Stronger safety controls to be introduced for products containing vitamin B6

A decision by the Therapeutic Goods Administration (TGA) will strengthen safety controls for products containing vitamin B6, and help to reduce the risk of nerve damage associated with the long-term consumption of high doses.

Products with low doses of vitamin B6 will continue to be available for general sale, while products containing higher doses will require advice from a pharmacist or a prescription from a doctor, depending on the dose:

• Oral preparations containing 50 mg or less per recommended daily dose will continue to be available for general retail sale.
• Oral preparations containing more than 50 mg but not more than 200 mg per recommended daily dose will be available over the counter with the advice of a pharmacist.
• Oral preparations containing more than 200 mg per recommended daily dose will continue to require a prescription.

These changes follow the TGA’s final decision to amend the Poisons Standard for vitamin B6. This decision was based on an extensive review process, including a public consultation showing strong support for tighter controls.

The decision strikes a balance between the benefits of vitamin B6, where some people may need low-dose supplementation, and the risks of prolonged ingestion of high doses, which can include damage to peripheral nerves.

Vitamin B6 deficiency is uncommon among the Australian population. The average adult requirement for vitamin B6 is 1.1-1.3 mg per day, and the recommended dietary intake for a healthy adult is 1.3-1.7 mg/day. Vitamin B6 deficiency is more likely to occur in the elderly, or those with alcohol dependence, obesity, or certain kidney, liver and autoimmune conditions.

The changes in vitamin B6 content will be implemented on 1 June 2027 to give industry, healthcare practitioners and businesses sufficient time to make the necessary changes, including updating product labelling and managing stock.

Consumers should always check the label of any vitamin or supplement products for vitamin B6. It is also called pyridoxine, pyridoxamine and pyridoxal.

If you experience tingling, burning or numbness in your hands or feet, stop taking the product immediately and seek medical advice as soon as possible.

You should talk to a registered healthcare professional about what treatment is right for you.

You can also report any side effects to the TGA via the Adverse Event Reporting System. Reporting helps us to improve medicine safety for everyone.