On Tuesday 25th November 2025, the Therapeutic Goods Administration (TGA) formally announced its decision to strengthen safety controls by amending the current Poisons Standard in relation to all supplements containing pyridoxine, pyridoxal or pyridoxamine (vitamin B6).
The decision was announced following a comprehensive review and public consultation regarding the significant rise in reported cases of peripheral neuropathy associated with long term and/or high dose vitamin B6 intake.
In accordance with the decision, as of 1st June 2027:
· Oral preparations containing 50 mg or less per recommended daily dose of pyridoxine, pyridoxal or pyridoxamine (Vitamin B6) will continue to be available for general retail sale (which includes practitioner only products),
· Oral preparations containing more than 50 mg and no more than 200 mg per recommended daily dose of pyridoxine, pyridoxal or pyridoxamine (Vitamin B6) will be restricted to behind the counter and require the advice of a pharmacist, and
· Oral preparations containing more than 200 mg per recommended daily dose of pyridoxine, pyridoxal or pyridoxamine (Vitamin B6) will continue to require a medical prescription.
Whilst the NHAA firmly believe that the risks of developing peripheral neuropathy from excessive intake of vitamin B6 relate largely to self-prescription and/or mismanagement of multiple supplements that contain the nutrient, we also feel that the decision is reasonable and necessary.
We feel that addressing vitamin B6 deficiency and/or utilising its therapeutic effects in
clinical context is viable at a 50mg daily dose, and we would further advise our practitioner members to:
· Prescribe vitamin B6 containing supplements only when clearly indicated in the patient case
· Select the lowest likely effective dose on a case-by-case basis
· Calculate vitamin B6 totals for patients taking multiple supplements (including self-prescribed), this includes accounting for all sources of pyridoxine, pyridoxal and pyridoxamine on the ingredients list
· Limit the duration of supplementation with regular reviews
· Alert your patients to signs of potential vitamin B6 toxicity (which include numbness, tingling, burning, pins and needles, weakness and/or balance changes)
· Educate your patients on meeting their vitamin B6 requirements from food (namely fish, beef liver and other organ meats, potatoes and other starchy vegetables, and fruit).1
The TGA notice of the final decision can be viewed HERE, and the associated media release can be viewed HERE. Please contact us at the NHAA if you need more information or clarity on how this decision affects you and the supplements you prescribe.
1 Office of Dietary Supplements (ODS), National Institutes of Health. Vitamin B6 – Health Professional Fact Sheet. 2023 Jun 16 [cited 2025 Dec 1]. Available from: https://ods.od.nih.gov/factsheets/VitaminB6-HealthProfessional/