One for Santa’s wish list is a standard recommended daily amount for Glucosamine Sulphate. Whilst children of the land will wake to wishes coming true next week, the confusion for consumers about Glucosamine Sulphate is likely to rumble till Christmas 2019.
Three months on from the 05 Sept 2018 announcement from the MHRA that Glucosamine food supplements can only be sold if they are lower than 1178mg glucosamine base per daily dose, changes to labelling are beginning to take effect. The original full article can be read via this link.
This government statement took effect immediately, with food supplement manufacturers having to take prompt action. No sell through date or transition period was announced or granted.
Glucosamine containing products (GCPs) especially glucosamine sulphate food supplements until this date were sold as a variety of strengths, all resulting in a recommended total daily dose of 1500mg Glucosamine Sulphate.
On 06 November the Pharmaceutical Services negotiating Committee (PSNC), who promote and support the interests of all NHS community pharmacies in England offered the following advice.
MHRA have advised that affected GCPs should be removed from counter and dispensary shelves to avoid the inadvertent sale or supply of unauthorised medicinal products. Any prescriptions received for GCPs with a daily dose of base glucosamine at 1178mg which cannot be met by a licensed product should be referred back to the prescriber.
GCPs that can no longer be dispensed or sold over-the-counter as food supplements are GCPs with a daily dose of base glucosamine at 1178mg/day or higher
GCPs that can legally be dispensed or sold over-the-counter as food supplements are GCPs with a daily dose of base glucosamine less than 1178mg
GCPs that can no longer be dispensed
GCPs with a daily dose of base glucosamine at 1178mg/day or higher
GCPs that can legally be dispensed
GCPs with a daily dose of base glucosamine less than 1178mg
Manufacturers are moving towards introducing a 1400mg Glucosamine sulphate product (below the 1178mg threshold), and maintaining the existing glucosamine sulphate products, but altering the recommended daily dose on each pack.
The following tabular summary details the quantity of Glucosamine Sulphate with associated recommended daily amounts in August 2018, compared with the likely pack recommendation in 2019.
| August 2018 | August 2019 | |||
|---|---|---|---|---|
| Strength per dosage form | Label Recommendation | Maximum level Glucosamine Sulphate recommended | Label Recommendation | Maximum level Glucosamine Sulphate recommended |
| 300mg | Take five dosage units per day | 1500mg | Take four dosage units per day | 1200mg |
| 500mg | Take three dosage units per day | 1500mg | Take two dosage units per day | 1000mg |
| 750mg | Take two dosage units per day | 1500mg | Take one dosage unit per day | 750mg |
| 1500mg | Take one dosage unit per day | 1500mg | Medicine | Medicine |
| 1400mg | Not available | n/a | Take one dosage unit per day | 1400mg |
So the packs sold in 2019 will be compliant but OTCExperts imagine that Healthcare Professionals and consumers alike will remain confused for a while.
Trading Standards enforcement can now take effect. Food supplements manufacturers recommend that all suppliers have a robust justification in place for any stock they still have and will be selling through ie supplies purchased in late August or products supplied in fulfilment of orders placed prior to the 05 September 2018 cut off. There was no cut-off date/permission to sell through, but the MHRA cannot be seen to impose financial penalties, where no notice was given.
Our Opinion
Tricky waters for manufacturers and pharmacists to navigate through this unofficial transition period.
