ABSTRACT: Functional foods are intended to help consumers manage or reduce disease risks or support the structure or function of the body. In the U.S.A., the term functional food is an intellectual concept that has not been defined in either statute or regulation. Functional foods are treated as conventional foods for purposes of determination of safety and, as such, are subject to the same regulatory approval process. Interest in and demand for more information concerning the health promoting properties of foods and dietary supplements has steadily increased. However, inequities in the regulatory process including the differing treatment of efficacy claims for dietary supplements and functional foods, confusion between structure/function, health claims, and qualified health claims, and the constraints of severely limited resources have all had an impact on the delivery of accurate information to consumers. Although their efforts are coordinated, different agencies view efficacy claims differently, employing different standards for levels of scientific evidence, and different processes for evaluation. A third-party review process that could provide a consistent and sound scientific basis to the evaluation of the evidence would be desirable. Recent proposals by the U.S. Food and Drug Administration concerning qualified health claims may help consumers get more of the information they need and enable them to make informed decisions.