At the same time as it ruled that glucosamine-containing products over 1,500mg can continue to be sold as supplements, the UK Court of Appeal has however urged the MHRA to revisit the issue.
The court was ruling on an appeal by the European arm of Chinese pharma company Blue Bio – which manufactures the prescription-only glucosamine product Dolenio – against the High Court’s rejection in 2013 of the company’s attempt to have glucosamine products at dosages over 1,500mg classed as medicines. If it had been successful, this would have removed glucosamine food supplements from the market.
After handing down the ruling, Lord Justice Lewison added that he would “remit the question whether to classify that whether to classify some or all GCPs as medicinal products for further consideration by the MHRA”.
In response to the decision, The Health Food Manufacturers’ Association (HFMA) said: “We are obviously disappointed that the court has taken this position. 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.
“As far as going forward is concerned, we will take our lead on this 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.”
Rob Verkerk, founder, executive and scientific director of the Alliance for Natural Health, commented: “In its ruling on 17 June, the Court of Appeal has essentially given the MHRA a firm wrap across the knuckles for treating these food supplements generically, rather than on a case by case basis. It has criticized the MHRA for simply accepting that these food supplements can co-exist in the market alongside the drug version, even when they share the same dosage and active ingredient.
“The MHRA now has to reconsider the dual status of food supplements that share the same dose and form of active, namely glucosamine sulphate, as Dolenio. The issue is complicated because pharmacists frequently push patients towards food supplements. While NICE guidelines themselves specifically state “Do not offer glucosamine or chondroitin products for the management of osteoarthritis”, millions have gained benefit from glucosamine, with good scientific reason.”