Joint health nutrient glucosamine has won a “profound” legal case in the UK High Court that affirms its right to be sold as a food supplement after a Chinese pharma firm sought to reclassify it purely as a drug.
"We are very pleased with the outcome of this highly significant case, which had a very real capacity to have a profound impact on the future for our members, this industry and, perhaps most significantly, consumer choice,” said Graham Keen, executive director of the UK Health Food Manufacturers’ Association (HFMA).
The HFMA joined the named defendant in the case, the UK Medicines and Healthcare Products Regulatory Agency (MHRA), in defending the right of glucosamine to exist on-market as both a food and a drug. In arguing its case the MHRA said it prefers a case-by-case approach depending on formulation, dosage, application and typical use.
An MHRA spokesperson told us, “The Judgment supports the original MHRA position that we do not agree that all glucosamine products should be classified as medicines and upholds our case by case consideration of products.”
The High Court action was mounted by the European arm of Chinese company BlueBio (Yantai) Pharmaceuticals last November and provoked a Westminster parliamentary motion to defend its food supplement status.
BlueBio is the holder of a prescription-only medicines registration across the EU’s 28 member states for its glucosamine sulphate product, Dolenio.
“We are relieved that the judge has so clearly rejected all of the claims made by the claimant in this case, and in such a speedy fashion,” Keen added.
“We have argued vigorously throughout the case that the current food supplement status for glucosamine should be maintained, and the Honourable Mr Justice Supperstone clearly agrees with this, citing much of our argument in his judgement.”
The parliamentary motion warned if BlueBio won it would increase product prices and reduce consumer cost.
Finland, whose medicines agency adopts a case-by-case assessment like the MHRA, last year altered its position in favour of food supplements, allowing both medicinal and food products.