A medical food for depression?


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.

Furthermore, this 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.


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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Advertising, Complementary medicine, Food, Medicine policy and tagged . Bookmark the permalink.

3 Responses to A medical food for depression?

  1. Richard Brinkman says:

    I am a 75 year old male and I have been bi-polar for most of my life. I started using Neurofolin about a year ago and it has been enormously beneficial. Fortunately I stocked up when I heard about the TGA inquiry and I can still have my Neurofolin daily for now.
    When will this product be ready available again?
    Neurofolin is little short of a lifesaver.

  2. Rachelle says:

    BRING BACK NEUROFOLIN!!! My husband and I were both on Neurofolin and it was totally life-changing for us! We both have MTHFR and He suffers with anxiety and it was the ONLY thing that worked amazingly for it, better than any anti-depressant or drug ever tried within 20mins! We too were warned that it was being recalled for a labelling issue and stocked up in 2019 but didn’t expect in 2021 for it to still be unavailable – we’re desperate to get it back again after having tried it in capsule form and not getting the same results as the orange flavoured drink – why are Drs writing complaint letters to the TGA for products that are majorly improving the lives of people struggling to deal with health situations where they finally find products that work – its only activated vitamin B9 for heavens sake! You pee out what you don’t use and you need for over 200 daily functions. If anyone reacts to VitaminB9 its an indication that something else isn’t right – your B12 is too low, gut issues, candida, mold or other methylation issues are going on – if that happens see someone knowledgable in methylation to help resolve the issue – don’t ban the vitamin! Ridiculous.

  3. Sandra says:

    This is a product that is recommended by psychiatrists themselves. I am a pharmacist and I was surprised by the amount of patients that were being recommended it by the psychiatrists in my area (Brisbane Spring Hill) and the patients would voluntarily and fervently tell me that it was the only thing that had worked, including for a teenage girl. Coincidentally, I tried it myself and was amazed by how much my cognition/brain fog and energy improved and then went for a blood test and found out I had the MTHFR mutation.

    Just hoping that the TGA sees beyond the regulations next time, if possible involve the Doctors who have patients using the product and put in a bit more consideration for those who now cannot access it.

    It is not a cheap product ( I recall around $70/month) and so it is unlikely for people to self-medicate when there’s an easier option of seeing a Dr for cheaper antidepressants or trying another OTC product

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