Not Quite Food, Not Quite Fiction

If you’ve ever stared suspiciously at your pantry wondering whether that neon-orange cheese puff qualifies as dinner or some sort of science experiment, you’re not alone. The FDA, the same folks who once agonized over what “natural” means (spoiler: still no consensus), have now turned their regulatory magnifying glass on a new target: ultra-processed foods. And in classic government fashion, they’re asking us all to help figure out what the term actually means.

In a significant move that could shape the regulatory future of food labeling and consumer disclosures, the FDA, in coordination with the U.S. Department of Agriculture (USDA), has issued a Request for Information (RFI) to formally define the term “ultra-processed foods” (UPFs). The comment period, which began in July 2025, is open to the public until September 23, 2025, and represents the first coordinated federal effort to establish a uniform definition for one of the most debated categories in the modern food supply.

This development marks a foundational step toward potential future labeling initiatives, dietary guidance updates, and broader public health strategies targeting the prevalence of highly processed products in the American diet.

Background: Regulatory Gap in Defining Ultra-Processed Foods

Despite the growing body of research linking ultra-processed foods to obesity, type 2 diabetes, cardiovascular disease, and other chronic illnesses, no federal regulatory definition of “ultra-processed” currently exists under the Federal Food, Drug, and Cosmetic Act (FDCA) or any related statute.

Existing frameworks—such as the NOVA classification developed by Brazilian public health researchers which categorizes foods based on the nature, extent and purpose of food processing rather than just nutrient content—have gained traction in academic and international policy circles but lack legal standing in the U.S. context. This definitional ambiguity creates challenges not only for regulatory enforcement but also for public understanding, food labeling accuracy, and industry compliance.

With approximately 70% of packaged food products in the U.S. food supply fitting general descriptions of UPFs, and an even higher proportion among children’s diets, the lack of clarity poses legal, commercial, and public health implications.

The RFI: Scope and Objectives

The FDA and USDA’s joint RFI seeks input on a number of key questions, including:

• Whether the term “ultra-processed” is appropriate, or whether other terms would better serve public understanding.
• Which ingredients, processing techniques, or nutrient characteristics should be considered in a regulatory definition.
• Whether the definition should consider the product’s nutritional value.
• How such a definition might align with or differ from existing classification systems (e.g., NOVA), and how it should be applied across diverse food categories.
• The implications for front-of-package labeling, school meal standards, nutrition assistance programs, and health claims made in food marketing.
• The potential for unintended consequences—such as the stigmatization of certain processed but nutritionally beneficial products.

Stakeholders are encouraged to submit scientific, technical, and policy-based responses, with particular emphasis on measurable criteria that could serve as a basis for future regulatory or research applications.

Legal and Policy Implications

While the FDA has not signaled any intent to ban ultra-processed foods outright, a formal definition could serve as the basis for new federal labeling requirements, updated dietary guidelines, and revised eligibility standards under public nutrition programs such as SNAP or the National School Lunch Program.

More immediately, a regulatory definition may inform the development of front-of-package labeling systems, a priority area for the FDA since the announcement of its nutrition labeling modernization strategy in 2022. The agency has also signaled interest in pursuing warning label initiatives, similar to those adopted in Chile and Mexico, which would rely on standardized definitions of processing and nutrient thresholds.

From a litigation standpoint, the regulatory acknowledgment of “ultra-processed” as a legally meaningful term could also influence consumer protection lawsuits, false advertising claims, and the scope of permissible marketing language. Legal practitioners should anticipate heightened scrutiny of food claims that imply healthfulness in products that may ultimately fall within a formal UPF definition.

Industry Considerations

For food manufacturers, the move toward defining UPFs presents both compliance risks and opportunities.

The FDA’s RFI on ultra-processed foods signals the agency’s intent to establish a standardized definition that could serve as the foundation for future regulatory action, including labeling requirements, marketing restrictions, and eligibility criteria for federal nutrition programs. For the regulated industry, this development presents both compliance challenges and strategic considerations, particularly for manufacturers of packaged and processed food products.

Companies should proactively assess their product formulations, ingredient disclosures, and labeling practices to evaluate potential alignment—or misalignment—with anticipated criteria. Additionally, engaging with the RFI process by submitting scientifically grounded comments allows industry stakeholders to help shape the regulatory framework before it crystallizes into formal guidance or rulemaking. Early preparation and regulatory foresight will be essential to mitigate risk and capitalize on reformulation or labeling opportunities in a more transparency-driven market.

 

Next Steps

The FDA’s RFI is available for public comment through September 23, 2025.

The FDA’s initiative to define “ultra-processed food” marks a significant inflection point in the evolution of U.S. food policy, and is bound to ruffle a few snack aisles along the way. As the agency seeks to align scientific evidence, regulatory standards, and legal terminology around a category that dominates the American diet yet lacks precise definition, stakeholders face both a regulatory obligation and a strategic opportunity.

Active engagement now can help shape how “ultra-processed” is ultimately understood—not just as a public health concern, but as a formally recognized term with legal and commercial implications.

For more information on FDA’s RFI, or for other questions on FDA compliance and enforcement issues, please contact us at info@garg-law.com.