Glucosamine: New Industry Guidance level for Food Supplements in United Kingdom

Following a Court of Appeal Judgment in 2016, the Medicines and Healthcare products Regulatory Agency (MHRA) in UK started a review of the classification of glucosamine containing products (GCPs), which included commissioning consumer research to understand how and why they are used.

After reviewing the level at which GCPs have a pharmacological effect on the body and evaluating why people use GCPs, MHRA has determined that GCPs, with a level of base glucosamine equal to or greater than 1178mg/day, will now be considered to be medicines. On the basis that 1500mg Glucosamine Sulphate or 1178mg Glucosamine (base) is seen as a ‘pharmacological dose’, a food supplement must provide a level which is below this and therefore has a health maintenance rather than pharmacological function.

The MHRA has accepted the HFMA (Health Food Manufacturers Association UK) proposal to issue guidance to members to reformulate their products so that they carry 1400mg doses of glucosamine sulphate (meaning that they do not meet the threshold of base glucosamine for pharmacological activity) and would not be regarded as falling under the second limb of the definition of a medicinal product. Further details can be found in the following document.

We hope this information, which has been kindly provided to us by the HFMA,  will help you to reformulate your existing GCP if required. Please do contact us if you would like to have details of the various grades available from the Gee Lawson range, which includes Vegetarian Glucosamine HCl, Suphate (both granular and powder) and N-Acetyl Glucosamine.