The U.S. Food and Drug Administration is proposing a major change in how new food ingredients are monitored, requiring manufacturers to notify the agency when they determine an ingredient is “Generally Recognized as Safe,” or GRAS.
Under the current system, companies can determine on their own that certain substances are GRAS and use them in foods without notifying the FDA. The agency operates a voluntary notification program, but manufacturers have not been required to participate.
The proposed rule, announced Monday, would make those notifications mandatory for substances added to both human and animal food. Companies would be required to provide information supporting their safety conclusions, giving regulators greater visibility into ingredients entering the U.S. food supply.
The FDA also plans to expand its public inventory of GRAS notifications so consumers, researchers and other interested groups can see more information about substances being added to food.
Ingredients already being used based on a company’s own GRAS determination would also be addressed. The proposal creates a temporary streamlined process allowing manufacturers to report existing uses to the FDA, which the agency says would help it prioritize ingredients for additional post-market safety review.
The GRAS exemption dates to 1958. It was designed for substances whose safety was generally recognized by qualified experts under their intended conditions of use. Over time, critics have raised concerns about companies being able to make those determinations without mandatory notification to federal regulators.
The proposal does not eliminate the GRAS category or automatically require every qualifying ingredient to undergo the same premarket approval process used for food additives. Instead, it would require companies relying on GRAS status to disclose those determinations to the FDA.
Federal health officials also announced that the Department of Health and Human Services and U.S. Department of Agriculture have submitted the government’s first proposed federal definition of “ultra-processed foods” for final review. Officials say a standardized definition could eventually be used to improve consistency in nutrition research and future food policy.
The FDA is seeking public comment before a final version of the GRAS rule is adopted.
Category: State & Nation
Scope: National
Tags: FDA, Food Safety, Food Ingredients, Consumer News, GRAS
Source: U.S. Food and Drug Administration / U.S. Department of Health and Human Services
