New proposed TGA regulations for Vitamin B6

The Australian Therapeutic Goods Administration (TGA) is proposing new regulations for vitamin B6 supplements in response to a rise in reported cases of peripheral neuropathy, a form of nerve damage. While vitamin B6 is essential for health, excessive intake can lead to toxicity, which is the primary concern driving these changes.

Key Points of the Proposed Changes

• Supplements (Listed Medicines): The maximum daily dose would be limited to 50 mg per day.

• Pharmacy-Only Medicines: Supplements with a daily dose of 50-200 mg would become "pharmacist-only" (Schedule 3), meaning they would require a consultation with a pharmacist before purchase.

• Prescription-Only: Doses of 200 mg or more per day would require a doctor's prescription.

These changes are an interim decision by the TGA, and the final decision will be made after a period of public consultation. The proposed changes are expected to take effect in February 2027 if upheld.

The "Sneaky B6" Problem

One of the main issues the TGA is addressing is that people are unknowingly consuming high amounts of vitamin B6 from multiple sources. It is not just found in multivitamins but is also a common ingredient in:

• Protein powders

• Energy drinks

• Fortified cereals

• PMS, stress and sleep formulas

• Cold and flu remedies

This can lead to a cumulative daily intake that far exceeds the recommended levels, even when each individual product seems to have a safe dose.

The Science Behind B6 Toxicity

Peripheral neuropathy is the most common symptom of B6 toxicity (and deficiency). It is characterised by tingling, numbness, pain, and weakness, typically in the hands and feet. While it can be caused by various factors like diabetes and other medical conditions, it is a known side effect of excessive vitamin B6 intake, especially at doses over 500 mg per day for extended periods. There are, however, reports of toxicity occurring at doses lower than 200 mg, particularly when people are combining multiple products. The good news is that these symptoms are often reversible once supplementation is stopped.

A Practical Action Plan

To ensure you are using supplements safely, it is recommended to:

• Know what to look for on the label: Carefully check the labels of all products you consume, not just multivitamins, for any of the following names:

  • Vitamin B6

  • Pyridoxine

  • Pyridoxal

  • Pyridoxamine

• Add it up: Add up the total daily intake of vitamin B6 from all sources. If it is approaching or exceeding 50 mg, you should consider reducing your intake.

• Know the Warning Signs: If you experience symptoms like tingling, numbness, or weakness in your hands or feet, stop taking B6 supplements and consult your practitioner.

• Consult a Practitioner: Always inform your doctor, naturopath, or nutritionist about all supplements you are taking, including seemingly minor ones like protein powders or energy drinks. They can help you assess your total intake and ensure you are not at risk.

The TGA's proposed changes highlight the importance of treating supplements with the same care and consideration as prescription medications. The goal is to maximise the health benefits of supplements while minimising the risks associated with overuse.