Pharmacy Daily | TGA acts to restrict B6 with new S3 category

THE Therapeutic Goods Administration (TGA) has announced its decision to strengthen safety controls for products containing vitamin B6, with the aim of reducing the risk of nerve damage associated with the long-term consumption of high doses (PD 05 Jun).

Products with low doses of vitamin B6 (50mg or less) will continue to be available for general sale, while products containing higher doses will require advice from a pharmacist or a prescription from a doctor, depending on the dose.

A new Schedule 3 category will apply to oral preparations containing more than 50mg but not more than 200mg per recommended daily dose, which will be available over the counter with the advice of a pharmacist.

Oral preparations containing more than 200mg per daily dose will continue to require a prescription (S4).

The Poisons Standard for vitamin B6 has been amended accordingly.

"The decision strikes a balance between the benefits of vitamin B6, where some people may need low-dose supplementation, and the risks of prolonged ingestion of high doses, which can include damage to peripheral nerves," said a TGA spokesperson, noting that deficiency is uncommon among the Australian population.

The final decision is a confirmation of the interim decision, which was opened to public comment in Jun (PD 30 Jun).

Around half of the submissions supported the proposed changes, while the rest said they were either too strict or not strict enough.

In handing down the final decision, the delegate to the Secretary of the Department of Health, Disability and Ageing noted that some submissions argued for products containing 50-200mg to be classified as S2 Pharmacy medicine.

However, the delegate said they remained "concerned that the widespread availability of vitamin B6 through multiple sources classifying high-dose vitamin B6 products as Pharmacy medicines will continue to pose risks to the consumer as professional advice is not required to be provided at the point of sale".

"For those in clinical need of vitamin B6 supplementation, high-dose preparations will still be available with pharmacist consultation or a prescription," they added.

At the moment there at least 125 medicines providing 50-200mg vitamin B6, of which 116 are listed complementary medicines.

"To continue to be available on the Australian market, these medicines will need to be registered on the Australian Register of Therapeutic Goods and their labels updated," the delegate noted.

The changes in vitamin B6 content will be implemented on 01 Jun 2027, allowing stakeholders time to enact changes and manage stock.

Read the final decision HERE. KB