This paper presents an analysis of the underlying assumptions and choices of the European regulatory process for health claims. The latter are scientifically substantiated statements, usually in the form of food labels, regarding the health benefits that a food may confer upon its consumer. We show that the European regulator (the European Food Safety Authority, EFSA) has adopted a particular construction (or definition) of a standard consumer of foods with health claims, as well as chosen to give preeminent importance to one particular objective of this regulation (protecting consumers from false claims). EFSAs choices of standards of proof (establishment of causality between food intake and desired outcome) and scientific methodology (randomized controlled trials) are coherent with this objective and the adopted definition of the consumer. We argue that it is not clear if consumers will react to the regulation as intended by the regulator, due to the possibility that only a fraction of consumers actually correspond to the regulators definition of a standard consumer of foods with health claims. We conclude that only empirical research on actual consumer uptake of the EU regulation would allow for an assessment of its effectiveness.