Dietary Supplement Regulation in the United States

Abstract

Dietary supplements play an important role in the growing nutrition industry in the United States and across the globe. Health and food safety authorities such as Health Canada, the European Commission, and the U.S. Food and Drug Administration continue to develop and implement regulations aimed at ensuring consumer access to safe and effective products. In the United States, the Federal Food, Drug, and Cosmetic Act (FDCA) governs dietary supplements under the larger category of food. However, it was not until 1994 that the Dietary Supplement Health and Education Act amended the FDCA to give definition to the term “dietary supplement” and to establish a regulatory framework specific to supplements. This Springer Brief aims to review and discuss the many current statutes and regulations addressing dietary ingredients, manufacturing standards, safety, labeling, and claims, all of which promote the safe use of dietary supplements and preserve continued consumer access. This Brief also provides an overview of how dietary supplements are regulated in Europe, Canada and Japan.