Today 5 Sept 2018, the MHRA has announced that going forward, that the agency intends to regard glucosamine containing products (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, from their review, that most people use GCP for a medicinal purpose. This means GCPs containing at least 1178mg/day of glucosamine cannot continue to be sold without a marketing authorisation. The full article can be read via this link.
The history, status and claims associated with GCPs is an interesting one. Glucosamine base 1178mg (equivalent to 1500mg Glucosamine Sulphate) has been regulated as both a food supplement and a medicinal product in the UK for many years. The differentiator being, the claim that can be legally made and so defining its regulatory status.
Glucosamine base (1178mg) as a medicinal product can be marketed for the ‘Relief of symptoms in mild to moderate osteoarthritis of the knee.’ Glucosamine base 1178mg, as a food supplement, cannot make a health claim. This follows the introduction of the Nutrition and Health Claims regulation (EC 1926/2006) and the creation of the positive list of authorised health claims. The 6-month transition period for the removal of non-authorised health claims from food supplements, began 14 Dec 2012. Glucosamine and its salts fell victim to this regulation. Legitimately, since 2013, the majority of glucosamine food supplements have been co-formulated with Vitamin C or Vitamin D in order to maintain a healthy joint claim on pack to signpost to consumers.
What’s next for Glucosamine 1178mg base products?
Interesting the National Institute for health and Care Excellence (NICE) in February 2014 issued guidance to not recommend glucosamine for osteoarthritis. Prescription volumes for Glucosamine 1500mg have dramatically decreased over the last ten years, with GPs and formularies directing patients to Food Supplements. In Dec 2017, a leaflet was published for patients, advising that Glucosamine and Chondroitin could no longer be prescribed.
Old Glucosamine MAAs could be reinvented, but much of the prevailing evidence and pressures of spiralling drug costs does not indicate that there is likely to be a return to prescription volumes of old. Food supplements manufacturers face the ‘pain’ of reformulation, supply chain challenges and renewed education on the part of the consumer to introduce new glucosamine food supplements that fall below the 1178mg threshold.