Nov 2025 Update by Warren Maginn, ANTA Clinical Nutrition Branch Chair
Following my previous discussion (which can be read below) regarding the TGA’s initial interim report on Vitamin B6, the TGA has just released their Final Report (ahead of schedule).
In short, after completing their extensive review, the TGA has opted to maintain their original interim decision (to keep all listed medicines which deliver 50 mg or less of any form of Vitamin B6 in their labelled daily dose, as unscheduled medicines).
This means that the vast majority of high potency clinical (practitioner-only) supplements containing Vitamin B6 remain available to natural medicine practitioners to prescribe.
Note: While a Natural Medicine practitioner trained in Clinical Nutrition may technically still be able to prescribe an even higher dose than this limit allowed on labels (i.e. by prescribing a greater number of capsules than the label states), given the extent of recent research into the risks of doing so among certain sensitive individuals, a practitioner would need to have very strong clinical rationale to do this, and have taken all reasonable steps to qualify the patient as not being within an at-risk group, along with frequent and diligent monitoring during the course of treatment.
Especially since the TGA made an additional determination that all medicines formulated and labelled to deliver higher doses (50–200 mg per day) should be classified as S3 Pharmacist-Only medications, and S4 Prescription-Only medications if over 200 mg (for which certain clinical needs do occasionally exist).
Keeping in mind that the Vitamin B6 Tolerable Upper Intake Level established by the NIH for adults is 100 mg.
This TGA decision appears to appropriately balance the rights and needs of the Australian public to broadly access important nutritional medicines for their specific health needs, while also providing some reasonable safeguards against extreme excesses that may occur in certain situations.
Please re-review the list of recommendations I provided in my original commentary below on how practitioners should navigate their use of Vitamin B6 containing products in clinical practice going forward.
You can read the TGA Delegate’s full final rationale on this review here:
https://www.tga.gov.au/sites/default/files/2025-11/notice-final-decision-to-amend-current-poisons-standard-pyridoxine-pyridoxa-pyridoxamine-vitamin-b6.pdf
Update from 24th July 2025
Dear ANTA Member,
I would like to provide an update on the recent media discussions surrounding Vitamin B6 regulation in Australia, and provide some explanations that may be helpful to all health practitioners seeking to better understand this important topic (especially those who prescribe supplements that contain Vitamin B6).
1. The TGA Interim Decision
Firstly, the recent interim decision from the TGA is (as the name suggests) not yet a final decision. However, it is the result of many months of evaluation into the safety of Vitamin B6 (consulting a wide variety of stakeholders and data sources), and can be read here
2. The Issue
This safety review was triggered by a growing awareness of the adverse events being reported by certain individuals taking supplements that contain Vitamin B6 (most notably symptoms of peripheral neuropathy).
See the symptoms of peripheral neuropathy here
These symptoms may have many explanations and causes, however they are of concern because they can involve damage to nerves that is significantly impairing, and quite long lived (especially when allowed to accumulate).
3. The Form Matters
While it has long been known that excessive doses of Vitamin B6 can cause this neuronal damage, it should also be noted that peripheral neuropathy is also well known to be caused by Vitamin B6 deficiency too (since nerves require Vitamin B6 to function), and not all forms of B6 have been equally implicated in this.
A 2017 study by Vrolijk et. al. compared the nerve damage potential of each of the main forms of Vitamin B6 (Pyridoxine, Pyridoxamine, and the most biologically active form Pyridoxal-5-Phosphate (P5P)) and found that only the Pyridoxine form caused cell death, whereas the other forms did not.
Interestingly, they found that one of key mechanisms behind this damage may be brought about by Pyridoxine (inactive B6) obstructing the utilisation of Pyridoxal-5-Phosphate (active B6). Which counter-intuitively suggests that some cases of peripheral neuropathy resulting from excessive Pyridoxine supplementation could in fact be facilitating a form of induced functional Vitamin B6 deficiency.
See the details of the study here
Therefore, while Pyridoxine is often described as being converted to Pyridoxal forms in the body, supplementing excessive amounts of Pyridoxine may exceed the body’s ability to convert and utilise vitamin B6 effectively.
It remains unclear what differing risks exist between the different B6 forms when taken orally (due to their differing metabolic pathways). However it has been suggested that supplementing Pyridoxal forms may present a lower risk than Pyridoxine forms.
4. Previous TGA Efforts
For decades the TGA has made little distinction between the B6 forms when requiring warnings about the risks of nerve damage on the labels of products that contain any form of vitamin B6.
Although, in 2022, in attempt to increase awareness, the TGA tightened labelling regulations to include a warning about the risks of peripheral neuropathy on the packaging of products that contain any form of Vitamin B6 equivalent to more than 10 mg of Pyridoxine per day.
This includes products that contain P5P (which are still typically calculated to have an equivalent amount of Pyridoxine – even though they do not contain free Pyridoxine).
5. What Changed?
Previously, only very high intakes of B6 (greater than 200 mg/day), taken over a long period of time, were considered capable of causing peripheral neuropathy.
However more recent research in Europe found that doses as low as 50 mg or even less may also bring about neuropathy in some very sensitive individuals. More research is needed to better understand what makes these individuals so sensitive to Vitamin B6.
Following their interim review the TGA has rejected the initial proposals to lower the allowable amount of Vitamin B6 in listed medicines to levels as low as 10 mg or even 5 mg, citing that this low level would remove over 1500 medicines from availability to those in the general public that need them.
A TGA spokesperson further asserted that many of the individuals involved in the adverse events that lead to the safety review would likely still have experienced issues with Vitamin B6 supplementation even at the proposed lower levels (and the full causes of their complications have not yet been fully elucidated, since multiple unique circumstances may be involved).
As a result, the recently publicised interim decision from the TGA allows listed medicines to contain up to 50mg of Vitamin B6 (in any form). Any greater doses will require either pharmacist dispensing (between 50-200 mg) and a doctors’ prescription for doses beyond 200 mg.
This means the TGA currently considers doses below 50 mg to be low risk in the general population.
6. What Further Changes Are Ahead?
The TGA will finalise their decisions around these regulations in the coming months (by February 2026).
During this time it is likely that various stakeholders will be active in various forms of media, proposing further amendments to this decision.
7. So What Does This Mean For Healthcare Practitioners?
- Should you avoid prescribing products containing vitamin B6?
Not if the patient can reasonably benefit from the presence of vitamin B6 as a supportive cofactor in the pursuit of any health or clinical treatment goals (especially when using the active Pyridoxal form). - However, caution is still advised around products that contain unnecessary amounts of B6 (especially products that contain the Pyridoxine form).
- Particular care should be taken to avoid excessive overlap between multiple products being taken at the same time. (avoid combination products that include unnecessary doses of ingredients not intended for supplementation)
- Always choose doses consciously, and aim for the lowest effective dose.
- Ensure you have sufficient training to identify when higher doses are warranted.
- Ensure it is within your scope of practice to prescribe doses higher than those instructed on the product label for any medicine.
- Ensure you are taking thorough medicine evaluations in your consultations. It is always important to find out everything your patient is taking (including any products you might have not prescribed).
- Advise patients of the risks and warning signs to look out for.
(Prompt cessation when issues emerge has been shown to limit complications and speed recovery) - Always provide your patients with clear prescription instructions, which includes a specific duration period before re-evaluation is required (so that patients do not take medicines for longer than necessary, or beyond suitable intervals to reconfirm safety and efficacy).
- Record all of these details clearly in your case notes.
Conclusion
Even though the TGA recently stated that “cases of peripheral neuropathy are rare, particularly at dosages below 50 mg/day, and the risk is negligible when compared to the number of products available and large volume of sales”, you should always remain vigilant to any adverse events arising from any medicine your patient is taking.
I hope this helps you navigate this slightly complex topic with greater clarity and confidence.
As an ANTA member, we will continue to keep you informed of the most notable changes to relevant regulations and practice guidelines, so you can adapt your practice accordingly.
Stay tuned.
To your best practice.
Warren Maginn
ANTA Clinical Nutrition Branch Chair