title: Breaking the gridlock: Regulation of dietary supplements in the United States.
abstract: Despite increasing use of dietary supplements by millions of consumers, regulation of these products has not kept pace with changes and risks in the market. A major reason for this policy gridlock is the inability of different parties to come to an agreement on a path forward. The purpose of this paper is to set out a new framework for regulation in which consumers, industry, and regulators can all find common ground. This framework is based on a conceptual shift from 'benefit versus risk', the model for prescription drugs, to 'access with safety'. Steps should include registration of all dietary supplements to permit easier enforcement against rogue products, a stronger disclaimer explaining the limited role of FDA in evaluating structure/function product claims, the establishment of standard laboratory techniques for characterization of products, and more clear authority for the agency when safety concerns arise. Copyright © 2015 John Wiley & Sons, Ltd.
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.
authors.forename: Akshay
authors.initials: A
authors.lastname: Kapoor
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA.
authors.forename: Joshua M
authors.initials: JM
authors.lastname: Sharfstein
mesh_terms: D019587:Dietary Supplements / Q000592:standards*; D006291:Health Policy; D006801:Humans; D007753:Laboratories / Q000592:standards; D007881:Legislation, Food; D014481:United States; D014486:United States Food and Drug Administration
keywords: FDA; dietary supplements; policy