The FDA proposed mandatory notice for new food additives in processed and packaged foods.
Why it matters: The move would tighten oversight of ingredients long covered by the GRAS pathway and could affect product launches, labeling and compliance across the food industry. It also sets up a fight over how much evidence companies must provide before adding new substances to foods.
- The proposal would require food manufacturers to notify regulators before introducing new ingredients or additives.
- The FDA says it would replace the current system that lets companies self-determine a substance is generally recognized as safe, or GRAS, without notifying the agency.
- FDA Commissioner Marty Makary said Americans want the agency to take a fresh look at chemical additives in the food supply.
- FDA says it will take comments on the proposal for 120 days.
U.S. health officials on Aug. 10 proposed a rule that would require food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods, according to AP.
The FDA said the change would replace the current system in which companies can decide for themselves that a substance is generally recognized as safe, or GRAS, without notifying the agency or submitting evidence. The agency's current GRAS framework says any intentionally added substance is a food additive subject to premarket review unless it is GRAS under the conditions of intended use or otherwise exempted by law, and its notification program has been voluntary since a 2016 final rule formalized the process.
The proposal fits into the FDA's 2026 Human Foods Program priorities, which say the agency will publish a proposed regulation requiring submission of GRAS notices for all new substances claimed to be GRAS. The agency also says it is developing a federal definition of ultra-processed food in 2026.
Acting FDA Commissioner Kyle Diamantas said, "Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety." Makary said, "Americans want the FDA to take a fresh look at some of the chemical additives that have become widespread in our food supply."
The move is framed as a transparency and post-market safety measure, not an immediate ban on existing ingredients. FDA's 2026 agenda also includes post-market reassessments of chemicals such as BHA, BHT, phthalates and propylparaben, and the agency separately finalized a post-market assessment program and launched reassessments of BHT and ADA this year.
The Center for Science in the Public Interest has called the current system a "secret GRAS loophole."
By the numbers
- 120 days - FDA will take comments on the proposal
- 1958 - the food additive framework dates to the Food Additive Amendments
- 2016 - FDA formalized the GRAS notification procedure in a final rule
Yes, but: The proposal does not immediately ban existing ingredients, and the FDA has not yet published the underlying rule text or Federal Register notice in the materials provided.
What's next: FDA will take public comments for 120 days. The agency also says it plans to publish a proposed GRAS regulation as part of its 2026 priorities.