Naturex, which acquired the ‘Pacran’ extract in question from Decas Botanical Synergies in 2012, said it stood behind the claim and would turn its focus to other parts of the world – for now.
“We stand behind Pacran’s robust clinical evidence,” said Naturex marketing director, Antoine Dauby, who noted 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.”
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded Pacran did not act, “against bacterial pathogens in the lower urinary tract.”
The article 13.5 emerging and proprietary science opinion can be found here.
CranMax axed
It wasn’t the only cranberry dossier rejected by the NDA. Danish pharma and supplements manufacturer Jemo-pharm A/S also had an article 13.5 claim rejected based on a CranMax extract for the same UTI condition.
“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,” the panel said.
CranMax is manufactured by New Jersey supplier Pharmachem. The company couldn’t be contacted at the time of publication.
The opinion can be found here.