HHS Moves to End Silent Self-Approval of Food Additives and Sends the First Federal Definition of Ultra-Processed Food for Final Review

HHS announced on Aug. 10 that the FDA has issued a proposed rule requiring manufacturers to notify the agency whenever they conclude that a substance added to human or animal food is Generally Recognized as Safe. Since Congress created the GRAS exemption in 1958, companies have been permitted to reach that conclusion themselves, and the FDA’s notification programs have been voluntary. HHS and the Agriculture Department separately submitted for final review the government’s first proposed definition of ultra-processed foods. Secretary Robert F. Kennedy Jr. said nearly 60% of the American diet is ultra-processed.

The GRAS proposal would close a gap researchers have criticized for years, in which a manufacturer could introduce a new ingredient without telling the regulator at all, and would expand the public inventory of notices. It also creates a time-limited streamlined pathway for substances already marketed under self-GRAS conclusions. A standardized federal definition would give nutrition research a common category where none exists.

Both actions are proposals. The GRAS rule must complete notice and comment before taking effect, and the ultra-processed food definition is at final review.