Updated with comment from Medical Brands' CEO.
The European Commission has released a draft decision that would mean the group of products depending on proanthocyanidins present in cranberry (Vaccinium Macrocarpon) extract, in order to prevent or treat cystitis, also known as bladder inflammation or infection, should not be classified as medical devices.
The need for the European Commission to make this decision on cranberry-derived products came as some companies -- notably the Dutch company Medical Brands in 2012 and Arkopharma, which later had its EU medical device status revoked by the French medicines agency (ANSM) -- were obtaining Class IIb medical device status in the EU for their patented cranberry-based products based on clinical data.
“The legal basis for this measure is Article 13 (1) (d) of the Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993 on medical devices). In particular, this Article allows the Commission to take a decision, at a request of a Member State, on whether a product or product group falls within a definition of a ‘medical device’ from Article 1 (2) (d) of the Medical Devices Directive,” the commission explained of its decision late Monday.
France requested that a decision should be taken by the commission on products with an intended action depending on cranberry extract to prevent or treat cystitis, which it said should not be qualified as medical devices.
Products in question have a principal intended action “achieved by pharmacological, immunological or metabolic means, notably by inhibiting adhesion between P-fimbriated E. coli and mucous membrane cells in the urinary tract,” the commission said.
Member states have provided comments on the draft decision and the commission says it’s analyzing those comments. The decision, if approved, will enter into force on the 20th day following its publication in the Official Journal of the European Union.
Some have called the “medical device” scheme for cranberry-derived products a scam, and ANSM’s decision to revoke the device status of Arkopharma’s product was due to the fact that the data backing the product’s use was insufficient.
Medical Brands, meanwhile, has noted that its Cranberry-Active product, which is still classified as a medical device under EU regulations, has been successful in the Dutch urinary tract infection market due to the product’s ability to “treat and prevent urinary tract infections” after the company spent more than $3 million on seven years’ worth of clinical trials.
Hendriks, CEO of Medical Brands, told Focus that the European Commission draft
policy seems driven more by political than scientific aims. He also said he
does not believe Medical Brands’ cranberry-derived product will be impacted by
this policy if it's finalized.
According to the Alliance for Natural Health, companies have tried to obtain the classification of a medical device because they cannot describe the potential health benefits of cranberries nor of any food supplement products derived from cranberries because of the Nutrition and Health Claims Regulation (NHCR; No.1924/2006), to protect consumers from “false, ambiguous or misleading” health claims.
Commission decision on the qualification of cranberry products