Media Release: 3 July 2025
The Australian Traditional-Medicine Society (ATMS) acknowledges the Therapeutic Goods Administration’s (TGA) interim decision to review and reclassify supplements containing high doses of vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine), in response to concerns about toxicity and potential nerve damage.
Peripheral neuropathy is associated with high doses of vitamin B6 (above 100 mg/day) taken over a prolonged period of time, and symptoms generally improve after discontinuation. 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 the large volume of sales.
As Australia’s largest professional association for complementary medicine practitioners, ATMS is committed to ensuring public safety, practitioner excellence, and informed access to natural health care. The findings regarding peripheral neuropathy associated with prolonged or high-dose vitamin B6 use are a timely reminder of the importance of professional guidance when using therapeutic supplements.
ATMS’s position on the TGA’s Interim decision in relation to pyridoxine, pyridoxal, or pyridoxamine:
Under the proposal, human therapeutic preparations containing between 5 mg and 200 mg of pyridoxine, pyridoxal or pyridoxamine would be included in a new Pharmacist Only Medicine (Schedule 3) entry.
- ATMS does not support this proposal as this will restrict complementary medicines to containing less than 5 mg (i.e., 4.99 mg) per daily dose. This, in turn, affects the standard of treatment offered by qualified, accredited health practitioners and the availability of TGA-listed complementary medicines. This may lead to the public purchasing products from overseas that contain higher doses and that have not undergone rigorous quality assurance tests as required by the Good Manufacturing Practice (GMP) guidelines or the various legislative instruments and therapeutic goods orders.
Schedule 4 – Amend entry
PYRIDOXINE, PYRIDOXAL OR PYRIDOXAMINE for human therapeutic use except:
(a) when included in Schedule 3; or
(b) in oral preparations containing 50 mg or less of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose.
- ATMS does not support the interim decision to amend Schedule 4
Schedule 3 – New Entry
PYRIDOXINE, PYRIDOXAL OR PYRIDOXAMINE for human therapeutic use in oral preparations containing more than 50 mg but less than 200 mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose.
- ATMS does not support the interim decision to create a new entry in Schedule 3.
- Instead, ATMS recommends the following for adults greater than 18 years of age:
- Where oral preparations contain less than 50 mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose, the preparation is classified as a listed medicine. It is available to the public without a consultation with a qualified accredited health practitioner.
- Where oral preparations contain more than 50 mg but less than 100 mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose, the listed medicine is classified as a practitioner-only listed medicine, whereby a person must consult with a qualified accredited health practitioner to obtain the listed medicine.
- Where oral preparations contain between 100 and 200 mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose, they are considered registered complementary medicines and are available under Schedule 4.
It is important to note that many Australians benefit from targeted supplementation, especially under the care of qualified natural medicine practitioners, such as naturopaths, nutritionists, and herbalists, who are highly trained to assess individual needs, identify potential interactions, and recommend appropriate, evidence-informed dosing strategies.
To ensure you are receiving advice from a properly accredited professional, consult a practitioner listed on the ATMS ‘Find a Practitioner’ directory: www.atms.com.au/find-a-practitioner.
ATMS continues to advocate for:
- Stronger public education on the safe use of complementary medicines,
- Clear and consistent product labelling to support health literacy, and
- Recognition of the vital role qualified accredited natural medicine practitioners play in guiding safe and effective use of supplements.
We remain committed to working with regulators, industry partners, and our professional members to ensure complementary medicine continues to serve the Australian public with safety, integrity, and professionalism.
For media enquiries or more information, please contact:
Annie Gibbins
Chief Executive Officer
Australian Traditional Medicine Society
Email: ceo@atms.com.au
Website: www.atms.com.au
