Currently, vitamin B6 products providing more than 10 mg equivalent pyridoxine per day must warn consumers to stop taking the products and see a healthcare practitioner if they experience tingling, burning or numbness.
The regulator is now proposing to tighten warning statements as part of its wider regulatory oversight for vitamin B6. This follows its decision to mandate that, from June 2027, all vitamin B6 supplements with a recommended daily dose of over 50 mg and up to 200 mg or less be classified as ‘pharmacist-only’ (Schedule 3) products from June 2027.
The TGA has proposed three options for strengthening the warning statements of vitamin B6 supplements and has opened a public consultation, which closes on Nov. 25.
Affected products are those containing vitamin B6 in the form of pyridoxine hydrochloride, pyridoxal 5-phosphate monohydrate and pyridoxal 5-phosphate.
A nine-month transition period will be granted from June 1, 2027 to help manufacturers comply with the new warning statement requirements.
The three proposals
One of the TGA’s proposals is to lower the dose threshold at which vitamin B6 supplements must carry a warning statement.
Currently, the requirement applies only to products providing more than 10 mg per day of pyridoxine require a warning statement. The TGA is proposing to reduce this threshold to 2 mg, a change that would affect an estimated 505 products.
“The proposed threshold is intended to capture medicines that contribute to supplemental vitamin B6 at amounts above typical dietary requirements and that may be relevant to cumulative intake,” the TGA explained in the proposal.
The second proposal is to add a warning that vitamin B6 may cause nerve damage.
As of Sept 18, 2026, the TGA’s Database of Adverse Event Notifications (DAEN) has 333 reports of peripheral neuropathy and related neuropathy and polyneuropathies for products containing vitamin B6.
The third proposal would require a standardized warning statement on the main label of all supplements containing vitamin B6—whether single-ingredient or multi-ingredient products.
The statement will also specify the amount of vitamin B6 per dose and provide precautionary advice relating to the concurrent use of multiple vitamin B6-containing products.
The proposed standardized warning statement would read: “This medicine contains X mg (expressed as pyridoxine equivalents) vitamin B6 per [dosage unit]. Consult your healthcare practitioner if taking more than one product containing vitamin B6 and/or if using for longer than one month.”
This change would affect approximately 1,373 products.
Stricter warnings to deter high-risk purchasing behavior
The TGA said stricter warnings were needed to deter consumer tendency to buy large volumes of vitamin B6 products with doses above the recommended intake.
Citing a recent study published in the Internal Medicine Journal this July, the TGA noted that high-risk vitamin B6 purchasing behaviors were widespread, including cumulative exposure from multiple lower-dose vitamin B6 products.
“The authors concluded that these patterns may not be fully addressed by implementation of the Schedule 3 changes and highlighted the need for strengthened risk communication and improved consumer awareness, noting that regulatory reform alone is unlikely to adequately mitigate high-risk vitamin B6 use in Australia,” the regulator stated in the proposal.
The study used sales data collected from market research firm IQVIA Consumer Health Basket Database between Aug. 2022 and July 2025. It reported that 20.3 million products with a maximum recommended daily intake (RDI) dose of 5 mg and above of total equivalent pyridoxine were purchased during the three-year period.
Of these, over half of the products purchased (11 million) contain dosages ranging from 10 to 49 mg.
Most products (29.06%) purchased provide a daily dosage of 5 to 9 mg, followed by 10 to 24 mg (26.26%) and 25 to 49 mg (27.94%). The remaining 16.75% of products purchased had a maximum daily dosage of 50 mg and above.
Specifying the vitamin B6 dose in the warning statement could help consumers identify products that contribute to their total vitamin B6 intake.
“Applying this statement to all vitamin B6-containing medicines, regardless of dose, is intended to improve visibility of vitamin B6 at the point of selection and use, and to assist consumers in identifying products that contribute to their total vitamin B6 intake,” the TGA stated.
