The Therapeutic Goods Administration has ordered that supplements containing high amounts of vitamin B6 must be removed from general sale after hundreds of reports of nerve damage, as well as other side effects, that have been linked to prolonged use.
The Australian drug regulator announced it would be strengthening safety controls to "help 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.
Those 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 and preparations containing more than 200 mg per recommended daily dose will continue to require a prescription.
The recommended dietary intake of vitamin B6 for a healthy adult is just 1.3 mg to 1.7 mg per day.
This decision was based on an extensive review process, including a public consultation showing strong support for tighter controls.
The process identified 250 reports of peripheral neuropathy and related conditions, with most of those reports made since 2023.
The decision strikes a balance between the benefits of vitamin B6, where some people, such as the elderly, or those with alcohol dependence, obesity or certain kidney, liver and autoimmune conditions, may need low-dose supplementation and the risks of prolonged ingestion of high doses.
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.