This bill requires the Food and Drug Administration (FDA) to revise its regulations relating to food additives that may be considered generally recognized as safe (GRAS). (A substance deemed GRAS is not subject to the premarket review requirements for food additives. A manufacturer may notify the FDA that it has determined that a substance is GRAS.)
The revised regulations must prohibit a manufacturer from marketing a substance as GRAS (or manufacturing or selling a food containing that substance) unless the manufacturer has notified the FDA that it has determined that the substance is GRAS and submitted certain information supporting this position, including information about the substance's cumulative effects.
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The FDA must maintain a public website with each GRAS submission and supporting information. There must be a period of at least 90 days for the FDA and the public to review and object to such submissions.
Furthermore, under the revised regulations, newly synthesized or novel chemicals and carcinogenic substances may not be deemed GRAS.
The FDA may not rely on experts with conflicts of interest when making a GRAS determination. The FDA must also (1) incorporate in its rules certain best practices for convening a GRAS panel, (2) create a process to systematically reassess any substances previously determined to be GRAS, and (3) reestablish the Food Advisory Committee to assist with establishing standards and procedures for reassessing substances.
Source last updated: Jan 3, 2025. Consult Congress.gov for the current record.
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