SUPPLEMENTS containing 50-200mg of vitamin B6 are proposed to be included in Schedule 3, the Therapeutic Goods Administration (TGA) has advised.
Supplements containing more than 200mg are to remain S4.
The interim decision follows an application to amend the Poisons Standard entry of vitamin B6 based on increasing reports of people experiencing nerve damage as a result of excessive intake of the vitamin (PD 05 Jun).
In handing down the interim decision, the unnamed delegate to the Secretary of the Department of Health, Disability and Ageing noted that it balances the limited benefits of supplemental vitamin B6 and its extensive use in listed medicines and fortified foods and beverages, against the risks of risks of peripheral neuropathy, including irreversible adverse effects.
The decision also took into account uncertainty about the total amount of vitamin B6 people consume and the current burden on consumers to calculate their total daily intake.
This is exacerbated by the different ingredient names used in labelling, which is inconsistent and confusing for consumers - pyridoxine,pyridoxine hydrochloride, pyridoxal 5-phosphate, and pyridoxal 5-phosphate monohydrate are used and not always described as vitamin B6.
In making products containing more than 50mg of vitamin B6 subject to discussion with a pharmacist, the "consultation can significantly help consumers in safe use of these supplements, including the difficulties of consumers determining their daily dosage, and reduce the risks from overuse, including potentially irreversible peripheral neuropathy", the delegated noted.
"The benefits of involving a healthcare professional in the decision to take dietary supplements should be encouraged where there are associated risks from use," they added.
The delegate considered that the original proposal to make supplements ranging from 5-200mg Schedule 3 was not supported in the literature and would impact more than 1,500 listed medicines, "imposing an immense regulatory burden for sponsors and pharmacies".
Meanwhile, the Advisory Committee on Medicines Scheduling argued in favour of the current scheduling, where only those supplements over 200mg are subject to increased oversight, which the delegate argued was unsatisfactory.
The proposed implementation date of the new scheduling is 01 Feb 2027.
The interim decision is open to comment until 27 Jul 2025 - see HERE for more. KB
The above article was sent to subscribers in Pharmacy Daily's issue from 30 Jun 25
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 30 Jun 25
