FDA and USDA Seek Feedback on Defining “Ultra-Processed Foods”

Background

The MAHA Commission, established via an Executive Order, has brought UPFs to the forefront of nutrition discussions in the U.S.²  As stated in both the RFI and the May 2025 report “The MAHA Report: Make Our Children Healthy Again: Assessment,” researchers have identified links between foods considered “ultra-processed” and certain negative health outcomes, including cardiovascular disease, obesity, and certain cancers.³ However, without a standard definition, the agencies state that this research can be difficult to interpret and incorporate into nutrition policy.

Historically, the most commonly referenced definition of UPFs came from the Brazilian “NOVA” system developed in 2009. Under this system, foods are classified into four categories: (1) unprocessed or minimally processed foods; (2) processed culinary ingredients; (3) processed foods; and (4) ultra-processed foods. Under the NOVA classification, UPFs (group 4) are identified based on multiple factors including “things like the use of certain ingredients and substances (such as emulsifiers, bulking agents, or thickeners), industrial processing technologies, as well as sophisticated packaging, that result in a palatable and appealing product.”⁴ However, as noted in the RFI, this system has been criticized for being over-inclusive by failing to differentiate between processed foods with low nutrient content and processed foods that are nutrient rich.

In recent months, several state legislatures have included UPFs as a concept in proposed legislation, which would require the states to propose regulatory definitions of UPF. The states have taken various approaches as they consider defining UPFs, including focusing on processing steps, substances with certain intended effects on foods, or the presence of certain listed ingredients. Seeing this inconsistency, FDA had indicated that it intends to develop a single nationwide definition of UPFs and the current RFI represents the first step in this effort.

Request for Information

The RFI cites the lack of a consistent definition of UPF as the rationale for the development of a single, uniform, federally coordinated definition. According to the RFI, a single definition will allow for consistency in both research and policy. To facilitate the joint effort to define this term, FDA and USDA are requesting data and information that is responsive a list of questions. The full list of questions is provided in Appendix A and the questions are paraphrased below.

• Current Classifications:
  • Are any of the current UPF classification systems or concepts appropriate?
  • What characteristics would be suitable for categorizing UPFs in the U.S. food supply?
• Ingredient List:
  • What types of ingredients that appear towards the beginning of the ingredient list (that is, ingredients that likely form most of a finished product by weight) should be used to characterize a food as ultra-processed?
  • What types of ingredients that contribute minimally to the overall composition and weight of a finished food should be used to characterize a food as ultra-processed?
  • Should natural and artificial flavors, and certified and non-certified colors, be considered separately when characterizing a food as a UPF?
  • Should the relative amount of an ingredient in a food influence whether the food is characterized as ultra-processed?
  • Are there other ingredient-related criteria that should or should not be used in defining a food as ultra-processed?
• Manufacturing/Processing:
  • What physical processing steps (i.e., heating, freezing, extruding, etc.) should be used to characterize a food as ultra-processed?
  • What biological processing steps (i.e., yeasts, enzymatic treatments, etc.) should be used to characterize a food as ultra-processed?
  • What chemical processing steps (i.e., pH adjustments, etc.) should be used to characterize a food as ultra-processed?
  • Are there other processing-related criteria that should or should not be used in defining a food as ultra-processed?
• Terminology:
  • Is “ultra-processed” the most appropriate term for these products or would another term better capture the concerns associated with these products?
• Nutrient Content:
  • Should the nutrient composition of a food be incorporated in a definition of UPF?
  • Are there other attributes, such as energy density or palatability, that should be used to characterize a food as ultra-processed?
• Integrated Approach:
  • Should the UPF definition incorporate multiple of the factors discussed above?

The RFI asks that commenters provide data and references to support their comments and, if referencing an existing definition, to specifically state which definition this is.

Next Steps

Companies and trade associations should consider commenting on the RFI in order to provide their perspective on a potential definition of UPFs, as well as the reasons why such a definition may not be scientifically valid, and instead, nutrient-based classification systems should be prioritized over processing-based schemes. Comments are due September 23, 2025.⁵ Hogan Lovells stands ready to assist in developing comments on the RFI.

Authored by Veronica Colas and Erin Pannek.

Appendix A. Full RFI Questions

1. What, if any, existing classification systems or policies should we consider in defining UPFs? What are the advantages and challenges in applying these systems (or aspects of them) to classify a food as ultra-processed? What are characteristics that would or would not make a given system (or aspect of the system) particularly suitable for the U.S. food supply? Please provide supporting data and explain your rationale in your response.
2. FDA-required ingredient labeling provides important information to consumers about what is in packaged foods. The ingredient declaration on a food label lists each ingredient by its common or usual name (21 CFR 101.4(a)(1)). This ingredient name sometimes provides information on specific forms of the ingredient used, such as “flour” versus “whole grain flour.” Additionally, ingredients are declared in descending order of predominance by weight (21 CFR 101.4(a)), which may help a consumer determine the relative proportion of whole versus processed ingredients. For certain types of ingredients, such as flavorings, colorings, and chemical preservatives, labeling must also provide the function of the ingredient (see 21 CFR 101.22). The following questions focus on the ingredient list on the labeling of packaged foods.
   1. In considering ingredients that appear toward the beginning of an ingredient list (that is, ingredients that likely form most of a finished food by weight), what types of ingredients (e.g., ingredients that may share a similar composition, function, or purpose) might be used to characterize a food as ultra-processed? Please provide supporting data and explain your rationale in your response.
   2. Ingredients that appear toward the end of an ingredient list may contribute minimally to the overall composition and weight of a finished food (for example, ingredients may sometimes be listed as containing 2% or less by weight of the finished food (21 CFR 101.4(a)(2))). What types of these less prominent ingredients (e.g., ingredients that may share a similar composition, function, or purpose) might be used to characterize a food as ultra-processed? Further, ingredients that function as flavorings are either natural flavors or artificial flavors; colorings are either certified (for instance, “FD&C Red No. 40”) or non-certified (for instance, “colored with beet juice”) (21 CFR 101.22). Should these various types of flavors and colors be considered separately when characterizing a food as ultra-processed? Please provide supporting data and explain your rationale in your response.
   3. To what etent, if any, should the relative amount of an ingredient used in a food influence whether the food should be characterized as ultra-processed? Please provide supporting data and explain your rationale in your response.
   4. What, if any, other ingredients or ingredient-related criteria not discussed previously should or should not be used to characterize a food as ultra-processed? Please provide supporting data and explain your rationale in your response.
3. FDA defines “manufacturing/processing,” in part, to mean making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients (21 CFR 117.3; see also 21 U.S.C. 321(gg) for the statutory definition of “processed food”). Certain FDA regulations, such as standards of identity, may prescribe methods of production or formulation (see, e.g., 21 CFR Part 133). Processing of a food is often achieved by a combination of physical, biological, and chemical methods; however, while processing information is sometimes found on food labeling, manufacturers are not always required to disclose processing information on food labeling. The following questions focus on the processing of an ingredient or a mixture of ingredients into the finished food and whether certain processing methods may contribute to a food being considered ultra-processed.
   1. Processing a food through physical means may include cutting, extracting juice by an application of force, heating, freezing, extrusion, and other physical manipulations. What physical processes might be used to characterize a food as ultra-processed? Please provide supporting data and explain your rationale in your response.
   2. Processing a food through biological means may include non-alcoholic fermentations of the food by microorganisms (for example, bacteria and yeasts), enzymatic treatment, and other biological manipulations. What biological processes might be used to characterize a food as ultra-processed? Please provide supporting data and explain your rationale in your response.
   3. Processing a food through chemical means may include pH adjustment and other chemical manipulations. What chemical processes might be used to characterize a food as ultra-processed? Please provide supporting data and explain your rationale in your response.
   4. What, if any, other processing-related techniques should or should not be used to characterize a food as ultra-processed? Please provide supporting data and explain your rationale in your response.
4. Is the term “ultra-processed” the best term to use, or is there other terminology that would better capture the concerns associated with these products? If there is another term to consider, please name and define that term and provide specific scenarios and citations (if available) to support its use.
5. FDA and USDA are aware of ongoing research on nutrition and other attributes relating to the health outcomes associated with consumption of UPFs. As noted in the background, FDA is also initiating a joint effort with NIH to answer questions such as how and why UPFs can harm people’s health.
   1. In considering nutritional attributes (such as information presented on the Nutrition Facts label), to what extent, if any, and how, should nutritional composition or the presence of certain nutrients be incorporated in a definition of UPFs? Please provide supporting data and explain your rationale in your response.
   2. What other attributes, such as energy density or palatability, might be used to characterize a food as ultra-processed? Please provide supporting data and explain your rationale in your response. If relevant to your answer, please also provide suggestions on how these attributes can be measured and/or potentially be incorporated into a definition of UPFs, if they are not readily apparent on the food labeling.
6. FDA and USDA are exploring whether and how to incorporate various factors, such as the ones discussed in the questions above, into a uniform definition of UPFs. How might these factors be integrated in the classification of a food as ultra-processed in a way that can be systematically measured and applied to foods sold in the U.S.? And what considerations should be taken into account in incorporating such a classification in food and nutrition policies and programs?