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Breaking the gridlock: Regulation of dietary supplements in the United States
Author(s) -
Kapoor Akshay,
Sharfstein Joshua M.
Publication year - 2015
Publication title -
drug testing and analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.065
H-Index - 54
eISSN - 1942-7611
pISSN - 1942-7603
DOI - 10.1002/dta.1892
Subject(s) - gridlock , enforcement , disclaimer , public economics , business , rulemaking , agency (philosophy) , clean air act , pace , product (mathematics) , function (biology) , economics , law , political science , politics , air pollution , philosophy , chemistry , geometry , mathematics , organic chemistry , epistemology , geodesy , evolutionary biology , biology , geography
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.