New research from the University of Sydney has found Australians have continued to purchase millions of high-dose vitamin B6 supplements despite a series of public health notices. Regulatory measures taken by the Therapeutic Goods Administration (TGA) have alerted Australians that both prolonged and high doses of vitamin B, can cause peripheral neuropathy in susceptible individuals, a potentially debilitating form of nerve damage.
Published in the Internal Medicine Journal, this is the first study to quantify vitamin B6 products purchased in Australian pharmacies to identify patterns of potentially high-risk use linked to peripheral neuropathy, for example large doses, multiple products and stockpiling behaviours. The study analysed data between 2023 to 2025 and found that millions of supplements purchased contained a total daily dose of 50mg or higher, exposing Australians to even higher risks.
Senior author, Associate Professor Joanna Harnett from the Sydney School of Pharmacy in the Faculty of Medicine and Health, said potentially harmful amounts of vitamin B6 continued to be purchased by Australians over the 3-year period examined (2023, 2024 and 2025).
"In fact, more than three million purchases involved vitamin B6-containing products with a combined total dose exceeding the new TGA threshold intended to minimise harm," Associate Professor Harnett said.
“Vitamin B6 is currently included in a range of supplements marketed for energy, mood, immunity and hormonal health. It is available over-the-counter without professional advice, meaning it is not always obvious to consumers that these products might contain high doses of vitamin B6."
“Chronic intake of high doses of vitamin B6 have been found to cause nerve damage, leading to symptoms like numbness, tingling, and pain and other neurological effects. This is often under-recognised by both consumers and health professionals, showing many are unaware of the risks associated with prolonged or high dose vitamin B6 intake."
Study findings
Over the three-year period, 20.32 million products with a maximum recommended daily dose of vitamin B6, (more than 5mg total equivalent pyridoxine), were purchased through 15.8 million transactions.
Around one in five pharmacy transactions containing vitamin B6 involved products with a combined total daily dose of more than 50mg of vitamin B6.
Over 3 million products containing 50mg or higher were purchased, many of which will now be restricted to Pharmacist-Only sale, but not until 1st Jul 2027.
Researchers identified high-risk purchasing behaviours, including buying multiple vitamin B6 products in a single transaction and repeat purchases that may indicate prolonged use or stockpiling.
While products containing more than 100 mg/day of vitamin B6 were no longer permitted in listed complementary medicines following regulatory changes implemented in 2022-2023, overall sales of vitamin B6 supplements remained stable.
The findings suggest that consumers can still exceed the new 50mg limit of vitamin B6 by combining lower-dose products, which are not covered by the new scheduling changes.
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Warnings ignored on large volumes of potentially harmful vitamin B6 doses – 9 News Australia
From 1 June 2027, products containing more than 50mg and less than 200 mg of vitamin B6 will be restricted to Pharmacist Only Medicine and those 200mg or higher will remain prescription only.
Professor Harnett said: “While the next stage of regulatory reform to be enforced from July next year is certainly welcome, it may not be sufficient on its own.
“To effectively reduce the risk of vitamin B6-related adverse effects, stronger consumer and health practitioner education about the potential harms associated with excessive intake is needed alongside regulatory changes to reduce ongoing high-risk exposure.
“In addition, there is still a further 12 months before the new regulatory changes come into force. The implementation period for scheduling extends the potential for stockpiling, meaning that higher‑risk exposure will persist without strengthened risk communication.
“These findings highlight the importance of timely risk communication and education during the transition period," she said.
Declaration
The researchers declare no conflicts of interest. The consumer sales data was funded by the University of Sydney Pharmacy School. Professor Harnett is a member of the NHMRC Nutrient Reference Value Vitamin B6 Expert Working Group. Please note this research is independent of her role at the NHMRC and was not carried out under this affiliation.
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