The TGA decision is based on an extensive review, prompted by widespread concerns earlier this year that high doses were causing toxicity and leading to lasting nerve damage.
The TGA says the tighter controls – which include restrictions on over-the-counter sales for higher doses – will strike a balance between the vitamin’s benefits and its potential harms.
This may leave some people confused about whether vitamin B6 is safe to take. How much is too much? And can supplements still be purchased over-the-counter?
B6 (also known as pyridoxine, pyridoxamine and pyridoxal) is an essential vitamin for good health, involved in more than 140 processes in the body.
But we can’t produce it ourselves, so we need to get it elsewhere – mainly from our diet.
B6 can be found in a wide range of foods, including animal products such as meat, poultry, fish, eggs and dairy.
Plant-based sources include:
The recommended dietary daily intake of B6 varies based on age. So wherever you get it – diet or supplements – this is the recommended amount per day.
The upper recommended limit for healthy adults is 50mg/day.
But the recommended intake is lower for infants and people who are pregnant or breastfeeding. For detailed information, visit the government’s Eat for Health website.
Vitamin B6 deficiency has been linked to diseases including some kinds of cancer, mental health disorders, and cardiovascular disease (such as heart attacks or strokes). However, this kind of deficiency is not common in Australia.
Still, some people choose to take vitamin B6 as a supplement. Or they may take other products and be unaware they contain it.
This can increase the risk of having too much – which can be toxic.
Taking high doses of vitamin B6 over a long time can lead to poisoning and cause peripheral neuropathy.
Toxicity from food sources is extremely rare, including among individuals with enzyme deficiencies that slow B6 metabolism.
Almost all documented vitamin B6 toxicity results from excessive supplement intake, as levels found in natural foods remain well below harmful thresholds.
The TGA’s decision to tighten rules about vitamin B6 products responds to a worrying number of peripheral neuropathy cases in Australia, linked to various vitamin supplements.
The tighter measures will come into effect on June 1 2027. The changes include:
This means the products now requiring prescriptions or pharmacist supervision have around 19–117 times the recommended intake. Products with 50mg per recommended daily dose or less will still be available over-the-counter.
The amount of B6 which might cause toxicity is not fully known, as it seems to vary across the population. Some studies have identified nerve damage in people taking less than 500mg/day, but not below 200mg/day. So this is likely why the TGA chose these limits.
The new regulations are likely to affect specific standalone B6 products, which tend to have the highest doses.
But B6 is commonly also added to multivitamins, “ageing support” supplements, skin and hair support products, and effervescent products such as Berocca. Most of these contain less than 50mg in the daily recommended dose, and so will continue to be available over the counter.
Many people are unaware how much vitamin B6 they are consuming, often across multiple supplements.
It is likely the combination of these products that leads to people unknowingly consuming significant enough doses to cause harm.
The TGA’s report also acknowledged the need for clearer labelling, including mandatory front-of-pack statements that indicate when a product contains vitamin B6 – especially in combination products.
Most of the 125 medicines containing more than 50mg and less than 200mg per recommended daily dose of vitamin B6 are currently listed as complementary medicines. They will need to be registered on the Australian Register of Therapeutic Goods and relabelled.
But the report says the TGA may decide to introduce further packaging changes, including strengthening warning statements and change how vitamin B6 is labelled.
People taking vitamin supplements of any kind should check the label to ensure they are not exceeding the recommendations (50mg/day is more than adequate) across all supplements.
Vasso Apostolopoulos, Distinguished Professor, Professor of Immunology, RMIT University and Jack Feehan, Vice Chancellors Senior Research Fellow in Immunology, RMIT University
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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