German courts pre-empting EC joint health claims
The actions have been brought on the grounds of misleading marketing but Frankfurt-based lawyer, Thomas Buttner, from the firm Forstmann, Buttner, Kruger, said they contravene the 2006 nutrition and health claim regulation (NHCR).
This is because the NHCR permits companies to continue making on-market claims in member states where they have approval until six months after EFSA negative opinions are written into European Community law.
The article 13.1 and article 14 opinions have not as yet been written into the law, and indeed the glucosamine opinions that were rejected on the grounds that the studies provided were not conducted on healthy populations, have raised discussions at European Commission standing committee level.
Misuse of EFSA opinions?
In a letter that formed part of a correspondence between Dutch probiotics company, Winclove Bio Industries, and the European Commission about implementation of the NHCR, Buttner claims German firms are using EFSA opinions to attack their competitors in the courts.
German firms have begun, he wrote, to, “misuse already published Scientific Opinions of EFSA to try to initiate court actions to prohibit all Health Claims which may have something in common with the Health Claim which was … evaluated by EFSA with a negative outcome.”
“Since the Scientific Opinions of EFSA will be published immediately all competitors, authorities and courts can use these scientific opinions for their decisions to evaluate advertising claims. In Germany this has already provoked a lot of court actions with the goal to stop certain Health Claims immediately.”
Preliminary injunctions
The legal mechanism involves preliminary injunctions, and Buttner said he knew of at least two actions in Frankfurt civil courts that had succeeded in prohibiting chondroitin and glucosamine claims being made on food supplements.
He said the practice went against the intention of the NHCR and made a mockery of the six-month transition period granted to firms to remove rejected claims from marketing materials.
Buttner called on the EC to either halt the prior publication of opinions or publish a disclaimer with all opinions that they are not binding and should not be employed to prohibit claims.
In rejecting an article 13.1 glucosamine-joint health/joint support claim in October, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) wrote: “In weighing the evidence, the Panel took into account that the evidence provided does not establish that patients with osteoarthritis are representative of the general population with respect to the status of joint tissues, or that results obtained in studies on subjects with osteoarthritis can be extrapolated to the maintenance of normal joints in the general population.”
