Australia is set to significantly strengthen its regulation of dietary supplements containing vitamin B6 (pyridoxine) beginning in 2027, following a reclassification by the country’s Therapeutic Goods Administration (TGA). The decision comes amid growing concern over reports of neurological harm linked to long-term, high-dose vitamin B6 supplementation.

Under the new rules, products containing more than 50 mg of vitamin B6 will be restricted to pharmacy-only sales, while supplements containing over 200 mg will require a medical prescription. Currently, many high-dose vitamin B6 products are readily available over the counter, including through online retailers.

Rising Reports of Vitamin B6–Induced Neuropathy

The regulatory change follows a substantial increase in reports of sensorimotor polyneuropathy associated with chronic exposure to high doses of vitamin B6. Affected individuals have described symptoms including numbness, tingling, burning sensations, loss of balance, and muscle weakness. In some cases, symptoms were severe and long-lasting, significantly affecting quality of life.

While vitamin B6 is an essential nutrient involved in amino acid metabolism, neurotransmitter synthesis, and immune function, excessive intake—particularly over extended periods—has been shown to be neurotoxic. Unlike many water-soluble vitamins, pyridoxine can accumulate in the body when consumed at high doses, leading to damage of peripheral nerves.

Dose, Duration, and Individual Susceptibility

Evidence suggests that the risk of neuropathy is strongly linked to both dose and duration of supplementation. Although early safety thresholds assumed that adverse effects occurred only at very high intakes, more recent case reports indicate that neuropathy may develop at moderate doses taken chronically, sometimes below previously accepted upper intake limits.

Individual susceptibility also appears to vary, with some people developing symptoms after months or years of supplementation at doses commonly marketed for fatigue, stress, or nerve health. This variability has complicated risk assessment and reinforced calls for stricter regulatory oversight.

Rationale Behind the TGA’s Decision

The TGA’s reclassification reflects a precautionary approach aimed at protecting consumers from unintended harm. By limiting access to higher-dose products, regulators hope to ensure that individuals using substantial amounts of vitamin B6 do so under professional supervision, with appropriate monitoring for adverse effects.

Pharmacy-only access for products above 50 mg will allow pharmacists to provide counseling on safe use, potential symptoms of toxicity, and interactions with other supplements or medications. Prescription-only status for doses exceeding 200 mg underscores the view that such high intakes should be reserved for clearly defined medical indications.

Implications for Consumers and Healthcare Providers

For consumers, the changes mean increased awareness of the risks associated with high-dose vitamin supplementation and a greater emphasis on informed use. Healthcare providers may also need to more routinely ask patients about supplement use when evaluating unexplained neuropathic symptoms.

Clinicians are encouraged to consider vitamin B6 toxicity in the differential diagnosis of peripheral neuropathy, particularly when common causes such as diabetes, alcohol use, or vitamin B12 deficiency have been excluded.

A Broader Signal on Supplement Safety

Australia’s decision may have broader implications beyond vitamin B6, highlighting growing regulatory scrutiny of dietary supplements that are often perceived as inherently safe. As evidence accumulates linking excessive intake of certain vitamins and minerals to adverse health outcomes, regulators worldwide may adopt similar measures to balance accessibility with safety.

Conclusion

The tightening of vitamin B6 regulations in Australia represents a significant step toward preventing supplement-related neurological harm. While vitamin B6 remains essential for health, this move reinforces the message that more is not always better. Appropriate dosing, professional guidance, and greater public awareness will be key to ensuring that supplementation supports health rather than undermines it.