Ocean Spray vows to return with more evidence

Fruit drinks supplier Ocean Spray said it would rethink the design of the clinical studies it carries out following the rejection by EU scientists of its health claim application relating to cranberries and urinary tract health.

The growers' co-operative was seeking approval under the European Nutrition and Health Claims Regulation to make an Article 14 disease risk reduction claim for its range of cranberry beverages and dried fruit products, Craisins.

It submitted a dossier to the European Food Safety Authority (EFSA) containing evidence that consumption of two servings per day of an Ocean Spray product, each containing 80mg of cranberry proanthocyanidins (PACs), helped reduce the risk of urinary tract infection (UTI) in women.

Ocean Spray said it was thought that PACs, an antioxidant that occurs at naturally high levels in cranberries, prevented UTIs by preventing E. Coli bacteria from attaching themselves to the bladder wall. It told EFSA it wished to make the claim: "Helps reduce the risk of urinary tract infection in women by inhibiting the adhesion of certain bacteria in the urinary tract."

But EFSA's Panel on Dietetic Products, Nutrition and Allergies (NDA), which assessed the application, said the dossier submitted was "not sufficient to establish a cause and effect relationship between the consumption of Ocean Spray cranberry products and the reduction? of the risk of UTI in women."

Issuing its opinion, the NDA panel said it accepted the claim proposed by Ocean Spray did constitute a benefit to health and accepted that in vitro studies cited by Ocean Spray demonstrated that cranberry products had the anti-adherence effect on bacteria claimed.

However, it found fault with all 12 of the human intervention studies submitted by Ocean Spray. Six concerned patients with conditions that rendered them irrelevant to Ocean Spray's target market of healthy women aged 16 or over, the panel said. Another study, said the NDA, involved PAC dosages six times higher than the 160mg per day quoted by Ocean Spray. The other five studies, including two sponsored by Ocean Spray, the panel rejected on various technical grounds which, it said, limited their value.

The NAD panel said it considered that "the provided studies do not establish that the anti-adherence effects of cranberry products in urine shown in vitro are predictive of the occurrence of a clinically relevant bacterial anti-adherence effect within the urinary tract under the conditions of use proposed for the claim."

Ocean Spray said it would endeavour to conduct studies in the future that would satisfy the NDA panel's criteria. In a statement, Ocean Spray said, "EFSA's opinion establishes the key foundations of the Ocean Spray's cranberry health proposition and provides us with a good platform for future research."

"We thank the NDA panel for its work and are pleased that it has recognised that proanthocyanidins are present in our products and that the anti-stick mechanism they exert is at work in helping remove E coli bacteria from the body," said Jared Konstanty, managing director of Ocean Spray Europe, Middle East and Africa.

"The NDA opinion demonstrates that the science is in place. Our clinical trials to date have been well received, and published in respected, peer-reviewed journals including JAMA. For the future we need to ensure our clinical studies are carried out to meet the exact requirements of the NDA Panel. We are committed to further research to ensure we reach these levels."