Maintaining a Level Playing Field: The Need for a Uniform Standard to Evaluate Health Claims for Foods and Dietary Supplements

March 2002

Issue: 57 Food and Drug Law Journal 25-41 (2002).

This article examines the recent decision of Pearson v. Shalala and examines its effect on health claims by food and dietary supplement manufacturers. This article begins by discussing the Food and Drug Administrations' (FDA's) resistance to health claims since the passage of the Nutrition Labeling and Education Act in 1990 and the court's decision in Pearson, which limited the FDA's ability to keep non-misleading information from consumers. Because of both FDA's intransigence and dietary supplement manufacturers' willingness to pursue their legal entitlement, this article predicts that the Pearson decision may lead to the emergence of different standards for evaluating health claims for foods and dietary supplements. It concludes by discussing the harms that could result from FDA's different standards of evaluation and proposes several alternative regulatory approaches for the agency to consider.


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