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.
It should be noted GCPs containing less than 1178 mg/day of glucosamine will continue to be widely available as food supplements. The public can expect to continue to be able to use these products.
MHRA determines whether products are medicinal or not on a case by case basis by weighing up a number of evidenced based factors in the light of the definition of a medicinal product contained in legislation and relevant European Court of Justice and domestic Court precedents.
Generally, medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK. Licensed medicinal products have to meet safety, quality and efficacy standards to protect public health.
MHRA is now working with individual companies, trade bodies and other stakeholders to make sure all are fully aware of the impact of this decision.