If finalized, the proposed rule issued by the Food and Drug Administration (FDA), would require food companies to notify the agency when introducing a new ingredient through the “generally recognized as safe” (GRAS) pathway, along with the basis to support its safety. But the proposal does not include a mandatory independent review of these ingredients to ensure their safety before entering the market, nor does it create a plan for conducting post-market reviews for GRAS ingredients.
Since the GRAS process was first established by Congress in 1958, companies have been allowed to self-certify the safety of new ingredients without notifying the federal government of the data to support its claim or without a full agency review of the product.
