Chinese pharma player Blue Bio mounted the appeal after its previous attempt to have glucosamine products classified as medicines was rejected in the UK High Court in 2014.
The UK Health Food Manufacturers' Association (HFMA), which was an 'interested party' to the Medicines and Healthcare products Regulatory Agency (MHRA) action to establish the case for glucosamine food supplements, said it was ‘disappointed’ the court had told the MHRA to revisit glucosamine.
“We are obviously disappointed that the Court has taken this position,” the HFMA said.
“Although Blue Bio was unsuccessful in its appeal to have the Court declare that all glucosamine-containing products marketed at an intake of 1500mg are de facto medicines, the Court took the view that the MHRA should have conducted a more in-depth review of the situation and essentially has remitted the matter back to the MHRA.
“We are now considering the implications of the judgment as well as the reasoning before commenting further."
The MHRA also expressed disappointment at the complex court verdict that the Department of Health agency should re-examine glucosamine's status.
"The MHRA is disappointed with this Judgment which relates to a complex case involving similar glucosamine products that are marketed as food supplements and medicinal products," an MHRA spokesperson told us. "Given the complexity, MHRA will review and reflect on the entire text of the Judgment before offering further comment on potential implications.”
The HFMA said it would wait for guidance from the MHRA.
"From the start it has been our intention to support the MHRA to the hilt in its efforts to resist Blue Bio's attempts to have the Courts require the MHRA to determine that all glucosamine-containing food supplements are medicinal, and on this critical point Blue Bio has clearly failed. We are extremely proud to have been the only organisation to support the MHRA in this way.”
Knuckle buster
Robert Verkerk, PhD, executive director of the Alliance for Natural Health-International (ANH-I) said the ruling was "highly significant and of great concern for the hundreds of glucosaminecontaining products sold as food supplements in the UK."
Even though the MHRA had been clear in the past that it treated the classification of glucosamine products on a case-by-case basis, Dr Verkerk noted that the court had taken a different view.
"It has essentially given the MHRA a firm rap across the knuckles for treating these food supplements generically, rather than on a case-by-case basis."
He referenced the complexity of the situation with the UK National Institute for Health and Care Excellence (NICE) advocating glucosamine supplement use for those with knee osteo-arthritis and a non-linear EU situation where glucosamine is available as a food supplement in 23 of 28 EU member states.
It was time "the definition of medicine in EU law it itself was amended to create less doubt as to what is or isn’t a medicine."
Dual status
The initial High Court action was mounted by the European arm of Chinese company Blue Bio (Yantai) Pharmaceuticals in late 2013 and provoked a Westminster parliamentary motion to defend its food supplement status.
Blue Bio is since 2009 the holder of a prescription-only medicines registration across the EU’s 28 member states for its glucosamine sulphate product, Dolenio. It sought to close the glucosamine supplements channel completely in the UK.
The MHRA determines such classifications on a case-by-case basis and has backed the joint health supplement’s dual status, even in the absence of approved EU food supplement health claims.
At the time of the previous case, Chris Whitehouse, director of strategy at UK pro-supplements group, Consumers for Health Choice (CHC), said “It is frankly ridiculous that an ingredient long present in food and food supplements should suddenly require a medicines licence just so that one company can maximise its profits.”
Blue Bio was not available for comment at the time of publication.
The full Court of Appeal ruling is here: