Issues in the substantiation process of health claims.

Attempts are being made at the international level within the framework of the Codex Alimentarius to establish guidelines for health claims. An important issue that has to be addressed is the process of substantiating any health claim. Previous papers have addressed aspects relating to the development and regulatory control of functional foods and certain issues relating to claims. This paper addresses several issues concerning the substantiation of health claims through the examination of the regulations and guidelines in several countries. They include (1) importance of human- and product-based studies; (2) concept of scientific consensus; (3) authorization of claim wording; (4) availability of scientific evidence to public (confidentiality). The paper finally proposes a system based on generic and innovative health claims.