TGA Introduces Stricter Controls on Vitamin B6 Products
26 Nov 2025
From June 2027, products with a recommended daily dose of 50–200 mg of vitamin B6 will only be available over the counter with advice from a pharmacist. Products exceeding 200 mg per day will remain prescription-only, while those under 50 mg can still be sold at general retail outlets.
The TGA’s decision comes after reports of 250 neuropathy-related adverse events linked to B6 supplements, with 208 cases reported since January 2023. Some individuals experienced nerve damage even at doses of 50 mg or lower. The regulator highlighted that the cumulative effects of B6 from multiple supplements can contribute to toxicity.
To raise awareness, the TGA plans to run a public education campaign explaining the risks associated with excessive B6 intake and multiple sources of the vitamin, including supplements, energy drinks, and weight-loss products.
Hobart GP and accredited dietitian Dr Sarah Edwards welcomed the move, describing it as “a long time coming.” She shared a patient case where chronic use of supplements containing B6 led to elevated levels and peripheral neuropathy, with some lasting nerve damage despite symptom improvement.
The TGA noted that over 125 products currently contain between 50–200 mg of B6 per maximum daily dose, most of them complementary medicines. Vitamin B6 deficiency is uncommon in Australia, with recommended daily intakes for healthy adults ranging from 1.3–1.7 mg. The tolerable upper limit is currently set at 50 mg/day for adults, a figure under review by the National Health and Medical Research Council (NHMRC), with results expected in early 2027.
While testing for B6 levels is not required for asymptomatic patients, Dr Edwards advises clinicians to educate supplement users about the risks of excessive intake and to reduce unnecessary products.
The TGA first strengthened warnings in 2022, requiring labels on products exceeding 10 mg/day to include information about peripheral neuropathy. The RACGP supports the new scheduling changes and calls for stronger regulation of health claims on B6 products, ensuring benefits outweigh potential risks.
RACGP President Dr Michael Wright said the tighter controls are “welcome news,” highlighting the importance of recognising and preventing this increasingly common form of nerve damage.
Source: Therapeutic Goods Administration (TGA), newsGP
