Australia’s Therapeutic Goods Administration (TGA) has announced new regulations affecting over 100 vitamin B6 products, following concerns about the risk of peripheral neuropathy associated with high doses of the supplement. The decision, revealed on November 25, comes after extensive feedback from both industry stakeholders and the public.
Currently, 116 health supplements in Australia offer vitamin B6, including forms such as pyridoxine, pyridoxal, and pyridoxamine, at a recommended daily dose (RDD) of more than 50mg but less than 200mg. These products are readily available on store shelves without the need for pharmacist intervention. However, the TGA’s new ruling will reclassify these supplements as Schedule 3, or ‘pharmacist-only’ medicines, necessitating registration on the Australian Register of Therapeutic Goods and updated labeling by June 2027.
Health Risks and Regulatory Changes
The TGA’s decision is driven by reports of adverse health effects, particularly peripheral neuropathy, linked to vitamin B6. Between January 2023 and October 2025, there were 250 reports of various neuropathies associated with vitamin B6 products, according to the TGA’s Database of Adverse Event Notifications (DAEN). Of these, 162 cases involved ‘hypervitaminosis B6’ and other symptoms suggestive of neuropathies.
“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,” stated the TGA.
The TGA also noted that the move aims to reduce toxicity risks from single products and combined exposure from multiple sources. This aligns with the current Upper Limit (UL) of vitamin B6 for adults set by the National Health and Medical Research Council (NHMRC) at 50 mg per day.
Public and Industry Feedback
Feedback on the TGA’s proposal was mixed, with 248 responses received. Of these, 115 supported the reclassification of vitamin B6 with an RDD of over 50mg and 200mg or less as ‘pharmacist-only’. Another 74 partially supported the proposal, while 42 opposed it. Submissions came from 17 organizations and 231 individuals.
Those opposing or partially supporting the proposal generally advocated for stricter regulations, including a further reduction in the maximum RDD of vitamin B6 available for general sale. This reflects a broader concern about the potential health risks associated with excessive vitamin B6 consumption.
Future Implications and Next Steps
Looking ahead, the NHMRC will review the UL of vitamin B6, with findings expected by early 2027. This review may lead to further adjustments in the availability of vitamin B6 supplements without pharmacist oversight.
The TGA’s decision underscores a growing trend towards stricter regulation of dietary supplements, balancing consumer access with safety concerns. As the health supplement industry continues to evolve, regulatory bodies worldwide are increasingly scrutinizing the safety and efficacy of these products.
For consumers, the reclassification means that by mid-2027, purchasing higher-dose vitamin B6 supplements will require consultation with a pharmacist, ensuring that users are informed about potential risks and appropriate usage.
As the regulatory landscape for dietary supplements continues to shift, stakeholders in the health and wellness industry will need to adapt to new compliance requirements, while consumers can expect greater oversight aimed at safeguarding public health.
