27-06-2025
Australia's TGA issues interim report to remove supplements high in B6 from shelves as toxicity cases rise
Major changes have been proposed to restrict access to a common over-the-counter vitamin, linked to a growing number of poisoning cases.
Vitamin B6 — often listed as pyridoxine, pyridoxal, pyridoxamine — is present in thousands of products in Australia as an additive, including medicines, multivitamin and mineral supplements, energy drinks and weight loss shakes.
174 reports of peripheral neuropathy, peripheral sensory neuropathy, small fibre neuropathy or chronic polyneuropathy for products containing B6 have been reported to the medicines' regulator, the Therapeutic Goods Administration (TGA), though medical practitioners predict the true number is significantly higher.
"While most of them have no side effects, if you are taking large doses of B6 your risk of peripheral neuropathy goes up."
"We know that reported cases of peripheral neuropathy are a massive underestimate of the problem in the community, because so many people are unaware that that vitamins can cause these symptoms."
In a new development to improve public safety, several recommendations have been handed down in a report penned by a senior TGA medical officer known as 'the delegate'.
Called the 'Interim Decision', the report acts on the advice of the government's Advisory Committee on Medicines Scheduling.
Most notably, it calls for the TGA to reclassify supplements containing more than 50mg of B6 as Schedule 3 (Pharmacist Only), by February 2027.
The move would affect around 100 products, requiring pharmacists to first speak with consumers before approving a purchase.
"Currently, preparations providing up to 200 mg of [B6] ... are available for self-selection without any professional guidance or oversight," the report states, adding "almost 80 per cent of these products provide a dose of more than 2 mg/day, which is above the RDI for pyridoxine, pyridoxal or pyridoxamine.
"The daily requirement of vitamin B6 can be easily obtained from the usual Australian diet, and the use of supplemental vitamin B6 provides limited benefit except in people who have a clinically diagnosed vitamin B6 deficiency.
A TGA spokesperson told 7.30 the decision, if implemented, "will reduce the maximum amount of vitamin B6 allowed in oral products than currently available for general sale".
"The interim decision balances the risks and benefits of using vitamin B6 including the risk of peripheral neuropathy, acknowledging its potential for irreversible harm at higher doses and variability in individual metabolism," the spokesperson said.
But, as detailed in the report, the proposed changes only account for around seven per cent of supplements containing B6 — there are more than 1,500 vitamins listed on the Australian Register of Therapeutic Goods, the majority of which are unscheduled and available over the counter.
The report also recommended supplements exceeding 200mg should be reclassified as prescription medicines or 'schedule 4'.
"It's a good thing that pharmacists will be able to have a really good counselling session with a patient, to make sure the item they're taking doesn't interact with other medications," said Caroline Diamantis, vice-president of the Pharmaceutical Society of Australia.
"People used to think that complimentary medicines were completely safe but the more we delve into it the more we understand they do have unwanted side-effects or interference with other medications," she told 7.30.
The interim decision also recommends tightening labelling rules, calling for clearer identification of vitamin B6 on packaging and stronger warnings to help consumers avoid accidental overexposure.
"Use of ingredient names in labelling is inconsistent and confusing for consumers … and not always described as vitamin B6," the report said.
"Of concern is that there are several products on the market where the front of the label provides no indication that vitamin B6 is an ingredient."
It suggested changing the language on warning labels to be more direct.
"Excess consumption of vitamin B6 can cause nerve damage. Stop use and see a doctor if you experience tingling, burning or numbness," was a suggestion.
The report also calls on the multi-billion-dollar complementary medicines sector to take greater responsibility for educating consumers and reducing the risk of vitamin B6 overexposure, noting current labelling places too much burden on consumers to calculate total B6 intake.
"Estimating the total daily vitamin B6 intake … is likely to be beyond the health literacy capability of the typical consumer," it said.
The CEO of Complementary Medicines Australia John O'Doherty told 7.30: "we'll be carefully reviewing the interim decision and the recommendations of the Advisory Committee on Medicines Scheduling."
Mr O'Doherty argued adverse events relating to the use of vitamin B6 are "extremely rare".
"Based on a comparison of sales data with the TGA's public Database of Adverse Events, the chance of a reaction is less than one in half a million — this is extremely rare," he said.
However, previous 7.30 investigations have found dozens of Australians have had issues from B6 toxicity, with many only becoming aware of their illness after seeing our reports.
The TGA delegate also warns the prevalence could be much higher.
"The true rate of occurrence of an adverse event cannot be determined from spontaneous adverse event reporting systems due to both general under-reporting and a lack of usage data," its report read.
"A low number of spontaneous adverse event reports cannot be considered evidence of the absence a safety issue."
Mr O'Doherty however agreed with some of the labelling recommendations, telling 7.30 his organisation has "been calling on the TGA to implement changes that allow labels and advertising to use terminology and ingredient names that consumers better understand."
"At CMA's request, this is now under internal review at the TGA", he said.
Medical negligence lawyer Nick Mann said the interim decision is a "small step in the right direction" but argued the TGA "can and should" go further.
Mr Mann told 7.30 his legal firm, Polaris, is pursuing a class action lawsuit against one of the largest companies in the complementary medicines industry, Blackmores, "as a matter of public interest and safety".
"We continue to investigate the potential class action, and given the response, the support and the evidence that's been pouring in ... with over 140 people contacting us to date," Mr Mann said.
"Each of them had heartbreaking stories about how their lives have been affected by B6 toxicity, and sadly, many of them continue to be affected long after ceasing supplements containing Vitamin B6.
"We've also had at least 10 doctors contact us to tell us about their own experiences with B6, and to let us know that they have discovered B6 toxicity in several of their patients, after taking supplements containing higher than the RDI of the vitamin over weeks and months," he said.
The interim decision recommends the changes be made by 1 February 2027 — offering an 18-month implementation period.
Watch 7.30, Mondays to Thursdays 7:30pm on ABC iview and ABC TV
Do you know more about this story? Get in touch with 7.30 here.
