TGA says some vitamin B6 to be removed, prescriptions needed after toxicity cases
The TGA has moved to impose stronger regulation of vitamin B6. (ABC News: Tom Hartley)
In short:
A number of vitamin B6 supplements will be removed from shelves by June 2027.
A rise in B6 toxicity cases led to a review and the policy change from the TGA.
Customers will require a pharmacist's supervision to purchase products containing more than 50mg of vitamin B6, and anything with more than 200mg will need a prescription.
The Therapeutic Goods Administration (TGA) will crack down on vitamin B6 after a rise in toxicity cases causing life-altering nerve damage to many Australians.
From June 2027, customers will require a pharmacist's supervision to purchase products containing more than 50mg of vitamin B6, and anything with more than 200mg will need a prescription.
The TGA had made an earlier concession it had failed to act fast enough, after 7.30 reported a rise in nerve injuries connected to the supplement.
Also called pyridoxine, pyridoxal, or pyridoxamine, the synthetic chemical is present in thousands of products in Australia as an additive, including medicines, multivitamin and mineral supplements, energy drinks and weight loss shakes.
The decision, made by a delegate of the TGA, follows an extensive review, including 248 public submissions.
It said 103 people reported "severe, sometimes permanent, health effects from vitamin B6 toxicity", including peripheral neuropathy, nerve damage, muscle weakness, "and significant impacts on daily life and employment".
"The considerable number of adverse events, difficulties in diagnosis and ensuing hardships on sufferers justify these restrictions,"the TGA delegate said.
Most of the 125 high-dose products on the market are complementary medicines — produced by major manufacturers in the multi-billion dollar sector.
Supplements containing vitamin B6 will be much more tightly regulated. (ABC News: Jerry Rickard)
The delegate's report, titled the Final Decision, detailed some of the confronting cases that were considered.
"Many people mentioned being unaware of vitamin B6 in various products, resulting in cumulative exposure from multiple sources," the delegate wrote.
"There were also repeated calls for stronger warnings regarding neurotoxicity and educational programs to raise awareness of possible overexposure to vitamin B6, particularly from multiple sources, and associated adverse effects."
Report practices in question
The report also directly challenged industry claims that nerve damage from vitamin B6 only occurs at high doses or after long-term use, saying it received convincing evidence of harm at much lower intakes.
It also highlighted that the studies industry submissions relied upon were funded by major vitamin B6 manufacturers, raising serious questions about conflicts of interest.
Loading..."Two submissions, one from a manufacturer and the other from a peak body, referred to a recent report, recommending a [recommended daily dose] of 50mg of vitamin B6 to be the tolerable maximum dosage for long-term use, with doses over 50mg to 100mg to be suitable for shorter durations."
"I note that all authors of the paper received honorarium from various major manufacturers of vitamin B6 products."
The peak body, Complementary Medicines Australia, pushed back against the proposed restrictions, in its initial submission, raising concerns about consumer access and the practical impact on pharmacists, but also made clear the industry's financial worries.
In a partially redacted letter, it highlighted the costs and delays involved in reformulating or relabelling products, restrictions on advertising, and potential loss of international sales.
Blackmores' Group, a major manufacturer, strongly downplayed the risks of vitamin B6, repeatedly characterising peripheral neuropathy as "rare", and risks "minimal", and linked only to very high or long-term doses — a position at odds with the TGA's evidence.
Energy drinks like these can contain high levels of vitamin B6. (ABC News: Cameron Lang)
The company emphasised extensive health benefits and argued that tighter controls were "disproportionate" and would impose "significant costs", "operational burdens", and "logistical challenges" on pharmacists and the broader healthcare system.
Much of the group's submission focused on market access and regulatory parity, noting vitamin B6 is widely sold in overseas supermarkets and warning that up-scheduling would restrict access to a "vital nutrient".
It also argued that the proposed change would affect global sales, reformulation requirements, and advertising.
Large health literacy gap
One element that became clear to the TGA's delegate was "the need for clearer labelling," including mandatory front-of-pack warnings indicating the presence of vitamin B6, "especially in combination products".
Geraldine Moses, a renowned drug safety researcher, said the restrictions were a "great relief", and the announcement was "a very long time coming".
"The UK has regulated vitamin B6 in doses greater than 50 milligrams per day as a prescription-only medicine since 1997," Dr Moses told 7.30.
"It's just a shame the TGA's ruling won't come into effect until June 2027.
"The TGA should provide the pharmacy profession with detailed education so they can handle pyridoxine requests safely and appropriately."
Terri-Lynne South is a dietician and GP, one of several health practitioners who has been advocating for tighter regulations.
Terri-Lynn South believes B6 toxicity is under-reported. (Supplied: Dr Terri-Lynn South)
Dr South said it was a "step in the right direction", but said consumers and healthcare professionals should also be aware that vitamin B6 can be found in high amounts in some food items, particularly energy drinks, which can contribute to excessive intake.
The TGA acknowledged a "health literacy gap," saying it will run a public awareness campaign to educate consumers about the multiple sources of vitamin B6 and possible harms from cumulative dose and excessive intake.
"In the lead up to the changes taking effect, the TGA will run a further public awareness campaign," the regulator said.
'I'm a survivor'
Keri McInerney is still grappling with the effects of inadvertently consuming too much vitamin B6, through daily supplements as part of a weight loss regimen.
Keri McInerney had to put her music career on hold when she suffered B6 toxicity. (Supplied: Keri McInerney)
Her career as an award-winning singer-songwriter was put on hold after accidentally poisoning herself with B6 several years ago.
"I've tried so hard for a number of years to advocate for change, and now with the TGA changes, I feel I can now stop calling myself a victim — I'm a survivor," Ms McInerney told 7.30.
"I absolutely feel vindicated, I'm over the moon.
"For years I saw doctors who told me it was in my head, there was nothing wrong, I was imagining my pain. I was offered anti-depressants time and time again or just disregarded.
Keri McInerney says there were times where she felt like she was not believed. (Suppled: Keri McInerney)
"It was absolutely debilitating, to be so very ill, dealing with chronic pain and treated like I didn't matter.
"I cried a lot. It was a very lonely journey, especially when no one's listening."
She said she was now contacted most days by people asking for help, and for information on "how to beat it."
"And to those still taking vitamins, protein shakes or package foods containing B6, please think twice about what you are taking, check your products.
"Your health depends on it."
'Inadvertent B6 overdose'
Chair of Public Health at the Australian Medical Association Michael Bonning was relieved by the outcome.
"It's so clear that there are many people in the community who have been harmed by inadvertent B6 overdose," Dr Bonning told 7.30.
"A 2021 Medical Journal of Australia study found that nearly 75 per cent of healthy Australians over 70 reported using complementary medicines either daily or occasionally, so appropriate regulation will likely have a larger beneficial effect on older Australians.
"The fact 231 people wrote individually to the regulator, to describe their experiences, goes to show just how widespread the issue is, and how urgently the public wanted change.
Michael Bonning says the supplements industry could still use more regulation. (ABC News: Rahni Sadler)
Medical negligence lawyer Nick Mann, whose firm is pursuing a class action against Blackmores, said the TGA's decision "shows that concerns from affected consumers and practitioners about the dangers of B6 are starting to be heard and understood".
"It was particularly pleasing that the TGA acknowledged the need for clearer labelling, the potential lasting permanent impact of vitamin B6 toxicity, and the weak evidence base put forward by manufacturers to justify the sale of products with high levels of B6," he said.
"What has struck me are the range of people who have been affected.
"We've now heard from over 2,000 Australians who have suffered the effects of Vitamin B6 toxicity — changes to vision, loss of sensation and function to their legs and hands, and a range of other impacts which for many people are both ongoing and devastating."
Dr Bonning suggested there was still work to be done.
"Supplements are still lightly regulated, which we need to address in Australia with a whole-of-system approach,"he said.
The sector now faces a one-and-a-half-year transition period to update labels, manage stock, and comply with the new scheduling rules, amid ongoing scrutiny over its safety practices.
The TGA said the time is necessary for changes to take place but that those taking supplements should take precautions.
"Consumers should always check the label of any vitamin or supplement products for vitamin B6," a TGA statement said.
'If you experience tingling, burning or numbness in your hands or feet, stop taking the product immediately and seek medical advice as soon as possible."
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