HHS Proposes Mandatory GRAS Notifications and First Federal Ultra-Processed Food Definition

The GRAS Proposal and the First Federal Ultra-Processed Food Definition

The U.S. Department of Health and Human Services said on Aug. 12, 2026, that it had proposed a new FDA rule requiring food and feed manufacturers to notify the agency whenever they determine that an added substance is generally recognized as safe, or GRAS. HHS also said it and the USDA had submitted for final review what it called the federal government’s first proposed definition of ultra-processed foods.

Under the current GRAS system, companies may decide on their own that an ingredient is safe based on publicly available scientific evidence and start using it without notifying the FDA. The proposed rule would close that gap by making the notification and underlying scientific data part of the agency’s oversight process. HHS Secretary Robert F. Kennedy Jr. tied the moves to chronic disease: he said nearly 60 percent of the American diet is made up of ultra-processed foods and more than one in five children have obesity.

Both actions are regulatory proposals rather than final requirements. The GRAS rule will go through FDA rulemaking, and the ultra-processed food definition is under final review. In a curated roundup of reactions, HHS highlighted support from medical groups, food trade associations and lawmakers, though several respondents said congressional action would be needed to make the changes durable.

Where the FDA Rule Leaves Food Makers, Industry Groups and Lawmakers

The GRAS Self-Certification Pathway the Rule Would End

The FDA currently treats GRAS conclusions as voluntary, allowing companies to market new substances without premarket approval. The proposal shifts that burden toward disclosure. As described, it would require notification when a company concludes a substance is GRAS, not when the FDA asks. That would give regulators a visible record of new ingredients and a chance to challenge the science before widespread use. Former FDA Commissioner Scott Gottlieb’s reaction that the agency has gone as far as it can without new Congressional authority indicates the proposal is designed to fit existing law, rather than create new statutory powers.

Why Industry Trade Groups Are Largely Endorsing the Rule

The International Dairy Foods Association, the Meat Institute, FMI and the American Feed Industry Association each supported a science-based modernization of GRAS in statements circulated by HHS. Their shared condition is that the new framework remain practical and not impede innovation or affordable food. That is not surprising: a clear federal notification standard can reduce state-by-state uncertainty and protect companies that already use formal FDA pathways, while still requiring additional compliance work. The American Heart Association and consumer advocates, by contrast, framed the change as a public health safeguard, not merely an administrative fix.

The UPF Definition’s Downstream Reach Is Still Unsettled

The first federal definition of ultra-processed foods, submitted for final review with USDA, does not by itself impose labeling or purchasing restrictions. Its significance is that, once finalized, it can anchor downstream policy: nutrition labeling, school meal standards, hospital food programs and nutrition education. Health advocate Minda Wilson’s caution that warning labels alone won’t reverse chronic disease points to the broader debate: the definition is a foundation, not a finished policy. The exact classification criteria remain unpublished in this announcement, so food manufacturers cannot yet know which products will fall inside the category.

Innovation vs. Transparency: The Industry’s Real Trade-Off

IDFA’s Michael Dykes and the Meat Institute’s Julie Ann Potts both emphasized preserving innovation and a practical, predictable pathway. The consequence is a balancing act: mandatory GRAS notifications create a public record that can surface questionable ingredients, but if the process becomes slow or burdensome, smaller manufacturers may face higher costs to bring new products to market. The proposal’s supporters argue that transparency itself is the innovation incentive, because consumers increasingly reward verifiable ingredients. Which effect dominates will depend on the final rule’s data requirements and FDA’s review capacity, details not included in the announcement.

Where Congress Fits In

Several responses, including those from Senator Cory Booker and Americans for Ingredient Transparency, argue the durable fix is statutory. The proposed rule can mandate notification, but it cannot expand FDA’s safety review powers beyond current law. That means food companies should view this as the first of possibly two tracks: an administrative rule that can be finalized through FDA, and a later legislative push to codify a national uniform GRAS framework. The administration’s framing as a “MAHA” win also positions the rule within the 2026 midterm political calendar, which may affect how quickly agencies move.

Next Steps for Food Manufacturers and Regulatory Teams

• Prepare for a mandatory GRAS notification workflow by mapping current self-certified ingredients and the scientific files that would support a notification, because the proposal targets the moment a manufacturer concludes a substance is GRAS.
• Engage with trade associations—IDFA, Meat Institute, FMI and AFIA have already signaled conditional support—so company-specific concerns about innovation and affordability are reflected in comment submissions.
• Review product portfolios against the forthcoming ultra-processed food definition once the proposed criteria are published, since the definition is designed to influence labeling, school meals and nutrition programs rather than act as a standalone restriction.
• Follow Senator Booker’s and former FDA Commissioner Gottlieb’s emphasis on legislative limits; a congressional framework could eventually supersede the FDA rule and impose more permanent national standards.