More than 50 questions – many of them highly specific to areas such as stool function and immune biomarkers – came from the floor for the nine Dietetic Products, Nutrition and Allergies (NDA) panelists or sub-working group members on-stage, headed by Juliane Kleiner, PhD.
Most of the questions sought clarity and guidance on what the NDA expected in a gut/immune claim submission – provoking a typical mantra that the science was emerging; that the regulation was a learning experience for all parties including the NDA; that it was very much adopting a “case-by-case” approach.
Fifty seven industry members, industry groups and academia had submitted comments to EFSA in the lead-up to the event, but most left feeling their concerns about biomarker validation; about trial design; about disease versus disease risk reduction had not been eased.
Frederic René, vice president of research and development at Danone Dairy, summed up the typical lacklustre response to the day when he told NutraIngredients: “For the day we spend, in fact there is nothing really new.”
René said the world’s biggest probiotics player, and therefore the company with potentially the most to lose if the NDA continues with its 100 per cent probiotic rejection rate, was still none-the-wiser about EFSA’s dossier requirements.
Danone – owner of drinkable yoghurt Actimel and spoonable yoghurt Activia – would wait for the official gut/immune health guidance, that would collate input from the previous comments and the Amsterdam meeting, he said.
Cook book claim making
Martin Katan, PhD, professor of nutrition at the VU University Institute of Health Sciences in the Netherlands, defended the NDA’s approach, and noted the day was characterised by, “lawyers asking legal questions to scientists”.
“From [the industry] point-of-view they are completely right, saying how much percent in which outcome should we find to be able to make a claim? but that’s not how science advances. I think the NDA panel quite rightly refuses to provide a cook book on how to validate the claim.”
“I think this field needs more serious mainstream science and less legalistic reasoning.”
Procedure
Professor Albert Flynn, the chair of the NDA, reiterated on the day that his panel is simply following the procedures as laid out in the 2006 nutrition and health claims regulation (NHCR) – and that means a very strict interpretation of the link between nutrients and disease risk reduction or beneficial effects.
At times a certain frustration at this state of affairs emanated from the NDA panellists when many questions were answered with the phrase, “We are bound by the regulation”.
“The legislature states you must reduce the risk factor of disease. It may not always make scientific sense but that is what is in the regulation and that is what we must follow,” professor Flynn said.
He said the day had provided much that would assist the agency in developing further guidelines in the gut health/immunity area.
Case-by-case
Many of the questions sought parameters from the NDA – how to measure stool consistency; what kind of outcomes were needed to demonstrate gastrointestinal dysfunction; is traveller’s diarrhoea a symptom or a disease (or both)?.
Time and again the NDA’s responses were similar – how can we tell you this when you have as much expertise as us? We can only look on each submission on a case-by-case basis.
Such responses only increased the sense of frustration in the room, with many accusing the NDA of failing to take responsibility for leading the way in biomarker development, trial design and clarifying its own methodologies.
Usually at least ten hands shot into the air when the opportunity came to ask questions with representatives from the likes of Danone, Beneo, Lallemand, Winclove, Yakult, Danisco and Unilever as well as consultants and academics all given plenty of floor-time to voice their concerns.
One leading probiotics supplier said the meeting had provided an opportunity to garner support for a formal motion against EFSA’s treatment of gut and immune health claims.
The draft guidance document, which will be updated in January, 2011, can be found here.
Some things EFSA said
In response to questions, EFSA said:
- It could not provide set guides for measuring stool consistency
- The NDA does not have the resources to engage in pre-assessment of claim submissions to give guidance on matters such as trial design
- Questionnaires (for instance in regard to IBS) are submissible
- Reducing diarrhoea is a beneficial physiological effect
- Effects recorded in non-EU populations are admissible
A webcast of the day can be found here.
The panelists were Albert Flynn, Henk van Loveren, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Martinus Løvik, Stephan Strobel, Maria Saarela and Juliane Kleiner.