Sucralose: The Sugar of the New Millennium - FDA's Role: A Hindrance or a Help?

Abstract

On April 3, 1998, McNeil Specialty Products was granted approval by the Food and Drug Administration (FDA) to market sucralose under the trademarked name "SPLENDA." Americans have been deprived the opportunity of this "miraculous" sugar substitute due to the laborious and politicized FDA approval process for new food additives. As a result, the FDA deprived consumers, or consumers in consultation with health care providers, from making choices about the use of this important food additive. The Amendments that passed in 1958 required FDA approval for the use of a food additive. As stated previously, the FDA is empowered with the responsibility of insuring that the use of any food additive is safe. In order for the FDA to approve a food additive, the sponsor must present data that the food additive is safe for that use. For example, a petition for the proposed food additive must be filed, similar to the FDA petition process. In 1991, the FDA proclaimed stevia as an unsafe food additive and completely banned the use of stevia. As such, an increasingly popular avenue to avoiding the FDA route is to classify a product not as a food additive, but simply as a food or a dietary supplement.

Keywords: sucralose, FDA, food additive, dietary supplement

JEL Classification: I18, K23, K32