Over 100 products will be affected be the new regulation.
Australia’s Therapeutic Goods Administration (TGA) announced the above today (Nov 25), after considering feedback from the industry and the public over the risk of peripheral neuropathy associated with vitamin B6 supplementation.
Vitamin B6, in this case, includes forms such as pyridoxine, pyridoxal, and pyridoxamine.
There are currently 116 health supplements or listed complementary medicines providing vitamin B6 at a maximum recommended daily dose (RDD) of more than 50mg but less than 200mg in Australia.
These products can be purchased from the shelves directly without going through the pharmacists.
Following the TGA’s decision, these 116 products will fall under Schedule 3 or ‘pharmacist-only’ medicine.
They will have to be registered on the Australian Register of Therapeutic Goods and their labels updated to remain on the Australian market after June 2027.
“Further labelling changes may also be required, should the TGA decide to strengthen the warning statements required and change how vitamin B6 is labelled on products,” the TGA said in the announcement.
“The Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2025 will also need to be amended to reflect the scheduling changes.”
Australia’s National Health and Medical Research Council (NHMRC) will also be reviewing the Upper Limits (UL) of vitamin B6, which is expected to be completed by early 2027.
Following the review, the limits of vitamin B6 health supplements available to the public without having to go through pharmacists will also be re-evaluated.
Disagreed parties want stricter limits
Out of the 248 public feedback received, 115 supported the TGA’s proposal to schedule vitamin B6 with RDD of over 50mg and 200mg or less as ‘pharmacist-only’. Another 74 partially supported the proposal, while 42 did not support it.
The 248 submissions included 17 from organizations and 231 from individuals.
Most submissions that did not support or partially supported TGA’s proposal wanted stricter regulation of vitamin B products – including further reduction in the maximum RDD of vitamin B6 that should be available for general sale.
250 peripheral neuropathy reports
There were 250 reports of peripheral neuropathy, peripheral sensory neuropathy, peripheral sensorimotor neuropathy, small fibre neuropathy, polyneuropathy, or chronic polyneuropathy associated with products containing vitamin B6 between January 2023 and October 2025.
This is based on data retrieved from TGA’s Database of Adverse Event Notifications (DAEN).
Of these, 162 reported ‘hypervitaminosis B6’ and/or ‘vitamin B6 increased’ with less specific reaction terms such as paraesthesia, burning sensation, which were possibly suggestive of neuropathies.
Some patients also reported adverse effects after taking daily pyridoxine doses between 25 mg to 400 mg for as little as two weeks to a longer period of 10 years.
“The above reports contrast with industry submissions claiming that neurological adverse events from vitamin B6 only occur at high doses 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, I have adhered to the 50 mg per maximum RDD as the cut-off for exemption from scheduling foreshadowed in my interim decision.
“This cut-off is in alignment with the current UL of vitamin B6 for adults 19 years and over set by the NHMRC of 50 mg per day,” said the TGA.
It also said that the move could reduce the toxicity risk from the use of a single product and from combined exposure from multiple sources.
“Submissions from individuals and organisations, including professional associations, universities and industry, broadly agreed with the 50 mg maximum RDD for unscheduled medicines,” it added.
