What is the MHRA?
The MHRA is the Medicines and Healthcare products Regulatory Agency: responsible for ensuring that medicines and medical devices work and are safe.
What does the new ruling mean?
Healthspan sells nutritional and food supplements and is not licensed to sell medicinal products. While the ruling is great news for those who take glucosamine, as it reinforces its efficacy, it does mean some changes to Healthspan's glucosamine products are required to make sure they abide by the rules.
What does this announcement mean for glucosamine?
It means that the MHRA recognises glucosamine as an effective medicine for mild-to-moderate osteo-arthritis of the knee. While there are still no EU-approved claims for glucosamine supplements, it's great to see official acknowledgment of the benefits of glucosamine.
It's important to note that the regulatory change doesn't mean that glucosamine products providing over 1,178mg of base glucosamine per day are in any way unsafe. The new regulations simply stipulate that anything over this dose can only be obtained with a prescription.
In practice, however, doctors are specifically advised not to prescribe glucosamine by the National Institute for Health and Care Excellence (NICE), as the cost of doing so would be prohibitive. This means that most people will still need to buy their own glucosamine supplements.
What does this mean for Healthspan's glucosamine products?
The ruling will only affect products that contain over 1,178mg of base glucosamine, or products with a recommended daily dose which provides over 1,178mg of base glucosamine.
For this reason, as a responsible company Healthspan can no longer offer Optiflex Glucosamine HCl 1,500mg, which contains 1,250mg of base glucosamine (the other 250mg is made up of the salt to which the glucosamine molecules are bound – they can't exist on their own). To replace this product, Healthspan is launching Optiflex Glucosamine HCl 1,325mg – containing 1,100mg of base glucosamine.
The reason the product will contain 1,100mg of base glucosamine, rather than the 1,178mg maximum stipulated by the MHRA, is because the MHRA requires a 'clear space' between the dose found in licensed medicines and the level found in food supplements, in order to provide a distinct differentiation between the two. Healthspan's food supplements will therefore have an upper level of 1,100mg base glucosamine, to demonstrate this requested clear space.
Healthspan will also be releasing a higher 1,500mg strength version of its Glucosamine Sulphate 2KCl formula.