A range of vitamin B6 supplements will be pulled from shelves to reduce the risk of severe health impacts, the medical watchdog has revealed.
From June 2027, Australians will need pharmacist supervision to buy products containing more than 50mg of B6 and a prescription for anything with more than 200mg of the vitamin.
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Supplements containing less than 50mg will remain available for general retail sale.
Vitamin B6, also known as pyridoxine, pyridoxamine and pyridoxal, is important for normal brain development and regulates the nervous system and immune system.
But several medical experts have backed the new safety controls, saying it is too easy to inadvertently exceed the recommended daily dose.
Most healthy adults can obtain the recommended 1.3-1.7 mg from their diet alone.
The decision, made by a delegate of the Therapeutic Goods Administration (TGA), comes after a rise in toxicity cases from overconsumption and follows an extensive review.
There were submissions from 103 people who 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”.
New restrictions on the sale of vitamin B6 will be introduced in mid-2027. Credit: 7NEWS Oliver Jones, a professor of chemistry at RMIT University said the vitamin is an essential nutrient for humans that we have to source externally because our bodies do not make it.
“Usually this is through the diet, but it can also be obtained from tablets (and) supplements,” Jones said.
“The problem is that vitamin B6 is in a range of products, so it is easy to accidentally take too much without realising.
“People may then not link their symptoms to the supplements, so they can be ill for some time and not know why.
“The issue of vitamin B6 toxicity illustrates an important point — you can have too much of a good thing. Everything is toxic in the right amount.”
Dr Ian Musgrave, a senior lecturer in medicine at the University of Adelaide, said dietary intake of vitamin B6 “will not cause toxicity”.
“There are many supplements that contain vitamin B6 — some supplements for stress may contain vitamin B6 levels well above the recommended daily intake, and long-term intake results in toxicity,” Musgrave said.
“Vitamin B6 can also be found in products such as energy drinks, breakfast cereals, or weight loss shakes. So there is significant potential for overdose.”
It was revealed earlier this year that more than 1000 Australians had contacted lawyers about neurological symptoms they believe are linked to excessive B6 in over-the-counter supplements.
Dominic Noonan O’Keefe, a 33-year-old father from Victoria, told how he began suffering unexplained symptoms including nerve pain, loss of balance, visual issues and overwhelming fatigue after he started taking supplements.
“I remember standing at my desk and I had this electric shock of nerve pain shoot up in my scalp,” he told 7NEWS.
“Everything became overwhelming. I couldn’t deal with it. The light was too bright. The noises were too loud. I thought I was having an aneurysm or something. I thought I was dying.”
University of Queensland adjunct associate professor Geraldine Moses said the new restricted access was a “great relief”.
“The toxicity of vitamin B6 has been known for over 30 years, so it is about time the TGA took steps to protect the public. It’s just a shame that this ruling won’t come into effect until June 2027,” Moses said.
“This decision has been a long time coming, as the UK has regulated Vitamin B6 in doses (above) 50mg as a prescription drug since 1997.
“In the meantime, thousands of Australians have unwittingly consumed high doses of B6, either from individual products or multiple products with doses that accumulate to an overdose.
“Thankfully, doctors are now more aware.”
There is at least 125 products on Australian shelves providing more than 50mg of vitamin B6 but less than 200mg.
There is at least 125 products on Australian shelves providing more than 50mg of vitamin B6 but less than 200mg. Credit: 7NEWS The TGA believes the strengthened safety controls balance the benefits of vitamin B6 and the “risks of prolonged ingestion of high doses, which can include damage to peripheral nerves”.
It said the mid-2027 deadline will offer enough time for the industry to update labelling and manage stock.
Vitamin B6 deficiency is uncommon in Australia but more likely to occur in the elderly, those with alcohol dependence, obesity, or certain kidney, liver and autoimmune conditions, but uncommon among the Australian population.
“If you experience tingling, burning or numbness in your hands or feet, stop taking the product immediately and seek medical advice as soon as possible,” the TGA said.