The U.S. Food and Drug Administration (FDA) can’t regulate what it can’t define. While researchers track associations between ultra-processed foods (UPFs) and health outcomes, the agency needs clear definitions and causal proof to act. This gap between nutritional research and regulatory authority shapes FDA decisions about modern food products, from labeling rules to safety assessments.

The Architecture of Inaction

The FDA’s new “healthy” labeling rule, effective February 2025, reveals how regulatory frameworks lag behind food technology. The rule specifies that products must “contain a certain amount of food from at least one of the food groups or subgroups… recommended by the Dietary Guidelines” (FDA, 2024). It tightens limits on sodium and added sugars. Yet nowhere does it mention processing levels, the very characteristic that distinguishes a fresh apple from apple-flavored breakfast cereal.

This omission isn’t an oversight. It’s structural. The FDA regulates based on what it can measure and legally define: nutrients, not processing methods. When researchers classify foods using NOVA criteria as “formulations of ingredients, mostly of exclusive industrial use, typically created by series of industrial techniques and processes” (Monteiro et al., 2019), they’re using language that works in academic papers but fails in regulatory documents. What exactly constitutes “industrial use”? How many “techniques and processes” transform food from minimally processed to ultra-processed? The law demands precision that processing classifications can’t provide.

GRAS: When Yesterday’s Solution Becomes Today’s Problem

The Generally Recognized As Safe (GRAS) system exemplifies how regulatory frameworks designed for one era struggle in another. Created in 1958 when food additives meant simple preservatives, GRAS now governs thousands of complex substances—emulsifiers that alter gut bacteria, synthetic flavors that bypass satiety signals, novel sweeteners with unknown metabolic effects.

Under GRAS, manufacturers self-certify safety. They decide what’s “generally recognized” as safe based on their own assessments. For individual additives in isolation, this might work. But UPFs contain intricate combinations of GRAS substances that have never been tested together. The system assumes additives act independently, an assumption that modern food science increasingly questions.

The Causation Conundrum

Recent research illustrates the FDA’s dilemma. Lane et al.’s (2024) comprehensive review found “ultra-processed food exposure… was associated with 32 health parameters spanning mortality, cancer, and mental, respiratory, cardiovascular, gastrointestinal, and metabolic health outcomes.” Association, not causation. That single word – “associated” – represents the gulf between research findings and regulatory action.

The FDA cannot restrict products based on associations, no matter how consistent. It needs proof of causation, the kind typically established through randomized controlled trials. But imagine recruiting thousands of people to eat only ultra-processed foods for years while a control group avoids them entirely. The ethical and practical barriers make such studies impossible. This leaves regulators trapped: they can’t get the evidence they need through methods they can use.

Innovation Outpaces Regulation

Food technology advances exponentially while regulatory frameworks inch forward. Today’s UPFs employ sophisticated techniques (protein isolation, chemical modification, nano-encapsulation, etc.) that didn’t exist when current regulations were written. A protein bar might contain dozens of ingredients that wouldn’t exist without industrial processing, yet each component meets existing safety standards.

The mismatch grows yearly. By the time FDA completes rulemaking for one issue, industry has developed new technologies that sidestep those rules entirely. It’s not cat-and-mouse; it’s horse-and-buggy chasing a Tesla.

Conclusion

The FDA’s struggle with UPFs epitomizes how regulatory systems designed for simple problems fail when confronting complex ones. Without legal definitions for processing, causal evidence for harm, or frameworks that match food technology’s pace, the agency will continue to struggle to keep up.

Breaking this cycle requires reimagining evidence standards for population-level risks, creating legal definitions for modern food categories, or accepting that some public health decisions must proceed with uncertainty.

References

Lane, M. M., Gamage, E., Du, S., Ashtree, D. N., McGuinness, A. J., Gauci, S., et al. (2024). Ultra-processed food exposure and adverse health outcomes: Umbrella review of epidemiological meta-analyses. BMJ, 384, e077310.

Monteiro, C. A., Cannon, G., Moubarac, J.-C., Levy, R. B., Louzada, M. L., & Jaime, P. C. (2019). Ultra-processed foods: What they are and how to identify them. Public Health Nutrition, 22(5), 936–941.

U.S. Food and Drug Administration (FDA). (2024). Food labeling: Nutrient content claims; Definition of term “healthy.” Federal Register, 89(249), 93629–93659.