Breaking the gridlock: Regulation of dietary supplements in the United States

Akshay Kapoor, Joshua M. Sharfstein

Research output: Contribution to journalComment/debatepeer-review

12 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)424-430
Number of pages7
JournalDrug Testing and Analysis
Issue number3-4
StatePublished - Mar 1 2016


  • Dietary supplements
  • FDA
  • Policy

ASJC Scopus subject areas

  • Analytical Chemistry
  • Environmental Chemistry
  • Pharmaceutical Science
  • Spectroscopy


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