title: Functional foods: the Food and Drug Administration perspective.
abstract: 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 accompanying the product. This information includes nutrient information, nutrient content claims, and various types of health claims. In marketing these foods, manufacturers may come under one of several existing regulatory options. The first decision manufacturers will make that will help determine their 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 categories 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 claims for dietary supplements.
authors.affiliation: Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, USA. sross@cfsan.fda.gov
authors.forename: S
authors.initials: S
authors.lastname: Ross
mesh_terms: D019587:Dietary Supplements; D004348:Drug Labeling; D005515:Food Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D007880:Legislation, Drug; D007881:Legislation, Food; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration