Ross S
Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, USA.
Am J Clin Nutr. 2000 Jun;71(6 Suppl):1735S-8S; discussion 1739S-42S. doi: 10.1093/ajcn/71.6.1735S.
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.
由于《联邦食品、药品和化妆品法案》（FFDCA）未对功能性食品给出法定定义，美国食品药品监督管理局无权为这类食品设立正式的监管类别。一种食品监管状态的主要决定因素是其预期用途，这在很大程度上由产品附带的标签及标签信息决定。这些信息包括营养信息、营养成分声明以及各类健康声明。在销售这些食品时，制造商可能会面临几种现有的监管选择之一。制造商做出的有助于确定其产品监管状态的首个决定是该产品是食品还是药品。因此，制造商和零售商的产品可能会被归入一系列法律和监管类别。本文介绍了FFDCA中对药品和食品的定义、各类食品的安全及标签要求，以及膳食补充剂可能的声明类型。
