Europe – Change in the classification of certain glucosamine products

Products containing doses equal to or greater than 1178mg/day of base glucosamine will now be considered to be medicines.

Following a Court of Appeal Judgment in 2016, the Medicines and Healthcare products Regulatory Agency (MHRA) 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 intends to regard GCPs, with a level of base glucosamine equal to or greater than 1178mg/day, as medicines. This is based both on the evidence of pharmacological effect and because it is clear, from our review, that most people use GCP for a medicinal purpose. This means GCPs containing at least 1178mg/day of glucosamine cannot continue to be sold without a marketing authorisation.

GCPs are widely available as food supplements and are widely used for joint health. There are also a number of GCPs, intended to treat the symptoms of osteoarthritis of the knee, which are either prescription-only medicines or are available from pharmacies…