TGA Implements Tiered Safety Controls for Vitamin B6 Supplements to Combat Nerve Damage Risk
The Therapeutic Goods Administration (TGA) has announced a decision to strengthen safety controls for products containing vitamin B6, aiming to reduce the risk of nerve damage associated with the long-term consumption of high doses.
The decision introduces a new tiered system governing the sale and dispensing of oral vitamin B6 preparations based on their recommended daily dosage. The TGA states that this approach strikes a balance between the benefits of vitamin B6, which some individuals may need for low-dose supplementation, and the recognized risks posed by prolonged ingestion of high doses, which can include damage to peripheral nerves.
New Dosage Controls Detailed
Under the new regulatory framework, access to vitamin B6 products will be determined by concentration:
- General Retail Sale: Oral preparations containing 50 mg or less per recommended daily dose will continue to be available for general retail sale.
- Pharmacist Advice Required: Oral preparations containing more than 50 mg but not more than 200 mg per recommended daily dose will be available over the counter, but only with the advice of a pharmacist.
- Prescription Required: Oral preparations containing more than 200 mg per recommended daily dose will continue to require a prescription from a doctor.
The strengthening of these safety controls follows the TGA’s final decision to amend the Poisons Standard for vitamin B6. This decision was based on an extensive review process, including a public consultation that demonstrated strong support for tighter controls.
Implementation Timeline and Rationale
The changes in vitamin B6 content requirements are scheduled for implementation on 1 June 2027. This extended timeframe is intended to provide industry, healthcare practitioners, and businesses sufficient time to enact the necessary modifications, including updating product labelling and managing existing stock.
While vitamin B6 deficiency is uncommon among the Australian population (the recommended dietary intake for a healthy adult is 1.3-1.7 mg/day), deficiency is more likely to affect certain groups, such as the elderly, individuals with alcohol dependence or obesity, or those with specific kidney, liver, or autoimmune conditions. The average adult requirement for vitamin B6 is 1.1-1.3 mg per day.
Consumers should always check the label of any vitamin or supplement product for vitamin B6, which is also referred to as pyridoxine, pyridoxamine, and pyridoxal. The TGA urges consumers who experience concerning symptoms, specifically tingling, burning or numbness in their hands or feet, to stop taking the product immediately and seek medical advice as soon as possible. Consumers are also encouraged to talk to a registered healthcare professional about appropriate treatment and can report any side effects to the TGA via the Adverse Event Reporting System to help improve medicine safety.
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