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The end of self-affirmed GRAS

Writer's picture: SandwalkSandwalk



On March 10, 2025, the US Health and Human Services (HHS) urged the Food and Drug Administration (FDA) to explore the ways to eliminate the "self-affirm" route from the Generally-Recognized As Safe (GRAS) framework. This will have a big impact on food innovation in the US, as self-affirmation was the avenue of choice for many players in the industry.


This move was expected, as disconformity with how the GRAS process is working was one of the topics discussed during the Confirmation Hearing of the Secretary of the HHS, Robert J. Kennedy Jr., in late January, 2025.


Even much earlier, on November 21, 2023, Senators Edward J Markey and Senator Cory Booker introduced the Ensuring Safe and Toxic-Free Foods Act, in which compulsory notification of GRAS dossiers was a central element.


 
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