The Therapeutic Goods Administration (TGA) has recently acknowledged that the blood toxicity associated with vitamin B6 is more significant than previously understood. In an infectious diseases forum in September, TGA’s chief medical adviser Robyn Langham strongly defended the agency’s regulatory framework. She underscored its strength while recognizing that the tide is turning on vitamin B6 supplements.
Vitamin B6 isn’t just in the prescription products—it’s in more than 1,500 OTC products, from magnesium supplements to multivitamins. The TGA’s interim report found that an incredible 80% of these supplements go above the tolerable upper intake level of 1.7mg/day. The TGA has proposed to reschedule supplements that have more than 50 milligrams of B6. This important change will help ensure greater consumer safety. Originally announced to take effect by July 2022, health professionals had been concerned about the unrealistic timeline that was imposed for these changes. Those won’t be implemented until 2027.
Rising Toxicity Cases
Health professionals in the field are seeing an alarming increasing trend in vitamin B6 toxicity cases. Currently, clinical pathologist Dr. David Kanowski operates the only clinic that tests for B6 blood samples. …massive and unprecedented” uptick in patients requesting blood tests for vitamin B6 toxicity. The monthly test order volume has more than doubled since January, exceeding 10,000 daily test requests.
In May, 4.5 percent of these tests, amounting to approximately 450 people, indicated results suggesting they were “very likely” to develop neuropathy. Dr. Kanowski noted the gravity of the situation:
“Sometimes we talk to doctors who think it’s a clerical error because the toxicity results are so high, and we say, ‘No it’s real. You need to sort it out.’” – Dr. David Kanowski
Together, these findings represent an urgent situation in public health. They set off calls for more stringent controls on vitamin B6 supplements.
Regulatory Responses and Concerns
FDA’s Robyn Langham admitted the potential hurdles in making the needed changes to vitamin B6 regulations. She reiterated that the TGA is resolute in making sure that the community remains safe. She observed that this is a process that can be slow for various reasons.
Despite this reassuringly inclusive language, a large number of health professionals are worried that these proposed changes don’t make enough of a change. Caroline Diamantis, a community pharmacist who testified at the listening session, voiced her concerns about the long timeline for implementation. She made plain how untenable the status quo has become and why immediate action must be taken without delay.
“They exist so that the safety of the Australian community is held right at the centre of everything that we do.” – Professor Robyn Langham
Langham’s statements highlighted the importance of keeping a close eye for adverse events linked to B6 toxicity. She remarked on the inadequacy of existing data in truly reflecting community health issues:
“2027 is too far away,” said Diamantis. “That will give the Australian community more protection and a greater sense of safety.” – Caroline Diamantis
With vitamin B6 widely available in OTC supplements, its necessity and safety are called into question. Dr. David Kanowski, the lead veterinarian on the case, noted that manufacturers routinely use B6 as a filler in numerous products. This practice serves to significantly bloat intake across the board for consumers.
“I think it’s sufficient to say that our database of adverse events doesn’t necessarily reflect the true incidence of what’s happening in the community.” – Professor Robyn Langham
The Impact of Excessive Supplementation
The TGA’s interim report concluded that “the benefits of supplemental intake of vitamin B6 to be negligible,” underscoring the need for greater scrutiny over its widespread use in supplements. With over 170 adverse events documented related to B6 toxicity, public health professionals are calling on consumers to be more careful.
Blackmores Group, a leading health product manufacturer, expressed support for tighter regulations as part of ensuring community safety and trust in supplement use:
Blackmores Group, a leading health product manufacturer, expressed support for tighter regulations as part of ensuring community safety and trust in supplement use:
“And when we see emerging issues such as this one, we are able … to develop tighter regulations.” – Blackmores Group
