Health giant Blackmores is potentially looking at a class action lawsuit after several people allegedly consumed high doses of vitamin B6 after taking its supplements.
These consumers allegedly suffered symptoms related to peripheral neuropathy after taking Blackmores’ vitamin B6 supplements. While Blackmores adheres to the Therapeutic Goods Administration (TGA)’s regulation of vitamin B6 levels in healthcare products and mandates warnings, a plaintiff represented by Polaris Lawyers claims the products he took had toxic levels of vitamin B6.
It’s important to note that a class action is not yet underway, but has been confirmed by Polaris Lawyers as proposed.
In May 2023, Dominic Noonan-O’Keeffe, the lead Plaintiff in the proposed class action against Blackmores, purchased and began taking Blackmores vitamin supplements. He claims he was unaware that the Blackmores Super Magnesium+ and Ashwagandha+ he was taking contained potentially toxic levels of vitamin B6 and could not have imagined the significant long-term medical problems that taking the supplement would cause.
Polaris Lawyers alleges that Dominic discovered that the Magnesium+ he had been taking contained approximately 29 times the recommended daily intake of vitamin B6.
Dominic started experiencing significant fatigue, excruciating headaches and hypersensitivity to his environment. His symptoms escalated with Dominic experiencing muscle spasms, neuralgia, heart palpitations, visual disturbances and loss of sensation across his body. Dominic was left unable to concentrate, struggling to sleep, constantly in pain and even at times found it difficult walking. His medical team would go on to allegedly identify neuropathy caused by excessive B6 levels in the Blackmores supplements.
Despite stopping the supplements in February 2024, he claims to still experience a variety of symptoms daily, including nerve pain, visual disturbances, muscle spasms and loss of sensation.
“At Blackmores, we are committed to the highest standards of product quality and consumer safety. All our products, including those containing vitamin B6, are developed in strict accordance with the safety and regulatory requirements of the TGA,” a Blackmores spokesperson told B&T.
“This includes compliance with maximum permitted daily doses and the inclusion of mandated warning statements on product labels.
“We are aware of media reports of an investigation into a potential class action involving Blackmores products containing vitamin B6. No formal legal claim has been received by Blackmores.
“Vitamin B6 is in a range of products within the vitamins and dietary supplement industry and its inclusion in some Blackmores products is consistent with industry practice and meets current regulatory requirements in all markets,” they added.
“The TGA is unable to provide comment on the class action against Blackmores or provide any comment on the Blackmores brand,” a TGA spokesperson told B&T.
“However, we can provide information on the regulation of medicines containing vitamin B6 in Australia and current TGA actions to address the risk of peripheral neuropathy associated with all medicines containing vitamin B6,” they added.
The situation brings to light the web of stakeholders at play in the healthcare industry, from regulatory bodies to healthcare companies and marketers, and researchers who ultimately influence regulatory standards.
The potential damage to the Blackmores brand, a household name known to Aussies looking to boost their health, could be significant.
“It’s alarming to walk down the vitamin aisle of any chemist in Australia and see vitamin supplements containing levels of B6 which are far and above the recommended daily intake,” Polaris Lawyers founder and principal Nick Mann said.
“What happened to Dominic is tragic, but he is not alone – we are aware of reports that excessive levels of B6 in over-the-counter supplements may have caused lasting injuries to hundreds of Australians.
“Polaris Lawyers is currently investigating a class action on behalf of anyone who has suffered injuries as a result of excessive levels of B6 as a result of taking Blackmores vitamin supplements.
“Consumers of supplements have a right to be confident that the product they purchase will be safe for their use. The fact that potentially harmful supplements have been approved for sale by the regulator does not alter the legal obligations of manufacturers to ensure that the products are safe for consumers,” Mann added.
Natural Nasties?
Some experts warn that the healthcare industry, particularly ‘natural’ products, are often seen as safe by consumers. However, dangerously high doses of vitamin B6 can harm peripheral nerves and in extreme cases, damage motor function.
“It’s always believed that natural products are safe, but that’s not true; there is always a risk. For a consumer perspective, it’s important to read the label and check with the pharmacist,” UNSW professor Dr Jocelin Chan told B&T.
It begs the question: if healthcare products are complying with TGA regulations, why have some consumers allegedly taken toxic levels of vitamin B6?
Chan noted that many consumers aren’t aware of how much vitamin B6 they are consuming. More than 1,500 products sold in Australia contain vitamin B6, including zinc vitamins, or any medicine for mood or energy. Many supplements and fortified foods, such as energy drinks, contain vitamin B6.
“It has always been known that a daily dose of 200 mg or above of vitamin B6 can cause neuropathy. However, there are reports lately showing that even 50 mg can cause that,” Chan added.
TGA’s Interim Decision
Since 2022, TGA, the Therapeutic Goods Administration, has mandated that any product containing more than 10 mg should have a warning label identifying the risk and symptoms of peripheral neuropathy associated with vitamin B6.
An interim decision recently released by the TGA proposes that all products containing 50-200 mg of vitamin B6 could become behind-the-counter.
Blackmores “acknowledges the interim decision issued by the TGA and we will ensure full compliance with its final determination, prioritising the safety of our products,” a spokesperson told B&T.
Currently, the maximum permitted daily dose of vitamin B6 in listed medicines is 100mg in adults, with lower amounts for children. Therefore, listed medicines indicated for adults that provide a daily dose of 100mg or less are compliant with the current Australian regulatory requirements.
The TGA’s interim decision proposes to reduce the maximum permitted daily dose of equivalent vitamin B6 in listed medicines to 50mg in adults.
The changes are proposed to be in effect on 1 February 2027, but this may change based on stakeholder views following consultation.
