The RACGP wants to see access to supplements containing certain levels of vitamin B6 restricted.
In a submission to the Therapeutic Goods Administration (TGA) as part of consultation on its proposal to make products containing 50–200 mg of vitamin B6 pharmacist-only medicines, the college expressed support.
“This is a positive step towards reducing the risk of harm from excessive vitamin B6 intake and improving safety and awareness,” the submission read.
“We agree scheduling is only one part of the regulatory framework for managing risks associated with medicines.”
High doses and/or prolonged use of vitamin B6 has been linked with peripheral neuropathy.
In late June the TGA decided to amend the scheduling of vitamin B6 in the future to restrict the access to medicines providing more than 50mg per RDD by classifying these as pharmacist-only medicines.
However, the RACGP noted that scheduling changes alone would not address the multiple sources through which individuals may be exposed to vitamin B6, including diet, fortified foods, and supplements.
It warned many people were unaware these combined sources could lead to excessive cumulative intake and potential health risks.
The submission stated clinical deficiency of vitamin B6 was rare, and there was limited evidence supporting supplementation benefits in individuals who were not deficient.
The RACGP said there was also need for public education campaigns to raise awareness of overconsumption, consistency in ingredient naming on product labels, strengthening labelling requirements through stronger wording of warning statements and clarity on the presence of the vitamin.
The body also called for a review by the Food Standards Australia New Zealand of the 10mg limit for formulated caffeinated beverages.
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The TGA’s interim proposal took into account a number of factors, including the limited benefits of the vitamin, the rareness of clinical deficiency, the extensive use of vitamin B6 in listed medicines and fortified foods and beverages, and the risks of peripheral neuropathy, including irreversible adverse effects.
“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.”
The TGA determination stated “under the current labelling requirements, it is difficult for a consumer to estimate their vitamin B6 intake and the widespread presence of vitamin B6 in listed medicines and food supplements makes it more challenging”.
The regulator had considered a 5mg cut-off for exemption from scheduling, but decided to make the cut-off 50 mg/day as the National Health and Medical Research Council established this as an upper level of intake for adults aged 19 and over.
The scheduling changes will impact more than 100 preparations currently listed in the ARTG that provide more than 50mg per RDD – excluding medicines containing vitamin B6 in combination with other active ingredients such as multivitamins – which accounts for 7% of the vitamin B6 only preparations.
The interim measures are set to be in place for 18 months as of February 2027 and the TGA plans on reviewing other regulatory controls currently in place for vitamin B6 preparations.
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