The U.S. Department of Health and Human Services (HHS) announced a proposed rule on August 10, 2026, requiring food manufacturers to notify the Food and Drug Administration (FDA) when determining that an ingredient is Generally Recognized as Safe (GRAS). The rule would end the decades-old practice of self-certification, replacing it with a mandatory notification system to enhance federal oversight of food additives.
In a separate but related action, the HHS and U.S. Department of Agriculture (USDA) submitted for final review the federal government’s first official definition of ultra-processed foods, a category long scrutinized for links to chronic health conditions. The proposals were unveiled by HHS Secretary Robert F. Kennedy Jr. during a press briefing at the Department of Health and Human Services in Washington, D.C.
Immediate Action & Core Facts
The proposed rule would require any entity introducing a GRAS substance into the food supply—including major manufacturers such as PepsiCo or Nestlé—to submit a notification to the FDA. Previously, companies could self-declare ingredients as GRAS without notifying regulators, a practice dating back to a 1958 congressional exemption. The FDA has operated voluntary notification programs for decades, but participation has been inconsistent. Under the new framework, all GRAS determinations would be subject to mandatory disclosure, creating a publicly accessible inventory of submitted notices.
The second development involves the finalization of the first federal definition of ultra-processed foods, a term previously used inconsistently across agencies and research studies. The USDA and HHS have not yet released the full text of the definition, but officials described it as a standardized framework to classify foods based on processing levels. The move follows years of growing concern among public health experts about the long-term safety of heavily processed foods, which have been associated with higher risks of obesity, diabetes, and cardiovascular disease.
Deeper Dive & Context
Rationale for the Proposed GRAS Rule
HHS and FDA officials framed the rule as a necessary step to address a longstanding transparency gap in food safety oversight. FDA Acting Commissioner Kyle Diamantas stated that mandatory notifications would give regulators "greater visibility into the substances used in human and animal food," enabling more efficient and timely responses to potential safety concerns. The proposal is part of the "Make America Healthy Again" (MAHA) initiative, a policy agenda led by Kennedy that seeks to modernize food system regulations and reduce chronic disease risks linked to dietary factors.
Critics of the current GRAS system have long argued that self-certification allows companies to introduce potentially harmful additives without sufficient scrutiny. A 2013 study by the Pew Charitable Trusts found that nearly 97% of GRAS notifications submitted voluntarily to the FDA were handled by a single consulting firm, raising concerns about conflicts of interest. The proposed rule does not ban any specific substances but aims to increase regulatory accountability by ensuring the FDA is aware of all GRAS determinations before they enter the market.
The Ultra-Processed Foods Definition
The push to define ultra-processed foods reflects broader scientific and policy debates about the health impacts of processed foods. The term, popularized by researchers such as Dr. Carlos Monteiro of the University of São Paulo, categorizes foods based on the extent of industrial processing, including the addition of preservatives, artificial flavors, and other additives. While the USDA and HHS have not disclosed the full criteria, early descriptions suggest the definition will align with NOVA food classification system, which groups foods into four categories: unprocessed, minimally processed, processed culinary ingredients, and ultra-processed.
Public health advocates have praised the move as a step toward evidence-based nutrition policy, noting that ultra-processed foods have been linked to higher rates of diet-related diseases. However, industry groups have warned that an overly broad definition could stigmatize certain foods without clear scientific justification. The Grocery Manufacturers Association (GMA) has previously argued that processing does not inherently equate to harm, pointing to examples like pasteurized milk or frozen vegetables, which undergo processing but remain nutritious.
Reactions and Broader Implications
The proposals have drawn mixed reactions from stakeholders. Proponents, including public health organizations and consumer advocacy groups, argue that the changes are long overdue and will restore trust in the food supply. The Center for Science in the Public Interest (CSPI) called the GRAS rule a "critical reform" that addresses a loophole exploited by industry for decades."
Opponents, including some food industry representatives and libertarian policy groups, contend that the rules could stifle innovation and impose unnecessary burdens on manufacturers. The Alliance for Food and Farming, a trade group representing fruit and vegetable producers, expressed concern that the ultra-processed foods definition might mislead consumers without improving safety outcomes. They argue that processing is essential for food safety and preservation, particularly for perishable items.
The HHS has not specified a timeline for implementation but indicated that the GRAS rule would undergo a public comment period before finalization. The ultra-processed foods definition is expected to be published in the Federal Register for final review in the coming months. Both measures are part of a broader effort by the MAHA initiative to overhaul food safety and nutrition policies, though critics question whether they address the root causes of recent foodborne illness outbreaks, such as cyclospora and salmonella, which have sickened hundreds across multiple states this year.