Proposal to reschedule levomefolate (levomefolic acid)
Limited timeframe to object (22 July 2022)
Dear members
At its 68th meeting on 26th April, the Medicines Classification Committee (MCC) discussed a proposal to reschedule Levomefolic acid, also known as 5-methyltetrahydrofolate (5-MTHF), the biologically active form of folate and the form found in circulation in the human body. This proposal derived from a medicine application that Medsafe have received which lists Levomefolate as an active ingredient.
Various parties including those from the natural health industry and Natural Health Products NZ, made submissions and comments in relation to this proposal prior to the 68th MCC meeting, including concerns that scheduling levomefolate at any level would mean that all products containing levomefolate would as a result, be regarded as medicines.
The MCC have decided to schedule levomefolate as a medicine as follows:
Levomefolate pharmacy-only:
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 For folate-form combination products the scheduling is:
That the Folic acid pharmacy only statement is updated to:
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
That the Folinic acid pharmacy-only statement is updated to:
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
This means that levomefolate (or a combination of folates including levomefolate) at a daily dosage of more than 500 mcg is a medicine. Levomefolate 500 mcg or less per day is not scheduled and is therefore permitted in a dietary supplement or food. Any combination product containing folinic acid is a medicine (as folinic acid is listed as a general sale medicine in the medicines classification database). Combination folate-form products 500 mcg or less containing folic acid can be a dietary supplement if they meet the requirements for folic acid in the Dietary Supplements Regulations 1985.
We are aware that some of the parties who made submissions and comments to the 68th MCC have not been notified by Medsafe that the minutes have been published or that the deadline for objection is 22 July (this Friday)
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
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.
If you decide to object we recommend you do so by 22 July 2022, noting the rationale for objection in the above link which is “ an opportunity to object to the recommendation made by the MCC, not to the initial proposal. The determination of whether an objection is valid will be made by the Medsafe Group Manager on advice from the Secretary of the MCC.”
Furthermore, you can provide any supporting evidence to us by 9am, Thursday 21 July 2022 and we will endeavour to incorporate this in our objection on behalf of our membership.
Note the proposed criteria for valid objections are
the MCC did not consider all the safety issues correctly (for example a new safety concern may have been identified since the start of the consultation)
the MCC did not consider all the benefits
there was a breach of the appropriate process. Financial or commercial reasons are not acceptable grounds for objection
We apologise for the late notice on this matter, but please make contact with us if you would like to discuss further.
