The Therapeutic Goods Administration (TGA) is seeking feedback through a public consultation - external site on its proposal to strengthen the labelling of low-risk products that contain vitamin B6.
This includes stronger warning statements and clearer labelling that indicates the presence and amount of vitamin B6 in these products.
The consultation forms part of the TGA's efforts to help Australians reduce excessive vitamin B6 intake and thereby minimise the potential risk of harm.
Too much of this vitamin can increase the risk of nerve damage, which can cause severe, debilitating and potentially long-term effects.
If introduced, new labelling requirements would apply to listed medicines that contain vitamin B6, specifically the following ingredients:
- pyridoxine hydrochloride
- pyridoxal 5-phosphate
- pyridoxal 5-phosphate monohydrate
Listed medicines are low-risk therapeutic products that can only contain pre-approved ingredients from the Permissible ingredients determination.
Vitamin B6 is included in medicines to treat vitamin B6 deficiency and those for general wellness. While people need a prescription to buy high-dose vitamin B6 medicines, many other products can be purchased at pharmacies, supermarkets and health food stores.
This feedback will be carefully considered before a final decision is made.
The proposed labelling changes follow the decision to strengthen access controls.
From 1 June 2027, changes to the Poisons Standard will classify oral vitamin B6 preparations that contain more than 50 mg to 200 mg per recommended daily dose of pyridoxine (vitamin B6) as 'Pharmacist only medicines'.
Pharmacist only medicines must be stored behind the counter. Consumers must consult with a pharmacist prior to purchase to ensure the medicine is used safely and appropriately.
