EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said Probi’s article 13.5 claim dossier contained studies with conflicted findings, sample populations with insufficient numbers and inconsistent dosages.
EFSA is yet to issue a positive opinion in regard to any probiotic claim although claims experts have noted that so far none of the assessed dossiers have been very strong and files submitted by the likes of probiotic giants Danone and Yakult have yet to be assessed.
It has rejected around ten probiotic-related article 13.5 and article 14 claims since the process began that is attempting to establish a central list of approved claims throughout the European Union by the end January, 2010.
Probi said it was considering its response to the opinion. “We will study it further and decide upon a course of action,” Probi research director, Niklas Larsson told NutraIngredients.com this morning. “We are not the first company EFSA has said no to and this health area is a very small part of our product portfolio.”
He said he was unaware of additional science in the area of probiotics and iron absorption that may strengthen the claim.
In regard to one of the NDA’s qualms that study populations were small, he noted that while this was the case, the results were significant.
“The regulation requires that you submit all clinical data in the area so that is what we did – some of the studies were stronger than others but that is the nature of the process,” he said. “This is a very specific area and the number of studies is not as great as other areas.”
The NDA noted there were five studies relevant to Probi’s submission that presented the ability of theLactobacillus plantarum 299v (DSM 9843) strain to improve iron absorption in adults at risk of iron deficiency. It found fault with all of them, either alone or in totality.
While the NDA did not dispute that improved iron absorption may be beneficial for human health, it found the five studies did not demonstrate causality as dosages varied, sample groups were too small and results inconsistent.
Four of the studies were human and employed non-haem iron levels measured by double isotope technique and whole body counting. Only two of the studies were published. The fifth was an unpublished in vitro study.
In two human, randomised, double-blind, crossover studies an oat gruel product fermented with L. plantarum 299v was compared with pasteurised fermented oat gruel, pH-adjusted non-fermented gruel and non-fermented gruel with added organic acids.
The study authors observed the control groups had up to 55 per cent less iron absorption than the select group, but the NDA said no power calculations were reported, and that the products differed in more ways than just their probiotic content, which compromised the results.
Another study involved 18 young women with low iron stores given a similar gruel product, in addition to iron supplements to determine colonic absorption, but no significant changes were detected, according to NDA.
In another two studies an iron and L. plantarum-supplemented fermented fruit drink was given to women aged 22-40 with low iron counts but who were not anaemic.
The statistically significant results of one study were combined with the non-significant result of another so that the absorbed iron levels were 28.8 per cent compared to 19.3 per cent for the combined control products.
NDA said this was “questionable especially as the studies used two different doses of L. plantarum 299v. Also, the positive effects observed in one of the studies could be overestimated when combined with the other study.”
The unpublished in vitro study provided “only very limited supportive evidence”.
Iron deficieny affects something like 30 per cent of adults in the world, according to the World Health Organization (WHO). It typically causes anaemia and is most prevalent in the developing world.
In Europe, iron deficiency remains common in pregnant women, children and women of reproductive age.
The full opinion can be found here.