The industry body added that levomefolate has been determined to be safe at a daily dose of 1mg per day by international regulators, on top of being sold in the country as an ingredient for many years without issues.
Also known as 5-methyltetrahydrofolate (5-MTHF), levomefolate is a biologically active form of folate. It is found in circulation in the human body and can be utilised directly by the body when consumed.
It has been used in dietary supplements and is often consumed by specific consumer groups – such as pregnant women to prevent the risk of neural tube defects in newborns that arise due to folic acid deficiency.
An example of a product containing levomefolate is Bayer’s Elevit.
The Medicines Classification Committee (MCC) formed by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) recently put out a proposal to schedule products containing more than 500 mcg levomefolate per day as a pharmacy-only product.
The definition of a levomefolate pharmacy-only product is: “For oral use in medicines containing more than 500 micrograms per recommended daily dose.
“When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose.”
In addition, the committee is proposing to categorise products containing folic acid and folinic acid as pharmacy-only if the two ingredients exist in more than 500mcg per recommended daily dose.
Industry body NHPNZ has raised concerns over the recommendations.
For one, it argued that scheduling levomefolate at any level would mean that all products containing levomefolate would as a result, be regarded as medicines.
“We will be objecting to this classification of levomefolate because levomefolate has been sold in New Zealand as an ingredient for many years without any issues,” NHPNZ said in a notice to members.
“International regulators have determined that levomefolate is safe at a daily dose of 1 mg per day.
“Restricting levomefolate to 500 mcg per day will limit export opportunities for NZ manufacturers as over half of the global market of supplements (by size) has a limit of 1mg per day."
The MCC, on the other hand, has made its rebuttal to NHPNZ, arguing that the scheduling of levomefolate would not necessarily indicate that all products containing the substance are medicines, citing the examples of folic acid and potassium.
“Scheduling of levomefolate would not necessarily indicate that all products containing this substance are medicines, just as not all products containing folic acid are medicines.
“Other examples such as potassium, which is scheduled and can be a medicine but is also an ingredient of many sports drinks, were discussed,” it said in its meeting minutes published on July 6.
Nonetheless, it highlighted that since some products containing levomefolate sold in New Zealand are for a therapeutic purpose – such as reducing the risk of neural tube defects in pregnancy – and thus, they should be considered as medicines, regardless of any classification.