Francois Andre Allaert is a Medical Doctor specialized in Public Health, completed his PhD in Biostatistics and Pharm D. He is strongly involved in the field of Medical Evaluation and especially in the evaluation of health claim. He is managing a human clinical center specifically approved by French health authorities for food supplement and enriched food evaluation. He is also managing the Chair for Health Claim Medical Evaluation at the Burgundy University of Dijon. He authored more than 1500 scientific oral communications and publications among which 210 are PubMed referred.
Abstract
In the European Regulation 1924/2006 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 EFSAs 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. The transition from an all-or-nothing system of health claims to a system graded by weight of evidence would be an alternative to the current system. This approach would be more consistent with the rationale of European Regulation which aims both to provide consumers with the best possible information by giving them the opportunity to exercise their free will in full knowledge of the facts and to promote research that meets sound scientific and medical grounds providing a basis for such information.