FDA and USDA Launch Joint Effort to Create Federal Definition for 'Ultra-Processed Foods'

The U.S. Food and Drug Administration (FDA) and the Department of Agriculture (USDA) have officially launched a joint regulatory effort to establish the first legally binding federal definition of "ultra-processed foods" (UPFs).[1]

The proposed framework, unveiled Monday, marks a historic shift in American nutrition policy. For decades, federal guidelines focused primarily on individual nutrients—advising Americans to limit sodium, sugar, and saturated fat. Now, regulators are targeting the industrial manufacturing processes themselves.[2][5]

The stakes are massive. An estimated 70% of packaged products in the U.S. food supply currently fall under the colloquial umbrella of ultra-processed foods. Furthermore, these highly engineered products account for more than 60% of the daily calories consumed by American children.[1]

Establishing a uniform definition is the critical first step in a broader regulatory cascade. Once codified, this definition will serve as the legal foundation for mandatory front-of-package warning labels and will dictate which products are eligible for the $20 billion National School Lunch Program.[4]

The push for a federal standard follows a year of intense information gathering. In July 2025, the agencies issued a joint Request for Information (RFI) to evaluate how to classify these foods. The resulting framework heavily reflects the broader agenda to combat diet-related chronic diseases championed by federal health officials.[1]

But defining "ultra-processed" in a legally enforceable way is notoriously difficult. Until now, global researchers have largely relied on the "NOVA" classification system, developed by Brazilian scientists in 2009.[3][5]

NOVA categorizes foods into four groups based on the extent of their physical and chemical alteration. Group 4, the ultra-processed category, is defined broadly as industrial formulations made with substances extracted from foods and cosmetic additives designed to enhance palatability.[3]

However, U.S. regulators concluded that NOVA is too ambiguous for federal rulemaking. Critics argue that NOVA groups nutritionally distinct items—like artificially sweetened zero-calorie yogurt and deep-fried cheese snacks—into the same high-risk category simply because both contain industrial emulsifiers or flavorings.[2][3]

To solve this, the FDA and USDA have proposed a novel "two-prong" matrix, heavily inspired by California's landmark AB 1264 legislation passed in late 2025, which banned certain UPFs from state public schools.[4]

Under the proposed federal mechanism, a product is legally classified as a UPF only if it meets two distinct conditions. First, it must contain at least one industrial additive with a defined technical effect—such as artificial colors, non-nutritive sweeteners, emulsifiers, or modified starches that are rarely used in home kitchens.

Second, the product must cross a specific nutritional threshold. This includes deriving more than 10% of its total calories from saturated fat, containing a 1:1 ratio of milligrams of sodium to calories, or exceeding strict limits on added sugars.

This hybrid approach attempts to bridge a fierce debate within the scientific community regarding the true danger of UPFs: Are they harmful because the physical processing destroys the "food matrix," or simply because they are highly palatable vehicles for empty calories?[2][3]

By requiring both an industrial additive and a poor nutrient profile, the agencies are targeting foods that are engineered to be hyper-palatable and easily overconsumed, while sparing minimally processed items that happen to use a preservative for safety.[2][5]

The food industry has mounted a swift defense against the proposal. Trade groups representing major manufacturers argue that the definition demonizes safe, FDA-approved ingredients that are essential for food safety, shelf life, and affordability.[4]

Industry lobbyists warn that stripping emulsifiers and preservatives from the supply chain could drastically increase food waste and raise grocery prices for low-income families who rely on shelf-stable products. They also point out that many fortified foods, including certain infant formulas and plant-based meat alternatives, could be inadvertently caught in the UPF net.[4]

Conversely, public health advocates argue the two-prong test includes too many loopholes. Some researchers warn that manufacturers will simply reformulate their products to sit just below the sodium or sugar thresholds, allowing them to keep using cheap industrial additives while dodging the UPF label entirely.[2][5]

The uncertainty surrounding the exact health mechanisms of UPFs remains a sticking point. While observational studies consistently link high UPF consumption to cardiovascular disease, obesity, and type 2 diabetes, randomized controlled trials isolating the exact biological cause are still ongoing.[2][3]

To address these gaps, the FDA and the National Institutes of Health (NIH) are currently funding a joint Nutrition Regulatory Science Program to study the metabolic effects of specific food processing techniques and how they alter human digestion.

The proposed definition now enters a mandatory 90-day public comment period. If finalized, the food industry will face a multi-year compliance window to either reformulate thousands of products or accept the new regulatory reality of warning labels and restricted market access.[1][4]