Medicines

Glucosamine products reclassified as “medicines” in UK


Glucosamine products are to be upscheduled as “medicines” instead of “food supplements” in the UK following a legal challenge on prescription status.

On 5 September, the Medicines and Healthcare Products Regulatory Agency (MHRA)  announced its decision to upschedule supplements containing 1178 mg/day or above levels of glucosamine as medicines.

The move means the makers of glucosamine products will need to seek a marketing authorisation or reformulate their products to lower doses.

The MHRA said the reclassification was based on a review of evidence of glucosamine’s pharmacological effects and the fact most consumers were using such products for medicinal effect.

Its review was prompted by a legal challenge from a glucosamine manufacturer that held a medicines marketing registration for its product across the EU and sought to bring competitors’ glucosamine products under consistent classification.

In a statement, the regulator said products that contained less than 1178 mg/day of glucosamine could continue to be sold as food supplements.

In Australia glucosamine supplements are classified as over the counter products, typically sold as tablets containing 1500 mg glucosamine sulphate or glucosamine hydrochloride.

While marketed as a natural remedy for joint health and the management of OA-related pain, Arthritis Australia (AA) says evidence for efficacy is “uncertain”.

In a statement it noted some studies have shown glucosamine sulphate improves pain slightly in the short-term (less than six months), but other studies have shown little benefit. There some evidence this form of glucosamine can slow cartilage breakdown in the knee.

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