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Abstract
Introduction:
In 2006, the European Parliament and Council issued a regulation (No. 1924/2006) for the nutrition and health claims made on foods, including food supplements. According to the regulation, the use of nutrition and health claims shall only be permitted if the substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect. In the field of joint and cartilage health, there is no clear scientific-based definition of the nature of such a beneficial nutritional or physiological effect. The objective of this paper is to scientifically define the possible content of health claims related to joint and cartilage health and to provide scientific guidelines for the design of clinical studies which need to be adopted to substantiate such health claims.
Methods:
Literature review up to September 2011 followed by a consensus expert discussion organized by the Group for the Respect of Ethics and Excellence in Science (GREES).
Results:
In line with the general principles of the PASSCLAIM and the Codex recommendations, the GREES identified four acceptable health claims related to joint and cartilage health based on the effects on discomfort, joint and cartilage structural integrity or risk factors for joint and cartilage diseases. The GREES considers that randomized controlled trials on a relevant outcome is the best design to assess health claims. Moreover, animal studies could also be of interest to substantiate some health claims, to assess the clinical relevance of endpoints used in human studies or to extrapolate data obtained in patients to the target (apparently) healthy population.
Conclusion:
According to the methodology and biomarkers used in the study and whether or not additional animal studies are provided to support the claim, various health claims can be acceptable in the field of joint and cartilage health.
Transparency
Declaration of funding
No funding has been received for this manuscript
Declaration of financial/other relationships
O.B. has received grants or has been reimbursed for attending meetings from IBSA, MSD, Novartis, Pfizer, Rottapharm, Servier, Theramex and Wyeth. He has also given advice to the European Food Safety Authority and the French Food Safety Agency.
B.A. has received fees from Servier, Novartis, Negma, Amgen, GlaxoSmithKline, Roche, Nycomed, Theramex, UCB, Expanscience, Lundbeck, Janssen Cilag and Horus.
P.R. has received fees from Wyeth/Pfizer, BMS, Expanscience, Genévrier, Sanofi-Avantis, Schering-Plough/MSD, Abbot, Novartis, Ipsen, Ménarini, Negma, Sobi, Savient, Fidia, Servier and Roche.
E.M. has received consulting fees or speakers’ fees for participation at symposia from Expanscience, IBSA-Genévrier, Genzyme, Nordic Pharma, Pierre Fabre Labs, Rottapharm and IRIS-Servier. He worked as investigator for TRB Chemedica.
P.B. is employed by Pierre Fabre.
V.C. has received grants from Danone, Greentech, Lesieur, Rousselot and Servier.
G.B.G. is employed by Expanscience.
A-E.L. is employed by Genévrier.
T.P. is employed by Nutraveris.
F.R. has received consulting fees, payments for participating in advisory boards and meeting presentations or research grants from Negma, GlaxoSmithKline, Rottapharm, Genévrier, Expanscience, Pierre Fabre, Bristol Myers Squibb and Servier.
P.Y-M. is employed by Sanofi.
Y.T. is employed by Servier.
N.U is employed by Grapsud.
L.R. is employed by Rottapharm.
J-Y.R. has received consulting fees or payments for participating in advisory boards for Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, and UCB. He has received lecture fees when speaking at the invitation of Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genévrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Theramex, Nycomed, and Novo Nordisk; and grant support from Bristol Myers Squibb, Merck Sharp & Dohme, Rottapharm, Teva, Lilly, Novartis, Roche, GlaxoSmithKline, Amgen, and Servier.
C.M. and J.G. have nothing to disclose.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgment
The authors would like to thank Professor Ambroise Martin, from University Claude Bernard in Lyon, France, and member of the NDA panel of the EFSA, for participation in the meeting.