The Regulation of Dietary Supplements in the United States

Abstract

Many Americans report using dietary supplements (DS) and there is evidence that the use of such products is increasing. Under the current regulatory system DS are not tested for safety or effectiveness, as with over the counter and prescription drugs, and the Food and Drug Administration (FDA) has limited authority to protect Americans from potential harm. DS in the United States have become a major public health and patient safety issue with injuries, illnesses, and deaths attributed to their use. Efforts in congress to legislate safer regulations have been met with limited success, in part because of the lobbying efforts of the DS industry. Although there is near consensus in the literature and among stakeholder government agencies that a modified FDA role is needed, resolving the issue requires a multifaceted approach. Along with political and legislative action, effort must be made to increase the American public’s knowledge of DS.