TGA announces new guidelines for products containing vitamin B6

New guidelines will restrict products containing certain levels of vitamin B6 in a bid to reduce the risk of nerve damage associated with the long-term consumption of high doses.

The Therapeutic Goods Administration said products with lower doses will remain available over the counter, while higher-dosage products will need advice from a pharmacist or a doctor's prescription.

Lower dosage products are defined as containing 50 milligrams or less per recommended daily dose, and will be available for general retail sale.

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Doses containing between 50mg and 200mg per recommended daily dose will require the advice of a pharmacist.

Doses containing more than 200mg per recommended daily dose will need a prescription.

These changes follow the TGA's final decision to amend the Poisons Standard for vitamin B6.

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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.

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The average adult requirement for vitamin B6 is 1.1mg to 1.3mg per day, and the recommended dietary intake for a healthy adult is 1.3mg to 1.7mg per 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.

These new safety guidelines will be implemented on June 1, 2027 to allow time for the necessary changes.

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.

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