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MINERVA GASTROENTEROLOGICA E DIETOLOGICA

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Minerva Gastroenterologica e Dietologica 2017 May 10

DOI: 10.23736/S1121-421X.17.02391-1

Copyright © 2017 EDIZIONI MINERVA MEDICA

lingua: Inglese

Grading health claims by weight of evidence would make for a better-informed public

François A. ALLAERT 1, 2 , Jacques VANDERMANDER 3, Florent HERPIN 2, Gabrielle VENTURA 3

1 Chair for Health Claim Medical Evaluation, ESC Dijon, Dijon, France; 2 CEN Nutriment, Department of Clinical Research, Dijon, France; 3 Synadiet, Paris, France


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In the European Regulation 1924/2006 (1) and especially its first recital; the evaluation of health claims (HC) by European Food Safety Agency (EFSA) was introduced so as “to ensure a high level of consumer protection, [and] give the consumer the necessary information to make choices in full knowledge of the facts…” Now, with 10 years of hindsight since the Regulation was adopted, it can be asked whether EFSA HC process of evaluation that led to a marginal number of accepted claims is consistent with this objective, not just for protecting consumers but for allowing them to decide freely and make informed choices. The aim of this paper is to demonstrate that the inclusion of a ranking of the weight of evidence in the assessment of EFSA’s scientific substantiation of HC would allow consumers to benefit from the very high standard of scientific evaluation performed by EFSA. The definition of standards of proof is a generalized practice and rests on the principle that evaluations of health practices should be understood in terms of descriptions ranging from formal proof from high‐power double‐blind placebo‐controlled studies to rankings based on the consensus views of experts or even agreement among professionals. Grading of weight of evidence – not of scientific expertise – is pervasive in all the recommendations or consensus meetings of health authorities or learned societies. This approach would stimulate research and product innovation as industrials would see a positive return on investment.


KEY WORDS: Clinical trials - European regulation - Health claims - Nutrition

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allaert@cenbiotech.com