French food supplements manufacturer Arkopharma has had its ‘EU medical device’ status revoked for a cranberry product that claimed to treat urinary tract infections (UTI) in women.
The European Commission was notified of the status removal after the French medicines agency (ANSM) assessed data backing the medical devices authorisation and found it be insufficient. The authorisation came via a Luxembourg agency known to be a, “soft touch” to industry insiders.
Arkopharma sent a letter to distributors and retailers on March 14 informing them its product ‘Cys-Control’ had reverted to food supplement status – as it stood before it achieved the medical device status.
There are no approved claims for cranberry’s ability to prevent or treat UTI under the EU nutrition and health claims regulation (NHCR), but Arkopharma’s letter states retailers can counsel that Cys-Contol can manage and prevent UTI.
Gunter Haesaerts, the president of another French cranberry supplement manufacturer, Pharmatoka, and the man who won a cranberry-UTI claim in France in 2004 before it was superseded by the strict EU NHCR laws, said Arkopharma would not be the first company to fall on the stake of EU medical device laws.
Haeaserts has long campaigned against the EU medical devices route that has attracted renewed interest since the imposition of the NHCR in recent years – and banning of cranberry claims in December 2012.
In that instance cranberry data failed to impress the European Food Safety Authority (EFSA) health claims panel despite its chief, professor Ambroise Martin, being part of the French food agency (ANSES) panel that approved the original proanthocyanidins (PACs)-based claim in 2004.
Pumpkins and golden carriages…
Medical devices has created a legal loophole that allows companies to make unsubstantiated claims, amplified by unqualified agencies rubber stamping approvals like the one in Luxembourg, Haeaserts stated.
“The end of the cranberry ‘medical device’ scam is in sight,” he said, calling those that pursued the medical devices route, “clever and profiteering”.
They had, “turned around their former food supplements and magically transformed their pumpkin into a golden carriage: A ‘medical device’.”
Haesaerts said cranberry-UTI treatment claims were not backed in the science and damaged the whole sector.
“This therapeutic indication means that the products could be considered to cure UTIs which actually means replace antibiotics. These dangerous and false claims may have caused substantial damage to the reputation of cranberry PACs bacterial anti-adhesion effect, which is well known for its contribution to the prophylactic reduction of recurrent UTIs…”
Haesaerts said he would continue to pursue others utilising the medical devices route.
“More are to follow and it appears that Pharmatoka’s intense lobbying with French and European regulators will pay out after all and restore fair competition in the marketplace whilst also eliminating the irresponsible claims that have been thrown at the non-suspecting consumer and health care provider.”
“The party is over now.”
PAC it in?
Arkopharma was unavailable for comment but Medical Brands, the Dutch player that achieved the first ‘Class IIb medical device’ cranberry-UTI registration in 2011 (‘I-Say’), said Arkophrma had been asking for trouble all along.
“Arkopharma used the medical device directive to attempt to reclassify their product from heaving no health claim to having a medical claim,” CEO Maikel Hendriks told us.
He said the crucial difference between I-Say and Cys-Control was the fact Arkopharma had based its application on cranberry’s PAC content’s ability to treat UTI – the same constituent already rejected by EFSA for prevention of UTI.
“When Arkopharma decided to register their PAC-based food supplement, they directly ignored EFSA opinions and made this into a borderline discussion [by the Luxembourg agency],” Hendriks said.
I-Say’s medical device dossier [not submitted to Luxembourg] had not been built on PAC science but other constituents to demonstrate the mechanism of action for prevention and treatment as the ‘Class IIb medical device’ directive demands.
“Competent authorities have questioned our compliance with the medical device directive. After supplying the scientific evidence the competent authorities have been satisfied.”
Hendriks added: “Self-care medical device is the fastest growing category in OTC [over-the-counter] products. Like every new category there will be questions and companies that are taking advantage. It is up to the industry to ensure a level playing field.”
After publication, David Hudson, spokesperson for Consumer Policy at the EC said: "The Commission is in the process of discussing with member states in the relevant working groups the classification of products that are on the borderline between the legislation on food supplement, medical devices and pharmaceuticals. The aim is to reach a common agreement on the main criteria to be applied for this classification."
See Hendriks talking about medical devices here
See Haesaerts talking about them here .