Tereos to spend €0.5m to resubmit rejected 'normal defecation' claim
The claim submitted through Beghin Meiji – Tereos Syral’s joint venture with Japanese company Meiji Co – stated the ingredient could “maintain normal intestinal transit regularity by increasing stool frequency” for the general population.
Yet EFSA’s dietetic products, nutrition and allergies (NDA) panel rejected the 13.5 claim, saying “a cause and effect relationship has not been established”.
“The Panel considers that one human intervention study did not show an effect of scFOS from sucrose at a dose of 5.7 g/day for 4 weeks on defecation frequency, consistency of stools or dry faecal mass and that in two other human intervention studies 10 g/day of scFOS increased faecal bulk, whereas higher amounts (12.5 g/day) consumed for shorter period did not,” it said in the opinion.
Speaking with NutraIngredients about the decision, the company said: “After analyzing the justifications regarding the negative opinion given by the EFSA experts and opinions already adopted for similar ingredients and benefits, and even if the EFSA's guidelines are not clear on the subject, we must recognize that our file had the major weakness to have only one positive clinical study for the requested claim at 5 g/day.”
This one study included 128 subjects and showed that after six weeks of scFOS consumption there was a 30% increase in the number of stools per week compared to the control.
The claim dossier included a total of 17 human studies, 11 animal studies and six in vitro studies through a literature review and proprietary data.
Yet Daniel Cochet, marketing and commercial development manager, and Frédérique Respondek, scientific and regulatory affairs manager, said it would be investing in more studies concerning a dose of 5 g per day and resubmitting the dossier by the end of the year.
“We want to obtain the claim. We have the resources, we have the funds,” Cochet said.
He said it was likely to cost around 500,000 euros for the quality and scale required. He estimated a successful claim costs a company at least one to two million euros.
This was based on the assumption that around six positive trials were needed to meet EFSA standards.
This may not be stated explicitly in regulation or EFSA guidance, Respondek said, but was clear from past successes and failures in the area.
The pair said there had been some confusion within the stop-the-clock process whereby EFSA asked it to justify its methods.
“The methodology used in this study has not been criticized by experts. However, they have identified a potential bias in the interpretation of the results. We were asked to clarify our statistical analysis during the Stop of the Clock but not clearly required to send new analysis of the results.”
Respondek said the mistake had taught the company to “to discuss more” and ask EFSA for greater clarification.
Other successful claims concerned higher doses, however the company said it remained convinced of the benefits of scFOS at low dosage.
In October last year EFSA approved a claim from DuPont for its bulk sweetener lactitol and the maintenance of ‘normal defecation’.
Also last year Beneo won a similar defecation claim for its inulin ingredient.
“Six studies involving 86 subjects consistently showed that consumption of ‘native chicory inulin’ at an amount of at least 12 g/day increases stool frequency,” the NDA panel wrote at the time.