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The MHRA is the Medicines and Healthcare products Regulatory Agency: responsible for ensuring that medicines and medical devices work and are safe.
The MHRA announced that products containing a daily dose of over 1,178mg of base glucosamine are now classed as medicines for 'mild to moderate osteoarthritis of the knee'. This is great news, as it reinforces how effective glucosamine can be. Healthspan sells nutritional and food supplements and is not licensed to sell medicinal products.
Although 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.
It means that the MHRA recognises glucosamine as an effective medicine for mild-to-moderate osteoarthritis 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.
The ruling will only affect products that contain over 1,178mg of base glucosamine, or products with a recommended daily dose that 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). 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 has also released a higher 1,500mg strength version of its Glucosamine Sulphate 2KCl formula.
One tablet of the new Glucosamine Sulphate 2KCl 1,500mg provides 888mg of base glucosamine. One tablet of the new Optiflex Glucosamine HCl 1,325mg provides 1,100mg of base glucosamine.
That means that even though the Optiflex Glucosamine HCl 1,325mg tablet is smaller than the Glucosamine Sulphate 2KCl 1,500mg tablet, it contains 23% more actual glucosamine.
The new products – Optiflex Glucosamine HCl 1,325mg and Glucosamine Sulphate 2KCl 1,500mg – will be released in March. Healthspan will continue to sell the remaining stock of Optiflex Glucosamine HCl 1,500mg until stock runs out.
The ruling means that Healthspan is required to change the recommended daily dose of some products. For example, ChondroMax contains 500mg of glucosamine HCl per tablet. The previous recommendation was to take up to 3 tablets a day – but this now provides more glucosamine than the MHRA's daily recommended dose.
For this reason Healthspan will instead recommend 2 ChondroMax tablets a day, to make sure the recommended dose does not exceed the 1,178mg stipulated by the MHRA.
If you're in doubt about your glucosamine dosage, please speak to your doctor or GP.
Healthspan's Optiflex Glucosamine HCl is patented and can't be found from any other supplier. By binding the glucosamine with hydrochloride instead of sulphate 2KCl, as used by many of its competitors, Healthspan's supplements offer 40% more actual glucosamine per gram. What's more, glucosamine tablets are often made using prawn or crustacean shells, but Healthspan pioneered a shellfish-free formulation made from a sustainable natural corn-based source.