Following recent concerns about vitamin B6 supplements, the Therapeutic Goods Administration (TGA) this week announced it will remove some vitamin B6 supplements from shelves by June 2027.
The TGA’s aim is to “strengthen safety controls for products containing vitamin B6, and to help reduce the risk of nerve damage associated with the long-term consumption of high doses”.
In a statement released on 25 November, the TGA says that “products with low doses” (50mg or less per recommended daily dose) of the vitamin will continue to be available for general sale, while products with “higher doses of vitamin B6 (more than 50mg but not more than 200mg per recommended daily dose) will require advice from a pharmacist or a prescription from a doctor”.
“Oral preparations containing more than 200mg per recommended daily dose will continue to require a prescription,” says the TGA.
These changes will be implemented by 1 June 2027 and come following an “extensive review process, including public consultation showing strong support for tighter controls”.
“The decision strikes a balance between the benefits of vitamin B6, where some people may need low-dose supplementation, and the risks of prolonged ingestion of high doses, which can include damage to peripheral nerves,” says the TGA.Â
‘Long time coming’
“This decision has been a long time coming, as the UK has regulated Vitamin B6 in doses >50mg as a prescription drug since 1997,” says Adjunct Associate Professor Geraldine Moses AM, from the School of Pharmacy and Pharmaceutical Sciences at the University of Queensland.
“As doses of B6 between 50mg and 200mg per day will now be regulated as Schedule 3 Pharmacist Only Medicines, the TGA should provide education to pharmacists so they can handle requests for vitamin B6 products safely and appropriately,” she says.
‘Pyridoxine can accumulate and cause irreversible damage’
While vitamin B6 is a water-soluble vitamin, Dr Vijay Suppiah, a senior lecturer in pharmacy at the University of South Australia, says that a common form of the vitamin, pyridoxine, “can accumulate in the body and cause irreversible damage”.
This is unlike other water-soluble vitamins.
“Recent evidence suggests that taking large amounts of pyridoxine can interfere with nerve function, causing symptoms like tingling, burning, and numbness,” he says.
“These effects can appear even at moderate doses in some people.
“Due to the widespread availability, some patients have been unknowingly taking excessive amounts from different combination products.”
While some people require vitamin supplementation to correct diagnosed deficiencies, Dr Suppiah points out that “vitamin B6 deficiency is uncommon among the Australian population”.
“Vitamin B6 deficiency is more likely to occur in the elderly, or those with alcohol dependence, obesity, or certain kidney, liver and autoimmune conditions,” he says.
“If you choose supplements, stick to low-dose options like multivitamins or B-complex products that provide less than 10mg per day.
“Always check labels and consult a healthcare professional before starting any high-dose regimen.”
‘A move in the right direction’
Dr Jack Janetzki, a lecturer in pharmacy and pharmacology at the University of South Australia, says “this is a move in the right direction” and that “pharmacists are well positioned” to help people understand the benefits vs the risks associated with vitamin B6 supplementation.
“Many people who purchase multivitamins and supplements do not know that the product contains vitamin B6 because of the different names that it goes by, and so they are at risk of taking too high a dose,” he says.
“Unknowingly combining products that contain already high doses of vitamin B6 puts the person at very high risk of adverse effects such as potentially long-lasting peripheral neuropathy, nerve damage and muscle weakness.
“Pharmacists are well-positioned to assist people in understanding both the benefits of taking vitamin B6 and the risks associated with its use, especially at higher doses or over the long term.”
Dietary sources of vitamin B6
According to the Nutrient Reference Values for Australia and New Zealand document, the average recommended dietary intake (RDI) for vitamin B6 for a healthy adult is 1.3-1.7mg/day.
Food sources of vitamin B6 include:
- Milk
- Ricotta cheese
- Salmon
- Tuna
- Eggs
- Chicken liver
- Beef
- Carrots
- Spinach
- Sweet potato
- Green peas
- Avocado
- Bananas
- Chickpeas.
‘Natural medicines can be powerful when used properly’
“The decision was expected, as the only substantive thing changed from what has been put out was the date of implementation,” says Jon Wardle, Professor of Public Health and Foundation Director, National Centre of Naturopathic Medicine, Faculty of Health, at Southern Cross University.
“However, it did recognise B6 as being safe when used appropriately, and the primary issue was people duplicating doses across multiple products. So, it does show a real need for increased education, not just for the public but for practitioners as well,” he says.
Professor Wardle, who is also the convenor of the Complementary Medicine Special Interest Group at the Public Health Association of Australia, says the RDI is there “to stop deficiency” and that for some people, higher doses may be required under the supervision of a healthcare practitioner.
“The recommended daily dose is there to stop deficiency, but therapeutic doses can be much higher, and for some people this is appropriate,” he says.
“But this is based on individual needs and should be discussed with a practitioner familiar with clinical nutrition.
“Natural medicines can be powerful when used properly, but like any medicine, they can cause issues if used incorrectly. Some can be good, but more is not always better.”
