Journal
DRUG TESTING AND ANALYSIS
Volume 8, Issue 3-4, Pages 424-430Publisher
WILEY
DOI: 10.1002/dta.1892
Keywords
dietary supplements; policy; FDA
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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 (c) 2015 John Wiley & Sons, Ltd.
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