Avemar, a Food for Special Medical Purposes for Cancer Patients?

Posted on August 20, 2021 by Dr Ken Harvey

This case is yet another example of a major discrepancy in consumer protection between therapeutic claims made for medicines for which the Therapeutic Goods Advertising Code applies (administered by the TGA), compared to therapeutic claims made for food for which FSANZ standards apply (administered by State & Territory Food Health Departments).

Avemar Australia sells sachets & tablets containing 14.5 grams of powdered fermented wheat germ extract to consumers and practitioners, via the Internet. The price (including delivery) for 1 box (30 sachets, one month’s supply) is $220AUD.

The product is claimed to be a Food for Special Medical Purposes for cancer patients undergoing clinical oncological treatments such as chemotherapy, radiation, and immune therapies.

Avemar | Nutritional Support

Food Safety Australia New Zealand (FSANZ) set food standards which are enforced by Australian State and Territory governments. Standard 2.9.5 defines Food for Special Medical Purposes as foods formulated for individuals who have special medically determined nutrient requirements or whose dietary management cannot be completely achieved without the use of the food. They are also intended to be used under medical supervision.

I am unaware of any evidence that supports the first two conditions applying to the product in question. In addition, this product is sold to consumers directly over the internet which contradicts the intended use of being under medical supervision.

A cancer patient found a bundle of Avemar brochures displayed, without permission, on an information table next to the ‘cancer patient only’ entry corridor inside the ICON North Lakes Cancer Centre, Qld.

Avemar brochure

The above claims are not in accord with the body of clinical evidence applicable to this product. A recent Australian systematic review of the effectiveness of Avemar as adjunct therapy in the treatment of cancer concluded that its clinical effectiveness has yet to be established. The U.S. Memorial Sloan Kettering Cancer Center notes that human studies are limited, and benefits must be confirmed by large-scale well-designed clinical trials.

If this product were classified as a therapeutic good, the above claims could constitute multiple breaches of the Therapeutic Goods Advertising Code. In addition, the product is promoted to cancer patients, a group especially vulnerable to such claims. Promoting a product for cancer is a prohibited representation and a serious breach of the Therapeutic Goods Act 1989, and the Therapeutic Goods Advertising Code (No 2) 2018.

However, food sponsors can self-declare their product a Food for Special Medical Purposes without any pre-market assessment by FSANZ or other authorities and the controls on advertising for therapeutic goods do not apply. In addition, Standard 2.9.5 has contradictory clauses with respect to claims and use under medical supervision.

Clause 2.9.5—4, “A claim in relation to food for special medical purposes must not: (a) refer to the prevention, diagnosis, cure or alleviation of a disease, disorder or condition…”.

Clause 2.9.5—10, says the following statements are required, (c) a statement indicating the medical purpose of the food, which may include a disease, disorder or medical condition for which the food has been formulated; and (d) a statement describing the properties or characteristics which make the food appropriate for the medical purpose indicated in paragraph (c)”.

Clause 2.9.5—5, says, “A food for special medical purposes must not be sold to a consumer, other than from or by: (a) a medical practitioner or dietitian; or (b) a medical practice, pharmacy or responsible institution; or (c) a majority seller of that food for special medical purposes (which is a let-out clause from ensuring medical supervision).

We are left with a major discrepancy in consumer protection between therapeutic claims made for medicines for which the Therapeutic Goods Advertising Code applies (administered by the TGA), compared to therapeutic claims made for food for which FSANZ standards apply (administered by State & Territory Food Health Departments). Previous publicised cases have involved Souvanaid, and Neurofolin, but the underlying problems remain unresolved.

The TGA eventually declared the ingredient of Neurofolin, L-Methylfolate (Levomefolic acid) to be a therapeutic good, see: https://www.legislation.gov.au/Details/F2019C00884.Which solved this case but did nothing about the underlying problem – that food sponsors can self-declare their product a Food for Special Medical Purposes without any pre-market assessment by FSANZ or other authorities and thus avoid advertising controls on therapeutic goods.

This case is more serious as it involves claims for cancer. I argue that FSANZ is responsible for this ongoing lamentable situation. FSANZ have failed to urge the government to apply pre-market evaluation to Food for Special Medical Purposes, failed to resolve contradictions in the Standard and failed to effectively liaise with the TGA to harmonise advertising standards across the food-medicine interface.

A complaint about the promotion of Avemar has been submitted to Food Safety Standards and Regulation Queensland and copied to FSANZ, TGA and ACCC (20 August 2021).

Mark Booth (past CEO of FSANZ) responded to my concerns about these problems in 2019. He left FSANZ on 6 August 2021 to take up a role in the private sector.

As you are aware, FSANZ’s role is the development and amendment of the food standards that comprise the Code. It does not enforce the Code or provide advice on compliance issues.

Premarket approval for Foods for Special Medical Purposes (FSMP) was not considered warranted when Standard 2.9.5 was developed by FSANZ and approved by the Ministerial Forum on Food Regulation in 2012.

Like other Standards in the Code, Standard 2.9.5 sets standards which various food laws require industry to comply with. It is for industry to determine whether or not their products comply with those laws and standards. If their products do not, they face the prospect of compliance action and sanction under the food laws.

This approach, together with the composition, labelling and other restrictions placed on FSMP by Standard 2.9.5, was considered appropriate given FSMPs’ purpose and role and their importance to those who must rely on them for their nutrition.

Update 30 August 2021

Still no acknowledgement of complaint sent on 20 August 2021, however, after many phone calls I found it has ended up at the Qld Gold Coast Public Health Unit. They told me they have started to assess the product (and its promotion) against FSANZ Standard 2.9.5.

They have now learnt that the TGA has contacted the Qld Government Food Safety Standards and Regulation (FSSR) advising that the TGA will be submitting the product to the Food Medicine Interface Working Group for assessment to determine if it should be regulated as a food or as a therapeutic good.  If the latter, it will not be followed up by the Qld Gold Coast Public Health Unit.

Update 31 August 2021

From foodsafety@health.qld.gov.au. “Please be advised that Avemar Granulate and Avemar Tablets from Avemar Australia (Medimpex Pty Ltd) have been assessed by Queensland Health and are of the view that Avemar Granulate and Avemar Tablets are likely therapeutic goods.  As such the matter will be referred to the Therapeutic Goods Administration for their appropriate action.”  

My response:

“I should be grateful if you could explain the reasoning behind your conclusion that Avemar Granulate and Avemar Tablets are therapeutic goods?

Avemar is derived from wheat germ that is traditionally included in health foods. It is produced by fermenting wheat germ with Saccharomyces cerevisiae (Baker’s yeast), followed by separation of the fermentation liquid, drying, and granulation. Aglycone-type 2-methoxy benzoquinone and 2,6-dimethoxybenzoquinone have been recognised as the most important bioactive compounds of this preparation. Sourdough, fermented with Lactobacillus plantarum LB1 and Lactobacillus rossiae LB5, produces similar quinones.

I used the TGA’s Food-Medicine Interface Guidance Tool (FMIGT), attached, which said the product is not a therapeutic good because there is a ‘standard’ in the Food Standards Code.

I did argue that this product did not fulfill the requirements of Standard 2.9.5, but the TGA’s FMIGT says, “Even if: there are therapeutic claims made about the product, it contains undisclosed Schedule 4 substances (such as sildenafil), or the product fails to comply with the requirements of the standard, it will not be a therapeutic good if it is a good to which that standard applies.”

From foodsafety@health.qld.gov.au. “You are correct to examine the requirements of standard 2.9.5 Food for special medical purposes as this is how the product has been marketed. However, the products do not fit within that standard.  You might refer to the definition within 2.9.5-2.

The products in their present formulation, containing negligible nutrients in a dosage size with dosage directions and claims made, do not fit within standard 2.9.5.  In their current form they are likely therapeutic goods.  As such, the matter is referred to the Therapeutic Goods Administration. 

You will need to direct any queries regarding the Food-Medicine Interface Guidance Tool to the Therapeutic Goods Administration as this is not a Queensland Health site.”

On 1 Sept 2021 I ask the TGA if they will change the FMIGT in response to the Qld decision. They responded, “We are not presently of the view that the FMIGT presently requires modification; it is consistent with what is a critical distinction between whether a standard applies to a good per the definition, and the requirements imposed on any good to which the standard applies.”

Update 13 September 2021

In response to a request for an update on my complaint from the TGA, “The status of this product is a complex technical-legal matter and the subject of an ongoing TGA investigation and, in line with the information provided on our website, we are currently liaising with our partner agencies to decide its status. As such, I do not wish to make a comment on the status of the product at this time.”

See also:

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TGA allows alcohol as a reward for COVID-19 vaccination

Posted on July 23, 2021 by Dr Ken Harvey

TGA rules initially prohibited alcohol, tobacco, or registered medicines from being offered as rewards to those who had received full COVID-19 vaccination. Accordingly, they had told the Prince Alfred Hotel in Port Melbourne to stop offering complimentary alcoholic beverages to vaccinated individuals. Following Prime Minsterial intervention the TGA now allows alcohol as a reward for COVID-19 vaccination.

Mr Morrison said while he understood the rule, the crackdown on free beers was “a bit heavy-handed”.  Health Minister Greg Hunt has now spoken to the TGA about relaxing the rules.

https://bit.ly/3eLgrxx

In response to Ministerial directives the TGA now allows alcohol as a reward for COVID-19 vaccination via the Therapeutic Goods (Restricted Representations – COVID-19 Vaccines) Permission (No. 2) 2021.

The caveat is that the offer of alcohol cannot encourages excessive or rapid consumption of alcohol, or have a strong or evident appeal to minors, and must comply with Responsible Service of Alcohol requirements.

One wonders how many people will be encouraged to get two shots of a COVID-19 vaccine so they can get a free beer? Are we now going to see drinkers embarking on free, government-endorsed, pub crawls of establishments offering alcohol vaccination “rewards”?

Also, is the focus on individual benefit the right approach? It’s interesting to contrast the government’s advertising focus on individuals (arm yourself) with other advertising (Message from Victoria) that focuses on community benefit.

See also:

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Have you got your COVID-19 vaccine yet?

Posted on July 5, 2021 by Dr Ken Harvey

The best vaccine is the one you have in your arm, now!

Also, people have queried if the Individual HealthCare Identifier (IHI) on the vaccine certificate could allow others to access additional myGov information, such as My Health Record. The answer is NO. Just as others knowing your Medicare number cannot be used (by itself) by to access more information, neither can the IHI.

See also:

And:

Especially:

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

Posted on June 15, 2021 by Dr Ken Harvey

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

Posted on June 11, 2021 by Dr Ken Harvey

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:

And (Oh dear):

TGA allows alcohol as a reward for COVID-19 vaccination – (medreach.com.au)

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Indemnity for vaccine manufacturers but not Australians

Posted on April 14, 2021 by Dr Ken Harvey

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!

Update 2 July 2021

COVID-19 indemnity scheme to protect health professionals and patients | Health Portfolio Ministers

“Details of the [proposed] COVID-19 Vaccine Claims Scheme will be finalised in consultation with peak bodies, indemnity insurers, patient groups and states and territories.”

Update 10 August 2021

Still coming, see correspondence from Ms Louise Morgan, Acting Assistant Secretary, Department of Health.

Update 29 August 2021

The COVID 19 Vaccine Claims Scheme registration page will go live on 6 September; please return to this page then to register.

Update 29 August 2021

The COVID 19 Vaccine Claims Scheme registration page will go live on 6 September 2012, revisit the following link then:

https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/covid-19-vaccine-claims-scheme

No Fault COVID-19 Indemnity Scheme | Health Portfolio Ministers

See also:

And:

And:

Finally:

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Hangover products still advertised despite complaints and lack of evidence

Posted on March 18, 2021 by Dr Ken Harvey
  • Some currently advertised Australian complementary medicine hangover products

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.

  • 30 July 2018 (on left) 17 March 2021 (on right)

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/

  • The same pack and claims, 7 August 2018 and 17 March 2021

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.

  • 30 July 2018 (on left) 17 Marck 2021 (on right)
  • Recoverthol testimonials 17 March 2021

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.

  • 17 March 2021

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/.

  • 17 March 2021
  • Testimonials 17 March 2021

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.

  • 17 March 2021

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/.

  • 17 March 2021

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.

  • 17 March 2021

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.

  • 17/03/2021

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

Posted on February 26, 2021 by Dr Ken Harvey
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

The Australian Prime Minister receiving the COVID-19 vaccine

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.

Posted on February 17, 2021 by Dr Ken Harvey

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.

Cat Media (Naturopathica) FatBlaster listed weight loss products

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:

FatBlaster FatMagnet, ARTG no 145959, complained about in July 2018, was finally cancelled by the TGA on 23 Dec 2020 as there was ‘insufficient evidence to support the indications’. However, it was still being promoted and sold in February 2021, albeit with the image of a slim person removed

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
More FatBlaster 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

Posted on February 2, 2021 by Dr Ken Harvey
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.

See also:

TGA stakeholder survey 2019-20 and 2020-21

Update 22/07/2021

Drug-induced liver injury in Australia, 2009–2020: the increasing proportion of non-paracetamol cases linked with herbal and dietary supplements

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