FDA proposes new food ingredient rule, but definition of 'ultra-processed' is delayed

The US Food and Drug Administration (FDA) has proposed a new rule that would require food manufacturers to formally notify the agency of all ingredients used in their products under the Generally Recognized As Safe (Gras) pathway. This move aims to close a long-standing regulatory loophole that has allowed new substances to enter the US food supply without rigorous review.

However, the administration has once again delayed the release of a definition for 'ultra-processed foods,' a highly anticipated announcement that experts say is crucial for transparency in the food system. Marion Nestle, a professor emerita at New York University, expressed frustration, questioning the delay for such a seemingly simple definition.

The proposed rule, submitted to the Federal Register, would transform the Gras framework, established in 1958, from a voluntary system to a mandatory notification process. Kyle Diamantas, acting commissioner of the FDA, stated on a press call that this change would apply to both existing and new ingredients.

Amaru Sanchez, a food and agriculture lawyer, described the proposal as a significant development for the food industry, though he raised questions about the FDA's regulatory authority to mandate such notifications, especially in light of recent legal decisions. The FDA also plans to release new guidance on biological hazards in ready-to-eat fresh-cut produce.

Experts like Nestle noted that while mandatory notification is an improvement, companies would still be responsible for proving the safety of their ingredients, and the FDA would face increased strain in reviewing these submissions. The agency has yet to clarify the process for when it rejects a company's safety proof. The delay in defining 'ultra-processed foods' comes amid ongoing large-scale foodborne illness outbreaks in the US, including cyclosporiasis and salmonella.