The scientific opinion from the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) published yesterday found that no cause an effect relationship existed for the claim:
“Daily administration of Yestimun helps to maintain the body´s defence against pathogens”
German firm Leiber had sought to prove that 0.45 g of Yestimun twice a day defended against pathogens in the upper respiratory tract, which causes the common cold.
Eike Hagemann, business unit director Health & Functional food at Lieber, said: “We do respect the opinion of the experts of the NDA Panel, although we have been confident that our provided information including the new study is sufficient to substantiate the claim ‘helps to maintain the body’s defence against pathogens in the upper respiratory tract’.
The unfavourable opinion marks Leiber’s second for Yestimun after EFSA rejected a claim that Yestimun initiated appropriate innate and adaptive immune responses in 2010.
Leiber: EFSA ‘inconsistent’
Hagemann said EFSA had been “inconsistent” in its two opinions.
In the first EFSA opinion, Leiber had submitted a study covering the whole seasonal year that showed only a small reduction in cold episodes during the cold season.
“Based on the information we had the confidence that a new study (now concentrating on the cold season) will provide the needed data. Therefore we started with the planning for the second study just two month after we received the first opinion from the EFSA,” said Hagemann.
However, EFSA dismissed the second study because one-study centre, multicentric design, reported below the statistical hypothesis and had been removed by Lieber in its analysis.
EFSA asked Leiber to take into account the missing study site, but the company refused.
“We can understand the panel’s request for the additional data, but the inclusion would not have provided the demanded significance and therefore would not have given valuable input,” said Hagemann.
Questionnaire feedback not forthcoming
EFSA also queried the validity of two questionnaires used in Leiber’s study submissions.
“Surprising to us, this issue was not questioned in the first opinion and therefore a similar questionnaire was used in the second study as well. Giving this feedback on our first application would have benefited us as adopting overworked questionnaire is a formality.”
Leiber continues to pursue health claim
He continued: “We will proceed to fulfill the requirements on the Health-Claim regulation, but information provided from our two opinions and the EFSA-guideline for gut health & immunity are inconsistent in our view, not leading to a clear statement for the next steps.
“Therefore we notified to the EFSA that we are willing to discuss our further purposes with them directly before starting our third attempt.”
EFSA yesterday also rejected a claim from Minami Nutrition Health to say eicosapentaenoic acid (EPA) “reduces the AA/EPA ratio in blood”.
Another claim from McNeil Nutritionals and Raisio Nutrition to say 2 g a day of plant stanols (as plant stanol esters) reduces cholesterol was also rejected.