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Authors

  1. Ellwood, Kathleen C. PhD

Abstract

Health claims were first authorized through the Nutrition Labeling and Education Act of 1990. The standard that the Congress set for scientific evidence for the claim was the significant scientific agreement standard. This standard was challenged by several manufacturers of dietary supplements. Several court decisions directed the US Food and Drug Administration to provide for qualified health claims on dietary supplements. In December 2002, a major new initiative, "The Consumer Health Information for Better Nutrition Initiative," was announced by the Food and Drug Administration. This initiative provided for the use of qualified health claims for both conventional human 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. The Food and Drug Administration must determine the claim language and disclaimer for each claim. Several letters of enforcement discretion for qualified health claims have been issued by the Food and Drug Administration