This paper analyzes the way in which the EFSA has addressed the limitations that the essentiality of nutrients presents to the requirement of obtaining evidence from RCTs for the scientific substantiation of health claims. By redefining the requirements to affirm causality in the case of essentiality of nutrients, the EFSA has constrained the debate on the relevance of different methodologies in the field of nutrition research. However, avoiding this methodological debate does not settle the controversy as to whether the EFSA's evidentiary hierarchy is the best for both investigating causal relationships in nutrition and for achieving social objectives such as fostering innovation and public health.
Keywords: Health claim; nutrition; regulatory science; scientific substantiation; standard of proof.