Photo by Brittani Burns on Unsplash
On August 10, the Department of Health and Human Services (HHS) announced two new food proposals. The first is a proposed FDA rule requiring manufacturers to notify the agency every time they decide an ingredient is Generally Recognized as Safe (GRAS). The second is the federal government’s first definition of “ultra-processed food,” submitted to the Office of Management and Budget (OMB) by HHS and the U.S. Department of Agriculture (USDA).
Despite being rolled out as separate initiatives, they work as one. The GRAS proposal builds an ingredient-level reporting regime across the entire food supply. The proposed definition of UPFs creates the category that system will eventually police.
While the proposed GRAS rule buries manufacturers in filings for ingredients that have been safe for decades, the UPF definition will tell shoppers that 70 percent of their grocery cart is “dangerous” without the science to back it up. The result will be higher prices, more litigation, and more signs of the nanny state in the grocery aisle.
Mandatory GRAS Filing Would Create Reporting Regime, Overstep FDA Authority, and Raise Grocery Costs
Congress deliberately created the GRAS pathway in the 1958 Food Additives Amendment. Substances with a long record of safe use – like salt, vinegar, baking soda, and thousands of ingredients since – were never supposed to run the full premarket approval gauntlet designed for novel chemical additives. FDA formalized a voluntary notification program in 2016 and has operated it that way ever since.
The proposed rule converts that voluntary system into a mandatory filing requirement and adds a retroactive piece, creating a limited window for manufacturers to file GRAS conclusions already in commercial use. Nearly every packaged food in the country would need a new filing for decisions that broke no rules when they were made.
This raises a basic question of authority. Requiring every GRAS conclusion to pass through the FDA rebuilds a version of the process Congress chose not to impose. Agencies do not get to narrow a statutory exemption by regulation, and courts have grown far less willing to assume they can.
Next, every mandatory notification requires toxicology reviews, regulatory counsel, and staff time on the company side and on the agency side. These additional burdens will inevitably raise grocery prices. This is especially concerning at a time when Americans name affordability, especially regarding grocery costs, as their top concern.
Large multinationals already have armies of lawyers and regulatory affairs professionals built for this. Small ingredient suppliers, regional manufacturers, and specialty producers, however, do not. They will either swallow costs they cannot pass along or leave the business altogether.
Fewer suppliers mean less competition. The rule therefore raises prices twice: once through compliance costs, and again through the consolidation those costs produce.
A Federal UPF Definition Would Mislabel Most of the Grocery Store
There simply isn’t enough settled science to responsibly create a federal classification for ultra-processed foods.
Processing is not a nutritional property. It describes how a food was made, not what it does in the body. Yes, most junk food is processed. However, very little of what that tells you is useful, because so is most of the food that keeps American families fed.
Existing evidence does not show that the degree of processing, on its own, determines whether a food is healthy. The NOVA framework most often cited in this debate was built as a research tool, not a regulatory standard. Observational studies linking higher ultra-processed food intake to worse outcomes do not prove causation.
The usual confounders compound the problem. People who eat diets rich in whole foods tend to have more money, more time, healthier habits, and exercise more. The deeper issue, though, is the overbroad category itself. Under the frameworks most often cited in this debate, “ultra-processed” covers anything from whole wheat bread and infant formula to Galactic Fruit Gushers and Peeps-flavored Pepsi. When we group these products together, we’re not measuring processing at all.
By FDA’s own estimate, foods commonly called ultra-processed make up roughly 70 percent of packaged grocery goods. The category sweeps in whole-grain breads, yogurts, fortified cereals, and shelf-stable staples that deliver nutrition, convenience, and affordability to working families. These processed but healthful foods are essential to Americans on tight budgets and those managing specific dietary needs.
Changes Will Lead to More Government Regulation and Frivolous Lawsuits
While the white paper definition carries no binding force, once the federal government formally defines “ultra-processed food,” state legislatures, regulators, advocacy groups, and courts will treat that definition as the authoritative benchmark. It will become the ready-made foundation for front-of-package labeling mandates, federal restrictions, school meal and nutrition program exclusions, and state ingredient laws.
The litigation risk is more immediate. Plaintiffs’ attorneys and government litigants have already filed numerous ultra-processed food cases in federal and state court, including a suit recently brought by the San Francisco City Attorney. A government definition creates no new cause of action, but it does hand artful trial lawyers a federal document to wave in front of juries in product-liability and consumer-protection cases.
OMB should reject the definition proposed by HHS and USDA, and HHS should withdraw its proposed GRAS rule. Neither will make Americans healthier, and both will make food more expensive.