New Jersey supplier Pharmachem says a European Food Safety Authority (EFSA) rejection of its ‘CranMax’ cranberry ingredient’s ability to prevent urinary tract infection (UTI) in women won’t change its European business plans.
While French supplier Naturex indicated it would turn its attention to other markets after its own ‘Pacran’ cranberry extract was also rebuffed by EFSA, president of Pharmachem subsidiary Proprietary Nutritionals, Dean Mosca, said the firm was disappointed by the rejection, but not disheartened about European prospects in cranberry supplements.
“We continue to see Europe as a large and interesting market,” Mosca told us from the booth of Ingredia – its French-based distributor – at Vitafoods Europe in Geneva.
“Obviously we are disappointed by this but it doesn’t affect our interest in growing our business in Europe.”
But he added: “It does however affect our will to conduct research. The problem here that is not the same in other parts of the world, is that the regulatory ambiguity makes it very hard to determine return on investment. But we will look at the opinion in more detail and hope for further guidance on this.”
Pharmachem-Proprietary Nutritionals did not actually submit the claim rather Danish pharma and supplements manufacturer Jemo-pharm A/S, whose article 13.5 claim submission was based on CranMax.
“One human study from which conclusions could be drawn for the scientific substantiation of the claim did not show an effect of CranMax on reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract,” said EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) of the claim.
The opinion can be found here .
For the other rejection delivered this month by EFSA, Naturex defended its ingredient.
“We stand behind Pacran’s robust clinical evidence,” said Naturex marketing director, Antoine Dauby, yesterday, noting an approved claim by the Korean Food and Drug Administration (KFDA).
“We will continue to pursue permissible health claims in other countries and to help women suffering from recurrent UTIs in Europe and the rest of the world.”
Naturex acquired the ‘Pacran’ extract in question from Decas Botanical Synergies in 2012.
That article 13.5 emerging and proprietary science opinion can be found here .
No cranberry-based claim has yet been approved under the EU nutrition and health claims regulation (NHCR) for UTI.