Australia's TGA Proposes New Regulations on Vitamin B6 Supplements Amid Toxicity Concerns

In response to a notable increase in cases of vitamin B6 toxicity, Australia's Therapeutic Goods Administration (TGA) has released an interim report recommending significant changes to the regulation of over-the-counter supplements containing high doses of vitamin B6. The report, issued on June 27, 2025, highlights the growing concern over health risks associated with excessive intake of this vitamin, which can lead to serious neurological issues, including peripheral neuropathy.

The TGA has documented 174 reports of peripheral neuropathy linked to vitamin B6 products. Dr. Michael Bonning, a representative from the Australian Medical Association, emphasized the urgency of addressing this issue by stating, "There are likely hundreds of thousands of Australians who are taking far too much vitamin B6. While most of them have no side effects, if you are taking large doses of B6, your risk of peripheral neuropathy goes up" (ABC News, 2025).

The interim report suggests reclassifying supplements containing more than 50 mg of vitamin B6 as Schedule 3 (Pharmacist Only), a move that would require pharmacists to counsel consumers before sale. Currently, these products are available for self-selection, with many containing doses exceeding the recommended daily intake (RDI) of 2 mg. A TGA spokesperson indicated that this decision aims to mitigate risks associated with high-dose vitamin B6, acknowledging potential irreversible harm (TGA, 2025).

Moreover, the report recommends that any supplements exceeding 200 mg of vitamin B6 be classified as prescription medicines (Schedule 4), further restricting access to high-dose variants. This recommendation is part of a broader effort to enhance public safety and provide consumers with necessary guidance when considering dietary supplements.

Caroline Diamantis, Vice-President of the Pharmaceutical Society of Australia, welcomed the proposed regulations. She stated, "It’s a good thing that pharmacists will be able to have a really good counseling session with a patient to ensure the item they’re taking doesn’t interact with other medications" (ABC News, 2025).

In addition to reclassification, the TGA's report calls for stricter labeling requirements. Current packaging often fails to clearly identify vitamin B6, leading to consumer confusion. The report suggests more explicit warning labels indicating the risks of excessive B6 consumption, such as potential nerve damage (TGA, 2025).

Despite the TGA's proactive measures, John O'Doherty, CEO of Complementary Medicines Australia, argued that adverse effects related to vitamin B6 are rare, citing a comparison of sales data with the TGA's adverse events database. He stated, "The chance of a reaction is less than one in half a million—this is extremely rare" (CMA, 2025). However, the TGA has cautioned that the actual number of adverse events may be significantly understated due to underreporting.

Legal actions are also on the rise as medical negligence lawyer Nick Mann has initiated a class action lawsuit against Blackmores, a leading company in the complementary medicines sector. Mann expressed that the TGA's interim decision is a "small step in the right direction" but insisted that further action is necessary to protect public health (Polaris Law, 2025).

The proposed changes are subject to a consultation period, with an implementation deadline set for February 1, 2027. This timeline presents an opportunity for stakeholders, including consumers, healthcare professionals, and the dietary supplement industry, to engage in discussions regarding the future of vitamin B6 regulation in Australia.

As the TGA moves forward with these recommendations, the implications for public health, consumer safety, and the complementary medicines industry remain significant. Stakeholders will need to monitor the effectiveness of these changes and consider further reforms to ensure the safety of dietary supplements in the Australian market.