Medsafe has announced that allergen warning statements will be required on all medicine labels by March 2024.
“This has been a safety issue for people with food allergies that we have campaigned on for many years,” says Allergy New Zealand CEO Mark Dixon.
Food allergies affect one in 10 infants and around 3% of the population. Even ingestion of a small amount of the food (the allergen) concerned can cause an allergic reaction. Reactions can range from mild to severe and life-threatening (anaphylaxis). There is no cure and sufferers have to completely avoid the food to prevent reactions.
Food allergens can be used in medicines as excipients i.e. as a substance which helps to stabilise or enhance the active ingredient of a medication. However, unlike foods, most medicines and therapeutic products are not required to list all their ingredients on the label. As a result, allergen information has not been easily obtainable by consumers or health professionals.
Warning statements will be required on both prescription and non-prescription medicines. The allergens that will need to be declared are the same as those on food labels – egg, milk, peanut, tree nuts, fish, shellfish, soya bean and sesame and their products, as well as gluten.
Similar regulations for allergen labelling on medicines were introduced in Australia in 2016 and became mandatory from 1 September 2020.
In New Zealand, new medicines will be required to declare allergens on their labels from March 2021, while existing products have until March 2024 to comply. Although Medsafe has said it will be encouraging pharmaceutical companies to update their labels as soon as possible, Mark says, “the transition period will be confusing for consumers". People will need to check with the health professional prescribing their medicine, or their pharmacist, if they are unsure.
“We are disappointed though, that dietary supplements and natural health products are not included in this,” Mark says. “People, including children with food allergies, often choose these products because they are on restricted diets, possibly not realising the risk.”
For more information, see: https://medsafe.govt.nz/consultations/WarningStatementsForAllergens/WarningStatementsforAllergens.asp