Following a review, MHRA (Medicine and Healthcare products Regulatory Agency) has announced that products containing doses equal to or greater than 1178mg/day of glucosamine, will now be considered to be medicines.
Donna Castle, Director of Public Affairs, comments:
“Glucosamine has been under review for a number of years and we welcome the clarity which the MHRA decision now provides.
“MHRA now regards products at or above a level of 1,178mg glucosamine (base), or the equivalent figure of 1500mg Glucosamine Sulphate, per daily intake to have a pharmacological effect. These products will therefore be classed as medicinal.
“This decision will take effect immediately, it is not possible for MHRA to sanction a transition period, due to the law governing medicines.
“As a result of MHRA’s decision, working in partnership with other trade bodies, HFMA and CRN, PAGB is recommending food supplement glucosamine products should have an upper level of 1100mg Glucosamine (base), equivalent to 1400mg Glucosamine Sulphate. We believe this will provide sufficient differentiation between medicinal and food supplement products.
“PAGB is working with MHRA, its member companies and other trade associations to make sure all are fully aware of the impact of this decision.”