The scientists, including veteran researchers Glenn Gibson, PhD, Mary Ellen Sanders, PhD, and Gregor Reid, PhD, said more pre- and probiotic experts should be involved in the process, as they called on the arms of the European Union to provide a “clear roadmap to understanding what is required to gain approval for an health claim on food, so that further investment in research is encouraged.”
EFSA has rejected 164 of 164 pre- and probiotic claims to date, and added to that number today in batch 5 of the article 13, general function claims list. See NutraIngredients today for more on that.
“Without doubt, fraudulent or exaggerated claims are being made on some products,” the scientists wrote.
“However, [ISAPP scientists] are concerned that claims supported by solid scientific evidence are also being rejected. They are further concerned that there is a lack of clarity regarding the criteria – from study design through wording of the claim – for a dossier suitable for a positive regulatory opinion.”
The letter questions EFSA’s rejection of science that has demonstrated positive results in peer review studies and journals, and its refusal to accept totality of evidence when particular endpoints do not reach statistical significance.
“…the NDA should adjust its approach on what it requires as the standard of evidence. A requirement of evidence of ‘the highest possible standard’ may be unrealistic for a functional food that is proposed to maintain health or reduce risk of disease.”
“Highest possible standard”
They went on: “In keeping with the legislation EFSA should strive for an assessment process of ‘the highest possible standard’. This would be a process that correctly evaluated the degree of support for a claim, that properly interpreted studies, that evaluated the strengths and weaknesses of studies to determine their true worth, and overall had mechanisms in place to assure that the spirit of the legislation is upheld.
“(It would also include proper distinctions between ‘probiotic’ and ‘prebiotic’, which were confused in the NDA opinion on lactulose) Such mechanisms would include the pre-application meetings and use of ad hoc experts.”
Of pre-submission meetings they said: “A mechanism for pre--‐application meetings should be instituted. This would enable companies to gain NDA feedback on a research approach before launching expensive and time--‐consuming studies. Increased use of scientific experts to augment the NDA panel could provide the expertise and perspective needed for a greater diversity of viewpoints and better balance to the evaluation process.”