title: Science in the regulatory setting: a challenging but incompatible mix?
abstract: Regulatory decisions informed by sound science have an important role in many regulatory applications involving drugs and foods, including applications related to dietary supplements. However, science is only one of many factors that must be taken into account in the regulatory decision-making process. In many cases, the scientific input to a regulatory decision must compete with other factors (e.g. economics, legal requirements, stakeholder interests) for impact on the resultant policy decision. Therefore, timely and effective articulation of the available science to support a regulatory decision can significantly affect the relative weight given to science. However, the incorporation of science into the regulatory process for dietary supplements is often fraught with challenges. The available scientific evidence has rarely been designed for the purpose of addressing regulatory questions and is often preliminary and of widely varying scientific quality. To add to the confusion, the same scientific evidence may result in what appears to be different regulatory decisions because the context in which the science is used differs. The underlying assumption is that scientists who have a basic understanding of the interface between science and policy decisions can more effectively provide scientific input into these decisions.
authors.affiliation: Office of Dietary Supplements, National Institutes of Health, 6100 Executive Blvd., Rm. 3B01, MSC 7517, Bethesda, MD 20892-7517, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Yetley
mesh_terms: D003257:Consumer Product Safety; D003657:Decision Making; D019587:Dietary Supplements / Q000592:standards*; D017277:Drug Approval; D004348:Drug Labeling; D019317:Evidence-Based Medicine; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug; D018673:Nutrition Policy; D011050:Policy Making; D014481:United States; D014486:United States Food and Drug Administration