Abstract
In this paper we present an analysis of the role of randomized controlled trials (RCTs) in the regulation of health claims (claims about additional health benefits provided by foods). Currently there is a line of thought in the nutrition sciences and in regulation that data from RCTs may be able to minimize, or even make superfluous, the role played by expert knowledge in decision making. We analyze the limitations of, as well as the possible intervention of expert judgment in RCTs in pharmacology and nutrition. As a result of our analysis, we argue that both RCTs and expert knowledge are necessary for data generation in health claim regulation. We argue that as far as data generation is concerned, nutrition is more complex than pharmacology, implying that RCTs are more difficult to effectively design and execute. What the latter means is that in nutrition and health claim regulation, expert knowledge is even more important than in pharmacology.
Keywords:
Health-Claim; Evidence; Nutrition; Decision-Making; RCT; Expertise