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Over-the-Counter B6 Supplements Face Class Action as TGA Plans Behind-Counter Controls

Over 300 Australians have reported nerve damage from high-dose B6 supplements as regulators advance plans to require pharmacist approval for dosages above 50mg by 2027.

Overview

  • Polaris Lawyers has received more than 300 inquiries from individuals reporting neurological injuries linked to high-dose B6 products, prompting a class action investigation against Blackmores.
  • The Therapeutic Goods Administration published an interim decision to classify supplements containing over 50mg of vitamin B6 as pharmacist-only medicines, with behind-counter sales set to begin in February 2027 pending final approval.
  • The TGA cited evidence of peripheral neuropathy in people taking less than 50mg of supplemental B6 and noted large inter-individual differences in sensitivity to vitamin toxicity.
  • A 2022 TGA alert logged 174 reports of nerve-damage conditions associated with B6 toxicity and highlighted concerns over under-reporting and unlabeled vitamin content in multi-ingredient supplements.
  • Blackmores asserts that all its B6-containing products meet current TGA requirements and says it will comply fully with any forthcoming regulatory changes.