Full Breakdown
Proposed Rule Would Make FDA GRAS Notifications Mandatory
9/1/2026, 4:29:04 AM
Core Proposal
The U.S. Food and Drug Administration is considering a rule that would require companies to notify the agency when they place a new ingredient on the market under the “generally recognized as safe” (GRAS) exemption. Companies could still sell the ingredient while the FDA reviews the submission, and the agency would use the lack of notification to prioritize post-market safety reviews. The public-comment period runs through early December, with a final rule potentially emerging as early as 2027.
Background & Context
Congress created the GRAS exemption in 1958 for substances such as salt and vinegar that were widely accepted at the time. An analysis by the Environmental Working Group (2025) found that about 99 % of food chemicals introduced since 1958 have entered the market through the GRAS pathway rather than the formal FDA additive approval process. The FDA’s Human Foods Program has logged more than 1,300 voluntary GRAS notices since 1997, but those notices have never been required before a product reaches consumers.
Official Statements & Responses
- Health Secretary Robert F. Kennedy Jr. frames the rule as part of his “Make America Healthy Again” agenda to modernize food-supply oversight.
- The FDA declined to comment on enforcement mechanisms or the agency’s capacity to review the additional notifications.
Criticism & Opposition
- Charles Benbrook, agricultural economist, argues the notification would consist only of “the company’s opinion” and lacks the data and public review required for formal additive approval.
- Patricia Zettler, law professor at Ohio State University and former FDA associate chief counsel, stresses that the GRAS pathway was “designed by Congress” and warns that the rule may not substantially alter industry practices.
- Marion Nestle, professor emerita at NYU, questions whether the FDA has sufficient staff—about 20 % of its workforce has left—to evaluate the increased flow of notifications.
Verbatim Quotes
- “Maybe the 'generally recognized as safe' pathway is bigger than Congress initially envisioned in 1958,” — Patricia Zettler
- “The FDA requires no data, no evidence, no explanation of the basis for their determination and confidence that such a food additive poses no risk,” — Charles Benbrook, to agricultural economist
- “FDA, like any administrative agency, can only do what Congress has authorized it to do by statute,” — Patricia Zettler
