Gras Overhaul: Less Onerous than Feared, but Legal Battle Likely

Brian Sylvester spoke with AgFunderNews about the FDA’s proposed rule that would effectively close the “self-GRAS” loophole by requiring companies to notify FDA of future Generally Recognized as Safe determinations. New ingredients would require full GRAS notices, while legacy self-GRAS substances could use a streamlined process identifying the substance and conditions of use without submitting complete safety dossiers. FDA could subsequently demand fuller reviews and would publish qualifying submissions without endorsing their safety.

Industry experts say the legacy pathway is less burdensome than feared, but implementation could strain FDA resources. The agency expects roughly 98 additional full notices annually, while existing reviews can already take a year or longer, potentially delaying commercialization.

Brian noted, "My advice remains largely the same as before the proposed rule published today. Companies relying on self-GRAS conclusions only should ensure those determinations are fully documented and defensible and that the underlying dossiers could withstand FDA scrutiny if required."

Read the full article.