Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

J Nutr. 2015 Aug;145(8):1683-6. doi: 10.3945/jn.115.211102. Epub 2015 Jun 10.


The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting.

Keywords: Dietary Supplement Health and Education Act; adverse event reporting; current Good Manufacturing Practices; dietary supplement; premarket approval; regulation; structure/function claim.

Publication types

  • Historical Article

MeSH terms

  • Dietary Supplements / standards*
  • Drug Industry / history
  • Drug Industry / legislation & jurisprudence
  • Drug Industry / standards
  • Government Regulation / history
  • History, 20th Century
  • History, 21st Century
  • Humans
  • Legislation, Food / history*
  • United States
  • United States Food and Drug Administration