|
FDA PROPOSES OVERHAUL OF FOOD INGREDIENT RULES -
TIGHTENING GENERALLY RECOGNIZED AS SAFE (GRAS) OVERSIGHT, AND SUBMITTING THE FIRST FEDERAL DEFINITION FOR ULTRA-PROCESSED FOODS
Washington D.C., (Aug 10, 2026) - Today the U.S. Food and Drug Administration (FDA) announced a new proposed rule requiring food ingredients to obtain premarket clearance. They also announced the submission of the first-ever federal definition of Ultra-Processed Foods (UPF) to the White House.
Overview
In 1958, Congress created the 'Generally Recognized as Safe' (GRAS) pathway to allow common, safe ingredients like vegetable oils and baking powder to bypass lengthy FDA pre-market reviews. Over time, however, the system evolved into the main route for new food ingredients to enter the market - frequently without the FDA's knowledge or oversight.
Today the FDA proposed a 140 page rule to transition the Generally Recognized as Safe (GRAS) program from a voluntary system into a mandatory notification process. This shift aims to increase oversight of the food supply by requiring manufacturers to submit safety findings for new additives and report existing ingredients.
“Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance post-market safety and to do so more promptly and efficiently to assure the safety of the food supply,” said Acting FDA Commissioner Kyle Diamantas, J.D. on Monday. The announcement also revealed that HHS and USDA have submitted the federal government's first proposed definition of Ultra-Processed Foods (UPFs) to the White House for final review.
These actions further the Trump Administration's Make America Healthy Again initiatives and build on recent efforts to modernize oversight of the nation's food supply. This new GRAS rule, if finalized, would be the most significant update to food ingredient regulations in decades. The FDA estimates the total cost of this GRAS compliance for the industry will range between $35–$210 million.
Key Proposed Changes
-
Mandatory GRAS Notifications for New Ingredients: The proposed rule amends 21 CFR Parts 170 & 570 to convert the voluntary Generally Recognized as Safe (GRAS) notification procedure into a mandatory program, requiring any person introducing a human or animal food substance into interstate commerce under a GRAS claim to formally notify the FDA of its safety basis.
-
Exemptions: Key exceptions to the mandatory submission requirement are established for substances covered by existing FDA "no questions" letters, codified GRAS regulations, effective Food Contact Notifications (FCNs), granted Threshold of Regulation (TOR) exemptions, or completed formal FDA evaluation programs (such as biotechnology or cell-culture consultations).
-
Current Ingredients: For substances already introduced into interstate commerce prior to the final rule's effective date based on an independent GRAS determination, firms have a time-limited 1-year window to submit streamlined information (identity, use conditions, and proof of prior marketing) to gain an exception, provided the substance was not previously subject to an FDA "insufficient basis" letter or "not GRAS" determination.
-
Future Process: The rule mandates electronic submission through FDA's Centralized Online Submission Module (COSM) or email, requires accurate English translations for foreign documentation, and sets structured agency review timelines (a 45-day initial pre-filing review and a 180-day evaluation period with up to two optional 90-day extensions).
-
Timeline: The proposal expands the Threshold of Regulation (TOR) exemption program beyond food contact materials to cover substances added directly to human food, establishing an effective date 60 days post-publication of the final rule and providing an 18-month compliance window for mandatory notification requirements.
Next Steps
-
Submit Comments: Prepare to submit public comments (on docket No. FDA-2024-N-2910 in the next 120 days).
-
Inventory Current Ingredients: Start to inventory all current ingredients’ GRAS status in preparation to comply with the new mandatory reporting and notification requirements.
-
Register for PLC’s:
-
Webinar on New GRAS Proposed Rule: Overview and Impact, scheduled for the week following Labor Day (exact date & time TBD - stay tuned!). (If you were a registered attendee of the Food Label Conference in June, this session is complimentary.)
-
Online Food Label Seminars (October 21–23, 2026) This virtual event will feature six one-hour seminars unpacking these and other regulatory initiatives from a legal risk perspective, and two in-depth sessions on USDA and FDA food label claims. Register here. Learn more about this year’s program.
Resources
PLC will continue to monitor developments and notify our Label Alert subscribers as soon as new information is available. PLC Regulatory Consultants are also available today to help you with your compliance projects. For more information, go to our website, Services Order form or contact us at labels@primelabel.com or (202) 546-3333.
| 
