OUP user menu

How the Us Food and Drug Administration evaluates the scientific evidence for health claims

Kathleen C Ellwood, Paula R Trumbo, Claudine J Kavanaugh
DOI: http://dx.doi.org/10.1111/j.1753-4887.2009.00267.x 114-121 First published online: 1 February 2010


Health claims describe the relationship between a substance (food or component of food) and a disease or health-related condition. They were first authorized through the Nutrition Labeling and Education Act of 1990. The standard set by the US Congress for the scientific evidence required to authorize a claim was the significant scientific agreement standard. This strong standard was challenged by several manufacturers of dietary supplements. Several court decisions directed the US Food and Drug Administration (FDA) to provide for dietary supplement claims not meeting the significant scientific agreement standard by adding a disclaimer to the claim that would eliminate the claim's potential to be misleading. In December 2002, the FDA announced a major new initiative, “The Consumer Health Information for Better Nutrition Initiative,” which, among other things, provided for the use of qualified health claims for both conventional foods and dietary supplements. The process for reviewing the scientific evidence for a claim reaching significant scientific agreement and for those that require qualifying language is the same. In January 2009, the FDA issued a guidance document entitled “Evidence-Based Review System for the Scientific Evaluation of Health Claims.” The process used by the FDA to review the scientific evidence for health claims and qualified health claims are described in this article.

  • evidence-based review
  • health claim
  • intervention study
  • observational study
  • significant scientific agreement
View Full Text

Sign in

Log in through your institution

Sign in as a personal subscriber

Log in through your institution

Purchase a personal subscription