Functional foods: the Food and Drug Administration perspective

Because the Federal Food, Drug, and Cosmetic Act (FFDCA) does not provide a statutory definition of functional foods, the Food and Drug Administration has no authority to establish a formal regulatory category for such foods. The primary determinant of the regulatory status of a food is its intended use, which is determined largely by the label and labeling information acc ompanying the product. This information includes nutrient information, nutr ient content claims, and various types of health claims. In marketing these foods, manufacturers may come under one of several existing regulatory opt ions. The first decision manufacturers will make that will help determine t heir product's regulatory status is whether the product is a food or a drug . Thus, manufacturers and retailers have a range of legal and regulatory ca tegories in which their products may be classified. This article describes the definitions provided in the FFDCA for a drug and a food, the safety and labeling requirements of various food categories, and types of possible cl aims for dietary supplements.