Former FDA official calls for new regulatory framework for dietary supplements

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Former FDA official calls for new regulatory framework for dietary supplements

Published: Thursday, November 5, 2015

Drug Testing and Analysis

DOI: 10.1002/dta.1892

November 2, 2015


Breaking the gridlock: Regulation of 

dietary supplements in the United States




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. 




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