There are ‘credible legal questions as to whether FDA has the legal authority to eliminate self-GRAS,’ say legal experts

Brian Sylvester spoke with AgFunderNews about the FDA's proposed rule that would eliminate the self-affirmed GRAS pathway, requiring mandatory submission of GRAS notices for food substances. Brian advises companies to "ensure their GRAS determinations are fully documented and defensible, and that the underlying dossiers could withstand FDA scrutiny if required." He also cautioned that firms should "not assume that mandatory submissions will ultimately be required," noting credible legal questions as to whether the FDA has the authority to eliminate self-GRAS without Congressional action. The article explores the potential legal and practical impacts of the proposed rule, including ambiguity regarding the status of self-GRAS ingredients already on the market.

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