New scheduling will restrict access to higher-dose vitamin B6 supplements after a sharp rise in reports of peripheral neuropathy.
The Therapeutic Goods Administration has ratified an interim decision tightening safety controls on vitamin B6 products to curb rising concerns about nerve damage linked to sustained high-dose use.
Under the updated scheduling announced this week by the regulator, low-dose products will remain available for general sale, while higher-dose formulations will require pharmacist oversight or a medical prescription depending on the daily dose.
This means oral preparations of pyridoxine, pyridoxal or pyridoxamine (vitamin B6) providing 50mg or less per day will remain unrestricted; those supplying more than 50mg but not more than 200mg per day will be pharmacist-only; and products exceeding 200 mg per day will continue to be prescription-only.
“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 TGA said in a statement.
“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.
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.
As reported in The Medical Republic in July this year, the vitamin is often included in multivitamins and magnesium supplements, alongside energy drinks and some weight loss shakes.
The interim decision followed rise in adverse events notifications to the TGA related to peripheral neuropathy. The move received strong support from the RACGP, which also called for “other actions to complement the interim decision”.
These included public education campaigns to raise awareness of overconsumption; consistency in ingredient naming on product labels; strengthening labelling requirements through stronger wording of warning statements and clarity on the presence of vitamin B6 ; and a review of by the Food Standards Australia New Zealand (FSANZ) of the appropriateness of the 10mg limit for formulated caffeinated beverages, given the risks from the use of multiple products containing vitamin B6.
“In addition, the RACGP recommends health claims made on vitamin B6 containing products be subject to stronger regulations and permitted only when robust evidence demonstrates the benefits clearly outweigh the potential risks,” RACGP president Michael Wright wrote in a submission to the TGA’s Advisory Committee on Medicines Scheduling in July.
Peripheral neuropathy is a known side effect of vitamin B6 and is characterised by tingling, burning, or numbness, usually in the hands or feet. Delayed diagnosis and continued exposure can lead to progression of neuropathy.
In its interim decision report released in June, the TGA revealed that as of 4 June 2025, there were 174 reports of peripheral neuropathy, peripheral sensory neuropathy, small fibre neuropathy or chronic polyneuropathy for products containing vitamin B6 on the TGA’s Database of Adverse Event Notifications (DAEN).
Of these, 102 also reported ‘Hypervitaminosis B6’ and/or ‘Vitamin B6 increased’. There were another 92 reports of ‘Hypervitaminosis B6’ and/or ‘Vitamin B6 increased’ with less specific reaction terms such as paraesthesia, burning sensation etc. also possibly suggestive of neuropathies.
“A majority of the 174 adverse events in DAEN were reported since 1 January 2023 (131 events, 75%) with 36 events being reported in 2023, 41 events in 2024, and 54 events to 4 June 2025,” the TGA said.
“The sustained reporting following the TGA’s safety update in 2022 and changes to label warnings for vitamin B6 products (effective 1 March 2022 with a one-year transition period) indicates that the incidence of adverse events may be higher than the pre-2023 reporting data suggested.”
The TGA reported it received 248 submissions in response to the public consultation on the interim decision, including 231 from individuals and 17 from organisations.
“Submissions from individuals included personal testimony of lived experience, professional opinions, clinical insights, and suggestions,” it said in the final decision report.
“More than 100 individuals (103) reported severe, sometimes permanent, health effects from vitamin B6 toxicity including peripheral neuropathy, nerve damage, muscle weakness, and significant impacts on daily life and employment. Thirty-eight of these individuals were diagnosed by general practitioners (GPs) or other specialists using vitamin B6 blood tests.
“Many stated that medical professionals did not initially recognise B6 toxicity as the cause of their symptoms resulting in significant delay to diagnosis, cost and personal adversity.”
The report noted that individual reports contrasted with industry submissions claiming that neurological adverse events from vitamin B6 only occurred at high dose and with long-term usage.
“Notwithstanding the limitations of self-reporting of adverse events, and the possibility of some overlap in reporting channels, the considerable number of adverse events, difficulties in diagnosis and ensuing hardships on sufferers justify the scheduling restrictions on vitamin B6 medicines available for general sale,” the report said.
Read the TGA’s notice of final decision here.
