HHS Takes Major Steps in Eliminating Self-GRAS and Defining Ultra-Processed Foods

The U.S. Department of Health and Human Services (HHS) has formally proposed a rule that would require manufacturers to notify the U.S. Food and Drug Administration (FDA) when determining that a substance is Generally Recognized As Safe (GRAS), eliminating the self-affirmation pathway to market, and, alongside the U.S. Department of Agriculture (USDA), has submitted for final review the federal government’s first proposed definition of ultra-processed foods (UPFs). However, the proposed UPF definition wasn’t disclosed in the Aug. 10 announcement.

FDA signaled in July in the White House’s 2026 Unified Regulatory Agenda that it aims to have the rule eliminating the self-affirmed GRAS pathway finalized by December; Kennedy first announced plans to eliminate “self-GRAS” in March of last year.  

Similarly, HHS, FDA, and USDA first sought information from the public to help create a federal standard definition for ultra-processed foods in July of 2025.

“Nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than one in five American children,” Kennedy said. “We cannot reverse America’s chronic disease epidemic without transforming our food system. These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy. President Trump and I promised to make America healthy again, and today we are turning that promise into policy.”

“President Trump has been committed to making America healthy again since the start of his administration, and today’s announcement is another step in achieving that goal. Secretary Kennedy has brought renewed attention to the food all Americans have been eating, and this action will bring greater transparency for consumers choosing their ingredients,” said U.S. Secretary of Agriculture Brooke L. Rollins. “Our nation’s farmers and ranchers are at the front line in the MAHA mission, and we continue to put real, healthy food at the top of the agenda every day in the Trump Administration.”

“Americans deserve confidence that the ingredients in their food are subject to transparent, science-based oversight, and today’s actions strengthen both sides of that equation,” said Acting FDA Commissioner Kyle Diamantas. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply. By advancing a proposed definition of ultra-processed foods, we seek to create a stronger foundation for future nutrition research. Together, these reforms represent a significant step toward a more transparent and modern food safety system.”

Industry Analysis

FDA officials have noted for many years that they lack much-needed visibility into substances that enter the food supply, since companies that commercialize their ingredients through the self-affirmed GRAS pathway aren’t required to notify the agency that they’ve done so.

The proposed rule would establish an amnesty period for ingredients that are already on the market based on self-GRAS conclusions, giving manufacturers time to provide FDA with information about existing uses in a “streamlined” submission process.

Leading trade associations representing dietary supplements and functional foods largely agree that eliminating companies’ ability to self-determine ingredients as GRAS outright would stifle innovation. Some propose that less restrictive alternatives, like mandatory product listing, could grant FDA the visibility it claims to lack.  

The Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), Natural Products Association (NPA), and other organizations have publicly called for less restrictive measures to address abuses of the self-GRAS pipeline. Instead, resources should target bad actors that self-affirm an ingredient is GRAS despite that ingredient having no historic presence in the food supply.

In a response to the announcement, CHPA maintained that GRAS reforms must remain practical and science-based to avoid consequences that could exceed what FDA can handle with its existing resources. Further, the association maintains that changes to the GRAS framework must remain consistent with the authority Congress provided FDA, which preserves contemporary standards that have defined the category of dietary supplements since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994.

Key concerns CHPA highlighted include: FDA imposing unrealistic timelines for self-affirmed GRAS ingredients already on the market; a lack of explicit federal preemption that could fuel duplicative state requirements; whether FDA has the resources and review capacity to take on the expanded requirements without delaying product availability; and whether the proposal balances transparency and oversight with consistency and the FDA’s existing authority.

“Improving transparency does not require upending a system that has long relied on scientific expertise and risk-based oversight,” said Scott Melville, president and CEO of CHPA. “FDA should pursue practical reforms that strengthen public confidence while making the best use of agency resources to protect public health.”

The agency may move, at least in part, on a Citizen Petition filed by former FDA Commissioner David Kessler, said Daniel Fabricant, PhD, president and CEO of NPA, on LinkedIn. The petition asks FDA to revoke the GRAS status of “processed refined carbohydrates,” arguing that there is no longer a consensus that they meet the GRAS standard of a “reasonable certainty of no harm.” This could set a precedent that “fundamentally alter(s) the pathway for a broad category of food ingredients … the closest precedent is FDA’s 2015 determination revoking the GRAS status of partially hydrogenated oils, a move that ultimately reshaped portions of the food supply.” Fabricant noted that Kessler’s petition argues that ultra-processed foods in and of themselves are contributing drivers of diet-related disease. “While the petition does not clearly define UPFs beyond their association with refined carbohydrates, the degree to which FDA and HHS embrace this broader theory could have far-reaching implications for future nutrition policy, ingredient regulation, product reformulation, and litigation risk.”

HHS and USDA noted that they’ve received feedback from thousands of stakeholders including industry, consumer organizations, researchers, and other members of the public on how UPFs should be defined.

Though the announcement doesn’t shed any light on the specifics of how UPFs will be defined, there’s been some industry concern that there will be an undue focus on the degree of processing, rather than nutritional content, of foods in determining their status as UPFs.

Because classical UPF definitions have captured foods like yogurt or whole grain bread, the Institute of Food Technologists (IFT) noted that in the context of public policy, certain types of processed foods shouldn’t be excluded from nutrition assistance programs and public health recommendations despite their processed status. Nutritional imbalances, as told by ingredient labels, should be held to a greater degree of scrutiny than a single processing method like cutting, fermentation, pasteurization, or pH adjustment, the association reported in its public comment on the matter.

“A federal framework must be grounded in robust scientific evidence and be meaningful to consumers. Such a framework must be grounded in robust scientific evidence and be meaningful to consumers,” to prove imporant in advancing research and policy to improve health outcomes, IFT stated.

“Yesterday’s announcement reflects the importance of transparency and science in building a food system that consumers can trust,” said Brendan Niemira, chief science and technology officer at IFT. “As federal agencies move forward, IFT and its members stand ready to share the expertise of the food science community to help ensure that policy decisions are evidence-based, practical, and effective in supporting a safe, nutritious, sustainable, and accessible food supply.”