Resignation from TGACC

My resignation from the Therapeutic Goods Advertising Consultative Committee (TGACC) was precipitated by the non-response of Adj Professor John Skerritt, Deputy Secretary, Health Products Regulation Group, Department of Health, to long-standing issues raised yet again at the Skepticon 2020 regulatory panel session. These includes ineffectual and token enforcement of complementary medicines violations by the TGA.

The problem has got worse with the TGA’s recent implementation of recommendations from the Review of the Therapeutic Goods Advertising Framework. The TGA has now got rid of its backlog of complaints by closing all complaints received (including new ones) with the following response.

‘Your complaint has been finalised. The information you provided will be used by the TGA to inform compliance and enforcement activities under the TGA’s updated advertising compliance framework. The TGA is transitioning towards responsive regulation by utilising an intelligence led, risk-based approach to compliance activities. Thank you for bringing this matter to the attention of the TGA’.

Why would anyone bother to submit any more detailed complaints now this is the only response? Presumably, the TGA hopes for just this reaction. They will then be able to cite a falling-off of complaints as ‘evidence’ that unethical advertising has been brought under control. See the articles below.

My talk (which sets out the issues) is available: Ken Harvey: Background to the Review

A video of the session is available below (Q&A starts at 51:57 minutes):

My resignation letter. Response from Adj Prof John Skerritt and Health Minister Greg Hunt

See also the appended correspondence:

——— Forwarded message ———
From: Kenneth Harvey <kenneth.harvey@monash.edu>
Date: Thu, 12 Nov 2020 at 15:51
Subject: Re: Rapid Recovery Hangover Relief – Outcome of advertising complaint – AC-BGKWMZBG/2019
To: TGA Advertising <tga.advertising@tga.gov.au>

Dear TGA advertising people,

I was intrigued by your appended response to this complaint, first sent to the TGA on 10 September 2018 and again on 31 October 2019.

This product is still being advertised today, e.g.

It is still listed on the ARTG (no 297954) with a permitted indication: ‘Helps decrease/reduce/relieve symptoms of occasional hangovers’, despite the lack of evidence for this indication. 

Yet, your new advertising framework lists ‘hangover products’ as priority 2! 
Why have you closed this complaint, but taken no action?

Also, I have pointed out that additional hangover products have recently been listed on the ARTG

Why have you not asked the sponsors to justify the claims made and the ‘traditional’ indications cited

Do you believe these products are appropriate, given public health concerns about Australian alcohol consumption?

Please respond. Or, should I be writing to the Minister of Health (and Shadow Minister) about these matters?

Sincerely,

Ken

On Thu, 12 Nov 2020 at 14:59, TGA Advertising <tga.advertising@tga.gov.au> wrote:


Dear Sir/Madam,

Your complaint (Case Ref. CC-39UT49KT/2019*) received on 31/10/2019 in relation to the advertiser, The Trustee for CW IP Unit Trust T/as Chemist Warehouse for the advertising of Rapid Recovery has been finalised.

The action taken in relation to this complaint was: Reviewed in accordance with the updated advertising compliance framework.The outcome was: Case closed.

The TGA has closed this complaint and the information you provided will be used to inform the compliance activities of the TGA.

Our new advertising compliance framework describes the TGA’s intelligence led, risk based approach in responding to reports of non-compliance.

Compliance activities under the new framework are focussed on three key priority areas. 
For more information, please visit our approach to managing advertising compliance.\

While your case has been closed, the information you provided will help the TGA to understand what issues are causing the most harm to Australian consumers, and where to focus our compliance monitoring and enforcement efforts.For more information on the TGA’s Regulatory Compliance Framework, please visit the TGA website.

Thank you for bringing this matter to the attention of the TGA.

Kind regards
Advertising Compliance Section
Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606

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Independent Review of the Therapeutic Goods Advertising Framework: Recommendations

In 2018, the Hon Greg Hunt MP, Minister for Health, committed to a review of the impact of the new therapeutic goods advertising measures within two years from the commencement of the changes to the Therapeutic Goods Act 1989 to support these measures. Ms Rosemary Sinclair AM led the independent review, which was conducted during the first half of 2020 and recently published. The Australian Government has accepted all 22 recommendations in her report.

However, if these recommendations are to be implemented the TGA will have to radically change its culture.

Key recommendations and my comments follow:

Recommendation: The complaints management system should be ‘reset’ to focus on published priorities that provide public health and consumer benefit and improved compliance outcomes.

Comment: To-date the TGA has failed to deal with complaints about misleading and deceptive advertising of therapeutic goods in public health priorities such as obesity and alcohol. See: Complementary medicine weight loss products complaints submitted to the TGA in 2018-2019 and Complaints about numerous hangover products submitted to the TGA in 2018

Recommendation: The TGA should develop a clear regulatory position on the use of the broadened sanctions and penalties to protect public health and safety, enhance its compliance and enforcement skills and reflect on the lessons learned from the COVID-19 experience.

Comment: The report notes that the TGA tended to adopt a ‘light-touch’ approach to industry advertising violations. Consumer groups noted that enforcement actions were not used effectively to deter behaviour, with an overuse of educational obligations letters, and a reluctance and time-consuming process for enforcing harsher penalties. See: TGA Therapeutic Goods Advertising Compliance 2018-19 Annual Report: Comments. More recently, the TGA has taken useful action on COVID-19 problem advertisements, but this has yet to be replicated in other areas of public health importance. See: The TGA and COVID-19: Starting to use its compliance teeth!

Recommendation: KPIs should focus on priorities and compliance outcomes rather than processes and deadlines.

Comment: The broad consensus from Departmental staff and stakeholders was that the current KPIs were not fit for purpose as they do not show achievement of advertising compliance outcomes. It was also suggested that the current KPIs, which focus on the timeliness of ‘closing’ complaints may lead to the risk that compliance officers prioritise deadlines over consideration of broader public health and compliance outcomes. See: The TGA, KPI’s and the budget surplus

Recommendation: Case studies of the TGA’s application and interpretation of the Code should be published and educational activities more effectively focus on consumer and industry benefit.

Comment: The previous Complaint Resolution Panel (CRP) published determinations on all complaints dealt with. These were educative for both complainants, advertisers, and industry. In the new TGA system around 80% of complaints are classified as ‘low priority’ and closed by sending the advertiser a regulatory obligations letter. No details of the product, sponsor or alleged Code breaches are published in the advertising complaint database. While the current volume of complaints may preclude detailed determinations, representative case studies are required. See: Launch of TGA Advertising Hub – Initial experience of submitting complaints

Recommendation: Information on cross-sector issues and complaint trends should be shared with other regulators such as FSANZ and ACCC.

Comment: See Where food meets medicine: reform needed.

Recommendation: The Therapeutic Goods Advertising Consultative Committee (TGACC) should be refocused to enhance its effectiveness as a collaborative forum focused on better outcomes for consumers through effective advertising compliance by industry.

Comment: To-date, the TGA has largely failed to use TGACC member’s expertise to discuss problems and solutions. Typically the TGA talks at the TGACC rather than talk with the group.

Recommendation: The TGA should develop a periodic (e.g. every two years) stakeholder survey to evaluate satisfaction with stakeholder engagement efforts and perceptions of the effectiveness of the TGA’s compliance framework.

Comment: The TGA has conducted regular stakeholder surveys but only recently have some non-industry stakeholders been surveyed. In addition, the methodology has not been consistent. See: TGA stakeholder survey 2019 and Share your views in the 2020 TGA stakeholder survey

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Complementary medicine weight loss products complaints submitted to the TGA in 2018-2019. Follow-up.

This research was conducted by a team of Monash University BSc students on a Work Integrated Learning (WIL) placement, supervised by Assoc Prof Ken Harvey.

Monash University WIL Medreach Team, July 2020

The team reviewed the following complaints submitted on:

The students found that all products complained about in 2018-2019 continue to be promoted today (29/07/2020). Screenshots of current advertisements are appended.

They also reviewed the following literature and found no evidence to support the claims made for ingredients used in complementary medicine weight loss products.

  • Pittler MH, Ernst E. Dietary supplements for body-weight reduction: a systematic review. Am J Clin Nutr. 2004;79(4):529-536. doi:10.1093/ajcn/79.4.529
  • Saper RB, Eisenberg DM, Phillips RS. Common dietary supplements for weight loss. Am Fam Physician. 2004;70(9):1731-1738.
  • Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and consumer protection: regulation of complementary medicines in Australia. Med J Aust. 2008;188(1):21-25.
  • Lobb A. Science of weight loss supplements: compromised by conflicts of interest?. World J Gastroenterol. 2010;16(38):4880-4882. doi:10.3748/wjg.v16.i38.4880
  • Mullin GE. Supplements for weight loss: hype or help for obesity? Part III. Nutr Clin Pract. 2015;30(3):446-449. doi:10.1177/0884533615578918
  • Maunder A, Bessell E, Lauche R, Adams J, Sainsbury A, Fuller NR. Effectiveness of herbal medicines for weight loss: A systematic review and meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2020;22(6):891-903. doi:10.1111/dom.13973

They highlighted 27 permissible indications that they believed facilitated weight loss claims despite the lack evidence to support them. These are listed here.

They submitted a paper on their research for consideration of publication.

Finally, the advertisements appended are a sample of complementary medicine weight loss products complained about in 2019-2019 that students found were still being promoted today.

https://www.chemistwarehouse.com.au/buy/88367/naturopathica-fatblaster-clinical-60-capsules
https://vitaminsonly.com.au/products/naturopathica-fat-blaster-max-60-tablets
https://www.chemistwarehouse.com.au/buy/71930/naturopathica-fatblaster-garcinia-max-60-capsules
https://www.westfield.com.au/products/pharmacy-4-less/fatblaster-triple-tea-fat-burner-60-tablets/0c888589-51f0-4509-b76d-2ddfdf91d30d
https://www.goodpricepharmacy.com.au/naturopathica-fatblaster-apple-cider-vinegar-garcinia-max-60-capsules
https://www.superpharmacy.com.au/products/naturopathica-fatblaster-reducta-appetite-suppressant-40-tablets
http://www.empiresupplies.com.au/impromy-metabolic-c12-30-capsules.html
https://www.chemistwarehouse.com.au/buy/90045/optislim-clinical-60-capsules
https://www.ebay.com.au/itm/Healthy-Care-Forskolin-125mg-60-Capsules-supports-weight-digestion-metabolism/253186748486
http://healthycare.com.au/index.php/our-products/weight-management/item/89318-hc-ultra-strength-garcinia-cambogia-10000-100-capsules?category_id=62
https://www.ebay.com.au/itm/BLOOMS-MELT-COMPLEX-60-CAPSULES-METABOLISM-THERMOGENESIS-GARCINIA-WEIGHT-LOSS/162770031097?
https://www.evelynfaye.com.au/cabot-health-metabocel.html

In addition, new weight loss listed products have been added to the ARTG. These include FatBlaster Platinum Metabolism which contains the same SLENDACOR™ ingredients of the cancelled FatBlaster Clinical with minor additions.

https://pharmacyjunction.com.au/product/naturopathica-fatblaster-clinical-60-capsules/
https://www.woolworths.com.au/shop/productdetails/91646/naturopathica-fat-blaster-platinum-metabolism

See als0:

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Towards independence from commercial interests in health

An important collection of resources from the British Medical Journal (BMJ)

Growing evidence shows that extensive financial relationships between industry and healthcare decision makers distort scientific research, medical education and the practice of medicine. The biggest problem is that industry sponsored studies produce more favourable results creating biased evidence that overplays benefits and downplays harms. In response, many individuals and groups around the world are moving towards independence from commercial interests in research, education, practice and policy. This BMJ collection charts and encourages that move.

https://www.bmj.com/commercial-influence

Editorials

Commercial interests, transparency, and independence
Ray Moynihan, Helen Macdonald, Carl Heneghan, Lisa Bero & Fiona Godlee

Declaring interests and restoring trust in medicine
Carl Heneghan & Margaret McCartney

Industry influence in indoor tanning research
Jerod Stapleton & Joel Hillhouse

Financial relations between leaders of US medical societies and industry
Jake Checketts & Matt Vassar

Commercial influence and covid-19
Ray Moynihan, Helen Macdonald, Lisa Bero & Fiona Godlee

Analysis

Pathways to Independence: towards producing and using trustworthy evidence
Ray Moynihan, Per Vandvik, Beate Wieseler, et al.

Improving researchers’ conflict of interest declarations
Quinn Grundy, Adam G Dunn & Lisa Bero

Research

“Asset exchange”—interactions between patient groups and pharmaceutical industry
Lisa Parker, Alice Fabbri, Quinn Grundy, Barbara Mintzes & Lisa Bero

Effect of revealing authors’ conflicts of interests in peer review: randomized controlled trial
Leslie John, George Loewenstein, Andrew Marder & Michael Callaham

Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases
Bruno Goupil, Frédéric Balusson, Florian Naudet, et al.

Association between financial links to indoor tanning industry and conclusions of published studies on indoor tanning: systematic review
Lola Adekunle, Rebecca Chen, Lily Morrison, et al.

Mixed methods evaluation of workshops for citizen health advocates about financial conflicts of interests in healthcare
Ray Moynihan, Alice Fabbri, Lisa Parker & Lisa Bero

Financial ties between leaders of influential US professional medical associations and industry: cross sectional study
Ray Moynihan, Loai Albarqouni, Conrad Nangla, Adam Dunn, Joel Lexchin, & Lisa Bero

Opinion

I’m more susceptible to drug company money that I’d like to be
Lisa Parker

Cochrane announces a new, more rigorous “conflict of interest” policy
Karla Soares-Weiser

The sun is shining on the South: advocacy and regulation of conflicts of interest in Chile
Bernardo Aguilera, Juan Carlos Almonte & Rodrigo Irarrázaval

Can expert bias be reduced in medical guidelines?
Sheldon Greenfield

The world’s most influential medical leaders are still dining on pharma’s pizza
Ray Moynihan

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TGA stakeholder survey 2019

Perceptions of the regulation of complementary medicines: GPs & consumers

This 2019 survey follows the first TGA (2018) survey of consumer perceptions about the regulation of complementary medicines. GPs were not surveyed in 2018. Pharmacists have yet to be surveyed. The results speak for themselves. It is suggested that such surveys should be a regularly repeated TGA key performance indicator (KPI).

For general practitioners, Qualtrics surveyed a validated sample of 138 current general practitioners (excluding those in the medical products industry) who had heard of the TGA before participating in the survey. Fieldwork for the general practitioner survey was conducted between 24 June and 1 July 2019.

The questions about GPs perception of the regulation of complementary medicines items were prefaced with the following instructions and definitions: ‘Shown below are some statements about complementary medicines (such as vitamins, minerals, herbal or aromatherapy products) that are available in Australia. Please indicate your level of agreement with each statement’.

The consumer sample was composed of 1,045 adult Australians aged 18 and above. The sample was weighted to achieve broad representation across age, gender, and state-based location. Fieldwork for the panel consumer survey commenced on 21 June 2019 and was completed on 26 June 2019.

The questions about consumer perceptions of complementary medicines items were prefaced with the following instructions and definitions: ‘Shown below are some statements about complementary medicines (such as vitamins, minerals, herbal or aromatherapy products) that are available in Australia. Please indicate your level of agreement with each statement’.

See also:

Update 2020:

The 2020 TGA stakeholder survey used a different methodology, was not publicised. and was only available for one month. See: https://www.tga.gov.au/media-release/share-your-views-2020-tga-stakeholder-survey

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The TGA and COVID-19: Starting to use its compliance teeth!

Significant changes were made to the advertising framework of therapeutic goods during 2018-19. These included the TGA taking over the advertising complaint system, an updated, legally enforceable, advertising Code and stronger investigative and compliance powers. Yet the TGA initially appeared reluctant to use the powers given, preferring instead to ‘educate’ industry rather than enforce the Therapeutic Goods Advertising Code.

Consumer groups have long argued that penalties, not negotiation, is required for sponsors, advertisers and products who repeatedly violate the rules. To change behaviour, these penalties must outweigh the profit that comes from breaking the law.

The COVID-19 environment has finally stimulated the TGA to action. Marketers never waste a crisis and misleading, deceptive and dangerous advertising claims to prevent or cure COVID-19 have proliferated. These have been accorded high priority by the TGA who are now starting to enforce the Therapeutic Goods Advertising Code using their compliance teeth.

TGA actions have included:

  • Warning letters requiring advertisers to cease and desist advertising within tight timeframes (generally 48 hours).
  • Focusing compliance responses on the most significant breaches, e.g. illegal advertising of unregistered goods or use of restricted or prohibited representations.
  • Stronger enforcement action such as infringement notices.
  • Publication of the details of infringement notices, now being done upon issue rather than upon payment to maximise the deterrence impact.

For example:

Next, what about tackling other areas of consumer concern such as numerous illegal products not on the ARTG, and others that lack evidence such as weight loss, hangover, cognitive enhancement and detox products?

See also:

Our desired TGA: Enforcing the Therapeutic Goods Advertising Code using their teeth!
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COVID-19 Scams – ABC update on MMSAustralia

On 5 May 2020, ABC 7:30 (Grace Tobin) reported on the ‘Genesis II Church of Health and Healing’. The Australian branch, MMSAustralia.com.au currently promotes and sells Master Mineral Solution (MMS) – chlorine dioxide (a bleach) as a ‘sacrament of the Church’.

Update 13/05/2020

Update 15/05/2020

  • The TGA infringement notices were issued on the evening of 12 May 2020.
  • At the same time a detailed “immediate notice to cease and desist”  was sent requiring MMS Australia to immediately cease advertising and supplying the product.
  • MMS Australia had until COB, Thursday 14 May to provide written confirmation to the TGA that the advertising has ceased.
  • If the TGA finds that advertising does not cease (for example on the MMS website), the TGA will immediately move to seek an interlocutory injunction against further promotion and supply in the Federal Court of Australia.

Update 28/05/2020

The MMS Australia web site appear to be raising their middle finger to the TGA’s twelve infringement notices totalling $151,200 for the alleged unlawful advertising of Miracle Mineral Supplement. Web site now open for sales via logon.

Update 29/05/2020

TGA initiates court proceedings against MMS Australia and director Charles Barton for alleged unlawful advertising

See also:

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COVID-19 Scams: Pulsed Electromagnetic Field Therapy (PEMF)

PEMF Therapy Australia promotes Pulsed Electromagnetic Field Therapy (PEMF) for the ‘Prevention and Healing Coronavirus Infections’ (and also other restricted representations such as diabetes). These devices do not appear to be listed on ARTG; they are therefore being illegally supplied and their promotion is making unapproved restricted representations.

https://www.pemf.com.au/ (taken 01/05/2020)

A search of PubMed for Pulsed Electromagnetic Field Therapy and COVID-19 produced no results. There is some evidence that PEMF can improve fracture healing but studies of PEMF for other conditions are inconclusive, most suggest that more and better conducted scientific trials are needed:

Others have suggested that PEMF is snake oil.

On 24 March 2020, the TGA issued a warning about illegal advertising relating to COVID-19 and stated they would act in relation to the illegal advertising of therapeutic products.

I have asked that the TGA to take immediate action against PEMF Therapy Australia, including ordering a prominent retraction be placed on the home page of their web site and that substantial fines be instituted via infringement notices (Complaint, AC-NK9C4WIV/2020).

See also:

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TGA clears Clive Palmer’s coronavirus ‘cure’ advertisement

It was reported that the Therapeutic Goods Administration (TGA) has dropped its investigation into newspaper advertisements taken out by the former federal politician Clive Palmer which said, ‘hydroxychloroquine was the best hope for those suffering COVID-19’.

Clive Palmer

An advertisement is defined in the Therapeutic Goods Act 1989 Subsection 3(1) as, ‘any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design’.

In my opinion, the following statements on page 5 of Palmer’s 3-page advertisement, taken out in major Australian newspapers ( copied below), are clearly intended to promote the use of the drug:

  • ‘hydroxychloroquine was the best hope for those suffering COVID-19’ and
  • ‘the best treatment for its citizens should the worst occur’ and
  • ‘Mr Palmer said it was critical that the drug remained available in hospitals for those who needed it to treat COVID-19’.

These statements are inaccurate, misleading and not in accord with current scientific opinion.

For example, pages 6 and 7 of the advertisement titled, ‘COVID-19 Response and Action’ (copied below) fail to mention that the early French study that hyped hydroxychloroquine has been discredited. It fails to mention negative trials of the fact that serious adverse events emerged in other trials. See:

A number of trials are ongoing and until these have been peer-reviewed, published and replicated, my view is that it is unethical to promote this drug as Palmer has done. It will create false hope in the community and place pressure on medical practitioners to prescribe inappropriately. It also raises a serious question as to why the TGA dropped its investigation of this matter?

The TGA has apparently chosen to interpret the definition of advertising to mean ‘sale’ which, arguably, is not in accord with the Therapeutic Goods Act.

I have submitted a complaint to the TGA about this advertising (AC-TNBK7OQ6/2020). I have also asked for an explanation of the TGA’s interpretation of the Act in this case.

Update 15/05/2020

At a meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC) held on 14/05/2020, Adjunct Prof John Skerritt, Deputy Secretary, Department of Health explained why the TGA had dropped its investigation into Clive Palmer’s 3-page hydroxychloroquine advertisements that ran in major Australian newspapers from April 28 to May 2, 2020.

Prof  Skerritt said, ‘Taken as a whole, the TGA felt the advertisements primarily promoted Mr Palmer’s efforts in donating hydroxychloroquine rather than hydroxychlorquine itself. The TGA accepted this was a line-ball decision.  

A key factor for TGA was that the product was going into the national medical stockpile and could only be released for clinical trials or use by doctors on the decision of the Chief Medical Officer or Deputy Chief Medical Officer.

It was noted the wording about the drug in the advertisement reflected careful legal crafting. In response to reports of inappropriate off-label prescribing of hydroxychloroquine the TGA placed prescribing restrictions on the drug on 24 March 2020; only certain specialists can now prescribe hydroxychloroquine to new patients.’

Dr Harvey reiterated that inaccurate and misleading statements in the advertisements about hydroxychloroquine were likely to create false hope in the community and had placed pressure on medical practitioners to prescribe inappropriately

See also:

The Age, Saturday, May 2, 2020, Page 5
The Age, Saturday, May 2, 2020, Page 6
The Age, Saturday, May 2, 2020, Page 7
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COVID-19 Scams: MMSAUSTRALIA.COM.AU – Chlorine dioxide

MMSAustralia.com.au currently describes itself as a ‘Ministry of the Genesis II Church of Health and Healing’. It promotes and sells Master Mineral Solution (MMS) – chlorine dioxide (a bleach) as a ‘sacrament of the Church’. For example, ‘Jim Humble Approved formulation of MMS1 is composed of the highest grade 22.4% Sodium Chlorite’. Price $32.50. This is yet another COVID-19 scam.

http://www.mmsaustralia.com.au/index.php

MMSAustralia.com.au links to (and thus endorses) a number of videos, testimonials, protocols and other material invoking Jim Humble that allege that MMS, ‘has proven to restore partial or full health to hundreds of thousands of people suffering from a wide range of diseases. These include prohibited representations such as COVID-19, cancer, coronary heart disease, depression and multiple sclerosis. Humble has published a document, ‘Coronavirus Update (COVID-19)’, that provides a protocol of using MMS for coronavirus.

Mark Grenon, self- described as the Archbishop and founder of the “Genesis II Church of Health and Healing, recently wrote to President Trump saying chlorine dioxide ‘can rid the body of Covid-19’ a few days before the president promoted disinfectant as treatment.

The ‘Church’ provides a $300 video course has that, upon completion, provides a ‘Minister of Health Certificate with Reverend I.D. card’ and a ‘Certificate of Authorization to start a Genesis II Church chapter’. We have two such ‘Reverends’ in Australia:

Genesis II Church RC232 AU
Reverend Peter Greg
PO box 83, Westminster 6061 Australia
E: healthchurch@nym.hush.com
M: 0403 880 869

Genesis II Church RC946
Reverend Francesco Duardo
Sydney, NSW Australia
E: fduardo56@optusnet.com.au
M: 0407 807 907

In August 2009, a Mexican woman travelling with her American husband on their yacht in Vanuatu took Miracle Mineral Solution (MMS) as a preventative for malaria. Within 15 minutes she was ill, and within twelve hours she was dead.

In 2010 the CRP upheld three complaints about MMS by me (and others) and recommended that the advertisements be withdrawn, and a retraction be published.

In 2014, the TGA issued a safety advisory about MMS after a report that four people were hospitalised in Victoria after using the product. The TGA noted that MMS was not approved for any therapeutic use and if used for this purpose can pose a serious risk to health.

In 2019, the U.S. FDA warned consumers about the dangerous and potentially life-threatening side effects of MMS.

On 24 March 2020, the TGA issued a warning about illegal advertising relating to COVID-19 and stated they would act in relation to the illegal advertising of therapeutic products.

On 8 April 2020, the U.S. FDA wrote a warning letter to Mark Grenon, Joseph Grenon, Jordan Grenon, and Jim Humble of the Genesis 2 Church noting that claims on their websites misleadingly represent MMS as safe and/or effective to cure, mitigate, treat, or prevent COVID-19. They were ordered to immediately cease making all such claims.

Regardless, MMS continues to be promoted for COVID-19 and other conditions by MMSAustralia.com.au. This promotion of an unauthorised therapeutic good breaches both the Therapeutic Goods Act and the Therapeutic Goods Advertising Code.

On 29 April 2020, I asked the TGA to take immediate action against this company, including ordering that a prominent retraction be placed on the home page of MMSAustralia.com.au and that significant fines be instituted via infringement notices (Complaint AC-Q6V4DYR1/2020).

http://www.mmsaustralia.com.au/index.php?act=viewProd&productId=103

Update 13/05/2020 – More publicity and TGA Acts

Update 15/05 2020

  • The TGA infringement notices were issued on the evening of 12 May 2020.
  • At the same time a detailed “immediate notice to cease and desist”  was sent requiring MMS Australia to immediately cease advertising and supplying the product.
  • MMS Australia had until COB, Thursday 14 May to provide written confirmation to the TGA that the advertising has ceased.
  • If the TGA finds that advertising does not cease (for example on the MMS website), the TGA will immediately move to seek an interlocutory injunction against further promotion and supply in the Federal Court of Australia.

The MMS Australia web site now shows

https://mmsaustralia.com.au/password

See also:

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