Glucosamine joint health opinion questioned by EC committee

15-Feb-2010 - Last updated on 04-Jun-2010 at 10:24 GMT

At least one European Union member state has queried a recent reduced cartilage degeneration article 14 health claim submission that was turned down by EFSA partially because the studies submitted were not conducted on healthy populations.

At a January 26 meeting of the Standing Committee, on the Food Chain and Animal Health Section on General Law, the opinion was sent out to member states for “reflection” after questions were asked about the European Food Safety Authority’s methodology regarding the relevance of trials conducted on diseased populations to health claims aimed at healthy populations.

One member state attendee said the extrapolation of results between populations should be evaluated on case-by-case basis and not ruled out point blank. Another held the opposite view, stating such extrapolation was scientifically unsound and potentially misleading to consumers.

EFSA’s article 14 opinion on the claim submitted by Dutch-based GP International Holding can be found here.

Extrapolation

Brussels-based consultancy, EAS Services, said the dismissal of trials conducted on diseased populations had been a factor in the rejection of a number of generic article 13.1 health claims, including a glucosamine-joint health claim.

"We understand that EFSA needs to ensure that the target group of the claim needs to match the target group on which the studies are performed, or that the studies allow extrapolation to this target group," said EAS regulatory affairs manager, Stefanie Geiser.

"However, it is currently not clear where the line is drawn. It is difficult for companies to understand which type of health condition will be accepted under the claims regulation and which will not. In addition it is difficult to understand why and on which basis certain studies performed on patients and relating to certain health conditions should be excluded, taking into account that disease risk reduction claims are included in the scope of the EU claims regulation. We therefore very much welcome that the Commission, member states and EFSA are now discussing the criteria for acceptance of such studies in more detail."

The issue is not due to be discussed again at committee level until April.

EFSA’s own guidelines highlight the fact that studies performed on non-healthy populations may be used as supporting evidence and should be evaluated on a case-by-case basis.

In rejecting GP International Holding’s article 14 dossier, EFSA’s Panel on Dietetic Products, Nutrition and Allergies noted that no studies had been provided on people without osteoarthritis.

It also pointed to, “the lack of evidence that patients with osteoarthritis are representative of the target population, and the lack of evidence that the in vitro study can predict an effect on cartilage degeneration in humans.”