The US Food and Drug Administration (FDA) is proposing changes to its rules regarding how food manufacturers notify them about ingredients introduced to the market. The proposed rule, submitted to the Federal Register on Monday, would require companies to submit all ingredients in foods brought to market under the Generally Recognized As Safe (Gras) pathway.
This move aims to close a regulatory loophole that previously allowed food companies to use ingredients deemed safe through scientific research or common use without mandatory notification. Kyle Diamantas, acting commissioner of the FDA, stated that if finalised, this rule would transition the Gras framework from a voluntary programme to a mandatory notification system, applying to both existing and new ingredients.
However, the Trump administration has again postponed defining "ultra-processed foods," a commitment made earlier this year. Robert F Kennedy Jr, secretary of the US Department of Health and Human Services (HHS), had previously promised a definition by April. Diamantas noted on Monday that a proposed definition has been submitted by the HHS and the US Department of Agriculture, aimed at future federal nutrition research, with more information to be shared later.
Marion Nestle, professor emerita of nutrition, food studies, and public health at New York University, questioned the delay in closing the loophole and the absence of the ultra-processed foods definition. Amaru Sanchez, a food and agriculture lawyer, highlighted that this proposed rule is a significant development for the food industry, potentially causing ripple effects across the food system. Sanchez also raised questions about the FDA's regulatory authority to mandate such a notification system.
The US is currently experiencing one of its largest recorded foodborne illness outbreaks, with over 10,000 confirmed cases of cyclosporiasis, alongside a salmonella outbreak in eggs and jalapeños.