FDA Moves to Mandate GRAS Notifications and Define Ultraprocessed Foods

FDA Seeks to Close GRAS Loophole with Mandatory Notification Rule

The Food and Drug Administration is proposing to require that manufacturers notify the agency whenever they independently decide a food additive is “generally recognized as safe” (GRAS). The rule, announced Monday, aims to close a long-standing regulatory gap in which companies can self-declare an ingredient safe and bring it to market without any FDA review.

Simultaneously, the Department of Health and Human Services and the USDA submitted a white paper to the Office of Management and Budget that proposes the federal government’s first definition of “ultraprocessed foods.” The document has not been made public, but the Consumer Brands Association immediately warned that any such definition would confuse consumers and raise grocery costs. The International Dairy Foods Association insisted any definition must be science-based.

The dual moves represent an attempt by the Trump administration—led by Acting FDA Commissioner Kyle Diamantas—to modernize food safety oversight and lay the groundwork for future nutrition research. The GRAS rule would add a public inventory of submitted notices and a streamlined pathway for substances already on the market. However, consumer advocates argue the proposal falls short of requiring FDA approval before products reach shelves.

Food industry groups, while supporting the GRAS modernization concept, stressed that only Congress can provide the clear mandate and resources needed for a durable system. They cautioned against a “patchwork” of state regulations if the federal framework remains incomplete.

What the GRAS Overhaul and UPF Definition Mean for Food Companies

Industry Pushback on Ultraprocessed Food Definition

Even without seeing the white paper, the Consumer Brands Association attacked the very idea, calling any definition of ultraprocessed foods “fundamentally flawed” and warning it would “pick winners and losers.” The group argued that because such a category could encompass up to 80% of the nation’s food supply, it would disrupt markets without a sound scientific basis. This signals intense resistance from major packaged-food companies, which fear labeling or marketing restrictions that could steer consumers toward less processed alternatives.

The GRAS Notification Proposal: A Half-Step, Say Critics

The proposed rule maintains the existing structure that allows companies to sell products during the notification process—it does not require premarket FDA clearance. The Center for Science in the Public Interest and others called this a fundamental flaw. Enforcement also remains unclear: the agency describes the notification as “mandatory,” but without a clear mechanism to compel compliance, consumer groups worry the loophole will persist. Still, for the first time, all new GRAS determinations would need to be logged with the FDA, creating a public record that could be used by researchers, competitors, and advocates to scrutinize ingredient safety.

Congressional Role Looms Large

Nearly every stakeholder—the administration, trade groups, and consumer organizations—agreed that lasting reform depends on legislation. FMI and the Americans for Ingredient Transparency coalition explicitly called for a national, uniform standard for ingredient review and labeling this year. Pending legislation could force a more rigorous GRAS system, while a federal UPF definition might ultimately shape school nutrition standards, dietary guidelines, and even advertising rules. Companies should anticipate a legislative push regardless of how the proposed rule and white paper fare inside the agencies.

Next Steps for Food Manufacturers and Investors

• Food manufacturers should begin auditing their GRAS self-determinations to compile documentation for potential mandatory notification requirements under the proposed rule, focusing on any substances not previously submitted to the FDA.
• Companies with a large share of products likely to fall under the eventual UPF definition should scenario-plan for labeling or marketing restrictions and for shifts in consumer demand, as suggested by BNP Paribas data showing a 7% retail sales growth advantage for minimally processed items over the most processed ones in the year ending June 2025.
• Engage early in the FDA’s rulemaking process—the proposal is open for public comment—and track the white paper’s fate at OMB, which could release a draft definition for additional input.
• Investors in packaged-food stocks should monitor congressional action on GRAS reform and any signals from the White House about the UPF definition, as these will determine the long-term regulatory landscape and potentially alter competitive dynamics between “real food” brands and highly processed competitors.