Australia's medicines regulator has ordered high vitamin B6 supplements removed from general sale in response to hundreds of reports of nerve damage and other side effects associated with long-term use.
From June 2027, any vitamin B6 product containing more than 50 mg in each recommended daily dose will be removed from the pharmacy counter. The recommended intake of vitamin B6 for a healthy adult is only 1.3 to 1.7 mg per day.
The solution follows Therapeutic Goods Management Overview and a public consultation process that identified 250 reports of peripheral neuropathy (or damage to nerves outside the brain and spinal cord) and related conditions, with the majority of these reports made after 2023.
Dr Evangeline Mantzioris, a sports nutritionist at the University of South Australia, said the rapid increase in the availability of vitamin B fortified foods and supplements, coupled with aggressive marketing, meant the TGA's changes were “sensible and necessary to protect the general population”.
What is the toxicity of B6?
Although the body can eliminate some excess vitamin B6, it cannot effectively remove all of it. Over time, it can accumulate in the blood to toxic levels. Peripheral neuropathy is a known side effect of vitamin B6 toxicity, the symptoms of which include tingling, burning and numbness, usually in the arms or legs. Delayed diagnosis and prolonged exposure can lead to permanent nerve damage.
Vitamin B6 is also often added to foods including energy drinks and protein powders, meaning people are unknowingly taking it from a variety of sources, Mantzioris said. Such cumulative exposure can cause peripheral neuropathy even at doses less than 50 mg when people use multiple products containing B6.
Mantzioris said the recommended daily intake of vitamin B6 was easily achieved through a varied diet rich in fruits, vegetables, animal products and dairy products, making it “universal in the diet” and deficiency was rare in Australia.
“When I first started in nutrition, you couldn't buy a lot of these fortified powders and high-dose supplements because they were mainly used for patients in the hospital who were malnourished or couldn't eat,” said Mantzioris, an accredited practicing dietitian. “Thanks to marketing, some people now mistakenly believe that they need to take such supplements “just in case.”
What will change?
Products with low doses of vitamin B6 (50 mg or less in each recommended daily dose) will continue to be widely available.
Products containing more than 50 mg will be available without a prescription only on pharmacist advice from June 2027. Oral medications containing more than 200 mg in each recommended daily dose will still require a prescription.
Older adults or people with alcohol addiction, obesity or certain kidney, liver and autoimmune diseases may be at risk for deficiency, but should consult their doctor before taking supplements, Mantzioris said.
How great is the risk of harm?
Taking vitamin B6 even in low doses can cause peripheral neuropathy in some, but people are more likely to get it if they take more than one supplement. The TGA said it was not yet clear why some people were more prone to this side effect than others.
It is important to note that vitamin B6 toxicity is associated with supplement use and not with whole food sources. Symptoms usually improve when supplements are stopped.
Why the delay and what should people do in the meantime?
The TGA said the changes will come into force from June 2027 to give industry, healthcare professionals and businesses “time to make necessary changes, including updating product labeling and stock management”.
Mantzioris said that at the same time, “I would probably err on the side of safety and be reluctant to take any higher content supplements without a proven deficiency and a doctor's recommendation.”
Consumers should always check the label of any vitamins or dietary supplements for the presence of vitamin B6, also called pyridoxine, pyridoxamine or pyridoxal, the TGA said.
Anyone who experiences tingling, burning or numbness in their hands or feet should stop taking any B6 products and seek medical attention.
Geraldine Moses, associate professor at the University of Queensland's School of Pharmacy and Pharmaceutical Sciences, said it was “a shame” the changes would not come into force until mid-2027.
“But that’s pretty standard for this kind of big change,” she said. “The vitamin and supplement industry is powerful and big, but B6 is found in so many products, so it's a lot of work. I dare say, although the government has agreed this schedule with the supplement industry.”
