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Presenter: Thea Bassett

Faculty Sponsor: Laura N. Vandenberg

School: UMass Amherst

Research Area: Public Health and Epidemiology

Session: Poster Session 5, 3:15 PM - 4:00 PM, Auditorium, A61

ABSTRACT

This research project examines the efficacy of the U.S Food and Drug Administration’s (FDA) oversight of the “Generally Recognized as Safe” (GRAS) notification system for food additives. The GRAS framework, which lessens the FDA’s role in the approval process of food additives, has been previously criticized for allowing independent manufacturers to determine the safety of their own additives based on assessments by any team of scientific experts, regardless of the experts’ affiliation with the sponsoring corporation. Through an analysis of primary documents and internal FDA correspondence related to the first GRAS notification submitted to the FDA for soy isoflavones by Archer Daniel Midland Company (ADM), this study examines whether the FDA’s implementation of the GRAS statute effectively protects public health. Our analysis found that the FDA failed to adequately address internal or external concerns about the endocrine-disrupting properties of soy isoflavones and disregarded growing concerns about the questionable scientific evidence presented in ADM’s GRAS notification. Despite international pressure to investigate the validity of soy isoflavones’ GRAS status, the FDA remained steadfast in its decision to follow the GRAS framework and relied solely on information provided by ADM in its determination. By adhering to the GRAS system’s flexible nature and allowing soy isoflavones to maintain GRAS status, the FDA set an alarming precedent for subsequent GRAS notifications. The findings of this research raise questions about the current oversight of food additive approvals and highlight the need for independent review within the GRAS notification process.