Vitamin B6 warning: Supplement firms advised to warn against excessive intake on product labels – Singapore HSA

In a regulatory update on May 23, the HSA said that the maximum allowable limit for vitamin B6 in health supplements was 100mg per day for adults, which was aligned with the upper limit set by Association of South East Asian Nations (ASEAN), Canada, and the US. 

“Peripheral neuropathy has been reported following chronic high-dose (>100mg/day) consumption of vitamin B6.​

“To date, HSA has received one local adverse event report in 2020 regarding non-serious severe neuralgia in a 65-year-old Chinese male who took a vitamin B6-containing product,” ​the regulator said, adding that there were no further details on the dose and duration of intake.

It has advised health supplements companies to inform consumers the potential risk of excessive vitamin B6 intake and developing peripheral neuropathy via product labelling.

It also told firms to monitor consumer feedback and report the cases.

“Companies dealing with health supplements containing vitamin and minerals are reminded to ensure that their products comply with the requirements, including the maximum limit for vitamins and minerals, stipulated in the guidelines on health supplements set out by the HSA.​

“You may wish to inform users of such products on this potential risk via labelling. Should your company receive feedback from consumers about possible adverse events such as peripheral tingling, burning or numbness, please advise them to seek medical attention.​

“Companies are advised to monitor these feedback from consumers and report to HSA using this online reporting form,” ​the regulator said on May 23.

Aside from health supplements, vitamin B6 is also sold as therapeutic products or pharmaceuticals in Singapore.

The regulator said that processes were in place to strengthen warnings on peripheral neuropathy in products with daily dose exceeding 100mg.

Peripheral neuropathy is usually characterised by numbness or a tingling or burning sensation in the limbs.

In March, the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens has reduced the daily upper limit of vitamin B6​ for adults from 25mg to 12mg, following a request from the European Commission.

The panel said​ that the relationship between excessive vitamin B6 intakes and the development of peripheral neuropathy was well established and was the critical effect on which the upper limit was based.