FDA’s proposed definition for ultra-processed food is awaiting review at the Office of Budget and Management, but it isn’t a proposed rule as many anticipated and the Trump administration originally signaled – it is a white paper.
The difference between a rule and white paper is as significant as the agency’s – notably solo – submission to OMB, and it could have a ripple effect across other pending food regulations.
On Aug. 3, OMB’s Office of Information and Regulatory Affairs received FDA’s “White Paper: Proposed Definition of Ultra Processed Food,” which is characterized as a notice and not economically significant – two signals that the document may not have the impact once anticipated.
As a white paper, the document is not legally binding and does not preempt any state level activity underway, such as California’s Assembly Bill 1264 passed last September, which defined UPF as a food or beverage with at least one functional ingredient, such as a dye, emulsifier or flavor enhancer; “high amounts” of saturated fat, sodium or added sugar, or a nonnutritive sweetener.
The submission of a white paper rather than a proposed rule suggests FDA is presenting its current thinking rather than a finalized regulatory position. It also could indicate the agency is still seeking interagency coordination, evaluating policy options, building consensus around the definition or deciding how it ultimately will use the definition. That might include labeling regulations, guidance, procurement standards or another policy vehicle.
A proposed rule, on the other hand, would need to be published in the Federal Register, explain legal authority and solicit public comment with the goal of creating an enforceable final rule - a process that could take years.
A nonbinding definition with broad implications
While a white paper lacks the force of law that a rule would have, it still “will shape the national food and nutrition conversation and likely influence the wave of state-level activity already under way,” Stephanie Simms Hodges, a nutrition policy consultant with The Nourished Principles, said in a LinkedIn post.
It also could provide the administration with a powerful mechanism to encourage voluntary industry action without the years-long rulemaking process required to establish mandatory regulations.
Indeed, HHS Secretary Robert F Kennedy Jr has shown a preference for securing voluntary industry commitments rather than relying on the slower, traditional rulemaking process, which requires formal notice-and-comment procedures. His campaign to remove synthetic food dyes illustrates the approach. Rather than proposing an immediate ban, he announced an “understanding” with consumer-packaged goods manufacturers to phase synthetic dyes out of their products over the coming years.
A white paper could give Kennedy and the FDA a similar opportunity with ultra-processed foods. While a definition would not be legally binding, it could establish a federal reference point that shapes public perception, informs state policymaking and provides plaintiffs, advocates, retailers and manufacturers with a common framework for evaluating products. Faced with shifting consumer sentiment or reputational risk, some companies could choose to reformulate products or reduce their reliance on ingredients associated with ultra-processed foods, even without a federal mandate.
The decision to move forward with a white paper rather than a proposed rule for now also allows the FDA to more quickly publish its definition, which it took on last summer when it issued a request for information along with the USDA.
White paper could influence FDA’s front-of-pack labeling plans
The white paper also could have significant implications for FDA’s regulatory agenda, including the agency’s pending front-of-pack nutrition labeling proposal, which Kennedy suggested could eventually incorporate an ultra-processed food designation.
A finalized federal definition would provide the foundation for identifying which products qualify for any UPF-related label claim or symbol.
Under the Biden administration, FDA proposed a front-of-pack Nutrition Info box that would quantify and qualify the percent daily value of select nutrients of concern with the goal of helping consumers more easily make informed dietary choices and incentivize food companies to make healthier products.
However, Kennedy signaled earlier this year that he would prefer a stoplight labeling model and potentially an insignia if a product qualified as a UPF under a shared definition.
The white paper could bring the administration closer to that idea by establishing the framework needed to identify which foods qualify as ultra-processed.
However, adding those elements to the proposal now could present legal hurdles.
Under the Administrative Procedure Act, agencies generally must issue a supplemental notice of proposed rulemaking if the final rule is not a “logical outgrowth” of what was originally proposed, explained Amaru Sanchez, an attorney at Akin Gump Strauss Hauer & Feld, in a LinkedIn post.
“It would be tough to argue that layering an additional icon/color scheme – and potentially a UPF label claim – onto the current front-of-pack proposed rule would constitute a logical outgrowth,” he argued, explaining: “The original PR proposed a black-and-white text box with “low/medium/high” descriptors – not a color-coded warning system, and certainly not a UPF-specific claim.”
He added: “That is a fundamentally different labeling paradigm.”
If FDA ultimately pursues that approach, it may need to issue a supplemental proposed rule to give stakeholders an opportunity to comment before finalizing the policy.
