What FDA and USDA’s New Pursuit of ‘Ultra-Processed Foods’ Definition Means for Emerging Litigation
In a significant development for the food industry, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have announced a joint Request for Information (RFI) to establish a uniform federal definition for ultra-processed foods (UPFs). This move, announced on July 24, 2025, is part of a broader initiative led by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and USDA Secretary Brooke L. Rollins to address the growing concerns about UPFs and their link to chronic diseases. As the agencies work toward a standardized definition, the implications for emerging litigation are profound, potentially reshaping the legal landscape for food manufacturers, retailers, and consumers. This article explores the context of this initiative, its potential impact on litigation, and the challenges and opportunities it presents for stakeholders.
The Push for a UPF Definition
Ultra-processed foods, as commonly understood, are industrially manufactured products containing ingredients not typically found in home kitchens, such as high-fructose corn syrup, artificial flavors, emulsifiers, and preservatives. These foods, including many cereals, snacks, sodas, and ready-to-eat meals, make up approximately 70% of packaged products in the U.S. food supply and account for over 60% of children’s caloric intake. Scientific studies have increasingly linked UPF consumption to adverse health outcomes, including obesity, Type 2 diabetes, cardiovascular disease, and certain cancers. Despite these concerns, no single, authoritative federal definition of UPFs exists, leading to inconsistencies in research, policy, and consumer understanding.
The FDA and USDA’s RFI, published in the Federal Register on July 25, 2025, seeks public input on criteria for defining UPFs, including ingredients, processing methods, nutritional attributes, and other factors like energy density and palatability. This initiative aligns with the “Make America Healthy Again” (MAHA) agenda, which emphasizes reducing diet-related chronic diseases. The agencies aim to finalize a definition that could influence federal nutrition guidelines, school lunch programs, the Supplemental Nutrition Assistance Program (SNAP), and institutional food services, such as those in military and Veterans Affairs facilities.
Emerging Litigation Landscape
The absence of a clear UPF definition has already sparked litigation, and the FDA and USDA’s efforts are likely to accelerate these legal challenges. A notable example is a December 2024 lawsuit filed in the Philadelphia Court of Common Pleas by plaintiff Bryce Martinez against major food companies, including Kraft Heinz, Mondelez, Coca-Cola, and PepsiCo. The 148-page complaint alleges that these companies designed and marketed UPFs to be addictive, contributing to the plaintiff’s development of Type 2 diabetes and non-alcoholic fatty liver disease at age 16. The lawsuit draws parallels to the tobacco industry’s tactics in the 1980s, accusing food manufacturers of prioritizing profits over public health.
This case, described as a “first-of-its-kind” by the law firm Morgan & Morgan, could set a precedent for future litigation. However, legal experts caution that such lawsuits face significant hurdles. Sarah Gallo, senior vice president of product policy for the Consumer Brands Association, argues that classifying foods as unhealthy based solely on processing oversimplifies the issue and could mislead consumers. Similarly, Leslie Krasny, a food regulatory expert, notes that most studies linking UPFs to health issues are observational, lacking the causality needed to hold manufacturers liable. David Joy, a partner at Keller & Heckman, adds that there is little precedent for courts finding food companies liable for health effects due to overconsumption.
Implications of a Federal UPF Definition
The establishment of a federal UPF definition could significantly influence litigation in several ways:
- Increased Regulatory Scrutiny and Labeling Requirements: A standardized definition may lead to new labeling requirements, such as “non-ultra-processed” labels, as suggested by FDA Commissioner Dr. Marty Makary. These labels could encourage companies to reformulate products to appeal to health-conscious consumers, but they could also expose manufacturers to lawsuits if their products are deemed mislabeled or misleading. For example, plaintiffs could argue that a product labeled as “non-ultra-processed” still contains harmful additives, leading to consumer deception claims.
- Strengthened Basis for Consumer Lawsuits: A clear UPF definition could provide plaintiffs with a stronger foundation to argue that food companies knowingly marketed harmful products. By referencing a federal standard, litigants could claim that manufacturers failed to warn consumers about the risks of UPFs, similar to tobacco litigation. However, the lack of established causality between UPF consumption and specific health outcomes remains a significant barrier.
- Impact on Institutional Food Programs: The UPF definition could affect policies governing school meals, SNAP, and institutional food services. For instance, a Massachusetts bill already defines UPFs to exclude them from school meals, and New York City successfully eliminated processed meats from its schools based on the 2015–2020 Dietary Guidelines for Americans (DGAs). A federal definition could lead to similar restrictions nationwide, prompting lawsuits from food companies challenging these regulations as overly restrictive or economically harmful.
- Industry Pushback and Lobbying: The food industry is expected to fiercely lobby against a restrictive UPF definition. Industry associations have already cautioned that the definition should be rooted in science and nutritional outcomes rather than the processing-focused NOVA classification system. This tension could lead to legal challenges if companies believe the final definition unfairly targets their products or imposes undue regulatory burdens.
Challenges and Opportunities
Defining UPFs is fraught with challenges. Nutrition experts warn that an overly broad definition could “demonize” nutrient-rich foods like whole-grain breads or yogurts, while a narrow definition might miss unhealthy products, such as sugar-laden cereals without artificial dyes. The FDA and USDA must balance these concerns while addressing the Generally Recognized as Safe (GRAS) loophole, which allows companies to self-affirm the safety of new additives without FDA oversight. HHS Secretary Kennedy has signaled intent to eliminate this loophole, which could further fuel litigation if companies challenge stricter regulations.
For consumers, a clear UPF definition offers opportunities for informed decision-making and potential health benefits. However, it could also exacerbate health disparities if low-cost UPFs, which are often more affordable than unprocessed foods, become less accessible due to new regulations or taxes. Litigation may arise from low-income communities arguing that such policies disproportionately harm their access to affordable food.
Conclusion
The FDA and USDA’s pursuit of a uniform UPF definition marks a pivotal moment for food policy and public health in the United States. While the initiative aims to address the chronic disease epidemic linked to UPF consumption, it also sets the stage for a wave of litigation. Food companies face potential lawsuits over deceptive marketing, failure to warn, or non-compliance with new regulations, while consumers and advocacy groups may leverage the definition to hold manufacturers accountable. As the RFI comment period closes on September 23, 2025, stakeholders across the food industry, legal community, and public health sector will closely watch how this definition shapes the future of food regulation and litigation.
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