On August 10, 2026, the US Department of Health and Human Services and the FDA released a proposed rule that would force food manufacturers to notify the agency every time they decide a new ingredient is safe enough to add to human or animal food.
The 140-page proposal was expected to appear in the Federal Register on August 11. It targets a decades-old loophole that has let companies self-affirm additives as "Generally Recognized as Safe," or GRAS, without alerting regulators or the public.
On the same day, HHS submitted to the White House Office of Management and Budget the first proposed federal definition of ultra-processed foods, developed with the US Department of Agriculture. The specific wording has not been made public.
Officials said the draft draws on responses to a joint FDA-USDA public consultation that closed in October 2025.
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What ultra-processed means for your cart
There is no single official US definition of ultra-processed foods today. Researchers most often use the NOVA framework, which describes them as industrial formulations built from sugar, oils, fats, salt, and substances rarely used in home cooking.
Think packaged sweet snacks, sugary drinks, most breakfast cereals, reconstituted meat products, instant noodles, and many ready meals. A federal definition would give agencies, researchers, and shoppers a single yardstick.
The stakes are large. "Nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than one in five American children," HHS Secretary Robert F. Kennedy Jr. said.
Where the GRAS loophole came from
GRAS itself dates to 1958, when Congress exempted long-familiar ingredients such as salt and vinegar from formal FDA approval. In 1997, the FDA added a voluntary notification pathway after saying it could no longer devote substantial resources to reviewing every new ingredient.
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Companies were then free to convene their own expert panels, decide an additive was safe, and put it on shelves without ever telling regulators.
An Environmental Working Group analysis cited by federal regulators found nearly 99 percent of food chemicals added since 2000 came in through this pathway, often without full health data.
What the new rule would change
Under the proposal, manufacturers would have to send the FDA their safety conclusions when they classify a new ingredient as GRAS. The information would go into a public online inventory that shoppers, researchers, and journalists could search.
A streamlined process would cover substances already on the market. Failing to notify the agency would count against a manufacturer when the FDA prioritizes ingredients for post-market review.
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The proposed rule is open for public comment for 120 days.
Praise, pushback, and open questions
Consumer groups called the rule overdue but incomplete. Peter Lurie, president of the Center for Science in the Public Interest, said the plan will need to be strengthened, noting that companies can still market ingredients before the FDA reviews the notification.
Melanie Benesh of the Environmental Working Group said the change is urgent but does not go far enough. She argued that "true GRAS reform requires...strong, science-based safety standards and thorough, independent FDA review" before chemicals reach food.
The food industry pushed back on the ultra-processed definition in particular. The Consumer Brands Association said any definition that sweeps up most of the US food supply lacks a sound scientific foundation and risks confusing shoppers and raising grocery bills.
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The FDA's legal authority to make GRAS notification mandatory is also uncertain following a Supreme Court decision that narrowed federal agency powers. Acting FDA Commissioner Kyle Diamantas said the agency is working with Congress on legislative options.
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