Dutch-based Medical Brands achieved the ‘Class IIa medical device’ registration via Germany that will permit it to make ‘treats UTI’ claims for its Cranberry-Active product in the European Union’s 27 member states and other nations like Australia that have mutual recognition agreements with the EU.
It is the first time a cranberry product has won such a medical claim, said president, Maikel Hendriks, who noted that the approval came as rejected cranberry health claims were entering EU law books.
“We are now searching for distribution partners,” Hendriks told us. “The product can sell in supermarkets but we prefer pharmacies. It is a borderline product between food and drugs and that is why we have focused on this approval.
“It would not have been possible before the enactment in 1993 of the Medical Devices Directive.”
He said the company had funded a large clinical study utilising Cranberry-Active that demonstrated UTI benefits and referenced about 15 others in its submission.
Medical Brands has a portfolio of about 35 medical products and so never considered a submission under the EU nutrition and health claims regulation (NHCR) that has sucked the juice out of all cranberry submissions so far although resubmissions are in lieu.
“We have never been interested in health claims but we know that this approval is perfect timing given the European Food Safety Authority cranberry rejections,” he said. “So companies that may soon have to alter their product claims due to that law may be interested in this.”
“Decas have been pushing it through their network and we are doing the same and the interest is already strong.”
Of the EFSA position he said, “we were very surprised by the EFSA rejections”, especially given the 2004 approval of a cranberry-UTI claim in France.
One of those EFSA rejections can be found here.
“Clearly our strong intellectual property, technical knowledge and most importantly our commitment to clinical substantiation was vital to the successful medical device registration approval,” said Dan Souza, senior director of sales and marketing for DBS.
Cranberry-Active will retail at about €20 for a 42-capsule pack and is recommended at two pills per day to deliver the UTI benefits to the estimated two thirds of women that suffer from the affliction at some point in their lives. It is manufactured by Medical Brands.
Medical Brands’ biggest markets are France, Spain and Poland and it is developing a presence in China, Taiwan and other south eastern Asian markets.
It will showcase the product at the Vitafoods expo and conference in Geneva, Switzerland, on May 22-24.