Products containing doses equal to or greater than 1178mg/day of base glucosamine will now be considered to be medicines, the MHRA has announced.
Following a Court of Appeal Judgment in 2016, the 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 that most people use GCP for a medicinal purpose.
This means that in future such products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK.
GCPs containing less than 1178 mg/day of glucosamine will continue to be widely available as food supplements.
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.