EFSA health claim opinion

EFSA cans cranberry health claim

By Shane Starling

- Last updated on GMT

Related tags: Ocean spray, Urinary tract infection

EFSA cans cranberry health claim
The European Food Safety Authority (EFSA) has issued a negative opinion to global cranberry leader Ocean Spray for an article 14 health claim relating consumption of cranberry and urinary tract infection (UTI) in women.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found Ocean Spray’s scientific dossier failed to support a link between UTI reduction and consuming Ocean Spray cranberry products containing 80mg of cranberry proanthocyanidins (PAC) per serving.

Cause and effect

Ocean Spray submitted its claim in relation to juice drinks and dried berries but the NDA took issue with several of the studies submitted, noting some used different formulations to those proposed in the claim, others had small samples or lacked a control group, were not sufficiently lengthy or had high drop-out rates.

These flaws limited “their value as a source of evidence to substantiate the claimed effect”, ​the NDA said of Ocean Spray’s submitted claim that stated: “Helps reduce the risk of urinary tract infection in women by inhibiting the adhesion of certain bacteria in the urinary tract”.

It applied to women over the age of 16.

The NDA acknowledged that anti-adherence properties had been demonstrated in in vitro ​trials, but these had not been backed by the clinical trials, “under the conditions of use proposed for the claim.”

It therefore concluded: “..the evidence provided is 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 by inhibiting the adhesion of certain bacteria in the urinary tract.”

Exact requirements

In response, Ocean Spray highlighted the fact the opinion acknowledged the role of proanthocyanidins (PAC) in fighting UTIs and pointed to the peer-reviewed, clinical trials that 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,”​ said the managing director of Ocean Spray Europe, Middle East and Africa, Jared Konstanty. “We are committed to further research to ensure we reach these levels.”

The NDA found that six of the 12 studies submitted by Ocean Spray were irrelevant because they were not conducted on a normal population of over-16-year-old women. One was ruled out because it used doses six times stronger than those proposed for the claim.

The other five were discounted for lacking statistical power, insufficient trial length and inadequate randomisation.

France approved a cranberry-UTI claim in 2004 and it remains the only country where such a claim exists. It is uncertain how the EFSA decision, if mandated by the European Commission and member states, will affect the status of the French claim.

The opinion can be read here​.

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