7 September 2018 - Deborah Wilkes
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified certain glucosamine products as medicines. A spokesperson for the MHRA told OTCToolbox the decision had "now taken effect", and the agency would "work with companies in respect of the sale of products which are currently in the supply chain".
The MHRA said in a statement that products containing doses equal to or greater than 1,178mg per day of base glucosamine – equivalent to 1,500mg glucosamine sulphate – would "now be considered to be medicines".
Janet Worrell, a regulatory affairs specialist at OTCexperts, told OTCToolbox the decision affected the vast majority of glucosamine food supplements on the market.
PAGB welcomes the clarity
Donna Castle, director of public affairs at the Proprietary Association of Great Britain (PAGB), said "glucosamine has been under review for a number of years and we welcome the clarity which the MHRA decision provides".
Castle said the decision would "take effect immediately", as it was not possible for the MHRA to sanction a transition period.
The MHRA said it was "now working with individual companies, trade bodies and other stakeholders to make sure all are fully aware of the impact of this decision".
The regulatory agency pointed out that products containing less than 1,178mg per day of glucosamine would continue to be widely available as food supplements.
Options for companies
The MHRA said companies affected by the decision should "seek a marketing authorisation or reformulate their products".
The PAGB is recommending that food supplements containing glucosamine should have an upper level of 1,100mg glucosamine, equivalent to 1,400mg glucosamine sulphate.
The MHRA said the reclassification was based on the "evidence of pharmacological effect", and because it was clear that "most people use glucosamine-containing products for a medicinal purpose".
"This means that glucosamine-containing products containing at least 1,178mg per day of glucosamine cannot continue to be sold without a marketing authorisation," commented the MHRA.
Following a 2016 Court of Appeal judgement on the classification of glucosamine-containing products, the MHRA commissioned consumer research to understand how and why the products are used.
Both a medicine and a food supplement
Worrell of OTCexperts told OTCToolbox that the history, status and claims associated with glucosamine-containing products in the UK was interesting, noting the legal status of glucosamine as a medicine was listed in the MHRA's statement.
"Glucosamine base 1,178mg has been regulated as both a food supplement and a medicinal product in the UK for many years," said Worrell. "The licensed glucosamine base 1,178mg product was authorised for 'Relief of symptoms in mild to moderate osteoarthritis of the knee', while glucosamine base 1,178mg as a food supplement could not make a health claim."
Worrell said she was aware that prescription volumes for glucosamine 1,500mg had decreased dramatically over the past 10 years, as general practitioners and formularies had directed patients towards food supplements.
OTCexperts believes old glucosamine marketing authorisations could be remarketed but much of the prevailing evidence and the pressures of spiralling prescription costs indicated there was unlikely 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 1,178mg threshold," commented OTCexperts.
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