!ALERT! IRON SUPPLEMENTS – CHECK YOUR PRODUCTS PLEASE
There is some attention currently on IRON SUPPLEMENTS around the legal amount allowed in a tablet/capsule and around the amount in a pack.
IF YOU HAVE AN IRON SUPPLEMENT IN YOUR RANGE PLEASE CHECK IT MEETS REGULATORY REQUIREMENTS IN NEW ZEALAND – we are aware that some products sold here do not, and companies concerned are being asked to RECALL stock.
The requirement for iron in general sale per Medsafe Medicine Classification is –
for oral use in medicines containing 24 milligrams or less per recommended daily dose either in medicines containing not more than 5 milligrams per dose unit or in medicines containing more than 5 milligrams per dose unit and in packs containing not more than 750 milligrams of iron; in parenteral nutrition replacement preparations
This means, we can have –
- Iron = 5mg per dose unit or less – no restriction on pack size
- Iron = 5mg plus to 24mg per dose unit – pack size restriction applies, i.e. no more than 750mg of iron per pack size
- Daily recommended dose should not exceed 24mg iron in both item 1 and 2 scenarios.
- There does not appear to be any specific restriction if iron is used in parenteral nutrition replacement preparations. However, this probably doesn’t impact the dietary supplement industry.
The requirements re. points 1-3 align with TGA requirements for listed medicines. In addition, TGA requires sponsor to use child resistant caps when each dose unit contains more than 5mg of iron.
PLEASE CHECK WITH YOUR IN HOUSE REGULATORY EXPERT OR A CONSULTANT.
The Medicines Regulations can be accessed for free from www.legislation.govt.nz. You will need to use the quick search at the top right hand corner to look them up or use the following link:
Medicines Regulations 1984
A list of prescription, restricted and pharmacy-only medicines can be found in Schedule 1 of the Regulations.
However, the Medicines Regulations are not always the most current list of scheduled medicines because medicines are considered to be scheduled as soon as a gazette notice is published, which happens at least twice a year, but the Regulations are updated less frequently. Therefore, the most up to date list of scheduled medicines can be found on the Medsafe website www.medsafe.govt.nz. You can find the link to “find the classification of an ingredient” on the right hand side of the home page under the heading “I want to…” or use the following link: Medsafe Classification Database
We recommend you search under the common name and any other name you might know a substance by to ensure it is not entered on the list under a different name. For example, if you search for vitamin B12 you will not find anything because it is entered on the list as cyanocobalamin.