Caruso’s Prostate EZE Max gets a TGA AUST L(A) listing

A new ‘TGA assessed’ symbol and AUST L(A) listing on complementary medicines are meant to alert consumers that the TGA had assessed their health claims and found them supported by scientific evidence.

On May 26, 2021, Caruso’s Prostate EZE Max became the first herbal complementary medicine to receive a Aust L(A) listing. The product contains herbal extracts of Prunus africana (Pygeum), Serenoa repens (Saw palmetto extract), Epilobium parviflorum (willowherb), Cucurbita pepo (pumpkin seed oil) and lycopene (found in tomatoes and some other red fruits and vegetables).

The TGA-assessed indication is, “For the relief of nocturia (night-time urinary frequency) associated with medically diagnosed benign prostatic hypertrophy (BPH)”.

This decision calls into question the evidence assessment undertaken by the TGA.

Figure 1 (A and B) in Coulson et al showed changes in daytime and night-time frequency of urination in the herbal and placebo group, measured by a daily record in a patient diary, with the frequency averaged at 1 month, 2 months and 3 months.

There are several discrepancies between the urinary frequencies reported in the text of the article and the tables in Figure 1. In addition, the graphs do not include zero in the y-axis; therefore, small trends and differences are exaggerated. Furthermore, they fail to show the ± 95% confidence intervals of the mean urinary frequency at each time point. These problems raise questions about the quality of the research and the conclusions reached. Based on my own calculations, I have re-graphed the data below showing the ± 95% confidence intervals.

The TGA Evidence guidelines for listed complimentary medicines (page 41) say:

“Confidence intervals of 95% are commonly employed to show the range within which the true outcome value could be expected to occur with 95% certainty. When 95% confidence intervals are generated for primary study outcome measures, the 95% confidence intervals of the intervention and exposed groups must not overlap”

The TGA uses complementary medicines as a source of income, without providing commensurate regulation or consumer protection. There are over 10,000 listed medicines (mainly complementary medicines) on the Australian Register of Therapeutic Goods (ARTG) with around two thousand new listings each year.

An application for listing costs the sponsor $860, the annual charge to keep it on ARTG is $1,160, hence the TGA’s annual income from listed products is $1,720,000 + $11,600,000, i.e., $13,320,000 per annum. Industry adds these costs to the price consumers pay.

Over the past 5 years, on average, the TGA assesses around 160 listed products a year, 75% of products evaluated have consistently been found non-compliant, mainly because companies were unable to produce evidence to substantiate claims for efficacy. About which the TGA takes only token action. The TGA has also given up on complaints.

Which raises the question, why is the TGA so lax in regulating complementary medicines?

At Skepticon 2020 I asked, is it due to:

  • Industry lobbying government (and the TGA) to maintain a profitable and export orientated industry despite breaking the law to do so?
  • A regulatory culture that favors industry assistance over consumer protection.
  • Lack of expertise (insufficient medical, pharmacy and public health staff)?
  • Limited financial resources (if so, why not increase industry charges)?
  • And who is responsible?

I got no answers.

See also:

The above response by CMA’s Carl Gibson says it all: “The industry, the CMA and the TGA work together to promote the appropriate regulation and advancement for our world-class sector, one that supports a growing number of jobs nationally and internationally.”

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TGA lifts ban on GPs promoting COVID-19 vaccines

I posted the following comment to: TGA lifts ban on GPs promoting COVID-19 vaccines | Australian Doctor Group (ausdoc.com.au)

Of course, health practitioners should be able to educate the public about COVID-19 vaccination!

But “Such rewards can be monetary or for example, include store vouchers, discounts, or frequent flyer points, but cannot include alcohol, tobacco or medicines (other than listed medicines)”.

Is this opening the floodgates to complementary medicine companies offering ineffective “immune boosters” to get the public hooked?

And isn’t a “reward” an inducement for the patient to return and thus a breach of the Medical and Pharmacy Board’s Codes of conduct which prohibit offering inducements or entering arrangements that could be perceived to provide inducements?

Antony.Scholefield@adg.com.au got a response from AHPRA about inducements and Codes of Conduct

“Offering rewards for COVID-19 vaccination consistent with TGA guidance is considered part of a public health campaign rather than advertising.

The National Law’s advertising requirements do not apply to public health information and advice.

Unless the promotion involves other advertising of a regulated health service, the advertising requirements of the National Law would not apply. 

As Good Medical Practice reflects the advertising provisions of the National Law, there is no conflict between the TGA advice and the code of conduct.”

Ok, but what about allowing complementary (but not other) medicines as a ‘reward’?

I do not yet have a response from a phone call to the Department of Health Media unit on 8/6/2021 and a follow up to Advertising Enquiry · Custom Portal (tga.gov.au) on 10/6/2021 where I asked,

Would this not be a breach of the Therapeutic Goods Advertising Code (No.2) 2018 s.20(1) which says an advertisement must not contain an offer of a sample (subject to Schedule 3)? 

In addition, I cannot see a blanket acceptance of gifts of listed medicines in the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2021. What is the legal basis for allowing complementary (but not other) medicines as a gift?

Also, given the latest death from the AZ vaccine, what about tackling the issue of no-fault medical compensation. By 2010, 19 countries around the world had accepted that society owes a duty of care (or of gratitude) to the very few individuals damaged by a vaccine and had introduced no-fault vaccine compensation schemes. Germany has had such a scheme for 50 years; New Zealand, the United States, Britain, and most European countries have compensation schemes. However, to date, Australia has not had a no-fault compensation scheme for vaccine injury, despite policies that compel Australians to vaccinate their children.

Update 16 June 2021

From: Advertising Enquiries Advertising.Enquiries@tga.gov.au
Sent: Wednesday, 16 June 2021 3:20 PM
To: Kenneth Harvey kharvey@bond.edu.au
Subject: Your advertising enquiry (our reference: AQ-818MQZI4/2021) [SEC=OFFICIAL]

Dear Dr Harvey

Thank you for your enquiry to the Therapeutic Goods Administration (TGA) dated 10 June 2021 (our reference: AQ-818MQZI4/2021) regarding the new regulatory arrangements for communicating about COVID-19 vaccines.

At the outset I would like to emphasise that these new regulatory arrangements have been designed to facilitate the dissemination of information about COVID-19 vaccines to support the Government’s national vaccination program. Importantly, all independently created promotional material must accord with Government messaging, which has been carefully crafted to encourage optimal uptake of the vaccines while ensuring information provided about the vaccines is accurate, balanced and readily understood by Australians.

These regulatory arrangements are time limited and will cease on 31 December 2022.

In terms of the offer of listed medicines as a reward, I note that item 2 of Schedule 1 of the Therapeutic Goods (Restricted Representations – COVID-19 Vaccines) Permission 2021 (the Permission), has the effect of allowing any party to provide valuable consideration to a person who has been fully vaccinated under the Government’s national COVID-19 vaccination program. Section 4 of the Permission defines valuable consideration as “any consideration of value but does not include alcohol, tobacco or medicines (other than listed medicines)”

The rationale for allowing the giving of listed medicines (but not registered medicines) as a reward for being fully vaccinated is as follows:

  1. This approach is in line with the TGA’s risk based regulatory approach where there are more rigorous controls on higher risk registered medicines than lower risk listed medicines. While no medicine is 100% risk-free, in general terms the risks associated with listed (mainly complementary medicines) are not as great as those associated with registered medicines. Listed medicines can be purchased off the shelf from pharmacies, health shops and supermarkets. Listed medicines contain only pre-approved low-risk ingredients and only low-level health claims can be made of them. Claims cannot be made that a listed medicine can treat a disease for example. While some registered medicines can be purchased off-the-shelf, the majority of them cannot.
  2. As there is generally more risk of harm from the use of registered medicines, and many of them cannot be advertised in Australia, these were excluded. Permitting the giving away of registered medicines that are for use in relation to specific health conditions, and where the imperative to select such a medicine on the basis of clinical need is greater than with listed medicines, was considered inappropriate. Alcohol and tobacco were similarly excluded due to the health risks associated with their use. The giving away of alcohol or tobacco as a reward for being fully vaccinated would contradict public health messaging about the dangers associated with tobacco use and alcohol overuse.
  3. It was considered that large complementary medicine companies that may be effective in positively influencing vaccination should not be excluded from participating in the ‘reward’ scheme.

To facilitate this arrangement, on 4 June 2021, an amendment was made to the Therapeutic Goods Advertising Code (No.2) 2018 (the Code), to remove the requirement for advertisements that are made in accordance with the Permission to comply with the Code. The Permission includes relevant requirements from the Code. Simply stated, the legislative requirements regarding the advertising of therapeutic goods set out in the Code (including, inter alia, section 20(1)) do not apply.

See also:

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Indemnity for vaccine manufacturers but not Australians

Typically, the Morrison government has provided indemnity for vaccine manufacturers but not Australians who are at risk of the exceedingly rare, but sometimes fatal, blood clots linked to the AstraZeneca vaccine.

A no-fault vaccine injury compensation scheme recognises that if the government promotes whole of community vaccination for collective good, then it should also accept the ethical and financial burden for the few people who will sustain a severe injury.

Many other countries have such schemes, including the UK, US, New Zealand, and Canada, why not Australia?

From The Age, Letters to the Editor, 14/04/2021, Dr Ken Harvey

The Australian Prime Minister has received his COVID-19 vaccine, but many vulnerable Australians still wait!

See also:

And:

And:

Finally:

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Hangover products still advertised despite complaints and lack of evidence

From July 2018 to July 2020, complaints about a convenience sample of eighteen complementary medicine hangover products, by eight sponsors, advertised on thirty different Internet sites (cases) were submitted to the TGA. It was alleged that all these advertisements breached the Therapeutic Goods Advertising Code and, as they encouraged excessive alcohol consumption, they represented a serious risk to public health.

Complaint details follow:

Followed up on 17 March 2021:

Hangover products are still advertised, despite complaints and lack of evidence. This has occurred even though hangover cures are said to be priority 2 (after COVID-19) on the TGA’s list of advertising compliance priorities. While some products had minor changes made to their claims, the overall impact was minimal.

In addition, extraordinarily little information about these complaints was found by searching their complaint reference numbers in the TGA Advertising Complaints and Investigations Information database. More information was sometimes found in ARTG cancellations requested by the sponsor or in ARTG cancellations by the TGA. All relevant information should be transparently presented in the complaint database to assist consumers to choose products wisely.

More recently the TGA has closed complaints with a statement to the complainant, ‘the information you provided will be used to inform the TGA’s new intelligence led, risk-based compliance approach’. No further public information is provided; there is now even less transparency about how the TGA is handling complaints.

Finally, hangover products are increasingly invoking the TGA’s new permitted indication, ‘Traditionally used in Chinese medicine to helps decrease/reduce/relieve symptoms of occasional hangovers in healthy individuals’. This permitted indication is nonsense and should be disallowed. Allowing traditional permitted indications undermines the scientific evidence base of complementary medicines.

Complaint AC-MW9QQH4F/2018, submitted 30 June 2018

The ARTG listings of all five BioRevive® Hydrodol® Hangover Relief Products complained about were cancelled by the sponsor on 29 Nov 2019, but then relisted with new ARTG numbers. The new products now claim only to support energy production and general health and wellbeing in adults, but they are still packaged as Before and After! See https://hydrodol.com.au/. Meanwhile, hangover claims persist on YouTube videos, e.g., ‘Hydrodol, natural hangover relief, taken while drinking‘ and Facebook.

Complaint AC-JY0FXQ3S/2018, submitted 07 August 2018

ARTG: 296905, Rejoove, Clever Health. No longer listed on ARTG, but still advertised with the same claims (now illegally) at https://rejoove.co/

ARTG: 291026, Recoverthol, Plus Daily Ltd. Still listed on the ARTG and still advertised, albeit with hangover claims and pictures of drink taken off the pack. However, hangover relief claims are still present in testimonials at https://recoverthol.com.au/how-it-works.

ARTG: 306807, Hangover Relief Boon, D & X Pty Ltd (and others). All ARTG listings were cancelled by the sponsor on 23 Mar 2020, but one is still advertised at http://www.dandx.com.au/Hangover-Relief.html. However, this product no longer appears to be sold.

ARTG: 304293, Hangover Relief, Body Armour Pty Ltd. Still listed on the ARTG and still advertised as ‘hangover relief + liver support’ with glowing testimonials at https://www.bodyarmour.com.au/.

Complaint AC-EN0KHC4U/2018 submitted 10 September 2018 and an AC-BGKWMZBG/2018; resubmitted 31 October 2019

ARTG: 297954, Rapid Recovery Hangover Relief, Phoenix Pharmaceuticals. No longer listed on ARTG but still being advertised (illegally) as ‘clinically proven’ by Chemist Warehouse and others.

12 November 2020; email from TGA, ‘case closed. The information you provided will be used to inform the TGA’s new intelligence led, risk-based compliance approach.

22 January 2021, ARTG No:297954 cancelled from the ARTG by the TGA under 30(2) of the Act. However, the sponsor has requested an internal review of this decision.

o9 March 2021, relisted by the sponsor with a new ARTG no: 356374 and new name: Rapid Recovery SOS; not yet being advertised.

Complaint AC-JJFAKREL/2020, submitted 09 July 2020

11 November 2020, the TGA closed the following complaints noting, ‘the information you provided will be used to inform the TGA’s new intelligence led, risk-based compliance approach’. Regardless, their promotion continues.

ARTG ID: 309239, Recovery Enhance, Enervite (Health Spring Australia). Pack still claims, ‘serious help for hangover symptoms’ (not on the ARTG permitted indications), still advertised at https://www.enervite.com.au/product/recovery-enhance/.

ARTG ID: 314758, N+ Hangover Relief, Life Biotech Pty Ltd. Invokes permitted indication, ‘Traditionally used in Chinese medicine to helps decrease/reduce/relieve symptoms of occasional hangovers in healthy individuals’, still advertised at: https://www.mrvitamins.com.au/products/nadvita-9354721000063.

We also have:

ARTG ID: 266432, Drink Smart, Australian Antarctic Ocean Bio-Technology Pty Ltd. Permitted indication: ‘Traditionally used in Asian medicine to decrease/reduce/relieve symptoms associated with occasional overindulgence in healthy individuals’. Advertised at Chemist Direct, etc.

In conclusion, hangover products are still advertised, despite complaints and lack of evidence for their claims. These advertisements breach the Therapeutic Goods Advertising Code, encourage excessive alcohol use and are a serious risk to public health. The TGA should act.

See also:

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COVID-19 Vaccines: Talks to U3A Melbourne City

Covid-19 Vaccines talk

COVID-19 Vaccines – Topics:

  • The Immune System
  • How vaccines work
  • Three ways to make vaccines
  • How COVID-19 vaccines compare
  • Side effects
  • Australian roll-out, 2021
  • Administration and precautions
  • Additional shots for healthy ageing
  • Resource links

This talk can be downloaded as a PDF

See also: https://theconversation.com/after-a-year-of-pain-heres-how-the-covid-19-pandemic-could-play-out-in-2021-and-beyond-156380

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Complementary medicines weight loss complaints submitted to the TGA in 2018-2019. Follow-up in February 2021.

From July 2018 to July 2019, complaints about a convenience sample of twenty-tw0 complementary medicine weight loss products, by eight sponsors, advertised on 140 different Internet sites (cases) were submitted to the TGA. FatBlaster products sponsored by Cat Media (Naturopathica) were highlighted.

The complaints and their TGA reference numbers follow:

These complaints were followed up in July 2020 by Monash Work Integrated Learning (WIL) students. They were reviewed again in February 2021. A detailed Excel file of the findings can be downloaded here; also, a PDF of the images of all products complained about in 2018-19, still advertised in 2021. An example follows:

A paper is being prepared for consideration of publication.

Update 17/03/2021. A TGA infringement notice was issued to My Community Pharmacy (Junction Rx) for illegal advertising of Naturopathica FatBlaster Apple Cider Vinegar & Garcinia Max. This product no longer appears to be advertised.

Update 24/03/ 2012. CW IP Pty Ltd fined $53,280 for alleged advertising breaches (of unlisted products) on the Chemist Warehouse and My Chemist websites; also, Epharmacy Group Pty Ltd fined $26,640 for alleged unlawful advertising (of unlisted products) on the ePharmacy website.

See also: TGA fines Chemist Warehouse | AJP

However, the following products that also lack a current ARTG listing are still being promoted at the time of writing.

Meanwhile, ‘FatBlaster Clinical’ (currently still being sold) was replaced by ‘FatBlaster Platinum + Thermoburn’ and ‘FatBlaster Platinum Metabolism’. The cancelled ‘FatBlaster FatMagnet also has a new listing: ‘FatBlaster FatMagnet Max’ with a new ingredient (Opuntia ficus-indica) that also doesn’t work.

New FatBlaster products

TGA action (albeit limited) appears to have eliminated the imagery of slim people on eleven weight loss products; however, ten remained unchanged.

There has also been a move by sponsors to use ‘traditional’ rather than ‘scientific’ evidence and to reformulate weight loss complementary medicines as food shakes to take advantage of the food-medicine regulatory divide.

New FatBlaster formulations: Traditional use and Food shakes

Yet another complaint was submitted to the TGA about these ongoing matters (AC-OD3FYZZ4/2021, 19 Feb 2021); followed-up on 24 Feb 2021, by AQ-JY6VZ5LA/2021 as no response had been received.

On 22 March 2021 I received the following from Advertising.Enquiries@tga.gov.au:

‘ At the time of submitting your report of suspected advertising non-compliance on 19 February 2021, you were provided with a receipt number (AC-OD3FYZZ4/2021). This is your reference for this matter. You will no longer receive an email to acknowledge the report that has been submitted.

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.

Additional information:

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Unnecessary, expensive and potentially dangerous supplements consumed by older Australians

Researchers are worried older Australians may be buying ineffective complementary medicine at the expense of evidence-based treatment options.

A new study found almost 75% of older Australians take at least one type of dietary supplement or complementary medicine, most of which are not recommended by current medical opinion. The researchers said that the widespread use of complementary medicine in this population raised questions about their marketing and promotion.

Complementary medicine by 14 757 respondents to complementary medicine question in the ASPirin in Reducing Events in the Elderly (ASPREE) Longitudinal Study of Older Persons (ALSOP) baseline medical questionnaire:

See also:

Hardly ‘borderline unethical’!

Numerous representative complaints have shown that this discrepancy between use and scientific evidence is largely due to unethical advertising by the complementary medicine industry. For example:

The industry targets vulnerable consumers, with products containing ingredients that lack efficacy and claims that undermine public health messages, such as weight loss, hangover, and lung detox products.

Promotional claims remain unchanged, despite new evidence that has resulted in the products no longer being recommended by current medical opinion. Examples include glucosamine for osteoarthritis and fish oil for ‘heart health’.

Irrational multivitamin / mineral / herbal combinations are extensively promoted for ‘stress, stamina vitality, etc.’, and to fill alleged nutritional gaps caused by busy lifestyles, while Australian Dietary Guidelines (healthy eating) are rarely mentioned.

Claims are extrapolating from a nutrient’s important role in the body to implying that taking this ingredient as a supplement will benefit normal healthy people. Examples include Coenzyme Q10 and nicotinamide riboside chloride (Vitamin B3).

Ingredients such as probiotics and multi-vitamins are added to unhealthy products such as ‘Kids Smart Vita Gummies’ and ‘Probiotic Choc Balls’ to give them a ‘health halo’.

Clinical trial results from specific, well-characterised herbal extracts are extrapolated to generic herbal ingredients, despite only being applicable to the extract used in the trial.

‘Traditional’ rather than ‘scientific’ claims are increasingly used, removing the need for complementary medicines to have a scientific evidence base.

Regrettably, the regulator (the TGA) has failed to address these issues.

Potentially dangerous supplements?

Complementary medicines are regarded by the TGA as low-risk products, but that does not mean they are without risk.

While it’s impossible to overdose on vitamins and minerals in food, it’s certainly possible to consume too much from supplements and experience adverse effects. This is especially so for fat-soluble vitamins that accumulate in the body such as Vitamin A, D & E.  Calcium supplementation has also been associated with kidney stones, gastrointestinal side effects, and possibly an increased risk of cardiovascular disease.

Green tea extract supplements used for weight loss have been linked to rare cases of liver damage that needed liver transplants. Herbal supplements can also cause serious adverse effects, such as allergic reactions to Echinacea; they can also interact with prescription drugs, for example St John’s Wort (Hypericum perforatum) interacts with many drugs and can nullify the effect of oral contraceptives.

In short, a healthy diet (Australian Dietary Guidelines) provides all the nutrients most people need and is without risk.  However, there can be good reasons to take specific evidence-based complementary medicines for particular purposes. The need for supplements should be discussed with your doctor.

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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 (see below). These include ineffectual and token enforcement of complementary medicines violations by the TGA.

The Therapeutic Goods Administration (TGA) regulates more than 10,000 listed products, mainly complementary medicines. Unlike registered prescription medicines, listed products have no pre-market evaluation. The TGA ‘trusts’ each product’s sponsor to obey the rules. There are only two TGA checks on the regulation of listed products: a small number of post-marketing reviews and the advertising complaint system.

TGA post-marketing surveillance assesses around 160 listed products a year (out of more than 10,000). Over the last five years, on average, around 75% of products assessed have consistently been found non-compliant, mainly because companies are unable to produce evidence to substantiate claims for efficacy.

Since July 2018, the TGA has had enhanced investigative and compliance powers to take over the advertising complaint system. The previous Complaint Resolution Panel (CRP) had upheld virtually all the complaints it received but had no power to sanction companies which repeatedly breached the Therapeutic Goods Advertising Code. While there was support for the TGA takeover, there were also concerns that the TGA had rarely acted on non-compliance with Panel determinations previously forwarded by the CRP.

Under the new complaint system, the TGA classified most complaints as ‘low priority’ and closed them by sending an ‘educational letter’ to the company concerned. This letter reminding the company of their regulatory obligations, but also pointed out that no further action would be taken. In the first year of the TGA takeover, there were around 2,000 complaints; in the second year, there were more than 3,000. Delays in dealing with complaints increased.

A review by consultants recommended that the TGA should stop dealing with individual complaints. As a result, outstanding and most new complaints were now closed by sending complainants a letter stating that their complaint will be used for ‘intelligence’ to set priorities.

‘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 also the articles below.

Skepticon 2020

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 July 2020

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

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