FDA Statutory Authority to Regulate the Safety of Dietary Supplements

Abstract

For almost a century, the Food and Drug Administration (FDA) has regulated nutrients and other dietary supplement ingredients and products under the food provisions initially of the Federal Food and Drugs Act of 1906 and now of the Federal Food, Drug and Cosmetic Act of 1938 (“FD&C Act”), as amended. Congress amended the FD&C Act through the Food Additives Amendment of 1958 and the Color Additive Amendments of 1960 to strengthen FDA authority over food ingredient safety. In 1976, Congress enacted the Vitamin-Mineral Amendments which provides that FDA may limit the contents of dietary supplements only for safety reasons. In 1994, Congress enacted the Dietary Supplement Health and Education Act (“DSHEA”) to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary supplements and dietary ingredients.