FDA Proposes New Rule for Food Companies to Provide More Ingredient Information
The FDA has proposed a new rule that would require food companies to provide more information on new ingredients before they enter the food supply. This rule aims to address a loophole in the current system and has become a priority for Health and Human Services Secretary Robert F. Kennedy Jr. and the Make America Healthy Movement.
Under the proposed rule, food companies would need to submit data for ingredients that are self-affirmed as safe under the Generally Recognized as Safe (GRAS) framework. This framework allows companies to bypass premarket review for certain chemicals or additives if they are considered safe by qualified experts.
While companies can self-affirm the safety of their products under GRAS, the FDA lacks a complete inventory of substances in the food supply. The new rule would shift to a mandatory notification system, requiring all manufacturers introducing new ingredients to provide safety information to the FDA.
Companies that have previously petitioned the FDA for GRAS approval and received a “no safety questions” determination would be exempt from the rule. Safety information provided by companies would be made available in public online inventories to ensure greater transparency for consumers.
The FDA introduced the self-affirmation pathway in 1997 to streamline the process of determining ingredient safety. Under the new rule, the FDA would have to make a pre-filing decision within 45 days and a safety determination within 180 days.
There are uncertainties regarding the FDA’s authority to require GRAS notifications, but the agency is working with Congress on legislative options to address this issue. The proposed rule is open for public comment for 120 days, and more information on ultra-processed foods is expected to be shared in the future.