EFSA’s Panel on Dietetic Products Nutrition and Allergies (NDA) continued to unanimously condemn pre- and probiotic health claim submissions in the recently published fifth batch of article 13, general function claims, provoking academics working in the biggest functional foods category into increased states of agitation.
The NDA is yet to back a single pre- or probiotic health claim submission, and researchers like Reading University’s Glenn Gibson, PhD, and Bob Rastall, PhD, have begun to wonder if “terminal damage” has not already been done to the sector in Europe both academically and commercially.
“We are becoming increasing concerned at the continuing negative attitude of the EFSA NDA panel towards prebiotics and probiotics,” they said in a joint statement to NutraIngredients.
“It is clear to us that the panel have little understanding of gut microbial ecology and they seem to have decided that prebiotics and probiotics are unacceptable no matter what evidence is accumulated. The panel demands a level of substantiation that cannot be realistically achieved in the complex ecosystem of the human gut.”
Terminal damage?
Dr’s Rastall and Gibson highlighted the much-maligned disease-oriented approach the NDA has followed since issuing its first nutrition and health claim regulation (NHCR) opinions in 2008.
“It is completely ridiculous to expect the food industry to provide the level of substantiation that would be required for a drug type intervention – the business models of the two industrial sectors are completely different."
"If something is not done to force some common sense into the NDA panel’s opinions we fear for the future of this sector of the food industry - assuming that prebiotics and probiotics are not already terminally damaged in Europe.”
Fructo-oligosaccharides (FOS) opinion
The recent NDA opinion that found against the ability of FOS to reduce gut pathogens affirmed the gulf between academia and the NDA.
There the NDA repeated its view that, “Increasing the number of any group of microorganisms in the gut, including lactobacilli and/or bifidobacteria, is not in itself considered to be a beneficial physiological effect”.
That position is, Gibson and Rastall complained, “completely out of step with the consensus of the scientists who actually know this field and have produced hundreds of studies to show this.”
“The NDA panel consistently demands substantiation data that are beyond what would reasonably be expected. For instance: ‘The Panel notes that the bacterial groups analysed in these studies are part of the commensal intestinal microbiota, and that no evidence was provided for the characterisation of any of these bacterial groups as pathogens’."
"This is hardly surprising – what do the panel expect researchers to do? Isolate every organism that might potentially be a pathogen and screen it in animals? This is scientific and economic nonsense.”
“The approach to evaluation means that it will always be possible to find some fault in a study, no matter how well conducted.”
Burdens of proof, burdens of healthcare
They said the system, as it stood, was damning one of the aims of the NHCR – to provide better and more reliable consumer information.
“The EU has provided millions of euros of funding in the functional food area over the years and pan-European projects involving hundreds of scientists have resulted in significant advances in our understanding in this field."
"This is likely to come to no practical benefit to EU consumers thanks to the misguided opinions of the NDA panel. This is not case elsewhere in the world and we fail to see why EFSA have not learnt from workable systems elsewhere.”
“These largely rely on the scientific literature, opinions of experts in the field and general peer review. In the long term, if Europeans are denied access to good validated products then the incidence of gut and related disorders will increase."
"This will place a further burden on all member States' health and welfare systems, provoke access to untested and inferior products, increase the expense of accessing prebiotics/probiotics from other continents and eventually achieve exactly the opposite of what the EFSA process was set up to do.”