With that agency, the European Food Safety Authority (EFSA), in 2011 rejecting generic, article 13 claims submitted in 2008 with input from all major cranberry players including Pharmatoka, Haesaerts has gone solo with a submission that comes just months before the French are set to delete their claim to comply with the European Union’s nutrition and health claims regulation (NHCR).
He said he expected to win the claim after closely following EFSA requirements, and, “a positive impact from the results of new studies that have been published between 2007 and 2012, gaining more insight into the biological action of bioactive cranberry proanthocyanidins (PACs) from the juice and from juice powders.”
“Pharmatoka is convinced that this petition will adequately answer questions expressed by the EFSA panel’s experts in [the 2011 opinion].”
Haesaerts said: “Millions of people in France have been using our and other cranberry food supplements containing 36 mg bioactive PACs measured by the BL-DMAC method. These products have proven their efficacy during the past eight years. Deleting the health claim in France can only confuse both customers and health care providers who have been actively promoting these products.”
“The order that the French authorities had brought to the cranberry food supplement market in now again in jeopardy.”
He added of the claim based on the company’s Urell/Ellura cranberry supplemnets: “We presented this 13.5 petition because EFSA, with all due respect, failed to assess the health claim wording we had submitted and which was the very same that had been approved by the French Agency.”
“We strongly believe that a 13.5 petition is the right way to go, in contrast to the ‘medical device’ road that some have announced after the global 13.1 refusal by EFSA. We also warn against their claim that, ‘cranberries can treat – read: cure – urinary tract infections which simply is not true. Leading health care providers have already pointed to the obvious risk for public health as a consequence of untreated urinary tract infections.”
The French claim stated 36mg of cranberry PACs per day, could, “help reduce the adhesion of certain E.coli bacteria to the urinary tract walls”.