For nearly seven decades, a company could decide on its own that a substance added to food was safe and put it into the food supply without ever telling the federal government. The Department of Health and Human Services has now proposed to end that arrangement.
At an event held at its Washington headquarters, the Department of Health and Human Services announced a proposed rule requiring manufacturers to notify the Food and Drug Administration whenever they conclude that a substance added to human or animal food is Generally Recognized as Safe. The agency would also expand its public inventory of those notices.
Alongside it, HHS and the U.S. Department of Agriculture submitted the federal government's first proposed definition of ultra-processed food for final review. The definition itself has not been released publicly.
The Loophole Congress Created and Never Closed
The GRAS exemption dates to a 1958 amendment to federal food law. It was written so that regulators would not have to review every familiar ingredient with a long history of safe use.
Over time, the exemption became a route to market. Manufacturers were permitted to reach their own conclusions that a substance was generally recognized as safe under its intended conditions of use. The FDA has long operated voluntary notification programs, but companies have not been required to tell the agency when they make those determinations.
Acting FDA Commissioner Kyle Diamantas said the proposal is aimed at "closing critical information gaps" and giving the agency greater visibility into substances entering the food supply.
The proposal does not change who makes the safety determination. Companies would still reach their own conclusions. What changes is that the FDA would learn about them. For substances already on the market based on industry self-GRAS conclusions, the proposal would establish a time-limited, streamlined submission pathway so manufacturers can tell the agency how those substances are currently being used, which HHS says would let the FDA prioritize post-market safety evaluations.
HHS Secretary Robert F. Kennedy Jr. framed the case in public health terms, saying nearly 60% of the American diet is made up of ultra-processed foods and that childhood obesity now affects more than one in five American children.
Two Actions, Two Very Different Stages
These are separate measures at different points in the regulatory process, and conflating them produces a misleading picture.
The GRAS measure is a proposed rule, not law. The FDA is seeking public feedback on the proposal under docket number FDA-2025-N-3262, and must review submissions and issue a final rule before anything binds a manufacturer.
The ultra-processed food definition is still at an earlier stage. HHS and USDA sent a whitepaper titled "Proposed Definition of Ultra-Processed Food" to the Office of Information and Regulatory Affairs. It is under review and has not been made public. HHS said the definition incorporates feedback from thousands of stakeholders, including industry, consumer organizations, researchers and members of the public, gathered after a joint request for information issued in July 2025.
A definition, on its own, does not restrict any product. It creates a category that agencies could later write rules against, and gives nutrition researchers a common yardstick. There is currently no single authoritative federal definition, and the term is most often associated with the NOVA classification system developed at the University of São Paulo, which places industrially manufactured formulations in its fourth and most processed category.
Reaction Split Between Not Far Enough and Too Far
Consumer and environmental groups welcomed the GRAS proposal while arguing it stops short. Food and Water Watch food policy director Rebecca Wolf called it "a baby step towards safer food" but said it falls short of the reform needed to keep dangerous chemicals out of the food supply. The Center for Science in the Public Interest made a related point, noting that the proposal would still let companies sell products before or during the notification process rather than requiring premarket review.
The Consumer Brands Association, which represents consumer packaged goods manufacturers, said it has serious concerns about the effort to define ultra-processed foods, arguing the effort lacks a sound scientific foundation and warning it will raise grocery costs and create consumer confusion. The International Dairy Foods Association said any policy in this area should rest on clear, consistent definitions and rigorous evidence.
Reporting has also indicated that the definition's release was delayed after intervention from food industry executives. Whether that delay reflects a substantive disagreement over scope has not been established publicly, since the text remains unreleased.
HHS said in its announcement that it encourages Congress to build on these efforts through legislation. Industry and retail groups, including FMI and the Americans for Ingredient Transparency coalition, echoed that call, arguing that durable reform requires Congress to give the FDA a clearer mandate and to head off a state-by-state patchwork of ingredient rules.
Nothing on a Grocery Shelf Changes This Week
For households, the immediate practical effect is close to zero. No product is being pulled, no label is changing, and no ingredient is being banned. A proposed rule open for comment is the beginning of a process, not the end of one.
The tools available to shoppers today are the ordinary ones. Ingredient statements on packaged food are required and disclose what is in a product. The FDA publishes its existing inventory of voluntarily submitted GRAS notices, which is incomplete by design and would become more complete under the proposal.
People with a specific medical reason to avoid a substance, including diagnosed food allergies or intolerances, should work with a clinician or a registered dietitian. Claims about additives circulating online are frequently overstated in both directions, and a general anxiety about ingredients is not the same as a documented sensitivity.
The comment window is the meaningful near-term step. Comments can be submitted electronically through the federal rulemaking portal or in writing to the FDA's Dockets Management Staff. After it closes, the agency must review submissions before issuing any final rule, a process that typically takes many months. The ultra-processed food definition could be released at any point during the review at OIRA.
Key Questions Answered
What did HHS actually propose? A rule requiring manufacturers to notify the FDA whenever they conclude an added substance is Generally Recognized as Safe, plus an expanded public inventory of those notices.
Does this stop companies from self-declaring ingredients safe? No. Companies would still make the determination themselves, and the proposal does not create premarket approval. The change is that the FDA would be told.
What is the ultra-processed food definition? It has not been released. HHS and USDA submitted a proposed definition for final regulatory review as a whitepaper.
Will any food be pulled from shelves? No. Neither action removes a product, changes a label or bans an ingredient.
When could this take effect? Only after the comment period closes and the FDA reviews submissions and issues a final rule, which typically takes many months.
Can the public weigh in? Yes. Comments can be submitted through the federal rulemaking portal under docket number FDA-2025-N-3262.
What can shoppers do now? Read ingredient statements, consult the FDA's existing GRAS notice inventory, and work with a clinician or dietitian on any documented sensitivity.
