It’s a multibillion-dollar business, and one in three Australians regularly take their products, but health experts are concerned the increasing popularity of herbs and supplements is contributing to a spate of liver transplants.
With more and more people turning to supplements for health reasons, general practitioner Dr Sam Manger warned the industry had become like “big pharma’’, employing the same sales tactics as major pharmaceutical companies and selling hundreds of dollars worth of concoctions to vulnerable people who had little understanding of the effects.
“It’s about money, it’s the new ‘big pharma’,” Dr Manger said. “It uses all the same dirty tricks but with far, far, less regulation and very low standards. It’s the Wild West.”
Dr Sam Manger has warned that the supplements industry is out of control. Dr Manger recently saw a patient who had spent more than $2000 on vitamins, minerals, homeopathic medicines and various tests when simple lifestyle changes would have fixed her ailments.
“She’d spent thousands over a month, the supplements caused a wide range of side effects and she had quite a severe reactive depression as a result, along with who-knows-what other supplement side effects that were interacting, and she had lost much of her savings,” he said. Dr Manger was so shocked he took a photograph of the pyramid of supplements that had been prescribed by an alternative health practitioner.
He also recently saw a man who sought alternative therapy for a carcinoma. “He had been using black salve for over a year at the recommendation of his natural therapist, it had grown to over 15cm long and a deep ulcer, I suspect it would be metastatic now and will be too late for him,” he said.
While some supplements like folate for pregnancy are evidenced-based and recommended by doctors, the supplement industry has doubled in value in the past 10 years, with an explosion of products with dubious claims, like protecting eyes from smartphones and making kids smarter.”
Professor Ken Harvey, from Monash University, said the Therapeutic Goods Administration (TGA) had failed in its duty to protect Australians from ineffective health products and dangerous supplements which made unsubstantiated claims.
On 3 December 2018 the Federal Court ruled that imported products made into capsules in Australia is not enough for them to be labelled ‘Made in Australia’.
The ACCC welcomed the Federal Court ruling that Nature’s Care Fish Oil 1000 + Vitamin D3 soft gel capsule (branded as Healthy care) will not be allowed to be labelled ‘Made in Australia’ under the Australian Consumer Law’s (ACL) Country of Origin labeling provisions. The ACCC said it provided evidence to support its view, consistent with its published guidance, that encapsulation and the addition of a vitamin should not be considered a ‘substantial transformation’ of imported ingredients.
Complementary Medicines Australia (CMA) CEO Carl Gibson said the government needed to act immediately to protect the billion export market which was now under threat. The ‘Made in Australia’ logo is a key marketing element for many territories, particularly China, with some estimates that complementary medicines have an export value of $5 billion per year. “We are one of the few manufacturing sectors in the country actually growing – and yet Australia is about to shoot itself in the foot and give away our competitive export advantage,” he said, saying the case outcome underlined “how Australian companies are being negatively impacted by the new ACCC guidelines”.
My own view is that CMA are essentially saying they will lose money if they stop misleading consumers about their labeling and obey Australian Consumer Law. Which would also happen if they stopped misleading consumers about the claims made for their products and obeyed the Therapeutic Goods Advertising Code!
On 5 December 2018 the Minister for Industry, Science and Technology, Karen Andrews, announced the Complementary Medicine Taskforce to review the impact of recent consumer law changes on the complementary healthcare sector. “The Morrison Government is committed to helping local industry tap into our export markets, and ensuring our business community has opportunities to sell more products overseas,” Minister Andrews said.
The Taskforce will consider and assess reported impacts on the Sector of the changes to the substantial transformation test under the ACL. Both industry and consumer interests will be considered in this process. The Department of Industry will provide the Chair and Secretariat for the Taskforce. The Terms of Reference are available. The Taskforce will provide advice to Government by the end of February 2019.
For more information, contact Graeme Wolff, Manager, Trade Facilitation Section, Strategic Policy Division, Department of Industry, Innovation and Science, Phone: +61 2 6213 7357 Email:email@example.com
This is the first complaint outcome reported where the TGA said compliance had been achieved after “formal action”. The complaint was received on 03/08/2018 and closed on 17/09/2018.
If you didn’t know the TGA’s complaint reference (AC-BULV1O9Q/2018) you have to trawl through 20 web pages of “complaint outcomes” to find it. No other information is provided in the TGA advertising hub.
However, a search of the main TGA web site for “Gumby gumby” does provide the Section 42DV Direction: By 7 September 2018, it directs the person responsible to cease making claims or representations for Gumby Gumby capsules outright, or in the form of testimonials (including the Gumby Gumby Australia Facebook site), that: “they have or may have an effect on cancer of any sort, location or grade; they have or may have an effect on arthritis, chronic fatigue syndrome, or skin diseases and they have or may have any other therapeutic use whatsoever while ever the capsules are not included in the Australia Register of Therapeutic Goods (ARTG)”.
The CanSurvive (Cancer) web site also sell this product claiming, Gumby Gumby has been used in a broad range of conditions where digestive support, detoxification and immune support may be required.
Compliance achieved by the TGA? I don’t think so!
The Facebook web page above was sent to the TGA Advertising Compliance Section on 09/01/2018 with a query as to whether compliance had been achieved.
In a response received on 11/01/2019 this query was assigned a new complaint reference AL-9M1WJCMS/2019 and it was stated it would proceed to an investigation categorised as “high” priority.
Subsequently, the TGA pointed out that that the Facebook page illustrated above was not the subject of complaint AC-BULV1O9Q/2018 for which a Directions Notice had been issued. They initiated a new case reference (AL-9M1WJCMS/2019) because this was a different advertiser .
In response, I pointed out that the Directions notice merely referred to the “Gumby Gumby Australia Facebook” and an Internet search for these words produced the page illustrated above. There would have been no confusion if the TGA had not redacted the URLs and screen shots of the relevant Face Book page on their Directions notice. Four questions arose which I have sent to the TGA:
The old CRP provided both URLs and advertisement copy in their determinations; is there a legislative or other reason why the TGA does not?
The TGA Advertising Complaint Outcome record for complaint AC-BULV1O9Q/2018 provides no link to the Directions notice, nor any information on any identified offences or breaches despite the fact that this case has been closed. Equally, the TGA Directions web page provided no link to the Advertising Complaint Outcome record. Why are these links not provided?
Why did TGA Advertising Compliance Section miss the additional Face Book site and other sites making similar claims? I would have thought that for a critical complaint breaching s.42DM, 42DMA and other provisions of the Therapeutic Goods Act 1989, the Advertising Compliance Section would have performed an Internet search for similar prohibited claims about the same product on other web sites. Clearly, this has not been done for this case (and others I am aware of). Is there a limitation of the legislation under which you operate that prohibits the TGA from acting proactively in these cases?
Why was complaint AC-BULV1O9Q/2018 accorded “critical” priority when complaint AL-9M1WJCMS/2019 (which also promotes Gumby gumby for cancer) was only accorded “high” priority?
Ken McLeod first posted concerns about the alleged cancer-curing properties of Gumby Gumby in the Skeptics in Australia Facebook Group on 15 February 2016.
This Freedom of Information (FOI) application reveals that the TGA summarised a detailed complaint alleging numerous specific breaches of the Therapeutic Goods Advertising Code 2015 by sending one sentence to the advertisers, “The complaint alleges the advertisement may be misleading to consumers and a reference to scientific information is misleading”.
Given the lack of detail the TGA sent to the advertisers, and advice that the complaint would not be pursued further, it is not surprising that the advertisements remain largely unchanged.
Under the previous complaint system, the CRP forwarded the entire
complaint to the advertiser (deidentified if requested). They also provided a public
determination on what aspects of the complaint were justified and specific
advice on what claims should be removed to comply with the Code. This was
educative both for the advertiser, the complainant and the industry. The TGA’s
new complaint system provides none of these benefits. It actively discourages complainants.
Why bother with submitting a detailed complaint if this information is not
passed on to the advertiser and no action results?
The new complaint system has now been in operation for 6 months. It has proved far worse than the system it replaced. Hopefully, it will be reviewed by a new government.
The background to my FOI application follow.
On 15 July 2018, I submitted a detailed 112 page complaint about the advertising claims of “Pain®Gone”. I noted that this medical device had previously had a complaint upheld by the Complaint Resolution Panel (CRP). However, the sponsor (and others) continued to make claims that I alleged breached numerous sections of the Therapeutic Goods Advertising Code 2015.
My complaint contained the relevant CRP determination, a critique of the unpublished clinical trial used to promote the product and a 2001 Pain Review article, “Transcutaneous Electrical Nerve Stimulation (TENS) and TENSlike devices: do they provide pain relief?” This article noted that information on the clinical effectiveness of high-voltage TENS-pens was lacking; only two small uncontrolled trials had been published and randomized controlled clinical trials were needed.
The TGA assigned a low priority to this complaint and it was
closed over the period 24 July 2018 to 2 August 2018 by a “compliance notice
sent with educational material” to various advertisers.
On 22 August 2018, I informed the TGA that the advertising for this device was unchanged. I was told that a reasonable amount of time should be afforded the advertiser to review the requirements and adjust their advertising. The TGA also noted that records for low priority complaints would eventually be analysed to see if further education was required. To-date (07/01/2019) the advertising remains largely unchanged.
On 17 October 2018 I submitted a FOI application to view the educational letter the TGA sent to the advertisers of this medical device. It noted that I had requested a copy of this letter from the TGA as I was concerned that the detailed allegations of Code breaches may not have been passed on. The TGA had refused this request. They stated that the details (nature) of complaints were included in correspondence with the advertiser without forwarding the complaint itself.
On 24 December 2018, I received the result of my FOI application. My detailed complaint was summarised in one sentence, “The complaint alleges the advertisement may be misleading to consumers and a reference to scientific information is misleading”.
The TGA letter did contain the screen shots of advertising material I submitted but without any of the information I provided about why the claims made breached various sections of the Code. The TGA letter also listed four sections of the Code that may have been relevant (with no explanation) whereas I had alleged breaches of ten.
The TGA letter merely recommended that the identified
advertisement should be reviewed as soon as possible to ensure it complied with
the law. The TGA also advised that they would not be pursuing this complaint
any further at this time, but advertising may be monitored for compliance and
any future complaints will be considered on their merits.
I dispute the TGA’s assertion that the details (nature) of my complaint was included in correspondence with the advertiser. Given the lack of detail the TGA sent to the advertisers, and the advice that the complaint would not be pursued further, it is not surprising that the advertisements remain largely unchanged.
Finally, I fail to see why the TGA cannot send the original complaint (in its entirety) to the advertiser (de-identified if requested), as distinct from a brief and unhelpful summary?
Ear candling is a widely promoted alternative medical practice that involves inserting and lighting a hollow candle in the ear canal.
It is claimed that candling creates a vacuum that removes wax and that it can also relieve ear ache, glue ear, tinnitus, sinus problems, chronic headache, migraine, sore throat, allergies and many more conditions.
In fact, ear candles and candling are ineffective and dangerous. They do not remove wax from the ear and they have no effect (apart from acting as a placebo) on the numerous conditions they claim to treat. They have caused injury from burns, ear canal occlusions, ear drum perforations and secondary ear canal infections with temporary hearing loss.
Friends of Science in Medicine also raised this matter with the TGA. They have pointed out that other regulators, such as the U.S. FDA and Health Canada, have provided public warnings, import alerts, seizures, injunctions, and warning letters about these matters. However, the TGA refused to act.
Instead, the TGA advised the government to exclude ear candles from the Therapeutic Goods framework, thus abdicating their responsibilities in this regard and transferring the regulatory responsibility to the ACCC. This disregarded the majority of public submissions about this proposal, including one from the ACCC, that opposed this change.
From 1 July 2018, the CRP was abolished and the TGA became responsible for all complaints about the advertising of therapeutic goods. At that time ear candles had not yet been added to the Therapeutic Goods (Excluded Goods) Order No 1 of 2011.
On 24 July 2018 a portfolio of 104 complaints about the promotion of ear candles was submitted to the TGA. On 21 September 2018 the TGA finalised this complaint by stating they had sent an educational letter to all the identified advertisers. They also said that the outcome of this complaint would not be published on the Advertising Complaints Outcomes. The reason given was that ear candles were expected to be excluded from the therapeutic goods regulatory framework before the end of 2018.
On 1 October 2018 the TGA made a new determination under section 7AA of the Therapeutic Goods Act 1989 excluding ear candles from the TGA’s jurisdiction. These products are now the responsibility of the ACCC.
I have now assessed the impact of the TGA’s “educational letter”. Almost 6 months after making my complaint, 51 (49%) of 104 advertiser web sites are unchanged; 12 (12%) have removed some claims and 41 (39%) had removed all the claims I alleged breached the Therapeutic Goods Advertising Code.
Thus, 61% of the web sites complained about continue to make misleading and deceptive claims which I allege breach both the Therapeutic Goods Advertising Code and Australian Consumer Law.
by Commissioner Haynes on the regulators of the financial services industry is
equally applicable to the TGA and the ACCC. A failure to enforce the law
undermines the authority of the regulator whose fundamental responsibility is
to do just that. It also encourages others to break the law, leading to a race
to the bottom.
Further action is required. Given the TGA’s abdication of their responsibilities, I have now written to the ACCC requesting that they publish a warning to consumers about misleading and deceptive therapeutic claims made about ear candles on their Scamwatch web site. I have also suggested they send this information to those organisations who members are mainly responsible for these advertisements. In addition, the ACCC should consider pursuing an illustrative court case against a large company such as Chemist Warehouse (see below) who continue to make misleading claims about ear candles despite having received the TGA’s “educational letter”.
Lucy Romanoff investigated the illegal promotion and supply of body-building supplements in Australia. This problem was highlighted by the ABC earlier this year, but no action has been taken by the TGA about the products mentioned.
One ingredient mentioned by the ABC was cardarine, recently placed into Schedule 10 of the Poisons Standard. This means that it is of such danger to health as to warrant total prohibition of sale, supply and use.
Yet Lucy found this ingredient (and other Scheduled drugs) in a body-building supplement, “The King Kong Stack”, advertised and supplied in Australia by Evolution Supplements. The complaint she worked up (and I submitted) is another example of the failure of the TGA to protect consumers from illegally supplied, dangerous products. Our complaint noted there are many other Australian body-building web sites supplying similar illegal drugs. This complaint was allocated reference number AL-IP17Y7E6/2018 and accorded “high”, not “critical” priority. The priority given is difficult to understand.
Darci Bucheli investigated the illegal promotion and supply of whole-body cryotherapy machines within Australia. Their alleged benefits include weight loss, relieving pain instantly, slowing down the ageing process, and improving acne, psoriasis, eczema and autoimmune diseases.
Conclusion: The critique by Commissioner Haynes on the regulators of the financial services industry is equally applicable to the TGA. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.
Postscript (18 December 2018): Whacko! The TGA has taken its first company court action in almost a decade after alleging a prescription ‘peptides’ seller breached the regulator’s advertising code. The TGA action against Peptides Clinics Australia is the first civil penalty proceedings against a company since 2009, a health department spokesperson said.
It is also the first legal action the regulator has conducted since it won new compliance powers in the change up to the advertising complaints model. “[The action] is the first set of proceedings using the new compliance and enforcement regime included in the [TGA Act] from 6 March 2018,” the spokesperson said.
Hopefully, this is the first of many similar actions by the TGA against numerous Australian companies promoting and supplying illegal, dangerous, scheduled poisons.
The purpose is to ensure consumers have some protection against potentially dangerous or fraudulent goods &/or misleading and deceptive claims made about them.
Given the TGA’s risk-based regulatory system, the protection provided is greater (but not absolute) for goods the TGA declares high-risk such as prescription pharmaceuticals and implantable devices. The TGA evaluates these goods prior to marketing but the assessment of medical devices is less rigorous than pharmaceuticals and has many flaws as shown by the Implant files. In addition, patient experience post-market may disclose serious adverse events that had not been picked up before the product was launched as shown by the withdrawal of Vioxx (Rofecoxib) and many examples in the Implant files.
The protection provided for goods the TGA regards as lower-risk, such as complementary medicines and Class I and II medical devices, is much less. There is no pre-market evaluation. For complementary medicines sponsors merely certify that the product meets legislative requirements: the ingredients are taken from the TGA approved list, they are manufactured under GMP standards and evidence is held for claims made. Similarly, for lower-risk medical devices, sponsors merely certify that the goods meet an essential principles check list.
The only additional checks are a limited amount of post-marketing surveillance by the TGA and the complaint process. The former has shown high rates of regulatory non-compliance and the latter is flawed by TGA inaction as shown in the cases detailed on December 3, 2018.
If a medicine or device is marketed in Australia without going through the above process it is being supplied illegally (a breach of the Therapeutic Goods Act 1989 s.42DL(1)(g)) and the potential for harm is much greater.
This is a serious breach of the law and I cannot understand why the TGA has failed to act on the cases appended.
The critique by Commissioner Haynes on the regulators of the financial services industry is equally applicable to the TGA. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.
“These items have a high chance of being counterfeit, containing the wrong amount of active ingredient, being contaminated with toxic chemicals, containing undisclosed or dangerous ingredients and/or being past their use by date”.
The TGA has recently issued infringement notices for the alleged importation of unapproved therapeutic goods used in cosmetic procedures.
But they have taken no action on the following six complaints about the advertising of therapeutic goods that have not been listed, registered or included on the Australian Register of Therapeutic Goods (ARTG). The companies involved have broken the law.
The critique by Commissioner Haynes on the financial services industry and their regulators is equally applicable to the complementary medicine industry and the TGA. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.
In September 2016 the Complaints Resolution Panel (CRP) received a complaint about advertisements for Nature’s Goodness Bioactivated Resveratrol which appeared on the sponsor’s and retailer websites.
The Panel referred this complaint to the TGA in October 2016 because of the possible breach of section 42DL(1)(g) of the Act (the product may not be entered in the Australian Register of Therapeutic Goods) and/or possible food interface issues.
Why has Nature’s Goodness Pty Ltd (Prosolution Group Pty Ltd, ABN 096725370) not received an infringement notice for the promotion and sale of unapproved therapeutic goods?
2016/10/028 Jay Cutler Elite Series Big T
In September 2016 the Complaints Resolution Panel (CRP) received the complaint about an advertisement for Jay Cutler Elite Series Big T
The Panel referred this complaint to the TGA on October 2016 because of the possible breach of section 42DL(1)(g) of the Act (the product may not be entered in the Australian Register of Therapeutic Goods).
Why have these web sites not received an infringement notice for the promotion and sale of unapproved therapeutic goods?
2016/10/026 ProSolution Plus
In September 2016 the Complaints Resolution Panel (CRP) received a complaint about advertisements for ProSolution Plus which appeared on the sponsor’s web site.
The Panel referred this complaint to the TGA on October 2016 because of the possible breach of section 42DL(1)(g) of the Act (the product may not be entered in the Australian Register of Therapeutic Goods).
No action appears to have been taken by the TGA on this referral. Over 2-years after the original complaint, the promotion of this product continues at: https://www.prosolutionpills.com.au/
Why has this company (Prosolution Group, ABN 096725370) not received an infringement notice for the promotion and sale of unapproved therapeutic goods?
2017/12/002 Ayurda Livgood
The Complaints Resolution Panel (CRP) received the complaint about an advertisement for Ayurda Livgood which appeared on the sponsor’s web site on 20 November 2017
The Panel referred this complaint to the TGA in December 2017 because of the possible breach of section 42DL(1)(g) of the Act (the product may not be entered in the Australian Register of Therapeutic Goods) and/or possible food interface issues.
The Complaints Resolution Panel (CRP) received the complaint about an advertisement for AusLabs SAMS, STACKS, PCT & SUPPORT, PEPTIDES which appeared on the sponsor’s web site and Facebook on 29 March 2018.
The Panel referred this complaint to the TGA because of the possible breaches of section 42DL(1)(g) of the Act (the products may not be entered in the Australian Register of Therapeutic Goods).
No action appears to have been taken by the TGA on this referral (and many others), and 12 months after the original complaint the promotion of this product continues: https://www.auslabs.co/
Why has this company (AusLabs Co, ABN: (35 603 534 541) not received an infringement notice for the promotion and sale of unapproved therapeutic goods?
AC-JJPZUJ0G/201 (Doctor’s Best Extra Strength Ginkgo)
In correspondence dated 29 November 2018 the TGA categorised the promotion of companies named in this complaint as follows:
Aussie Well – CM:0017193 – Categorisation Low
Lean Machine – CM:0017194 – Categorisation Medium
Mega Vitamins – CM:0017195 – Categorisation Low
Rewardia – CM:0017196 – Categorisation Low
Trusted Health Supplies – CM:0017197 Categorisation Medium
I do not understand how the TGA arrived at these different priorities when the advertising of all the companies cited contained the same serious breaches of the Therapeutic Goods Act and Code.
All these company web sites promote and sell a product, “Doctor’s Best Extra Strength Ginkgo” (and many others) that appears to have been imported direct from the U.S.A. without being listed on the ARTG.
Thus, all web sites breach the Therapeutic Goods Act 1989 42DL(g) and 22(5) and the Therapeutic Goods Advertising Code 2015, s.4(1)(a).
For this reason, I suggested this complaint should be categorised as “critical”. Yet the TGA prioritised individual components as “low” or “medium” priority.
Why have infringement notices for the alleged importation of unapproved therapeutic goods not been issued to the companies highlighted in my complaint, e.g. LeanMachine (ABN 55 293 601 285), Trusted Health Supplies (ABN 92 046 652 410), Rewardia (ABN 24 64419354) and AussieWell (ABN 15 036 836769)?
Mal Vickers provided an analysis of therapeutic goods advertising breaches; a league table of companies with the most Code violations and failure of the Therapeutic Goods Administration (TGA) to enforce the law. Mary Malek showed how the TGA disregarded public submissions to its consultations. Kithmini Cooray presented a complaint about the unethical marketing of ‘Bright Brains’, a herbal product targeting ambitious students, about which the TGA said they achieved compliance. Ken Harvey raised grave concerns about the TGA’s new complaint system that appears to put the interests of industry ahead of consumers.
The audience did not agree that the ongoing advertising of ‘Bright Brains’, illustrated by Kithmini, had achieved compliance with the Therapeutic Goods Advertising Code 2015. In short, they disagreed with the TGA outcome statement about this complaint.
Which led to an interesting discussion on the TGA’s two key performance indicators (KPIs); time to action a complaint and time to close a complaint.
If ‘low priority’ complaints are closed by merely sending an educational letter to the advertiser (usually on the same day the complaint is received) then there is no difficulty in meeting time-based KPIs.
Equally, higher priority complaints (such as Bright Brains above) can easily meet their KPIs if they are closed by stating that compliance has been achieved when it has not. Presumably this complaint was closed by an assurance given by the advertiser, but without checking to see if compliance was actually achieved.
KPI’s can also be more easily met if no information is provided on why some alleged Code violations were accepted but others were not.
The Department of Health has disparaged the old Complaint Resolution Panel (CRP) on the grounds that it was slow. They promised the new TGA complaint system would be faster.
The CRP sent every complaint they judged to breach the Code (broke the law) to the advertiser for a considered response. They published on their web site a full determination on the claims alleged to breach the Code, often running into many pages. Yes, this process took time, but the end result was transparent and educational for advertisers and complainants. Contrast this, with current TGA published complaint ‘outcomes’.
These results raise questions about the competence of TGA staff assessing complaints and/or suggest they are far too willing to accept assurance of compliance from advertisers, or minor amendments, as an easy way of closing the complaint to meet their KPIs.
This “tick and flick” approach is convenient for the TGA and industry and but it is appalling consumer protection. It also disregards the purpose of the Therapeutic Goods Advertising Code 2015 and the Therapeutic Goods Act 1989 which the TGA is meant to uphold.
The critique by Commissioner Haynes on regulators of the financial services industry is equally applicable to the TGA. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.by