Move to slash amount of vitamin B6 considered safe by 72 per cent

Move to reduce amount of vitamin B6 considered safe by 72 per cent In short: The National Health and Medical Research Council (NHMRC) has recommended reducing the upper limit of daily human consumption of vitamin B6 to 14 milligrams, down from the current 50mg. Synthetic vitamin B6 is added to thousands of products sold in Australia, including supplements like multivitamins, protein powders and energy drinks, What's next? The Therapeutic Goods Administration says it is waiting for the NHMRC recommendation process to be completed before it commits to taking "further regulatory action" on products containing vitamin B6. Months after taking vitamin supplements, Dominic Noonan-O'Keefe says he feared he was dying. His body was overwhelmed by pain and numbness, his mind overcome with dread. "Every millimetre of my body was exploding with misfiring, misdirected signals to my brain," he told 7.30. "There were lightning bolts through my body 24 hours a day. It was the most awful thing I've ever lived through." Today, more than two years after he stopped taking the supplements, he said the pain had "turned down", but he still lived with balance and vision problems, among a long list of symptoms he attributes to unknowingly consuming too much vitamin B6. Amid a public health crackdown, Australia's peak health research body is moving to cut the amount of vitamin B6 considered safe to consume. The medicines regulator has also confirmed it will act within weeks to bring in stronger warnings and labelling, as consumers are urged to check what is in their cabinets. Proposed change to 'upper limit' Vitamin B6 is an essential nutrient found naturally in foods like meat, fish and vegetables. But the synthetic form, also known as pyridoxine, is added to thousands of products sold in Australia — from supplements like multivitamins, B-complex tablets, magnesium and zinc tablets, to fortified foods and drinks including protein powders, energy drinks and weight-loss shakes. Since 2006, regulators, doctors and manufacturers have all worked from the same figure: the intake of up to 50 milligrams of vitamin B6 a day was safe. That threshold is known as the "upper limit". But after an extensive review of global evidence, Australia's peak health research body, the National Health and Medical Research Council (NHMRC), has now recommended reducing it by 72 per cent to 14mg. "There's really no good reason to be taking 50mg of vitamin B6, unless of course you're suffering from severe malnutrition," said Tim Green, who co-chaired the working group behind the proposed change. The amount of B6 people are advised to consume for good health — around 1.3mg a day — is not changing. Professor Green said a deficiency would be rare. "It wouldn't happen with a normal Australian diet," he said. Matt Silsby, a neurologist and neurophysiologist, said B6 toxicity typically caused "primarily sensory symptoms, pins and needles or prickling or painful symptoms", and sometimes cramps or muscle twitches. In more serious cases, he said it could "get quite severe and lead to nerve damage", and in a subset of those patients that damage can be permanent. He was quick to stress that symptoms "could potentially have very many causes", and it's "not appropriate to just attribute everything to the vitamin B6 level". Regulators, manufacturers face potential shake-up The review followed years of mounting concern and, recently, a dramatic intervention by the medicines regulator. In November last year the Therapeutic Goods Administration (TGA) — which had conceded it had been too slow to act — moved to pull high-dose B6 products from general sale, while also asking the NHMRC to review the science behind the limit. According to the recommendation, the new limit would apply to all adults, including during pregnancy and breastfeeding, with lower limits for children scaled down by body weight, to as little as 4mg a day for under-4s. Alexandra Jones, a food policy expert at the George Institute for Global Health, told 7.30 the proposed reduction was "encouraging" and brought Australia "closer to the approach adopted by the European Food Safety Authority", which enforces some of the most conservative safety limits in the world. The upper limit is also a key reference that medicine and food regulators draw on when deciding what can be sold, how it is labelled, and what sits behind the pharmacy counter. "The outcomes of the NHMRC's work are not regulatory, but they do provide an important scientific foundation for updating guidance to consumers and potentially updating policy and regulation down the track," Dr Jones said. The working group acknowledged the change could carry "cost implications for manufacturers", but said its decision was "made on the basis of population health". "There's nobody who's going to be harmed by lowering it," Professor Green said, "but there will be people who may be harmed by keeping it at 50 milligrams." 'Hidden' in supplements and energy drinks Just how many Australians have been affected is impossible to say. Pathology clinics across the country sounded the alarm more than a year ago, noting a spike in concerning results. But the TGA's surveillance of cases has been cumbersome. The TGA publicly lists reports of potential issues related to medicines as "adverse events". As of August 13, the current number of potential peripheral neuropathy cases linked to pyridoxine (B6) since 2020 was 279. But even by the TGA's own admissions, that number should not be considered an accurate reflection of prevalence in the community. The Australian lobby group for complementary medicines, CMA, which represents major manufacturers, maintains that adverse events are "extremely rare". A CMA spokesperson told 7.30 "high doses of vitamin B6 are often recommended by healthcare practitioners for specific therapeutic benefits or preventing deficiency". Professor Green believes toxicity cases are under-reported and what has been recorded officially was "likely the tip of the iceberg", probably skewed towards the most "severely affected people". Another issue in trying to understand prevalence is that toxicity symptoms exist on a spectrum and can often mimic other conditions. Dr Silsby, who is researching the effect of B6 on nerves, said patients rarely realise how much they are taking and were often "absolutely shocked" when they figured out how many of their products contain B6. "It can be hidden or unexpected in supplements … and we always ask them to go home and check through their cabinets and to stop anything that contains it,"he said. Professor Green himself admitted he unknowingly took B6 in a magnesium supplement for a while. "If I can't figure it out, having been in this area for 20 years, how is the general public meant to?" he said. For many people, though, the biggest source of hidden B6 is not vitamin supplements. The NHMRC working group's analysis found that in 2023, nearly a third (32.9 per cent) of Australians' dietary vitamin B6 intake came from just three sources: electrolyte, energy and fortified drinks; cereal-based dishes like sandwiches and pasta; and poultry — but noted the latter two groups contain too little B6 to be a concern. Dr Jones said the revised limit was "yet another good reason for energy drink consumers to rethink that habit". While individual drinks are in the safe range of vitamin B6, problems could potentially arise if people consume multiple products containing synthetic B6. "A single can of a popular energy drink can contain around 5 milligrams," she said, "so those drinking multiple cans, and particularly those combining energy drinks with supplements, need to take note." But while the NHMRC offers advice, the rules governing what goes into foods and drinks are set separately by Food Standards Australia New Zealand (FSANZ). Dr Jones told 7.30 the onus should not be on consumers "to maintain vigilance and read the fine print on everything," and said FSANZ should "consider updating guidance on an appropriate 'one day quantity' and potentially limiting the content of B6 permissible in energy drinks". FSANZ said it would "carefully consider the final outcomes and any implications for food regulation", once a final recommendation was accepted. The Australian Beverages Council, whose membership includes energy drink manufacturers, said it was consulting members over the proposal and would "comply with any relevant regulatory changes". It noted the TGA's review had found supplements, not drinks, to be the largest source of dietary B6. Complementary Medicines Australia — which represents about 80 per cent of the sector — played down the significance of the recommended change, noting the new figure is a dietary guideline, not a rule for medicines, and that supplements already carry warning labels and follow the regulations. Previous safe limit set on 'biased' evidence The NHMRC group behind the recommendation included toxicologists, pharmacologists, neurologists, a chemical pathologist, a GP, public health experts and a specialist in complementary medicines, as well as a member with lived experience of B6 toxicity. An external review commissioned found the evidence behind the old 50mg figure was thin, resting largely on small, decades-old overseas studies that carried a "high risk of bias". There had never been much solid data to work from, Professor Green said, because proper studies would mean deliberately harming people. "People don't normally set out to poison people in studies," he told 7.30, adding that some of the earlier research would be considered "unethical" by modern standards. What had changed, he said, was how much B6 people now consume, often without knowing, driven by the proliferation of supplements in recent years. "The more people you start exposing to supplements, the more things that are going to come up that you didn't expect," he said, explaining that the committee primarily considered mounting adverse-event reports and recent international guidance, to "err on the side of caution." The 'slow cogs' of progress Mr Noonan-O'Keefe told 7.30 the NHMRC's recommendation was "fantastic" and "going in the right direction", and hoped the TGA was paying close attention. "I hope they look at this latest body of evidence, which has existed for a long time, and recognise the level of action they've taken to date is insufficient," he said. Under the TGA's current settings, products containing up to 50mg of vitamin B6 will remain on general sale until at least June 2027, more than three times the dose the new science says is safe. In a statement to 7.30, the TGA said it had run a successful public safety campaign earlier this year and said "in the coming weeks" it intended to consult on further measures —including stricter labelling, as well as lowering the threshold at which products must carry a warning about nerve damage. But the TGA spokesperson wouldn't commit to "further regulatory action", including considering scheduling changes, until the final NHMRC recommendations process was complete. "A time frame for this work has not been decided," the spokesperson said. That wait is hard to accept for people living with the consequences of toxicity. "What are we waiting for?" Mr Noonan-O'Keefe said. "A working group has established the issue, so the regulator knows and we expect them to be swift — not slow-turning cogs." The NHMRC proposal is open for public submissions until September 30, with a final decision expected next year. From there it would be up to the regulators to decide whether what's on the shelves should more closely match the recommendation. Watch 7.30, Mondays to Thursdays 7:30pm on ABC iview and ABC TV