Audience: Clinicians. Published 13 November 2026 (AEDT). TGA consultation open 14 October to 25 November 2026.
The TGA is consulting on amendments to the Permissible Ingredients Determination for listed medicines containing pyridoxine hydrochloride, pyridoxal 5-phosphate or pyridoxal 5-phosphate monohydrate, following the final scheduling decision that makes oral preparations providing more than 50 mg and up to 200 mg pyridoxine per day Schedule 3 from 1 June 2027.
Proposed changes
- Standardised main-label statement on all B6-containing listed medicines: amount per dosage unit as pyridoxine equivalents, and advice to consult a practitioner if using more than one B6 product or for longer than one month.
- Strengthened warning (“Vitamin B6 may cause nerve damage…”), with the threshold lowered from more than 10 mg to more than 2 mg pyridoxine per day.
- Listed B6 products not to be directed for infants under 12 months; 14–18 year age band wording clarified.
- Adult maximum daily dose for listed medicines falls from 100 mg to 50 mg from 1 June 2027 (already decided). Proposed label transition runs to 1 March 2028.
Evidence cited by the TGA
The TGA reviewed 112 adverse event reports (1 January 2024 to 29 April 2026) of elevated B6 levels or neuropathy-type symptoms with latency data. Onset was under one month in 10 (9%) and beyond 12 months in 74 (66%). Of 20 early-onset cases with an established dose (range 21–100 mg/day), 18 involved doses at or below 50 mg/day. The DAEN recorded 250 neuropathy-related reports for B6-containing products as at 31 October 2025.
Practical implications
When assessing paraesthesia or sensory neuropathy, ask about every supplement, including multi-ingredient products where B6 may be listed only by its chemical name. The TGA’s data suggest cumulative and longer-term exposure at doses below 50 mg/day is relevant, so the Schedule 3 change alone may not capture at-risk use.
Limitations
Proposals are not final. Spontaneous reports cannot establish incidence or causality and dose data were incomplete. NHMRC nutrient reference values for B6 are under revision, so the 2 mg threshold may be adjusted.
Prepared with AI assistance from the linked official sources; not individually reviewed by a clinician. General information only, not individual medical advice.
Sources
TGA: Consultation on vitamin B6 changes to permissible ingredients (accessed 13 November 2026, AEDT).
TGA consultation paper, Version 1.0, October 2026 (accessed 13 November 2026, AEDT).