Probi chief executive officer Michael Oredsson said his company was baffled by EFSA’s response to its appeal, which it said failed to address the issues it raised in the appeal to EFSA’s initial opinion published in April, 2009.
“We didn’t really get any comments on our appeal and we will seek a dialogue with EFSA and the Commission since we believe it is still unclear why our application and the case we put forward in our appeal has been rejected,” Oredsson told NutraIngredients.com.
“We will see if ‘unofficial’ dialogue is at all possible since there is very little available in terms of official dialogue. We are puzzled by the opinion since we have used clinical protocols that are considered state of the art in the case of iron absorption.”
The article 13.5 claim proposed a link between consumption of the probiotic strain, Lactobacillus plantarum 299v (DSM 9843), and improved iron absorption in adults at risk of iron deficiency.
Probi’s appeal statements were backed by the Dutch Association of Natural Products Manufacturers (NPN) but in response, the head of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), Dr Juliane Kleiner, wrote:
“The Panel would like to state that the arguments brought forward by the applicant and the NPN do not change the conclusions of the opinion. We consider that the scientific issues raised have already been adequately covered in the EFSA opinion.”
EFSA is yet to issue a positive opinion for any probiotic health claim.
Flaws
In its appeal Probi highlighted what it believes are flaws in EFSA’s assessment of its dossier such as undervaluing small-sample studies and employing mandatory p-values of 0.05 per cent.
Probi said it had employed ‘gold-standard’ methodologies in regard to iron absorption testing and that its sample sizes were large enough to derive a significant effect.
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. No fresh data was submitted.
In its April opinion, the NDA noted five studies relevant to the claim, and rejected them all for the above reasons although it did not dispute that improved iron absorption may be beneficial for human health.
Four of the studies were human and employed non-haem iron levels measured by double isotope technique and whole body counting.
In its submission, the NPN stated: “…it is our believe that the opinion is fundamentally flawed, not up to international standards and not in conformity with the Terms of Reference set for EFSA in assessment of article 13 claims."
Iron deficieny affects something like 30 per cent of adults in the world, according to the World Health Organization (WHO). It typically causes anaemia.