The regulator’s interim decision classifies some formulations of B6 as pharmacist-only medicines, but the GP college wants to see stronger regulation on health claims.
If the TGA wants to tackle vitamin B6 toxicity it should also strengthen labelling requirements and the types of health claims that products are permitted to display, says the RACGP.
Earlier this year, the TGA made an interim decision to amend the Poisons Standard to classify supplement preparations containing 50-200mg/day of B6 as schedule 3 pharmacy-only medicines.
The vitamin is often included in multivitamins and magnesium supplements, alongside energy drinks and some weight loss shakes.
Products containing less than 50mg/day will continue to be exempt from scheduling.
The interim decision followed an uptick in TGA adverse events notifications related to peripheral neuropathy, and – if confirmed – will be implemented for 18 months from February 2027.
In a submission to the drugs regulator dated this week, the RACGP said the reclassification would be a “positive step” toward reducing risk of harm.
“We agree scheduling is only one part of the regulatory framework for managing risks associated with medicines,” the submission read.
“Scheduling changes alone will not address the multiple sources through which individuals may be exposed to vitamin B6, including through diet, fortified foods, and supplements.
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“… Clinical deficiency of vitamin B6 is rare, and there is limited evidence supporting supplementation benefits in individuals who are not deficient.”
To that end, the college also supported a public education campaign to raise awareness of overconsumption, consistency in ingredient naming, strengthening labelling requirements through stronger wording of warning statements and a review by Food Standards Australia New Zealand on the risks of toxicity from the use of multiple products containing B6.
“In addition, the RACGP recommends health claims made on vitamin B6 containing products be subject to stronger regulations and permitted only when robust evidence demonstrates the benefits clearly outweigh the potential risks,” it said.
The scheduling change will impact more than 100 preparations currently listed on the ARTG.
According to the TGA, sponsors will “need to decide whether to continue marketing these products, reformulate the level of vitamin B6 to be 50 mg or below, or phase them out of the market”.