The affected vitamin B6 supplements have a recommended daily dosage (RDD) of more than 50mg.
As “pharmacist-only” medicines, these products would be regulated as Schedule 3 products and would only be available over-the-counter upon pharmacist advice.
The Therapeutic Goods Administration (TGA) proposed the above in its report titled “Notice of interim decision to amend (or not amend) the current Poisons Standard in relation to pyridoxine, pyridoxal or pyridoxamine (vitamin B6)”.
The interim decision is now open for public feedback which closes on July 27.
Currently, vitamin B6 dietary supplements freely available to consumers without any professional guidance or oversight can contain a RDD of up to 200mg.
“Almost 80% of these products provide a dose of more than 2 mg/day, which is above the RDI for pyridoxine, pyridoxal or pyridoxamine,” said the TGA in the notice.
Pyridoxine, pyridoxal and pyridoxamine are different forms of vitamin B6.
Concerns
The stricter control is in response to reports of peripheral neuropathy arising from high dose vitamin B6 consumption.
“A pharmacist-consumer 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 benefits of involving a health-care professional in the decision to take dietary supplements should be encouraged where there are associated risks from use.
“Several European regulatory agencies advise taking no more than 10 mg/day of vitamin B6 except under medical advice,” said the TGA in the notice.
Over 100 products - equivalent to 7% of vitamin B6 only formulations - would be affected by this development.
“The scheduling changes will impact more than 100 preparations currently listed in the ARTG (Australian Register of Therapeutic Goods) that provide more than 50 mg per RDD of vitamin B6 (excludes medicines containing vitamin B6 in combination with other active ingredients such as multivitamins) which accounts for 7% of the vitamin B6 only preparations,” said the TGA.
Affected manufacturers would need to decide if they want to reformulate the level of vitamin B6 in their products to be 50 mg or below, or phase them out of the market.
They can also continue manufacturing vitamin B6 with RDD exceeding 50mg. However, these products would need to be registered with the TGA and have to undergo pre-market evaluation.
“Studies on the efficacy and reformulation of some these products may also be required,” the TGA added.
The TGA has proposed a transition period of 18 months before the regulation is implemented on 1 February, 2027.
CMA: A higher threshold would be appropriate
Complementary Medicines Australia (CMA), the association representing Australia’s dietary supplements or complementary medicines industry, believes that a higher threshold would be appropriate.
Prior to the release of the interim notice, the TGA had considered to make vitamin B6 with RDD of over 5mg as ‘pharmacist only’ medicines in response to a proposal by a private applicant.
The CMA said it had strongly opposed the proposal, arguing that the restrictive measure was not supposed by available evidence.
Furthermore, a greater number of vitamin B6 supplements - approximately 1,500 - would be affected if the permitted RDD for vitamin B6 supplements was set at 5mg and below.
“If adopted, this would have severely limited access to a broad range of multivitamins, magnesium supplements and other common complementary medicine formulations – creating major disruptions across the supply chain and restricted access for consumers.
“Pharmacists would also face significant and onerous new requirements for supply, storage and staff training.
“CMA strongly opposed the proposal, arguing that the available evidence did not justify such a restrictive measure and that the proposal was disproportionate to the risk,” it said in its Regulatory Outcomes Report 2025 published late last month.
While it has helped increase the RDD limit to more than 5mg as seen in TGA’s interim notice, it believes a higher threshold would still be appropriate.
“Due to ongoing advocacy, we have helped achieve an interim decision with a significantly higher scheduling threshold than 5mg, and a more proportionate regulatory approach that will only impact a handful of medicines (rather than the over 1500 originally anticipated).
“However, we maintain that a higher threshold would still be appropriate,” it said.
