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FDA Sends Ultra-Processed Food Definition to OMB — But Not as a Rule

White paper signals progress, but its reach and legal force remain unclear

Analysis  ·  August 4, 2026

The Food and Drug Administration (FDA) has formally moved its proposed definition of ultra-processed food into White House review, marking the clearest indication yet that the Trump administration has advanced beyond gathering information and is preparing to publish a federal framework. The Office of Information and Regulatory Affairs received FDA’s “White Paper: Proposed Definition of Ultra-Processed Food” on Aug. 3. The submission, assigned RIN 0910-ZD60, is classified as a notice, carries no legal deadline and is not designated economically significant.

The procedural details are important 

FDA did not submit a proposed rule, advance notice of proposed rulemaking or formal guidance document. A white paper can establish the administration’s scientific and policy position, shape later regulatory actions and provide a common reference for federal agencies, states and researchers. But publication of the paper would not, by itself, impose new labeling, formulation or sales requirements on food manufacturers.

That makes the submission an important milestone, but not the finish line.

From a joint FDA/USDA Effort to an FDA-only document 

FDA and USDA began the process jointly in July 2025, requesting public information to help create a uniform definition for food products in the U.S. supply. The agencies emphasized that no universally accepted definition exists and asked whether a federal standard should consider ingredients, manufacturing techniques, nutrient composition, energy density, palatability and other measurable characteristics. They also warned that an overly broad definition could classify some whole-grain products and yogurts as ultra-processed even though those foods may contribute to healthy dietary patterns.

FDA’s own 2026 priorities continued to describe the definition as a collaborative effort involving USDA and other federal partners. The fact that the document now under OMB review is listed only under HHS and FDA is therefore notable, although it does not necessarily mean USDA has been excluded from its development. FDA may simply be serving as the lead drafting agency.

Still, USDA participation eventually will be essential if the administration wants a genuinely government-wide standard. FDA regulates most foods sold in interstate commerce, while USDA oversees traditional meat, poultry and certain processed egg products. USDA also administers school meals and other nutrition programs that could eventually use a UPF definition in purchasing or eligibility standards. Without coordination, similar products could be treated differently depending on which agency has jurisdiction.

Why the white paper format matters

The choice of a white paper gives the administration flexibility. FDA can publish its preferred definition relatively quickly, use it to guide research and policy development and then determine which applications require formal rulemaking.

It also avoids immediately answering harder legal and economic questions. A binding front-of-package label, mandatory disclosure, product restriction or federal procurement requirement would generally require additional agency action, including a proposal, public comments and an explanation of FDA’s statutory authority.

The new RIN has not been published in the Unified Regulatory Agenda, further indicating that this is not yet being handled as a conventional rulemaking. The omission could mean the action was developed after the agenda was assembled, but it also reinforces the likelihood that the administration views the white paper primarily as a policy foundation for later actions.

HHS Secretary Robert F. Kennedy Jr. has repeatedly linked the definition to broader food-labeling policy. In June, he said the administration had completed a definition, that it was at OMB and that publication was expected within months. He also said the definition could serve as the basis for a red-yellow-green front-of-package labeling system.

That suggests the white paper may be only the first step in a broader sequence: First, define ultra-processed foods. Then, determine how the classification should appear on labels, influence federal nutrition programs or guide restrictions on certain products.

Figure 1. From joint information-gathering to White House review: the ultra-processed food definition’s path so far and the steps that remain. Source: OIRA/RegInfo.gov filings, FDA-USDA request for information, HHS statements.

The definition could be broad, narrow or hybrid

The biggest unresolved question is whether FDA will focus on how food is made, what ingredients it contains or its nutritional profile.

A processing-based approach modeled closely on the Nova classification system could sweep in a large range of packaged foods, including fortified breads, breakfast cereals, flavored dairy products, meat alternatives and shelf-stable meals. Such an approach would face criticism for treating processing itself as the problem, even when a product has favorable nutrient content.

An ingredient-based definition could focus more narrowly on substances such as certain flavors, colors, emulsifiers, stabilizers, sweeteners, protein isolates or modified starches. That would be easier to apply from an ingredient label but could produce arbitrary results when an ingredient is present only in a small quantity or serves a legitimate safety or nutritional function.

A nutrient-based definition would concentrate on added sugar, sodium, saturated fat or energy density. However, that approach risks becoming little more than another nutrient-profile standard rather than a true definition of ultra-processing.

The FDA/USDA request for information examined all three approaches and repeatedly asked how they could be integrated into a system that is measurable and consistently applied. That makes a hybrid definition the most plausible outcome: an initial screen based on industrial ingredients or processing methods, followed by nutritional criteria and exemptions for foods recognized as beneficial. That is an inference from the questions the agencies asked, not yet a confirmed feature of the white paper.
 

Table 1. Three ways FDA could define “ultra-processed” — and the hybrid outcome the agencies’ own questions point toward. Source: FDA-USDA request for information (July 2025).

Potential effects on agriculture and food companies

The immediate impact on farmers and commodity markets would be limited because the white paper itself would not regulate products. The longer-term consequences could be substantial if the definition is incorporated into labeling, school-meal purchasing, federal nutrition assistance, marketing restrictions or state laws.

A broad definition could pressure food companies to reformulate products and reduce their use of refined sweeteners, starches, oils, flavor systems and other manufactured ingredients. That could affect demand for corn-based sweeteners, soybean and dairy ingredients, wheat-based additives and products containing processed meat.

Meanwhile, minimally processed fruits, vegetables, grains, dairy products and animal proteins could benefit from stronger “real food” marketing and changes in consumer purchasing.

Table 2. Where the pressure and the opportunity would fall if a broad definition is adopted and later embedded in labeling, procurement or nutrition programs. Source: analysis of FDA-USDA docket and market exposure.

The outcome will vary sharply by product. A definition that includes explicit exemptions for nutrient-dense foods could protect items such as whole-grain bread, fortified cereal and yogurt. A rigid processing test could place those products in the same category as candy, soft drinks and salty snacks — the result FDA and USDA cautioned against in their original request.

A federal definition also could influence litigation and state regulation even before federal mandates are issued. States have considered significantly different UPF definitions, ranging from lists of designated additives to specified processing methods. A federal white paper could become a powerful benchmark, but because it is not a regulation, it may not preempt conflicting state requirements.

OMB meetings will be an early signal

As of Aug. 4, OIRA’s public database showed no outside meetings scheduled on the FDA white paper. That could change quickly as food manufacturers, commodity organizations, consumer groups, nutrition researchers and state officials seek to influence the final document.

OIRA publicly discloses the participants, subject matter and written materials associated with meetings requested by outside parties. The number of meetings will provide one measure of stakeholder concern, but their substance will be more revealing: whether participants focus on scientific validity, agency jurisdiction, effects on farmers, labeling costs, healthy-food exemptions or potential litigation.

OIRA reviews generally are limited to 90 days, although the review can be extended and the FDA submission has no legal deadline. That means publication could come relatively quickly, but there is no guaranteed completion date.

Bottom line

The OMB submission shows that the administration has moved the ultra-processed food debate from an open-ended information-gathering exercise to a specific proposed federal definition.

But the FDA-only authorship, the white paper format and the absence of the action from the regulatory agenda leave several major issues unresolved. The document may establish an influential federal benchmark, but the consequential decisions — labeling, procurement, nutrition-program restrictions, enforcement and coordination with USDA — will require additional steps.

For agriculture and the food industry, the central issue is no longer whether the federal government will define ultra-processed food. It is how broad that definition will be, which products will be exempted and how aggressively the administration will use it once it is published.

Sources: OIRA/RegInfo.gov submission records (RIN 0910-ZD60); FDA-USDA Request for Information on ultra-processed foods (July 2025); FDA 2026 priorities; HHS public statements; OIRA meeting-disclosure database, as of Aug. 4, 2026.

AG POLICY & MARKETS DAILY   |   FOOD POLICY  |  ULTRA-PROCESSED FOODS — TUESDAY, AUGUST 4, 2026