The Medicines and Healthcare products Regulatory Agency (MHRA) is to begin classifying some glucosamine-containing supplements as medicinal products, meaning they can no longer be sold without marketing authorisation.
The decision follows the 2016 Court of Appeal judgement which quashed the MHRA’s decision to classify the glucosamine product Dolenio as medicinal when similar products are considered nutrient supplements. The Court also called on the agency to review the classification of glucosamine-containing products (GCPs) in general.
In a statement issued earlier this week, the MHRA said it has now completed the review, which included commissioning consumer research to understand how and why the products 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 1178 mg/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 1178 mg/day of glucosamine cannot continue to be sold without a marketing authorisation,” the MHRA said.
GCPs containing less than 1178 mg/day of glucosamine will continue to be widely available as food supplements.
The agency says, “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”.