Australia’s drug regulator has ordered that supplements with high levels of vitamin B6 be removed from general sale in response to hundreds of reports of nerve damage and other side-effects linked to long-term use.
From June 2027 any vitamin B6 product containing more than 50mg in each recommended daily dose will be moved behind the pharmacy counter. The recommended dietary intake of vitamin B6 for a healthy adult is just 1.3mg to 1.7mg a day.
The decision follows a Therapeutic Goods Administration review and public consultation process identifying 250 reports of peripheral neuropathy – or damage to the nerves outside of the brain and spinal cord – and related conditions, with most of those reports made since 2023.
Dr Evangeline Mantzioris, a sports dietitian at the University of South Australia, said the rapid growth in the availability products and supplements enriched with vitamin B, combined with strong marketing of them, meant the TGA changes “are sensible and needed to protect the general population”.
What is B6 toxicity?
While the body can eliminate some excess vitamin B6, it can not efficiently eliminate it all. Over time it can build up in the blood to toxic levels. Peripheral neuropathy is a known side-effect of vitamin B6 toxicity, with symptoms including tingling, burning and numbness, usually in the hands or feet. Delayed diagnosis and continued exposure can cause permanent nerve damage.
Vitamin B6 is also commonly added to products including energy drinks and protein powders, according to Mantzioris, meaning people are unknowingly ingesting it from multiple sources. This cumulative exposure can cause peripheral neuropathy even at doses less than 50mg, when people are using several B6-containing products.
Mantzioris said the recommended daily intake of B6 was easily met through eating a varied diet rich in fruit, vegetables, animal foods and dairy, making it “ubiquitous in the diet” and deficiency uncommon in Australia.
“When I first started in dietetics, you couldn’t buy a lot of these enriched powders and high-dose supplements as they were mostly used for patients in hospital who were malnourished or couldn’t eat,” said Mantzioris, an accredited practising dietician. “With marketing, some people now also wrongly feel that they need to take supplements like these, ‘just in case’.”
What will change?
Products with low doses of vitamin B6 of 50mg or less in each recommended daily dose will continue to be available for general sale.
Products containing more than 50mg will only be available over-the-counter with pharmacist advice from June 2027. Oral preparations containing more than 200mg in each recommended daily dose will continue to require a prescription.
The elderly, or those with alcohol dependence, obesity or certain kidney, liver and autoimmune conditions may be at risk of deficiency but should consult with their doctor before taking supplements, Mantzioris said.
How great is the risk of harm?
Taking vitamin B6 even at low doses can cause peripheral neuropathy in some, but people are more likely to get it if they are taking more than one supplement. The TGA said it was not yet clear why some people are more prone to this side-effect than others.
Importantly, vitamin B6 toxicity is associated with supplement use, not with whole-food sources. Symptoms generally improve after stopping supplements.
Why the delay and what should people do in the meantime?
The TGA said the changes would take effect from June 2027 to give industry, healthcare practitioners and businesses “time to make the necessary changes, including updating product labelling and managing stock”.
Mantzioris said that in the meantime “I would probably err on the side of safety and not want to consume any supplements that have the higher levels in them without a proven deficiency and doctor guidance”.
Consumers should always check the label of any vitamin or supplement products for vitamin B6, also called pyridoxine, pyridoxamine or pyridoxal, the TGA said.
Anyone experiencing tingling, burning or numbness in their hands or feet should stop taking any B6 products and seek medical advice.
Geraldine Moses, an adjunct Associate Prof in the School of pharmacy and pharmaceutical sciences at the University of Queensland, said it was “a shame” the changes won’t take effect until mid-2027.
“But, it’s pretty standard for this sort of big change,” she said. “The vitamin and supplements industry is powerful and big but B6 is in a bazillion products so it’s a big job. I dare say though the government negotiated that timeline with the supplement industry.”
