Vitamin supplements with high levels of B6 will be removed from general sale in Australia – here’s what you need to know | Nutrition
Australia’s medicines regulator has ordered that supplements containing high levels of vitamin B6 be withdrawn from general sale in response to hundreds of reports of nerve damage and other side effects linked to long-term use.
Starting June 2027, any vitamin B6 product containing more than 50 mg in each recommended daily dose will be moved behind the pharmacy counter. The recommended dietary intake of vitamin B6 for a healthy adult is only 1.3 mg to 1.7 mg per day.
The decision follows a review and public consultation process by the Therapeutic Goods Administration identifying 250 reports of peripheral neuropathy – or damage to nerves outside the brain and spinal cord – and related conditions, with most of these reports made since 2023.
Dr Evangeline Mantzioris, a sports dietitian at the University of South Australia, said the rapid growth in the availability of vitamin B-fortified products and supplements, combined with heavy marketing of them, meant the TGA changes “are sensible and necessary to protect the general population”.
What is B6 toxicity?
Although the body can eliminate some excess vitamin B6, it cannot eliminate it all effectively. 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 such as 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 below 50 mg, when people use multiple B6-containing products.
Mantzioris said the recommended daily intake of vitamin B6 was easily achieved through a varied diet, rich in fruits, vegetables, animal foods and dairy products, making it “ubiquitous in the diet” and a rare deficiency in Australia.
“When I first started in dietetics, you couldn’t buy a lot of these fortified powders and high-dose supplements because they were primarily used for hospitalized patients who were malnourished or couldn’t eat,” said Mantzioris, a certified practicing dietitian. “With marketing, some people now wrongly feel that they need to take supplements like these, ‘just in case’.”
What will change?
Products containing low doses of vitamin B6 of 50 mg or less in each recommended daily dose will continue to be available for general sale.
Products containing more than 50 mg will only be available over the counter with the advice of a pharmacist from June 2027. Oral preparations containing more than 200 mg in each recommended daily dose will continue to require a prescription.
Older adults, or those with alcohol dependence, obesity or certain kidney, liver and autoimmune diseases, may be at risk of deficiency but should consult their doctor before taking supplements, Mantzioris said.
How big is the risk of harm?
Taking vitamin B6, even in low doses, can cause peripheral neuropathy in some, but people are more likely to experience it if they take more than one supplement. The TGA said it was not yet clear why some people are more prone to this side effect than others.
It is important to note that vitamin B6 toxicity is associated with the use of supplements and not whole food sources. Symptoms usually improve after stopping the supplements.
Why the delay and what should people do in the meantime?
The TGA said the changes would come into force from June 2027 to give industry, healthcare professionals and businesses “time to make necessary changes, including updating product labeling and inventory management”.
Mantzioris said that in the meantime, “I would probably err on the side of safety and not want to consume supplements containing higher levels without a proven deficiency and a doctor’s advice.”
Consumers should always check the label of any product containing vitamins or supplements for vitamin B6, also known as pyridoxine, pyridoxamine or pyridoxal, the TGA said.
Anyone experiencing tingling, burning, or numbness in their hands or feet should stop taking any B6 product and seek medical attention.
Geraldine Moses, an adjunct 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 effect until mid-2027.
“But it’s pretty common for this kind of big change,” she said. “The vitamin and supplement industry is powerful and important, but B6 is in a billion products, so it’s a big job. I daresay, although the government negotiated this timeline with the supplement industry.”
