Health claims regulation and the hierarchy of evidence

The European regulatory process for health claims (claims about a relationship between consumption of specific food ingredients and desired health outcomes) has sparked debate about the level of evidence that can be considered... [ view full abstract ]

The European regulatory process for health claims (claims about a relationship between consumption of specific food ingredients and desired health outcomes) has sparked debate about the level of evidence that can be considered adequate for authorization of such claims. Our contribution analyzes the controversies about methodological choice that underlie regulatory decision making by way of a study of regulatory documents and scientific publications. Central to the operationalization of the regulation, which is responsibility of the European Food Safety Authority, is a hierarchy of evidence. This hierarchy of methodologies for generating regulation-relevant data encompasses, in descending order, human (intervention and observation), animal, in vitro and other types of studies. Current regulatory practice places a higher value on the former types of studies, particularly human intervention trials, in line with clinical trials for pharmaceuticals. In this way the regulatory process aims at minimizing false positives in order to protect consumers from insufficiently substantiated claims, but has made obtaining positive evaluations for health claims difficult. This raises the question as to the adequacy of applying such a hierarchy of evidence in health claim regulation, given that it is not clear if methodologies for data generation taken from pharmaceuticals regulation are adequate for the nutrition context. Our results show that those who criticize reliance on data from human intervention studies point to the necessity for relaxing the standards of proof and selecting other scientific methodologies on the basis of non cognitive values