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FDA Proposes Mandatory Notices for GRAS Food Additives

The proposal increases transparency in the food supply pending congressional action to expand FDA authority.

Overview

  • HHS and the FDA unveiled the proposal on Monday, Aug. 10, to require companies to notify the agency when they conclude a substance is Generally Recognized as Safe (GRAS) and to publish the scientific basis for those notices.
  • Under the plan the FDA would check submissions for completeness within 45 days and aim to complete substantive reviews within 180 days.
  • The agency could request more data or find a submission does not meet GRAS standards while companies would still be allowed to market products before FDA completes its review.
  • HHS and USDA have sent a federal definition of “ultra‑processed foods” for final interagency and White House review, a separate step that could shape future dietary guidance or policy.
  • Supporters call the rule a long‑overdue transparency fix, critics note the FDA may lack staff and enforcement tools to vet thousands of existing additives, and administration officials say Congress must grant pre‑market authority for deeper reform.