Supplements containing high levels of vitamin B6 will soon be removed from general sale in Australia following a decision by the Therapeutic Goods Administration (TGA). This move comes after the medicines watchdog received over 100 reports of severe and sometimes permanent health effects linked to these products.
Under the new regulations announced by the TGA on Tuesday, customers will need to consult a pharmacist to purchase oral supplements containing more than 50 milligrams of vitamin B6. Products with less than 50 milligrams will remain available over the counter, while those exceeding 200 milligrams will still require a prescription. The changes will impact approximately 125 products currently on the Australian market, with the new rules set to take effect in June 2027 to allow manufacturers and health practitioners time to adjust product labels and manage stock.
Understanding Vitamin B6 and Its Risks
Vitamin B6 is an essential nutrient found naturally in various meat and plant sources and is commonly added to over-the-counter supplements to support metabolic processes. While most Australians receive adequate amounts of this vitamin through their diet, cases of toxicity due to excessive consumption are on the rise.
In their final decision, the TGA noted that 103 out of 231 submissions to their review were from individuals who experienced severe and sometimes permanent symptoms after taking vitamin B6 supplements. Reported issues included peripheral neuropathy, nerve damage, and muscle weakness, all of which significantly impacted daily life and employment.
“The considerable number of adverse events, difficulties in diagnosis and ensuing hardships on sufferers justify the scheduling restrictions on vitamin B6 medicines available for general sale,” the TGA delegate stated.
Industry Response and Public Concerns
Industry representatives argued that toxicity cases are rare and typically occur in patients consuming higher doses over extended periods. However, reports have emerged of individuals experiencing severe symptoms even with lower doses, including two cases reported to the NSW poisons hotline involving less than 50 milligrams of vitamin B6.
Dominic Noonan-O’Keeffe, the lead plaintiff in a potential class action against wellness giant Blackmores over their B6 supplements, expressed dissatisfaction with the TGA’s decision, which he believes does not adequately protect the public.
“We’re happy that something’s being done at all, but it doesn’t go anywhere near far enough to protect the community,” he said. “They’ve missed the mark.”
There is widespread agreement among submissions that many products containing vitamin B6, including those with magnesium and ashwagandha, lack clear labeling. This has led to cumulative exposure from multiple sources, prompting calls for mandatory front-of-pack statements to notify consumers of the presence and potential risks of vitamin B6.
Regulatory History and Future Implications
Since 2020, the TGA has mandated warning statements on all supplements containing daily doses of more than 50 milligrams of B6. In 2022, the threshold was further lowered to 10 milligrams due to concerns about public awareness regarding the dangers of elevated B6 intake.
The announcement comes as part of a broader effort to ensure consumer safety and informed decision-making in the supplement market. As the industry adapts to these new regulations, consumers are encouraged to remain vigilant and consult healthcare professionals when considering supplement use.
Looking ahead, the TGA’s decision may set a precedent for other countries grappling with similar concerns over supplement safety. As awareness grows, the balance between access to nutritional supplements and consumer protection will continue to be a focal point in public health discussions.
