The role of epistemic policies in regulatory science: scientific substantiation of health claims in the European Union

Abstract

This paper presents an analysis of the concept of scientific substantiation in European health claims regulation. It focuses on the controversies about the demand for the establishment of cause-and-effect relationships between food consumption and health outcomes in claim substantiation. Our analysis, on the basis of regulatory and scientific documents, identifies two opposing views about the aims of health claims regulation. Each of these two stances links certain regulatory objectives with specific epistemic policies, that is particular sets of scientific methodology, criteria, and procedure. The regulators, in selecting a demanding evidentiary approach based on a hierarchy of methodologies that requires causal data for substantiation of claims, give priority to preventing the authorization of false claims. The opposing view, espoused by the critics of this approach, opts for less demanding requirements for substantiation, implying the market availability of a wider range of products with health claims that may provide individual as well as public health benefits. We argue that one of the objectives that underlie the European regulators’ demand for causal data is to protect their own credibility, by trying to isolate them from value-laden debates about the limitations of scientific methodologies, as well as the societal and policy implications of regulatory decision-making.