In 1994, the 103rd US Congress passed the Dietary Supplement Health and Education Act (DSHEA). This legislation, along with previous laws and the 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act, has provided the US Food and Drug Administration (FDA) with statutory authority to regulate dietary supplements and those who manufacture, distribute, and sell them. It also enabled FDA to take enforcement action against unsafe or mislabeled products and those who sell them—fulfilling the agency's mandate to protect and promote public health and safety. A comprehensive framework of regulations also has evolved through the public notice and comment rulemaking process. These regulations address essential aspects of the safety, labeling, health-related claims, and quality of dietary supplements. Consistent with its legal mandate, FDA has taken a primary role—using interagency collaborations as needed, particularly with the Federal Trade Commission (FTC)—to pursue enforcement actionsagainst non-compliant products and companies. And yet, critics still charge that the dietary supplement industry remains "unregulated" and many members of the media use this word to characterize it. This is a myth. Today, dietary supplements represent a major industry in the national marketplace, the products of which are used widely and safely by millions of Americans under a comprehensive set of statutes of regulations.
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