Home Trade industry New Zealand industry body opposes Medsafe’s recommendation to schedule levomefolate

New Zealand industry body opposes Medsafe’s recommendation to schedule levomefolate

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The industry body added that levomefolate has been determined to be safe at a daily dose of 1mg per day by international regulators, in addition to being sold in the country as an ingredient for many years without issue.

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 used 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 newborn babies that occur due to folic acid deficiency .

An example of a product containing levomefolate is Elevit from Bayer.

The Medicines Classification Committee (MCC) formed by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) recently presented a proposal to schedule products containing more than 500 mcg of levomefolate per day as product reserved for pharmacies.

The definition of a levomefolate pharmaceutical product is as follows: For oral use in drugs containing more than 500 micrograms per recommended daily dose.

“Where the drug contains a combination of folic acid, folinic acid, or levomefolic acid, the drug should provide no more than a combined total of 500 micrograms of folic acid, folinic acid, and levomefolic acid. levomefolic per maximum recommended daily dose.”

Additionally, the committee proposes to classify products containing folic acid and folinic acid as drugstore products only if both ingredients exist at more than 500 mcg per recommended daily dose.

Industry body NHPNZ has raised concerns about the recommendations.

On the one hand, he argued that listing levomefolate at any level would mean that all products containing levomefolate would therefore be considered drugs.

“We will oppose 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 500mcg per day will limit export opportunities for New Zealand manufacturers, as more than half of the global supplement market (by size) has a 1mg per day limit. »

MCC Rebuttal

The MCC, on the other hand, refuted NHPNZ, arguing that listing levomefolate would not necessarily indicate that all products containing the substance are drugs, citing the examples of folic acid and potassium.

Scheduling of levomefolate would not necessarily indicate that all products containing this substance are drugs, just as not all products containing folic acid are drugs.

“Other examples such as potassium, which is programmed and can be a drug but is also an ingredient in many sports drinks, were discussed,” he said in his meeting minutes published on July 6.

However, he pointed out that since some levomefolate-containing products sold in New Zealand are for therapeutic purposes – such as reducing the risk of neural tube defects during pregnancy – and should therefore be considered as drugs, regardless of their classification.