Health claims and observational human data: relation between dietary fat and cancer

The US Food and Drug Administration review that provided the basis for auth orizing a food-label health claim linking the risk of cancer to dietary fat intake illustrated several considerations in the use of epidemiologic data , and observational data in particular, to support dietary recommendations. The review suggested the need for clear and established criteria for judgi ng the qualify of observational human data as well as the importance of mak ing the evaluation process for individual studies transparent and organized . The review, which provided for a claim in the absence of controlled human studies, also suggested that observational data may play a greater role wh en the nature of the relation to be described by a health-claim statement i s broad and general rather than targeted and specific. Of particular import ance was the relevance of available data to the questions inherent in showi ng a diet-disease relation, the need to consider the totality of the eviden ce, and the key role that existing authoritative reports must play in estab lishing the basis for relation.