The TGA recently had a $10 million fine awarded by the Federal Court against Peptide Clincs Pty Ltd for breaches of advertising regulations, including advertising prescription-only medicines to the public. However, the company involved had gone into liquidation some months earlier and will not pay. In its media release the TGA said,
Please report non-compliant advertisements to the TGA, such as those promoting unapproved therapeutic goods that claim to be image enhancing. The TGA will investigate and take action.
An advertisement for therapeutic goods containing any claim relating to weight management must not feature individuals in images or visual representations
This version of the Code took effect on 1 January 2019. The TGA noted that they would show discretion about its enforcement for the first 6-months of 2019.
In a complaint sent to the TGA on 29 July 2019 (AC-MBNGMHNQ/2019) I documented 103 advertisements, from 35 advertisers, concerning 19 products that breach this section of the Code (and many others). One example is appended.
Numerous previous complaints about weight loss products had been submitted to the TGA on 6 July 2018 (AC-GBKDH2XG/2018) and 16 August 2018 (AC-NJ15VLQ9/2018). To-date, no outcome has yet been published by the TGA.
Meanwhile, misleading claims for complementary medicine weight loss products continue, invariably using imagery of slim, svelte bodies, despite this also being a breach of the current Therapeutic Goods Advertising Code.
The overweight and obese are a vulnerable and increasing population and such people are inevitably attracted to products promising a “quick fix”. It is particularly reprehensible that misleading and deceptive claims for these products continue to be made as they are likely to divert consumers from more evidence-based weight loss programs as well as waste their money.
Following a safety investigation by the TGA, Global Therapeutics, is recalling all batches and all pack sizes of its Fusion Hair Tonic and Oriental Botanicals Hairpro capsules, due to the risk of liver injury caused by an ingredient: Fallopia multiflora also known by the Chinese name ‘he shou wu’ (何首乌). It is marketed for hair thinning, ‘blood tonifying’ and a variety of other conditions.
It is now a TGA requirement that listed medicines containing Fallopia multiflora for oral use to have the following warning on the product label: ‘Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional’.
However, other products containing Fallopia multiflora continue to be promoted without these warnings (above). Do they escape warnings by being regarded as a food, not a medicine? See:
The university initially stood by the claim, but on Monday, following repeated questions from The Age and The Sydney Morning Herald it acknowledged there was no evidence to support that assertion.
It now has withdrawn the press release and launched an investigation into how it was produced, and said it would change its practices to always highlight industry funding.
The study itself involved dosing human cells in a lab with concentrated elderberry juice. There were no tests on humans, or even on mice. In addition, the press release did not mention the study was funded by Pharmacare, a company that sells elderberry-based natural supplement Sambucol.
“This is an appalling misrepresentation of this Pharmacare-funded in-vitro study,” said associate professor Ken Harvey, president of Friends of Science in Medicine. “It was inappropriate and misleading to imply from this study that an extract was ‘proven to fight flu’.” See also:
Relevant to concerns about FSANZ Standard 2.6.5 which has allowed products such as Souvanaid® and Ceretain® to be self-assessed and promoted for the dietary management of Alzheimer’s dementia or related mild cognitive impairment.
On supplements, WHO says: Vitamins B and E, polyunsaturated fatty acids and multi-complex supplementation should not be recommended to reduce the risk of cognitive decline and/or dementia. Quality of evidence: moderate. Strength of the recommendation: strong.
As reported by CBS News: Eating well, and possibly following a Mediterranean-style diet, may help prevent dementia, the guidelines say. But they take a firm stance against vitamin B or E pills, fish oil or multi-complex supplements that are promoted for brain health because there’s strong research showing they don’t work.
“There is currently no evidence to show that taking these supplements actually reduces the risk of cognitive decline and dementia, and in fact, we know that in high doses these can be harmful,” said the WHO’s Dr. Neerja Chowdhary. “People should be looking for these nutrients through food … not through supplements”. Maria Carrillo, chief science officer of the Alzheimer’s Association, agreed.
Neurofolin® (containing 15 mg of L-methylfolate calcium) is a self-declared food for special medical purposes promoted for dietary support of depression management.
Advertisments claim that L-methylfolate is, “an active form of folate known to be deficient in individuals with depressive disorders and helps nutritionally support mood regulation”.
There are listed medicines containing the same ingredient, such as L-5MTHF (ARTG no: 270098), whose TGA indication requirement states: “Product presentation must not imply or refer to mental illnesses, disorders or conditions”.
Mental illnesses such as depression are regarded as
restricted representations by the Therapeutic
Goods Act 1989. Advertisements for therapeutic goods may only refer to such
a representation if prior approval has been obtained.
Yet Neurofolin® is self-declared and promoted as, “a food
for special medical purposes for the dietary support of depression management”
and this claim does not need prior approval (according to FSANZ Standard 2.6.5).
I argue there is insufficient evidence to support the use of L-methylfolate calcium for depression, either as adjunctive, or especially as sole therapy. In my opinion, depression does NOT have special medically determined nutrient requirements for 15 mg of L-methylfolate calcium daily and there is no good evidence that the dietary management of patients with depression cannot be completely achieved without the use of this “food”. In short, Neurofolin® does not meet the requirements of FSANZ Standard 2.6.5.
In addition, I allege the advertising claims made breach
Australian Consumer Law (and would breach many sections of the Therapeutic
Goods Advertising Code if this product was classified as a complementary
medicine). Furthermore, the regulatory double standard involved is misleading
for consumers and unfair to the complementary medicine industry.
I have sent a complaint to the TGA, with a copy to FSANZ, because this is yet another example of problems at the Food-Medicine interface which both the TGA and FSANZ have so-far failed to deal with. I presume the TGA will hand-ball the complaint to the Victorian Health Department because the company involved is based in Victoria. Regardless of who deals with this complaint, I have requested a written determination as to whether Neurofolin® meets the requirements of FSANZ Standard 2.6.5.
case, and others such as Souvanaid®, Ceretain® and Neurothrive®, raise
important questions regarding the ability of product sponsors to self-declare under
FSANZ Standard 2.6.5 that their products are beneficial for serious conditions
such as depression and Alzheimer’s disease
without any independent assessment of all the available evidence. I argue that sponsor
self-determination of Standard 2.6.5 is inappropriate and an independent
assessment of evidence should be required before a product can be promoted as a
“food for special medicinal purposes”.
I have asked that the appropriateness of “food” sponsors to self-declare “food for special medicinal purposes” without independent assessment be addressed by both FSANZ and the TGA.
Join us for the Melbourne edition of this year’s global March for Science event. Bring a picnic lunch and a poster to celebrate science with us, and join in a panel discussion that will challenge and inspire you to be a better advocate for science.
When: Saturday, 4 May 2019, 12:30 pm-4 pm; Where: The Royal Society of Victoria, 8 La Trobe Street Melbourne
Starting at 12:30 pm we will hold a picnic on the grounds
of the Royal Society of Victoria (or on the ground floor of the building in
case of wet weather).
This will be free, but you will need to bring your own everything. There will be a poster competition with prizes to be awarded at about 3:30 pm. This is an opportunity to be creative *and* civil in your poster making (my poster is here).
The panel discussion, will be 2 pm to 3:30 pm, followed by tea and biscuits, for a $5 fee. Our host is Mike Flattley, CEO of the Royal Society of Victoria.
Dr Amy Edwards (Homeward Bound 3; Postdoctoral Research Officer, Ecology, Environment & Evolution, Latrobe University)
Dr Anita Goh (Homeward Bound 3; Superstars of STEM 2019; Clinical Neuropsychologist and Research Fellow, National Ageing Research Institute. Neuropsychiatry Unit, Royal Melbourne Hospital. Academic Unit for Psychiatry of Old Age, The University of Melbourne)
Dr Kudzai Kanhutu (Superstars of STEM 2019; Infectious diseases physician, Telehealth Clinical lead, Deputy Medical Information Officer, Royal Melbourne Hospital. University of Melbourne)
Mr Simon Pampena (Catalyst reporter and presenter of Outrageous Acts of Science) is is a leading Australian mathematician and communicator. He has also been honing his comedic skills with the goal of making math accessible to everyone.
March for Science is a non-partisan, grassroots movement calling for better science literacy, open science communication between scientists and the public, stable investment in science by the government, and evidence-based policy.