Karen R. Zimm, Ph.D.
Jeremy Banaszewski, M.S., Temple University

Abstract

This review article discusses the recent developments surrounding FD&C Red No. 3, a synthetic colorant utilized in various dosage forms. The significance of colorants in product identification and the implications of the FDA’s recent regulatory actions are examined. This article also analyzes historical perspectives, scientific evidence regarding safety, and the possible consequences of the ongoing enforcement of the Delaney Clause.

Keywords

            FD&C Red No. 3, erythrosine, E127, Delaney Clause

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