Industry submissions argued toxicity cases were rare and occurred only in patients taking higher doses over a sustained period. But many people have reported severe symptoms even when taking much lower doses, including two people who had called the NSW poisons hotline reporting adverse effects while taking less than 50 milligrams.
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Dominic Noonan-O’Keeffe, the lead plaintiff in a potential class action against wellness giant Blackmores over their B6 supplements, said the TGA’s decision fell short of the 5 milligram threshold recommended by those who had 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 was widespread agreement in the submissions that many products containing vitamin B6, including many magnesium and ashwagandha supplements, were not clearly labelled, and recommended mandatory front-of-pack statements notifying customers of their presence and potential risks.
“Many people mentioned being unaware of vitamin B6 in various products resulting in cumulative exposure from multiple sources,” the TGA said.
Since 2020, the TGA has required all supplements containing daily doses of more than 50 milligrams of B6 to carry a warning statement. The agency again lowered the threshold to 10 milligrams in 2022, concerned about a lack of awareness regarding the dangers of elevated B6 intake.
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