Food labelling: When is a medicine not a medicine?

Matt Woodley

12/06/2019 2:33:58 PM

Concerns have been raised over alleged double standards regarding the regulation of food products promoted as having ‘special medical purposes’.

Woman drinking
Many of the foods said to be for special medical purposes are consumed in liquid form.

Public health advocate Dr Ken Harvey believes vagueness surrounding the line between complementary medicines and food marketed as beneficial for certain health conditions creates a ‘double standard’ at the food–medicine interface.
Dr Harvey is concerned this could mislead consumers and be unfair to the complementary medicine industry.
‘Regulators need to look at it and FSANZ [Food Standards Australia New Zealand] does need to have some prior approval process,’ he said
Complementary medicines listed on the Australian Register of Therapeutic Goods (ARTG) through the Therapeutic Goods Administration (TGA) are generally assessed for quality and safety, but not efficacy. Restrictions also apply when advertising a listed medicine, including on claims or implications that it will be useful in the treatment or prevention of serious illnesses that would require the involvement of a health professional.
Contrastingly, sponsors registering products via FSANZ self-declare that their products are beneficial for serious conditions without independent assessment of the available evidence.
As such, perceived double standards can occur when a food that contains the same primary ingredient as a listed medicine is regulated and marketed differently.
Dr Harvey argues there are numerous examples of foods for special medical purposes (FSMPs) that in his opinion should have to be registered via the TGA instead of FSANZ, such as Souvenaid (a once-daily drink) and Ceretain (a protein-based drink), which are marketed as beneficial for people with Alzheimer’s.
Another, Neurofolin (a soluble powder added to water), contains 15 mg of L-methylfolate calcium and is promoted as ‘a food for special medical purposes for the dietary support of depression management’.
‘There are listed medicines solely containing the same ingredient as this “food”, 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”,’ Dr Harvey said.
‘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.’
Attempts to resolve this issue by amending legislation have so far been unsuccessful. The Australian Competition and Consumer Commission (ACCC) has also declined to take a more active role via section 18 of the Competition and Consumer Act 2010, with a spokesperson stating, ‘The ACCC is not in a position to step in where another regulator has resource constraints or makes a different assessment of priorities given our broad consumer and competition remit’.
Aside from advertising concerns, Dr Harvey also believes there is insufficient evidence to support the use of L-methylfolate calcium for depression – either as an adjunctive, or especially as a sole therapy.
Dr Carolyn Ee, Chair of the RACGP Specific Interests Integrative Medicine network, agrees that Neurofolin appears to be a nutraceutical supplement, and should therefore be subject to the same restrictions as listed complementary medicines.
She told newsGP a person looking at an indication on a supplement bottle is not making an informed decision about their healthcare, and people experiencing depression should seek professional help from a GP.
‘The best decisions are shared decisions and informed by the best available evidence and patient preferences,’ Dr Ee said.
‘In the interests of patient safety this should be investigated thoroughly. I would strongly encourage all patients with suspected depression to seek help from a medical professional who can discuss all the available evidence-based options for management of this disabling condition.
‘Having said that, there is emerging evidence on the potential role of nutraceuticals as an adjunctive treatment in depression, but clearly this discussion about the level of evidence and safety must happen with the assistance of a well-informed health professional and should be integrated with current best practice – including the use of psychological treatments and antidepressants as appropriate.’

Dr Ken Harvey believes food for special medical purposes should be registered via the TGA.

Industry perspective
Jamie Hughes, Managing Director and founder of Grunbiotics – the company that markets Neurofolin and Ceretain – told newsGP that Australian regulation of FSMPs is ‘very challenging’ from the perspective of a product sponsor.
‘[The challenge] is mainly due to the obvious potential for overlap between the food and therapeutic goods regulators for products that are a defined as foods, but have a special medical purpose,’ he said.
‘Unfortunately, there is currently no mechanism for us to receive pre-market clarification from the regulators, and as a newly evolving area where awareness is still catching up to the science, there is very little precedence for the category to be guided by. 
‘Our preference would be to see the Australian regulators implement an FSMP dossier requirement and pre-market registration process, similar to the process we have to follow for the registration of our products in the EU.’
However, Mr Hughes disputed Dr Harvey’s criticisms that there is a lack of evidence supporting Neurofolin, and pointed out L-methylfolate has been added to RANZCP guidelines.
‘The purpose of Neurofolin is to address a dietary need of many depression patients that until now has remained unmet,’ he said.
‘There is a very good level of scientific and clinical evidence supporting the product – well above many [listed medicine] products.
‘It’s helping a lot of people, but it’s important to note that it is not intended as a treatment for depression in its own right.’
Grunbiotic’s website concurs with Mr Hughes’ assertion that Neurofolin is only to be used ‘together with your current antidepressant therapy as advised by your healthcare professional’. Yet, numerous other pharmacy websites promoting its use indicate ‘it may be used alone or with antidepressants under the supervision of a healthcare professional’.
Additionally, Neurofolin’s own website promotes media reports that variously describe it as a medication and state that it can be used as a standalone treatment.
FSANZ response
Dr Harvey wrote to FSANZ’s Chief Executive Officer Mark Booth about his concerns, and provided newsGP with the response.
Mr Booth stated concerns that Neurofolin advertising claims are in breach of Australian Consumer Law and that it does not comply with FSANZ Standard 2.9.5 are ‘not [matters] that Food Standards Australia New Zealand can respond to’.
‘FSANZ’s role is the development and amendment of the food standards that comprise the [Australia New Zealand Food Standards] Code. It does not enforce the Code or provide advice on compliance issues,’ he said.
‘I have also noted your concern that industry can sell and promote products as foods for special medical purposes without any independent assessment. Premarket approval for 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.
‘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.’

food Food Standards Australia New Zealand regulation TGA Therapeutic Goods Administration

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