TGA Interim Decision on Changes to Vitamin B6 (Pyridoxine) in Australia

What you need to know

The Therapeutic Goods Administration (TGA) is the Australian authority responsible for regulating medicines, including vitamins and supplements, to ensure public safety. You may have seen the media coverage recently, when the TGA released its interim decision regarding changes to the regulation of Vitamin B6 (also known as pyridoxine) in Australia.

As medicine experts, ask your pharmacist if you have any questions or concerns.

Here is what you need to know as a consumer:

What is Vitamin B6

Vitamin B6 is an essential nutrient involved in many bodily functions, including metabolism, brain function, and immune response.

Vitamin B6 is known by several names, including Pyridoxine, Pyridoxal, Pyridoxamine, Pyridoxine hydrochloride (often abbreviated as pyridoxine HCl).

Naturally, B6 is found in foods such as poultry, fish, potatoes, chickpeas, bananas, and fortified cereals. Vitamin B6 is also present in a wide array of products, such as:

  • Multivitamin supplements
  • B-complex vitamins
  • Energy drinks and fortified beverages
  • Protein powders and meal replacement products
  • Some cold and flu remedies
  • Prescription medications containing B6, often used to treat certain deficiencies or

Australians generally get enough key nutrients in their diet so clinical deficiency of vitamin B6 in Australia is rare. Vitamin B6 deficiency is usually caused by medicines that make B6 inactive in our bodies (such as isoniazid, a medicine used to treat Tuberculosis), protein-energy undernutrition (not getting enough protein in the diet), malabsorption from the gut (where B6 is not taken into our body and remains in the gut so it is ineffective), alcohol use disorder, impaired renal/kidney function or autoimmune diseases.

Vitamin B6 is water-soluble, so excess amounts are usually excreted in urine, but ongoing high intakes (usually from supplements) can accumulate and cause harm.

Taking a natural medicine does not mean it is totally safe – ask your pharmacist.

Reason for the TGA Review

While Vitamin B6 is essential for health, taking too much can lead to toxicity, particularly when consumed in high doses for extended periods. The most notable risk is peripheral neuropathy —damage to the nerves in the arms and legs, which may cause numbness, tingling, or even irreversible nerve damage. Other side effects can include sensitivity to sunlight, skin lesions, gastrointestinal issues, and, in rare cases, neurological disorders

Concerns were raised about the safety of high-dose Vitamin B6 supplements, as excessive intake over time has been linked to adverse health effects, particularly nerve damage (peripheral neuropathy). With increasing reports of such side effects, the TGA initiated a review to consider if stricter controls are needed.

Key Points of the Interim Decision

  • The TGA proposes to lower the maximum daily dose of Vitamin B6 available in over-the-counter supplements to reduce the risk of toxicity.
  • The interim decision recommends enhanced warning statements on labels of products containing higher doses of Vitamin B6, to alert consumers to the potential risk of nerve damage if taken in excess or for prolonged periods.
  • Products containing doses above the revised limit may become pharmacist-only or prescription-only, meaning consumers would need to consult a doctor or pharmacist before purchase.
  • The TGA plans to implement a transition period, allowing manufacturers and retailers time to update packaging and comply with new requirements.

What This Means for You

As a consumer, it is important to:

  • Check the dosage of Vitamin B6 in any supplements and other products (see list above) that you
  • Be aware of the symptoms of Vitamin B6 toxicity, such as tingling, numbness, or weakness in the hands and
  • Consult your pharmacist or healthcare professional before taking high-dose Vitamin B6 supplements or if you have concerns about your vitamin intake.

Next Steps

In summary, the TGA’s proposed changes are aimed at protecting consumers from the possible long-term risks associated with excessive Vitamin B6 intake, while still ensuring access to essential vitamins for general health.

The TGA’s interim decision is followed by a public consultation, after which a final decision will be made.

Ask your pharmacist who will keep you informed as this process progresses.

As medicine experts, ask your pharmacist if you have any questions or concerns. 

Reference:

https://www.tga.gov.au/sites/default/files/2025-06/notice-interim-decision-amend-or-not-amend-current-poisons-standard-pyridoxine-pyridoxal- pyridoxamine-vitaminb6.pdf