Supplements containing high levels of vitamin B6 are set to be removed from general sale in Australia following a decision by the Therapeutic Goods Administration (TGA). The move comes after the TGA received over 100 reports of severe and sometimes permanent health effects linked to these products.
Under the new regulations announced on Tuesday, consumers will need to consult a pharmacist to purchase oral supplements containing more than 50 milligrams of vitamin B6. Products with less than this amount will remain available over the counter, while those exceeding 200 milligrams will still require a prescription.
Regulatory Changes and Market Impact
The changes, which will affect approximately 125 products currently available in Australia, are not slated to take effect until June 2027. This delay is intended to allow manufacturers and healthcare providers ample time to update product labels and manage existing stock.
Vitamin B6, an essential nutrient found naturally in various foods and commonly added to supplements, plays a crucial role in the metabolic process. Despite its importance, most Australians obtain sufficient amounts through their diet, making deficiency rare. However, cases of toxicity due to excessive intake are on the rise.
Health Risks and Consumer Safety
In its final decision, the TGA highlighted that 103 out of 231 submissions to their review were from individuals who experienced severe symptoms after consuming B6 supplements. These symptoms included peripheral neuropathy, nerve damage, and muscle weakness, significantly impacting 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.
While industry submissions argued that toxicity cases are rare and typically occur with sustained high doses, there are reports of severe symptoms even at lower doses. Notably, two individuals reported adverse effects to the NSW poisons hotline while taking less than 50 milligrams.
Industry Response and Consumer Advocacy
Dominic Noonan-O’Keeffe, leading a potential class action against wellness company Blackmores over their B6 supplements, expressed disappointment with the TGA’s decision. He noted that it fell short of the 5 milligram threshold recommended by those who suffered toxicity.
“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 magnesium and ashwagandha supplements, lack clear labeling. This has led to calls for mandatory front-of-pack statements to inform consumers of the presence and potential risks of B6.
Historical Context and Future Implications
Since 2020, the TGA has mandated warning statements on supplements containing more than 50 milligrams of B6. In 2022, the threshold was lowered to 10 milligrams due to concerns over consumer awareness of the dangers associated with high B6 intake.
The announcement reflects a growing trend of regulatory bodies taking action to mitigate health risks associated with dietary supplements. As the implementation date approaches, manufacturers and healthcare professionals will need to adapt to the new standards, ensuring consumer safety remains a priority.
As the situation develops, consumers are urged to stay informed and consult healthcare professionals when considering supplement use. The TGA’s decision underscores the importance of balancing nutrient intake with safety, setting a precedent for future regulatory measures in the supplement industry.
