A medical food for depression?

Neurofolin® (containing 15 mg of L-methyl folate calcium) is a self-declared food for particular medical purposes promoted for dietary support of depression management.

Advertisements claim that L-methyl folate 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.” 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-methyl folate 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-methyl folate calcium daily, and there is no good evidence that the dietary management of patients with depression cannot be achieved entirely 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 breach Australian Consumer Law (and would breach many sections of the Therapeutic Goods Advertising Code if this product was classified as complementary medicine). Furthermore, the regulatory double standard is misleading 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. 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 severe 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. A proof evaluation 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.

Postscript:

• FOI found a previous complaint dated 29 May 2018; although heavily redacted, it does identify similar concerns.
• See also TGA Recall Notification (Neurofolin) and
• TGA Consultation: Proposed clarification that goods are therapeutic goods – goods containing folate substances in certain circumstances
• Following the above consultation, the TGA eventually declared the ingredient of Neurofolin (and other folates) to be a therapeutic good if represented as being food for particular medical purposes. This curtailed the promotion but did nothing about the underlying problem – food sponsors can self-declare their product as “food for special medical purposes” without any pre-market assessment by FSANZ or other authorities.