Christiane Alexander, PhD, senior consultant at German consultancy analyze & realize, said there was little guidance in the guidance about trial design that may win lead to approvals under the EU’s new hyper-strict health claims system.
Impossible demands
“Unfortunately, the guidance paper published last week by EFSA does not provide any useful clues for clinical trial design,” Alexander told us. “This is because what it demands is impossible to meet.”
For this reason she said the, “joint health category remains the most difficult health area of all when it comes to substantiating health claims.”
Referenced measures like mobility, stiffness and discomfort-pain were not useful, Alexander observed, as they were disease symptoms and therefore not permissible as biomarkers under the terms of the nutrition and health claims regulation (NHCR).
The fact the NDA continues to favour studies among healthy populations added to the difficulty of substantiating claims for nutrients like glucosamine and chondroitin, which to date have been denied claims despite backing in the scientific literature and strong food supplement sales.
Conservative attitude
“The industry producing joint health foods and supplements is left to demonstrate the impossible: Disease symptoms in non-diseased people. Preclinical changes in biomarkers like cartilage breakdown are only tolerated as supportive evidence,” Alexander added.
“Although lots of new research has clearly elucidated the molecular and cellular mechanisms leading to joint health pathology, especially in the case of early stages of osteoarthritis, EFSA‘s latest opinion on glucosamine effects submitted by Merck reveals the very conservative attitude still in existence towards joint health research.”
“Unfortunately, this will lead to devastating changes in the market place, opening all doors to dubious products that can be obtained via the internet.”
Some clarification
However Jérôme Le Bloc’h, from thehealth claim and food safety department at French consultancy, Nutraveris, said the guidance to which 29 parties had commented, had provided some clarification – mostly in the joint health area.
“Thanks to the large number of comments provided by various parties, the final guidance has been clarified,” Le Bloc’h said.
“EFSA has specified several key points that will allow the design of new clinical studies potentially accepted by the experts for the substantiation of a health claim related to joint. Even if subjects with osteoarthritis are still rejected by EFSA, some very specific population subgroups may be accepted.”
One example of such a sub-group was obese people with joint discomfort who,“may be accepted as subjects with knee misalignment.”
“This position of EFSA permits the recruitment of a borderline population, i.e. a healthy population but with articular pain/discomfort. Since the studied population is the major rate-limiting factor regarding joint application, this clarification provided by EFSA may appear as a small openness for further applications.”
Other less significant clarifications included the recognition of questionnaires on joint stiffness and discomfort, “in addition to the classical visual analogue scale.”Self-reported outcome measures may also be acceptable.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) issued guidance this month on bone, joints, skin, and oral health claims.
