Breaking the gridlock: Regulation of dietary supplements in the United States. Issue 3 (2nd November 2015)

• Record Type: Journal Article
• Authors: Kapoor, Akshay; Sharfstein, Joshua M.
• Other Names: Cohen Pieter A. guestEditor.; Brandt Simon D. guestEditor.
• Is Part Of: Drug testing and analysis. Volume 8:Issue 3/4(2016:Mar./Apr.)
• Page Start: 424
• Page End: 430
• Publication Date: 2015-11-02
• Subjects: dietary supplements -- policy -- FDA; Drugs -- Analysis -- Periodicals; Drug testing -- Periodicals; Chemistry, Forensic -- Periodicals; 615.1901
• DOI: 10.1002/dta.1892
• Languages: English
• ISSNs: 1942-7603

Abstract

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. Abstract : Despite use of dietary supplements by millions of consumers, regulation of these products has not kept pace with changes and risks in the market. This paper sets 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."