The Therapeutic Goods Administration (TGA) will strengthen safety controls for products containing vitamin B6 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.
The average adult requirement for vitamin B6 is 1.1-1.3 mg/day and recommended dietary intake for a healthy adult is 1.3-1.7 mg/day.
From June 2027, consumers will require a pharmacist’s supervision to purchase products containing more than 50mg of vitamin B6, and anything with more than 200mg will need a prescription.
The TGA’s decision follows reports both in Australia and overseas of increased risk of peripheral neuropathy with prolonged ingestion of high doses.
Earlier this year, the TGA made the interim decision to amend the Poisons Standard to classify supplement preparations containing 50-200mg/day of B6 as schedule 3 pharmacy-only medicines.
The ABC reported the TGA had made an earlier concession that it had failed to act fast enough after a 7.30 reported a rise in nerve injuries linked to the vitamin B6 supplement.
The TGA’s final decision to amend the Poisons Standard for vitamin B6 followed an extensive review process, including a public consultation showing strong support for tighter controls.
Health professionals should advise consumers to always check the label of any vitamin or supplement products for vitamin B6, also called pyridoxine, pyridoxamine and pyridoxal.
The TGA’s decision is available here
