EFSA: healthy population extrapolation possible if data backs it
Speaking at a Cantox Health Sciences International-hosted health claims conference, Juliane Kleiner PhD highlighted gastrointestinal discomfort as an area where data collected on targeted populations could be extrapolated into healthy populations. Her reflection will be of keen interest to pro- and prebiotics players.
However Dr Kleiner cast doubt on whether such extrapolation was possible in the area of joint health and osteoporosis, where she said diseased and healthy joint fibres were sufficiently different to make extrapolation more problematic.
“Provide us the evidence and we will do the extrapolation,” she said, noting, “We are all on a learning curve with this but we are, as we always have been, considering the totality of the evidence.”
She said it was a “value judgement” as to how appropriate study populations were for extrapolation to broader populations.
Guidance on what was up for extrapolation was being built up on a case-by-case basis, she said, and would eventually be added to Q&A guidance documents.
Dr Kleiner recommended the proprietary and emerging science, article 13.5 route as a means for the resubmission of claims that the NDA will process in five months.
A big Thursday
Further insight into the existence (or otherwise) and interpretation of such evidence will be provided this Thursday when the Panel on Dietetic Products, Nutrition and Allergies (NDA) which Dr Kleiner heads publishes a further 400 generic, article 13.1 health claims.
The NDA will then have published about 920 article 13.1 claims, leaving a further 3000 or so on its books, with a commitment to publish another 600 this coming July.
Dr Kleiner told NutraIngredients the NDA had increased its communication with applicants, especially for article 13.5 and article 14 disease reduction and children’s claims on matters such as characterisation.
“We are employing the stop-the-clock procedure more to go back to the applicants with questions.”
But Cantox’s Kathy Musa-Velosa PhD noted Health Canada and FDA actively, “encourage applicants to communicate about ‘data gaps’.”
“Perhaps more could be done in the EU in this area,” she said.
Along withy Cantox claims experts, Health Canada and US Food and Drug Administration representatives joined Dr Kleiner in making presentations about the health claims systems in their countries. While the systems in place in Canada and the US differ from that of the European Union, the broad similarity in scientific standards in all three jurisdictions was noted, with human intervention trials carrying the most weight, but other evidence considered where deemed appropriate.
The lack of established disease risk factors (known as biomarkers in the US and Canada) was discussed, with Musa-Velosa stating the lack of established risk factors in the EU system acted as a hindrance to trial design and submission certainty.
She said the fact the EU 2006 nutrition and health claims regulation failed to define disease complicated matters, and wondered whether EFSA recommending referencing the International Statistical Classification of Diseases and Related Health Problems (ICD-10), would help matters.
She said the example of colorectal polyps demonstrated how diseases and disease risk factors were not always clearly demarcated.
To listen to a podcast with Musa-Veloso on risk factors and biomarkers, click here.