RACGP backs TGA vitamin B6 restrictions

The RACGP has thrown its support behind a plan to crack down on the availability of vitamin B6 products in the wake of mounting safety concerns.
 
Last month, the Therapeutic Goods Administration (TGA) released an interim decision, detailing plans to make products containing 50–200 mg of vitamin B6 pharmacist-only medicines.
 
In making its proposal, the TGA cited its growing concern over the widespread availability of vitamin B6 from a variety of sources, including diet, fortified foods and supplements.
 
This availability has reportedly led to the body receiving 170 reports relating to peripheral neuropathy as a result of vitamin B6 poisoning since 2020.
 
Responding to a call for public consultation on the proposal, a new RACGP submission has described the plan as a ‘positive step’ towards reducing the risk of harm from excessive vitamin B6 intake and improving safety and awareness.
 
However, RACGP President Dr Michael Wright said in the submission that scheduling changes alone will not address the multiple sources through which individuals may be exposed to vitamin B6.
 
‘Many people are unaware these combined sources can lead to excessive cumulative intake and potential health risks,’ he said.
 
‘Clinical deficiency of vitamin B6 is rare, and there is limited evidence supporting supplementation benefits in individuals who are not deficient.’
 
GP Dr Mary Buchanan would also like to see the changes go further.
 
It was five years ago that Dr Buchanan started taking a daily dose of magnesium for pain relief – little did she know this would result in a vitamin B6 toxicity diagnosis.
 
It is a diagnosis that has gone on to impact every aspect of her daily life.
 
‘I’ve had persistent problems with my legs, I was down to walking about 50 metres, now I do a bit more than that and I’m now up to walking about 200 metres,’ she told newsGP.
 
‘It still affects me, and I think now I’m probably the best I’m going to be really.’
 
Dr Buchanan has shared her story widely in hopes no one else will have to go through what she has.
 
She is happy to see the TGA making progress when it comes to vitamin B6 access but thinks there is much more that can be done.
 
‘They should be moving quicker, and they should be doing much more to reduce the amount of vitamin B6 in the tablets,’ Dr Buchanan said.
 
‘The TGA needs to take all this into account – there’s a real problem here and we have to do much more investigation.
 
‘There should be more education, it’s very hard to educate the public but it could come as a notice from the TGA, or something even in the newspaper to say, “be careful”, we need to work out how to get that information up and out there.’
 
In its submission, the RACGP also backed TGA recommendations to further limit customer access to vitamin B6 products, including public education campaigns to raise awareness of overconsumption and a review of the appropriateness of the 10 mg limit for formulated caffeinated beverages.
 
The college has also called for product labels to be overhauled, recommending consistency in ingredient naming on product labels, stronger wording of warning statements, and clarity on the presence of vitamin B6 on products.
 
‘In addition, the RACGP recommends health claims made on vitamin B6-containing products be subject to stronger regulations and permitted only when robust evidence demonstrates the benefits clearly outweigh the potential risks,’ Dr Wright said.
 
In a bid to enhance safety and awareness of vitamin B6 toxicity, the TGA has already moved to strengthen labelling requirements so products containing daily doses over 10 mg must carry a warning about peripheral neuropathy.
 
If the TGA’s latest proposal is upheld following the current public consultation period, the changes will take effect from February 2027, with hundreds of products potentially impacted.
 
The RACGP has labelled this implementation period ‘appropriate’, saying it gives time for the industry and healthcare professionals to prepare for changes and for the TGA to review additional regulatory controls on vitamin B6.
 
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