The US Department of Health and Human Services has moved to tighten federal oversight of how food manufacturers introduce new ingredients to the market, closing a long-standing regulatory loophole while stopping short of defining “ultra-processed foods.”
The Food and Drug Administration’s proposed rule targets the process by which companies self-certify certain additives as “generally recognized as safe,” or GRAS — a designation that has allowed thousands of ingredients to enter the food supply without direct agency review. Under the current system, manufacturers can determine an ingredient is safe and bring it to market without notifying regulators, leaving the FDA with limited visibility into what Americans consume.
The announcement comes amid mounting food safety concerns and one of the largest foodborne illness outbreaks in recent memory, intensifying scrutiny of the agency’s ability to monitor the ingredient pipeline.
Despite earlier pledges to reform food regulation dramatically, the administration did not deliver a formal definition of ultra-processed foods, a commitment made earlier this year. Officials said more details would follow at a later date, drawing criticism that the changes fall short of promised action.
The GRAS pathway has long been a focal point for food-policy advocates, who argue that self-certification has allowed additives to reach consumers with insufficient oversight. Closing the loophole would require companies to notify the FDA before marketing new ingredients, giving regulators a clearer picture of what enters the supply chain.
The push forms part of a broader effort to overhaul US food standards. Researchers have increasingly linked heavily processed products to poor health outcomes, and new methods for measuring dietary intake have added urgency to calls for clearer labelling and classification standards.
The absence of an ultra-processed foods definition remains a sticking point. Without a formal standard, agencies face difficulty setting targeted policies, from school nutrition guidelines to public health campaigns. Critics contend that repeated delays undercut the administration’s stated goal of reshaping the American diet.
The proposed ingredient rule will now enter a public comment period before it can be finalized. Officials have signalled that further measures addressing ultra-processed foods will be introduced separately, though no timeline has been confirmed.