Last week’s issuance of a request for information (RFI) in the Federal Register by the FDA and the US Department of Agriculture (USDA) marks the first step in the administration’s effort to address health concerns associated with the consumption of ultra-processed foods (UPF). As part of this process, the administration is seeking public involvement to help establish a uniform definition of UPFs. The notice consists of a series of questions about the criteria that should be used to define the term UPF (e.g., ingredients, processing methods, or nutritional attributes) but does not explain how the agencies intend to use the ultimate definition.
As stakeholders work on responding to the questions in the RFI, in addition to consideration of the potential impact on ingredient selection, labeling, and marketing, food companies will also need to consider the litigation risks of such a definition. In particular, we anticipate that some state attorneys general may expand their existing formal investigations into allegations that food manufacturers have allegedly engaged in deceptive acts and practices in violation of state consumer protection laws common to all 56 states and territories. In some states, these same statutes may give rise to a private right of action, and we anticipate that plaintiff’s lawyers may use the connection between certain foods and health outcomes as a basis for deceptive advertising and related class action claims.
Background
UPFs and the health concerns associated with their consumption are a key pillar of the “Make America Healthy Again” platform. This RFI is an initial salvo in the administration’s efforts to tackle the larger problem of chronic diseases (e.g., diabetes, obesity) in the United States by targeting a perceived culprit—ultra-processed foods. Although some states have established a definition for UPF (or highly processed food), there is no single, universally accepted definition.
FDA and USDA believe there will be value, from a research and regulatory perspective, in establishing a single definition but acknowledge that there are multiple considerations that complicate this effort. For example, foods that might be considered ultra-processed may also include whole grain products or yogurt, which are known to have beneficial effects on health. As part of their request for information, FDA and USDA are asking for feedback on the following to assist them in developing a definition for UPF:
- Classification Systems: What existing systems should be considered to define UPFs? The notice refers to Nova, which is a classification system developed by Brazilian researchers that has ingredient, substance, and processing factors that determine whether a food is a UPF, as an existing example.
- Ingredients: Which ingredients (whether listed first or last by weight) signal that a food is ultra-processed? Should flavors and colors (whether natural or artificial) be a factor?
- Processing: What physical (e.g., cutting, heating, freezing), biological (e.g., fermentation), or chemical processes (e.g., pH adjustment) might be used to characterize a food as ultra-processed?
- Nutritional attributes: To what extent should nutritional composition or presence of certain nutrients be incorporated in the UPF definition?
Implications for Industry
An RFI is an initial step in what is often a multi-year rulemaking process. For example, FDA’s effort to update its “healthy” regulation on food labels took eight years from RFI to issuance of the final rule. For now, the RFI provides industry with notice as to the issues on which FDA and USDA are focused and provides an opportunity to provide feedback on why certain ingredients or processing techniques are not associated with adverse health outcomes and are necessary to the safe and nutritious manufacturing of foods. It is also possible that a federal definition of UPF would preempt and address the patchwork of similar state laws that are being passed, which may benefit the food industry.
If a definition of UPF is finalized, it could have wide-reaching consequences that range from impacts on food formulation and food labels to public policy. For example, FDA could determine that all UPF must bear a front-of-package warning label because failure to do so would be an omission of material fact about the safety of the product. In a similar vein, USDA could establish a certification program similar to its organic program, which will allow foods to use an icon that indicates such food is not a UPF. USDA could also use the definition to alter what the government pays for through the Supplemental Nutrition Assistance Program (SNAP) or school lunch program.
A final definition could also result in a disruption in the supply chain and related commercial supply contracts, producing shortages of certain ingredients, food development, and formulation, as companies develop ways to reformulate their products to avoid the UPF definition. Other products may not be able to adjust their formulation to avoid being categorized as a UPF and may see a loss in revenue as government programs (and potentially consumers as well) decrease their spending on UPFs.
In addition to the regulatory impacts of any future FDA or USDA action, for the processed food industry there remains the significant risk of litigation. The plaintiff’s bar has already seized on the increased awareness and scientific research on the connection between certain foods and adverse health outcomes as the basis of class action lawsuits. The industry may also face risk of personal injury claims associated with the alleged increased risk of diabetes, obesity, and other diseases as a result of the failure to warn consumers about the risks associated with consuming UPFs. These risks will only increase with a formal definition of UPF.
Conclusion
Stakeholders are invited to submit comments and responses to the RFI before the comment period closes on September 23, 2025. If a definition of UPF were to be finalized and implemented, it could have significant impacts on public policy as well as industry. As such, we will be monitoring this issue closely.