"On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the FDA to revise its GRAS (Generally Recognized as Safe) regulations by eliminating the self-affirmed GRAS pathway. Currently, companies can independently determine an ingredient is GRAS without notifying the FDA, but the proposed change would require all GRAS determinations to be submitted for FDA review. This move aims to increase transparency and safety oversight for both domestic and imported foods. However, since the GRAS exemption is written into federal law, fully eliminating it would require Congressional action—something HHS says it is exploring. If adopted, the change could significantly impact ingredient approvals, increasing regulatory burdens for manufacturers."

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USA
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HHS
United States
FDA