine and how to take it; it was not a clinical study. The Code requires that citations in advertising to scientific or clinical literature, either explicitly or impliedly, must be sufficiently identified to enable consumers to access it. The citation to the consumer leaflet, which in itself is not scientific or clinical literature, failed to identify the study relevant to the implied citation requirement. As such, this aspect of the advertisement contravened section 15(3)(b) of the Code.
Animal study
Pre-clinical (animal) studies are not, in isolation, adequate support for scientific indications for listed medicines (see Evidence Guidelines). While such studies may provide support for the biological plausibility of the mechanism of action for a medicine, they are not sufficient support for clinical representations.
Clinical trial
The TGA requested the advertiser to provide the evidence it held in support of the 'clinically tested' claim. The advertiser provided a single clinical study that investigated a relatively small number of participants. The study was also funded by the manufacturer of the product. The TGA advised the advertiser that the evidence they provided was not an adequate and appropriate body of evidence to support the claim of 'clinically tested'. The advertiser subsequently advised that other clinical studies were available, however, they did not consider them to be relevant to the product advertised. The TGA considered that the use of the claim 'clinically tested' without the support of appropriate clinical evidence was also likely to mislead and therefore breached section 9(b) of the Code.
As the clinical representations were inappropriately referenced, the TGA considered that the representations were inaccurate and invalid and therefore a breach of subsection 9(a) of the Code).
The use of the term 'clinically tested' claim in this advertisement (like 'clinically proven') implied there is a high level of certainty in the health benefits reported for the advertised product - i.e. it has been clinically trialled (tested in humans) and proven to be effective for the purposes identified. To be able to use such a claim, there would need to be unequivocal, robustly designed, published peer-reviewed clinical trial(s) conducted on the actual advertised product, or an identical formulation and dose (see the Advertising Code guidance for subsection 9(b)). Otherwise, such a claim is considered unsubstantiated and likely to mislead consumers about the effectiveness of the product.
The Code sets out the requirements that all claims must be valid and accurate, truthful, not misleading. The Code also requires that clinical representations made in an advertisement must be consistent with the body of scientific or clinical evidence applicable to the advertised therapeutic goods.
Therefore, this advertisement was also found to be unsubstantiated and misleading, in breach of sections 9(a) and 9(b) of the Code.
Full details of the alleged breaches can be found in the Advertising Complaints and Investigations Information, reference number AC-CE8WFJYQ/2018.
Generally, this case demonstrates the importance of providing appropriate citations in advertising to studies that reflect the nature of the claim (an animal study is not a clinical study) and the importance of having evidence of a sufficient rigour to support the strength of the therapeutic claim. Additionally, advertisers should be aware that they must hold all of the evidence needed to substantiate a claim before using it in advertising and that they need to provide all of that evidence to the TGA if requested. The TGA will not conduct literature searches looking for evidence to support a particular claim should an advertiser fail to provide sufficient evidence.
Actions taken
The advertiser was issued with a warning letter and required to amend their website to remove reference to 'clinically tested'. This occurred, as well as changes to packaging to ensure it complies with the Code. The case was completed on 20 June 2019.
Case study 5: PRP Stem Cell Therapy, Stem Cell Hair Technology Factors
'Restore, repair and rejuvenate to maximise cell life'
Advanced Hair Studio of Australia advertised Stem Cell Hair Growth Factors to treat hair loss on their website.
About the complaint and advertisement
A complaint against the advertising of this product was made on 21 September 2018, and was categorised as medium. The claims the advertiser 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.
Summary of breaches
The TGA determined that the advertising had breached ten 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 used imagery unrelated to the product to give the false impression that the product had produced good results for patients.
In addition, the product was neither included in the ARTG nor exempt from inclusion and therefore also breached the Act.
Full details of the alleged breaches can be found in the Advertising Complaints and Investigations Information Portal, reference number AC-BJXBKMT6/2018.
Action taken
The TGA sent a warning letter to the advertiser to remove non-compliant material from their website. This warning was complied with and the material was removed. The case was completed on 21 June 2019.
Case study 6: Ease-A-Cold Cough, Cold & Flu
'Clinically proven'
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.
About the complaint and advertisement
A complaint about the advertising of this product was received on 5 July 2018. The complaint alleged that the Health365 website, as well as a range of other websites (with some operated by pharmacies), breached the Code by using claims that had been found to be misleading under the previous complaints handling framework. These claims included that the product was "clinically proven" and "scientifically formulated" to shorten a cold.
Summary of breaches
Consistent with Case study 4 (Seremind), the 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). Similarly, the use of the terms 'clinical', 'clinically', 'scientifically', coupled with 'trialled', 'tested' or 'formulated', implies a higher level of certainty associated with the health benefit of the advertised product. Unless supported by well-designed clinical studies on the specific advertised product, such claims also may mislead consumers about the effectiveness of the product. 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.
Full details of the alleged breaches can be found in the Advertising Complaints and Investigations Information Portal, reference number CC-Q5FQMAI9/2018. Details of the cases involving the other advertisers identified in the complaint can be located by searching the portal for 'AL-B81GN1V3/2018'.
Action taken
The TGA required the advertiser to amend web site to remove the references to "clinically proven" and "scientifically trialled", reminding them of the sanctions and penalties which may apply. The advertiser complied and removed the material. The case was completed on 3 October 2018.
Prohibited and restricted representations
The Act tightly controls the use of references to serious forms of diseases, conditions, ailments and defects (collectively, conditions). People suffering from, or concerned about, such conditions are likely to be particularly vulnerable. As such the Act prohibits the use of references to such conditions without express permission from the TGA to ensure that any advertising making reference to them will not take advantage of consumer vulnerabilities, as well as being accurate, balanced and not misleading.
Certain references to the most serious types of conditions - namely, cancer, mental illness, HIV/AIDS, hepatitis C and sexually transmitted infections - are prohibited. Where there is a public health interest concerned (e.g. being able to promote the use of condoms for the prevention of HIV and STI transmission), the TGA can permit the use of these prohibited representations. References to serious forms of other conditions (e.g. diabetes, asthma) are restricted representations.
As demonstrated in Case studies 1 to 3, complaints about advertisements referring to prohibited or restricted representations without permission that hold significant public health and safety implications (e.g. by promoting an unregistered good that is likely to harm patients) are categorised as 'critical'. However, in accordance with the TGA's complaints handling framework, references to prohibited or restricted representations, in the absence of significant public health and safety concerns, may be captured in a lower category.
Case study 7: Sensitive Imago Biofeedback Machine
'Restore proper communication between cells and organs in your body'
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.
About the complaint and advertisement
On 16 October 2018, the TGA received a complaint about True Medicine's promotion of Sensitive Imago Biofeedback Machine, a bioresonance device.
Summary of breaches
Upon investigation, TGA found that the device was not included in the ARTG and there was no exemption from inclusion. The TGA also reviewed the material provided, and found that the advertisement also contained unapproved prohibited representations (including references to assisting with anxiety and panic attacks) and restricted representations (including asthma, recurrent infections and thyroid conditions).
Full details of the alleged breaches can be found in the Advertising Complaints and Investigations Information Portal, reference number CC-B1XL8AAN/2018.
Action taken
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 their website. This case was completed on 27 March 2019.
Safety and 'no side effects' claims
Therapeutic goods may have unintended consequences or trigger an adverse event. For these reasons, the Code specifically prohibits therapeutic goods from being advertised as safe or having no side-effects, even if qualified or supported by evidence. Similarly, advertising claims that imply a therapeutic good is "safe" are also prohibited.
Case study 8: Compounded PEA and Sublingual Hormone Spray
'Safe... no adverse effects'
About the complaint and advertisement
On 1 August 2018, the 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 case was categorised as medium.
Summary of breaches
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. Therefore, the advertisement breached multiple sections of the Act and also the Code.
Full details of the alleged breaches can be found in the Advertising Complaints and Investigations Information Portal, reference number AL-EON1Z6US/2018.
Action taken
The advertiser removed all references to the product from their website. The case was closed 6 September 2018.
Disease education activities
The purpose of disease education activities is to provide information and increase public awareness about health conditions and their management.
These activities can be a valuable source of information for Australian consumers as they raise awareness about diseases, aid recognition of symptoms and encourage consumers to seek appropriate advice if necessary.
Disease education activities must not however promote therapeutic goods. It can sometimes be difficult to distinguish between material that may have the effect of promoting particular therapeutic goods and material that is only providing disease information.
The party responsible for the material must ensure that the material would not stimulate demand for specific therapeutic goods.
While a disease education activity may make reference to a range of treatment options, this information must not be likely to encourage consumers to either seek to obtain a particular medicine, or seek a prescription for a particular medicine.
A disease education activity also must not encourage consumers to seek to obtain a particular medical device or seek from a health professional the use of a particular medical device. Special care is required for activities where there is not a range of treatment options, as the information may draw attention to one specific therapeutic good, whether that good is named or not.
Case study 9: Know Meningococcal
'Don't assume your child is protected'
About the complaint
In December 2018 the TGA received a complaint from a healthcare professional about the "Know Meningococcal" campaign run by GlaxoSmithKline Australia Pty Ltd, alleging that it may cause fear and distress in a consumer as it was a form of direct to consumer advertising. A subsequent complaint was received in February 2019 noting that, in the complainant's view, the material was a product or brand advertisement presented as a community service advertisement. The complainant queried why the company was allowed to promote a single vaccine brand.
The categorisation decision for this case was not straightforward. This case involved an extensive advertising campaign across multiple media. It appeared that the campaign was intended to be a 'disease education activity', a type of activity that normally falls outside the jurisdiction of the TGA, as it did not relate directly to therapeutic goods.
However, in this particular case the TGA assessed the campaign materials and determined that they met the definition of 'advertise' in the Act they promoted the use or supply of therapeutic goods, including goods sponsored by the advertiser.
The TGA viewed increased public knowledge concerning meningococcal disease as being a positive outcome for the Australian public, and that, in principle, an education campaign about meningococcal disease might be consistent with government public health messaging. However, because the material constituted advertising of therapeutic goods it contravened the Act and Code.
Summary of breaches
The TGA assessed the material and determined that it met the definition of 'advertise' in the Act because it promoted the use or supply of meningococcal B vaccines and was not simply promoting consumer awareness of meningococcal disease. This meant that the advertisement was promoting prescription only medicines (vaccines) and referred to a restricted representation, meningococcal disease, without permission - both contraventions of the Act.
The advertising also implied that harm would occur if the product was not taken, in breach of the Code.
Full details of the alleged breaches can be found in the Advertising Complaints and Investigations Information, reference numbers AC-HCEUITSO/2018 and AC-ZLV1JXC9/2019.
Action taken
The TGA contacted the advertiser. The advertiser immediately removed the campaign upon being advised of the TGA's concerns and during the course of the management of the complaint modified the disease awareness campaign to address those concerns and ensure the campaign did not constitute promotion of vaccines. In this instance, the TGA accepted that the Know Meningococcal campaign could be reinstated following removal of those elements promoting vaccines, to focus instead on improving public awareness of meningococcal disease, with emphasis on seeking medical professional advice.
Low category cases
As set out in the TGA's advertising complaints handling framework, cases categorised as low are not subjected to a formal investigation and no formal regulatory finding is made in these cases.
For low cases an obligations letter will be sent to the advertiser. The obligations letter will inform the advertiser of the alleged non-compliance and will provide information and guidance to rectify the advertising and to assist with future advertising compliance. It does, however provide an opportunity for the advertiser to be assisted with their compliance without penalty or sanction.
Once closed, low category cases are published in the advertising complaints and investigations database. However, for reasons of natural justice, the outcome will not specify the details of the advertiser or the goods involved because the TGA has not fully investigated nor made a formal finding in relation to the advertising.
The following de-identified case studies provide examples of low category cases handled by the TGA during the reporting period.
Case study 10: Bioresonance device
Implied TGA endorsement, good represented as 'having no harmful side effects'
About the complaint and advertisement
On 16 August 2018, the TGA received a complaint about an online advertisement to the public for a 'bioresonance' device. The advertisement made a claim to the effect that the device had been approved by the TGA. The advertisement also made a claim that that the use of the device would not result in side-effects.
The case was categorised as low as the advertisement did not represent the device for use in relation to serious forms of diseases, ailments, defects or disorders. While representing that a good has been 'approved by the TGA' and that the good is free of side-effects are advertising contraventions, these representations were not considered to pose any risk to the public. Additionally, the case appeared to be an isolated advertising non-compliance by an advertiser who had not come to the attention of the TGA prior to the complaint being received.
Summary of actions taken
The TGA issued an obligations letter to the advertiser, advising of the complaint. The letter requested the advertiser to review the identified advertisement and other relevant advertising of therapeutic goods to ensure full compliance with the law. The letter highlighted in particular the following requirements under the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code 2015:
- S.42DL(9) of the Act - Advertisements for therapeutic goods must not contain a suggestion or implication that the goods have been recommended or approved by or on behalf of a government or government authority
- S.4(2)(i) of the 2015 Code - An advertisement for therapeutic goods must not contain any claim, statement or implication that the goods are safe or that their use cannot cause harm or that they have no side-effects.
- S.4(6)(b)(i) of the 2015 Code- An advertisement for therapeutic goods must not contain or imply endorsement by and government agency.
The TGA is also, as part of its assurance activities, undertaking a systematic approach to bringing about compliance in the sector involved with 'bio-resonance' devices.
Learning for advertisers
While this advertisement was required to comply with the 2015 Code, advertisers should note that the requirement that advertisements must not contain an endorsement from, or imply that the therapeutic goods are endorsed by a government authority is also provided at S.16(2)(a) of the Therapeutic Goods Advertising Code (No.2) 2018. Additionally, it is a contravention of the Act to suggest or imply that the therapeutic goods have been recommended or approved by a government authority. Therefore, statements such as 'TGA approved' and 'included on the ARTG as a Class 1 medical device' are not permitted to be used in advertisements for therapeutic goods.
The TGA has provided guidance on how advertisers can compliantly advise the public that an advertised good is entered in the ARTG.
The requirement of the 2015 Code that an advertisement for therapeutic goods must not contain any claim, statement or implication that the goods are safe or that their use cannot cause harm or that they have no side-effects is the same as the requirement at S.10(d)(i) of the Therapeutic Goods Advertising Code (No.2) 2018. Advertisers should note that representations about the goods being safe or having no-side effects can be implied (i.e. not overtly stated). For further information, see Safety and 'no side effects' claims above and the TGA's guidance on this requirement.
Case study 11: Online advertisement for herbal medicine
References not provided on request
About the complaint and advertisement
On 27 June 2019, the TGA received a complaint about an online advertisement to the public for an herbal medicine, which was entered in the ARTG. The advertisement claimed that laboratory testing on the active ingredient in the medicine demonstrated that the ingredient worked by triggering the body's own anti-oxidant pathways. No details of the scientific studies were provided in the advertisement that would enable the reader to identify the studies. However, the advertisement invited readers to request the references. The complainant approached the advertiser for the references but their request was refused.
The case was categorised as low as it appeared to be an isolated advertising non-compliance and there were no concerns that the advertising was misleading as to the content or proper use or identification of the therapeutic goods.
Summary of actions taken
The TGA issued an obligations letter to the advertiser, advising of the complaint. The letter requested the advertiser to review the identified advertisement, and other relevant advertising for therapeutic goods, as soon as possible to ensure they comply with the law. The letter highlighted in particular the following requirements under the Therapeutic Goods Advertising Code (No.2) 2018 that may be of concern:
- S.9(b) - Advertising for therapeutic goods must be truthful, balanced and not misleading or likely to mislead, including in its claims, presentations, representations and comparisons.
- S.15(3)(b) - Where an advertisement contains a citation to scientific or clinical literature, either explicitly or impliedly, the study must be sufficiently identified to enable consumers to access it.
Learnings for advertisers
Advertisers should note that the requirements set out in section 15 of the Code must be met wherever an express or implied reference to scientific or clinical literature is appears. A reference to 'laboratory testing' purporting to demonstrate the mechanism of action of a medicine is an implied reference to scientific literature. While offering to provide a copy of references on request may be acceptable to meet the requirements of section 15 where that information is not in the public domain, such a claim will be likely to be misleading if the advertiser does not provide the information when requested by a member of the public.