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TGA Tightens Access to High-Dose Vitamin B6 With Tiered Controls Starting 2027

The move seeks to cut peripheral nerve injuries from prolonged high doses by steering stronger formulations to clinical oversight.

Overview

  • Products at 50 mg or less per recommended daily dose will remain in general retail, 50–200 mg will require pharmacist advice, and doses above 200 mg will need a prescription.
  • The changes take effect on June 1, 2027 and will apply to roughly 125 products currently on the Australian market.
  • The decision follows an amendment to the Poisons Standard after a safety review and public consultation that included more than 100 reports of severe adverse effects.
  • Regulators are targeting cases of peripheral neuropathy linked to sustained high intake, as toxicity reports rise while deficiency in the general population remains uncommon.
  • Consumers are urged to check labels for vitamin B6 (pyridoxine, pyridoxamine, pyridoxal), stop use and seek medical advice if tingling or numbness occurs, and report side effects to the TGA.