FDA and USDA Look to Define “Ultra-Processed Foods”: What You Need to Know

Client Alert  |  July 30, 2025

Gibson Dunn is closely monitoring developments and is prepared to help companies consider and address the implications of the agencies’ request for information, including through regulatory counseling, preparing comments in response, agency and legislative engagement, and litigation.

On July 25, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) published in the Federal Register a request for information (RFI) seeking public input on a definition of “ultra-processed foods” (UPFs) (the “UPF RFI”).[1] The UPF RFI represents a significant opportunity for affected parties to shape food policy and regulation. Comments on the UPF RFI are due by September 23, 2025, and should be submitted to Docket No. FDA-2025-N-1793. A formalized, federal definition of UPF has the potential to have far-reaching impacts, not just on food regulation, but on government programs, on how consumers approach nutrition, and more.

Key features of the UPF RFI include:

  • Reference to Existing UPF Definitions but Open to Alternatives: FDA and USDA note that there is no single uniform definition for UPFs but acknowledge various existing definitions. The UPF RFI highlights as the most common classification the Nova system, which identifies UPFs based on factors including “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.”[2] However, the UPF RFI acknowledges that a number of states and third parties have taken different approaches, including by defining UPFs as foods that: (1) include substances with certain intended effects, such as stabilizers, thickeners, and coloring or flavoring agents; (2) have undergone certain processing steps, such as hydrogenation of oils or hydrolysis of proteins; or, (3) contain one or more specified ingredients.[3] The agencies note that existing UPF classification systems may not be able to fully capture the characteristics of UPFs that impact health. For example, some foods classified as UPFs under existing frameworks may include foods considered beneficial to health and recommended as part of healthy dietary patterns, such as whole grain products and yogurt. Accordingly, the UPF RFI opens the door for interested parties to propose an alternate pathway for the agencies to define the term “UPF.” Indeed, the agencies seek input on whether an alternative to the term “ultra-processed” is appropriate.[4]
  • A Multi-Faceted Approach to Defining UPF: The UPF RFI requests inputs on a broad, diverse set of factors for potential inclusion in a UPF definition. This request could foreshadow a complex regulatory regime determining what foods are UPFs, and what requirements apply to both UPFs and foods that do not fall within the category.
    • Food ingredients: The agencies seek input on both ingredients that form significant part of finished foods by weight and that minimally contribute to their composition (including those listed as consisting of 2% or less of the food), as well as on whether the relative amounts of ingredients within a food should impact whether it is characterized as a UPF. The UPF RFI also asks whether a UPF definition should incorporate, and distinguish between, “certified” food colorings that are synthetically produced and “non-certified” food colorings that generally include dyes and pigments from natural sources.[5]
    • Food processing steps: Specific food processing steps may also impact whether a food is considered a UPF. In particular, the agencies request feedback on what physical (e.g., cutting, extraction, heating, freezing, extrusion), biological (e.g., non-alcoholic fermentation, enzymatic treatment), and chemical (e.g., pH adjustment) manipulations to food and food ingredients should or should not be incorporated into a UPF definition.[6]
    • Nutritional and other attributes of food: FDA and USDA also seek input on other characteristics of food that might be relevant to whether it is a UPF. These include nutritional attributes, including information on the Nutrition Facts label, and other attributes, such as energy density and palatability.[7]
  • Broad Implications at FDA, USDA, and Beyond: The implications of a formalized, federal definition of UPF will be significant, both for members of the food industry that seek to ensure that their products are not considered UPFs and for those members of industry whose products fall within the definition. FDA and USDA make clear that the UPF definition is part of the Trump Administration’s approach to combatting preventable diet-related chronic diseases, including cardiovascular diseases and type 2 diabetes, which was foreshadowed in the May 2025 report of the Make America Healthy Again (MAHA) Committee (the “MAHA Report”).[8] The Department of Health and Human Services (HHS), which includes FDA, and USDA, as well as other federal and state governmental entities could use the UPF definition in far-reaching ways, such as by:
    • Developing new or modified FDA food labeling and manufacturing requirements;
    • Including recommendations regarding the consumption of UPFs in the Dietary Guidelines for Americans;
    • Limiting types of foods that are eligible the National School Lunch Program (NSLP) and nutrition assistance programs, including the Supplemental Nutrition Assistance Program (SNAP), and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), as well as the National School Lunch Program (NSLP);
    • Shaping research on food and nutrition the federal government conducts and funds; and
    • Including the definition of UPF in federal and state legislation, including legislation on new food labeling requirements, research funding, and limits on government-funded nutrition assistance and school lunch programs.

Interested parties should consider submitting comments to the docket. Gibson Dunn is closely monitoring developments and is prepared to help companies consider and address the implications of the UPF RFI, including through regulatory counseling, preparing comments in response, agency and legislative engagement, and litigation.

[1] 90 Fed. Reg. 35305 (July 25, 2025).

[2] Id. at 35306.

[3] Id. at 35307.

[4] Id. at 35308.

[5] Id. at 35307; see also FDA, “Color Additives in Foods.”

[6] UPF RFI at 35307-08.

[7] Id. at 35308.

[8] UPF RFI at 35306; see also Make America Healthy Again (MAHA) Commission, The MAHA Report: Make Our Children Healthy Again (May 22, 2025) (“MAHA Report”).

The following Gibson Dunn lawyers prepared this update: Katlin McKelvie, Eric Womack, and Carlo Felizardo.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding the issues discussed in this update. Please contact the Gibson Dunn lawyer with whom you usually work, the authors, or any leader or member of the firm’s Consumer Protection or FDA & Health Care practice groups:

Gustav W. Eyler – Washington, D.C. (+1 202.955.8610, geyler@gibsondunn.com)
Katlin McKelvie – Washington, D.C. (+1 202.955.8526, kmckelvie@gibsondunn.com)
John D. W. Partridge – Denver (+1 303.298.5931, jpartridge@gibsondunn.com)
Jonathan M. Phillips – Washington, D.C. (+1 202.887.3546, jphillips@gibsondunn.com)
Eric Womack – Washington, D.C. (+1 202.887.3528, ewomack@gibsondunn.com)
Carlo Felizardo – Washington, D.C. (+1 202.955.8278, cfelizardo@gibsondunn.com)

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