Government Repudiation of Americans’ Safety: A Call for Reformulation of FDA’s GRAS Notification Program

Roxana R. Soroudi


This Article examines a seemingly benign exemption from the legal definition of “food additive.” This exemption allows manufacturers to add substances to food without notice to FDA or the public. The so-called “GRAS exemption” has burgeoned into a black hole through which substances can go to market, inadequately tested and unbeknownst to consumers. This Article proposes changes to the Final GRAS Rule and assesses the likely outcome of pending litigation brought against FDA by a coalition of stakeholders.