Vitamin B6 toxicity: stronger supplement warnings proposed

Medicine Safety & Regulation Checked Consultation open

Australia’s TGA [Therapeutic Goods Administration] has proposed clearer labels and stronger warnings for listed medicines containing vitamin B6. The aim is to help people recognise B6 in their supplements and reduce the risk of vitamin B6 toxicity from excessive intake, particularly when taking several products.

The labelling changes are under consultation and are not yet final.

TGA announcement, 14 October 2026

What would change?

Reports of suspected B6-related nerve damage have increased. By 31 October 2025, the TGA had recorded 250 neuropathy reports involving B6 products. Of these, 208 (83%) were reported from January 2023 onward, including 130 in the first 10 months of 2025. These reports do not by themselves prove B6 caused each case or establish the rate of toxicity among users.

TGA reporting figures: final scheduling decision, page 7

The proposals would require:

  • A prominent main-label statement identifying vitamin B6 and its amount per dosage unit.
  • A stronger warning explicitly identifying the risk of nerve damage.
  • Warnings on products providing more than 2 mg [milligrams] daily, expressed as pyridoxine equivalents, replacing the current threshold of more than 10 mg.
  • Advice to consult a healthcare practitioner when taking multiple B6 products or using them for longer than one month.

The one-month wording prompts a discussion with a healthcare practitioner. It does not establish a safe duration of use.

TGA consultation paper, pages 11-16 (PDF)

For patients

B6 can appear in multivitamins, magnesium, zinc and other supplements, so check the labels of all products you take.

The TGA advises stopping the product and seeking medical advice promptly if you develop tingling, burning or numbness, usually in the hands or feet.

These can be symptoms of peripheral neuropathy, meaning damage to nerves outside the brain and spinal cord. Normal dietary intake of B6 is not associated with this nerve damage.

TGA consumer advice

For health professionals

The TGA recommends considering B6 toxicity in patients presenting with peripheral neuropathy and reviewing their total intake. Include supplements taken together and foods or drinks fortified with B6. The risk cannot be excluded below 50 mg daily.

TGA professional advice

When will changes happen?

Consultation on the labels closes 25 November 2026. Separately, a confirmed access change begins 1 June 2027: oral products providing more than 50 mg and up to and including 200 mg per recommended daily dose become pharmacist-only.

Products providing 50 mg or less remain available for general sale; those above 200 mg remain prescription-only.

Consultation dates · Confirmed access changes

Disclaimer: This article is for general educational information only and is not medical advice. It does not diagnose, treat, or replace care from a qualified health professional. Always speak with a qualified health professional about personal health questions, medicines, pregnancy, medical conditions, or before changing treatment.

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