March 12, 2025
In a significant shift aimed at bolstering food safety and consumer trust, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration (FDA) to revise its "Generally Recognized as Safe" (GRAS) rule. This move targets long-standing concerns over the self-affirmation process that allows food companies to introduce new ingredients without public disclosure or FDA oversight.
But what exactly is changing—and how will this affect manufacturers and consumers alike? Below, we break it all down.
What Is the FDA GRAS Rule and Why It Matters for Food Safety
The FDA’s GRAS rule allows food manufacturers to independently determine whether an ingredient is "Generally Recognized as Safe" (GRAS) based on expert consensus. Under the current framework, companies can self-affirm an ingredient's safety without informing the FDA or disclosing the ingredient to the public.
While the FDA has encouraged voluntary notification of GRAS determinations, it is not mandatory. As a result, there is a significant lack of transparency about what new substances may be added to the U.S. food supply. This has raised concerns among consumer advocacy groups and health experts who believe the system needs reform to ensure food ingredient safety.
Why the FDA Is Reforming the GRAS Rule in 2025
In March 2025, Health and Human Services Secretary Robert F. Kennedy Jr. instructed the FDA to revise the GRAS rule. The goal: close the loophole that allows companies to self-affirm the safety of food ingredients without FDA review or public knowledge.
This directive requires companies to notify the FDA and provide safety data before introducing new ingredients into food products. According to Kennedy, this step is essential for restoring public trust in the food system and ensuring that all food additives are subject to regulatory oversight.
How the GRAS Rule Reform Will Impact Food Manufacturers and Ingredient Approval
Under the proposed changes, food companies will no longer be able to self-affirm GRAS status behind closed doors. Instead, they must:
Notify the FDA before marketing foods with new ingredients.
Submit safety data for FDA review.
Publicly disclose information about GRAS determinations.
For manufacturers, this reform introduces new compliance requirements, likely increasing the time and cost associated with bringing new food ingredients to market. However, it also provides a clearer regulatory pathway and greater consumer confidence in product safety.
The Role of Transparency in Food Labeling and Consumer Confidence
In addition to reforming GRAS notifications, the FDA is also considering front-of-package nutrition labeling. These proposed labels would make it easier for consumers to understand what’s in their food at a glance.
Improved transparency can help consumers make more informed choices and drive demand for healthier, safer food products. By requiring disclosure of new ingredients and their safety data, the FDA aims to rebuild trust between consumers, manufacturers, and regulators.
What GRAS Rule Changes Mean for Consumers: Greater Food Ingredient Transparency and Safety
For consumers, the reform means greater visibility into what’s added to the food supply. Instead of hidden additives approved through internal company processes, new ingredients will undergo FDA review and be publicly disclosed.
This change promises to:
Enhance food safety.
Improve consumer confidence.
Hold companies accountable for ingredient safety.
In short, consumers will be better informed and better protected.
Next Steps for Food Companies Under the Revised FDA GRAS Regulations
For food manufacturers and private labelers, now is the time to:
Review existing GRAS determinations to ensure they meet the likely new standards.
Prepare to submit notifications and safety data to the FDA.
Stay updated on FDA guidance regarding front-of-package labeling and GRAS notification procedures.
Companies that proactively align with the proposed changes will be better positioned to maintain consumer trust and regulatory compliance in the evolving U.S. food safety landscape.
Conclusion
The FDA’s proposed reform of the GRAS rule represents a landmark shift in food ingredient oversight. By closing the self-affirmation loophole and increasing transparency, these changes aim to protect public health and strengthen consumer confidence in the U.S. food system.
As the details unfold, food businesses should stay informed and ready to adapt. Regulatory compliance is no longer just a box to check—it’s a key factor in maintaining consumer trust and building a sustainable future in the food industry.
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